SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 20-F
   
o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
   
þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 20082010
OR
   
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                    to                    
   
o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report
Commission file number: 0-22320
Trinity Biotech plc
(Exact name of Registrant as specified in its charter
and translation of Registrant’s name into English)
Ireland
(Jurisdiction of incorporation or organization)

IDA Business Park, Bray, Co. Wicklow, Ireland
(Address of principal executive offices)
Kevin Tansley
Chief Financial Officer
Tel: +353 1276 9800
Fax: +353 1276 9888
IDA Business Park, Bray, Co. Wicklow, Ireland
(Address of principal executive offices)
Kevin Tansley
Chief Financial Officer
Tel: +353 1276 9800
Fax: +353 1276 9888
IDA Business Park, Bray, Co. Wicklow, Ireland
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
   
Title of each class Name of each exchange on which registered
None None
Securities registered or to be registered pursuant to Section 12(g) of the Act:
American Depositary Shares (each representing 4 ‘A’ Ordinary Shares, par value $0.0109)US$0.0109)
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:None
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report:
82,017,58184,116,865 Class ‘A’ Ordinary Shares and 700,000 Class ‘B’ Shares
(as of December 31, 2008)2010)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yeso Noþ
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Yeso Noþ
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.
Yesþ Noo
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer or a smaller reporting company. See the definitions of “largeand large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
     
Large accelerated filero Accelerated filerþ Non-accelerated fileroSmaller reporting companyo
(Do not check if a smaller reporting company)
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
     
U.S. GAAPo International Financial
Reporting Standards as
issued by
the International Accounting
Accounting Standards Board
þ
 Othero
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow:
Item 17o Item 18o
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yeso Noþ
This Annual Report on Form 20-F is incorporated by reference into our Registration Statements on Form F-3 File No. 333-113091, 333-112568, 333-116537, 333-103033, 333-107363 and 333-114099 and our Registration Statements on Form S-8 File No. 33-76384, 333-220, 333-5532, 333-7762, 333-124384 and 333-124384.333-166590.
 
 

 

 


 

TABLE OF CONTENTS
     
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PART I
     
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  14 
     
  37 
     
  4244 
     
  4446 
     
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  4648 
     
  5659 
     
  5760 
     
PART II
     
  5760 
     
  5860 
     
  5861 
     
  5962 
     
  5962 
     
  5962
62
63 
     
PART III
     
  6063 
     
  6063 
     
  134131 
     
Exhibit 10c
 Exhibit 12.1
 Exhibit 12.2
 Exhibit 13.1
 Exhibit 13.2
 Exhibit 15.1

 

 


General
As used herein, references to “we”, “us”, “Trinity Biotech” or the “Group” in this form 20-F shall mean Trinity Biotech plc and its world-wide subsidiaries, collectively. References to the “Company” in this annual report shall mean Trinity Biotech plc.
Our financial statements are presented in US Dollars and are prepared in accordance with International Financial Reporting Standards (“IFRS”) both as issued by the International Accounting Standards Board (“IASB”) and as subsequently adopted by the European Union (“EU”). The IFRS applied are those effective for accounting periods beginning on or after 1 January 2007.2010. Consolidated financial statements are required by Irish law to comply with IFRS as adopted by the EU which differ in certain respects from IFRS as issued by the IASB. These differences predominantly relate to the timing of adoption of new standards by the EU. However, as none of the differences are relevant in the context of Trinity Biotech, the consolidated financial statements for the periods presented comply with IFRS both as issued by the IASB and as adopted by the EU. All references in this annual report to “Dollars” and “$” are to US Dollars, and all references to “euro”“Euro” or “€” are to European Union euro.Euro. Except as otherwise stated herein, all monetary amounts in this annual report have been presented in US Dollars. For presentation purposes all financial information, including comparative figures from prior periods, have been stated in round thousands.
Forward-Looking Statements
This Annual Report on Form 20-F contains forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “should” and similar expressions or the negative versions thereof and which also may be identified by their context. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. The Company assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors — please refer to the risk factors in Item 3 for a more comprehensive outline of these risks and the threats which they pose to the Company and its results.
Item 1Identity of Directors, Senior Management and Advisers
Not applicable.
Item 2Offer Statistics and Expected Timetable
Not applicable.
Item 3Selected Consolidated Financial Data
The following selected consolidated financial data of Trinity Biotech as at December 31, 20082010 and 20072009 and for each of the years ended December 31, 2008, 20072010, 2009 and 20062008 have been derived from, and should be read in conjunction with, the audited consolidated financial statements and notes thereto set forth in Item 18 of this annual report. The selected consolidated financial data as at December 31, 2006, 20052008, 2007 and 20042006 and for the years ended December 31, 20052007 and December 31,200431, 2006 are derived from the audited consolidated financial statements not appearing in this Annual Report. This data should be read in conjunction with the financial statements, related notes and other financial information included elsewhere herein.

 

1


CONSOLIDATED STATEMENT OF OPERATIONS DATA
                                        
 Year ended December, 31  Year ended December, 31 
 2008 2007 2006 2005 2004  2010 2009 2008 2007 2006 
 Total Total Total Total Total  Total Total Total Total Total 
 US$’000 US$’000 US$’000 US$’000 US$’000  US$‘000 US$‘000 US$‘000 US$‘000 US$‘000 
 
Revenues
 140,139 143,617 118,674 98,560 80,008  89,635 125,907 140,139 143,617 118,674 
                      
Cost of sales  (77,645)  (75,643)  (62,090)  (51,378)  (40,047)  (45,690)  (68,891)  (77,645)  (75,643)  (62,090)
Cost of sales — restructuring expenses   (953)         (953)  
Cost of sales — inventory write off / provision   (11,772)  (5,800)        (11,772)  (5,800)
                      
Total cost of sales
  (77,645)  (88,368)  (67,890)  (51,378)  (40,047)  (45,690)  (68,891)  (77,645)  (88,368)  (67,890)
 
Gross profit
 62,494 55,249 50,784 47,182 39,961  43,945 57,016 62,494 55,249 50,784 
  
Other operating income 1,173 413 275 161 302  1,616 437 1,173 413 275 
  
Research and development expenses  (7,544)  (6,802)  (6,696)  (6,070)  (4,744)  (4,603)  (7,341)  (7,544)  (6,802)  (6,696)
Research and development — restructuring expenses   (6,907)         (6,907)  
                      
Total research and development expenses
  (7,544)  (13,709)  (6,696)  (6,070)  (4,744)  (4,603)  (7,341)  (7,544)  (13,709)  (6,696)
            
 
Selling, general and administrative expenses  (47,816)  (51,010)  (42,422)  (34,651)  (29,332)  (26,929)  (36,013)  (47,816)  (51,010)  (42,422)
Selling, general and administrative — impairment charges and restructuring expenses  (87,882)  (20,315)        (87,882)  (20,315)  
                      
Total selling, general and administrative expenses
  (135,698)  (71,325)  (42,422)  (34,651)  (29,332)  (26,929)  (36,013)  (135,698)  (71,325)  (42,422)
  
Operating (loss)/ profit
  (79,575)  (29,372) 1,941 6,622 6,187 
Net gain on divestment of business and restructuring expenses 46,474     
 
Operating profit/(loss)
 60,503 14,099  (79,575)  (29,372) 1,941 
  
Financial income 65 457 1,164 389 302  1,352 8 65 457 1,164 
Financial expenses  (2,160)  (3,148)  (2,653)  (1,058)  (824)  (495)  (1,192)  (2,160)  (3,148)  (2,653)
                      
Net financing costs
  (2,095)  (2,691)  (1,489)  (669) 522 
Net financing income/(costs)
 857  (1,184)  (2,095)  (2,691)  (1,489)
                      
  
(Loss)/ profit before tax
  (81,670)  (32,063) 452 5,953 5,665 
Profit/(loss) before tax
 61,360 12,915  (81,670)  (32,063) 452 
  
Income tax (expense)/ credit 3,892  (3,309) 2,824  (673) 49   (942)  (1,091) 3,892  (3,309) 2,824 
                      
  
(Loss)/ profit for the year (all attributable to equity holders)
  (77,778)  (35,372) 3,276 5,280 5,714 
Profit/(loss) for the year (all attributable to owners of the parent)
 60,418 11,824  (77,778)  (35,372) 3,276 
                      
  
Basic (loss)/ earnings per ‘A’ ordinary share (US Dollars)  (0.96)  (0.47) 0.05 0.09 0.10 
Basic (loss)/ earnings per ‘B’ ordinary share (US Dollars)  (1.91)  (0.94) 0.10 0.18 0.20 
Diluted (loss)/ earnings per ‘A’ ordinary share (US Dollars)  (0.96)  (0.47) 0.05 0.09 0.09 
Diluted (loss)/ earnings per ‘B’ ordinary share (US Dollars)  (1.91)  (0.94) 0.10 0.18 0.18 
Basic (loss)/ earnings per ADS (US Dollars)  (3.82)  (1.86) 0.19 0.36 0.41 
Diluted (loss)/ earnings per ADS (US Dollars)  (3.82)  (1.86) 0.19 0.35 0.37 
Basic earnings/(loss) per ‘A’ ordinary share (US Dollars) 0.71 0.14  (0.96)  (0.47) 0.05 
Basic earnings/(loss) per ‘B’ ordinary share (US Dollars) 1.43 0.28  (1.91)  (0.94) 0.10 
Diluted earnings/(loss) per ‘A’ ordinary share (US Dollars) 0.70 0.14  (0.96)  (0.47) 0.05 
Diluted earnings/(loss) per ‘B’ ordinary share (US Dollars) 1.39 0.28  (1.91)  (0.94) 0.10 
Basic earnings/(loss) per ADS (US Dollars) 2.85 0.57  (3.82)  (1.86) 0.19 
Diluted earnings/(loss) per ADS (US Dollars) 2.79 0.57  (3.82)  (1.86) 0.19 
Weighted average number of shares used in computing basic EPS 81,394,075 76,036,579 70,693,753 58,890,084 55,132,024  84,734,378 83,737,884 81,394,075 76,036,579 70,693,753 
 
Weighted average number of shares used in computing diluted EPS 81,394,075 76,036,579 72,125,740 67,032,382 65,527,802  86,661,535 83,772,094 81,394,075 76,036,579 72,125,740 

 

2


Consolidated Balance Sheet Data
                                        
 December December December December 31, December 31,  December December December December December 
 31,2008 31,2007 31,2006 2005 2004  31, 2010 31, 2009 31, 2008 31, 2007 31, 2006 
Consolidated Balance Sheet Data US$’000 US$’000 US$’000 US$’000 US$’000 
 US$’000 US$’000 US$’000 US$’000 US$’000  
Net current assets (current assets less current liabilities) 39,494 36,298 60,996 44,964 53,448  89,068 42,835 39,494 36,298 60,996 
Non current liabilities  (27,897)  (35,623)  (45,928)  (19,083)  (16,636)
Non-current liabilities  (7,331)  (27,500)  (27,897)  (35,623)  (45,928)
Total assets 129,509 215,979 249,131 184,602 156,040  160,874 132,445 129,509 215,979 249,131 
Capital stock 1,070 991 978 830 776  1,092 1,080 1,070 991 978 
Shareholders’ equity 65,905 136,845 167,262 133,618 118,894  141,287 79,344 65,905 136,845 167,262 
No dividends were declared in any of the periods from December 31, 20042006 to December 31, 2008.2009. The Board have proposed a final dividend of 10 cent per ADR in respect of 2010 and this proposal will be submitted to shareholders for their approval at the next Annual General Meeting of the Company. As provided in the Articles of Association of the Company, dividends or other distributions are declared and paid in US Dollars.
Risk Factors
Before you invest in our shares, you should be aware that there are various risks, which are described below. You should consider carefully these risks together withconsider all of the other information includedset forth in this annual report before you decide to purchase our shares.
Trinity Biotech’s operating results may be subject to fluctuations.
Trinity Biotech’s operating results may fluctuate as a result of many factors related to its business,Form 20-F, including the competitive conditionsfollowing risk factors, when investing in our securities. The risks described below are not the industry, major reorganisations of the Group’s activities, loss of significant customers, delays in the development of new products and currency fluctuations, as described in more detail below, and general factors such as the size and timing of orders, the prevalence of various diseases and general economic conditions. In the event of lower operating profits, this could have a negative impact on cash generated from operations and also negatively impact shareholder value.
A need for capital might arise in the future if Trinity Biotech’s capital requirements increase or revenues decrease.
Uponly ones that we face. Additional risks not currently known to now Trinity Biotech has funded its operations through the sale of its shares and securities convertible into shares, cashflows from operations and bank borrowings. Trinity Biotech expects that the proceeds of equity financings, bank borrowings, lease financing, current working capital and sales revenues will fund its existing operations and payment obligations. However, if our capital requirements are greater than expected, or if our revenues do not generate sufficient cashflows to fund our operations, we may need to find additional financing which may not be available on attractive terms or at all. Any future financing could have an adverse effect on our current shareholders or the price of our shares in general.
Trinity Biotech’s acquisition strategy may be less successful than expected, and therefore, growth may be limited.
Trinity Biotech has historically grown organically and through the acquisition of, and investment in, other companies, product lines and technologies. There can be no guarantees that recent or future acquisitions can be successfully assimilatedus or that projected growth in revenues or synergies in operating costs can be achieved. Our ability to integrate future acquisitionswe presently deem immaterial may also impair our business operations. We could be materially adversely affected by inexperience in dealing withany of these risks.
Our long-term success depends upon the successful development and commercialization of new technologies, and changes in regulatory or competitive environments. Additionally, even during a successful integration, the investment of management’s time and resources in the new enterprise may be detrimental to the consolidationproducts.
Our long-term viability and growth will depend upon the successful discovery, development and commercialization of other products from our existing business.

3


The diagnostics industry is highly competitive, and Trinity Biotech’s research and development could be rendered obsolete by technological advances of competitors.
Trinity Biotech’s principal business is the supply of medical diagnostic test kits and related diagnostic instrumentation. The diagnostics industry is extremely competitive. Trinity Biotech is competing directly with companies which have greater capital resources and larger marketing and business organisations than Trinity Biotech. Trinity Biotech’s ability to grow revenue and earnings may be adversely impacted by competitive product and pricing pressures and by its inability to gain or retain market share as a result of the action of competitors.
We have invested in research and development (“R&D”) but there can be no guarantees that our R&D programmes will not be rendered technologically obsolete or financially non-viable by the technological advances of our competitors, which would also adversely affect our existing product lines and inventory. The main competitors of Trinity Biotech (and their principal products with which Trinity Biotech competes) include Siemens (Sysmex® CA, D-Dimer plus, Enzygnost®), Zeus Scientific Inc. (Zeus EIA, IFA), Diasorin Inc. (ETI™), Abbott Diagnostics (AxSYM™, IMx™), Diagnostic Products Corp. — DPC (Immulite™), Bio-Rad (ELISA, WB & A1c), Roche Diagnostics (COBAS AMPLICOR™, Ampliscreen™, Accutrend™) and OraSure Technologies, Inc (OraQuick®).
Trinity Biotech is highly dependent on suitable distributors worldwide.
Trinity Biotech currently distributes its product portfolio through distributors in approximately 80 countries worldwide. Our continuing economic success and financial security is dependent on our ability to secure effective channels of distribution on favourable trading terms with suitable distributors.
Trinity Biotech’s business could be adversely affected by changing market conditions resulting in the reduction of the number of institutional customers.
The diagnostics industry is in transition with a number of changes that affect the market for diagnostic test products. Changes in the healthcare industry delivery system have resulted in major consolidation among reference laboratories and in the formation of multi-hospital alliances, reducing the number of institutional customers for diagnostic test products. There can be no assurance that we will be able to enter into and/or sustain contractual or other marketing or distribution arrangements on a satisfactory commercial basis with these institutional customers.
Trinity Biotech’s long-term success depends on its ability to develop new products subject to stringent regulatory control. Even if new products are successfully developed, Trinity Biotech’s proprietary know-how, manufacturing techniques and trade secrets may be copied by competitors. Furthermore, Trinity Biotech’s patents have a limited life time and are thereafter subject to competition with generic products. Also, competitors might claim an exclusive patent for products Trinity Biotech plans to develop.
activities. We are committed to significant expenditure on research and development (“R&D”).&D. However, there is no certainty that this investment in research and development will yield technically feasible or commercially viable products. Our organic growth and long-term success is dependent on our ability to develop and marketDevelopment of new products but this workdiagnostic tests is subject to very stringent regulatory control and very significant costs in research, development and marketing. Failure to introduce new products could significantly slow our growth and adversely affect our market share.
Even whenTechnological advances in the industry could render our products are successfully developedobsolete.
We have invested in research and development but there can be no guarantees that our R&D programmes will not be rendered technologically obsolete or financially non-viable by the technological advances of our competitors, which would also adversely affect our existing product lines and inventory. The main competitors of Trinity Biotech (and their principal products with which Trinity Biotech competes) include Siemens (Immulite™, Enzygnost®), Inverness Medical Innovations, Inc. (Determine™, Wampole™, Athena™), Diasorin Inc. (Liasion™, ETIMAX™), Abbott Diagnostics (AxSYM™, IMx™), Bio-Rad (ELISA, WB, Bioplex™ & A1c), Roche Diagnostics (COBAS AMPLICOR™, Ampliscreen™, Accutrend™) and OraSure Technologies, Inc (OraQuick®).
We may be unable to protect or obtain proprietary rights that we utilize or intend to utilize.
In developing and marketed, Trinity Biotech’s ownershipmanufacturing our products, we employ a variety of the technology behind these products has a finite life.proprietary and patented technologies. In general, generic competition, which can arise through replication of the Trinity Biotech’s proprietary know-how, manufacturing techniquesaddition, we have licensed, and trade secrets or after the expiration of a patent, can have a detrimental effect on a product’s revenue, profitabilityexpect to continue to license, various complementary technologies and market share. There can be no guaranteemethods from academic institutions and public and private companies. We cannot provide any assurance that the net income and financial position of Trinity Biotechtechnologies that we own or license provide protection from competitive threats or from challenges to our intellectual property. In addition, we cannot provide any assurances that we will not be adversely affected by competition from generic products. Conversely, on occasion, certain companies have claimed exclusive patent, copyright and other intellectual property rights tosuccessful in obtaining licenses or proprietary or patented technologies in the diagnostics industry. If these technologies relate to Trinity Biotech’s planned products, Trinity Biotech would be obliged to seek licences to use this technology and, in the event of being unable to obtain such licences or it being obtainable on grounds that would be materially disadvantageous to Trinity Biotech, we would be precluded from marketing such products, which could adversely impact our revenues, sales and financial position.future.

 

43


Trinity Biotech’s patent applications could be rejected or the existing patents could be challenged; our technologies could be subject to patent infringement claims; and trade secrets and confidential know-how could be obtained by competitors.
We can provide no assurance that the patents Trinity Biotech may apply for will be obtained or that existing patents will not be challenged. The patents owned by Trinity Biotech and its subsidiaries may be challenged by third parties through litigation and could adversely affect the value of our patents. We can provide no assurance that our patents will continue to be commercially valuable.
Trinity Biotech currently owns 15 US patents with remaining patent lives varying from less than one year to 14 years. In addition to these US patents, Trinity Biotech owns a total of 7 additional non-US patents with expiration dates varying between the years 2009 and 2023.
Also, our technologies could be subject to claims of infringement of patents or proprietary technology owned by others. The cost of enforcing our patent and technology rights against infringers or defending our patents and technologies against infringement charges by others may be high and could adversely affect our business.
Trade secrets and confidential know-how are important to our scientific and commercial success. Although we seek to protect our proprietary information through confidentiality agreements and other contracts, we can provide no assurance that others will not independently develop the same or similar information or gain access to our proprietary information.
Trinity Biotech’sOur business is heavily regulated and non-compliance with applicable regulations could reduce revenues and profitability.
Our manufacturing and marketing of diagnostic test kits are subject to government regulation in the United States of America by the Food and Drug Administration (“FDA”), and by comparable regulatory authorities in other jurisdictions. The approval process for our products, while variable across countries, is generally lengthy, time consuming, detailed and expensive. Our continued success is dependent on our ability to develop and market new products, some of which are currently awaiting approval from these regulatory authorities. There is no certainty that such approval will be granted or, even once granted, will not be revoked during the continuing review and monitoring process.
We are required to comply with extensive post market regulatory requirements. Non-compliance with applicable regulatory requirements of the FDA or comparable foreign regulatory bodies can result in enforcement action which may include recalling products, ceasing product marketing, paying significant fines and penalties, and similar actions that could limit product sales, delay product shipment, and adversely affect profitability.
Our business could be adversely affected by changing market conditions.
The diagnostics industry is in transition with a number of changes that affect the market for diagnostic test products. Changes in the healthcare industry delivery system have resulted in major consolidation among reference laboratories and in the formation of multi-hospital alliances, reducing the number of institutional customers for diagnostic test products. There can be no assurance that we will be able to enter into and/or sustain contractual or other marketing or distribution arrangements on a satisfactory commercial basis with these institutional customers.
Future acquisitions may be less successful than expected, and therefore, growth may be limited.
Trinity Biotech’sBiotech has historically grown organically and through the acquisition of, and investment in, other companies, product lines and technologies. There can be no guarantees that recent or future acquisitions can be successfully assimilated or that projected growth in revenues or synergies in operating costs can be achieved. Our ability to integrate future acquisitions may also be adversely affected by inexperience in dealing with new technologies, and changes in regulatory or competitive environments. Additionally, even during a successful integration, the investment of management’s time and resources in the new enterprise may be detrimental to the consolidation and growth of our existing business.
Our revenues are highly dependent on a network of distributors worldwide.
Trinity Biotech currently distributes its product portfolio through distributors in approximately 75 countries worldwide. Our continuing economic success and financial security is dependent on our ability to secure effective channels of distribution on favourable trading terms with suitable distributors.
Our patent applications could be rejected or the existing patents could be challenged; our technologies could be subject to patent infringement claims; and trade secrets and confidential know-how could be obtained by competitors.
We can provide no assurance that the patents Trinity Biotech may apply for will be obtained or that existing patents will not be challenged. The patents owned by Trinity Biotech and its subsidiaries may be challenged by third parties through litigation and could adversely affect the value of our patents. We can provide no assurance that our patents will continue to be commercially valuable.
Trinity Biotech currently owns 6 US patents with remaining patent lives varying from less than one year to 16 years. In addition to these US patents, Trinity Biotech owns a total of 5 additional non-US patents with expiration dates varying between the years 2011 and 2023.

4


Also, our technologies could be subject to claims of infringement of patents or proprietary technology owned by others. The cost of enforcing our patent and technology rights against infringers or defending our patents and technologies against infringement charges by others may be high and could adversely affect our business.
Trade secrets and confidential know-how are important to our scientific and commercial success. Although we seek to protect our proprietary information through confidentiality agreements and other contracts, we can provide no assurance that others will not independently develop the same or similar information or gain access to our proprietary information.
Trinity Biotech may be subject to liability resulting from its products or services.
Trinity Biotech may be subject to claims for personal injuries or other damages resulting from its products or services. Trinity Biotech has global product liability insurance in place for its manufacturing subsidiaries up to a maximum of €6,500,000 (US$8,679,000) for any one accident, limited to a maximum of €6,500,000 (US$8,679,000) in any one year period of insurance. A deductible of US$25,000 is applicable to each insurance event that may arise. There can be no assurance that our product liability insurance is sufficient to protect us against liability that could have a material adverse effect on our business.
Significant interruptions in production at our principal manufacturing facilities and/or third-party manufacturing facilities would adversely affect our business and operating results.
Products manufactured at our facilities in Bray, Ireland, Jamestown, New York, Kansas City Missouri and Carlsbad, California comprised approximately 76% of revenues in 2010. Our global supply of these products and services is dependent on the uninterrupted and efficient operation of these facilities. In addition, we currently rely on a small number of third-party manufacturers to produce certain of our diagnostic products and product components. The operations of our facilities or these third-party manufacturing facilities could be adversely affected by fire, power failures, natural or other disasters, such as earthquakes, floods, or terrorist threats. Although we carry insurance to protect against certain business interruptions at our facilities, there can be no assurance that such coverage will be adequate or that such coverage will continue to remain available on acceptable terms, if at all. Any significant interruption in the Group’s or third-party manufacturing capabilities could materially and adversely affect our operating results.
We are highly dependent on our senior management team and other key management personnel.employees, and the loss of one or more of these employees could adversely affect our operations.
Trinity Biotech’s success is dependent on certain key management personnel. Our key employees at December 31, 20082010 were Ronan O’Caoimh, our CEO and Chairman, Rory Nealon, our COO, Jim Walsh, our Chief Scientific Officer and Kevin Tansley, our CFOCFO/Company Secretary. If such key employees were to leave and Secretary. Competition for qualified employees among biotechnology companies is intense, and the loss of such personnel or the inabilitywe were unable to attract and retain the additional highly skilled employees required for the expansion ofobtain adequate replacements, our activities,operating results could be adversely affect our business. In the USA, the UK, France and Germany we have been able to attract and retain qualified personnel. In Ireland, we have experienced some difficulties in attracting and retaining staff due to competition from other employers in our industry.affected.
Trinity Biotech isWe are dependent on its suppliers for the primary raw materials required for its test kits.
The primary raw materials required for Trinity Biotech’s test kits consist of antibodies, antigens or other reagents, glass fibre and packaging materials which are acquired from third parties. Although Trinity Biotech does not expect to be dependent upon any one source for these raw materials, alternative sources of antibodies with the characteristics and quality desired by Trinity Biotech may not be available. Such unavailability could affect the quality of our products and our ability to meet orders for specific products.

 

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Trinity Biotech mayWe could be subject to liability resulting from its products or services.adversely affected by healthcare reform legislation.
Trinity Biotech may be subjectChanges in government policy could have a significant impact on our business by increasing the cost of doing business, affecting our ability to claims for personal injuries or other damages resulting from itssell our products or services. Trinity Biotech has global product liability insuranceand negatively impacting our profitability. The newly enacted Patient Protection and Affordable Care Act imposes a new 2.3% excise tax on medical device makers beginning in place for its manufacturing subsidiaries up to a maximum of6,500,000 (US$9,555,000) for any one accident, limited to a maximum of6,500,000 (US$9,555,000) in any one year period of insurance. A deductible of US$25,000 is applicable to each insurance event that may arise. There can be no assurance that our product liability insurance is sufficient to protect us against liability that2013, which could have a material adversenegative impact on our results of operations and our cash flows. At present, given the infancy of the enacted reform, we are unable to predict what effect the legislation might ultimately have on reimbursement rates for our products. If reimbursement amounts for diagnostic testing services are decreased in the future, such decreases may reduce the amount that will be reimbursed to hospitals or physicians for such services and consequently could place constraints on the levels of overall pricing, which could have a material effect on our sales and/or results of operations. Other elements of this legislation could meaningfully change the way healthcare is developed and delivered, and may materially impact numerous aspects of our business.
Currency fluctuationsGlobal economic conditions may adversely affecthave a material adverse impact on our earnings and assets.results.
Trinity Biotech records itsWe currently generate significant operating cash flows, which combined with access to the credit markets provides us with discretionary funding capacity for research and development and other strategic activities. Current uncertainty in global economic conditions poses a risk to the overall economy that could impact demand for our products, as well as our ability to manage normal commercial relationships with our customers, suppliers and creditors, including financial institutions. If global economic conditions deteriorate significantly, our business could be negatively impacted, including such areas as reduced demand for our products from a slow-down in the general economy, supplier or customer disruptions resulting from tighter credit markets and/or temporary interruptions in our ability to conduct day-to-day transactions through our financial intermediaries involving the payment to or collection of funds from our customers, vendors and suppliers.
Our sales and operations are subject to the risks of fluctuations in US Dollars, euro and Swedish Kroner and prepares its financial statements in US Dollars. currency exchange rates.
A substantial portion of our expensesoperations are denominated in euro. However, Trinity Biotech’s revenues are primarily denominated in US Dollars.Ireland and Europe is one of our main sales territories. As a result, the Group is affected by fluctuationschanges in currency exchange rates, especially the exchange rate between the USU.S. dollar and the euro which may adversely affectcan have significant effects on our earnings and assets. The percentageresults of 2008 consolidated revenue denominated in US Dollars was approximately 66%. Of the remaining 34% revenue, 26% relates to revenue denominated in Euro and 8% relates to sterling, yen and Swedish Kroner denominated revenues. Thus, a 10% decrease in the value of the euro would have approximately a 3% adverse impact on consolidated revenues.
As part of the process of mitigating foreign exchange risk, the principal exchange risk identified by Trinity Biotech is with respect to fluctuations in the euro. This is attributable to the level of euro denominated expenses exceeding the level of euro denominated revenues thus creating a euro deficit. Trinity Biotech continuously monitors its exposure to foreign currency movements and based on expectations on future exchange rate exposure implements a hedging policy which may include covering a portion of this exposure through the use of forward contracts. In the medium term, our objective is to increase the level of non-US Dollar denominated revenue, thus creating a natural hedge of the non-US Dollar expenditure.operations.
The conversion of our outstanding employee share options and warrants would dilute the ownership interest of existing shareholders.
The warrants issued in 20042008 and 20082010 and the total share options exercisable at December 2008,2010, as described in Item 18, note 19 to the consolidated financial statements, are convertible into American Depository Shares (ADSs), 1 ADS representing 4 Class “A” Ordinary Shares. The exercise of the share options exercisable and of the warrants will likely occur only when the conversion price is below the trading price of our ADSs and will dilute the ownership interests of existing shareholders. For instance, should the options and warrant holders of the 8,670,0135,226,413 ‘A’ Ordinary shares (2,167,503(1,306,603 ADSs) exercisable at December 31, 20082010 be exercised, Trinity Biotech would have to issue 8,670,0135,226,413 additional ‘A’ ordinary shares (2,167,503(1,306,603 ADSs). On the basis of 82,017,58184,116,865 ‘A’ ordinary shares outstanding at December 31, 2008,2010, this would effectively dilute the ownership interest of the existing shareholders by approximately 10%6%.
It could be difficult for US holders of ADSs to enforce any securities laws claims against Trinity Biotech, its officers or directors in Irish Courts.
At present, no treaty exists between the United States and Ireland for the reciprocal enforcement of foreign judgements. The laws of Ireland do however, as a general rule, provide that the judgements of the courts of the United States have in Ireland the same validity as if rendered by Irish Courts. Certain important requirements must be satisfied before the Irish Courts will recogniserecognize the United States judgement. The originating court must have been a court of competent jurisdiction, the judgement may not be recognisedrecognized if it is based on public policy, was obtained by fraud or its recognition would be contrary to Irish public policy. Any judgement obtained in contravention of the rules of natural justice will not be enforced in Ireland.

 

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Item 4
Information on the Company
History and Development of the Company
Trinity Biotech (“the Group”) develops, acquires, manufactures and markets medical diagnostic products for the clinical laboratory and point-of-care (“POC”) segments of the diagnostic market. These products are used to detect autoimmune, infectious and sexually transmitted diseases, diabetes and disorders of the blood, liver and intestine. The Group is also a significant provider of raw materials to the life sciences industry. The Group sells worldwide in over 8075 countries through its own sales force and a network of international distributors and strategic partners.
Trinity Biotech was incorporated as a public limited company (“plc”) registered in Ireland in 1992. The Company commenced operations in 1992 and, in October 1992, completed an initial public offering of its securities in the US. The principal offices of the Group are located at IDA Business Park, Bray, Co Wicklow, Ireland. The Group has expanded its product base through internal development and acquisitions.
The Group, which has its headquarters in, Bray Ireland, employs in excess of 700approximately 345 people worldwide and markets its portfolio of over 500350 products to customers in 8075 countries around the world. Trinity Biotech markets its products in the US through a direct sales force and in the rest of the world through a combination of direct selling and a network of national and international distributors. The Group has established direct sales forces in the US, Germany, France and the UK. Trinity Biotech has manufacturing facilities in Bray, Ireland, and Lemgo, Germany, in Europe and in Jamestown, New York, Carlsbad, California and Kansas City, Missouri in the USA.
In May 2010, the Group sold its worldwide Coagulation business to Diagnostica Stago for US$90 million. Diagnostica Stago purchased the share capital of Trinity Biotech (UK Sales) Limited, Trinity Biotech GmbH and Trinity Biotech S.à r.l., along with Coagulation assets of Biopool US Inc. and Trinity Biotech Manufacturing Limited. Included in the sale are Trinity’s lists of coagulation customers and suppliers, all coagulation inventory, intellectual property and developed technology. In total, 321 Trinity employees transferred their employment to Diagnostica Stago following the sale.
The following represents the acquisitions made by Trinity Biotech in recent years.
Acquisition of Haemostasis business of bioMerieux Inc
In June 2006, Trinity Biotech acquired the haemostasis business of bioMerieux Inc. (“bioMerieux”) for a total consideration of US$44.4 million, consisting of cash consideration of US$38.2 million, deferred consideration of US$5.5 million (net of discounting) and acquisition expenses of US$0.7 million. At December 31, 2006, Trinity Biotech had accrued US$5,688,000 for the deferred consideration to be paid in June 2007 and June 2008 (see Item 18, note 26 to the consolidated financial statements). Deferred consideration of US$3,208,000 was paid to bioMerieux in June 2007. At December 31, 2007, the Group had accrued deferred consideration US$2,725,000 (net of discounting) and the Group paid this deferred consideration in June 2008.
Acquisition of the distribution business of Laboratoires Nephrotek SARL
In October, 2006, Trinity Biotech acquired the French distribution business of Laboratoires Nephrotek SARL (“Nephrotek”) for a total consideration of US$1,175,000, consisting of cash consideration of US$1,060,000 and acquisition expenses of US$115,000.
Acquisition of the immuno-technology business of Cortex Biochem Inc
In September 2007, the Group acquired the immuno-technology business of Cortex Biochem Inc (“Cortex”) for a total consideration of US$2,925,000, consisting of cash consideration of US$2,887,000 and acquisition expenses of US$38,000.
Acquisition of certain components of the distribution business of Sterilab Services UK
In October 2007, the Group acquired certain components of the distribution business of Sterilab Services UK (“Sterilab”), a distributor of Infectious Diseases products, for a total consideration of US$1,489,000, consisting of cash consideration of US$1,480,000 and acquisition expenses of US$9,000.

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Principal Markets
The primary market for Trinity Biotech’s tests remains the US.USA. During fiscal year 2008,2010, the Group sold 50%60% (US$69.954.0 million) (2007: 48%(2009: 54% or US$68.468.1 million) (2006: 51%(2008: 50% or US$60.769.9 million) of product in the US.USA. Sales to non-US (principally European and Asian/ African) countries represented 50%40% (US$70.235.6 million) for fiscal year 2008 (2007: 52%2010 (2009: 46% or US$75.257.8 million) (2006: 49%(2008: 50% or US$57.970.2 million).
For a more comprehensive segmental analysis please refer to Item 5, “Results of Operations” and Item 18, note 2 to the consolidated financial statements.

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Principal Products
Trinity Biotech develops, acquires, manufactures and markets a wide range of clinical in-vitro diagnostic products. The completeThis product portfolio, firstly split by point of use, is divided into 2 product lines which are sold underthen subdivided on the followingbasis of application.
Product portfolio sub-division with associated established brand names:
       
Clinical Laboratory Clinical Laboratory
Point-Of-Care Infectious DiseaseHbA1c + Hb Variant Clinical Chemistry
HaemostasisDiseasesChemistryPoint of Care
Trini™UniGold™ Bartels® Primus™ UniGold™EZ™
Biopool
Recombigen®
 CAPTIA™EZ™Capillus™
Amax™MarDx®Captia™   Recombigen®
Destiny™ MicroTrak™MarDx®    
  MarBlot®    
MicroTrak™
TheseTrinity Biotech also sells raw materials to the life sciences industry and research institutes globally through the Company subsidiary, Fitzgerald Industries.
Trinity Biotech products are sold through our direct sales organisations in USA UK, France and Germany and through our network of over 80 principal distributor partners into approximately 75 countries in the rest of the world.
Point of Care (POC)
Point of Care refers to diagnostic tests which are carried out in the presence of the patient.
UniGold™ HIV
Trinity Biotech makes a very significant contribution to the global effort to meet the challenge of HIV. The Group’s principal product is UniGold™ HIV.
In Africa, UniGold™ HIV has been used for several years in voluntary counselling and testing centres (VCTs) in the sub-Saharan region where they provide a cornerstone to early detection and treatment intervention. The UniGold™ HIV brand is recognized for its quality and reliability. These same factors are the springboard in some countries for national testing algorithm changes in favour of wider usage of UniGold™ HIV.
In the USA, the Centres for Disease Control (CDC) recommend the use of rapid tests to control the spread of HIV/AIDS. As part of this, UniGold™ HIV is used in public health facilities, hospitals and other outreach facilities.
The Future of Point-Of-Care at Trinity Biotech
Point-Of-Care is strategically key to the growth of Trinity Biotech in the future. The company has already invested in establishing 3 new product development teams in the US and Ireland to provide a product pipeline for future growth. In phase one, the areas of development focus include rapid tests for:
Sexually transmitted diseases: Building on the existing success with HIV, the products will include rapid tests for Syphilis, Herpes simplex (HSV) 1 & 2 and HIV combination assay (1 & 2 + Antigen)
Enteric pathogens: Separate products for Clostridium toxin A&B, Giardia and Cryptosporidium
Respiratory pathogens: Flu A&B, Streptococcus pneumoniae,
Clinical Laboratory
Trinity Biotech supplies the clinical laboratory segment of thein-vitrodiagnostic market with a range of diagnostic tests and instrumentation which detect infectiousdetect:
Infectious diseases: bacterial and viral diseases sexually transmitted diseases, blood coagulation and autoimmune disorders. We also sell raw materials to the life sciences industry. Within the clinical laboratory product line, there are three product portfolios, namely haemostasis, infectious diseases
HbA1c and clinical chemistry.Hb Variant: Diabetes and Haemoglobin disorders.
Haemostasis
The haemostasis product line comprises test kitsClinical Chemistry: Liver & kidney disease and instrumentation used in the detection of blood coagulation and clotting disorders. The market for blood clotting and bleeding tests continues to grow due to an aging population and improvement in healthcare systems. Trinity Biotech’s instrumentation and assays for haemostasis are recognized as being among the highest quality available. The comprehensive product offering is marketed globally to hospitals, clinical laboratories, commercial reference laboratories and research institutions.haemolytic anaemia.

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During 2008 we commenced the rationalization of the three existing haemostasis brands of Amax, Biopool and Destiny under a single brand name called “Trini”. At the end of 2008 we launched the Destiny MAX instrument, which is specifically designed to service the high throughput segment of the market. This market segment is valued at approximately $500million per year. Prior to the launch of the Destiny MAX, this segment was not served by the existing Trinity Biotech instrument product range
Infectious Diseases
The infectious diseases product line is the most diverse within Trinity Biotech.Biotech manufactures products for niche/specialised applications in Infectious Disease and Autoimmune disorders. The products are used to perform tests onwith patient samples and the results generated are reported tohelp physicians to guide diagnosis for a broad range of infectious diseases. This product line has grown to include diagnostic kits for autoimmune diseasesThe key niche/specialist disease areas served by the Trinity Biotech products include: (1) Lyme disease, (2) Sexually transmitted diseases: Syphilis, Chlamydia and Herpes simplex, (3) Respiratory infections: Legionella, Flu A&B, (4) Epstein Barr Virus, (5) other viral pathogens, e.g. Measles, Mumps, Rubella and Varicella, (6) Autoimmune disorders (e.g. lupus, celiac and rheumatoid arthritis), hormonal imbalances, sexually transmitted diseases (syphilis, chlamydia and herpes), intestinal infections, lung/bronchial infections, cardiovascular and a wide range of other diseases..
The vast majority of the infectious diseases product line is FDA cleared for sale in the USA and CE marked for sale in Europe. Products are sold in over 8075 countries, with the focus on North America, Europe and Asia.

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HbA1c and Hb Variants


The main driversPrimus Corporation, a Trinity Biotech company, focuses on products for thein-vitrodiagnostic testing for haemoglobin A1c (HbA1c) used in the monitoring of expansiondiabetes. Primus manufactures a range of instrumentation using patented HPLC (high pressure liquid chromatography) technology.
HbA1c : These products are the most accurate and opportunityprecise methods available for detection and monitoring the product line have been:patient status and overall diabetic control.
 1. 
Haemoglobin Variants: The increased Trinity Biotech instrumentation offering/portfolio through collaboration with AdaltisPrimus Ultra2 instrument is the most accurate and Dynexprecise method for detection of haemoglobin variants which is important for screening populations for genetic abnormalities that can lead to conditions such as Sickle Cell Anaemia and implementation of a system sell (i.e. combining instruments and reagents) strategy;
2.Focus on key accounts in affiliate markets;
3.Expansion of product portfolio to meet market demands; and
4.Increase in our geographical spread with new partnerships in major markets in Asia-Pacific.Thalassemia.
Neonatal Haemoglobin: The most recent addition, the GeneSys system, designed for assay and detection of Haemoglobin variants in neo-natal screening, addresses the largest segment of this niche area, i.e. the reference laboratories (responsible for state-wide screening of newborns).
The current Primus products are sold through the Trinity Biotech sales and marketing organization to clinical and reference laboratories directly in the USA and via distribution in other countries.
In preparation for the planned 2011 launch of a new high throughput HbA1c instrument, the Premier Hb 9210 (formerly known as Pdx), Trinity Biotech has entered into a distribution agreement with Menarini Diagnostics, for Europe. The US launch is expected later in 2011. This new instrument will also give access to markets not previously open to Trinity Biotech due to instrument price and test capability.
Clinical Chemistry
The Trinity Biotech speciality clinical chemistry business includes reagent products such as ACE, Bile Acids, Lactate, Oxalate and Glucose 6 phosphate dehydrogenaseGlucose-6-Phosphate Dehydrogenase (G6PDH) that are clearly differentiated in the marketplace. These products are suitable for both manual and automated testing and have proven performance in the diagnosis of many disease states from liver and kidney disease to G6PDH deficiency which is an indicator of haemolytic anaemia.
In 2005, Trinity Biotech acquired Primus Corporation, a leader in the field of in-vitro diagnostic testing for haemoglobin A1c used in the monitoring of diabetes. Primus manufactures a range of instrumentation using patented HPLC (high pressure liquid chromatography) technology. These products are the most accurate and precise methods available for detection and monitoring the patient status and overall diabetic control. The Primus product range also includes HPLC equipment specifically designed to detect haemoglobin variants which is important for screening populations for genetic abnormalities that can lead to conditions such as sickle cell anaemia. Primus sells the products to physicians’ offices and reference laboratories directly in the USA and via a distribution network in other countries. In addition, the group developed the GeneSys system for assay and detection of Haemoglobin variants in neo-natal screening and the system was FDA cleared and launched in the US in May 2008. Since the launch of the GeneSys system in the US, three state laboratory services had adopted the method for their state-wide screening programs for all neonates. Primus, as part of its research and development, continues to focus on developing a sub one minute assay for A1c determination.
Point of Care (POC)
Point of Care refers to diagnostic tests which are carried out in the presence of the patient. Trinity Biotech’s current range of POC tests principally test for the presence of HIV antibodies. The Group’s principal products are UniGold™ and Capillus™.
UniGold™ and Capillus™ products have been used for several years in voluntary counselling and testing centres (VCTs) in sub-Saharan Africa where they provide a cornerstone to early detection and treatment intervention. In the USA, the Centres for Disease Control (CDC) recommend the use of rapid tests to control the spread of HIV/AIDS. As part of this, UniGold HIV is used in public health facilities, hospitals and other outreach facilities. Trinity Biotech, through both UniGold™ and Capillus™, make a very significant contribution to the global effort to meet the challenge of HIV.
In November 2007, Trinity Biotech received FDA clearance on the TRIstat™ point-of-care system, which will be used in physician laboratories, diabetes clinics and health centres for the rapid determination of Haemoglobin A1c. The TRIstat system is undergoing the completion of CLIA (Clinical Laboratory Improvement Act) clinical trials for the definition of ease of use and these are expected to be completed in mid 2009.
Sales and Marketing
Trinity Biotech sells its product through its own direct sales-force in four countries:the United States. Our sales team in the United States Germany, France and the United Kingdom. In the United States there are approximately 93 sales and marketing professionalsis responsible for the sale ofmarketing and selling the Trinity Biotech range of haemostasis reagents and instrumentation, clinical chemistry, point of care, and infectious disease, Primus and clinical chemistry products. The Group also has
Through its sales forces of 23and marketing organisation in Ireland, Trinity Biotech sells:
Its Clinical Chemistry product range directly to hospitals and laboratories in Germany 11 in France and 16France;
All products directly to hospitals and laboratories in the UK. In addition to our direct sales operations, Trinity Biotech also operates in approximately 80 countries,UK; and
All product lines through over 300 independent distributors and strategic partners.partners in a further 75 countries.

 

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Manufacturing and Raw Materials
Trinity Biotech uses a wide range of biological and non-biological raw materials. The primary raw materials required for Trinity Biotech’s test kits consist of antibodies, antigens, human plasma, latex beads, rabbit brain phospholipids, bovine source material, other reagents, glass fibre and packaging materials. The reagents used as raw materials have been acquired for the most part from third parties. Although Trinity Biotech is not dependent upon any one source for such raw materials, alternative sources of antibodies and antigens with the specificity and sensitivity desired by Trinity Biotech may not be available from time to time. Such unavailability could affect the supply of its products and its ability to meet orders for specific products, if such orders are obtained. Trinity Biotech’s growth may be limited by its ability to obtain or develop the necessary quantity of antibodies or antigens required for specific products. Thus, Trinity Biotech’s strategy is, whenever possible, to establish alternative sources of supply of antibodies.
Competition
The diagnostic industry is very competitive. There are many companies, both public and private, engaged in the sale of medical diagnostic products and diagnostics-related research and development, including a number of well-known pharmaceutical and chemical companies. Competition is based primarily on product reliability, customer service and price. Innovation in the market is rare but significant advantage can be made with the introduction of new disease markers or innovative techniques with patent protection. The Group’s competition includes several large companies such as, but not limited to, Roche, Abbott, Johnson & Johnson, Siemens (from the combined acquisitions of Bayer Diagnostics, Dade-Behring and DPC), Beckman Coulter, Inverness Medical Innovations, Inc., Bio-Rad and Thermo Fisher.
Patents and Licences
Patents
Many of the Trinity Biotech’s tests are not protected by specific patents, due to the significant cost of putting patents in place for Trinity Biotech’s wide range of products. However, Trinity Biotech believes that substantially all of its tests are protected by proprietary know-how, manufacturing techniques and trade secrets.
From time-to-time, certain companies have asserted exclusive patent, copyright and other intellectual property rights to technologies that are important to the industry in which Trinity Biotech operates. In the event that any of such claims relate to its planned products, Trinity Biotech intends to evaluate such claims and, if appropriate, seek a licence to use the protected technology. There can be no assurance that Trinity Biotech would, firstly, be able to obtain licences to use such technology or, secondly, obtain such licences on satisfactory commercial terms. If Trinity Biotech or its suppliers are unable to obtain or maintain a licence to any such protected technology that might be used in Trinity Biotech’s products, Trinity Biotech could be prohibited from marketing such products. It could also incur substantial costs to redesign its products or to defend any legal action taken against it. If Trinity Biotech’s products should be found to infringe protected technology, Trinity Biotech could also be required to pay damages to the infringed party.
Licences
Trinity Biotech has entered into a number of key licensing arrangements including the following:
In 2005 Trinity Biotech obtained a license from the University of Texas for the use of Lyme antigen (Vlse), thus enabling the inclusion of this antigen in the Group’s Lyme diagnostic products. Trinity also entered a Biological Materials License Agreement with the Centre for Disease Control (CDC) in Atlanta, GA, USA for the rights to produce and sell the CDC developed HIV Incidence assay.
In 2002, Trinity Biotech obtained the Unipath and Carter Wallace lateral flow licences under agreement with Inverness Medical Innovations (“IMI”). In 2006, Trinity Biotech renewed its license agreement with Inverness Medical Innovations covering IMI’s most up to date broad portfolio of lateral flow patents, and expanded the field of use to include over the counter (“(”OTC”) for HIV products, thus ensuring Trinity Biotech’s freedom to operate in the lateral flow market with its UniGoldUniGold™ technology.
On December 20, 1999 Trinity Biotech obtained a non-exclusive commercial licence from the National Institute of Health (“NIH”) in the US for NIH patents relating to the general method of producing HIV-1 in cell culture and methods of serological detection of antibodies to HIV-1.
Trinity Biotech has also entered into a number of licence/supply agreements for key raw materials used in the manufacture of its products.
Each of the key licensing arrangements terminates on the expiry of the last of the particular licensed patents covered by the respective agreement, except in the case of one of the agreements which expires in 2015. Each licensor has the right to terminate the arrangement in the event of non-performance by Trinity Biotech. The key licensing arrangements requires the Group to pay a royalty to the license holder which is based on sales of the products which utilize the relevant technology being licensed. The royalty rates vary from 2% to 8.5% of sales. The total amount paid by Trinity Biotech under key licensing arrangements in 2010 was US$1,233,000 (2009: US$899,000).

 

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Government Regulation
The preclinical and clinical testing, manufacture, labelling, distribution, and promotion of Trinity Biotech’s products are subject to extensive and rigorous government regulation in the United States and in other countries in which Trinity Biotech’s products are sought to be marketed. The process of obtaining regulatory clearance varies, depending on the product categorisation and the country, from merely notifying the authorities of intent to sell, to lengthy formal approval procedures which often require detailed laboratory and clinical testing and other costly and time-consuming processes. The main regulatory bodies which require extensive clinical testing are the Food and Drug Administration (“FDA”) in the US, the Irish Medicines Board (as the authority over Trinity Biotech in Europe) and Health Canada.
The process in each country varies considerably depending on the nature of the test, the perceived risk to the user and patient, the facility at which the test is to be used and other factors. As 50%60% of Trinity Biotech’s 20082010 revenues were generated in the US and the US represents approximately 43% of the worldwide diagnostics market, an overview of FDA regulation has been included below.
FDA Regulation
Our products are medical devices subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act. The FDA’s regulations govern, among other things, the following activities: product development, testing, labeling, storage, pre-market clearance or approval, advertising and promotion and sales and distribution.
Access to US Market.Each medical device that Trinity Biotech may wish to commercially distribute in the US will require either pre-market notification (more commonly known as 510(k)) clearance or pre-market application (“PMA”) approval prior to commercial distribution. Devices intended for use in blood bank environments fall under even more stringent review and require a Blood Licence Application (“BLA”). Some low risk devices are exempted from these requirements. The FDA has introduced fees for the review of 510(k) and PMA applications. The fee for a PMA or BLA in 20082010 is in the region of US$200,000.
510(k)510(k) Clearance Pathway. To obtain 510(k) clearance, Trinity Biotech must submit a pre-market notification demonstrating that the proposed device is substantially equivalent in intended use and in safety and effectiveness to a “predicate device” — either a previously cleared class I or II device or a class III preamendment device, for which the FDA has not called for PMA applications. The FDA’s 510(k) clearance pathway usually takes from 3 to 9 months, but it can take longer. After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance or could even require a PMA approval.
PMA Approval Pathway. A device that does not qualify for 510(k) clearance generally will be placed in class III and required to obtain PMA approval, which requires proof of the safety and effectiveness of the device to the FDA’s satisfaction. A PMA application must provide extensive preclinical and clinical trial data and also information about the device and its components regarding, among other things, device design, manufacturing and labeling. In addition, an advisory committee made up of clinicians and/or other appropriate experts is typically convened to evaluate the application and make recommendations to the FDA as to whether the device should be approved. It generally takes from one to three years but can take longer.
Although the FDA is not bound by the advisory panel decision, the panel’s recommendation is important to the FDA’s overall decision making process. The PMA approval pathway is more costly, lengthy and uncertain than the 510(k) clearance process. It generally takes from one to three years or even longer. After approval of a PMA, a new PMA or PMA supplement is required in the event of a modification to the device, its labeling or its manufacturing process. As noted above, the FDA has recently implemented substantial fees for the submission and review of PMA applications.
BLA approval pathway.BLA approval is required for some products intended for use in a blood bank environment, where the blood screened using these products may be administered to an individual following processing. This approval pathway involves even more stringent review of the product.
Clinical Studies. A clinical study is required to support a PMA application and is required for a 510(k) pre-market notification. Such studies generally require submission of an application for an Investigational Device Exemption (“IDE”) showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.

 

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Post-market Regulation
After the FDA permits a device to enter commercial distribution, numerous regulatory requirements apply, including the Quality System Regulation (“QSR”), which requires manufacturers to follow comprehensive testing, control, documentation and other quality assurance procedures during the manufacturing process; labeling regulations; the FDA’s general prohibition against promoting products for unapproved or “off-label” uses; and the Medical Device Reporting (“MDR”) regulation, which requires that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur.
Trinity Biotech is subject to inspection by the FDA to determine compliance with regulatory requirements. If the FDA finds any failure to comply, the agency can institute a wide variety of enforcement actions, ranging from a public warning letter to more severe sanctions such as fines, injunctions, and civil penalties; recall or seizure of products; the issuance of public notices or warnings; operating restrictions, partial suspension or total shutdown of production; refusing requests for 510(k) clearance or PMA approval of new products; withdrawing 510(k) clearance or PMA approvals already granted; and criminal prosecution.
Unanticipated changes in existing regulatory requirements or adoption of new requirements could have a material adverse effect on the Group. Any failure to comply with applicable QSR or other regulatory requirements could have a material adverse effect on the Group’s revenues, earnings and financial standing.
There can be no assurances that the Group will not be required to incur significant costs to comply with laws and regulations in the future or that laws or regulations will not have a material adverse effect upon the Group’s revenues, earnings and financial standing.
CLIA classification
Purchasers of Trinity Biotech’s clinical diagnostic products in the United States may be regulated under The Clinical Laboratory Improvements Amendments of 1988 (“CLIA”) and related federal and state regulations. CLIA is intended to ensure the quality and reliability of clinical laboratories in the United States by mandating specific standards in the areas of personnel qualifications, administration and participation in proficiency testing, patient test management, quality control, quality assurance and inspections. The regulations promulgated under CLIA established three levels of diagnostic tests (“waived”, “moderately complex” and “highly complex”) and the standards applicable to a clinical laboratory depend on the level of the tests it performs.
Export of products subject to 510(k) notification requirements, but not yet cleared to market, are permitted without FDA export approval, if statutory requirements are met. Unapproved products subject to PMA requirements can be exported to any country without prior FDA approval provided, among other things, they are not contrary to the laws of the destination country, they are manufactured in substantial compliance with the QSR, and have been granted valid marketing authorisationauthorization in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa or member countries of the European Union or of the European Economic Area (“EEA”). FDA approval must be obtained for exports of unapproved products subject to PMA requirements if these export conditions are not met.
There can be no assurance that Trinity Biotech will meet statutory requirements and/or receive required export approval on a timely basis, if at all, for the marketing of its products outside the United States.
Regulation outside the United States
Distribution of Trinity Biotech’s products outside of the United States is also subject to foreign regulation. Each country’s regulatory requirements for product approval and distribution are unique and may require the expenditure of substantial time, money, and effort. There can be no assurance that new laws or regulations will not have a material adverse effect on Trinity Biotech’s business, financial condition, and results of operation. The time required to obtain needed product approval by particular foreign governments may be longer or shorter than that required for FDA clearance or approval. There can be no assurance that Trinity Biotech will receive on a timely basis, if at all, any foreign government approval necessary for marketing its products.

 

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Organisational Structure
Trinity Biotech plc and its subsidiaries (“the Group”) is a manufacturer of diagnostic test kits and instrumentation for sale and distribution worldwide. Trinity Biotech’s executive offices are located at Bray, Co. Wicklow, Ireland while its research and development, manufacturing and marketing activities are principally conducted at Trinity Biotech Manufacturing Limited, based in Bray, Co. Wicklow, Ireland Trinity Biotech (UK Sales) Limited, based in Berkshire England, Trinity Biotech GmbH, based in Lemgo, Germany, and at Trinity Biotech (USA), MarDx Diagnostics Inc, Primus Corporation and Biopool US Inc. based in Jamestown, New York State, Carlsbad, California, Kansas City, Missouri and Berkeley Heights,Jamestown, New JerseyYork State respectively. The Group’s distributor of raw materials for the life sciences industry, Fitzgerald Industries, is based in Concord,Acton, Massachusetts and Bray, Co. Wicklow, Ireland.
For a more comprehensive schedule of the subsidiary undertakings of the Group please refer to Item 18, note 31 to the consolidated financial statements.
Property, Plant and Equipment
Trinity Biotech has fivefour manufacturing sites worldwide, three in the US (Jamestown, NY, Kansas City, MO and Carlsbad, CA), and one in Bray, Co. Wicklow, Ireland and one in Lemgo, Germany.Ireland. The US and Irish facilities are each FDA and ISO registered facilities. As part of its ongoing commitment to quality, Trinity Biotech was granted the latest ISO 9001: 2000 and ISO 13485: 2003 certification. This certificate was granted by the Underwriters Laboratory, an internationally recognised notified body. It serves as external verification that Trinity Biotech has an established an effective quality system in accordance with an internationally recognised standard. By having an established quality system there is a presumption that Trinity Biotech will consistently manufacture products in a controlled manner. To achieve this certification Trinity Biotech performed an extensive review of the existing quality system and implemented any additional regulatory requirements.
Trinity Biotech’s Irish manufacturingUntil the divestiture of our Coagulation business in May 2010, our facilities and research and development facilities consisting of approximately 45,000 square feet areoffices in Ireland were located in four buildings at IDA Business Park, Bray, Co. Wicklow. Following the divestiture, the lease on one of these buildings was assigned to Diagnostica Stago and the lease on another of the buildings is currently in the process of being assigned to Diagnostica Stago. Upon completion of this assignment, the Company will have leases on the remaining two buildings at IDA Business Park, Bray, Co. Wicklow. The lease to be transferred to Diagnostica Stago in 2011 relates to the manufacturing and research and development facility consisting of approximately 45,000 square feet. This facility is ISO 9001 approved and was purchased in December 1997. The facilities includefacility includes offices, research and development laboratories, production laboratories, cold storage and drying rooms and warehouse space. Trinity Biotech spent US$4.2 million buying and fitting outThe annualised rent on this facility is €479,000(US$639,000). Diagnostica Stago has been reimbursing the facility. In December 1999,Company for the Group soldpayments made on this lease since the facility for net proceedsdivestiture of US$5.2 million and leased it back from the purchaser for 20 years. The current annual rent, which is reviewed every five years, is set at479,000 (US$704,000).Coagulation business in May 2010.
Trinity Biotech has entered into a number of related party transactions with JRJ Investments (“JRJ”), a partnership owned by Mr O’Caoimh and Dr Walsh, directors of the Company, and directly with Mr O’Caoimh and Dr Walsh, to provide current and potential future needs for the Group’s manufacturing and research and development facilities, located at IDA Business Park, Bray, Co. Wicklow, Ireland. In July 2000, Trinity Biotech entered into a 20 year lease with JRJ for a 25,000 square foot warehouse adjacent to the existing facility at a current annual rent of275,000 €275,000 (US$404,000)367,000). As described above, this was the lease which was assigned to Diagnostica Stago during 2010.
In November 2002, Trinity Biotech entered into an agreement for a 25 year lease with JRJ, for 16,700 square feet of offices at an annual rent of381,000 €381,000 (US$560,000)509,000), payable from 2004. In December 2007, the Group entered into an agreement with Mr O’Caoimh and Dr Walsh pursuant to which the Group took a lease on an additional 43,860 square foot manufacturing facility in Bray, Ireland at a rate of17.94 €17.94 per square foot (including fit out) giving a total annual rent of787,000 €787,000 (US$1,157,000)1,051,000). See Item 7 — Major Shareholders and Related Party Transactions).Transactions.
Trinity Biotech USA operates from a 24,000 square foot FDA and ISO 9001 approved facility in Jamestown, New York. The facility was purchased by Trinity Biotech USA in 1994. Additional warehousing space is also leased in upstate New York at an annual rental charge of US$128,000.133,000.
MarDx operates from two facilities in Carlsbad, California. The first facility comprises 21,500 square feet and is the subject of a five year lease, renewed in 2006,2009, at an annual rental cost of US$259,000.255,978. The second adjacent facility comprises 14,500 square feet and is the subject of a fivethree year lease, renewedamended in 2006,2009, at an annual rental cost of US$174,000.
Trinity Biotech closed its facility located in Umea, Sweden during 2008 and thus the lease was not renewed at this facility during the year.
Trinity Biotech GmbH owns an ISO 9001 approved manufacturing and office facility of 78,000 square feet in Lemgo, Germany.172,356.

 

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Trinity Biotech sold its facility located in Lemgo, Germany during 2010 as part of the Sale of its Coagulation business — see Item 18, note 3 for further information.
The Group also has sales and marketing functions which operate from additionalhad leases on premises in the UK and France. Trinity Biotech leasesFrance which were transferred to Diagnostica Stago in May 2010, following the sale of the Coagulation business. These consisted of two units in Berkshire, UK, at an annual rent of £91,000 (US$169,000). In 2006, Trinity Biotech entered into141,000) and a lease for a 5,750 square foot premises in Paris, France, at an annual rent of46,000 €46,000 (US$68,000)61,000).
Additional office space is leased by the Group in Ireland, Kansas City, Missouri Concord,and Acton, Massachusetts and Berkeley Heights, New Jersey at an annual cost of US$170,000,€115,000(US$154,000), US$100,000 US$109,000 and US$274,000,86,000 respectively.
At present we have sufficient productive capacity to cover demand for our product range. We continue to review our level of capacity in the context of future revenue forecasts. In the event that these forecasts indicate capacity constraints, we will either obtain new facilities or expand our existing facilities.
We do not currently have any plans to expand or materially improve our facilities.
In relation to products produced at our facilities — these are as follows:
Bray, Ireland— Point of Care/HIV, Immunoflourescence and Clinical Chemistry products are manufactured at this site.
Jamestown, New York— this site specializes in the production of Microtitre Plate EIA products for infectious diseases and auto-immunity.
Carlsbad, California— this facility specializes in the development and manufacture of products utilizing Western Blot technology. Our Lyme suite of products is manufactured at this facility.
Kansas City, Missouri— this site is responsible for the manufacture of the Group’s A1c range of products.
We are fully in compliance with all environmental legislation applicable in each jurisdiction in which we operate.
Capital expenditures and divestitures
Trinity Biotech has no divestitures or significant capital expendituresPlease refer to Item 18, note 29 with regard to the acquisition of Phoenix Bio-tech Corp. in progress.2011 and to Item 18, note 3 concerning the divestiture of the Coagulation business during 2010.
Item 5
Operating and Financial Review and Prospects
Operating Results
Trinity Biotech’s consolidated financial statements include the attributable results of Trinity Biotech plc and all its subsidiary undertakings collectively. This discussion covers the years ended December 31, 2008,2010, December 31, 20072009 and December 31, 2006,2008, and should be read in conjunction with the consolidated financial statements and notes thereto appearing elsewhere in this Form 20-F. The financial statements have been prepared in accordance with IFRS both as issued by the International Accounting Standards Board (“IASB”) and as subsequently adopted by the European Union (“EU”) (together “IFRS”). Consolidated financial statements are required by Irish law to comply with IFRS as adopted by the EU which differ in certain respects from IFRS as issued by the IASB. These differences predominantly relate to the timing of adoption of new standards by the EU. However, as none of the differences are relevant in the context of Trinity Biotech, the consolidated financial statements for the periods presented comply with IFRS both as issued by the IASB and as adopted by the EU.

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Trinity Biotech has availed of the exemption under SEC rules to prepare consolidated financial statements without a reconciliation to U.S. generally accepted accounting principles (“US GAAP”) as at and for the three year period ended December 31, 20082010 as Trinity Biotech is a foreign private issuer and the financial statements have been prepared in accordance with IFRS both as issued by the International Accounting Standards Board (“IASB”) and as subsequently adopted by the European Union (“EU”).
Overview
Trinity Biotech develops, manufactures and markets diagnostic test kits used for the clinical laboratory and point of care (“POC”) segments of the diagnostic market. These test kits are used to detect infectious diseases, sexually transmitted diseases, blood disorders and autoimmune disorders. The Group markets over 500350 different diagnostic products in approximately 8075 countries. In addition, the Group manufactures its own and distributes third party haemostasis and infectious diseasesdisease diagnostic instrumentation. The Group, through its Fitzgerald operation, is also a significant provider of raw materials to the life sciences industry.
Factors affecting our results
The global diagnostics market is growing due to, among other reasons, the ageing population and the increasing demand for rapid tests in a clinical environment.
Our revenues are directly related to our ability to identify high potential products while they are still in development and to bring them to market quickly and effectively. Efficient and productive research and development is crucial in this environment as we, like our competitors, search for effective and cost-efficient solutions to diagnostic problems. The growth in new technology will almost certainly have a fundamental effect on the diagnostics industry as a whole and upon our future development.
The comparability of our financial results for the years ended December 31, 2010, 2009, 2008, 2007 2006 and 20052006 have been impacted by acquisitions made by the Group in threetwo of the four years.five years and by the divestiture of the Coagulation business in 2010. There were no acquisitions made in 2010, 2009 or 2008. In 2007, the Group acquired the immuno-technology assets of Cortex and certain components of the distribution business of Sterilab. In 2006, the Group acquired the Haemostasiscoagulation business of bioMerieux (subsequently divested) and a direct selling entity in France. In 2005, Group acquired Primus Corporation and Research Diagnostics Inc (“RDI”).

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For further information about the Group’s principal products, principal markets and competition please refer to Item 4, “Information on the Company”.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with IFRS. The preparation of these financial statements requires us to make estimates and judgements that affect the reported amount of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
On an on-going basis, we evaluate our estimates, including those related to intangible assets, contingencies and litigation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We believe the critical accounting policies described below reflect our more significant judgements and estimates used in the preparation of our consolidated financial statements.
Revenue Recognition
Revenue from the sale of goods is recognised in the statement of operations when the significant risks and rewards of ownership have been transferred to the buyer. Revenue from products is generally recorded as of the date of shipment, consistent with our typical ex-works shipment terms. Where the shipment terms do not permit revenue to be recognised as of the date of shipment, revenue is recognised when the Group has satisfied all of its obligations to the customer in accordance with the shipping terms. Revenue, including any amounts invoiced for shipping and handling costs, represents the value of goods supplied to external customers, net of discounts and excluding sales taxes.

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Revenue from services rendered is recognised in the statement of operations in proportion to the stage of completion of the transaction at the balance sheet date.
Revenue is recognised to the extent that it is probable that economic benefit will flow to the Group, that the risks and rewards of ownership have passed to the buyer and the revenue can be measured. No revenue is recognised if there is uncertainty regarding recovery of the consideration due at the outset of the transaction or the possible return of goods.
The Group leases instruments under operating and finance leases as part of its business. In cases where the risks and rewards of ownership of the instrument pass to the customer, the fair value of the instrument is recognised as revenue at the commencement of the lease and is matched by the related cost of sale. In the case of operating leases of instruments which typically involve commitments by the customer to pay a fee per test run on the instruments, revenue is recognised on the basis of customer usage of the instruments.
Research and development expenditure
We write-off research and development expenditure as incurred, with the exception of expenditure on projects whose outcome has been assessed with reasonable certainty as to technical feasibility, commercial viability and recovery of costs through future revenues. Such expenditure is capitalised at cost within intangible assets and amortised over its expected useful life of 15 years, which commences when commercial production starts.
Factors which impact our judgement to capitalise certain research and development expenditure include the degree of regulatory approval for products and the results of any market research to determine the likely future commercial success of products being developed. We review these factors each year to determine whether our previous estimates as to feasibility, viability and recovery should be changed.
At December 31, 20082010 the carrying value of capitalised development costs was US$5,338,000 (2007:10,073,000 (2009: US$19,150,000)12,785,000) (see Item 18, note 12 to the consolidated financial statements). The decrease in 20082010 was attributable to an impairment lossas a result of US$21,480,000 which arose from the Group’s annual impairment review (see Item 18, note 3 to the consolidated financial statements). This decrease was partially offset by development costs of US$8,426,0005,887,000 being capitalised in 2008.
In December 2007, as part2010 which were more than offset by amortisation of an overall restructuring announced,US$297,000 and reductions associated with the Group announced its intention to focus on a smaller number of R&D projects, with a particular focus on projects which will make the greatest contribution to the strategic growth and developmentdivestment of the Group. As partCoagulation business; which had a net book value of the Group restructuring it was decided to terminate or suspend a number of projects. As a result, US$5,134,000 of development costs were written off for the year ended December 31, 2007.8,289,000.

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Impairment of intangible assets and goodwill
Definite lived intangible assets are reviewed for indicators of impairment annually while goodwill and indefinite lived assets are tested for impairment annually, individually or at the cash generating unit level. Factors considered important, as part of an impairment review, include the following:
Significant underperformance relative to expected, historical or projected future operating results;
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;
Obsolescence of products;
Significant decline in our stock price for a sustained period; and
Our market capitalisation relative to net book value.
Significant underperformance relative to expected, historical or projected future operating results;
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;
Obsolescence of products;
Significant decline in our stock price for a sustained period; and
Our market capitalisation relative to net book value.
When we determine that the carrying value of intangibles, non-current assets and related goodwill may not be recoverable based upon the existence of one or more of the above indicators of impairment, any impairment is measured based on our estimates of projected net discounted cash flows expected to result from that asset, including eventual disposition. Our estimated impairment could prove insufficient if our analysis overestimated the cash flows or conditions change in the future.
The recoverable amount of goodwill and intangible assets contained in each of the Group’s CGU’s is determined based on the greater of the fair value less cost to sell and value in use calculations. The Group operates in one business segmentmarket sector (namely diagnostics) and accordingly the key assumptions are similar for all CGU’s. The value in use calculations use cash flow projections based on the 20092011 budget and projections for a further four years using a projected revenue and cost growth raterates of between 3% and a cost growth rate of 3%5%. At the end of the five year forecast period, terminal values for each CGU, based on a long term growth rate are used in the value in use calculations. The cashflows and terminal values for the CGU’s are discounted using pre-tax discount rates which range from 8%18% to 41%32%.

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Asset impairment charges totalling $85,793,000 have been recognised
The value in use calculation is subject to significant estimation, uncertainty and accounting judgements and are particularly sensitive in the statement of operations in the year ended December 31, 2008. In accordance with IAS 36 the Group carries out an annual impairment review of the asset valuations. The Group carries out its impairment review on 31 December each year. In determining whether a potential asset impairment exists, the Group considered a range of internal and external factors. One such factor was the relationship between the Group’s market valuation and the book value of its net assets.
Trinity Biotech’s market capitalization in the recent equity market conditions was significantly below the book value of its net assets. In such circumstances given the accounting standard requirements, the Group decided to recognize at December 31, 2008 a non-cash impairment charge of US$81.3 million after tax. The impairment was recorded against goodwill and other intangible assets, property, plant and equipment and prepayments.
following areas. In the event that there was a variation of 10% in the assumed level of future growth in revenues, which would represent a reasonably likely range of outcomes, therethe following impairment loss/write back would be the following impact on the level of the goodwill impairment loss recorded at December 31, 2008:2010:
An increase in impairment of US$5.3 million in the event of a 10% decrease in the growth in revenues.
A decrease in impairment of US$5.0 million in the event of a 10% increase in the growth in revenues.
No impairment loss or reversal of impairment in the event of a 10% increase in the growth in revenues.
No impairment loss or reversal of impairment in the event of a 10% decrease in the growth in revenues.
Similarly if there was a 10% variation in the discount rate used to calculate the potential goodwill impairment of the carrying values, which would represent a reasonably likely range of outcomes, there would be the following impact on the level of the goodwill impairment lossloss/write back would be recorded at December 31, 2008:2010:
An increase in
No impairment loss or reversal of impairment of US$4.8 million in the event of a 10% increase in the discount rate.
A decrease in impairment of US$4.7 million in the event of a 10% decrease in the discount rate

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No impairment loss or reversal of impairment in the event of a 10% increase in the discount rate
Allowance for slow-moving and obsolete inventory
We evaluate the realisability of our inventory on a case-by-case basis and make adjustments to our inventory provision based on our estimates of expected losses. We write off any inventory that is approaching its “use-by” date and for which no further re-processing can be performed. We also consider recent trends in revenues for various inventory items and instances where the realisable value of inventory is likely to be less than its carrying value. Given the allowance is calculated on the basis of the actual inventory on hand at the particular balance sheet date, there were no material changes in estimates made during 2006, 20072008, 2009 or 20082010 which would have an impact on the carrying values of inventory during those periods, except as discussed below.
At December 31, 20082010 our allowance for slow moving and obsolete inventory was US$16,461,0006,400,000 which represents approximately 28.0%26.7% of gross inventory value. This compares with US$18,234,000,12,566,000, or approximately 29.1%24.3% of gross inventory value, at December 31, 20072009 (see Item 18, note 15 to the consolidated financial statements) and US$7,284,000,16,461,000, or approximately 13.8%28.0% of gross inventory value, at December 31, 2006.2008. There has been no significant changea small increase in the estimated allowance for slow moving and obsolete inventory as a percentage of gross inventory between 20072010 and 2008.2009. In the case of finished inventory, the size of this provision has been calculated based on the expected future sales of products which are being rationalised. In the case of raw materials and work in progress, the size of the provision has been based on expected future production of these products. Management is satisfied that the assumptions made with respect to future sales and production levels of these products are reasonable to ensure the adequacy of this provision. The change in the estimated allowance for slow moving and obsolete inventory as a percentage of gross inventory in 2007 compared to 2006 was principally due a US$11,772,000 provision recorded in 2007 arising from the rationalisation of the Group’s haemostasis and infectious diseases product lines announced as part of the Group’s restructuring of its business in December 2007 (See Item 18, note 3 to the consolidated financial statements). In the event that the estimate of the provision required for slow moving and obsolete inventory was to increase or decrease by 2% of gross inventory, which would represent a reasonably likely range of outcomes, then a change in allowance of US$1,176,000480,000 at December 31, 2008 (2007:2010 (2009: US$1,253,000) (2006:1,035,000) (2008: US$1,057,000)1,176,000) would result.
Allowance for impairment of receivables
We make judgements as to our ability to collect outstanding receivables and where necessary make allowances for impairment. Such impairments are made based upon a specific review of all significant outstanding receivables. In determining the allowance, we analyse our historical collection experience and current economic trends. If the historical data we use to calculate the allowance for impairment of receivables does not reflect the future ability to collect outstanding receivables, additional allowances for impairment of receivables may be needed and the future results of operations could be materially affected. Given the specific manner in which the allowance is calculated, there were no material changes in estimates made during 20082010 or 20072009 which would have an impact on the carrying values of receivables in these periods. At December 31, 2008,2010, the allowance was US$619,0001,443,000 which represents approximately 0.4%1.6% of Group revenues. This compares with US$657,000855,000 at December 31, 20072009 which represents approximately 0.5%0.7% of Group revenues (see Item 18, note 16 to the consolidated financial statements) and to US$1,074,000619,000 at December 31, 2006,2008, which represents approximately 0.9%0.4% of Group revenues. In the event that this estimate was to increase or decrease by 0.4% of Group revenues, which would represent a reasonably likely range of outcomes, then a change in the allowance of US$561,000359,000 at December 31, 2008 (2007:2010 (2009: US$574,000) (2006:504,000) (2008: US$475,000)561,000) would result.
Accounting for income taxes
Significant judgement is required in determining our worldwide income tax expense provision. In the ordinary course of a global business, there are many transactions and calculations where the ultimate tax outcome is uncertain. Some of these uncertainties arise as a consequence of revenue sharing and cost reimbursement arrangements among related entities, the process of identifying items of revenue and expense that qualify for preferential tax treatment and segregation of foreign and domestic income and expense to avoid double taxation. In addition, we operate within multiple taxing jurisdictions and are subject to audits in these jurisdictions. These audits can involve complex issues that may require an extended period of time for resolution. Although we believe that our estimates are reasonable, no assurance can be given that the final tax outcome of these matters will not be different than that which is reflected in our historical income tax provisions and accruals. Such differences could have a material effect on our income tax provision and profit in the period in which such determination is made. Deferred tax assets and liabilities are determined using enacted or substantively enacted tax rates for the effects of net operating losses and temporary differences between the book and tax bases of assets and liabilities.

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While we have considered future taxable income and ongoing prudent and feasible tax planning strategies in assessing whether deferred tax assets can be recognised, there is no assurance that these deferred tax assets may be realisable.
The extent to which recognised deferred tax assets are not realisable could have a material adverse impact on our income tax provision and net income in the period in which such determination is made. In addition, we operate within multiple taxing jurisdictions and are subject to audits in these jurisdictions. These audits can involve complex issues that may require an extended period of time for resolution. In management’s opinion, adequate provisions for income taxes have been made.

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Item 18, note 13 to the consolidated financial statements outlines the basis for the deferred tax assets and liabilities and includes details of the unrecognized deferred tax assets at year end. The Group does not recognize deferred tax assets arising on unused tax losses except to the extent that there are sufficient taxable temporary differences relating to the same taxation authority and the same taxable entity which will result in taxable amounts against which the unused tax losses can be utilised before they expire.
Share-based payments
For equity-settled share-based payments (share options), the Group measures the services received and the corresponding increase in equity at fair value at the measurement date (which is the grant date) using a trinomial model. Given that the share options granted do not vest until the completion of a specified period of service, the fair value, which is assessed at the grant date, is recognised on the basis that the services to be rendered by employees as consideration for the granting of share options will be received over the vesting period.
The share options issued by the Group are not subject to market-based vesting conditions as defined in IFRS 2,Share-based Payment. Non-market vesting conditions are not taken into account when estimating the fair value of share options as at the grant date; such conditions are taken into account through adjusting the number of equity instruments included in the measurement of the transaction amount so that, ultimately, the amount recognised equates to the number of equity instruments that actually vest. The expense in the statement of operations in relation to share options represents the product of the total number of options anticipated to vest and the fair value of those options; this amount is allocated to accounting periods on a straight-line basis over the vesting period. Given that the performance conditions underlying the Group’s share options are non-market in nature, the cumulative charge to the statement of operations is only reversed where the performance condition is not met or where an employee in receipt of share options relinquishes service prior to completion of the expected vesting period. Share based payments, to the extent they relate to direct labour involved in development activities, are capitalised.
The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the options are exercised. The Group does not operate any cash-settled share-based payment schemes or share-based payment transactions with cash alternatives as defined in IFRS 2.
Impact of Recently Issued Accounting Pronouncements
The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) both as issued by the International Accounting Standards Board (“IASB”) and as subsequently adopted by the European Union (“EU”). The IFRS applied are those effective for accounting periods beginning on or after 1 January 2008.2010. Consolidated financial statements are required by Irish law to comply with IFRS as adopted by the EU which differ in certain respects from IFRS as issued by the IASB. These differences predominantly relate to the timing of adoption of new standards by the EU. However, as none of the differences are relevant in the context of Trinity Biotech, the consolidated financial statements for the periods presented comply with IFRS both as issued by the IASB and as adopted by the EU. During 2007,2010, the IASB and the International Financial Reporting Interpretations Committee (“IFRIC”) issued additional standards, interpretations and amendments to existing standards which are effective for periods starting after the date of these financial statements. A list of these additional standards, interpretations and amendments, and the potential impact on the financial statements of the Group, is outlined in Item 18,note 1(z).

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Subsequent Events
Acquisition of Phoenix Bio-tech Corp.
On January 4, 2011, the Group purchased 100% of the common stock of Phoenix Bio-tech Corporation for US$2.5 million. Phoenix Bio-tech manufactures and sells products for the detection of syphilis. This acquisition has not been reflected in the financial statements for the year ended December 31, 2010 as it was completed subsequent to the financial year end. The fair values of the acquired assets and liabilities have not been established yet.
Phoenix Bio-tech was founded in 1992 and is based in Toronto, Canada. It sells its products under the TrepSure and TrepCheck labels. Phoenix’s annual revenues are approximately US$1.25 million. Prior to the acquisition, Trinity Biotech distributed Phoenix Bio-tech’s syphilis products on a non-exclusive basis in the USA.
The key terms of the acquisition are as follows:
Consideration of US$2,500,000. US$1,000,000 was payable on closing and the remaining US$1,500,000 is payable in four instalments in the period April 2011 to January 2012.
The consideration of US$2,500,000 includes acquired net working capital of approximately US$500,000.
As the initial accounting and fair value assessment for the business combination is incomplete at the time that these financial statements were authorised for issue the following disclosures cannot be made but will be reported if relevant in the Form 20-F for the period ended December 31, 2011:
A qualitative description of the factors that make up the goodwill to be recognised,
Details of the indemnification assets,
Details of acquired receivables,
The amounts recognised as of the acquisition date for each major class of asset acquired and liability assumed,
Details of contingent liabilities recognised; and
The total amount of goodwill that is expected to be deductible for tax purposes.
Dividend
In 2011 the Company announced that it intended to commence a dividend policy, to be paid once a year. In this regard, the Board of Directors has proposed a final dividend of 10 cent per ADR in respect of 2010 and this proposal will be submitted to shareholders for their approval at the next Annual General Meeting of the Company. As provided in the Articles of Association of the Company, dividends or other distributions are declared and paid in US Dollars.

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Results of Operations
Year ended December 31, 20082010 compared to the year ended December 31, 20072009
The following compares our results in the year ended December 31, 20082010 to those of the year ended December 31, 20072009 under IFRS. Our analysis is divided as follows:
 1. 
Overview
 2. 
Revenues
 3. 
Operating ExpensesProfit
 
 4. 
LossProfit for the year
1. Overview
In 2010, Trinity Biotech divested its coagulation business and this was the main reason for the US$36.3 million decline in revenues compared to 2009. Excluding coagulation revenues, the decrease was US$4.8 million, representing a reduction of 6% compared to 2009. In 2010, point-of-care revenues declined by 11%, largely due to the company’s decision not to ship to a major HIV customer beginning in the second half of 2009 and continuing into 2010 due to credit related issues. Lower levels of public expenditure on testing in the US market also caused the reduction in point-of-care revenues. Clinical laboratory revenues (excluding coagulation) declined by just under 5%.
The gross margin is 49% for 2010, which is 3.7% higher than the gross margin for 2009. The increase in gross margin this year is primarily attributable to the divestiture of the coagulation business. Due to the costly instrument servicing requirements in the coagulation business, it was the Group’s least profitable product line.
The divestiture of the coagulation business resulted in a once-off gain of US$46.8 million.
The table hereunder compares the profit before tax for year ended December, 2010 to the previous financial year.
             
  Year ended December 31, 
  2010  2009    
  US$’000  US$’000  %Change 
             
Profit before Tax  61,360   12,915     
             
Profit before Tax (2010 figure shown before net gain on divestment of business and restructuring expenses)  14,886   12,915   15.3%
The profit before tax is US$61.4 million for the year ended December 31, 2010 which compares to a profit before tax of US$12.9 million for the year ended December 31, 2009. Excluding the gain on the divestiture of the coagulation business and the impact of restructuring expenses in 2010, the profit before tax would have been US$14.9 million in 2010. On a like-for-like basis, there was therefore an increase in profit before tax of 15.3% in 2010. The US$2.0 million increase in profit before tax was primarily due to the elimination of bank debt, causing the net interest expense of US$1.2m in 2009 to become net interest income of US$0.9m in 2010.
The profit for the year ended December 31, 2010 was US$60.4 million which compares to a profit for the year ended December 31, 2009 of US$11.8 million. Excluding the gain on the divestiture of the coagulation business and the impact of restructuring expenses in 2010, the profit for 2010 would have been US$13.6 million.
2. Revenues
The Group’s revenues consist of the sale of diagnostic kits and related instrumentation and the sale of raw materials to the life sciences industry. Revenues from the sale of the above products are generally recognised on the basis of shipment to customers. The Group ships its products on a variety of freight terms, including ex-works, CIF (carriage including freight) and FOB (free on board), depending on the specific terms agreed with customers. In cases where the Group ships on terms other than ex-works, the Group does not recognise the revenue until its obligations have been fulfilled in accordance with the shipping terms.

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No right of return exists in relation to product sales except in instances where demonstrable product defects occur. The Group has defined procedures for dealing with customer complaints associated with such product defects as they arise.
The Group also derives a portion of its revenues from leasing infectious diseases diagnostic instruments to customers. In cases where the risks and rewards of ownership of the instrument passes to the customer, the fair value of the instrument is recognised at the time of sale matched by the related cost of sale. In the case of operating leases of instruments which typically involve commitments by the customer to pay a fee per test run on the instruments, revenue is recognised on the basis of customer usage of the instruments. In certain markets, the Group also earns revenue from servicing infectious diseases located at customer premises.
Revenues by Product Line
Trinity Biotech’s revenues for the year ended December 31, 2010 were US$89,635,000 compared to revenues of US$125,907,000 for the year ended December 31, 2009, which represents a decrease of US$36,272,000 or 29%. The following table sets forth selected sales data for each of the periods indicated.
             
  Year ended December 31,    
  2010  2009    
  US$’000  US$’000  % Change 
             
Revenues
            
Clinical Laboratory
  73,553   107,778   (31.8%)
             
Point of Care
  16,082   18,129   (11.3%)
          
             
Total
  89,635   125,907   (28.8%)
          
Clinical Laboratory
In 2010 Clinical Laboratory revenues decreased by US$34,225,000 which equates to a 32% decline. The decrease was largely due to the divestiture of the coagulation product line in May 2010. Excluding coagulation, clinical laboratory revenues decreased by US$2.8 million when compared to 2009. This represents a decrease of 4.5%.
The decrease was caused by four main factors:
a slower lyme season due to weather conditions in the USA;
lower sales of antibodies and antigens by our Fitzgerald business due to the fact that 2009 sales of antibodies and antigens benefitted from the incidence of H1N1;
the move from selling direct in France and Germany to a distribution selling model; and
changes in exchange rates, principally the strengthening of the US Dollar against the Euro.
These decreases were partially offset by a growth in sales of our clinical chemistry product line.

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Point of Care
Our principal Point of Care product is Unigold™, which tests for the presence of HIV antibodies. Our two main markets for Point of Care tests are USA and Africa. Point of Care revenues decreased by US$2,047,000, which represents a decline of 11%.
Point of Care revenues in the USA decreased by 10% mainly due to lower levels of public expenditure on testing in the US market. In Africa, revenues decreased by 7% largely due to the company’s decision not to ship to a major HIV customer due to credit related issues beginning in the second half of 2009 and continuing into 2010.
Revenues by Geographical Region
The following table sets forth selected sales data, analysed by geographic region, based on location of customer:
             
  Year ended December 31,    
  2010  2009    
  US$‘000  US$‘000  % Change 
             
Revenues
            
Americas  53,993   68,130   (21%)
Europe  15,890   32,389   (51%)
Asia/Africa  19,752   25,388   (22%)
          
Total
  89,635   125,907   (29%)
          
In the Americas, the 21% decrease amounting to US$14,137,000 is primarily attributable to a reduction in coagulation revenue due to the divestiture of this business in May 2010. The other main factor was a slower lyme season due to weather conditions in the USA.
Revenues in Europe decreased by US$16,499,000, or 51% compared to 2009. The decrease was mainly due to the divestiture of the coagulation product line and the move to a distributor selling model for non-coagulation products in Germany and France in the post-divestiture period. Part of the decrease was due to the weakening of the Euro against the US Dollar.
Asia/Africa revenues experienced a decline of 22%, or US$5,636,000 compared to 2009. There were two main reasons for the decrease in Asia/Africa revenues. Firstly, coagulation sales ceased in April 2010 as a result of the divestiture of the coagulation product line. Secondly, there were lower sales of Trinity’s Unigold™ rapid HIV tests following Trinity’s decision not to ship to a major customer in Africa due to the credit related issues.
For further information about the Group’s principal products, principal markets and competition please refer to Item 4, “Information on the Company”.

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3. Operating Profit
The following table sets forth the Group’s operating profit
             
  Year ended December 31,    
  2010  2009    
  US$’000  US$’000  %Change 
             
Revenues  89,635   125,907   (29%)
Cost of sales  (45,690)  (68,891)  (34%)
          
Gross profit  43,945   57,016   (23%)
Other operating income  1,616   437   270%
Research & development  (4,603)  (7,341)  (37%)
SG&A expenses  (26,929)  (36,013)  (25%)
Net gain on divestment of business and restructuring expenses  46,474       
          
Operating profit  60,503   14,099   329%
          
Cost of sales
Total cost of sales decreased by US$23,201,000 from US$68,891,000 for the year ended December 31, 2009 to US$45,690,000, for the year ended December 31, 2010, a decrease of 34%. The main reasons for the decrease in cost of sales in 2010 were the lower revenues following the divestiture of the coagulation business and the transfer of approximately 190 coagulation production employees to Diagnostica Stago in May 2010.
Gross margin
The gross margin of 49.0% in 2010 compares to a gross margin of 45.3% in 2009. The increase in gross margin in 2010 is attributable to the divestiture of the coagulation business, which was the product line with the lowest gross margin.
Other operating income
Other operating income comprises income from the provision of services to Diagnostica Stago under a Transition Services Agreement (TSA) and rental income from sublet properties. TSA income commenced in May 2010 and it accounts for the increase of US$1,179,000 compared to the year ended December 31, 2009. A variety of services were provided to Stago including accounting, information technology and logistics support and warehousing services.
Research and development expenses
Research and development (“R&D”) expenditure reduced from US$7,341,000 in 2009 to US$4,603,000 in 2010. The decrease was caused by the transfer of approximately 46 coagulation specialists to Diagnostica Stago in May 2010. For details of the Company’s various R&D projects see “Research and Products under Development” in Item 5 below.
Selling, General & Administrative expenses (SG&A)
Total SG&A expenses decreased by US$9,084,000 from US$36,013,000 for the year ended December 31, 2009 to US$26,929,000 for the year ended December 31, 2010. The decrease is primarily due to the transfer of approximately 85 coagulation employees and the transfer of our UK, German and French premises to Diagnostica Stago.
Net gain on divestment of business and restructuring expenses
This comprises the gain on the sale of the worldwide coagulation business of US$46.8 million and a charge for restructuring expenses of US$0.3 million. There were no equivalent gains or expenses in 2009. The gain comprised consideration of US$89.9 million less US$43.1 million for coagulation net assets and other attributable costs such as professional fees. For further information on the divestiture, refer to Item 18, note 3.
The restructuring expenses related to a re-organisation of the Group’s HIV manufacturing activities and comprised termination payments of US$0.3 million for employees located in Ireland.

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The following table outlines the breakdown of SG&A expenses in 2010 compared to 2009.
                 
  Year ended December 31,       
  2010  2009  (Decrease)    
  US$’000  US$’000  US$’000  % Change 
SG&A (excl. share-based payments and amortisation)  24,260   33,567   (9,307)  (28%)
Share-based payments  1,080   487   593   122%
Amortisation  1,589   1,959   (370)  (19%)
             
Total
  26,929   36,013   (9,084)  (25%)
             
Selling General & Administrative Expenditure (excluding share-based payments and amortisation)
SG&A expenses excluding share-based payments and amortisation decreased from US$33,567,000 for the year ended December 31, 2009 to US$24,260,000 for the year ended December 31, 2009, which represents a decrease of 28%.
The decrease this year of US$9,307,000 is mainly due to the transfer of approximately 48% of the Group’s selling, general and administrative employees to Diagnostica Stago in May, 2010. Stago purchased Trinity’s UK, German and French operations employing 43 selling, general and administrative employees. A further 42 selling, general and administrative employees in Ireland and USA were transferred to Stago.
SG&A costs also reduced in 2010 due to the full year effect of the cost reduction measures implemented during 2009 (for a summary of these measures please refer to last year’s analysis of the results of operations), including the rationalisation of the Group’s US finance function and overhead savings in communications, utilities and professional fees. The Group continued its cost reduction program in 2010 with the notable initiatives being the introduction of remote working arrangements for all US sales staff which allowed the closure of a sales office in New Jersey and the rationalisation of the customer service function in the US.
Share-based payments
The expense represents the fair value of share options granted to directors and employees which is charged to the statement of operations over the vesting period of the underlying options. The Group has used a trinomial valuation model for the purposes of valuing these share options with the key inputs to the model being the expected volatility over the life of the options, the expected life of the option, the option price and the risk free rate.
The Group recorded a total share-based payments charge of US$1,109,000 (2009 : US$521,000). The increase of US$588,000 in the total share-based payments expense is due to the granting of new share options to employees and directors during 2009 and 2010. The total charge is shown in the following expense headings in the statement of operations: US$29,000 (2009:US$19,000) was charged against cost of sales, US$31,000 (2009: US$15,000) was charged against research and development expenses and US$1,049,000 (2009 : US$487,000) was charged against selling, general and administrative expenses.
For further details refer to Item 18, note 19 to the consolidated financial statements.
Amortisation
Amortisation reduced from US$1,959,000 for the year ended December 31, 2009 to US$1,589,000 for the year ended December 31, 2010. The decrease of US$370,000 is mainly due to the divestiture of all coagulation intangible assets, including the Destiny range of instruments, to Diagnostica Stago as part of the divestiture of the coagulation business.

24


4. Profit for the year
The following table sets forth selected statement of operations data for each of the periods indicated.
             
  Year ended December 31,    
  2010  2009    
  US$’000  US$’000  %Change 
Operating profit  60,503   14,099   329%
Net financing income/(costs)  857   (1,184)  172%
          
Profit before tax  61,360   12,915   375%
Income tax expense  (942)  (1,091)  (14%)
          
Profit of the year  60,418   11,824   411%
          
Net Financing income/(costs)
Net financing income is US$857,000 for year end December 31, 2010 compared to a net financing cost of US$1,184,000 in 2009. Financial expenses decreased from US$1,192,000 for year end December 31, 2009 to US$495,000 in 2010. The decrease is due to the repayment of all bank loans from the proceeds of sale of the coagulation business. Financial income increased from US$8,000 for year end December 31, 2009 to US$1,352,000 in 2010 due to higher balances on deposit and due to the interest income earned on the deferred consideration. The deposit balances totalled US$55.6 million at December 31, 2010 compared to US$1.4 million at December 31, 2009.
Taxation
The Group recorded a tax charge of US$942,000 for the year ended December 31, 2010 compared to US$1,091,000 for the year ended December 31, 2009. The decrease is due to a lower deferred tax charge in respect of temporary differences as a result of the sale of the Group’s coagulation property, plant, equipment and intangible assets. This decrease was partially offset by an increase in current year taxable profits in the Group’s Irish operations. The 2010 tax charge comprises US$847,000 of current tax and US$95,000 of deferred tax. For further details on the Group’s tax charge please refer to Item 18, note 9 and note 13 to the consolidated financial statements.
Profit for the year
The profit for the year amounted to US$60,418,000 which represents an increase of US$48,594,000 when compared to US$11,824,000 in 2009. Excluding the after tax impact of the gain on the sale of the coagulation business of US$47,129,000 and the restructuring expenses of US$301,000, the 2010 profit for the year would be US$13,590,000. The increase in profits in 2010 of US$1,766,000 compared to 2009, excluding once-off gains and expenses, represents an increase of 14.9%.

25


Results of Operations
Year ended December 31, 2009 compared to the year ended December 31, 2008
The following compares our results in the year ended December 31, 2009 to those of the year ended December 31, 2008 under IFRS. Our analysis is divided as follows:
5.
Overview
6.
Revenues
7.
Operating Profit/(loss)
8.
Profit/(loss) for the year
1. Overview
Group revenues declined by US$14.2 million to US$125.9 million, representing a decrease of 10% compared to 2008. The decrease was mainly due to an 11% decrease in Clinical Laboratory revenues. The main reason for the decrease in Clinical Laboratory revenues was a decrease in coagulation revenues, caused by a reduction in the number of installed instruments and by the strengthening of the US Dollar against both the Euro and Sterling. Point of Care revenues decreased by 5%, largely due to the company’s decision not to ship to a major HIV customer due to credit related issues in the second half of 2009.
The gross margin for the year ended December 31, 2009 is 45.3%, which is 0.7% higher than the gross margin for 2008. The increase in gross margin this year is primarily attributable to a reduction in overheads and payroll costs following a cost reduction program, lower depreciation charges and the more favourable Euro exchange rate compared to the previous financial year.
In 2008, Trinity Biotech recognised an impairment charge of US$85.8 million in the statement of operations relating to the carrying value of goodwill and other intangible assets, property, plant and equipment and prepayments. This non-cash impairment charge, which was triggered by a comparisonprepayments, in the statement of our market capitalisation versus the book value of our net assets as required under IFRS accounting standards, contributed to the company recording a loss for the year of US$77.8 million.
operations. Additionally in December 2008, we recognised restructuring expenses of US$2.1 million. This is made up of US$1.5 million in relation to the resignation of the Company’s former Chief Executive and US$0.6 million in relation to costs associated with the implementation of headcount reductions as part of a cost cutting programme announced in December 2008.
Before the impactwere recognised. The total effect of these impairment and restructuringonce-off charges on the Company would have recorded2008 results was a reduction in profit before tax of US$6.2 million.87.9 million and a reduction of US$83.1m in profit after tax.

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The following table sets forth a breakdown of impairment chargeshereunder compares the operating profit/(loss) and restructuring expenses incurred in the current financial year:
             
  Year ended December 31, 2008 
  Impairment  Restructuring  Total 
  US$’000  US$’000  US$’000 
Selling, general & administration expenses
            
Impairment of property, plant and equipment (Item 18, note 11)  13,095      13,095 
Impairment of goodwill and other intangible assets (Item 18, note 12)  71,684      71,684 
Impairment of prepayments (Item 18, note 16)  1,014      1,014 
             
Employee termination payments     589   589 
Director’s compensation for loss of office and share option expense     1,465   1,465 
Other restructuring expenses     35   35 
          
Total impairment loss and restructuring expenses before tax
  85,793   2,089   87,882 
          
             
Income tax impact of impairment loss and restructuring expenses (Item 18, note 9)  (4,536)  (215)  (4,751)
          
Total impairment loss and restructuring expenses after tax
  81,257   1,874   83,131 
          
For theprofit after tax for year ended December, 31, 2007, the impact of restructuring expenses and a goodwill impairment was a charge2009 to the statement of operations after tax of US$38.4 million.previous financial year.
Group revenues decreased by US$3.5 million in 2008, representing a decline of 2%. This was mainly attributable to lower Point of Care revenues. During 2008 revenues from HIV products grew in the USA but this was more than offset by lower revenue for HIV tests in Africa. The latter was due to particularly strong sales in 2007 with the result that the return to more normal sales levels resulted in a decline in overall Point of Care revenues.
             
  Year ended December 31,    
  2009  2008    
  US$’000  US$’000  %Change 
             
Operating Profit/(loss)  14,099   (79,575)    
             
Operating Profit (2008 figure shown before impairment and restructuring charges)  14,099   8,307   70%
             
Profit/(loss) after Tax  11,824   (77,778)    
             
Profit after Tax (2008 figure shown before impairment and restructuring charges)  11,824   5,353   121%
The gross marginoperating profit is US$14.1 million for the year ended December 31, 2008 was approximately 45%. In 2007, excluding the impact of US$12.7 million restructuring expenses and write-offs, the gross margin would have been 47%. The lower gross margin in 2008 reflects the impact of lower sales of Uni-Gold™ HIV products, as these products typically command higher margins. Gross margins were also adversely impacted by the weaker US dollar during 2008 compared2009 which compares to 2007.
Thean operating loss wasof US$79.6 million for the year ended December 31, 2008 which compares to an operating loss of US$29.4 million for the year ended December 31, 2007.2008. Excluding the impact of impairment charges and restructuring expenses in both 2007 and 2008, the operating profit would be $8.3have been US$8.3 million in 2008, compared to US$10.6 million2008. On a like-for-like basis, there was therefore an increase in 2007, a declineoperating profit of 22%. This decline is mainly attributable70% in 2009. The increase in operating profit was due to the impact of significant decrease in revenue from higher margin HIV tests in Africa and the adverse change in the euro to US dollar exchange rate. The Group succeeded in significantly offsetting these negative effects by implementing cost reduction measures more than offsetting the negative effect of a 10% fall in revenues. The profitability in 2009 was also helped by a reduction in depreciation and amortisation charges and by driving revenue growth in its other product lines, principally infectious disease and clinical chemistry.more favourable Euro versus US Dollar exchange rates.

26


The lossprofit for the year ended December 31, 20082009 was US$77.811.8 million which compares to a loss for the year ended December 31, 20072008 of US$35.477.8 million. Excluding the after tax impact of the restructuring expenses and goodwill impairment, the profit for 20072008 would have been US$3.05.4 million. Similarly, if the after tax impact of the restructuring expenses and impairment charges is excluded from the 2008 results, the profit for the year would be US$5.3 million. Despite a loss before tax being recorded for the year in ended December 31, 2007, we recorded a tax charge of US$3.3 million due to the derecognition of deferred tax assets of US$3.8 million in relation to unused tax losses.
In December 2008, the Group’s new haemostasis analyzer, Destiny Max, was launched in markets outside the USA. Destiny Max represents the largest development project ever undertaken by the Group. Its launch represents a major success for the Group. Notwithstanding that the launch came close to the end of the year, the Group was proud to announce it had achieved the first sales of instruments in Japan, Italy and Ireland in 2008. The submission to the FDA for approval of Destiny Max was filed in December 2008. The Group expects to launch Destiny Max in the USA towards the end of quarter 2, 2009.

19


2. Revenues
The Group’s revenues consist of the sale of diagnostic kits and related instrumentation and the sale of raw materials to the life sciences industry. Revenues from the sale of the above products are generally recognised on the basis of shipment to customers. The Group ships its products on a variety of freight terms, including ex-works, CIF (carriage including freight) and FOB (free on board), depending on the specific terms agreed with customers. In cases where the Group ships on terms other than ex-works, the Group does not recognise the revenue until its obligations have been fulfilled in accordance with the shipping terms.
No right of return exists in relation to product sales except in instances where demonstrable product defects occur. The Group has defined procedures for dealing with customer complaints associated with such product defects as they arise.
The Group also derives a portion of its revenues from leasing infectious diseases and haemostasiscoagulation diagnostic instruments to customers. In cases where the risks and rewards of ownership of the instrument passes to the customer, the fair value of the instrument is recognised at the time of sale matched by the related cost of sale. In the case of operating leases of instruments which typically involve commitments by the customer to pay a fee per test run on the instruments, revenue is recognised on the basis of customer usage of the instruments. In certain markets, the Group also earns revenue from servicing infectious diseases and haemostasiscoagulation instrumentation located at customer premises.
Revenues by Product Line
Trinity Biotech’s revenues for the year ended December 31, 20082009 were US$140,139,000125,907,000 compared to revenues of US$143,617,000140,139,000 for the year ended December 31, 2007,2008, which represents a decrease of US$3,478,00014,232,000 or 2.4%10%. The following table sets forth selected sales data for each of the periods indicated.
                        
 Year ended December 31,    Year ended December 31,   
 2008 2007    2009 2008   
 US$’000 US$’000 % Change  US$’000 US$’000 % Change 
  
Revenues
  
Clinical Laboratory 121,143 119,113  2% 107,778 121,143  (11%)
 
Point of Care 18,996 24,504  (23%) 18,129 18,996  (5%)
       
        
Total
 140,139 143,617  (2%) 125,907 140,139  (10%)
              
Clinical Laboratory
In 20082009 Clinical Laboratory revenues increaseddecreased by US$2,030,00013,365,000 which equates to a growth rate of 2%.an 11% decline. The growthdecrease was driven by strong demand for infectious disease tests and clinical chemistry tests, which increased by 8% and 9% respectively. These increases were largely offset bymainly due to a 5% decline in sales of haemostasis products.
Salescoagulation products in advance of infectious diseases products have increased by US$3,401,000. The 8% increase in 2008 is principally due to higher salesthe worldwide launch of Lyme kits in the US market, a full year’s trading for the Cortex Biochem and Sterilab Services businesses which were acquired in September and October 2007 respectively, and lastly an increase in sales of antibodies by our Fitzgerald business. The Fitzgerald revenues were weakened in 2007 by a poor flu season in that year and 2008 saw a recovery to a more typical level.
Clinical chemistry revenues grew by 9% or US$1,567,000 mainly due to increased sales of diabetes tests in US, Europe and Asia. The demand for in vitro diagnostic tests for haemoglobin A1c and haemoglobin variants continues to grow as diabetes becomes more prevalent.Destiny Max instrument.
The decrease in haemostasiscoagulation revenues of US$2,938,000 was mainly caused by a decreasereduction in customersthe installed customer base and by movements in theforeign exchange rates. The installed base of MDA instruments in the US and UK and, to a lesser extent, a reductiondeclined in advance of the Amax instrument base in Germany. The MDA and Amax 400 instruments are large scale instruments inlaunch of the late stage of their life cycles. The newly developed Destiny Max instrument, whichinstrument. The Destiny Max was launched in all markets except US in December 2008,by July 2009 and is the naturaldesignated replacement for the MDA and Amax 400 instruments. Its introduction to our product range will help to curtail customer losses in that endMDA. 5% of the market. Increased haemostasis revenues through our distributor networkoverall decrease was caused by changes in Western Europe and Latin America partially offsetexchange rates, principally the effectstrengthening of the lower revenue in US UK and Germany.Dollar against the Euro.

 

2027


Point of Care
Our principal Point of Care products areproduct is Unigold™ and Capillus™ and they test, which tests for the presence of HIV antibodies. 2007 was an exceptionally strong yearSales of Point of Care tests decreased by US$867,000, which equates to a 5% decline.
Our two main markets for salesPoint of Care tests are Africa and USA. Sales of HIV tests in Africa. Revenues fromAfrica decreased by 18% largely due to the company’s decision not to ship to a major HIV sales in Africa revertedcustomer due to more normal levels in 2008 and were 16% higher than in 2006, a more comparable year. Meanwhilecredit related issues in the important US market,second half of 2009. Point of Care revenue continuesrevenues continued to show strong growth in the USA with an increase this year of 18%17% compared to 2007.2008. Outside of our two main Point of Care markets, revenues increased by 4% in 2009, with most of this increase coming from Latin America.
Revenues by Geographical Region
The following table sets forth selected sales data, analysed by geographic region, based on location of customer:
            
 Year ended December 31,               
 2008 2007    Year ended December 31,   
 US$’000 US$’000 % Change  2009 2008   
  US$‘000 US$‘000 % Change 
Revenues
  
Americas 69,915 68,481  2% 68,130 69,915  (3%)
Europe 43,481 43,631  0% 32,389 43,481  (26%)
Asia/Africa 26,743 31,505  (15%) 25,388 26,743  (5%)
              
Total
 140,139 143,617  (2%) 125,907 140,139  (10%)
              
The 2% increase3% decrease in the Americas amounting to US$1,434,0001,785,000 is primarily attributable to a reduction in coagulation revenue arising from an erosion of the MDA customer base. This reduction was largely offset by growth in the sales of the Unigold rapid HIV test, higher sales of infectious diseasediseases tests mainly Lyme’sLyme disease and higher revenues relatingfor diabetes related tests.
European revenues experienced a decline of US$11,092,000, or 26% compared to diabetes tests. These increases were largely offset by2008. 9% of the decrease was due to the weakening of both Euro and Sterling against the US Dollar. The remaining 17% decrease was mainly due to a reduction in haemostasis revenuecoagulation revenues arising from an erosion of the MDAinstalled customer base.
European revenues were consistent with the previous year. A decreasebase of medium and high throughput analyzers, particularly in revenue in the German market was offset by increased sales to distributors in other European markets mainly relating to haemostasis products.UK and Germany.
A US$4,762,0001,355,000 decrease in Asia/Africa revenues is primarilylargely due to lower sales of Trinity’s Unigold rapid HIV tests following Trinity’s decision not to ship to a major customer in Africa partly offset by higher haemostasis revenues indue to the region.credit related issues.
For further information about the Group’s principal products, principal markets and competition please refer to Item 4, “Information on the Company”.

 

2128


3. Operating ExpensesProfit/(loss)
The following table sets forth the Group’s operating expenses.profit/(loss)
                        
 Year ended December 31,    Year ended December 31,   
 2008 2007    2009 2008   
 US$’000 US$’000 % Change  US$’000 US$’000 %Change 
  
Revenues 140,139 143,617  (2%) 125,907 140,139  (10%)
Cost of sales  (77,645)  (75,643)  3%  (68,891)  (77,645)  (11%)
Cost of sales — restructuring expenses   (953)  (100%)
Cost of sales — inventory write off/ provision   (11,772)  (100%)
       
Gross profit 62,494 55,249  13% 57,016 62,494  (9%)
Other operating income 1,173 413  184% 437 1,173  (63%)
Research & development  (7,544)  (6,802)  11%  (7,341)  (7,544)  (3%)
Research & development — restructuring expenses   (6,907)  (100%)
SG&A expenses  (47,816)  (51,010)  (6%)  (36,013)  (47,816)  (25%)
SG&A expenses — impairment charges and restructuring expenses  (87,882)  (20,315)  333%   (87,882)  (100%)
              
Operating (loss)  (79,575)  (29,372)  171%
Operating profit/(loss) 14,099  (79,575) 
              
Cost of sales
Total cost of sales decreased by US$10,723,0008,754,000 from US$88,368,000 for the year ended December 31, 2007 to US$77,645,000 for the year ended December 31, 2008 a decrease of 12%. The decrease is primarily attributable to the restructuring expenses of US$12,725,000 recognised in cost of sales in 2007, partially offset by an increase in cost of sales (excluding once-off items) of $2,002,000.
Included in cost of sales68,891,000, for the year ended December 31, 2007 was US$11,772,000 for an inventory write off and US$953,000 for restructuring expenses. These charges resulted from2009, a decision taken by the Boarddecrease of Directors of Trinity Biotech during 2007 to restructure the business. Under the restructuring plan, the company undertook to reduce the number of products and instruments within the two key product lines of haemostasis and infectious diseases. As a result, the Group recognised US$11,772,000 for inventory written off relating to those haemostasis and infectious diseases products and instruments being rationalised for the year ended December 31, 2007. As part of the restructuring, the Group also recognised an additional amount of US$953,000 in cost of sales for termination payments for the year ended December 31, 2007.
Excluding the inventory write off and restructuring expenses incurred, the cost of sales in 2007 would have been $75,643,000, which is 3% lower than the comparable figure in 2008.11%. The two main reasons for the increasedecrease in cost of sales in 20082009 were the adverselower revenues, the savings achieved by a cost reduction program and the change in the euroEuro exchange rate compared to the previous financial yearyear.
The cost reduction program succeeded in reducing a wide range of direct costs including wages and the changesalaries, utilities and freight costs. Depreciation charges decreased also in the sales mix. 2009.
A significant proportion of the Group’s Cost of Sales is denominated in Euro. During 20082009 the average Euro versus US Dollar exchange rate was 8% higher6% lower than in 20072008 and this had the effect of increasingreducing Cost of Sales. The sales mix changed principally because of the decline in revenues from HIV tests in Africa with an increase in revenues for Infectious Disease and Clinical Chemistry revenues.
Gross margin
The gross margin of 45%45.3% in 20082009 compares to a gross margin of 38%44.6% in 2007.2008. The increase in gross margin in 20082009 is primarily attributable to a reduction in overheads and payroll costs following the impactcost reduction program, lower depreciation charges and the slightly more favourable Euro exchange rate compared to the previous financial year.
Other operating income
Other operating income comprises government grants and rental income from sublet properties. The 63% reduction in 2009 is mainly due to lower government grants following the completion of the restructuring expenses and the inventory write off recorded in 2007. Excluding the impact of the US$12.7 million restructuring expenses and inventory write off, the gross margin in 2007 would have been 47%, which is slightly higher than the 2008 gross margin. The main reasons for this reduction are the impact of lower sales of Uni-Gold HIV products, as these products achieve higher margins, and secondly the gross margin was adversely impacted by the weaker US dollar during 2008 compared to 2007.related grant-aided activity.

22


Research and development expenses
Research and development (“R&D”) expenditure reduced from US$13,709,000 in 2007 to US$7,544,000 in 2008. In 2007, R&D restructuring expenses of US$6,907,000 were incurred and this is largely the reason for the higher expenditure in 2007. The restructuring expenses in 2007 consisted of US$5,573,000 of development and licence costs written off, US$1,094,000 written off the carrying value of technology intangible assets acquired from BioMerieux and lastly termination payments amounting2008 to US$240,000.
Research and development expenditure, excluding the impact of last year’s restructuring expenses, increased by $742,000 compared to 2007.7,341,000 in 2009. The main reason for the increasedecrease was the change in the US Dollar to Euro exchange rate, which caused research and development costs incurred in our Irish and German operations to increasedecrease by about 8%approximately 6%. The other reason for the increase in R&D expenditureThis decrease was thepartly offset by an increase in average R&D headcount from 51 in 2007 to 57 in 2008.2008 to 61 in 2009. For a considerationdetails of the Company’s various R&D projects see “Research and Products under Development” in Item 5 below.
Selling, General & Administrative expenses (SG&A)
Total SG&A expenses increaseddecreased by US$64,373,00099,685,000 from US$71,325,000135,698,000 for the year ended December 31, 20072008 to US135,698,000US$36,013,000 for the year ended December 31, 2008.2009. The increasedecrease is primarily due to the higher impairment charges and restructuring expenses of US$87,882,000 incurred in 2008, which were partially offset by a reduction in SG&A expenses excluding share-based payments and amortisation. 2008.

29


The following table outlines the breakdown of SG&A expenses in 20082009 compared to 2007.2008.
                
 Year ended December 31, Increase/                   
 2008 2007 (decrease)    Year ended December 31,     
 US$’000 US$’000 US$’000 % Change  2009 2008 (Decrease)   
  US$’000 US$’000 US$’000 % Change 
SG&A (excl. share-based payments and amortisation) 43,269 46,368  (3,099)  (7%) 33,567 43,314  (9,747)  (23%)
SG&A — impairment charges and restructuring expenses 87,882 20,315 67,567  333%  87,882  (87,882)  (100%)
Share-based payments 931 1,224  (293)  (24%) 487 886  (399)  (45%)
Amortisation 3,616 ��3,418 198  6% 1,959 3,616  (1,657)  (46%)
                  
Total
 135,698 71,325 64,373  90% 36,013 135,698  (99,685)  (73%)
                  
Selling General & Administrative Expenditure (excluding share-based payments and amortisation)
SG&A expenses excluding share-based payments and amortisation decreased from US$46,368,000 for the year ended December 31, 2007 to US$43,269,00043,314,000 for the year ended December 31, 2008 to US$33,567,000 for the year ended December 31, 2009, which represents a decrease of 7%23%.
The decrease would have been greater than 7% butthis year of US$9,747,000 is mainly attributable to cost reductions as follows:
a cost reduction program involving a headcount reduction was announced in December 2008, which delivered payroll cost savings in SG&A of approximately US$5,100,000 in 2009. The headcount reduction also had the effect of reducing travel and other employee expenses by almost US$1,000,000.
other headcount reductions implemented in 2009 contributed to a further reduction in SG&A payroll costs of US$700,000. These headcount reductions mainly involved the rationalisation of the French sales and US finance functions.
a salary reduction for an adverse changedirectors and senior managers was implemented in the euro exchange rate compared to the previous financial year. Aearly 2009 and resulted in a cost saving of approximately US$700,000.
a significant proportion of the Group’s SG&A expenses are denominated in euro.Euro. During 20082009 the average euroUS dollar versus US dollarEuro exchange rate was 8% higher6% lower compared to 20072008 and this had the effect of increasingreducing SG&A expenses by about US$1,800,000.
Despite1,100,000. The US dollar also strengthened versus Sterling in 2009 and this had the adverse change ineffect of reducing the euro exchange rate, there was a decrease of US$3,099,000 inreported SG&A costs for our UK selling entity by just over US$350,000.
through strict cost control the Group succeeded in reducing its selling overheads and administrative expenses (excluding restructuring expenses, goodwill impairment, share-based paymentsby about US$750,000 in 2009. A wide range of overhead savings were achieved, including communications, utilities, travel costs, legal and amortisation) in 2008 due to cost reductions as follows:professional fees and recruitment fees.
a reorganisation of our sales force mainly in the US was announced in December 2007. As a result, a headcount reduction was implemented which delivered payroll cost savings of about US$1,000,000 in 2008. Other headcount reductions in management and administrative functions reduced SG&A payroll costs by a further US$900,000.
through cost control the Group succeeded in reducing its selling overheads and administrative expenses by about US$2,000,000 in 2008. Further cost cutting measures were announced by the Board in December 2008 but due to timing these measures did not have a significant impact on the 2008 figures. The full benefit of these cost cutting measures, which mainly comprise further headcount reductions in sales, marketing and administration, will be seen in 2009.
a reduction in professional fees including audit fees of approximately US$700,000.
the closure of the plant in Umea, Sweden during 2008 reduced administrative expenses by about US$180,000.
the US dollar strengthened versus Sterling in the second half of 2008 and this had the effect of reducing the reported SG&A costs for our UK selling entity by just over $100,000.

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SG&A impairment charges and restructuring expenses
AnNo impairment charges or restructuring expenses were recorded in 2009. In 2008, an impairment charge of US$85,793,000 was recorded in year ended December 31, 2008recognized arising out offrom the annual impairment review of the asset valuations included on the balance sheet. The Company has recognized an impairment loss against goodwill and other intangible assets (US$71,684,000), property, plant and equipment (US$13,095,000) and prepayments (US$1,014,000). By its nature this adjustment has no cash implications for the Group and does not impact on debt covenants.
Restructuring expenses of US$2,089,000 were recorded in SG&A in year ended December 31, 2008. This iswas made up of US$1,465,000 arising from the resignation of the Company’s former Chief Executive and US$589,000 in relation to costs associated with the implementation of headcount reductions as part of the cost cutting measures announced in December 2008.reductions. Other restructuring costs amounted to US$35,000. The restructuring, which consists of a combination of head count and overhead reductions, will generate a saving of approximately US$6 million in 2009. The cash flow benefit will also be approximately US$6 million in 2009. In total the Company’s headcount has been reduced by 70 full-time employees which equates to a reduction of approximately 10% of the overall work force.
In the 2007 statement of operations, a goodwill impairment loss of US$19,156,000 was recognised. Additionally, restructuring expenses of US$1,159,000 were included in SG&A in 2007 primarily relating to termination payments (US$842,000) and onerous lease obligations resulting from the closure of the Swedish manufacturing operation (US$116,000).
Share-based payments
The expense represents the value of share options granted to directors and employees which is charged to the statement of operations over the vesting period of the underlying options. The Group has used a trinomial valuation model for the purposes of valuing these share options with the key inputs to the model being the expected volatility over the life of the options, the expected life of the option and the risk free rate.
The Group recorded a total share-based payments charge of US$1,166,000 (2007:521,000 (2008: US$1,403,000) in 2008.1,166,000). The total charge is shown in the following expense headings in the statement of operations: US$51,000 (2007:19,000 (2008: US$71,000)51,000) was charged against cost of sales, US$48,000 (2007:15,000 (2008: US$108,000)48,000) was charged against research and development expenses and US$886,000 (2007:487,000 (2008: US$1,224,000)886,000) was charged against selling, general and administrative expenses. AIn 2008 a further share option charge of US$181,000 has beenwas included within the selling, general and administrative expenses restructuring charge. This amount is relatedcharge relating to the share option cost associated with the resignation of the former Chief Executive Officer, Mr Brendan Farrell.Officer.

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The decrease of US$237,000645,000 in the total share-based payments expense is primarily because share option holders ended their employment with the company and thereby forfeited their share options. For further details refer to Item 18, note 19 to the consolidated financial statements.
Amortisation
Amortisation reduced from US$3,616,000 for the year ended December 31, 2008 to US$1,959,000 for the year ended December 31, 2009. The increase in amortisationdecrease of US$198,000 from US$3,418,000 to US$3,616,0001,657,000 is primarilypartially due to the fullreduction resulting from the prior year impactwrite down of the amortisation charge relating to the Group’s acquisitions in 2007. There was a full year’s amortisation charge in 2008 for thecarrying value of intangible assets valued onfollowing the acquisition of the immuno-technology business of Cortex Biochem Inc. This business was acquired in September 2007 and the amortisation expense was higher in 2008 by an amount of US$106,000 due to the full year effect. Similarly, there was an increase of US$82,000 in amortisation for the intangible assets valued on the acquisition of the Sterilab Services distribution business which was acquired in October 2007. The remaining increase of US$10,000 is attributable to the amortisation of software assets and capitalised development projects costs, which are being amortised over their expected lives.annual impairment review carried out at December 31, 2008.

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4. LossProfit/(loss) for the year
The following table sets forth selected statement of operations data for each of the periods indicated.
             
  Year ended December 31,    
  2008  2007    
  US$’000  US$’000  % Change 
Operating (loss)  (79,575)  (29,372)  171%
Net financing costs
  (2,095)  (2,691)  (22%)
          
(Loss) before tax  (81,670)  (32,063)  155%
Income tax credit/(expense)
  3,892   (3,309)  (218%)
          
(Loss) of the year  (77,778)  (35,372)  120%
          
             
  Year ended December 31,    
  2009  2008    
  US$’000  US$’000  %Change 
Operating profit/(loss)  14,099   (79,575)  118%
Net financing costs  (1,184)  (2,095)  (43%)
          
Profit/(Loss) before tax  12,915   (81,670)  116%
Income tax (expense)/credit  (1,091)  3,892   128%
          
Profit/(Loss) of the year  11,824   (77,778)  115%
          
Net Financing Costs
Net financing costs decreased by US$596,000911,000 from US$2,691,000 in 2007 to US$2,095,000 in 2008.2008 to US$1,184,000 in 2009. The decrease is primarily due to a combination of lower interest bearing loan balances outstanding and lower interest rates. The interest bearing loan balances at December 31, 20072008 were US$42,133,00036,121,000 compared to US$36,121,00031,856,000 at December 31, 2008.2009. The interest rate for the majority of the Group’s borrowings is based on LIBOR rates, which reduced significantly during 2008.2009. The deposit interest earned during the year reduced from US$457,00065,000 to US$65,0008,000 due to lower cash balances and lower interest rates.
Taxation
The Group recorded a tax charge of US$1,091,000 for the year ended December 31, 2009 compared to a net tax credit of US$3,892,000 for the year ended December 31, 2008. The 2009 tax charge comprises US$1,000 of current tax and US$1,090,000 of deferred tax. In 2008, the net deferred tax credit iswas primarily attributable to the impairment of goodwill and other intangible assets, property, plant and equipment. For further details on the impairment please refer to Item 18, note 328 and for further details on the Group’s tax charge please refer to Item 18, note 9 and note 13 to the consolidated financial statements.
(Loss)Profit/(loss) for the year
The lossprofit for the year amounted to US$77,778,00011,824,000 which represents an increase of US$42,406,00089,602,000 when compared to the loss for the year of US$35,372,00077,778,000 in 2007.2008. Excluding the after tax impact of the restructuring expenses and impairment loss of US$83,131,000, the 2008 profit for the year would have been US$5,353,000. This compares to a profit for the year ended December 31, 2007 of US$2,991,000, excluding the after tax impact of the inventory write off, restructuring expenses and goodwill impairment of US$38,363,000. A decrease in net financing costs and a decrease in the income tax expense resulted in thisThe increase in profits after tax excluding once off items.

25


Year ended December 31, 2007in 2009 of US$6,471,000 compared to the year ended December 31, 2006
The following compares our results in the year ended December 31, 2007 to those of the year ended December 31, 2006 under IFRS. Our analysis is divided as follows:
1.
Overview
2.
Revenues
3.
Operating Expenses
4.
Retained Profit
1. Overview
The financial results for the year ended December 31, 2007 are impacted by the announcement made by Trinity Biotech in December 2007 to restructure its business. The restructuring included the following elements:
the rationalisation of the Haemostasis and Infectious Diseases reagent and instrumentation product lines resulting in an inventory write off of US$11,772,000;
the closure of the Group’s operation in Sweden, resulting in an inventory write off of US$147,000 (included in the total inventory write off in 2007 of US$11,772,000), a write down of property, plant & equipment of US$42,000, termination payments of US$332,000 and accrued lease obligations of US$116,000;
the streamlining of the Group’s development activities which resulted in a write off of capitalised development and license costs of US$6,667,000 and,
the reorganisation of the US sales force coupled with a redundancy programme to reduce headcount across the Group resulting in additional termination payments of US$1,703,000 (exclusive of termination payments made as part of the closure of the Swedish manufacturing operation of US$332,000). Total termination payments for the year amounted to US$2,035,000 of which US$2,016,000 has been accrued at December 31, 2007.
In addition, in accordance with IAS 36,Impairment of Assets, the Group also recognised an impairment provision of US$19,156,000 against goodwill. A further US$1,094,000 was written off technology intangible assets acquired from BioMerieux and this charge is included in research and development expenses as part of the total amount written off for capitalised development and license costs of US$6,667,000. Please refer to Item 18, note 3 to the consolidated financial statements for a more comprehensive discussion on the restructuring in 2007.
The impact of this restructuring and goodwill impairment is a charge to the statement of operations after tax of US$38,363,000 for the year ended December 31, 2007.
             
  Restructuring  Impairment  Total 
  US$’000  US$’000  US$’000 
             
Cost of sales
            
Inventory provision  11,772      11,772 
Termination payments  953      953 
          
   12,725      12,725 
          
             
Research & development
            
Write-off of capitalised development and license costs  6,667      6,667 
Termination payments  240      240 
          
   6,907      6,907 
          
             
Selling, general & administration expenses
            
Impairment of goodwill     19,156   19,156 
Termination payments  842      842 
Lease obligation provision  116      116 
Other  201      201 
          
   1,159   19,156   20,315 
          
             
Total restructuring expenses and goodwill impairment before tax
  20,791   19,156   39,947 
Income tax impact of restructuring expenses and goodwill impairment  (1,584)     (1,584)
Total restructuring expenses and goodwill impairment after tax
  19,207   19,156   38,363 
          

26


In 2007, Group revenues increased by US$24.9 million, which represented a growth rate of 21%. In 2007 haemostasis continued to be the Group’s most significant product line representing 42% of product revenues. Haemostasis revenues increased by 31% in 2007, primarily due to the full year impact of the acquisition of the haemostasis business of BioMerieux in 2006. The remaining revenues came from the infectious diseases (29%), point of care (12%) and clinical chemistry (17%) product lines. Geographically, 48% of sales were generated in the Americas, 30% in Europe and 22% in the rest of the world.
The gross margin for the year ended December 31, 2007 was 38%. In 2007, as part of the overall restructuring expense, the Group recognised US$11,772,000 in cost of sales for inventory written off relating to those haemostasis and infectious diseases products and instruments being rationalised for the year ended December 31, 2007. The Group also recognised an additional charge of US$953,000 in cost of sales for termination payments for the year ended December 31, 2007. Excluding the impact of the US$12.7 million for the restructuring expenses, the gross margin would be 47% which is broadly consistent with the gross margin for the year ended December 31, 2006,2008, excluding the impact of the inventory provision of US$5.8 million, of 48%.
The operating loss was US$29,372,000 for the year ended December 31, 2007 which compares to an operating profit of US$1,941,000 for the year ended December 31, 2006. The movement is primarily due to the impact of the US$39.9 million for restructuring expenses and goodwill impairment. Excluding the impact of the restructuring expenses and goodwill impairment in 2007 and the inventory provision of US$5.8 million in 2006, the operating profit increased by 37% primarily due to increased sales, of which US$13,523,000 relates to the impact of acquisitions made in 2007 and 2006 and US$11,420,000 is as a result of organic growth. However, the impact of increased sales, which grew by 21%, was offset by increased selling, general & administrative (SG&A) and research and development (R&D) costs. This resulted in an operating margin, excluding the impact of the restructuring expenses and goodwill impairment, of 7%. In 2006, the operating margin, excluding the impact of the US$5.8 million inventory provision was also 7%.
The loss for the year ended December 31, 2007 was US$35,372,000 which compares to a profit for the year ended December 31, 2006 of US$3,276,000. Excluding the after tax impact of the restructuring expenses and goodwill impairment, the profit for the year would be US$2,991,000, which represents a decrease in profit for the year of 9% (compared to an increase in operating profit of 37%). Although profit before tax increased in 2007, the profit after tax was lower than 2006. This is due to the impact of the derecognition of deferred tax assets of US$3,780,000 in relation to unused tax losses and higher net interest financing costs in 2007.
2. Revenues
The Group’s revenues consist of the sale of diagnostic kits and related instrumentation and the sale of raw materials to the life sciences industry. Revenues on the sale of the above products are generally recognised on the basis of shipment to customers. The Group ships its products on a variety of freight terms, including ex-works, CIF (carriage including freight) and FOB (free on board), depending on the specific terms agreed with customers. In cases where the Group ships on terms other than ex-works, the Group does not recognise the revenue until its obligations have been fulfilled in accordance with the shipping terms.
No right of return exists in relation to product sales except in instances where demonstrable product defects occur. The Group has defined procedures for dealing with customer complaints associated with such product defects as they arise.
The Group also derives a portion of its revenues from leasing infectious diseases and haemostasis diagnostic instruments to customers. In cases where the risks and rewards of ownership of the instrument passes to the customer, the fair value of the instrument is recognised at the time of sale matched by the related cost of sale. In the case of operating leases of instruments which typically involve commitments by the customer to pay a fee per test run on the instruments, revenue is recognised on the basis of customer usage of the instruments. In certain markets, the Group also earns revenue from servicing infectious diseases and haemostasis instrumentation located at customer premises.

27


Revenues by Product Line
The following table sets forth selected sales data for each of the periods indicated.
             
  Year ended December 31,    
  2007  2006    
  US$’000  US$’000  % Change 
             
Revenues
            
Infectious diseases  41,293   42,051   (2%)
Haemostasis  60,759   46,476   31%
Clinical Chemistry  17,061   14,868   15%
Point of Care  24,504   15,279   60%
          
Total
  143,617   118,674   21%
          
Trinity Biotech’s consolidated revenues for the year ended December 31, 2007 were US$143,617,000 compared to consolidated revenues of US$118,674,000 for the year ended December 31, 2006, which represents an overall increase of US$24,943,000.
Infectious Diseases Revenues
Sales of infectious diseases products have decreased by US$758,000. This decrease is principally due to a reduction in sales of flu anti-bodies through our Fitzgerald business due to a poor flu season principally attributable to mild winter conditions in Fitzgerald’s US and Asian markets. This was partially offset by improved Lyme sales in the US, increased sales in the Group’s direct selling operation in France during its first full year of trading and the impact of the acquisition of Sterilab in the United Kingdom.
Haemostasis Revenues
The net increase in haemostasis revenues of US$14,283,000 is principally attributable to increased sales arising from the full year impact of the acquisition of the haemostasis business of BioMerieux in 2006 (US$12,224,000). The remaining increase is attributable to the 8% growth in the Group’s Amax and Biopool product ranges (US$2,059,000).
Clinical Chemistry Revenues
The increase in clinical chemistry revenues of US$2,193,000 is principally due to international sales of the Primus products. Primus specialises in the field of in vitro diagnostic testing for haemoglobin A1c and haemoglobin variants (used in the detection and monitoring of diabetes patients).
Point of Care
Sales of Point of Care products have increased by US$9,225,000 which is primarily attributable to increased sales of Trinity’s Unigold rapid HIV test in Africa and the US.
Revenues by Geographical Region
The following table sets forth selected sales data, analysed by geographic region, based on location of customer:
             
  Year ended December 31,    
  2007  2006    
  US$’000  US$’000  % Change 
             
Revenues
            
Americas  68,481   60,748   13%
Europe  43,631   34,452   27%
Asia/Africa  31,505   23,474   34%
          
Total
  143,617   118,674   21%
          
The US$7,733,000 increase in the Americas is primarily attributable to the following factors:
An increase in haemostasis sales including the full year impact of bioMerieux haemostasis products which was acquired in June 2006;
the growth in the sales of Trinity’s Unigold rapid HIV test.

28


The US$9,179,000 increase in Europe is primarily due to increased sales arising from the full year impact of the acquisition of BioMerieux and sales of Infectious Diseases products in France.
The US$8,031,000 increase in Asia/Africa is primarily due to increased sales of Trinity’s Unigold rapid HIV tests in Africa.
For further information about the Group’s principal products, principal markets and competition please refer to Item 4, “Information on the Company”.
3. Operating Expenses
The following table sets forth the Group’s operating expenses.
             
  Year ended December 31,    
  2007  2006   
  US$’000  US$’000  % Change 
             
Revenues  143,617   118,674   21%
Cost of sales  (75,643)  (62,090)  22%
Cost of sales — restructuring expenses  (953)     100%
Cost of sales — inventory write off/ provision  (11,772)  (5,800)  103%
          
Gross profit  55,249   50,784   9%
Other operating income  413   275   50%
Research & development  (6,802)  (6,696)  2%
Research & development — restructuring expenses  (6,907)     100%
SG&A expenses  (51,010)  (42,422)  20%
SG&A expenses — restructuring expenses  (20,315)     100%
          
Operating (loss)/ profit  (29,372)  1,941   (1613%)
          
Cost of sales
Total cost of sales increased by US$20,478,000 from US$67,890,000 for the year ended December 31, 2006 to US$88,368,000, for the year ended December 31, 2007, an increase of 30%. The increase is primarily attributable to the restructuring expenses of US$12,725,000 recognised in cost of sales in 2007, partially offset by the inventory provision in 2006 of US$5.8 million. Cost of sales, excluding the impact of the restructuring expenses of US$12.7 million in 2007 and the US$5.8 million inventory provision in 2006, increased by US$13,553,000 from US$62,090,000 for the year ended December 31, 2006 to US$75,643,000, for the year ended December 31, 2007, an increase of 22%. This increase in cost of sales is broadly in line with the increase in revenues for the Group. Cost of sales excluding the US$12.7 million for the inventory write off and restructuring expenses for the year represents 53% of revenues, which is broadly in line with the cost of sales excluding the US$5.8 million inventory provision as a percentage of revenue in 2006 (52%). See Revenues section above for details on movements in revenues during 2007.
Included in cost of sales for the year ended December 31, 2007 is US$12,725,000 for the inventory write off and restructuring expenses, resulting from a decision taken by the Board of Directors of Trinity Biotech during 2007 to restructure the business. Under the restructuring plan, Trinity Biotech undertook to reduce the number of products and instruments within the two key product lines of haemostasis and infectious diseases. As a result, the Group has recognised US$11,772,000 for inventory written off relating to those haemostasis and infectious diseases products and instruments being rationalised for the year ended December 31, 2007. As part of the restructuring, the Group also recognised an additional amount of US$953,000 in cost of sales for termination payments for the year ended December 31, 2007.
In 2006, the Group made a US$5.8 million inventory provision resulting from the acquisition of the haemostasis business of bioMerieux in 2006. This arose from the process of combining the acquired bioMerieux range of products with the Group’s existing product range. As part of this process it was decided to discontinue various existing products, hence the requirement for the inventory provision.

29


Gross margin
The gross margin for 2007 was 38% which compares to a gross margin in 2006 of 43%. The decrease in gross margin in 2007 is primarily attributable to the impact of the restructuring expenses and goodwill impairment. Excluding the impact of the US$12.7 million restructuring expenses, the gross margin would have been 47%, which is broadly in line with the 2006 gross margin excluding the impact of the US$5.8 million inventory provision of 48%.
Research and development expenses
Research and development (“R&D”) expenditure increased to US$13,709,000 in 2007 compared to expenditure of US$6,696,000 in 2006. The increase in research and development expenditure is primarily attributable to the total restructuring expenses recognised in R&D in 2007 of US$6,907,000. The total R&D restructuring expenses of US$6,907,000 consists of US$5,134,000 of development costs written off, US$439,000 for license costs written off and a further US$1,094,000 written off technology intangible assets acquired from BioMerieux. Termination payments included in R&D amounted to US$240,000. Research and development expenditure, excluding the impact of the write-off of capitalised development and license costs of US$6,667,000 and termination payments of US$240,000 resulting from the restructuring activities, increased to US$6,802,000 in 2007 compared to expenditure of US$6,696,000 in 2006. This represents 5% of consolidated revenues, which is consistent with 2006. For a consideration of the Company’s various R&D projects see “Research and Products under Development” in Item 5 below.
Selling, General & Administrative expenses (SG&A)
The following table outlines the breakdown of SG&A expenses in 2007 compared to a similar breakdown for 2006.
                 
  Year ended December 31,  Increase/    
  2007  2006  (decrease)    
  US$’000  US$’000  US$’000  % Change 
                 
SG&A (excl. share-based payments and amortisation)  46,368   38,719   7,649   20%
SG&A restructuring expenses and goodwill impairment  20,315      20,315   100%
Share-based payments  1,224   1,016   208   20%
Amortisation  3,418   2,687   731   27%
             
Total
  71,325   42,422   28,903   68%
             
Selling General & Administrative Expenditure (excluding share-based payments and amortisation)
Total SG&A expenses increased from US$42,422,000 for the year ended December 31, 2006 to US$71,325,000 for the year ended December 31, 2007, whichonce-off charges, represents an increase of US$28,903,000. The increase is primarily due to the restructuring expenses and an increase in SG&A expenses excluding share-based payments and amortisation. Total SG&A expenses excluding share-based payments and amortisation increased from US$38,719,000 for the year ended December 31, 2006 to US$66,683,000 for the year ended December 31, 2007, which represents an increase of 72%121%. Of the total increase of US$27,964,000, US$20,315,000 relates to restructuring expenses incurred in 2007. SG&A expenses (excluding restructuring expenses, goodwill impairment, share-based payments and amortisation) increased 20% or by US$7,649,000 from US$38,719,000 to US$46,368,000, which compares to revenue growth of 21% during the same period.
The principal reasons for the increase in SG&A expenses (excluding restructuring expenses, goodwill impairment, share-based payments and amortisation) of US$7,649, 000 in 2007, are as follows:
Increased SG&A costs in the Head Office/Irish operations of US$4,327,000. This is mainly due to a combination of strengthening of the Group’s marketing and central administration functions in conjunction with increased professional fees associated with the implementation of Sarbanes Oxley;
An increase of US$2,057,000 in the Group’s European operations (excluding Ireland). Of this increase, US$1,465,000 related to the full year impact of the direct sales operation in France acquired in 2006. The remaining increase of US$592,000 arose principally in the UK mainly due to the increase in employee numbers and related costs associated with the expansion of this entity following the acquisition of the haemostasis business of bioMerieux in 2006;
Increased SG&A costs of US$1,265,000 in the USA. This is primarily due to the full year impact of the increased personnel and related costs following the acquisition of the haemostasis business of bioMerieux in June 2006.

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SG&A restructuring expenses and goodwill impairment
Arising from the 2007 impairment review, a goodwill impairment loss of US$19,156,000 was recognised in the consolidated statement of operations for the year ended December 31, 2007. This impairment loss arose in Trinity Biotech Manufacturing Limited, one of the Group’s cash generating units (“CGU’s”). Trinity Biotech Manufacturing Limited manufactures haemostasis, infectious diseases, point of care and clinical chemistry products at its plant in Bray, Ireland, which are then sold to third party distributors and other selling entities within the Group. A further US$1,094,000 was written off technology intangible assets acquired by BioMerieux and this charge is included in research and development expenses as part of the total amount written off for capitalised development and license costs of US$6,667,000. The remaining restructuring expenses of US$1,159,000 included in SG&A primarily relate to termination payments (US$842,000) and onerous lease obligations resulting from the closure of the Swedish manufacturing operation (US$116,000).
Share-based payments
The Group recorded a total charge to the statement of operations in 2007 of US$1,403,000 (2006: US$1,141,000) for share-based payments. Of the 2007 charge US$71,000 (2006: US$89,000) was charged against cost of sales. Of the remaining US$1,332,000, US$108,000 (2006: US$36,000) was charged against research and development expenses and US$1,224,000 (2006: US$1,016,000) was charged against selling general and administrative expenses.
The expense represents the value of share options granted to directors and employees which is charged to the statement of operations over the vesting period of the underlying options. The Group has used a trinomial valuation model for the purposes of valuing these share options with the key inputs to the model being the expected volatility over the life of the options, the expected life of the option and the risk free rate. The expense for 2007 is broadly in line with that of 2006 and is due to the impact of the newly issued options being offset by a reduction in the expense resulting from forfeiture of previous share options, granted to employees and key management personnel but not vested at the time of forfeiture. For further details refer to Item 18, note 19 to the consolidated financial statements.
Amortisation
The increase in amortisation of US$731,000 from US$2,687,000 to US$3,418,000 is largely attributable to the impact of amortisation of intangible assets acquired as part of the Group’s acquisitions in 2007 and 2006 (see Item 18, note 26 to the consolidated financial statements). The Group acquired the haemostasis business of BioMerieux and a direct selling operation in France in 2006 and the full year impact of these acquisitions on the 2007 amortisation charge was US$579,000. A further US$56,000 was amortised in relation to intangible assets valued on the acquisition of the immuno-technology business of Cortex and certain components of the distribution business of Sterilab, a distributor of Infectious Diseases products, in 2007. The remaining increase of US$96,000 is mainly attributable to amortisation of development costs which were capitalised and are now being amortised over the expected life of the products to which they related.
4 ( Loss)/ profit for the year
The following table sets forth selected statement of operations data for each of the periods indicated.
             
  Year ended December 31,    
  2007  2006    
  US$’000  US$’000  % Change 
Operating (loss)/ profit  (29,372)  1,941   (1613%)
Net financing costs
  (2,691)  (1,489)  81%
          
(Loss)/ profit before tax  (32,063)  452   (7194%)
Income tax (expense)/ credit
  (3,309)  2,824   (217%)
          
(Loss)/ profit of the year  (35,372)  3,276   (1180%)
          
Net Financing Costs
Net financing costs increased to US$2,691,000 compared to US$1,489,000 in 2006. This increase is primarily due to the impact of the additional debt financing taken on by the Group during 2006 and 2007. The loan facility was amended in July 2006, increasing the original loan facility by US$30 million to US$41.34 million due to the acquisition of the haemostasis business of bioMerieux. In October 2007, the revolver loan element of the facility increased by US$5 million from US$2,000,000 to US$7,000,000 to fund the acquisition of Cortex and Sterilab in 2007. The increased interest expense in relation to this additional debt was offset by lower interest charges in relation the Group’s convertible notes as they were being repaid during 2006. Deposit interest earned during the year decreased from US$1,164,000 in 2006 to US$457,000 due to lower cash balances held on deposit.

 

31


Taxation
The Group recorded a net tax charge of US$3,309,000 for the year ended December 31, 2007. This compared to a tax credit of US$2,824,000 for 2006. This represented a decrease in current tax of US$98,000 which is more than offset by an increase in deferred tax of US$6,231,000. The decrease in current tax is primarily attributable to current year losses in the US, Ireland and Germany resulting from the restructuring. The net deferred tax expense is primarily attributable to the derecognition of deferred tax assets in relation to unused tax losses. The derecognition of these deferred tax assets was considered appropriate due to uncertainty over the timing of the utilisation of the unused tax losses. For further details on the Group’s tax charge please refer to Item 18, note 9 and note 13 to the consolidated financial statements.
(Loss)/ profit for the year
The loss for the year amounted to US$35,372,000 which represents a decrease of US$38,648,000 when compared to the profit for year of US$3,276,000 in 2006. Excluding the after tax impact of the inventory write off, restructuring expenses and goodwill impairment of US$38,363,000, the profit for the year would have been US$2,991,000. This compares to a profit for the year ended December 31, 2006, excluding the after tax impact of the US$5.8 million inventory provision, of US$3,276,000.
Liquidity and Capital Resources
Financing
Trinity Biotech has aDuring 2010 the Group repaid in full the outstanding portion of its US$48,340,000 club banking facility with Allied Irish Bank plc and Bank of Scotland (Ireland) Limited (“the banks”). using the proceeds from the divestiture of the coagulation business. The facility consistsconsisted of a five year US Dollar floating interest rate term loan of US$41,340,000 and a one year revolver of US$7,000,000.
The facility was amended in October 2008, increasing the length of the term to July 2012, and amending the repayment schedule from $4,134,000 every January and July (originally commencing January 2007) to an amount of $1,072,000 in July 2008, $2,144,000 in January 2009, $3,215,000 in July 2009 and every six months thereafter, with a final payment of US$6,430,000 payable in July 2012. Hence, during 2008 an amount of $4,134,000 and $1,072,000 were paid in January and July respectively. The revolver loan element of the facility has remained at US$7,000,000. This facility ishad been secured on the assets of the Group.Group (see Item 18, note 25(c)).
Various covenants apply to the Group’s bank borrowings. AtThe balance on this facility at December 31, 2008, the total amount outstanding under the facility amounted to2010 was therefore US$34,551,000,NIL (December 31, 2009:US$29,327,000, net of unamortised funding costs of US$314,000.180,000).
During 2008, the Group issued 7,260,816 ‘A’ Ordinary shares as part of a private placement. These shares were issued for a consideration of US$7,115,600, settled in cash. The Group incurred costs of US$438,000 in connection with the issue of these shares.
Working capital
In the Group’s opinion the Group will have access to sufficient funds to support its existing operations for at least the next 12 months. These funds will consist of the Group’smonths by utilising existing cash resources and cash generated from operations and where required debt and/or equity funding or the proceeds of asset disposals.operations.
The amount of cash generated from operations will depend on a number of factors which include the following:
The ability of the Group to continue to generate revenue growth from its existing product lines;
The ability of the Group to generate revenues from new products following the successful completion of its development projects;
The extent to which capital expenditure is incurred on additional property plant and equipment;
The level of investment required to undertake both new and existing development projects;
Successful working capital management in the context of a growing group.
Where cash generated from operations is not sufficient to meet the Group’s obligations, additional debt or equity funding will need to be raised. The cost and availability of debt funding will depend on prevailing interest rates at the time and the size and nature of the funding being provided. The availability of debt and equity will depend on market conditions at the time, which is of relevance at present given the constraints being experienced in international funding markets.

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The Group expects that it will have access to sufficient funds to repay the debthas some finance lease obligations which were outstanding at December 31, 2008. These obligations include the repayment of the remaining bank loans and finance leases. The timing of these repayment obligations2010 and the expected maturity dates of these are set out in more detail in Item 11.
In the event that the Group makes any further acquisitions, we believe that the Group may be required to obtain additional debt and/or equity funding. The exact timing and amount of such funding will depend on the Group’s ability to identify and secure acquisition targets which fit with the Group’s growth strategy and core competencies.
Cash management
As at December 31, 2008,2010, Trinity Biotech’s consolidated cash and cash equivalents were US$5,184,000.58,002,000. This compares to cash and cash equivalents excluding restricted cash, of US$8,700,0006,078,000 at December 31, 2007.2009.
Cash generated from operations for the year ended December 31, 20082010 amounted to US$12,946,000 (2007:22,973,000 (2009: US$18,178,000)15,533,000), a decreasean increase of US$5,232,000.7,440,000. The decreaseincrease in cash generated from operations of US$5,232,0007,440,000 is attributable to a decreasean increase in operating cash flows before changes in working capital of US$2,396,0001,433,000 and unfavourablefavourable working capital movements of US$2,836,000.6,007,000. The decreaseincrease in operating cash flows before changes in working capital of US$2,396,0001,433,000 is primarily due to lowerhigher net profits arising in 2010 from decreased revenue in 2008.improved gross margin following the divestiture of the coagulation business. The unfavourablefavourable working capital movements are primarily due to a deteriorationthe effect of the substantial cash inflow from trade and other payables of US$11,983,000 being partially offset by the increase in cash flows fromoutflows for trade and other receivables of US$9,357,000 which was mainly offset by decreased cash outflows with respect to inventories (US$9,163,000)778,000 and reduced cash flows from trade and other payables (US$2,642,000).inventory of US$5,198,000. The cash generated from operations was attributable to a lossprofit before interest, taxation and taxationgain on divestiture of business of US$79,575,000 (2007: loss before interest and taxation of13,728,000 (2009: US$29,372,000)14,099,000), as adjusted for non cash items of US$95,266,000 (2007:7,403,000 (2009: US$47,459,000) less5,599,000) plus cash outflowsinflows due to changes in working capital of US$2,745,000 (2007:1,842,000 (2009: cash inflowsoutflows of US$91,000)4,165,000).
The increase in other non cash charges from US$47,459,0005,599,000 for the year ended December 31, 20072009 to US$95,266,0007,403,000 for the year ended December 31, 20082010 is mainly attributable to the impairment chargemovement in 2008 (see Item 18, note 3 toitems including inventory provisions and the consolidated financial statements). An impairment loss of US$71,684,000 (2007: US$19,156,000) was recognised against the intangible assets of the Group during 2008.share option expense.
The net cash outflowsinflows in 20082010 due to changes in working capital of US$2,745,0001,842,000 are due to the following:
An increaseA decrease in accounts receivable byof US$4,131,0003,094,000 due to an increasea decrease in debtors days in the year ;as a result of better collections;
A decreaseAn increase in inventory of US$2,826,000 due to the strategic build up of certain stock items during the course of the year; and
An increase in trade and other payables byof US$676,0001,574,000 due mainly to the paymenttiming of deferred consideration during the year;payments to suppliers.

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A decrease in inventory by US$2,062,000 due to a Group wide emphasis on inventory management.
Net interest paidreceived amounted to US$2,576,000 (2007:339,000 (2009: net interest paid of US$2,373,000)871,000). This consisted of interest paidreceived of US$2,639,000 (2007:842,000 (2009: US$2,802,000)12,000) on the Group’s cash deposits and interest payments of US$503,000 (2009: US$883,000) on the Group’s interest bearing debtdebt; including bank loans convertible notes and finance leases and was partially offset byleases. The movement from a net interest payment amount in 2009 to a net interest received amount in 2010 was brought about by the elimination of US$63,000 (2007: US$429,000)bank debt in 2010 and the placing of funds on deposit following the Group’s cash deposits.sale of the coagulation business.
Net cash outflowsinflows from investing activities for the year ended December 31, 20082010 amounted to US$14,688,000 (2007:56,885,000 (2009: net cash outflows of US$8,415,000)10,335,000) which were principally made up as follows:
Deferred considerationProceeds from the divestiture of the coagulation business, net of associated costs, of US$2,802,000 was paid to bioMerieux during 2008;65,886,000
Payments to acquire intangible assets of US$8,981,000 (2007:6,233,000 (2009: US$7,851,000)8,103,000), which principally related to development expenditure capitalised as part of the Group’s on-going product development activities;
Acquisition of property, plant and equipment of US$3,713,000 (2007:2,784,000 (2009: US$8,262,000)2,481,000) incurred as part of the Group’s investment programme for its manufacturing and distribution activities;
Proceeds from the disposal of property, plant and equipment of US$808,000 (2007:16,000 (2009: US$84,000) mainly relating to the Group’s disposal of assets in the Swedish entity during 2008.249,000).
Net cash inflowsoutflows from financing activities for the year ended December 31, 20082010 amounted to US$481,000 (2007:27,984,000 (2009: US$3,512,000). The main driver of the cash outflow of US$1,108,000). The Group received US$7,116,000 from its issue of ordinary shares in 2008 (2007: US$454,000). These inflows were offset by2010 was the repayment of long-term debt and other liabilities of US$5,224,000 (2007:29,775,000 (2009: US$8,285,000) and5,400,000). This payment in 2010 has resulted in all bank debt being eliminated from the Group balance sheet as at December 31, 2010. Other cash outflows included expenses paid in connection with share issues and debt financing of US$624,000 (2007:74,000 (2009: US$70,000). Also offsetting the inflows were68,000) and payments in respect of finance lease liabilities of US$787,000 (2007:638,000 (2009: US$294,000)546,000). These outflows were partially offset by the receipt of US$1,023,000 from the issue of ordinary shares in 2010 (2009: US$897,000). Ordinary shares issued in 2010 and 2009 are as a result of share options and warrants exercised during the course of the year. The Group also received US$1,480,000 from the proceeds of new finance leases (2009: US$1,298,000). The Group did not receive any proceeds from long-term debt in 2010 (2009: US$307,000).

33


The majority of the Group’s activitiestransactions are conducted in US Dollars. The primary foreign exchange risk arises from the fluctuating value of the Group’s euroEuro denominated expenses as a result of the movement in the exchange rate between the US Dollar and the euro.Euro. Trinity Biotech continuously monitors its exposure to foreign currency movements and based on expectations on future exchange rate exposure implements a hedging policy which may include covering a portion of this exposure through the use of forward contracts. When used, these forward contracts are cashflow hedging instruments whose objective is to cover a portion of these euroEuro forecasted transactions.
As at December 31, 2008,2010, total year end borrowings wereinterest-bearing debt, consisting entirely of leases, was US$36,121,000 (2007:273,000 (2009: US$42,133,000)31,856,000 — consisting of bank loans and leases) and cash and cash equivalents were US$5,184,000 (2007:58,002,000 (2009: US$8,700,000)6,078,000). For a more comprehensive discussion of the Group’s level of borrowings at the end of 2008,2010, the maturity profile of the borrowings, the Group’s use of financial instruments, its currency and interest rate structure and its funding and treasury policies please refer to Item 11 “Qualitative and Quantitative Disclosures about Market Risk”.
Contractual obligations
The following table summarises our minimum contractual obligations and commercial commitments, including interest, as of December 31, 2008:2010:
                                        
 Payments due by Period  Payments due by Period 
 less than 1 more than  less than 1 more than 
 Total year 1-3 Years 3-5 Years 5 years  Total year 1-3 Years 3-5 Years 5 years 
Contractual Obligations US$’000 US$’000 US$’000 US$’000 US$’000  US$’000 US$’000 US$’000 US$’000 US$’000 
Bank loans 36,291 13,079 13,493 9,719  
 
Capital (finance) lease obligations 1,748 514 950 284   285 172 113   
Operating lease obligations 57,690 4,438 7,463 6,194 39,595  36,556 2,411 4,527 4,320 25,298 
                      
Total 95,729 18,031 21,906 16,197 39,595  36,841 2,583 4,640 4,320 25,298 
                      
In the past, Trinity Biotech incursincurred debt and raisesraised equity to pursue its policy of growth through acquisition. However, since the divestiture of the coagulation business in 2010, the Group has now eliminated bank debt and has considerable cash resources. The Group intends to grow organically for the foreseeable future and Trinity Biotech believes that with further funds generated from operations, it will have sufficient funds to meet its capital commitments and continue existing operations forin to the foreseeable future, in excess of 12 months. If operating margins on sales were to decline substantially or if the Group was to make a large and unanticipated cash outlay, the Group would have further funding requirements. If this were the case, there can be no assurance that financing will be available at attractive terms, or at all. The Group believes that success in raising additional capital or obtaining profitability will be dependent on the viability of its products and their success in the market place. Since December 31, 2007 the Group has agreed amendments to its bank facility, for more information see Item 18, note 29.

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Impact of Currency Fluctuation
Trinity Biotech’s revenue and expenses are affected by fluctuations in currency exchange rates especially the exchange rate between the US Dollar and the euro.Euro. Trinity Biotech’s revenues are primarily denominated in US Dollars and its expenses are incurred principally in US Dollars and euro.Euro. The weakening of the US Dollar could have an adverse impact on future profitability. Management are actively seeking to reduce the mismatch in this regard to mitigate this risk. The revenues and costs incurred by US subsidiaries are denominated in US Dollars.
Trinity Biotech holds most of its cash assets in US Dollars. As Trinity Biotech reports in US Dollars, fluctuations in exchange rates do not result in exchange differences on these cash assets. Fluctuations in the exchange rate between the euroEuro and the US Dollar may impact on the Group’s euroEuro monetary assets and liabilities and on euroEuro expenses and consequently the Group’s earnings.
Off-Balance Sheet Arrangements
After consideration of the following items the Group’s management have determined that there are no off-balance sheet arrangements which need to be reflected in the financial statements.
Leases with Related Parties
The Group has entered into lease arrangements for premises in Ireland with JRJ Investments (“JRJ”), a partnership owned by Mr O’Caoimh and Dr Walsh, directors of Trinity Biotech plc, and directly with Mr O’Caoimh and Dr Walsh. Independent valuers have advised Trinity Biotech that the rent fixed with respect to these leases represents a fair market rent. Details of these leases with related parties are set out in Item 4 “Information on the Company”, Item 7 “Major Shareholders and Related Party Transactions” and Item 18, note 2826 to the consolidated financial statements.

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Research & Development (“R&D”) carried out by third parties
Certain of the Group’s R&D activities have been outsourced to third parties. These activities are carried out in the normal course of business with these companies.
In 2005 a software development company based in France was contracted to develop and enhance the software in the Destiny Max instrument. Under the terms of the contract, all software developed by the software development company is the property of Trinity Biotech. Fees were agreed for each separate software development task and payment was made once a specific project milestone had been achieved. A total of €271,000 (US$362,000) was paid to this software development company in 2010. Additionally, a number of individuals acted as third party consultants working principally on the Destiny Max, Premier Hb9210 and Tristat instruments. The total amount paid to R&D consultants in 2010 was US$960,000.
Research and Products under Development
History
Historically, Trinity Biotech had been primarily focused on infectious diseases diagnostics. The Group acquired a broad portfolio of microtitre plate (“EIA”) and Western Blot products and has added to these over the last number of years through additional internally developed products. More recently, the Group has entered into several other diagnostic areas including haemostasispoint-of-care (POC) and clinical chemistry. The Research and Development (“R&D”) activities of the Group have mirrored this expansion by developing new products in these areas also. There were no significant development projects in their research phase during 2010.
Centres of Excellence
Trinity Biotech has research and development groups focusing separately on microtitre plate based tests, rapid tests, western blotWestern Blot products, clinical chemistryClinical Chemistry products haemostasis and immunofluorescent assays.Point-of-Care products. These groups are located in Ireland Germany and the US and largely mirror the production capability at each production site, hence creating a centre of excellence for each product type. In addition to in-house activities, Trinity Biotech sub-contracts some research and development from time to time to independent researchers based in the US and Europe.

34


Principal Development Projects
The following table sets forth for each of the main development projects, the costs incurred during each period presented and the cumulative costs incurred as at 31 December 2010:
Total project
costs to
December 31,
201020092010
Product NameUS$’000US$’000US$’000
Premier Hb 9210 Instrument for Haemoglobin A1c testing2,5691,0234,381
Destiny Max coagulation instrument*9563,23414,686
Bordetella Pertussis Western Blot test337156493
Tristat point of care instrument3181,0724,094
HIV Ag-Ab rapid test247247
Syphilis Rapid point-of-care test185185
Unigold Recombigen HIV Rapid enhancement1424562,157
*
Note that this and other coagulation projects ceased in May 2010 following the divestiture of the Coagulation Business — see Item 18, note 3.
The costs in the foregoing table mainly comprise the cost of internal resources, such as the payroll costs for the development teams and attributable overheads. The remainder mainly comprises materials, consumables and third party consultants’ costs.
The following table sets forth the estimated cost to complete each of the main development projects which were underway in 2010. The total estimated completion costs are anticipated to be incurred evenly up to the completion date of the relevant project.
Total costs toEstimated date
completefor completion
Product NameUS$’000US$’000
Various point-of-care rapid tests1,4002012
Premier Hb 9210 Instrument for Haemoglobin A1c testing1,1722011
HIV Ag-Ab rapid test1,0002013
Syphilis Rapid point-of-care test7502012
Unigold Recombigen HIV Rapid enhancement5002011
IgM CAPITA4002012
Tristat point of care instrument3302011
There are inherent risks and uncertainties associated with completing development projects on schedule. In our experience the main risks to the achievement of a project’s planned completion date occur primarily during the product’s verification and validation phase. During this phase the product must attain successful results from in-house product testing and from third party clinical trials. Obtaining regulatory approval on a timely basis is another variable in achieving a project’s planned completion date.
We acknowledge that some aspects of a new product development are to an extent outside of the control of the Group. Notwithstanding the uncertainty surrounding these external factors, we believe the planned completion dates of these projects are realistic and achievable. If major development projects were severely delayed, in our opinion it would not impact significantly on Trinity Biotech’s financial position or on the capitalization criteria. As the manufacturing lead time for these new products is relatively short, it is anticipated that material cash inflows will commence shortly after each of the project’s planned completion date.

35


The following is a listdescription of the principal projects which are currently being undertaken by the R&D groups within Trinity Biotech.Biotech:
Microtitre PlatePoint-of-Care (“POC”) Development Group
EnhancementDuring 2010, the company commissioned and staffed a new POC product development unit at its Carlsbad, CA facility. This facility has been equipped with state of HSV 2the art POC assay development equipment and the Group has commenced development of microtitre plate assaya portfolio of Point-of-Care/ lateral flow infectious disease tests. Initial tests include an enteric panel of assays for the detection of HSV2 IgG
Trinity Biotech is alreadyGiardia and Cryptosporidium antigens in human stool samples. We have also commenced development of a leading supplier of diagnostic teststest for the detection of infectious disease. Enhancement was recently completed ontreponemal and nontreponemal Syphilis antibodies in human whole blood. It is envisaged some tests will reach clinical trial stage and be submitted to the HSV2 IgG EIA assay. Development and transfer to production was completed by December 2008 including some external evaluation work.
HIV Incidence AssayFDA for 510k approval later in 2011.
In late 2005, Trinity enteredresponse to the increased incidence of the new strain of HIV called HIV-2, we are developing a Biological Materials License Agreement with the Centre for Disease Control (CDC) in Atlanta, Georgia,new assay for the rightssimultaneous detection of p24 HIV Antigen (Ag) and Antibodies (Ab) to produceHIV-1 and sell the CDC devisedHIV-2 in human serum, plasma or whole blood. The test is intended as an aid to detect p24 HIV Incidence assay. The technology was transferredantigen and antibodies to Trinity during 2006 and the product was developed by the Group during 2007 with the design and development of key raw materials. Final development was completed at end of 2008.HIV-1/HIV-2 from infected individuals.
Western Blot Development Group
A Western Blot kit is a test where antigens (usually proteins) from a specific bacteria or virus are transferred onto a nitrocellulose strip. When a patient’s plasma is added to the strip, if antibodies to that bacteria or virus are present in a patient’s sample, then they will bind to the specific antigens on the strip. If antibodies to any of the antigens are present in sufficient concentration, coloured bands corresponding to one or more of those antigens will be visible on the reacted nitrocellulose strip.
US LymePertussis Western Blot
For many years, Trinity Biotech’s US Domestic Lyme Western Blot has been a market leader. During 2008,2010, a project was undertaken to further develop the Bordetella pertussis Western Blot product by adding an additional stripsstripe for Adenylate Cyclase per assay kit which involved incorporating the introduction of new larger production equipment.kit. This work finished in 2010 when the newly developed product was successfully completed and the Group will launch the enhanced product in early 2009.
Automated Blotting Instrument and Blot Scanner
In 2006 a project was initiated to introduce the use of an automated blotting instrument with Trinity Biotech’s Western Blot tests, initially focusing on the US Lyme Western Blot allowing increased throughput for end-users. This work progressed successfully, culminating on the commencement of validation of the system in late 2006. Validation was completed in early 2007 with launch of the system, which is called TrinBlot. In 2008 the Group continued to extend the range of products which can be used on the TrinBlot, in addition to the introduction of an automated scanner to aid in the interpretation of the western blots. This system was validatedtransferred into production and launched for use with US Lyme in 2008 and will continue for other products in 2009.onto the European market.

35


Clinical Chemistry Development Group
TriStat POC
Trinity Biotech, at its Kansas City site, has developed a point of care test called TriStat for the measurement of haemoglobin A1c for which FDA approval was obtained in late 2007. The Group continued to enhance this product during 2008 culminating in preparation for CLIA trial in late 2008. CLIA trials are planned for early 2009 followed by launch of the product worldwide following successful CLIA waiver approval.
Haemoglobin assay development
In 2007 the Group initiated a project to develop a variant haemoglobin assay for neo-natal screening. Development was completed in early 2008 and the product launched in 2008.
Medium throughput HPLCPremier Hb 9210 Instrument for Haemoglobin testingA1c Testing
This project entails the development of a new HPLCHigh Performance Liquid Chromotography (HPLC) instrument for testing haemoglobin A1c. This is a measure of a patient’s average blood sugar control over the last two to replace the current PDQ analyzer.three months. The new instrument will allow access to markets not previously open to Trinity Biotech due to instrument price and test capability (A1c and variant). Development was initiated in late 2007, continued in 2008through 2010 and is expected to continue through 2009. Launchlaunch initially in the non-US market in the first half of 2011.
HbA1c testing is one of the fastest growing markets in the diagnostics industry. Diabetes is the fourth leading cause of death by disease in the world and the number of diabetic patients is expected to reach 370 million in 2010.
Haemostasis Development Group
Destiny Max Development Project2030. In the U.S. alone some 20.8 million Americans (7 percent of the population) have the disease with a full 54 million Americans considered to be pre-diabetic. The total laboratory HbA1c market worldwide is expected to reach $272 million by 2012.
The GroupPremier Hb9210 analyser is a best in class instrument with the process of launching a new high throughput haemostasis instrument called the Destiny Max. The Destiny Max instrument is intended to meet the requirements of large laboratories, commercial laboratories, reference laboratories and anti-coagulation clinics, i.e. high volume laboratories. In so doing, Trinity Biotech will be able to compete effectivelyfollowing key advantages:
Patented boronate affinity technology, therefore eliminating interference from haemoglobin variants,
Results available in an overall system approach whereby placement1 minute enabling fastest patient result turnaround times,
State of the Destiny Max instrumentsart software using touch screen technology to facilitate ease of use with operators,
Modular instrument which will drive increased salessignificantly reduce the cost of the associated Trinity Biotech reagents, controls and accessories. Development of the instrument continued in 2008 when the design was finalised. The design was validated in late 2008, including external clinical trials. Non US launch was achieved in late 2008 as well as 510K submission to the FDA. FDA approval is expected in 2009 followed by US launch.on-site maintenance.

36


Trend Information
For information on trends in future operating expenses and capital resources, see “Results of Operations”, “Liquidity and Capital Resources” and “Impact of Inflation” under Item 5.

36


Item 6
Directors and Senior Management
Directors
       
Name Age Title
       
Ronan O’Caoimh 5355  Chairman and Chief Executive Officer
       
Rory Nealon 4143  Director, Chief Operations Officer
       
Jim Walsh, PhD 5052  Non Executive Director, Chief Scientific Officer
       
Denis R. Burger, PhD 6567  Non Executive Director
       
Peter Coyne 4951  Non Executive Director
       
Clint Severson 6062  Non Executive Director
       
James D. Merselis 5557  Non Executive Director
       
Executive Officer
      
       
Kevin Tansley 3840  Chief Financial Officer & Company Secretary
Board of Directors & Executive Officers
Ronan O’Caoimh, Chairman and Chief Executive Officer,co-founded Trinity Biotech in June 1992 and acted as Chief Financial Officer until March 1994 when he became Chief Executive Officer. He was also elected Chairman in May 1995. In November 2007, it was decided to separate the role of Chief Executive Officer and Chairman and Mr O’Caoimh assumed the role of Executive Chairman. In October 2008, following the resignation of the Chief Executive Officer, Mr. O’Caoimh resumed the role of Chief Executive Officer and Chairman. Prior to joining Trinity Biotech, Mr O’Caoimh was Managing Director of Noctech Limited, an Irish diagnostics company. Mr O’Caoimh was Finance Director of Noctech Limited from 1988 until January 1991 when he became Managing Director. Mr O’Caoimh holds a Bachelor of Commerce degree from University College Dublin and is a Fellow of the Institute of Chartered Accountants in Ireland. On March 30, 2011, the service agreement with Ronan O’Caoimh as Chief Executive Officer was terminated and replaced by an agreement with Darnick Limited.
Rory Nealon, Chief Operations Officer, joined Trinity Biotech as Chief Financial Officer and Company Secretary in January 2003. He was appointed Chief Operations Officer in November 2007. Prior to joining Trinity Biotech, he was Chief Financial Officer of Conduit plc, an Irish directory services provider with operations in Ireland, the UK, Austria and Switzerland. Prior to joining Conduit he was an Associate Director in AIB Capital Markets, a subsidiary of AIB Group plc, the Irish banking group. Mr Nealon holds a Bachelor of Commerce degree from University College Dublin, is a Fellow of the Institute of Chartered Accountants in Ireland, a member of the Institute of Taxation in Ireland and a member of the Institute of Corporate Treasurers in the UK.

37


Jim Walsh, PhD, Non-executive directorExecutive Director, initially joined Trinity Biotech in October 1995 as Chief Operations Officer. Dr. Walsh resigned from the role of Chief Operations Officer in 2007.2007 to become a Non Executive Director of the Company. In October, 2010 Dr. Walsh rejoined the company as Chief Scientific Officer. Prior to joining the Trinity Biotech, Dr Walsh was Managing Director of Cambridge Diagnostics Ireland Limited (CDIL). He was employed with CDIL since 1987. Before joining CDIL he worked with Fleming GmbH as Research & Development Manager. Dr Walsh has a degree in Chemistry andholds a PhD in MicrobiologyChemistry from University College Galway. Dr Walsh remains on the Board as a non executive director of the Company.

37


Denis R. Burger, PhD, Non-executive director, co-founded Trinity Biotech in June 1992 and acted aswas Chairman from June 1992 to May 1995. He is currently Chairman of BioCurex, Inc, a cancer diagnostics, OTC:BB listed company and is also non-executive directorChairman of the Company and serves as an independent director on the boards of two other NASDAQ-listed companies.Lorus Therapeutics, Inc, a cancer therapeutics, TSX listed company. Until March 2007, Dr Burger was the Chairman and Chief Executive Officer of AVI Biopharma Inc, an Oregon based bio-technology Company.a NASDAQ listed biotechnology company. He was also a co-founder and, from 1981 to 1990, Chairman of Epitope Inc. In addition, Dr Burger has held a professorship in the Department of Microbiology and Immunology and Surgery (Surgical Oncology) at the Oregon Health and Sciences University in Portland. Dr Burger received his degree in Bacteriology and Immunology from the University of California in Berkeley in 1965 and his Master of Science and PhD in 1969 in Microbiology and Immunology from the University of Arizona.
Peter Coyne, Non-executive director, joined the board of Trinity Biotech in November 2001 as a non-executive director. Mr Coyne is a director of AIB Corporate Finance a subsidiary of AIB Group plc, the Irish banking group. Heand has extensive experience in advising public and private groups on all aspects of corporate strategy. Prior to joining AIB, Mr Coyne trained as a chartered accountant and was a senior manager in Arthur Andersen’s Corporate Financial Services practice. Mr Coyne holds a Bachelor of Engineering degree from University College Dublin and is a Fellow of the Institute of Chartered Accountants in Ireland.
Clint Severson, Non-executive director, joined the board of Trinity Biotech in November 2008 as a non-executive director. Mr Severson is currently Chairman, President and CEO of Abaxis Inc., a NASDAQ traded diagnostics company based in Union City, California. Since November 2006, Mr. Severson has also served on the Board of Directors of CytoCore, Inc. From February 1989 to May 1996, Mr. Severson served as President and Chief Executive Officer of MAST Immunosystems, Inc., a privately-held medical diagnostic company and to date he has accumulated over 30 years experience in the medical diagnostics industry.
James D. Merselis, Non-executive director, joined the board of Trinity Biotech in February 2009 as a non-executive director. Mr2009. Mr. Merselis is currently President and CEO of ITC Nexus Dx Holding Company, Inc, a privately held, New Jersey-based diagnostics company working to improve patient care by providing rapid and reliable point of care (POC) medical test information. Prior to this Mr. Merselis served as President and CEO of Alverix, Inc., a privately held optoelectronics company developing portable medical diagnostic instruments. Most recently, Mr. Merselis served as President and CEO ofinstruments , HemoSense, Inc. (NASDAQ: HEM), a point-of-care diagnostics company focused initially on providing patients and physicians with rapid test results to help manage the risk of stroke with the drug warfarin or Coumadin. Prior to his tenure at HemoSense, Mr Merselis served as President and CEO of Micronics, Inc., a microfluidics company. In addition, MrOver twenty-two years, Mr. Merselis has held a numberseries of increasingly responsible executive positions over twenty-two years with Boehringer Mannheim Diagnostics (now Roche Diagnostics).
Kevin Tansley, Chief Financial Officer, joined Trinity Biotech in June 2003 and was appointed Chief Financial Officer and Secretary to the Board of Directors in November 2007. Prior to joining Trinity Biotech in 2003, Mr Tansley held a number of financial positions in the Irish electricity utility ESB. Mr Tansley holds a Bachelor of Commerce degree from University College Dublin and is a Fellow of the Institute of Chartered Accountants in Ireland.

38


Compensation of Directors and Officers
The basis for the executive directors’ remuneration and level of annual bonuses is determined by the Remuneration Committee of the board. In all cases, bonuses and the granting of share options are subject to stringent performance criteria. The Remuneration Committee consists of Dr Denis Burger (committee chairman and senior independent director), Mr Peter Coyne, Mr Clint Severson and Mr Ronan O’Caoimh.James Merselis. Directors’ remuneration shown below comprises salaries, pension contributions and other benefits and emoluments in respect of executive directors. Non-executive directors are remunerated by fees and the granting of share options. Non-executive directors who perform additional services on the Audit Committee or Remuneration Committee receive additional fees. The fees payable to non-executive directors are determined by the board. Each director is reimbursed for expenses incurred in attending meetings of the board of directors.

38


Total directors and non-executive directors’ remuneration, excluding pension, for the year ended December 31, 20082010 amounted to US$2,900,000.2,082,000. The pension charge for the year amounted to US$241,000.127,000. See Item 18, note 6 to the consolidated financial statements. The split of directors’ remuneration set out by director is detailed in the table below:
                     
      Defined          
  Salary/  contribution  Compensation  Total  Total 
  Benefits  pension  for loss of  2008  2007 
Director US$’000  US$’000  office  US$’000  US$’000 
Ronan O’Caoimh  495   98      593   927 
Brendan Farrell  483   75   1,283   1,841   681 
Rory Nealon  439   68      507   509 
Jim Walsh              270 
                
   1,417   241   1,283   2,941   2,387 
                
                     
          Defined       
  Salary/  Performance  contribution  Total  Total 
  Benefits  related bonus  pension  2010  2009 
Executive Director US$’000  US$’000  US$’000  US$’000  US$’000 
Ronan O’Caoimh  560   450   82   1,092   644 
Rory Nealon  377   300   37   714   419 
Jim Walsh*  77      8   85    
                
   1,014   750   127   1,891   1,063 
                
                                
 Total Total  Total Total 
 Fees Other 2008 2007  Fees Other 2010 2009 
Non-executive director US$’000 US$’000 US$’000 US$’000  US$’000 US$’000 US$’000 US$’000 
Denis R. Burger 68  68 65  73  73 70 
Peter Coyne 68  68 65  73  73 70 
James Merselis      63  63 53 
Clint Severson 5  5   63  63 60 
Jim Walsh 59 44 103  
Jim Walsh* 46 39 85 60 
                  
 200 44 244 130  318 39 357 313 
                  
*Dr. Jim Walsh is included as a non-executive director of the Company up until his appointment as Chief Scientific Officer in October 2010 and accordingly his remuneration after that point has been categorised with the two other executive directors.
                    
                     Defined     
 Defined      Salary/ Performance contribution Total Total 
Chief Financial Salary/ Performance contribution Total Total  Benefits related bonus pension 2010 2009 
Officer & Company Benefits related bonus pension 2008 2007 
Secretary US$’000 US$’000 US$’000 US$’000 US$’000 
Officer & Company Secretary US$’000 US$’000 US$’000 US$’000 US$’000 
Kevin Tansley 329 43 36 408 55  285 300 28 613 317 
                      
 329 43 36 408 55 
           
As at December 31, 2008 there are no amounts which are set aside or2010 an amount of $58,000 was accrued by thea Company or its subsidiariessubsidiary to provide pension, retirement or similar benefits for the directors.
The total share-based compensation expense recognised in the consolidated statement of operations in 20082010 in respect of options granted to both executive and non executive directors and the Company Secretary amounted to US$776,000.814,000. See Item 18, note 6 to the consolidated financial statements.

39


The directors and Company Secretary were granted 1,665,0002,500,000 share options during 2008. No options2010 and were granted to2,220,000 share options during 2009 — the directors during 2007.terms of which are as follows:
2010 Share Options Granted:
Number of OptionsExercise Price ofDate of Option
Director/Executive OfficerGrantedOptions GrantedGrant*
Ronan O’Caoimh800,000 ‘A’ sharesUS$1.52 per ‘A’ share21 May 2010
Rory Nealon500,000 ‘A’ sharesUS$1.52 per ‘A’ share21 May 2010
Denis Burger60,000 ‘A’ sharesUS$1.52 per ‘A’ share21 May 2010
Peter Coyne60,000 ‘A’ sharesUS$1.52 per ‘A’ share21 May 2010
Jim Walsh60,000 ‘A’ sharesUS$1.52 per ‘A’ share21 May 2010
Clint Severson60,000 ‘A’ sharesUS$1.52 per ‘A’ share21 May 2010
James Merselis60,000 ‘A’ sharesUS$1.52 per ‘A’ share21 May 2010
Jim Walsh400,000 ‘A’ sharesUS$1.57 per ‘A’ share4 October 2010
Kevin Tansley500,000 ‘A’ sharesUS$1.52 per ‘A’ share21 May 2010
*All options issued are subject to a 7 year life from date of grant.
2009 Share Options Granted:
Number of OptionsExercise Price ofDate of Option
Director/Executive OfficerGrantedOptions GrantedGrant*
Ronan O’Caoimh800,000 ‘A’ sharesUS$0.66 per ‘A’ share8 May 2009
Rory Nealon500,000 ‘A’ sharesUS$0.66 per ‘A’ share8 May 2009
Denis Burger60,000 ‘A’ sharesUS$0.66 per ‘A’ share8 May 2009
Peter Coyne60,000 ‘A’ sharesUS$0.66 per ‘A’ share8 May 2009
Jim Walsh60,000 ‘A’ sharesUS$0.66 per ‘A’ share8 May 2009
Clint Severson120,000 ‘A’ sharesUS$0.66 per ‘A’ share8 May 2009
James Merselis120,000 ‘A’ sharesUS$0.66 per ‘A’ share8 May 2009
Kevin Tansley500,000 ‘A’ sharesUS$0.66 per ‘A’ share8 May 2009
*All options issued are subject to a 7 year life from date of grant.
In addition, see Item 7 — Major Shareholders and Related Party Transactions for further information on the compensation of Directors and Officers.
Directors’ Service Contracts
The Company has entered into service contracts with its Executive Directors and Officers. These contracts contain certain termination provisions which are summarised below.
On March 30, 2011, the service agreement with Ronan O’Caoimh as Chief Executive Officer was terminated and replaced by an agreement with Darnick Limited, a company wholly-owned by members of Mr. O’Caoimh’s immediate family. Pursuant to the agreement, Darnick Limited will provide the Company with the services of Mr. O’Caoimh as Chief Executive Officer. The agreement contains certain non-competition and confidentiality provisions. The term of the agreement will continue until such time as it is terminated by either party, subject to the Company providing one year’s notice. Where termination occurs within 12 months of a change of control of the Company two year’s notice will apply. Darnick Limited may terminate the agreement on six month’s notice. Mr. O’Caoimh will remain as Chairman of the Board of Directors.

40


Under the terms of his service contract Rory Nealon, Chief Operations Officer, is entitled to 12 months salary and benefits in the event of termination by the Company. Where termination arises within 12 months of a change in control of the Company, Mr. Nealon is entitled to 18 months salary and benefits.
Under the terms of his service contract Kevin Tansley, Chief Financial Officer, is entitled to 12 months salary and benefits in the event of termination by the Company. Where termination arises within 12 months of a change in control of the Company, Mr. Tansley is entitled to 18 months salary and benefits.
Under the terms of his service contract, entered into in October 2010, Jim Walsh, Chief Scientific Officer, is entitled to 12 months salary and benefits in the event of termination by the Company. Where termination arises within 12 months of a change in control of the Company, Dr. Walsh is entitled to 18 months salary and benefits.
Board Practices
The Articles of Association of Trinity Biotech provide that one third of the directors in office (other than the Managing Director or a director holding an executive office with Trinity Biotech) or, if their number is not three or a multiple of three, then the number nearest to but not exceeding one third, shall retire from office at every annual general meeting. If at any annual general meeting the number of directors who are subject to retirement by rotation is two, one of such directors shall retire and if the number of such directors is one that director shall retire. Retiring directors may offer themselves for re-election. The directors to retire at each annual general meeting shall be the directors who have been longest in office since their last appointment. As between directors of equal seniority the directors to retire shall, in the absence of agreement, be selected from among them by lot.

39


The board has established Audit, Remuneration and Compensation Committees. The functions and membership of the Remuneration Committee are described above. The Audit Committee reviews the Group’s annual and interim financial statements and reviews reports on the effectiveness of the Group’s internal controls. It also appoints the external auditors, reviews the scope and results of the external audit and monitors the relationship with the auditors. The Audit Committee comprises two of the twofour independent non-executive directors of the Group, Mr Peter Coyne (Committee Chairman) and Dr Denis Burger.Mr James Merselis. The Compensation Committee currently comprises Mr Ronan O’Caoimh (Committee Chairman) and Mr Rory Nealon. The Compensation Committee administers the Employee Share Option Plan. The Committee determines the exercise price and the term of the options. Options granted to the members of the Committee are approved by the Remuneration Committee and individual option grants in excess of 30,000 shares are approved by the full board of directors. Share options granted to non-executive directors are decided by the other members of the board.
Because Trinity Biotech is a foreign private issuer, it is not required to comply with all of the corporate governance requirements set forth in NASDAQ Rule 43505600 as they apply to U.S. domestic companies. The Group’s corporate governance measures differ in the following significant ways. The Audit Committee of the Group currently consists of two members — while U.S. domestic companies listed on NASDAQ are required to have three members on their audit committee. In addition,way; the Group has not appointed an independent nominations committee or adopted a board resolution addressing the nominations process. Finally, the Group’s Executive Chairman serves on the Group’s Remuneration Committee with two non-executive independent directors, while U.S. domestic companies are required to have executive officer compensation determined by a remuneration committee comprised solely of independent directors or a majority of the independent directors.
Employees
As of December 31, 2008,2010, Trinity Biotech had 711343 employees (2007: 762)(2009: 658) consisting of 5829 research scientists and technicians, 418210 manufacturing and quality assurance employees, and 235104 finance, administration, sales and marketing staff (2007: 48(2009: 60 research scientists and technicians, 450422 manufacturing and quality assurance employees, and 264176 finance, administration, sales and marketing staff). Trinity Biotech’s future hiring levels will depend on the growth of revenues.
The geographic spread of the Group’s employees was as follows: 310121 in Bray, Co. Wicklow, Ireland 272and 222 in its US operations, 96 in Germany, 16 in the United Kingdom and 17 in France.operations.
Stock Option PlanPlans
The boardBoard of directors hasDirectors have adopted the Employee Share Option Plan, asPlans (the “Plans”), with the most recently updated inadopted Share Option Plan being the 2006 (the “Plan”), thePlan. The purpose of whichthese Plans is to provide Trinity Biotech’s employees, consultants, officers and directors with additional incentives to improve Trinity Biotech’s ability to attract, retain and motivate individuals upon whom Trinity Biotech’s sustained growth and financial success depends. The Plan isThese Plans are administered by a Compensation Committee designated by the board of directors. Options under the PlanPlans may be awarded only to employees, officers, directors and consultants of Trinity Biotech.

41


The exercise price of options is determined by the Compensation Committee. The term of an option will be determined by the Compensation Committee, provided that the term may not exceed seven years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with Trinity Biotech (or one year after such termination because of death or disability) except where a longer period is approved by the board of directors. Under certain circumstances involving a change in control of Trinity Biotech, the Committee may accelerate the exercisability and termination of options. As of February 28, 2009, 4,114,0852011, 7,352,086 of the options outstanding were held by the directors and officersCompany Secretary of Trinity Biotech.Biotech as follows:
           
  Number of Options  Exercise Price   
Director/Company Secretary (‘A’ Shares)  (Per ‘A’ Share)  Expiration Date of Options
Ronan O’Caoimh  450,000  US$2.56  26 August 2011
   250,000  US$1.67  2 November 2012
   350,000  US$2.09  13 December 2013
   175,000  US$1.07  18 March 2015
   66,666  US$0.74  16 September 2015
   533,334  US$0.66  8 May 2016
   800,000  US$1.52  21 May 2017
Rory Nealon  175,000  US$2.56  26 August 2011
   100,000  US$1.67  2 November 2012
   150,000  US$2.09  13 December 2013
   200,000  US$1.07  18 March 2015
   240,000  US$0.74  16 September 2015
   500,000  US$0.66  8 May 2016
   500,000  US$1.52  21 May 2017
Denis Burger  60,000  US$2.56  26 August 2011
   25,000  US$1.67  2 November 2012
   25,000  US$2.09  13 December 2013
   60,000  US$0.66  8 May 2016
   60,000  US$1.52  21 May 2017
Jim Walsh  168,750  US$2.56  26 August 2011
   50,000  US$1.67  2 November 2012
   25,000  US$2.09  13 December 2013
   60,000  US$0.66  8 May 2016
   60,000  US$1.52  21 May 2017
   400,000  US$1.57  4 October 2017
Peter Coyne  60,000  US$2.56  26 August 2011
   25,000  US$1.67  2 November 2012
   25,000  US$2.09  13 December 2013
   60,000  US$0.66  8 May 2016
   60,000  US$1.52  21 May 2017
Clint Severson  120,000  US$0.66  8 May 2016
   60,000  US$1.52  21 May 2017
James Merselis  120,000  US$0.66  8 May 2016
   60,000  US$1.52  21 May 2017
Kevin Tansley  20,000  US$2.79  19 May 2011
   20,000  US$1.59  16 August 2012
   30,000  US$1.78  26 July 2013
   75,000  US$2.24  07 March 2014
   150,000  US$1.07  18 March 2015
   150,000  US$0.74  16 September 2015
   333,336  US$0.66  8 May 2016
   500,000  US$1.52  21 May 2017

42


As of February 28, 20092011 the following options were outstanding:
         
  Number of ‘A’  Range of Range of
  Ordinary Shares  Exercise Price Exercise Price
  Subject to Option  per Ordinary Share per ADS
 
 
Total options outstanding  8,374,0489,266,102  US$0.74-US$0.66-US$4.00 US$2.96-US$2.63-US$16.00

40


In January 2004, the Group completed a private placement and as part of this the investors were granted five year warrants to purchase an aggregate of 1,058,824 ‘A’ Ordinary Shares of Trinity Biotech at an exercise price of US$5.25 per ordinary share and the agent received 200,000 warrants to purchase 200,000 ‘A’ Ordinary Shares of Trinity Biotech at an exercise price of US$5.25 per ordinary share. As of February 28, 2009 all of these warrants had expired.
In addition,April 2010, the Company granted warrants to purchase 2,178,24440,000 Class ‘A’ Ordinary Shares (vesting immediately) in April 2008.. These warrants were issued at an exercise price of US$1.391.50 per ordinary share and have a term of fiveseven years. As of February 28, 20092011 there were warrants to purchase 2,178,2441,672,244 ‘A’ Ordinary Shares in the GroupCompany outstanding.

 

4143


Item 7
Major Shareholders and
Related Party Transactions
As of February 28, 20092011 Trinity Biotech has outstanding 82,017,58184,252,189 ‘A’ Ordinary shares and 700,000 ‘B’ Ordinary shares. Such totals exclude 10,452,29210,938,346 shares issuable upon the exercise of outstanding options and warrants.
The following table sets forth, as of February 28, 2009,2011, the Trinity Biotech ‘A’ Ordinary Shares and ‘B’ Ordinary Shares beneficially held by (i) each person believed by Trinity Biotech to beneficially hold 5% or more of such shares, (ii) each director and officerthe Company Secretary of Trinity Biotech, and (iii) all officersdirectors and directorsthe Company Secretary as a group.
Except as otherwise noted, all of the persons and groups shown below have sole voting and investment power with respect to the shares indicated. The Group is not controlled by another corporation or government.
                                        
 Number of ‘A’ Percentage Number of ‘B’ Percentage    Number of ‘A’ Percentage Number of ‘B’ Percentage Percentage 
 Ordinary Shares Outstanding Ordinary Shares Outstanding Percentage  Ordinary Shares Outstanding Ordinary Shares Outstanding Total 
 Beneficially ‘A’ Ordinary Beneficially ‘B’ Ordinary Total  Beneficially ‘A’ Ordinary Beneficially ‘B’ Ordinary Voting 
 Owned Shares Owned Shares Voting Power  Owned Shares Owned Shares Power 
William Blair & Company Investment Management 11,763,664  14.0%    13.7%
 
Goldman Capital Management, Inc. 6,714,000  8.0%    7.8%
 
Heartland Advisors, Inc. 5,888,000  7.0%    6.9%
  
Ronan O’Caoimh  6,395,955(1)  7.7%    7.5%  4,974,995(1)  5.8%    5.7%
  
Rory Nealon  650,000(2)  0.8%    0.8%  1,051,666(2)  1.2%    1.2%
  
Jim Walsh  1,868,198(3)  2.3%    2.2%  1,657,362(3)  2.0%    1.9%
  
Denis R. Burger  192,416(4)  0.2%    0.2%  130,000(4)  0.2%    0.2%
  
Peter Coyne  145,417(5)  0.2%    0.2%  130,000(5)  0.2%    0.2%
  
Kevin Tansley  134,083(6)  0.2%    0.2%
 
Clint Severson        88,000(6)  0.1%    0.1%
  
James Merselis        40,000(7)  0.1%    0.1%
  
Potenza Investments Inc, (“Potenza”)
Statenhof Building, Reaal
2A 23 50AA
Leiderdorp Netherlands
    500,000(7)  71.4%  1.2%
Officers and Directors 9,386,069  11.4%    11.1%
as a group (6 persons)  (1)(2)(3)(4)(5)(6)  
Kevin Tansley  353,252(8)  0.4%    0.4%
 
Potenza Investments Inc.    500,000(9)  71.4%  1.2%
 
Directors & Co. Secretary as a group (8 persons) 8,425,275(1)(2)(3)(4)(5)(6)(7)(8)  9.7%    9.5%
   
(1) Includes 1,304,5001,137,499 shares issuable upon exercise of options.
 
(2) Includes 450,000851,666 shares issuable upon exercise of options.
 
(3) Includes 484,583263,750 shares issuable upon exercise of options.
 
(4) Includes 145,146130,000 shares issuable upon exercise of options.
 
(5) Includes 145,417130,000 shares issuable upon exercise of options.
 
(6) Includes 82,08340,000 shares issuable upon exercise of options.
 
(7) Includes 40,000 shares issuable upon exercise of options.
(8)Includes 301,252 shares issuable upon exercise of options.
(9)These ‘B’ shares have two votes per share.

 

4244


Related Party Transactions
The Group has entered into various arrangements with JRJ Investments (“JRJ”), a partnership owned by Mr O’Caoimh and Dr Walsh, directors of Trinity Biotech, and directly with Mr O’Caoimh and Dr Walsh, to provide for current and potential future needs to extend its premises at IDA Business Park, Bray, Co. Wicklow, Ireland.
In July 2000, Trinity Biotech entered into an agreement with JRJ pursuant to which the Group took a lease of a 25,000 square foot premises adjacent to the existing facility for a term of 20 years at a rent of7.62 €7.62 per square foot for an annual rent of190,000 €190,000 (US$279,000)254,000). During 2006, the rent on this property was reviewed and increased to11.00 €11.00 per square foot, resulting in an annual rent of275,000 €275,000 (US$404,000)367,000). The lease on this property was assigned to Diagnostica Stago in May, 2010 following the divestiture of the coagulation business.
In November 2002, the Group entered into an agreement for a 25 year lease with JRJ for offices that have been constructed adjacent to its premises at IDA Business Park, Bray, Co. Wicklow, Ireland. The annual rent of381,000 €381,000 (US$560,000)509,000) is payable from January 1, 2004. There was a rent review performed on this premises in 2009 and further to this review, there was no change to the annual rental charge.
In December 2007, the Group entered into an agreement with MrMr. O’Caoimh and Dr Walsh pursuant to which the Group took a lease on an additional 43,860 square foot manufacturing facility in Bray, Ireland at a rate of17.94 €17.94 per square foot (including fit out) giving a total annual rent of787,000 €787,000 (US$1,157,000)1,051,000).
Independent valuers have advised the Group that the rent in respect of each of the leases represents a fair market rent.
Trinity Biotech and its directors (excepting Mr O’Caoimh and Dr Walsh who express no opinion on this point) believe that the arrangements entered into represent a fair and reasonable basis on which the Group can meet its ongoing requirements for premises.
Rayville Limited, an Irish registered company, which is wholly owned by the four executive directors and certain other executives of the Group, owns all of the ‘B’ non-voting Ordinary Shares in Trinity Research Limited, one of the Group’s subsidiaries. The ‘B’ shares do not entitle the holders thereof to receive any assets of the company on a winding up. All of the ‘A’ voting ordinary shares in Trinity Research Limited are held by the Group. Trinity Research Limited may, from time to time, declare dividends to Rayville Limited and Rayville Limited may declare dividends to its shareholders out of those amounts. Any such dividends paid by Trinity Research Limited are ordinarily treated as a compensation expense by the Group in the consolidated financial statements prepared in accordance with IFRS, notwithstanding their legal form of dividends to minority interests, as this best represents the substance of the transactions.
In February 2008, Dr. Walsh advanced a loan to Trinity Biotech Manufacturing Limited amounting to650,000 (US$956,000) at an annual interest rate of 5.68%. The company repaid the loan to Dr. Walsh prior to the year end. There were no other director loans advanced during 20082010 and there were no loan balances payable to or receivable from directors at January 1, 20082010 and at December 31, 2008.2010.
In December 2006, the Remuneration Committee ofJune 2009, the Board approved the payment of a dividend of US$5,331,000$2,830,000 by Trinity Research Limited to Rayville Limited on the ‘B’ shares held by it. This amount was then lent back by Rayville to Trinity Research Limited. This loan was partially used to fund executive compensation in 2007 and will fund future executive compensation over the next number of years under the arrangement described above, with the amount of such funding being reflected in compensation expense over the corresponding period. As the dividend is matched by a loan from Rayville Limited to Trinity Research Limited which is repayable solely at the discretion of the Remuneration Committee of the Board and is unsecured and interest free, the Group netted the dividend paid to Rayville Limited against the corresponding loan from Rayville Limited in the 2007 and 20062009 & 2010 consolidated financial statements.
The amount of payments to Rayville included in compensation expense was US$1,911,000,1,866,000, US$2,061,0001,071,000 and US$1,866,0002,149,000 for 2006, 20072008, 2009 and 20082010 respectively, of which US$1,779,000,1,610,000, US$1,867,000887,000 and US$1,609,9051,431,000 respectively related to the key management personnel of the Group. There were no dividends payable to Rayville Limited as of December 31, 2010 or 2009. Dividends payable to Rayville at December 31, 2008 amounted to US$60,000. There were no dividends payable to Rayville Limited as of December 31, 2006 or 2007. Of the US$1,866,0002,149,000 of payments made to Rayville Limited in 2008,2010, US$386,000565,000 represented repayments of the loan to Trinity Research Limited referred to above.

 

4345


Item 8
Financial Information
Legal Proceedings
In 2008 Trinity Biotech has filed a civil suit with a New York court against the former shareholders of Primus Corporation. Trinity Biotech claimsclaimed that the defendants unjustly received an overpayment of US$512,000 based on the fraudulent and wrongful calculation of the earnout payable to the shareholders of Primus Corporation. Trinity Biotech also allegesalleged that one of the former shareholders, Mr Thomas Reidy, failed to return stock certificates and collateral pledged by Trinity Biotech as security for the payment of a $3US$3 million promissory note given to the defendants by Trinity Biotech as part of compensation under the share purchase agreement for acquiring Primus. During 2009, all of the defendants with the exception of Mr. Reidy settled the legal action. The caseUS District Court, Southern District of New York granted a judgment against Mr. Reidy ordering him to pay Trinity damages of US$200,000 plus interest and to return stock certificates and collateral pledged by Trinity Biotech as security for the payment of the US$3 million promissory note. Mr Reidy has not yet been heard.paid any damages or interest due to Trinity Biotech.
In 2010, Laboratoires Nephrotek, formerly a distributor for Trinity Biotech, took a legal action in France against the Group, claiming damages of US$0.8 million. They claim that certain instruments supplied by Trinity Biotech did not operate properly in the field. No court hearings have occurred in relation to this case yet. Trinity Biotech will be defending the claim.
There are also a small number of legal cases being brought against the Group by certain of its former employees in the previously owned French subsidiary, Trinity Biotech France S.à r.l.
The ultimate resolution of the aforementioned proceedings is not expected to have a material adverse effect on our financial position, results of operations or cash flows.
Item 9
The Offer and Listing
Trinity Biotech’s American Depository Shares (“ADSs”) are listed on the NASDAQ National Cap Market under the symbol “TRIB”. In 2005, the Trinity Biotech adjusted the ratio of American Depository ReceiptsShares (“ADSs”) to Ordinary Shares and changed its NASDAQ Listing from the NASDAQ Small Capital listing to a NASDAQ National Market Listing. The ratio of ADSs to underlying Ordinary Shares has changed from 1 ADS : 1 Ordinary Share to 1 ADS : 4 Ordinary Shares and all historical data has been restated as a result.
The Group’s ‘A’ Ordinary Shares were also listed and traded on the Irish Stock Exchange until November 2007, whereby the Company de-listed from the Irish Stock Exchange. The Group’s depository bank for ADSs is The Bank of New York Mellon. On February 28, 2009,2011, the reported closing sale price of the ADSs was US$1.198.89 per ADS. The following tables set forth the range of quoted high and low sale prices of Trinity Biotech’s ADSs for (a) the years ended December 31, 2004, 2005, 2006, 2007, 2008, 2009 and 2008;2010; (b) the quarters ended March 31, June 30, September 30 and December 31, 2007;2009; March 31, June 30, September 30 and December 31, 2008;2010; and (c) the months of March, April, May, June, July, August, September, October, November and December 20082010 and January and February 20092011 as reported on NASDAQ. These quotes reflect inter-dealer prices without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.
         
  ADSs 
  High  Low 
Year Ended December 31
        
         
2004 $23.96  $9.40 
2005 $11.72  $6.28 
2006 $9.54  $7.09 
2007 $11.75  $5.72 
2008 $6.95  $1.25 
         
2007
        
Quarter ended March 31 $10.45  $8.68 
Quarter ended June 30 $11.74  $9.13 
Quarter ended September 30 $11.75  $10.05 
Quarter ended December 31 $11.40  $5.72 
         
2008
        
Quarter ended March 31 $6.95  $4.15 
Quarter ended June 30 $4.61  $3.39 
Quarter ended September 30 $3.90  $2.82 
Quarter ended December 31 $3.10  $1.25 
ADSs
         
Year Ended December 31 High  Low 
2006 US$9.54  US$7.09 
2007 US$11.75  US$5.72 
2008 US$6.95  US$1.25 
2009 US$5.70  US$1.05 
2010 US$8.93  US$3.76 

 

4446


         
  ADSs 
  High  Low 
Month Ended
        
March 31, 2008 $5.01  $4.15 
April 30, 2008 $4.61  $3.53 
May 31, 2008 $4.06  $3.39 
June 30, 2008 $4.25  $3.81 
July 31, 2008 $3.90  $3.31 
August 31, 2008 $3.40  $3.03 
September 30, 2008 $3.39  $2.82 
October 31, 2008 $3.10  $2.05 
November 30, 2007 $2.35  $1.56 
December 31, 2008 $1.79  $1.25 
January 31, 2009 $2.25  $1.61 
February 29, 2009 $1.95  $1.15 
ADSs
         
2009 High  Low 
Quarter ended March 31 US$2.35  US$1.05 
Quarter ended June 30 US$4.84  US$1.50 
Quarter ended September 30 US$5.70  US$3.06 
Quarter ended December 31 US$4.43  US$3.33 
ADSs
         
2010 High  Low 
Quarter ended March 31 US$6.24  US$3.76 
Quarter ended June 30 US$6.67  US$5.26 
Quarter ended September 30 US$6.67  US$5.71 
Quarter ended December 31 US$8.93  US$6.15 
ADSs
         
Month Ended High  Low 
March 31, 2010 US$6.24  US$4.71 
April 30, 2010 US$6.24  US$5.47 
May 31, 2010 US$6.67  US$5.26 
June 30, 2010 US$6.60  US$5.81 
July 31, 2010 US$6.42  US$5.79 
August 31, 2010 US$6.45  US$5.71 
September 30, 2010 US$6.67  US$5.90 
October 31, 2010 US$7.16  US$6.15 
November 30, 2010 US$8.69  US$7.04 
December 31, 2010 US$8.93  US$7.60 
January 31, 2011 US$8.83  US$8.00 
February 28, 2011 US$9.19  US$8.03 
The number of record holders of Trinity Biotech’s ADSs as at February 28, 20092011 amounts to 446,693, inclusive of those brokerage firms and/or clearing houses holding Trinity Biotech’s securities for their clienteleclients (with each such brokerage house and/or clearing house being considered as one holder).

 

4547


Item 10
Memorandum and
Articles of Association
Objects
The Company’s objects, detailed in Clause 3 of its Memorandum of Association, are varied and wide ranging and include principally researching, manufacturing, buying, selling and distributing all kinds of patents, pharmaceutical, medicinal and diagnostic preparations, equipment, drugs and accessories. They also include the power to acquire shares or other interests or securities in other companies or businesses and to exercise all rights in relation thereto. The Company’s registered number in Ireland is 183476.
Powers and Duties of Directors
A director may enter into a contract and be interested in any contract or proposed contract with the Company either as vendor, purchaser or otherwise and shall not be liable to account for any profit made by him resulting therefrom provided that he has first disclosed the nature of his interest in such a contract at a meeting of the board as required by Section 194 of the Irish Companies Act 1963. Generally, a director must not vote in respect of any contract or arrangement or any proposal in which he has a material interest (otherwise than by virtue of his holding of shares or debentures or other securities in or through the Group). In addition, a director shall not be counted in the quorum at a meeting in relation to any resolution from which he is barred from voting.
A director is entitled to vote and be counted in the quorum in respect of certain arrangements in which he is interested (in the absence of some other material interest). These include the giving of a security or indemnity to him in respect of money lent or obligations incurred by him for the Group, the giving of any security or indemnity to a third party in respect of a debt or obligation of the Group for which he has assumed responsibility, any proposal concerning an offer of shares or other securities in which he may be interested as a participant in the underwriting or sub-underwriting and any proposal concerning any other company in which he is interested provided he is not the holder of or beneficially interested in 1% or more of the issued shares of any class of share capital of such company or of voting rights.
The Board may exercise all the powers of the Group to borrow money but it is obliged to restrict these borrowings to ensure that the aggregate amount outstanding of all monies borrowed by the Group does not, without the previous sanction of an ordinary resolution of the Company, exceed an amount equal to twice the adjusted capital and reserves (both terms as defined in the Articles of Association). However, no lender or other person dealing with the Group shall be obliged to see or to inquire whether the limit imposed is observed and no debt incurred in excess of such limit will be invalid or ineffectual unless the lender has express notice at the time when the debt is incurred that the limit was or was to be exceeded.
Directors are not required to retire upon reaching any specific age and are not required to hold any shares in the capital of the Group. The Articles provide for retirement of the directors by rotation.
All of the above mentioned powers of directors may be varied by way of a special resolution of the shareholders.
Rights, Preferences and Restrictions Attaching to Shares
The ‘A’ Ordinary Shares and the ‘B’ Ordinary Shares rank pari passu in all respects save that the ‘B’ Ordinary Shares have two votes per share and the right to receive dividends and participate in the distribution of the assets of the Company upon liquidation or winding up at a rate of twice that of the ‘A’ Ordinary Shares.
Where a shareholder or person who appears to be interested in shares fails to comply with a request for information from the Company in relation to the capacity in which such shares or interest are held, who is interested in them or whether there are any voting arrangements, that shareholder or person may be disenfranchised and thereby restricted from transferring the shares and voting rights or receiving any sums in respect thereof (except in the case of a liquidation). In addition, if cheques in respect of the last three dividends paid to a shareholder remain uncashed, the Company is, subject to compliance with the procedure set out in the Articles of Association, entitled to sell the shares of that shareholder.
At a general meeting, on a show of hands, every member who is present in person or by proxy and entitled to vote shall have one vote (so, however, that no individual shall have more than one vote) and upon a poll, every member present in person or by proxy shall have one vote for every share carrying voting rights of which he is the holder. In the case of joint holders, the vote of the senior (being the first person named in the register of members in respect of the joint holding) who tendered a vote, whether in person or by proxy, shall be accepted to the exclusion of votes of the other joint holders.

 

4648


One third of the directors other than an executive director or, if their number is not three or a multiple of three, then the number nearest to but not exceeding one third, shall retire from office at each annual general meeting. If, however, the number of directors subject to retirement by rotation is two, one of such directors shall retire. If the number is one, that director shall retire. The directors to retire at each annual general meeting shall be the ones who have been longest in office since their last appointment. Where directors are of equal seniority, the directors to retire shall, in the absence of agreement, be selected by lot. A retiring director shall be eligible for re-appointment and shall act as director throughout the meeting at which he retires. A separate motion must be put to a meeting in respect of each director to be appointed unless the meeting itself has first agreed that a single resolution is acceptable without any vote being given against it.
The Company may, subject to the provisions of the Companies Acts, 1963 to 20072009 of Ireland, issue any share on the terms that it is, or at the option of the Company is to be liable, to be redeemed on such terms and in such manner as the Company may determine by special resolution. Before recommending a dividend, the directors may reserve out of the profits of the Company such sums as they think proper which shall be applicable for any purpose to which the profits of the Company may properly be applied and, pending such application, may be either employed in the business of the Company or be invested in such investments (other than shares of the Company or of its holding company (if any)) as the directors may from time to time think fit.
Subject to any conditions of allotment, the directors may from time to time make calls on members in respect of monies unpaid on their shares. At least 14 days notice must be given of each call. A call shall be deemed to have been made at the time when the directors resolve to authorise such call.
The Articles do not contain any provisions discriminating against any existing or prospective holder of securities as a result of such shareholder owning a substantial number of shares.
Action Necessary to Change the Rights of Shareholders
In order to change the rights attaching to any class of shares, a special resolution passed at a class meeting of the holders of such shares is required. The provisions in relation to general meetings apply to such class meetings except the quorum shall be two persons holding or representing by proxy at least one third in nominal amount of the issued shares of that class. In addition, in order to amend any provisions of the Articles of Association in relation to rights attaching to shares, a special resolution of the shareholders as a whole is required.
Calling of AGM’s and EGM’s of Shareholders
The Company must hold a general meeting as its annual general meeting each year. Not more than 15 months can elapse between annual general meetings. The annual general meetings are held at such time and place as the directors determine and all other general meetings are called extraordinary general meetings. Every general meeting shall be held in Ireland unless all of the members entitled to attend and vote at it consent in writing to it being held elsewhere or a resolution providing that it be held elsewhere was passed at the preceding annual general meeting. The directors may at any time call an extraordinary general meeting and such meetings may also be convened on such requisition, or in default may be convened by such requisitions, as is provided by the Companies Acts, 1963 to 20062009 of Ireland.
In the case of an annual general meeting or a meeting at which a special resolution is proposed, 21 clear days notice of the meeting is required and in any other case it is seven clear days notice. Notice must be given in writing to all members and to the auditors and must state the details specified in the Articles of Association. A general meeting (other than one at which a special resolution is to be proposed) may be called on shorter notice subject to the agreement of the auditors and all members entitled to attend and vote at it. In certain circumstances provided in the Companies Acts, 1963 to 20062009 of Ireland, extended notice is required. These include removal of a director. No business may be transacted at a general meeting unless a quorum is present. Five members present in person or by proxy (not being less than five individuals) representing not less than 40% of the ordinary shares shall be a quorum. The Company is not obliged to serve notices upon members who have addresses outside Ireland and the US but otherwise there are no limitations in the Articles of Association or under Irish law restricting the rights of non-resident or foreign shareholders to hold or exercise voting rights on the shares in the Company.
However, the Financial Transfers Act, 1992 and regulations made thereunder prevent transfers of capital or payments between Ireland and certain countries. These restrictions on financial transfers are more comprehensively described in “Exchange Controls” below. In addition, Irish competition law may restrict the acquisition by a party of shares in the Company but this does not apply on the basis of nationality or residence.

 

4749


Other Provisions of the Memorandum and Articles of Association
The Memorandum and Articles of Association do not contain any provisions:
which would have an effect of delaying, deferring or preventing a change in control of the Company and which would operate only with respect to a merger, acquisition or corporate restructuring involving the Company (or any of its subsidiaries); or
governing the ownership threshold above which a shareholder ownership must be disclosed; or
imposing conditions governing changes in the capital which are more stringent than is required by Irish law.
which would have an effect of delaying, deferring or preventing a change in control of the Company and which would operate only with respect to a merger, acquisition or corporate restructuring involving the Company (or any of its subsidiaries); or
governing the ownership threshold above which a shareholder ownership must be disclosed; or
imposing conditions governing changes in the capital which are more stringent than is required by Irish law.
The Company incorporates by reference all other information concerning its Memorandum and Articles of Association from the Registration Statement on Form F-1 on June 12, 1992.
Irish Law
Pursuant to Irish law, Trinity Biotech must maintain a register of its shareholders. This register is open to inspection by shareholders free of charge and to any member of the public on payment of a small fee. The books containing the minutes of proceedings of any general meeting of Trinity Biotech are required to be kept at the registered office of the Company and are open to the inspection of any member without charge. Minutes of meetings of the Board of Directors are not open to scrutiny by shareholders. Trinity Biotech is obliged to keep proper books of account. The shareholders have no statutory right to inspect the books of account. The only financial records, which are open to the shareholders, are the financial statements, which are sent to shareholders with the annual report. Irish law also obliges Trinity Biotech to file information relating to certain events within the Company (new share capital issues, changes to share rights, changes to the Board of Directors). This information is filed with the Companies Registration Office (the “CRO”) in Dublin and is open to public inspection. The Articles of Association of Trinity Biotech permit ordinary shareholders to approve corporate matters in writing provided that it is signed by all the members for the time being entitled to vote and attend at general meeting. Ordinary shareholders are entitled to call a meeting by way of a requisition. The requisition must be signed by ordinary shareholders holding not less than one-tenth of the paid up capital of the Company carrying the right of voting at general meetings of the Company. Trinity Biotech is generally permitted, subject to company law, to issue shares with preferential rights, including preferential rights as to voting, dividends or rights to a return of capital on a winding up of the Company. Any shareholder who complains that the affairs of the Company are being conducted or that the powers of the directors of the Company are being exercised in a manner oppressive to him or any of the shareholders (including himself), or in disregard of his or their interests as shareholders, may apply to the Irish courts for relief. Shareholders have no right to maintain proceedings in respect of wrongs done to the Company.
Ordinarily, our directors owe their duties only to Trinity Biotech and not its shareholders. The duties of directors are twofold, fiduciary duties and duties of care and skill. Fiduciary duties are owed by the directors individually and owed to Trinity Biotech. Those duties include duties to act in good faith towards Trinity Biotech in any transaction, not to make use of any money or other property of Trinity Biotech, not to gain directly or indirectly any improper advantage for himself at the expense of Trinity Biotech, to act bona fide in the interests of Trinity Biotech and exercise powers for the proper purpose. A director need not exhibit in the performance of his duties a greater degree of skill than may reasonably be expected from a person of his knowledge and experience. When directors, as agents in transactions, make contracts on behalf of the Company, they generally incur no personal liability under these contracts.
It is Trinity Biotech, as principal, which will be liable under them, as long as the directors have acted within Trinity Biotech’s objects and within their own authority. A director who commits a breach of his fiduciary duties shall be liable to Trinity Biotech for any profit made by him or for any damage suffered by Trinity Biotech as a result of the breach. In addition to the above, a breach by a director of his duties may lead to a sanction from a Court including damages of compensation, summary dismissal of the director, a requirement to account to Trinity Biotech for profit made and restriction of the director from acting as a director in the future.

 

4850


Material Contracts
SeeOther than contracts entered into in the ordinary course of business, the following represents the material contracts entered into by the Group:
Divestiture of Coagulation business to Diagnostica Stago SAS
In May 2010, the Group sold its worldwide Coagulation business to Diagnostica Stago for US$89.9 million. The gain on the divestiture was US$46.8m (see Item 4 “History18, note 3). Diagnostica Stago purchased the share capital of Trinity Biotech (UK Sales) Limited, Trinity Biotech GmbH and DevelopmentTrinity Biotech S.à r.l., along with Coagulation assets of Biopool US Inc. and Trinity Biotech Manufacturing Limited. As part of the Company” regarding acquisitions madesale, the Group also assigned leasing arrangements on a facility in Bray, Ireland to Diagnostica Stago. Included in the sale are Trinity’s lists of coagulation customers and suppliers, all coagulation inventory, intellectual property and developed technology. In total, 321 Trinity employees transferred their employment to Diagnostica Stago as part of the divestiture of the Coagulation business.
The Group received consideration of US$67.4 million and interest on deferred consideration of US$1.0 million in 2010. A further US$11.25 million will be received from Diagnostica Stago in May 2011 and the remaining US$11.25 million will be received in May 2012. No conditions or earnout provisions will apply to this deferred element of the consideration, which is supported by a bank guarantee.
Acquisition of the Group.immuno-technology business of Cortex Biochem Inc
In September 2007, the Group acquired the immuno-technology business of Cortex Biochem Inc (“Cortex”) for a total consideration of US$2,925,000, consisting of cash consideration of US$2,887,000 and acquisition expenses of US$38,000.
The main terms and conditions in the Cortex purchase agreement were as follows:
1.Trinity Biotech acquired Cortex’s lists of customers and suppliers, inventory of immuno reagents, certain accounts receivable and accounts payable balances and the Cortex Biochem website.
2.The vendor undertook not to compete directly with the Cortex business for a period of three years after the sale of the business to Trinity
3.All of the purchase consideration was payable on signing of the contract.
Acquisition of certain components of the distribution business of Sterilab Services UK
In October 2007, the Group acquired certain components of the distribution business of Sterilab Services UK (“Sterilab”), a distributor of Infectious Diseases products, for a total consideration of US$1,489,000, consisting of cash consideration of US$1,480,000 and acquisition expenses of US$9,000.
The main terms and conditions in the Sterilab purchase agreement were as follows:
1.Trinity Biotech acquired a list of customers, inventory of infectious diseases and autoimmune products and all diagnostic instruments placed with Sterilab’s customers.
2.The vendor undertook not to compete directly with Trinity’s infectious disease business in the United Kingdom for a period of one year after the sale of the Sterilab business to Trinity.
3.All of the purchase consideration was payable on signing of the contract.
Exchange Controls and Other Limitations
Affecting Security Holders
Irish exchange control regulations ceased to apply from and after December 31, 1992. Except as indicated below, there are no restrictions on non-residents of the Republic of Ireland dealing in domestic securities, which includes shares or depositorydepositary receipts of Irish companies such as Trinity Biotech, andBiotech. Except as indicated below, dividends and redemption proceeds subjectalso continue to the withholding where appropriate of withholding tax as described under Item 10, arebe freely transferable to non-resident holders of such securities.
The Financial Transfers Act, 1992 was enacted in December 1992. This Act gives power to the Minister offor Finance of the Republic of Ireland to make provision for the restriction of financial transfers between the Republic of Ireland and other countries.countries and persons. Financial transfers are broadly defined and include all transfers whichthat would be movements of fundscapital or payments within the meaning of the treaties governing the member states of the European Communities.Union. The acquisition or disposal of ADSs or ADRs representing shares issued by an Irish incorporated company and associated payments may fallfalls within this definition. In addition, dividends or payments on redemption or purchase of shares interest payments, debentures or other securities in an Irish incorporated company and payments on a liquidation of an Irish incorporated company would fall within this definition. Currently, orders under this Act prohibit any financial transfer to or by the order of or on behalf of residents of the Federal Republic of Yugoslavia, Federal Republic of Serbia, Angola and Iraq, any financial transfer in respect of funds and financial resources belonging to the Taliban of Afghanistan (or related terrorist organisations), financial transfers to the senior members of the Zimbabwean government and financial transfers to any persons, groups or entities listed in EU Council Decision 2002/400/EC of June 17, 2002 unless permission for the transfer has been given by the Central Bank of Ireland. Trinity Biotech does not anticipate that Irish exchange controls or orders under

51


At present the Financial Transfers Act, 1992 will have a material effect on its business.
Forprohibits financial transfers involving the purposeslate Slobodan Milosevic and associated persons, Burma (Myanmar), Belarus, certain persons indicted by the International Criminal Tribunal for the former Yugoslavia, Usama bin Laden, Al-Qaida, the Taliban of Afghanistan, Democratic Republic of Congo, Democratic People’s Republic of Korea (North Korea), Iran, Iraq, Côte d’Ivoire, Lebanon, Liberia, Zimbabwe, Uzbekistan, Sudan, Somalia, Republic of Guinea, certain known terrorists and terrorist groups, and countries that harbor certain terrorist groups, without the prior permission of the orders relating to Iraq and the Federal RepublicCentral Bank of Yugoslavia, reconstituted in 1991 as Serbia and Montenegro, a resident of those countries is a person living in these countries, a body corporate or entity operating in these countries and any person acting on behalf of any of these persons.Ireland.
Any transfer of, or payment for,in respect of, an ordinary share or ADS involving the government of any country whichthat is currently the subject of United Nations sanctions, any person or body controlled by any governmentof the foregoing, or country under United Nations sanctions orby any persons or body controlledperson acting on behalf of these governments of countries,the foregoing, may be subject to restrictions required under thesepursuant to such sanctions as implemented into Irish law. We do not anticipate that orders under the Financial Transfers Act, 1992 or United Nations sanctions implemented into Irish law will have a material effect on our business.
Taxation
The following discussion is based on US and Republic of Ireland tax law, statutes, treaties, regulations, rulings and decisions all as of the date of this annual report. Taxation laws are subject to change, from time to time, and no representation is or can be made as to whether such laws will change, or what impact, if any, such changes will have on the statements contained in this summary. No assurance can be given that proposed amendments will be enacted as proposed, or that legislative or judicial changes, or changes in administrative practice, will not modify or change the statements expressed herein.
This summary is of a general nature only. It does not constitute legal or tax advice nor does it discuss all aspects of Irish taxation that may be relevant to any particular Irish Holder or US Holder of ordinary shares or ADSs.
This summary does not discuss all aspects of Irish and US federal income taxation that may be relevant to a particular holder of Trinity Biotech ADSs in light of the holder’s own circumstances or to certain types of investors subject to special treatment under applicable tax laws (for example, financial institutions, life insurance companies, tax-exempt organisations, and non-US taxpayers) and it does not discuss any tax consequences arising under the laws of taxing jurisdictions other than the Republic of Ireland and the US federal government. The tax treatment of holders of Trinity Biotech ADSs may vary depending upon each holder’s own particular situation.

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Prospective purchasers of Trinity Biotech ADSs are advised to consult their own tax advisors as to the US, Irish or other tax consequences of the purchase, ownership and disposition of such ADSs.
US Federal Income Tax Consequences to US Holders
The following is a summary of certain material US federal income tax consequences that generally would apply with respect to the ownership and disposition of Trinity Biotech ADSs, in the case of a purchaser of such ADSs who is a US Holder (as defined below) and who holds the ADSs as capital assets. This summary is based on the US Internal Revenue Code of 1986, as amended (the “Code”), Treasury Regulations promulgated thereunder, and judicial and administrative interpretations thereof, all as in effect on the date hereof and all of which are subject to change either prospectively or retroactively. For the purposes of this summary, a US Holder is: an individual who is a citizen or a resident of the United States; a corporation created or organised in or under the laws of the United States or any political subdivision thereof; an estate whose income is subject to US federal income tax regardless of its source; or a trust that (a) is subject to the primary supervision of a court within the United States and the control of one or more US persons or (b) has a valid election in effect under applicable US Treasury regulations to be treated as a US person.
This summary does not address all tax considerations that may be relevant with respect to an investment in ADSs. This summary does not discuss all the tax consequences that may be relevant to a US holder in light of such holder’s particular circumstances or to US holders subject to special rules, including persons that are non-US holders, broker dealers, financial institutions, certain insurance companies, investors liable for alternative minimum tax, tax exempt organisations, regulated investment companies, non-resident aliens of the US or taxpayers whose functional currency is not the dollar, persons who hold ADSs through partnerships or other pass-through entities, persons who acquired their ADSs through the exercise or cancellation of employee stock options or otherwise as compensation for services, investors that actually or constructively own 10% or more of Trinity Biotech’s voting shares, and investors holding ADSs as part of a straddle or appreciated financial position or as part of a hedging or conversion transaction.

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If a partnership or an entity treated as a partnership for US federal income tax purposes owns ADSs, the US federal income tax treatment of a partner in such a partnership will generally depend upon the status of the partner and the activities of the partnership. The partners in a partnership which owns ADSs should consult their tax advisors about the US federal income tax consequences of holding and disposing of ADSs.
This summary does not address the effect of any US federal taxation other than US federal income taxation. In addition, this summary does not include any discussion of state, local or foreign taxation. You are urged to consult your tax advisors regarding the foreign and US federal, state and local tax considerations of an investment in ADSs.
For US federal income tax purposes, US Holders of Trinity Biotech ADSs will be treated as owning the underlying Class ‘A’ Ordinary Shares represented by the ADSs held by them. The gross amount of any distribution made by Trinity Biotech to US Holders with respect to the underlying shares represented by the ADSs held by them, including the amount of any Irish taxes withheld from such distribution, will be treated for US federal income tax purposes as a dividend to the extent of Trinity Biotech’s current and accumulated earnings and profits, as determined for US federal income tax purposes. The amount of any such distribution that exceeds Trinity Biotech’s current and accumulated earnings and profits will be applied against and reduce a US Holder’s tax basis in the holder’s ADSs, and any amount of the distribution remaining after the holder’s tax basis has been reduced to zero will constitute capital gain. The capital gain will be treated as a long-term or short-term capital gain depending on whether or not the holder’s ADSs have been held for more than one year as of the date of the distribution.
Dividends paid by Trinity Biotech generally will not qualify for the dividends received deduction otherwise available to US corporate shareholders.
Subject to complex limitations, any Irish withholding tax imposed on such dividends will be a foreign income tax eligible for credit against a US Holder’s US federal income tax liability (or, alternatively, for deduction against income in determining such tax liability). The limitations set out in the Code include computational rules under which foreign tax credits allowable with respect to specific classes of income cannot exceed the US federal income taxes otherwise payable with respect to each such class of income. Dividends generally will be treated as foreign-source passive category income or, in the case of certain US Holders, general category income for US foreign tax credit purposes. Further, there are special rules for computing the foreign tax credit limitation of a taxpayer who receives dividends subject to a reduced tax, see discussion below.

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A US Holder will be denied a foreign tax credit with respect to Irish income tax withheld from dividends received on the ordinary shares to the extent such US Holder has not held the ordinary shares for at least 16 days of the 31-day period beginning on the date which is 15 days before the ex-dividend date or to the extent such US Holder is under an obligation to make related payments with respect to substantially similar or related property. Any days during which a US Holder has substantially diminished its risk of loss on the ordinary shares are not counted toward meeting the 16-day holding period required by the statute. The rules relating to the determination of the foreign tax credit are complex, and you should consult with your personal tax advisors to determine whether and to what extent you would be entitled to this credit.
Subject to certain limitations, “qualified dividend income” received by a noncorporate US Holder in tax years beginning on or before December 31, 20102012 will be subject to tax at a reduced maximum tax rate of 15%. Distributions taxable as dividends paid on the ordinary shares should qualify for the 15% rate provided that either: (i) we are entitled to benefits under the income tax treaty between the United States and Ireland (the “Treaty”) or (ii) the ADSs are readily tradable on an established securities market in the US and certain other requirements are met. We believe that we are entitled to benefits under the Treaty and that the ADSs currently are readily tradable on an established securities market in the US. However, no assurance can be given that the ordinary shares will remain readily tradable. The rate reduction does not apply unless certain holding period requirements are satisfied. With respect to the ADSs, the US Holder must have held such ADSs for at least 61 days during the 121-day period beginning 60 days before the ex-dividend date. The rate reduction also does not apply to dividends received from passive foreign investment companies, see discussion below, or in respect of certain hedged positions or in certain other situations. The legislation enacting the reduced tax rate contains special rules for computing the foreign tax credit limitation of a taxpayer who receives dividends subject to the reduced tax rate. US Holders of Trinity Biotech ADSs should consult their own tax advisors regarding the effect of these rules in their particular circumstances.
Upon a sale or exchange of ADSs, a US Holder will recognise a gain or loss for US federal income tax purposes in an amount equal to the difference between the amount realised on the sale or exchange and the holder’s adjusted tax basis in the ADSs sold or exchanged. Such gain or loss generally will be capital gain or loss and will be long-term or short-term capital gain or loss depending on whether the US Holder has held the ADSs sold or exchanged for more than one year at the time of the sale or exchange.

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For US federal income tax purposes, a foreign corporation is treated as a “passive foreign investment company” (or PFIC) in any taxable year in which, after taking into account the income and assets of the corporation and certain of its subsidiaries pursuant to the applicable “look through” rules, either (1) at least 75% of the corporation’s gross income is passive income or (2) at least 50% of the average value of the corporation’s assets is attributable to assets that produce passive income or are held for the production of passive income. Based on the nature of its present business operations, assets and income, Trinity Biotech believes that it is not currently subject to treatment as a PFIC. However, no assurance can be given that changes will not occur in Trinity Biotech’s business operations, assets and income that might cause it to be treated as a PFIC at some future time.
If Trinity Biotech were to become a PFIC, a US Holder of Trinity Biotech ADSs would be required to allocate to each day in the holding period for such holder’s ADSs a pro rata portion of any distribution received (or deemed to be received) by the holder from Trinity Biotech, to the extent the distribution so received constitutes an “excess distribution,” as defined under US federal income tax law. Generally, a distribution received during a taxable year by a US Holder with respect to the underlying shares represented by any of the holder’s ADSs would be treated as an “excess distribution” to the extent that the distribution so received, plus all other distributions received (or deemed to be received) by the holder during the taxable year with respect to such underlying shares, is greater than 125% of the average annual distributions received by the holder with respect to such underlying shares during the three preceding years (or during such shorter period as the US Holder may have held the ADSs). Any portion of an excess distribution that is treated as allocable to one or more taxable years prior to the year of distribution during which Trinity Biotech was classified as a PFIC would be subject to US federal income tax in the year in which the excess distribution is made, but it would be subject to tax at the highest tax rate applicable to the holder in the prior tax year or years. The holder also would be subject to an interest charge, in the year in which the excess distribution is made, on the amount of taxes deemed to have been deferred with respect to the excess distribution. In addition, any gain recognised on a sale or other disposition of a US Holder’s ADSs, including any gain recognised on a liquidation of Trinity Biotech, would be treated in the same manner as an excess distribution. Any such gain would be treated as ordinary income rather than as capital gain. Finally, the 15% reduced US federal income tax rate otherwise applicable to dividend income as discussed above, will not apply to any distribution made by Trinity Biotech in any taxable year in which it is a PFIC (or made in the taxable year following any such year), whether or not the distribution is an “excess distribution”.

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If Trinity Biotech became a PFIC, a US Holder may make a “qualifying electing fund” election in the year Trinity Biotech first becomes a PFIC or in the year the holder acquires the shares, whichever is later. This election provides for a current inclusion of Trinity Biotech’s ordinary income and capital gain income in the US Holder’s US taxable income. In return, any gain on sale or other disposition of a US Holder’s ADSs in Trinity Biotech, if it were classified as a PFIC, will be treated as capital, and the interest penalty will not be imposed. This election is not made by Trinity Biotech, but by each US Holder. The PFIC must provide certain information to the IRS in order to qualify as a Qualified Electing Fund. US Holders should contact their tax advisor for further information on this area.
Alternatively, if the ADSs are considered “marketable stock” a US Holder may elect to “mark-to-market” its ADSs, and such US Holder would not be subject to the rules described above. Instead, such US Holder would generally include in income any excess of the fair market value of the ADSs at the close of each tax year over its adjusted basis in the ADSs. If the fair market value of the ADSs had depreciated below the US Holders adjusted basis at the close of the tax year, the US Holder may generally deduct the excess of the adjusted basis of the ADSs over its fair market value at that time. However, such deductions generally would be limited to the net mark-to-market gains, if any, that the US Holder included in income with respect to such ADSs in prior years. Income recognized and deductions allowed under the mark-to-market provisions, as well as any gain or loss on the disposition of ADSs with respect to which the mark-to-market election is made, is treated as ordinary income or loss (except that loss is treated as capital loss to the extent the loss exceeds the net mark-to-market gains, if any, that a US Holder included in income with respect to such ordinary shares in prior years). However, gain or loss from the disposition of ordinary shares (as to which a “mark-to-market” election was made) in a year in which Trinity Biotech is no longer a PFIC, will be capital gain or loss. The ADSs should be considered “marketable stock” if they traded at least 15 days during each calendar quarter of the relevant calendar year in more than de minimis quantities.
If Trinity Biotech were to become a CFC, each US Holder treated as a US Ten-percent Shareholder would be required to include in income each year such US Ten-percent Shareholder’s pro rata share of Trinity Biotech’s undistributed “Subpart F income.” For this purpose, Subpart F income generally would include interest, original issue discount, dividends, net gains from the disposition of stocks or securities, net gains on forward and option contracts, receipts with respect to securities loans and net payments received with respect to equity swaps and similar derivatives.

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Any undistributed Subpart F income included in a US Holder’s income for any year would be added to the tax basis of the US Holder’s ADSs. Amounts distributed by Trinity Biotech to the US Holder in any subsequent year would not be subject to further US federal income tax in the year of distribution, to the extent attributable to amounts so included in the US Holder’s income in prior years under the CFC rules but would be treated, instead, as a reduction in the tax basis of the US Holder’s ADSs, the PFIC rules discussed above would not apply to any undistributed Subpart F income required to be included in a US Holder’s income under the CFC rules, or to the amount of any distributions received from Trinity Biotech that were attributable to amounts so included.
Distributions made with respect to underlying shares represented by ADSs may be subject to information reporting to the US Internal Revenue Service and to US backup withholding tax at a rate equal to the fourth lowest income tax rate applicable to individuals (which, under current law, is 28%). Backup withholding will not apply, however, if the holder (i) is a corporation or comes within certain exempt categories, and demonstrates its eligibility for exemption when so required, or (ii) furnishes a correct taxpayer identification number and makes any other required certification.
Backup withholding is not an additional tax. Amounts withheld under the backup withholding rules may be credited against a US Holder’s US tax liability, and a US Holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the Internal Revenue Service.
Any US Holder who holds 10% or more in vote or value of Trinity Biotech will be subject to certain additional United States information reporting requirements.
US Holders may be subject to state or local income and other taxes with respect to their ownership and disposition of ADSs. US Holders of ADSs should consult their own tax advisers as to the applicability and effect of any such taxes.

 

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Republic of Ireland Taxation
For the purposes of this summary, an “Irish Holder” means a holder of ordinary shares or ADSs evidenced by ADSs that (i) beneficially owns the ordinary shares or ADSs registered in their name; (ii) in the case of individual holders, are resident, ordinarily resident and domiciled in Ireland under Irish taxation laws; (iii) in the case of holders that are companies, are resident in Ireland under Irish taxation laws; and (iv) are not also resident in any other country under any double taxation agreement entered into by Ireland.
For Irish taxation purposes, Irish Holders of ADSs will be treated as the owners of the underlying ordinary shares represented by such ADSs.
Solely for the purposes of this summary of Irish Tax Considerations, a “US Holder” means a holder of ordinary shares or ADSs evidenced by ADSs that (i) beneficially owns the ordinary shares or ADSs registered in their name; (ii) is resident in the United States for the purposes of the Republic of Ireland/United States Double Taxation Convention (the Treaty); (iii) in the case of an individual holder, is not also resident or ordinarily resident in Ireland for Irish tax purposes; (iv) in the case of a corporate holder, is not a resident in Ireland for Irish tax purposes and is not ultimately controlled by persons resident in Ireland; and (v) is not engaged in any trade or business in Ireland and does not perform independent personal services through a permanent establishment or fixed base in Ireland.
Since its incorporation the Group has not declared or paid dividends on its ‘A’ Ordinary Shares or ‘B’ Ordinary Shares. The Board has, however, decided that it is now an appropriate time to commence a dividend policy, to be paid once a year. In this regard, the Board have proposed a final dividend of Directors does not expect10 cent per ADR in respect of 2010 and this proposal will be submitted to pay dividendsshareholders for their approval at the foreseeable future. Should Trinity Biotech begin paying dividends, such dividendsnext Annual General Meeting of the Company. The payment of a dividend will generally be subject to dividend withholding tax (DWT) at the standard rate of income tax in force at the time the dividend is paid, currently 20%. Under current legislation, where DWT applies, Trinity Biotech will be responsible for withholding it at source.
DWT will not be withheld where an exemption applies and where Trinity Biotech has received all necessary documentation from the recipient prior to payment of the dividend.
Corporate Irish Holders will generally be entitled to claim an exemption from DWT by delivering a declaration which confirms that the company is resident in Ireland for tax purposes, to Trinity Biotech in the form prescribed by the Irish Revenue Commissioners. Such corporate Irish Holders will generally not otherwise be subject to Irish tax in respect of dividends received.
Individual Irish Holders will be subject to income tax on the gross amount of any dividend (that is the amount of the dividend received plus any DWT withheld), at their marginal rate of income tax (currently either 20% or 41% depending on the individual’s circumstances)circumstances excluding PRSI and other levies). Individual Irish Holders will be able to claim a credit against their resulting income tax liability in respect of DWT withheld. Individual Irish Holders may, depending on their circumstances, also be subject to the Irish income levy of 1%, the health levyUniversal Social Charge of up to 2.5%10% and pay related social insurancePay Related Social Insurance contribution of up to 3%4% in respect of their dividend income.
Shareholders who are individualsUnder the Irish Taxes Consolidation Act 1997, dividends paid by Trinity Biotech to non-Irish shareholders will, unless exempted, be subject to DWT. Such a shareholder will not suffer DWT on dividends if the shareholder is:
an individual resident in the US (and(or certain other countries)countries with which Ireland has a double taxation treaty) and who are notis neither resident ornor ordinarily resident in Ireland may receive dividends free of DWT where the shareholder has provided Trinity Biotech with the relevant declaration and residency certificate required by legislation.Ireland; or
Corporate shareholders
a corporation that areis not resident in Ireland and who arewhich is ultimately controlled by persons resident in the US (or certain other countries) or corporate holders of ordinary shares resident in a relevant territory (being a countrycountries with which Ireland has a double tax treaty, which includes the United States)taxation treaty); or
a corporation that is not resident in a member state ofIreland and the European Union other than Ireland which are not controlled by Irish residents or whose principal class of whose shares or(or its 75% parent’s principal class of sharesshares) are substantially or regularly traded on a recognised stock exchangeexchange; or
is otherwise entitled to an exemption from DWT.
In order to avail of the above exemption, certain declarations must be made in advance to the paying company.
A self-assessment system applies to a company resident in a country withtreaty jurisdiction receiving dividends under which Ireland has a tax treaty, may receive dividends free of DWT where theynon-resident company will provide Trinity Biotech witha declaration and certain information to the relevant declaration, auditors’ certificate and Irish Revenue Commissioners’ certificatedividend paying company or a certificate from the tax authority in the relevant territory as required by Irish law.
US resident holders of ordinary shares (as opposed to ADSs) should note that these documentation requirements may be burdensome. As described below, these documentation requirements do not apply in the case of holders of ADSs. US resident holders who do not comply with the documentation requirements or otherwise do not qualify for an exemption may be ableintermediary to claim treaty benefits under the treaty. US resident holders who are entitled to benefits under the treaty will be able to claim a partial refund of DWT from the Irish Revenue Commissioners.exemption.

 

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Special DWT arrangements are available in the case of shares held by US resident holders in Irish companies through American depository banks using ADSs whowhere such banks enter into intermediary agreements with the Irish Revenue Commissioners and hence such banks are viewed as qualifying intermediaries under Irish Tax legislation.
Under such agreements, American depository banks who receive dividends from Irish companies and pay the dividends on to the US resident ADS holders are allowed to receive and pass on a dividend from the Irish company on a gross basis (without any withholding) if:
the depository bank’s ADS register shows that the direct beneficial owner of the dividends has a US address on the register, or
there is an intermediary between the depository bank and the beneficial shareholder and the depository bank receives confirmation from the intermediary that the beneficial shareholder’s address in the intermediary’s records is in the US.
Where the above procedures have not been complied with and DWT is withheld from dividend payments to US Holders of ordinary shares or ADSs evidenced by ADSs, such US Holders can apply to the Irish Revenue Commissioners claiming a full refund of DWT paid by filing a declaration, a certificate of residency and, in the case of US Holders that are corporations, an auditor’s certificate, each in the form prescribed by the Irish Revenue Commissioners.
The DWT rate applicable to US Holders is reduced to 5% under the terms of the Treaty for corporate US Holders holding 10% or more of our voting shares, and to 15% for other US Holders. While this will, subject to the application of Article 23 of the Treaty, generally entitle US Holders to claim a partial refund of DWT from the Irish Revenue Commissioners, US Holders will, in most circumstances, likely prefer to seek a full refund of DWT under Irish domestic legislation.
Under the Irish Taxes Consolidation Act 1997, non-Irish shareholders may, unless exempted, be liable to DWT tax on dividends received from Trinity Biotech. Such a shareholder will not suffer DWT on dividends if the shareholder is:
an individual resident in the US (or certain other countries with which Ireland has a double taxation treaty) and who is neither resident nor ordinarily resident in Ireland; or
a corporation that is not resident in Ireland and which is ultimately controlled by persons resident in the US (or certain other countries with which Ireland has a double taxation treaty); or
a corporation that is not resident in Ireland and whose principal class of shares (or its 75% parent’s principal class of shares) are substantially or regularly traded on a recognised stock exchange; or
is otherwise entitled to an exemption from DWT.
legislation (see above).
Disposals of Ordinary Shares or ADSs
Irish Holders that acquire ordinary shares or ADSs will generally be considered, for Irish tax purposes, to have acquired their ordinary shares or ADSs at a base cost equal to the amount paid for the ordinary shares or ADSs. On subsequent dispositions, ordinary shares or ADSs acquired at an earlier time will generally be deemed, for Irish tax purposes, to be disposed of on a “first in first out” basis before ordinary shares or ADSs acquired at a later time. Irish Holders that dispose of their ordinary shares or ADSs will be subject to Irish capital gains tax (CGT) to the extent that the proceeds realised from such disposition exceed the indexed base cost of the ordinary shares or ADSs disposed of and any incidental expenses. The current rate of CGT is 22%.25% and this applies to disposals made on or after 8 April 2009. Indexation of the base cost of the ordinary shares or ADSs will only be available up to 31 December 31, 2002, and only in respect of ordinary shares or ADSs held for more than 12 months prior to their disposal.
Irish Holders that have unutilised capital losses from other sources in the current, or any previous tax year, can generally apply such losses to reduce gains realised on the disposal of the ordinary shares or ADSs.
An annual exemption allows individuals to realise chargeable gains of up to1,270 €1,270 in each tax year without giving rise to CGT. This exemption is specific to the individual and cannot be transferred between spouses. Irish Holders are required, under Ireland’s self-assessment system, to file a tax return reporting any chargeable gains arising to them in a particular tax year.
Where disposal proceeds are received in a currency other than euroEuro they must be translated into amounts to calculate the amount of any chargeable gain or loss. Similarly, acquisition costs denominated in a currency other than euroEuro must be translated at the date of acquisition in euroEuro amounts.

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Irish Holders that realise a loss on the dispositiondisposal of ordinary shares or ADSs will generally be entitled to offset such allowable losses against capital gains realised from other sources in determining their CGT liability in a year. Allowable losses which remain unrelieved in a year may generally be carried forward indefinitely for CGT purposes and applied against capital gains in future years.
Transfers between spouses who live together will not give rise to any chargeable gain or loss for CGT purposes with the acquiring spouse acquiring the same pro rata base cost and acquisition date as that of the transferring spouse.

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US Holders will not be subject to Irish capital gains tax (CGT) on the disposal of ordinary shares or ADSs provided that such ordinary shares or ADSs are quoted on a stock exchange at the time of disposition. The stock exchange for this purpose is the Nasdaq National Market (NASDAQ). While it is our intention to continue the quotation of ADSs on NASDAQ, no assurances can be given in this regard.
If, for any reason, our ADSs cease to be quoted on NASDAQ, US Holders will not be subject to CGT on the disposal of their ordinary shares or ADSs provided that the ordinary shares or ADSs do not, at the time of the disposal, derive the greater part of their value from land, buildings, minerals, or mineral rights or exploration rights in Ireland.
A gift or inheritance of ordinary shares will be, or in the case of ADSs may be, within the charge to capital acquisitions tax, regardless of where the disponer or the donee/successor in relation to the gift/inheritance is domiciled, resident or ordinarily resident.The capitalresident. Capital acquisitions tax is chargedlevied at a rate of 22%25% on the taxable value of the gift or inheritance above acertain tax-free threshold.thresholds. This tax-free threshold is determined by the amount of the current benefit and of previous benefits, received within the group threshold since December 5, 1991, which are within the charge to the capital acquisitions tax and the relationship between the former holder and the successor. Gifts and inheritances between spouses are not subject to the capital acquisitions tax. Gifts of up to3,000 €3,000 can be received each year from any given individual without triggering a charge to capital acquisitions tax. Where a charge to Irish CGT and capital acquisitions tax arises on the same event, capital acquisitions tax payable on the event can be reduced by the amount of the CGT payable. There should be no clawback of the same event credit of CGT offset against capital acquisitions tax provided the donee/successor does not dispose of the ordinary shares or ADRsADSs within two years from the date of gift/inheritance.
The Estate Tax Convention between Ireland and the United States generally provides for Irish capital acquisitions tax paid on inheritances in Ireland to be credited, in whole or in part, against tax payable in the United States, in the case where an inheritance of ordinary shares or ADSs is subject to both Irish capital acquisitions tax and US federal estate tax. The Estate Tax Convention does not apply to Irish capital acquisitions tax paid on gifts.
Irish stamp duty, which is a tax imposed on certain documents, is payable on all transfers of ordinary shares of an Irish registered company (other than transfers made between spouses, transfers made between 90% associated companies, or certain other exempt transfers) regardless of where the document of transfer is executed. Irish stamp duty is also payable on electronic transfers of ordinary shares. A transfer of ordinary shares made as part of a sale or gift will generally be stampable at the ad valorem rate of 1% of the value of the consideration received for the transfer, or, if higher, the market value of the shares transferred. A minimumAny instrument executed on or after 24 December 2008 which transfers stock or marketable securities on sale where the amount or value of the consideration is €1,000 or less may be exempt from stamp dutyduty. To avail of1.00 will apply to a transfer of ordinary shares. the exemption the instrument must be certified in accordance with Revenue guidelines. Where the consideration for a sale is expressed in a currency other than euro,Euro, the duty will be charged on the euroEuro equivalent calculated at the rate of exchange prevailing at the date of the transfer.
Transfers of ordinary shares where no beneficial interest passes (e.g. a transfer of shares from a beneficial owner to a nominee), will generally be exempt from stamp duty if the transfer form contains an appropriate certification, otherwise a nominal stamp duty rate of12.50 will apply.certification.
Transfers of ADSs are exempt from Irish stamp duty as long as the ADSs are quoted on any recognised stock exchange in the US or Canada.
Transfers of ordinary shares from the Depositary or the Depositary’s custodian upon surrender of ADSs for the purposes of withdrawing the underlying ordinary shares from the ADS system, and transfers of ordinary shares to the Depositary or the Depositary’s custodian for the purposes of transferring ordinary shares onto the ADS system, will be stampable at the ad valorem rate of 1% of the value of the shares transferred if the transfer relates to a sale or contemplated sale or any other change in the beneficial ownership of ordinary shares. Such transfers will be exempt from Irish stamp duty if the transfer does not relate to or involve any change in the beneficial ownership in the underlying ordinary shares and the transfer form contains the appropriate certification. In the absence of an appropriate certification, stamp duty will be applied at the nominal rate of12.50.

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The person accountable for the payment of stamp duty is the transferee or, in the case of a transfer by way of gift or for consideration less than the market value, both parties to the transfer. Stamp duty is normally payable within 30 days after the date of execution of the transfer. Late or inadequate payment of stamp duty will result in liability for interest, penalties and fines.

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Dividend Policy
Since its inception Trinity Biotechincorporation the Group has not declared or paid dividends on its ‘A’ Ordinary Shares or ‘B’ Ordinary Shares. Trinity Biotech anticipates, forIn 2011 the foreseeable future,Company announced that it intended to commence a dividend policy, to be paid once a year. In this regard, the Board of Directors has proposed a final dividend of 10 cent per ADR in respect of 2010 and this proposal will retain any future earnings in orderbe submitted to fundshareholders for their approval at the business operationsnext Annual General Meeting of the Group. Trinity Biotech does not, therefore, anticipate paying any cash or share dividends on its ‘A’ Ordinary SharesCompany.
As provided in the foreseeable future.
Any cashArticles of Association of the Company, dividends or other distributions if made, are expected to be madedeclared and paid in US Dollars, as provided for by the Articles of Association.Dollars.
Documents on Display
This annual report and the exhibits thereto and any other document that we have to file pursuant to the Exchange Act may be inspected without charge and copied at prescribed rates at the Securities and Exchange Commission public reference room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549; and on the Securities and Exchange Commission Internet site (http://www.sec.gov). You may obtain information on the operation of the Securities and Exchange Commission’s public reference room in Washington, D.C. by calling the Securities and Exchange Commission at 1-800-SEC-0330 or by visiting the Securities and Exchange Commission’s website at http://www.sec.gov, and may obtain copies of our filings from the public reference room by calling (202) 551-8090. The Exchange Act file number for our Securities and Exchange Commission filings is 000-22320.
Item 11
Qualitative and Quantitative Disclosures about Market Risk
Qualitative information about Market Risk
Trinity Biotech’s treasury policy is to manage financial risks arising in relation to or as a result of underlying business needs. The activities of the treasury function, which does not operate as a profit centre, are carried out in accordance with board approved policies and are subject to regular internal review. These activities include the Group making use of spot and forward foreign exchange markets.
Trinity Biotech uses a range of financial instruments (including cash, bank borrowings, convertible notes, forward contracts, promissory notes and finance leases) to fund its operations. These instruments are used to manage the liquidity of the Group in a cost effective, low-risk manner. Working capital management is a key additional element in the effective management of overall liquidity. Trinity Biotech does not trade in financial instruments or derivatives.
The main risks arising from the utilisation of these financial instruments are interest rate risk, liquidity risk and foreign exchange risk.
Trinity Biotech’s reported net income, net assets and gearing (net debt expressed as a percentage of shareholders’ equity) are all affected by movements in foreign exchange rates.
The Group borrows in US dollarsdollars. At December 31, 2010 Group borrowings were at floating and fixed rates of interest. At December 31, 20082009 Group borrowings were at both fixed and floating rates of interest. Year-end borrowings totalled US$34,553,000 (2007:273,000 (2009: US$42,133,000)31,856,000), (net of cash: US$29,369,000 (2007: netsurplus of cash: US$33,433,000))57,729,000), (2009: deficit of US$25,778,000), at interest rates of 2.74% (2007: 5.0%ranging from 5.02% to 6.99%5.29% (2009: 2.53% to 6.61%). — see Item 18, note 27.
The total year-endYear-end borrowings consistsconsist entirely of fixed rate debt of US$1,570,000 (2007:273,000 (2009: US$2,325,000)2,529,000) at interest rates ranging from 5%5.02% to 7.54% (2007: 5.0%5.29% (2009: 6% to 6.32%6.61%) and. There was no floating rate debt ofat December 31, 2010 (2009: US$34,551,000 (2007: US$39,808,000)29,327,000 at an interest ratesrate of 2.74% (2007: 6.49% to 6.99%2.53%). In broad terms, a one-percentage point increase in interest rates would increase interest income by US$55,000 (2007:580,000 (2009: US$87,000)61,000) and increasewould not affect the interest expense byin 2010 (2009: US$349,000 (2007: US$401,000)295,000) resulting in an increase in interest income of US$580,000 (2009: increase in the net interest charge of US$294,000 (2007: increase by US$314,000)234,000).

56


Long-term borrowing requirements are met by funding in the US and Ireland. Short-term borrowing requirements are primarily drawn under committed bank facilities. At the year-end, 36% of total long term borrowings fell due for repayment within one year.
The majority of the Group’s activities are conducted in US Dollars. The primary foreign exchange risk arises from the fluctuating value of the Group’s euroEuro denominated expenses as a result of the movement in the exchange rate between the US Dollar and the euro.Euro. Arising from this, where considered necessary, the Group pursues a treasury policy which aims to sell US Dollars forward to match a portion of its uncovered euroEuro expenses at exchange rates lower than budgeted exchange rates. These forward contracts are primarily cashflow hedging instruments whose objective is to cover a portion of these euroEuro forecasted transactions. These forward contracts normally have maturities of less than one year after the balance sheet date. TheThere were no forward contracts in place at December 31, 2008 have maturity dates of less than one year after the balance sheet date. Where necessary, the forward contracts are rolled over at maturity.31,2010.

59


The Group had foreign currency denominated cash balances equivalent to US$1,257,000215,000 at December 31, 2008 (2007:2010 (2009: US$1,659,000)518,000).
Quantitative information about Market Risk
Interest rate sensitivity
Trinity Biotech monitors its exposure to changes in interest and exchange rates by estimating the impact of possible changes on reported profit before tax and net worth. The Group accepts interest rate and currency risk as part of the overall risks of operating in different economies and seeks to manage these risks by following the policies set above.
Trinity Biotech estimates that the maximum effect of a rise of one percentage point in one of the principal interest rates to which the Group is exposed, without making any allowance for the potential impact of such a rise on exchange rates, would be an increase in the lossprofit before tax for 20082010 by approximately 0.4%0.9%.
The table below provides information about the Group’s long term debt obligations, including variable rate debt obligation which are sensitive to changes in interest rates.obligations. The table presents principal cash flows and related weighted average interest rates by expected maturity dates. Weighted average variable rates are based on rates set at the balance sheet date. The information is presented in US Dollars, which is Trinity Biotech’s reporting currency.
                                                                
Group        
Maturity After Fair  After Fair 
Before December 31 2009 2010 2011 2012 2013 2014 Total value  2011 2012 2013 2014 2015 2015 Total value 
Long-term debt
  
Variable rate — US$000 12,225 6,331 6,367 9,628   34,551 34,551          
Average interest rate  2.74%  2.74%  2.74%  2.74%  2.74%          
  
Fixed rate — US$000 432 419 441 278   1,570 1,597  162 111     273 273 
Average interest rate  6.25%  6.14%  6.12%  6.12%    6.16%   5.09%  5.06%      5.08%  5.08%
Exchange rate sensitivity
At year-end 2008,2010, approximately 16%0.5% of the Group’s US$65,905,000141,287,000 net worth (shareholders’ equity) was denominated in currencies other than the US Dollar, principally the euro.Euro.
A strengthening or weakening of the US Dollar by 10% against all the other currencies in which the Group operates, would not materially reducehave the approximate effect of reducing or increasing the Group’s 20082010 year-end net worth.worth by US$71,000.
Item 12
Description of Securities Other than Equity Securities
Not applicable.
Part II
Item 13
Defaults, Dividend Arrearages and Delinquencies
Not applicable.

57


Item 14
Material Modifications to the Rights of Security Holders and Use of Proceeds
Not applicable.

60


Item 15
Control and Procedures
Evaluation of Disclosure Controls and Procedures
The Group’s disclosure and control procedures are designed so that information required to be disclosed in reports filed or submitted under the Securities Exchange Act 1934 is prepared and reported on a timely basis and communicated to management, to allow timely decisions regarding required disclosure.Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, have evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(d) of the Securities Exchange Act of 1934 as of the end of the period covered by this Form 20-F. The Chief Executive Officer and Chief Financial Officer have concluded that disclosure controls and procedures were effective as of December 31, 2008.2010.
In designing and evaluating our disclosure controls and procedures, our management, with the participation of the Chief Executive Officer and Chief Financial Officer, recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgement in evaluating the cost-benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Group have been detected.
Management’s Annual Report on Internal Control over Financial Reporting
The management of Trinity Biotech are responsible for establishing and maintaining adequate internal control over financial reporting. Trinity Biotech’s internal control over financial reporting is a process designed under the supervision and with the participation of the principal executive and principal financial officers to provide reasonable assurance regarding the reliability of financial reporting and preparation of Trinity Biotech’s financial statements for external reporting purposes in accordance with IFRS both as issued by the IASB and as subsequently adopted by the EU.
Trinity Biotech’s internal control over financial reporting includes policies and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions and dispositions of assets; provide reasonable assurances that transactions are recorded as necessary to permit preparation of the financial statements in accordance with IFRS and that receipts and expenditures are being made only in accordance with the authorization of management and the directors of Trinity Biotech; and provide reasonable assurance regarding prevention or timely detection of unauthorised acquisition, use or disposition of Trinity Biotech’s assets that could have a material effect on our financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements. Also, projections of any evaluation of the effectiveness of internal control to future periods are subject to the risk that controls may become inadequate because of changes in conditions, and that the degree of compliance with the policies or procedures may deteriorate.
Management has assessed the effectiveness of internal control over financial reporting based on criteria established in the Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment, management has concluded that the Group’s internal control over financial reporting was effective as of December 31, 2008.2010.
Our independent auditor, Grant Thornton, a registered public accounting firm, has issued an attestation report on the Group’s internal control over financial reporting as of December 31, 20082010 (see Item 18).
Changes in Internal Controls over Financial Reporting
During the 2006 year end financial statement close process, a material weakness was identified in relation to controls concerning revenue recognition from a cut off perspective. As a result of this material weakness the Group reviewed internal controls, particularly over the area of revenue cut off and remediated control weaknesses. Regarding the item specifically mentioned in the Form 20-F for 2006 the Group implemented controls to ensure that instructions provided to third party logistics providers to ensure that all goods had been collected prior to raising an invoice are followed and accordingly comply with Group policy.

58


Except for the matters referred to above,thereThere were no changes to our internal control over financial reporting that occurred during the period covered by this Form 20-F that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

61


Item 16
16A Audit Committee Financial Expert
Mr Peter Coyne is an independent director and a member of the Audit Committee.
Our board of directors has determined that Mr Peter Coyne meets the definition of an audit committee financial expert, as defined in Item 401 of Regulation S-K.
This determination is made on the basis that Mr Coyne is a Fellow of the Institute of Chartered Accountants in Ireland and was formerly a senior manager in Arthur Andersen’s Corporate Financial Services practice. Mr Coyne is currently a director of AIB Corporate Finance, a subsidiary of AIB Group plc, the Irish banking group and has extensive experience in advising public and private groups on all aspects of corporate strategy.
16B Code of Ethics
Trinity Biotech has adopted a code of ethics that applies to the Chief Executive Officer, Chief Financial Officer, Chief Accounting Officer and all organisation employees. Written copies of the code of ethics are available free of charge upon request. If we make any substantive amendments to the code of ethics or grant any waivers, including any implicit waiver, from a provision of these codes to our Chief Executive Officer, Chief Financial Officer or Chief Accounting Officer, we will disclose the nature of such amendment or waiver on our website.
16C Principal Accounting fees and services
Fees Billed by Independent Public Accountants
The following table sets forth, for each of the years indicated, the fees billed by our independent public accountants and the percentage of each of the fees out of the total amount billed by the accountants.
                     
  Year ended December 31, 2008  Year ended December 31, 2007 
  Grant Thornton fees  KPMG fees      KPMG fees    
  US$'000  US$'000  %  US$'000  % 
Audit  515      88%  1,341   100%
Audit-related     45   8%      
Tax     24   4%      
                  
Total  515   69       1,341     
                  
During 2008, we engaged Grant Thornton, as our independent auditors for the fiscal year ended December 31, 2008, and chose not to renew the engagement of KPMG which served as the Company’s independent auditors for the fiscal year ended December 31, 2007. We have agreed to indemnify and hold KPMG harmless against and from any and all legal costs and expenses incurred by KPMG in successful defense of any legal action or proceeding that arises as a result of KPMG’s consent to the incorporation of its audit report on our past financial statements in this Annual Report on Form 20-F.
                 
  Year ended December 31,  Year ended December 31, 
  2010  2009 
  US$’000  %  US$’000  % 
Audit  694   95%  625   89%
 
Audit-related  8   1%  6   1%
Tax  32   4%  70   10%
               
Total  734       701     
               
Audit services include audit of our consolidated financial statements, as well as work only the independent auditors can reasonably be expected to provide, including statutory audits. Audit related services are for assurance and related services performed by the independent auditor, including due diligence related to acquisitions and any special procedures required to meet certain regulatory requirements. Tax fees consist of fees for professional services for tax compliance and tax advice.
Pre-Approval Policies and Procedures
Our Audit Committee has adopted a policypolicies and procedures for the pre-approval of audit and non-audit services rendered by our independent public accountants, Grant Thornton. The policy generally pre-approves certain specific services in the categories of audit services, audit-related services, and tax services up to specified amounts, and sets requirements for specific case-by-case pre-approval of discrete projects, those which may have a material effect on our operations or services over certain amounts.

59


Pre-approval may be given as part of the Audit Committee’s approval of the scope of the engagement of our independent auditor or on an individual basis. The pre-approval of services may be delegated to one or more of the Audit Committee’s members, but the decision must be presented to the full Audit Committee at its next scheduled meeting. The policy prohibits retention of the independent public accountants to perform the prohibited non-audit functions defined in Section 201 of the Sarbanes-Oxley Act or the rules of the SEC, and also considers whether proposed services are compatible with the independence of the public accountants.
16D Exemptions from the Listing Requirements and Standards for Audit Committee
Not applicable.

62


16 E Purchase of equity securitiesEquity Securities by the issuerIssuer and affiliates and purchasersAffiliated Purchasers
The maximum number of shares that may yet be purchased under the Group share option plan by Trinity Biotech or on the Group’s behalf at December 31, 20082010 was 8,201,758 (2007: 7,465,330)8,301,453 (2009: 8,201,758). No shares were purchased by Trinity Biotech or on our behalf or by any affiliated purchaser in 2008 and 2007.2010 or 2009. No shares were purchased as part of a publicly announced repurchase plan or program in 2008 and 2007.2010 or 2009.
Part III
Item 17
Financial Statements
The registrant has responded to Item 18 in lieu of responding to this item.
Item 18
Financial Statements

 

6063


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Shareholders of Trinity Biotech plc
We have audited Trinity Biotech plc’s internal control over financial reporting as of December 31, 2008,2010, based on criteria established inInternal Control — Integrated Frameworkissued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Trinity Biotech’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting, appearing under Item 15 in this Annual Report on Form 20-F. Our responsibility is to express an opinion on Trinity Biotech plc’s internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, Trinity Biotech maintained, in all material respects, effective internal control over financial reporting as of December 31, 2008,2010, based on criteria established inInternal Control — Integrated Frameworkissued by COSO.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheetsheets of Trinity Biotech plc and subsidiaries, as of December 31, 2008,2010 and 2009, and the related consolidated statements of operations recognised income and expense and cash flows for each of the years in the three year period ended December 31, 20082010 and our report dated April 7, 200914, 2011 expressed an unqualified opinion on those consolidated financial statements.
Grant Thornton

Dublin, Ireland
April 7, 200914, 2011

 

6164


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Shareholders of Trinity Biotech plc
We have audited the accompanying consolidated balance sheetsheets of Trinity Biotech plc and subsidiaries (the Company) as of December 31, 20082010 and 2009 and the related consolidated statements of operations, recognisedcomprehensive income, and expense, and cash flows for the year ended December 31, 2008. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit.
We conducted our auditchanges in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Trinity Biotech plc and subsidiaries as of December 31, 2008 and the results of their operations and their cash flows for the year ended December 31, 2008, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board and as adopted by the European Union.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the effectiveness of Trinity Biotech plc’s internal control over financial reporting as of December 31, 2008, based on criteria established inInternal Control — Integrated Frameworkissued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO), and our report dated April 7, 2009 expressed an unqualified opinion on the effective operation of internal control over financial reporting.
Grant Thornton

Dublin, Ireland
April 7, 2009

62


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Shareholders of Trinity Biotech plc
We have audited the accompanying consolidated balance sheet of Trinity Biotech plc and subsidiaries (the Company) as of December 31, 2007, and the related consolidated statements of operations, recognised income and expense,equity and cash flows for each of the years in the two-yearthree year period ended December 31, 2007.2010. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform thean audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Trinity Biotech plc and subsidiaries as of December 31, 2007,2010 and 2009 and the results of their operations and their cash flows for each of the years in the two-yearthree year period ended December 31, 2007,2010, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board and as adopted by the European Union.
KPMGWe also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Trinity Biotech plc’s internal control over financial reporting as of December 31, 2010, based on criteria established inInternal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO), and our report dated April 14, 2011 expressed an unqualified opinion on the effective operation of internal control over financial reporting.
Grant Thornton
Dublin, Ireland
April 2, 200814, 2011

 

6365


CONSOLIDATED STATEMENTS OF OPERATIONS
                 
      Year ended December, 31 
      2008  2007  2006 
      Total  Total  Total 
  Notes  US$’000  US$’000  US$’000 
                 
Revenues
  2   140,139   143,617   118,674 
 
Cost of sales      (77,645)  (75,643)  (62,090)
Cost of sales — restructuring expenses  3      (953)   
Cost of sales — inventory write off/ provision  2,3      (11,772)  (5,800)
              
Total cost of sales
      (77,645)  (88,368)  (67,890)
                 
Gross profit
      62,494   55,249   50,784 
                 
Other operating income  5   1,173   413   275 
                 
Research and development expenses      (7,544)  (6,802)  (6,696)
Research and development — restructuring expenses  3      (6,907)   
              
Total research and development expenses
      (7,544)  (13,709)  (6,696)
                 
Selling, general and administrative expenses      (47,816)  (51,010)  (42,422)
Selling, general and administrative — impairment charges and restructuring expenses  3   (87,882)  (20,315)   
              
Total selling, general and administrative expenses
      (135,698)  (71,325)  (42,422)
                 
Operating (loss)/ profit
      (79,575)  (29,372)  1,941 
              
                 
Financial income  4   65   457   1,164 
Financial expenses  2,4   (2,160)  (3,148)  (2,653)
              
Net financing costs
      (2,095)  (2,691)  (1,489)
              
                 
(Loss)/ profit before tax
  6   (81,670)  (32,063)  452 
                 
Total income tax credit /(expense)  2,9   3,892   (3,309)  2,824 
              
                 
(Loss)/ profit for the year (all attributable to equity holders)
  2   (77,778)  (35,372)  3,276 
              
                 
Basic (loss)/ earnings per ordinary share
(US Dollars)
  10   (0.96)  (0.47)  0.05 
Basic (loss)/ earnings per ‘B’ ordinary share
(US Dollars)
  10   (1.91)  (0.94)  0.10 
Diluted (loss)/ earnings per ordinary share (US Dollars)  10   (0.96)  (0.47)  0.05 
Diluted (loss)/ earnings per ‘B’ ordinary share (US Dollars)  10   (1.91)  (0.94)  0.10 
Basic (loss)/ earnings per ADS (US Dollars)  10   (3.82)  (1.86)  0.19 
Diluted (loss)/ earnings per ADS (US Dollars)  10   (3.82)  (1.86)  0.19 
               
    Year ended December, 31 
    2010  2009  2008 
    Total  Total  Total 
  Notes US$‘000  US$‘000  US$‘000 
               
Revenues
 2  89,635   125,907   140,139 
               
Cost of sales
    (45,690)  (68,891)  (77,645)
            
 
Gross profit
    43,945   57,016   62,494 
               
Other operating income 5  1,616   437   1,173 
               
Research and development expenses
    (4,603)  (7,341)  (7,544)
            
               
Selling, general and administrative expenses    (26,929)  (36,013)  (47,816)
Selling, general and administrative — impairment charges and restructuring expenses 28        (87,882)
            
Total selling, general and administrative expenses
    (26,929)  (36,013)  (135,698)
               
Net gain on divestment of business and restructuring expenses 3  46,474       
               
Operating profit/(loss)
    60,503   14,099   (79,575)
            
               
Financial income 2, 4  1,352   8   65 
Financial expenses 2, 4  (495)  (1,192)  (2,160)
            
Net financing income/(costs)
    857   (1,184)  (2,095)
            
               
Profit/(loss) before tax
 6  61,360   12,915   (81,670)
               
Total income tax (expense)/credit 2, 9  (942)  (1,091)  3,892 
            
               
Profit/(loss) for the year (all attributable to owners of the parent)
 2  60,418   11,824   (77,778)
            
               
Basic earnings/(loss) per ordinary share (US Dollars) 10  0.71   0.14   (0.96)
Basic earnings/(loss) per ‘B’ ordinary share (US Dollars) 10  1.43   0.28   (1.91)
Diluted earnings/(loss) per ordinary share (US Dollars) 10  0.70   0.14   (0.96)
Diluted earnings/(loss) per ‘B’ ordinary share (US Dollars) 10  1.39   0.28   (1.91)
Basic earnings/(loss) per ADS (US Dollars) 10  2.85   0.57   (3.82)
Diluted earnings/(loss) per ADS (US Dollars) 10  2.79   0.57   (3.82)

 

6466


CONSOLIDATED STATEMENTS OF RECOGNISEDCOMPREHENSIVE INCOME AND EXPENSE
                                
 Year ended December 31,  Year ended December 31, 
 2008 2007 2006  2010 2009 2008 
 Notes US$’000 US$’000 US$’000  Notes US$‘000 US$‘000 US$‘000 
 
Profit/(loss) for the year 2 60,418 11,824  (77,778)
Other comprehensive income:
 
Foreign exchange translation differences 18  (806) 1,072 1,347   (750) 215  (806)
Cash flow hedges:
  
Effective portion of changes in fair value  (252) 224 226  70  (31)  (252)
Deferred tax on income and expenses recognised directly in equity 26  (23) 4  6 3 26 
              
Net (expense) / income recognised directly in equity
  (1,032) 1,273 1,577 
Cash flow hedge recycled to the statement of operations    (166)
(Loss)/ profit for the year 2  (77,778)  (35,372) 3,276 
        
Total recognised income and expense (all attributable to equity holders)
  (78,810)  (34,099) 4,687 
Other comprehensive income
  (674) 187  (1,032)
                
 
Total Comprehensive Income (all attributable to owners of the parent)
 59,744 12,011  (78,810)
       

 

6567


CONSOLIDATED BALANCE SHEETS
                      
 December 31, December 31,  December 31, December 31, 
 2008 2007  2010 2009 
 Notes US$’000 US$’000  Notes US$‘000 US$‘000 
ASSETS
           
Non-current assets
           
Property, plant and equipment 11 11,855 26,409  11  5,999   12,174 
Goodwill and intangible assets 12 38,525 104,928  12  37,248   44,822 
Deferred tax assets 13 3,051 3,937  13  4,680   5,801 
Other assets 14 877 896  14  11,623   1,212 
             
Total non-current assets
 54,308 136,170     59,550   64,009 
             
           
Current assets
           
Inventories 15 42,317 44,420  15  17,576   39,198 
Trade and other receivables 16 27,418 25,683  16  25,529   22,931 
Income tax receivable 282 782     217   229 
Derivative financial instruments 29  224 
Cash and cash equivalents 17 5,184 8,700  17  58,002   6,078 
             
Total current assets
 75,201 79,809     101,324   68,436 
     
         
               
TOTAL ASSETS
 2 129,509 215,979  2  160,874   132,445 
             
           
EQUITY AND LIABILITIES
           
Equity attributable to the equity holders of the parent
           
Share capital 18 1,070 991     1,092   1,080 
Share premium 18 159,864 153,961     161,599   160,683 
Accumulated deficit 18  (99,493)  (22,908)    (25,412)  (87,070)
Translation reserve 18  (9) 797     (544)  206 
Other reserves 18 4,473 4,004     4,552   4,445 
             
Total equity
 65,905 136,845     141,287   79,344 
             
           
Current liabilities
           
Interest-bearing loans and borrowings 20 12,656 15,821  20  162   12,625 
Derivative financial instruments 29 27   27     58 
Income tax payable 5 86     597   24 
Trade and other payables 22 22,969 24,779  21  11,447   12,844 
Other financial liabilities 23  2,725 
Provisions 24 50 100  22  50   50 
             
Total current liabilities
 35,707 43,511     12,256   25,601 
             
           
Non-current liabilities
           
Interest-bearing loans and borrowings 20 23,465 26,312  20  111   19,231 
Other payables 25 59 74  23  30   59 
Deferred tax liabilities 13 4,373 9,237  13  7,190   8,210 
             
Total non-current liabilities
 27,897 35,623     7,331   27,500 
             
TOTAL LIABILITIES
 2 63,604 79,134  2  19,587   53,101 
             
           
     
TOTAL EQUITY AND LIABILITIES
 129,509 215,979     160,874   132,445 
             

 

6668


STATEMENT OF CHANGES IN EQUITY
                                 
  Share  Share                       
  capital  capital                  (Accumulated    
  ‘A’  ‘B’                  deficit)/    
  ordinary  ordinary  Share  Translation  Warrant  Hedging  retained    
  shares  shares  premium  reserve  reserve  reserves  earnings  Total 
  US$’000  US$’000  US$’000  US$’000  US$’000  US$’000  US$’000  US$’000 
                                 
Balance at January 1, 2008  979   12   153,961   797   3,803   201   (22,908)  136,845 
Total comprehensive income           (806)     (226)  (77,778)  (78,810)
Share-based payments                    1,193   1,193 
Options exercised                        
Class A shares issued in private placement  79      7,037               7,116 
Share issue expenses        (439)              (439)
Fair Value of Warrants issued during the year        (695)     695          
                         
Balance at December 31, 2008  1,058   12   159,864   (9)  4,498   (25)  (99,493)  65,905 
                         
                                 
Balance at January 1, 2009  1,058   12   159,864   (9)  4,498   (25)  (99,493)  65,905 
Total comprehensive income           215      (28)  11,824   12,011 
Share-based payments                    599   599 
Options exercised  10      887               897 
Share issue expenses        (68)              (68)
                         
Balance at December 31, 2009  1,068   12   160,683   206   4,498   (53)  (87,070)  79,344 
                         
                                 
Balance at January 1, 2010  1,068   12   160,683   206   4,498   (53)  (87,070)  79,344 
Total comprehensive income           (750)     76   60,418   59,744 
Share-based payments                    1,240   1,240 
Options exercised  12      1,011               1,023 
Share issue expenses        (64)              (64)
Fair Value of Warrants issued during the year        (31)     31          
                         
Balance at December 31, 2010  1,080   12   161,599   (544)  4,529   23   (25,412)  141,287 
                         

69


CONSOLIDATED STATEMENT OF CASH FLOWS
                              
 Year ended December 31,  Year ended December 31, 
 2008 2007 2006  2010 2009 2008 
 Notes US$’000 US$’000 US$’000  Notes US$‘000 US$‘000 US$‘000 
Cash flows from operating activities
               
(Loss)/ profit for the year  (77,778)  (35,372) 3,276 
Profit/(loss) for the year    60,418   11,824   (77,778)
Adjustments to reconcile net profit to cash provided by operating activities:
               
Depreciation 4,425 4,341 3,736     1,230   1,786   4,425 
Amortisation 3,616 3,418 2,687     1,589   1,959   3,616 
Income tax (credit)/expense  (3,892) 3,309  (2,824)
Income tax expense/(credit)    942   1,091   (3,892)
Financial income  (65)  (457)  (1,164)    (1,352)  (8)  (65)
Financial expense 2,160 3,148 2,653     495   1,192   2,160 
Share-based payments 1,166 1,403 1,141     1,109   521   1,166 
Foreign exchange losses on operating cash flows 77  (26)  (100)    351   109   77 
(Profit)/loss on disposal / retirement of property, plant and equipment  (682) 17  (2)
Loss/(profit) on disposal / retirement of property, plant and equipment    12   66   (682)
Impairment of assets 3 85,793 19,156   28        85,793 
Non- cash restructuring expenses 3  18,573  
Inventory write off   5,800 
Gain on divestment of business 3  (46,775)      
Other non-cash items 871 577 469     3,112   1,158   871 
                  
Operating cash flows before changes in working capital
 15,691 18,087 15,672     21,131   19,698   15,691 
(Increase)/decrease in trade and other receivables  (4,131) 5,226  (9,962)
Decrease/(increase) in inventories 2,062  (7,101)  (5,434)
(Decrease)/increase in trade and other payables  (676) 1,966 8,041 
Decrease/(increase) in trade and other receivables    3,094   3,872   (4,131)
(Increase)/decrease in inventories    (2,826)  2,372   2,062 
Increase/(decrease) in trade and other payables    1,574   (10,409)  (676)
                  
Cash generated from operations
 12,946 18,178 8,317     22,973   15,533   12,946 
Interest paid  (2,639)  (2,802)  (1,642)    (503)  (883)  (2,639)
Interest received 63 429 839     842   12   63 
Income taxes paid 359  (456)  (146)
Income taxes (paid)/received    (239)  70   359 
                  
Net cash provided by operating activities
 10,729 15,349 7,368 
Net cash generated by operating activities
    23,073   14,732   10,729 
                  
               
Cash flows from investing activities
               
Payments to acquire subsidiaries and businesses 26   (4,414)  (39,334)
Proceeds from divestiture of coagulation business (net)    65,886       
Deferred consideration to acquire subsidiaries and businesses  (2,802)  (3,472)  (6,802)          (2,802)
Payments to acquire intangible assets  (8,981)  (7,851)  (6,085)    (6,233)  (8,103)  (8,981)
Disposal/ (acquisition) of financial assets  15,500  (6,500)
Proceeds from disposal of property, plant and equipment 808 84 205     16   249   808 
Acquisition of property, plant and equipment  (3,713)  (8,262)  (4,751)    (2,784)  (2,481)  (3,713)
                  
Net cash used in investing activities
  (14,688)  (8,415)  (63,267)
Net cash generated by/(used in) investing activities
    56,885   (10,335)  (14,688)
                  
               
Cash flows from financing activities
               
Proceeds from issue of ordinary share capital 7,116 454 25,265     1,023   897   7,116 
Proceeds from borrowings, short-term debt  5,000 6,000 
Proceeds from borrowings, long-term debt   24,000        307    
Expenses paid in connection with share issue and debt financing  (624)  (70)  (1,526)    (74)  (68)  (624)
Repayment of long-term debt  (5,224)  (8,285)  (1,276)    (29,775)  (5,400)  (5,224)
Proceeds from new finance leases  2,087 78     1,480   1,298    
Payment of finance lease liabilities  (787)  (294)  (276)    (638)  (546)  (787)
Repayment of convertible debt    (3,644)
                  
Net cash provided by (used in) financing activities
 481  (1,108) 48,621 
Net cash (used in)/generated by financing activities
    (27,984)  (3,512)  481 
                  
               
(Decrease) / increase in cash and cash equivalents  (3,478) 5,826  (7,278)
Increase/(decrease) in cash and cash equivalents    51,974   885   (3,478)
Effects of exchange rate movements on cash held  (38) 53 218     (50)  9   (38)
Cash and cash equivalents at beginning of year 8,700 2,821 9,881     6,078   5,184   8,700 
                  
Cash and cash equivalents at end of year
 17 5,184 8,700 2,821  17  58,002   6,078   5,184 
                  

 

6770


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
1. BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES
 
  The principal accounting policies adopted by Trinity Biotech plc and its subsidiaries (“the Group”), are as follows:
a) 
Statement of compliance
 
  The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) both as issued by the International Accounting Standards Board (“IASB”) and as subsequently adopted by the European Union (“EU”) (together “IFRS”). The IFRS applied are those effective for accounting periods beginning on or after 1 January 2008.2010. Consolidated financial statements are required by Irish law to comply with IFRS as adopted by the EU which differ in certain respects from IFRS as issued by the IASB. These differences predominantly relate to the timing of adoption of new standards by the EU. However, as none of the differences are relevant in the context of Trinity Biotech, the consolidated financial statements for the periods presented comply with IFRS both as issued by the IASB and as adopted by the EU.
b) 
Basis of preparation
 
  The consolidated financial statements have been prepared in United States Dollars (US$), rounded to the nearest thousand, under the historical cost basis of accounting, except for derivative financial instruments and share-based payments which are initially recorded at fair value. Derivatives are also subsequently carried at fair value.
 
  The preparation of financial statements in conformity with IFRS requires management to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
 
  The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods.
 
  Judgements made by management that have a significant effect on the financial statements and estimates with a significant risk of material adjustment in the next year are discussed in note 30.
 
  Having considered the Group’s current financial position, its cashflow projections, its existing bank debt facility and other potential sources of funding available to the Group, the directors believe that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these consolidated financial statements and that it is appropriate to continue to prepare the consolidated financial statements on a going concern basis.
 
  The accounting policies set out below have been applied consistently to all periods presented in these consolidated financial statements. The accounting policies have been applied consistently by all Group entities.
Certain prior year amounts have been reclassified to conform to current presentation.
c) 
Basis of consolidation
 
  
Subsidiaries
 
  Subsidiaries are entities controlled by the Company. Control exists when the Company has the power, directly or indirectly, to govern the financial and reporting policies of an entity so as to obtain benefits from its activities. In assessing control, potential voting rights that presently are exercisable or convertible are taken into account. The financial statements of subsidiaries are included in the consolidated financial statements from the date that control commences until the date that control ceases.
 
  
Transactions eliminated on consolidation
 
  Intra-group balances and any unrealised gains or losses or income and expenses arising from intra-group transactions are eliminated in preparing the consolidated financial statements.

 

6871


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
1.BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
d) 
Property, plant and equipment
 
  
Owned assets
 
  Items of property, plant and equipment are stated at cost less any accumulated depreciation and any impairment losses (see note 1(h)). The cost of self-constructed assets includes the cost of materials, direct labour and attributable overheads. It is not Group policy to revalue any items of property, plant and equipment.
 
  Depreciation is charged to the statement of operations on a straight-line basis to write-off the cost of the assets over their expected useful lives as follows:
     
 Leasehold improvements 5-105-15 years
 Office equipment and fittings 10 years
 Buildings 50 years
 Computer equipment 3-5 years
 Plant and equipment 5-105-15 years
  Land is not depreciated. The residual values, if not insignificant, useful lives and depreciation methods of property, plant and equipment are reviewed and adjusted if appropriate, at each balance sheet date.
 
  
Leased assets — as lessee
 
  Leases under terms of which the Group assumes substantially all the risks and rewards of ownership are classified as finance leases. Property, plant and equipment acquired by way of finance lease is stated at an amount equal to the lower of its fair value and present value of the minimum lease payments at inception of the lease, less accumulated depreciation and any impairment losses.
 
  Depreciation is calculated in order to write-off the amounts capitalised over the estimated useful lives of the assets, or the lease term if shorter, by equal annual instalments. The excess of the total rentals under a lease over the amount capitalised is treated as interest, which is charged to the statement of operations in proportion to the amount outstanding under the lease. Leased assets are reviewed for impairment (see note 1(h)).
  Leases other than finance leases are classified as “operating leases”, and the rentals thereunder are charged to the statement of operations on a straight linestraight-line basis over the period of the leases. Lease incentives are recognised in the statement of operations on a straight-line basis over the lease term.
 
  
Leased assets — as lessor
 
  Leases where the Group substantially transfers the risks and benefits of ownership of the asset to the customer are classified as finance leases within finance lease receivables. The Group recognises the amount receivable from assets leased under finance leases at an amount equal to the net investment in the lease. Finance lease income is recognised as revenue in the statement of operations reflecting a constant periodic rate of return on the Group’s net investment in the lease.
 
  Assets provided to customers under leases other than finance leases are classified as operating leases and carried in property, plant and equipment at cost and are depreciated on a straight-line basis over the useful life of the asset or the lease term, if shorter.
 
  
Subsequent costs
 
  The Group recognises in the carrying amount of an item of property, plant and equipment the cost of replacing part of such an item when that cost is incurred if it is probable that the future economic benefits embodied within the item will flow to the Group and the cost of the replaced item can be measured reliably. All other costs are recognised in the statement of operations as an expense as incurred.

 

6972


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
1.BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
e) 
Business combinations
  All business combinations are accounted for by applying the purchaseacquisition method.
  The costrevised standard on business combinations (IFRS 3R) introduced major changes to the accounting requirements for business combinations. It retains the major features of a business combination is measuredthe purchase method of accounting, now referred to as the aggregate ofacquisition method. The most significant changes in IFRS 3R that impact the fair values at the date of exchange of assets given, liabilities incurred or assumed and equity instruments issued in exchange for control together with any directly attributable expenses. To the extent that settlement of all or any part of a business combination is deferred for a period of 12 months or longer, the fair value of the deferred component is determined through discounting the amounts payable to their present value at the date of exchange. The discount component is unwoundGroup are as an interest charge in the statement of operations over the life of the obligation.follows:
acquisition-related costs of the combination are recorded as an expense in the income statement. Previously, these costs would have been accounted for as part of the cost of the acquisition
any contingent consideration is measured at fair value at the acquisition date. If the contingent consideration arrangement gives rise to a financial liability, any subsequent changes are generally recognised in profit or loss. Previously, contingent consideration was recognised only once its payment was probable and changes were recognised as an adjustment to goodwill
the measurement of assets acquired and liabilities assumed at their acquisition-date fair values is retained. However, IFRS 3R includes certain exceptions and provides specific measurement rules.
  Where aIFRS 3R has been applied prospectively to business combination agreement providescombinations for an adjustment to the cost of the combination contingent on future events, the estimated present value of the adjustment is included in the cost at the acquisition date. Changes in these amounts subsequently are reflected in goodwill.
When the initial accounting for a business combination is determined provisionally, any subsequent adjustments to the provisional values allocated to the identifiable assets, liabilities and contingent liabilities are made within twelve months ofwhich the acquisition date is on or after 1 January 2010. Business combinations for which the acquisition date is before 1 January 2010 have not been restated and treated retrospectively as an adjustment to goodwill.were accounted for by applying the purchase method.
f) 
Goodwill
  In respect of business combinations that have occurred since January 1, 2004 (being the transition date to IFRS), goodwill represents the difference between the cost of the acquisition and the fair value of the net identifiable assets acquired.
  
In respect of acquisitions prior to this date, goodwill is included on the basis of its deemed cost, which represents the amount recorded under the old basis of accounting, Irish GAAP, (“Previous GAAP”). Save for retrospective restatement of deferred tax as an adjustment to retained earnings in accordance with IAS 12,Income Taxes,the classification and accounting treatment of business combinations undertaken prior to the transition date were not reconsidered in preparing the Group’s opening IFRS balance sheet as at January 1, 2004.
  To the extent that the Group’s interest in the net fair value of the identifiable assets, liabilities and contingent liabilities acquired exceeds the cost of a business combination, the identification and measurement of the related assets, liabilities and contingent liabilities are revisited accompanied by a reassessment of the cost of the transaction, and any remaining balance is immediately recognised in the statement of operations.
  At the acquisition date, any goodwill is allocated to each of the cash generating units expected to benefit from the combination’s synergies. Following initial recognition, goodwill is stated at cost less any accumulated impairment losses (see note 1(h)).
g) 
Intangibles, including research and development (other than goodwill)
  An intangible asset, which is an identifiable non-monetary asset without physical substance, is recognised to the extent that it is probable that the expected future economic benefits attributable to the asset will flow to the Group and that its cost can be measured reliably. The asset is deemed to be identifiable when it is separable (that is, capable of being divided from the entity and sold, transferred, licensed, rented or exchanged, either individually or together with a related contract, asset or liability) or when it arises from contractual or other legal rights, regardless of whether those rights are transferable or separable from the Group or from other rights and obligations.
 The technical feasibility of a new product is determined by a specific feasibility study undertaken at the first stage of any development project. The majority of our new product developments involve the transfer of existing product know-how to a new application. Since the technology is already proven in an existing product which is being used by customers, this facilitates the proving of the technical feasibility of that same technology in a new product. The results of the feasibility study are reviewed by a design review committee comprising senior managers. The feasibility study occurs in the initial research phase of a project and costs in this phase are not capitalized.

73


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
1.BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
The commercial feasibility of a new product is determined by preparing a discounted cash flow projection. This projection compares the discounted sales revenues for future periods with the relevant costs. As part of preparing the cash flow projection, the size of the relevant market is determined, feedback is sought from customers and the strength of the proposed new product is assessed against competitors’ offerings. Once the technical and commercial feasibility has been established and the project has been approved for commencement, the project moves into the development phase.
  Intangible assets acquired as part of a business combination are capitalised separately from goodwill if the intangible asset meets the definition of an asset and the fair value can be reliably measured on initial recognition. Subsequent to initial recognition, these intangible assets are carried at cost less any accumulated amortisation and any accumulated impairment losses (note 1(h)). Definite lived intangible assets are reviewed for indicators of impairment annually while indefinite lived assets and those not yet brought into use are tested for impairment annually, either individually or at the cash generating unit level.

70


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
  
Research and development
  Expenditure on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, is recognised in the statement of operations as an expense as incurred. Expenditure on development activities, whereby research findings are applied to a plan or design for the production of new or substantially improved products and processes, is capitalised if the product or process is technically and commercially feasible and the Group has sufficient resources to complete the development. The expenditure capitalised includes the cost of materials, direct labour and attributable overheads and third party costs. Subsequent expenditure on capitalised intangible assets is capitalised only when it increases the future economic benefits embodied in the specific asset to which it relates. All other development expenditure is expensed as incurred. Subsequent to initial recognition, the capitalised development expenditure is carried at cost less any accumulated amortisation and any accumulated impairment losses (note 1(h)).
  Expenditure on internally generated goodwill and brands is recognised in the statement of operations as an expense as incurred.
Amortisation
Amortisation
  Amortisation is charged to the statement of operations on a straight-line basis over the estimated useful lives of intangible assets, unless such lives are indefinite. Intangible assets are amortised from the date they are available for use. The estimated useful lives are as follows:
     
Patents and licences 6-15 years
 
Capitalised development costs 15 years
 
Other (including acquired customer and supplier lists) 6-15 years
The Group uses a useful economic life of 15 years for capitalized development costs. This is a conservative estimate of the likely life of the products. The Group is confident that products have a minimum of 15 years life given the inertia that characterizes the medical diagnostics industry and the barriers to entry into the industry. The following factors have been considered in estimating the useful life of developed products:
(a)once a diagnostic test becomes established, customers are reluctant to change to new technology until it is fully proven, thus resulting in relatively long product life cycles. There is also reluctance in customers to change to a new product as it can be costly both in terms of the initial changeover cost and as new technology is typically more expensive.
(b)demand for the diagnostic tests is enduring and robust within a wide geographic base. The diseases that the products diagnose are widely prevalent (HIV, diabetes and Chlamydia being just three examples) in many countries. There is a general consensus that these diseases will continue to be widely prevalent in the future.
(c)there are significant barriers to new entrants in this industry. Patents and/or licenses are in place for many of our products, though this is not the only barrier to entry. There is a significant cost and time to develop new products, it is necessary to obtain regulatory approval and tests are protected by proprietary know-how, manufacturing techniques and trade secrets.

74


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
1.BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
  Certain trade names acquired are deemed to have an indefinite useful life.
  Where amortisation is charged on assets with finite lives, this expense is taken to the statement of operations through the ‘selling, general and administrative expenses’ line.
  Useful lives are examined on an annual basis and adjustments, where applicable, are made on a prospective basis.
h) 
Impairment
  The carrying amount of the Group’s assets, other than inventories and deferred tax assets, are reviewed at each balance sheet date to determine whether there is any indication of impairment. If any such indication exists, the asset’s recoverable amount (being the greater of fair value less costs to sell and value in use) is assessed at each balance sheet date.
  Fair value less costs to sell is defined as the amount obtainable from the sale of an asset or cash-generating unit in an arm’s length transaction between knowledgeable and willing parties, less the costs that would be incurred in disposal. Value in use is defined as the present value of the future cash flows expected to be derived through the continued use of an asset or cash-generating unit. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the future cash flow estimates have not yet been adjusted. The estimates of future cash flows exclude cash inflows or outflows attributable to financing activities and income tax. For an asset that does not generate largely independent cash flows, the recoverable amount is determined by reference to the cash generating unit to which the asset belongs.
  For goodwill, assets that have an indefinite useful life and intangible assets that are not yet available for use, the recoverable amount is estimated at each balance sheet date at the cash generating unit level. The goodwill and indefinite-lived assets were reviewed for impairment at December 31, 2006,2008, December 31, 20072009 and December 2008.2010. See note 12.
  An impairment loss is recognised whenever the carrying amount of an asset or its cash-generating unit exceeds its recoverable amount. Impairment losses are recognised in the statement of operations.
  Impairment losses recognised in respect of cash-generating units are allocated first to reduce the carrying amount of any goodwill allocated to cash-generating units and then to reduce the carrying amount of other assets in the cash-generating units on a pro-rata basis.

71


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
  An impairment loss is reversed only to the extent that the asset’s carrying amount does not exceed the carrying amount that would have been determined, net of depreciation or amortisation, if no impairment loss had been recognised.
  An impairment loss in respect of goodwill is not reversed.
  Following recognition of any impairment loss (and on recognition of an impairment loss reversal), the depreciation or amortisation charge applicable to the asset or cash generating unit is adjusted prospectively with the objective of systematically allocating the revised carrying amount, net of any residual value, over the remaining useful life.
i) 
Inventories
  Inventories are stated at the lower of cost and net realisable value. Cost is based on the first-in, first-out principle and includes all expenditure which has been incurred in bringing the products to their present location and condition, and includes an appropriate allocation of manufacturing overhead based on the normal level of operating capacity. Net realisable value is the estimated selling price of inventory on hand in the ordinary course of business less all further costs to completion and costs expected to be incurred in selling these products.
  The Group provides for inventory, based on estimates of the expected realisability of the Group’s inventory. The estimated realisability is evaluated on a case-by-case basis and any inventory that is approaching its “use-by” date and for which no further re-processing can be performed is written off. Any reversal of an inventory provision is recognised in the statement of operations in the year in which the reversal occurs.

75


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
1. BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
j) 
Trade and other receivables
  Trade and other receivables are stated at their amortised cost less impairment losses incurred. Cost approximates fair value given the short dated nature of these assets.
k) 
Trade and other payables
 
  Trade and other payables are stated at cost. Cost approximates fair value given the short dated nature of these liabilities.
l) 
Cash and cash equivalents
  Cash and cash equivalents comprise cash balances and short-term deposits with a maturity of threesix months or less. The Group has no short-term bank overdraft facilities. Where restrictions are imposed by third parties, such as lending institutions, on cash balances held by the Group these are treated as financial assets in the financial statements.
m) 
Interest-bearing loans and borrowings
 
  
Loans and borrowings, including promissory notes
  Under IFRS interest-bearing loans, borrowings and promissory notes are recognised initially at fair value less attributable transaction costs. Subsequent to initial recognition, interest-bearing borrowings are stated at amortised cost, with any difference between cost and redemption value being recognised in the statement of operations over the period of the borrowings on an effective interest basis.
Convertible notes
Under IFRS convertible notes that can be converted into share capital at the option of the holder, where the number of shares issued does not vary with changes in their fair value, are accounted for as compound financial instruments. Transaction costs that relate to the issue of a compound financial instrument are allocated to the liability and equity components in proportion to the allocation of proceeds. The equity component of the convertible notes is calculated as the excess of the issue proceeds over the present value of the future interest and principal payments, discounted at the market rate of interest applicable to similar liabilities that do not have a conversion option. The interest expense recognised in the statement of operations is calculated using the effective interest rate method.
n) 
Share-based payments
  For equity-settled share-based payments (share options), the Group measures the services received and the corresponding increase in equity at fair value at the measurement date (which is the grant date) using a trinomial model. Given that the share options granted do not vest until the completion of a specified period of service, the fair value, which is assessed at the grant date, is recognised on the basis that the services to be rendered by employees as consideration for the granting of share options will be received over the vesting period.

72


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
  
The share options issued by the Group are not subject to market-based vesting conditions as defined in IFRS 2,Share-based PaymentsPayment. Non-market vesting conditions are not taken into account when estimating the fair value of share options as at the grant date; such conditions are taken into account through adjusting the number of equity instruments included in the measurement of the transaction amount so that, ultimately, the amount recognised equates to the number of equity instruments that actually vest. The expense in the statement of operations in relation to share options represents the product of the total number of options anticipated to vest and the fair value of those options; this amount is allocated to accounting periods on a straight-line basis over the vesting period. Given that the performance conditions underlying the Group’s share options are non-market in nature, the cumulative charge to the statement of operations is only reversed where the performance condition is not met or where an employee in receipt of share options relinquishes service prior to completion of the expected vesting period. Share based payments, to the extent they relate to direct labour involved in development activities, are capitalised, see 1(g).
  The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the options are exercised. The Group does not operate any cash-settled share-based payment schemes or share-based payment transactions with cash alternatives as defined in IFRS 2.
o) 
Government grants
  Grants that compensate the Group for expenses incurred such as research and development, employment and training are recognised as revenue or income in the statement of operations on a systematic basis in the same periods in which the expenses are incurred. Grants that compensate the Group for the cost of an asset are recognised in the statement of operations as other operating income on a systematic basis over the useful life of the asset.

76


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
1. BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
p) 
Revenue recognition
 
  
Goods sold and services rendered
  Revenue from the sale of goods is recognised in the statement of operations when the significant risks and rewards of ownership have been transferred to the buyer. Revenue from products is generally recorded as of the date of shipment. Revenueshipment, consistent with our typical ex-works shipment terms. Where the shipment terms do not permit revenue to be recognised as of the date of shipment, revenue is recognised when the Group has satisfied all of its obligations to the customer.customer in accordance with the shipping terms. Revenue, including any amounts invoiced for shipping and handling costs, represents the value of goods supplied to external customers, net of discounts and excluding sales taxes.
  Revenue from services rendered is recognised in the statement of operations in proportion to the stage of completion of the transaction at the balance sheet date.
  Revenue is recognised to the extent that it is probable that economic benefit will flow to the Group, that the risks and rewards of ownership have passed to the buyer and the revenue can be measured. No revenue is recognised if there is uncertainty regarding recovery of the consideration due at the outset of the transaction or the possible return of goods.
  The Group leases instruments under operating and finance leases as part of its business. In cases where the risks and rewards of ownership of the instrument pass to the customer, the fair value of the instrument is recognised as revenue at the commencement of the lease and is matched by the related cost of sale. In the case of operating leases of instruments which typically involve commitments by the customer to pay a fee per test run on the instruments, revenue is recognised on the basis of customer usage of the instruments. See also note 1(d).
 
  
Other operating income
  Rental income from sub-leasing premises under operating leases, where the risks and rewards of the premises remain with the lessor, is recognised in the statement of operations as other operating income on a straight-line basis over the term of the lease.
 Other operating income also comprises income derived from the Transitional Services Agreement (TSA) which the Group entered into with Diagnostica Stago in 2010. The services provided by the Group under the TSA mainly include: accounting, information technology and logistics support and warehousing services. This income is not treated as revenue since the TSA activities are incidental to the main revenue-generating activities of the Group.
q) 
Employee benefits
 
  
Defined contribution plans
  The Group operates defined contribution schemes in various locations where its subsidiaries are based. Contributions to the defined contribution schemes are recognised in the statement of operations in the period in which the related service is received from the employee.

73


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
  
Other long-term benefits
  Where employees participate in the Group’s other long-term benefit schemes (such as permanent health insurance schemes under which the scheme insures the employees), or where the Group contributes to insurance schemes for employees, the Group pays an annual fee to a service provider, and accordingly the Group expenses such payments as incurred.
 
  
Termination benefits
  Termination benefits are recognised as an expense when the Group is demonstrably committed, without realistic possibility of withdrawal, to a formal detailed plan to either terminate employment before normal retirement date, or to provide termination benefits as a result of an offer made to encourage voluntary redundancy.

77


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
1. BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
r) 
Foreign currency
  A majority of the revenue of the Group is generated in US dollars. The Group’s management has determined that the US dollar is the primary currency of the economic environment in which the Company and its subsidiaries (with the exception of the Group’s subsidiaries in Germany and Sweden) principally operate. Thus the functional currency of the Company and its subsidiaries (other than those subsidiaries in Germany and Sweden) is the US Dollar. The functional currency of the German and Swedish subsidiaries is the euroEuro and the Swedish Kroner, respectively. The presentation currency of the Company and Group is the US Dollar. Monetary assets and liabilities denominated in foreign currencies are translated at the rates of exchange ruling at the balance sheet date. The resulting gains and losses are included in the statement of operations. Non-monetary assets and liabilities that are measured in terms of historical cost in a foreign currency are translated using the exchange rate at the date of the transaction.
  Results and cash flows of subsidiary undertakings, which have a functional currency other than the US Dollar, are translated into US Dollars at average exchange rates for the year, and the related balance sheets have been translated at the rates of exchange ruling on the balance sheet date. Any exchange differences arising from the translations are recognised in the currency translation reserve via the statement of recognised income and expense.changes in equity.
 Where Euro or Sterling amounts have been referenced in this document, their corresponding US Dollar equivalent has also been included and these equivalents have been calculated with reference to the foreign exchange rates prevailing at December 31, 2010.
s) 
Derivative financial instruments
  The activities of the Group expose it primarily to changes in foreign exchange rates and interest rates. The Group uses derivative financial instruments, when necessary, such as forward foreign exchange contracts to hedge these exposures.
  The Group enters into forward contracts to sell US Dollars forward for euro.Euro. The principal exchange risk identified by the Group is with respect to fluctuations in the euroEuro as a substantial portion of its expenses are denominated in euroEuro but its revenues are primarily denominated in US Dollars. Trinity Biotech monitors its exposure to foreign currency movements and may use these forward contracts as cash flow hedging instruments whose objective is to cover a portion of this euroEuro expense.
  At the inception of a hedging transaction entailing the use of derivatives, the Group documents the relationship between the hedged item and the hedging instrument together with its risk management objective and the strategy underlying the proposed transaction. The Group also documents its quarterly assessment of the effectiveness of the hedge in offsetting movements in the cash flows of the hedged items.
  Derivative financial instruments are recognised at fair value. Where derivatives do not fulfil the criteria for hedge accounting, they are classified as held-for-trading and changes in fair values are reported in the statement of operations. The fair value of forward exchange contracts is calculated by reference to current forward exchange rates for contracts with similar maturity profiles and equates to the current market price at the balance sheet date.
  The portion of the gain or loss on a hedging instrument that is deemed to be an effective cash flow hedge is recognised directly in the hedging reserve in equity and the ineffective portion is recognised in the statement of operations. As the forward contracts are exercised the net cumulative gain or loss recognised in the hedging reserve is transferred to the statement of operations and reflected in the same line as the hedged item.

74


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
t) 
Segment reporting
  
A segmentOperating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is a distinguishable componentresponsible for allocating resources and assessing performance of the Group that is engaged either in providing products or services (business segment), or in providing products or services within a particular economic environment (geographical segment), which is subject to risks and returns different to thoseoperating segments, has been identified as the Board of other segments. Stemming from the Group’s internal organisational and management structure and its system of internal financial reporting, segmentation by geographic location of assets is regarded as being the predominant source and nature of the risks and returns facing the Group and is thus the primary segment format under IAS 14,Segment Reporting.Business segmentation is therefore the secondary segment format.
Directors.
u) 
Tax (current and deferred)
  Income tax on the profit or loss for the year comprises current and deferred tax. Income tax is recognised in the statement of operations except to the extent that it relates to items recognised directly in equity, in which case it is recognised in equity.

78


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
1. BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
  Current tax represents the expected tax payable (or recoverable) on the taxable profit for the year using tax rates enacted or substantively enacted at the balance sheet date and taking into account any adjustments stemming from prior years.
  Deferred tax is provided on the basis of the balance sheet liability method on all temporary differences at the balance sheet date which is defined as the difference between the tax bases of assets and liabilities and their carrying amounts in the financial statements. Deferred tax assets and liabilities are not subject to discounting and are measured at the tax rates that are anticipated to apply in the period in which the asset is realised or the liability is settled based on tax rates and tax laws that have been enacted or substantively enacted at the balance sheet date. Deferred tax assets are recognised when it is probable that future taxable profits will be available to utilize the associated losses or temporary differences. The amount of deferred tax provided is based on the expected manner of realisation or settlement of the carrying amount of assets and liabilities.
  Deferred tax assets and liabilities are recognised for all temporary differences (that is, differences between the carrying amount of the asset or liability and its tax base) with the exception of the following:
 i. Where the deferred tax liability arises from goodwill not deductible for tax purposes or the initial recognition of an asset or a liability in a transaction that is not a business combination and affects neither the accounting profit nor the taxable profit or loss at the time of the transaction; and
 ii. Where, in respect of temporary differences associated with investments in subsidiary undertakings, the timing of the reversal of the temporary difference is subject to control and it is probable that the temporary difference will not reverse in the foreseeable future.
  Where goodwill is tax deductible, a deferred tax liability is not recognised on initial recognition of goodwill. It is recognised subsequently for the taxable temporary difference which arises when the goodwill is amortised for tax with no corresponding adjustment to the carrying value of the goodwill.
  The carrying amounts of deferred tax assets are subject to review at each balance sheet date and are derecognised to the extent that future taxable profits are considered to be inadequate to allow all or part of any deferred tax asset to be utilised.
v) 
Provisions
  A provision is recognised in the balance sheet when the Group has a present legal or constructive obligation as a result of a past event, and it is probable that an outflow of economic benefits will be required to settle the obligation.
w) 
Cost of sales
  Cost of sales comprises product cost including manufacturing and payroll costs, quality control, shipping, handling, and packaging costs and the cost of services provided.
x) 
Finance income and costs
  Financing expenses comprise costs payable on leases, loans and borrowings including promissory notes. Interest payable on loans and borrowings, promissory notes and convertible notes is calculated using the effective interest rate method. Interest payable on finance leases is allocated to each period during the lease term so as to produce a constant periodic rate of interest on the remaining balance of the liability. Financing expenses also includes the financing element of long term liabilities which have been discounted.

75


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
  Finance income comprisesincludes interest income on deposits and is recognised in the statement of operations as it accrues, using the effective interest method. Finance income also includes interest on the deferred consideration due to the Group as part of the divestiture of the Coagulation business in 2010.
y) 
Warrant reserve
  The Group calculates the fair value of warrants at the date of issue taking the amount directly to equity. The fair value is calculated using a recognised valuation methodology for the valuation of financial instruments (that is, the trinomial model). The fair value which is assessed at the grant date is calculated on the basis of the contractual term of the warrants.

79


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
1. BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
z) 
New IFRS Standards and Interpretations not applied
  The IASB and IFRIC have issued additional standards and interpretations which are effective for periods starting on or after January 1, 2008,2010, some of which have not yet been adopted by the EU. The following standards and interpretations have yet to be adopted by the Group:
     
International Financial Reporting Standards (IFRS/IAS) Effective date
IFRS 31 (Revised) Business CombinationsFirst-time Adoption of International Financial Reporting Standards — Limited Exemption from Comparative IFRS 7 Disclosures for First-time Adopters July 1, 2009 (adopted by the EU)
IFRS 8Operating SegmentsJanuary 1, 2009 (adopted by the EU)
IAS 1
(amendment)Presentation of Financial StatementsJanuary 1, 20092010 (not adopted by the EU)
IAS23 (amendment)Borrowing CostsJanuary 1, 2009 (notyet adopted by the EU)
IAS 2724 Consolidated and Separate Financial StatementsRelated Party Disclosures (Revised) JulyJanuary 1, 20092011 (not yet adopted by the EU)
IAS 32/ IAS 1 (amendment)32 Puttable Instruments and Obligations arising on LiquidationFinancial Instruments: Presentation — Classification of Rights Issues (Amendment) JanuaryFebruary 1, 20092010 (not yet adopted by the EU)
IFRS 2 Share- based PaymentsVesting Conditions and CancellationsJanuary 1, 2009 (not adopted by the EU)
IAS 39
(amendment)
Eligible hedged itemsJuly 1, 2009 (not adopted by the EU)
IFRS 1
(amendment)

Cost of an Investment in a Subsidiary, Jointly Controlled Entity or Associate

January 1, 2009 (not adopted by the EU)
     
International Financial Reporting Interpretations Committee (IFRIC)  
IFRIC 1314 Customer Loyalty ProgrammesPrepayments of a Minimum Funding Requirement (Amendment) January 1, 20092011 (not yet adopted by the EU)
IFRIC 1519 Agreements for the Construction of Real EstateExtinguishing Financial Liabilities with Equity Instruments JanuaryJuly 1, 20092010 (not adopted by the EU)
IFRIC 16Hedges of a Net Investment in a Foreign OperationJanuary 1, 2009 (notyet adopted by the EU)
  The Group does not anticipate that the adoption of these standards and interpretations will have a material effect on its financial statements on initial adoption. Upon adoption
Standards, amendments and interpretations to existing standards that are not yet effective and have not been adopted early by the Group.
At the date of authorisation of these financial statements, certain new standards, amendments and interpretations to existing standards have been published but are not yet effective, and have not been adopted early by the Group.
Management anticipates that all of the relevant pronouncements will be adopted in the Group’s accounting policies for the first period beginning after the effective date of the pronouncement. Information on new standards, amendments and interpretations that are expected to be relevant to the Group’s financial statements is provided below. Certain other new standards and interpretations have been issued but are not expected to have a material impact on the Group’s financial statements.
Annual Improvements 2010 (effective from 1 July 2010 and later)
The IASB has issued Improvements to IFRS 2010 (2010 Improvements). Most of these amendments become effective in annual periods beginning on or after 1 July 2010 or 1 January 2011. The 2010 Improvements amend certain provisions of IFRS 83R, clarify presentation of the reconciliation of each of the components of other comprehensive income and IAS 1,clarify certain disclosure requirements for financial instruments. The Group’s preliminary assessments indicate that the Group may be required to disclose additional information2010 Improvements will not have a material impact on its operating segments but this will have no effect on reported income or net assets.the Group’s financial statements.
 
IFRS 9 Financial Instruments (effective from 1 January 2013)
The IASB aims to replace IAS 39 Financial Instruments: Recognition and Measurement in its entirety. The replacement standard (IFRS 9) is being issued in phases. To date, the chapters dealing with recognition, classification, measurement and derecognition of financial assets and liabilities have been issued. These chapters are effective for annual periods beginning 1 January 2013. Further chapters dealing with impairment methodology and hedge accounting are still being developed.
Management have yet to assess the impact that this amendment is likely to have on the financial statements of the Group. However, they do not expect to implement the amendments until all chapters of IFRS 9 have been published and they can comprehensively assess the impact of all changes

80


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
2. SEGMENT INFORMATION
 
  Segment informationOperating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is presented in respectresponsible for allocating resources and assessing the performance of the Group’s geographical andoperating segments, has been identified as the Board of Directors. Management has determined the operating segments based on the reports reviewed by the Board of Directors, which are used to make strategic decisions. The Board considers the business segments. The primary format, geographical segments, isfrom a geographic perspective based on the Group’s management and internal reporting structure. Sales of product between companies in the Group are made on commercial terms which reflect the nature of the relationship between the relevant companies. Segment results, assets and liabilities include items directly attributable to a segment as well as those that can be allocated on a reasonable basis. Unallocated items comprise interest-bearing loans, borrowings and expenses and corporate expenses. Segment capital expenditure is the total cost during the periodyear to acquire segment plant, property and equipment and intangible assets that are expected to be used for more than one period, whether acquired on acquisition of a business combination or through acquisitions as part of the current operations.

76


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
Geographical segments
 
  The Group comprises two main geographical segments (i) the Americas and (ii) Rest of World. The Group’s geographical segments are determined by the location of the Group’s assets and operations.
The Group has also presented a geographical analysis of the segmental data for Ireland onas is consistent with the basisinformation used by the Board of the aggregation thresholds contained in IAS 14.
BusinessDirectors. The reportable operating segments
The Group operates in derive their revenue primarily from one business segment,source (i.e. the market for diagnostic tests for a range of diseases and other medical conditions.conditions). In determining the nature of its segmentation, the Group has considered the nature of the products, their risks and rewards, the nature of the production base, the customer base and the nature of the regulatory environment. The Group acquires, manufactures and markets a range of diagnostic products. The Group’s products are sold to a similar customer base and the main body whose regulation the Group’s products must comply with is the Food and Drug Administration (“FDA”) in the US.
  The following presents revenue and profit information and certain asset and liability information regarding the Group’s geographical segments.
a) The distribution of revenue by geographical area based on location of assets was as follows:
Revenue
                     
      Rest of World       
  Americas  Ireland  Other  Eliminations  Total 
Year ended December 31, 2008 US$’000  US$’000  US$’000  US$’000  US$’000 
                     
Revenue from external customers  48,615   72,676   18,848      140,139 
Inter-segment revenue  28,345   22,248   12,435   (63,028)   
                
Total revenue  76,960   94,924   31,283   (63,028)  140,139 
                
Revenue
                                        
 Rest of World      Rest of World     
 Americas Ireland Other Eliminations Total  Americas Ireland Other Eliminations Total 
Year ended December 31, 2007 US$’000 US$’000 US$’000 US$’000 US$’000 
Year ended December 31, 2010 US$‘000 US$‘000 US$‘000 US$‘000 US$‘000 
  
Revenue from external customers 37,095 64,210 42,312  143,617  37,643 45,642 6,350  89,635 
Inter-segment revenue 24,815 27,196 10,134  (62,145)   21,786 12,154 7,101  (41,041)  
                      
Total revenue 61,910 91,406 52,446  (62,145) 143,617  59,429 57,796 13,451  (41,041) 89,635 
                      
                                        
 Rest of World      Rest of World     
 Americas Ireland Other Eliminations Total  Americas Ireland Other Eliminations Total 
Year ended December 31, 2006 US$’000 US$’000 US$’000 US$’000 US$’000 
Year ended December 31, 2009 US$‘000 US$‘000 US$‘000 US$‘000 US$‘000 
  
Revenue from external customers 33,247 55,665 29,762  118,674  46,286 65,529 14,092  125,907 
Inter-segment revenue 21,161 24,968 9,679  (55,808)   25,527 20,843 9,588  (55,958)  
                      
Total revenue 54,408 80,633 39,441  (55,808) 118,674  71,813 86,372 23,680  (55,958) 125,907 
                      

77


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
                     
      Rest of World       
  Americas  Ireland  Other  Eliminations  Total 
Year ended December 31, 2008 US$‘000  US$‘000  US$‘000  US$‘000  US$‘000 
                     
Revenue from external customers  48,615   72,676   18,848      140,139 
Inter-segment revenue  28,345   22,248   12,435   (63,028)   
                
Total revenue  76,960   94,924   31,283   (63,028)  140,139 
                
b) The distribution of revenue by customers’ geographical area was as follows:
                        
 December 31, 2008 December 31, 2007 December 31, 2006  December 31, 2010 December 31, 2009 December 31, 2008 
Revenue US$’000 US$’000 US$’000  US$‘000 US$‘000 US$‘000 
Americas 69,915 68,481 60,748  53,993 68,130 69,915 
Europe (including Ireland) * 43,481 43,631 34,452  15,890 32,389 43,481 
Asia / Africa 26,743 31,505 23,474  19,752 25,388 26,743 
              
 140,139 143,617 118,674  89,635 125,907 140,139 
              
* Revenue for customers in Ireland is not disclosed separately due to the immateriality of these revenues.

81


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
2.SEGMENT INFORMATION (CONTINUED)
c) The distribution of revenue by major product group was as follows:
                        
 December 31, 2008 December 31, 2007 December 31, 2006  December 31, 2010 December 31, 2009 December 31, 2008 
Revenue US$’000 US$’000 US$’000  US$‘000 US$‘000 US$‘000 
Clinical Laboratory 121,143 119,113 103,395 
Clinical laboratory 73,553 107,778 121,143 
Point of care 18,996 24,504 15,279  16,082 18,129 18,996 
              
 140,139 143,617 118,674  89,635 125,907 140,139 
              
d) The distribution of segment results by geographical area was as follows:
 
  
Year ended December 31, 20082010
                 
      Rest of World    
  Americas  Ireland  Other  Total 
  US$’000  US$’000  US$’000  US$’000 
Result before exceptional expenses
  807   10,848   (2,391)  9,264 
Impairment expense (note 3)  (17,645)  (66,152)  (1,996)  (85,793)
Restructuring expenses (note 3)  (185)  (1,904)     (2,089)
             
Result after exceptional expenses
  (17,023)  (57,208)  (4,387)  (78,618)
                 
Unallocated expenses *              (957)
                
Operating loss              (79,575)
Net financing costs (note 4)              (2,095)
Loss before tax              (81,670)
Income tax credit (note 9)              3,892 
                
Loss for the year              (77,778)
                
                 
      Rest of World    
  Americas  Ireland  Other  Total 
  US$‘000  US$‘000  US$‘000  US$‘000 
Result before Gain on Sale and Restructuring
  7,103   4,912   2,600   14,615 
Net gain on divestment of business and restructuring expenses (note 3)  5,745   32,918   7,811   46,474 
             
Result after Gain on Sale and Restructuring  12,848   37,830   10,411   61,089 
                 
Unallocated expenses *              (586)
                
Operating profit              60,503 
Net financing income (note 4)              857 
                
Profit before tax              61,360 
Income tax expense (note 9)              (942)
                
Profit for the year              60,418 
                
  
Year ended December 31, 20072009
                 
      Rest of World    
  Americas  Ireland  Other  Total 
  US$’000  US$’000  US$’000  US$’000 
Result before goodwill impairment and restructuring expenses
  15   10,868   447   11,330 
Goodwill impairment (note 3)     (19,156)     (19,156)
Restructuring expenses (note 3)  (6,215)  (11,961)  (2,615)  (20,791)
             
Result after goodwill impairment and restructuring
  (6,200)  (20,249)  (2,168)  (28,617)
                 
Unallocated expenses *              (755)
                
Operating loss              (29,372)
Net financing costs (note 4)              (2,691)
                
Loss before tax              (32,063)
Income tax expense (note 9)              (3,309)
                
Loss for the year              (35,372)
                

78


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
                 
      Rest of World    
  Americas  Ireland  Other  Total 
  US$‘000  US$‘000  US$‘000  US$‘000 
Result
  9,073   7,004   (1,211)  14,866 
Unallocated expenses *              (767)
                
Operating profit              14,099 
Net financing costs (note 4)              (1,184)
                
Profit before tax              12,915 
Income tax expense (note 9)              (1,091)
                
Profit for the year              11,824 
                
  
Year ended December 31, 20062008
                 
      Rest of World    
  Americas  Ireland  Other  Total 
  US$’000  US$’000  US$’000  US$’000 
Result
  (6,621)  10,790   (1,843)  2,326 
Unallocated expenses *              (385)
                
Operating profit              1,941 
Net financing costs (note 4)              (1,489)
Profit before tax              452 
Income tax credit (note 9)              2,824 
                
Profit for the year              3,276 
                
                 
      Rest of World    
  Americas  Ireland  Other  Total 
  US$‘000  US$‘000  US$‘000  US$‘000 
Result before exceptional expenses
  807   10,848   (2,391)  9,264 
Impairment expense (note 28)  (17,645)  (66,152)  (1,996)  (85,793)
Restructuring expenses (note 28)  (185)  (1,904)     (2,089)
             
Result after exceptional expenses
  (17,023)  (57,208)  (4,387)  (78,618)
                 
Unallocated expenses *              (957)
                
Operating loss              (79,575)
Net financing costs (note 4)              (2,095)
                
Loss before tax              (81,670)
Income tax credit (note 9)              3,892 
                
Loss for the year              (77,778)
                
* Unallocated expenses represent head office general and administration costs of the Group which cannot be allocated to the results of any specific geographical area.

82


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
2. SEGMENT INFORMATION (CONTINUED)
e) The distribution of segment assets and segment liabilities by geographical area was as follows:
As at December 31, 2008
                 
      Rest of World    
  Americas  Ireland  Other  Total 
  US$’000  US$’000  US$’000  US$’000 
Assets and liabilities
                
Segment assets  58,248   128,907   19,630   206,785 
Impairment (note 3)  (17,645)  (66,152)  (1,996)  (85,793)
             
Segment assets after goodwill impairment and restructuring  40,603   62,755   17,634   120,992 
Unallocated assets:
                
Income tax assets (current and deferred)              3,333 
Cash and cash equivalents              5,184 
                
Total assets as reported in the Group balance sheet              129,509 
                
                 
Segment liabilities before restructuring  6,909   10,451   4,601   21,961 
Impact of restructuring (note 22)  6   1,138      1,144 
             
Segment liabilities after restructuring  6,915   11,589   4,601   23,105 
Unallocated liabilities:
                
Income tax liabilities (current and deferred)              4,378 
Interest-bearing loans and borrowings (current and non-current)              36,121 
                
Total liabilities as reported in the Group balance sheet              63,604 
                

79


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
  
As at December 31, 20072010
                                
 Rest of World    Rest of World   
 Americas Ireland Other Total  Americas Ireland Other Total 
 US$’000 US$’000 US$’000 US$’000  US$‘000 US$‘000 US$‘000 US$‘000 
Assets and liabilities
  
Segment assets before goodwill impairment and restructuring 61,551 154,285 24,090 239,926 
Goodwill impairment (note 3)   (19,156)   (19,156)
Impact of restructuring  (5,469)  (10,626)  (2,115)  (18,210)
         
Segment assets after goodwill impairment and restructuring 56,082 124,503 21,975 202,560 
Segment assets 36,726 61,249  97,975 
Unallocated assets:
  
Income tax assets (current and deferred) 4,719  4,897 
Cash and cash equivalents 8,700  58,002 
      
Total assets as reported in the Group balance sheet 215,979  160,874 
      
  
Segment liabilities before restructuring 5,885 15,387 4,390 25,662 
Impact of restructuring (note 22) 808 691 517 2,016 
         
Segment liabilities after restructuring 6,693 16,078 4,907 27,678 
Segment liabilities 2,315 9,212  11,527 
Unallocated liabilities:
  
Income tax liabilities (current and deferred) 9,323  7,787 
Interest-bearing loans and borrowings (current and non-current) 42,133  273 
      
Total liabilities as reported in the Group balance sheet 79,134  19,587 
      
As at December 31, 2009
                 
      Rest of World    
  Americas  Ireland  Other  Total 
  US$‘000  US$‘000  US$‘000  US$‘000 
Assets and liabilities
                
Segment assets  37,355   65,693   17,289   120,337 
Unallocated assets:
                
Income tax assets (current and deferred)              6,030 
Cash and cash equivalents              6,078 
                
Total assets as reported in the Group balance sheet              132,445 
                
                 
Segment liabilities  2,695   7,749   2,567   13,011 
Unallocated liabilities:
                
Income tax liabilities (current and deferred)              8,234 
Interest-bearing loans and borrowings (current and non-current)              31,856 
                
Total liabilities as reported in the Group balance sheet              53,101 
                
f) The distribution of long-lived assets, which are property, plant and equipment, goodwill and intangible assets and other non-current assets (excluding deferred tax assets)assets and deferred consideration), by geographical area was as follows:
                
 December 31, 2008 December 31, 2007  December 31, 2010 December 31, 2009 
 US$’000 US$’000  US$‘000 US$‘000 
Rest of World — Ireland 33,511 95,675  27,433 38,756 
Rest of World — Other 7,174 10,029   6,815 
Americas 10,572 26,529  16,299 12,637 
          
 51,257 132,233  43,732 58,208 
          

83


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
2.SEGMENT INFORMATION (CONTINUED)
g) The distribution of depreciation and amortisation by geographical area was as follows:
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’000 
Depreciation:
            
Rest of World — Ireland  1,799   1,450   1,336 
Rest of World — Other  1,149   1,537   1,163 
Americas  1,477   1,354   1,237 
          
   4,425   4,341   3,736 
          
             
Amortisation:
            
Rest of World — Ireland  3,113   2,971   2,298 
Rest of World — Other  206   151   104 
Americas  297   296   285 
          
   3,616   3,418   2,687 
          

80


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
Depreciation:
            
Rest of World — Ireland  276   325   1,799 
Rest of World — Other  296   900   1,149 
Americas  658   561   1,477 
          
   1,230   1,786   4,425 
          
             
Amortisation:
            
Rest of World — Ireland  1,475   1,712   3,113 
Rest of World — Other  55   169   206 
Americas  59   78   297 
          
   1,589   1,959   3,616 
          
h) The distribution of share-based payment expense by geographical area was as follows:
                        
 December 31, 2008 December 31, 2007 December 31, 2006  December 31, 2010 December 31, 2009 December 31, 2008 
 US$’000 US$’000 US$’000  US$‘000 US$‘000 US$‘000 
Rest of World — Ireland 996 1,146 922  1,032 470 996 
Rest of World — Other 38 37 24  1 17 38 
Americas 132 220 195  76 34 132 
              
 1,166 1,403 1,141  1,109 521 1,166 
              
  See note 19 for further information on share-based payments.
i) The distribution of impairment & restructuring expenses (see note 3) by geographical area was as follows:
December 31, 2008
US$’000
Impairment:
Rest of World — Ireland66,152
Rest of World — Other1,996
Americas17,645
85,793
Restructuring expenses:
Rest of World — Ireland1,904
Rest of World — Other
Americas185
2,089
Asset Impairments arose as a result of the annual impairment review which was performed on 31 December 2008(see note 3).
The Board of Directors announced a restructuring of the business in December 2008, which resulted in certain one-off expenditure being incurred. These termination payments and other restructuring costs resulted in an after tax charge of $1.9 million (see note 3).

81


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
Impairment:
            
Rest of World — Ireland        66,152 
Rest of World — Other        1,996 
Americas        17,645 
          
         85,793 
          
             
Restructuring expenses:
            
Rest of World — Ireland  301      1,904 
Rest of World — Other         
Americas        185 
          
   301      2,089 
          
  
December 31, 2007
US$’000
Impairment:
RestThe 2010 restructuring expenses were incurred in connection with a programme involving a re-organisation of World — Ireland19,156
Restthe Group’s HIV manufacturing activities and comprised termination payments for employees located in Ireland. This restructuring cost is included within Net gain on divestment of World — Other
Americas
19,156
Restructuring expenses:
Restbusiness and restructuring expenses, on the face of World — Ireland11,961
Rest of World — Other6,215
Americas2,615
20,791
the income statement.
In 2007, the total restructuring expenses above of US$20,791,000 includes an inventory write off of US$11,772,000. As part of the restructuring plan (see note 3), Trinity Biotech undertook to reduce the number of products and instruments within the two key product lines of Haemostasis and Infectious Diseases. As a result, the Group has recognised US$11,772,000 for inventory written off relating to those Haemostasis and Infectious Diseases products and instruments being rationalised for the year ended December 31, 2007. The write off was included as part of the total restructuring expenses in cost of sales in the 2007 statement of operations. The distribution of the inventory write off by geographical area was as follows:
  
December 31, 2007
US$’000
Inventory write off
RestAsset impairments arose as a result of World — Ireland4,146
Rest of World — Other2,279
Americas5,347
11,772
In 2006, the Group undertook to write off inventory of US$5.8 million. Following the acquisition of the haemostasis business of bioMerieux Inc (“bioMerieux”), Trinity Biotech sought to combine the range of products acquired with the Group’s existing product range. As part of this process it was decided to discontinue various existing products and this resulted in a US$5.8 million write-off of inventory. This write-off was disclosed as a separate line item in cost of sales in the 2006 statement of operations. The distribution of the inventory provision recognised in 2006 by geographical area was as follows:
December 31, 2006
US$’000
Inventory provision
Rest of World — Ireland1,751
Rest of World — Other2,362
Americas1,687
5,800

82


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
j)The distribution of interest expense by geographical areathe annual impairment review which was as follows:
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’000 
Rest of World — Ireland  1,817   2,595   1,982 
Rest of World — Other  8   15   12 
Americas  335   538   659 
          
   2,160   3,148   2,653 
          
k)The distribution of taxation credit / (expense) by geographical area was as follows:
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’000 
Rest of World — Ireland  3,716   531   (1,156)
Rest of World — Other  9   (662)  975 
Americas  167   (3,178)  3,005 
          
   3,892   (3,309)  2,824 
          
l)During 2008, 2007 and 2006 there were no customers generating 10% or more of total revenues.
m)The distribution of capital expenditure, including expenditure on non-current assets in business combinations, by geographical area was as follows:
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
Rest of World — Ireland  8,101   14,742 
Rest of World — Other  1,239   3,130 
Americas  3,507   3,199 
       
   12,847   21,071 
       
3.IMPAIRMENT CHARGES AND RESTRUCTURING EXPENSES
Asset impairment charges totalling US$85,793,000 have been recognised in the statement of operations in the year ended December 31, 2008. In accordance with IAS 36 the Group carries out an annual impairment review of the asset valuations. The Group carries out its impairment reviewperformed on 31 December each year. In determining whether a potential asset impairment exists, the Company considered a range of internal and external factors. One such factor was the relationship between the Group’s market valuation and the book value of its net assets.
Trinity Biotech’s market capitalization in the recent equity market conditions was significantly below the book value of its net assets. In such circumstances given the accounting standard guidance, the Group decided to recognize at December 31, 2008 a non-cash impairment charge of US$81.3 million after tax. The impairment was taken against goodwill and other intangible assets, property, plant and equipment and prepayments (see notes 11, 12 and 16). The tax impact of the impairment charges is described in note 9.
The Board of Directors announced a restructuring of the business in December 2008. The restructuring aimed to reduce costs through improved operational efficiency within the Group. As a result of the restructuring, there was a reduction in the size of the workforce, mainly affecting the sales, marketing and administration functions. Termination payments and other restructuring costs resulted in an after tax charge of US$1.9 million in the current year. Included in this amount is US$1.5 million relating to the resignation of Brendan Farrell as Chief Executive Officer in October 2008.

83


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
The impact of the above items on the statement of operations for the year ended December 31, 2008 was as follows:
             
  Impairment  Restructuring  Total 
  US$’000  US$’000  US$’000 
             
Selling, general & administration expenses
            
Impairment of PP&E (note 11)  13,095      13,095 
Impairment of goodwill and other intangible assets (note 12)  71,684      71,684 
Impairment of prepayments (note 16)  1,014      1,014 
             
Employee termination payments(a)
     589   589 
Director’s compensation for loss of office and share option expense(b)
     1,465   1,465 
Other restructuring expenses     35   35 
          
Total impairment loss and restructuring expenses before tax
  85,793   2,089   87,882 
          
             
Income tax impact of impairment loss and restructuring expenses (note 9)  (4,536)  (215)  (4,751)
          
Total impairment loss and restructuring expenses after tax
  81,257   (1,874)  83,131 
          
(a)Under the restructuring plan announced in December 2008 the Group’s workforce was reduced by about 10%(see note 28). The redundancies occurred in the Group’s US, Irish and German operations. The total redundancy costs amounted to US$589,000, of which an amount of US$156,000 is accrued at December 31, 2008.
(b)An expense of US$1,465,000 was recorded in the current year in relation to the resignation of the former Chief Executive Officer, Brendan Farrell. Mr. Farrell left the company in October 2008. The expense comprises termination payments of US$1,283,000, of which US$988,000 is included in accrued restructuring expenses at December 31, 2008, and an accelerated share option expense of US$182,000.
In December 2007, the Board of Directors announced a restructuring of the business. The impact of this restructuring resulted in an after tax charge to the statement of operations of US$19,207,000 for the year ended December 31, 2007. In addition, the Group recognised an impairment loss of US$19,156,000 against goodwill (see note 12).
The restructuring included the following elements:
the rationalisation of the Haemostasis and Infectious Diseases reagent and instrumentation product lines;
the reorganisation of the US sales force;
the closure of the Group’s operation in Sweden;
the streamlining of the Group’s development activities and,
a redundancy programme to reduce headcount across the Group.

 

84


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
The impact of the above items on the statement of operations for the year ended December 31, 2007 was as follows:
             
  Impairment       
  Loss  Restructuring  Total 
Year Ended 31 December 2007 US$’000  US$’000  US$’000 
Cost of sales
            
Inventory provision(a) (c)
     11,772   11,772 
Termination payments(c) (d)
     953   953 
          
      12,725   12,725 
          
Research & development
            
Write-off of capitalised development and license costs(b)
     6,667   6,667 
Termination payments(c) (d)
     240   240 
          
      6,907   6,907 
          
Selling, general & administration expenses
            
Impairment of goodwill (note 12)  19,156      19,156 
Termination payments(c) (d)
     842   842 
Lease obligation provision(c)
     116   116 
Other     201   201 
          
   19,156   1,159   20,315 
          
             
Total inventory write off, restructuring expenses and goodwill impairment before tax
  19,156   20,791   39,947 
Income tax impact of inventory write off, restructuring expenses and goodwill impairment (note 9)            
      (1,584)  (1,584)
          
Total inventory write off, restructuring expenses and goodwill impairment after tax
  19,156   19,207   38,363 
          
The non cash element of the restructuring expenses amounted to US$18,573,000 and the goodwill impairment of US$19,156,000 also had no cash impact.
(a)2. Under the 2007SEGMENT INFORMATION (CONTINUED)
The Board of Directors announced a restructuring plan, Trinity Biotech undertook to reduce the number of products and instruments within the two key product lines of Haemostasis and Infectious Diseases. The purpose of the rationalisation was to reduce complexitybusiness in the business, to improve sellingDecember 2008, which resulted in certain one-off expenditure being incurred. These termination payments and operating efficiencies and to eliminate low revenue generating products. As a result, the Group recognisedother restructuring costs resulted in an after tax charge of US$11,772,000, including US$147,000 in respect of the closure of the Swedish operation1.9 million (see note (c)), for inventory written off relating to those Haemostasis and Infectious Diseases products and instruments being rationalised for the year ended December 31, 2007.28).
 
(b)j) The Group decided to terminate or suspend a numberdistribution of product development projects, which resulted in a write-off of capitalised developmentinterest income and license costs for the year ended December 31, 2007 of US$6,667,000.interest expense by geographical area was as follows:
Under IFRS the Group writes off research and development expenditure as incurred, with the exception of expenditure on projects whose outcome has been assessed with reasonable certainty as to technical feasibility, commercial viability and recovery of costs through future revenues. Such expenditure is capitalised at cost within intangible assets as development costs. Factors which impact our judgement to capitalise certain research and development expenditure include the degree of regulatory approval for products and the results of any market research to determine the likely future commercial success of products being developed. We review these factors each year to determine whether our previous estimates as to feasibility, viability and recovery should be changed.
                     
      Rest of World       
Interest Income Americas  Ireland  Other  Eliminations  Total 
Year ended December 31, 2010 US$‘000  US$‘000  US$‘000  US$’000  US$‘000 
                     
Interest Income Earned     910         910 
Interest on Deferred Consideration  98   344         442 
Inter-segment Interest Income     428      (428)   
                
Total revenue  98   1,682      (428)  1,352 
                
                     
      Rest of World       
Interest Expense Americas  Ireland  Other  Eliminations  Total 
Year ended December 31, 2010 US$‘000  US$‘000  US$‘000  US$’000  US$‘000 
                     
Interest Expense  85   410         495 
Inter-segment Interest Expense  73   355      (428)   
                
Total revenue  158   765      (428)  495 
                
                     
      Rest of World       
Interest Income Americas  Ireland  Other  Eliminations  Total 
Year ended December 31, 2009 US$‘000  US$‘000  US$‘000  US$’000  US$‘000 
                     
Interest Income Earned     6   2      8 
Inter-segment Interest Income     1,157      (1,157)   
                
Total revenue     1,163   2   (1,157)  8 
                
                     
      Rest of World       
Interest Expense Americas  Ireland  Other  Eliminations  Total 
Year ended December 31, 2009 US$‘000  US$‘000  US$‘000  US$’000  US$‘000 
                     
Interest Expense  11   1,178   3      1,192 
Inter-segment Interest Expense  184   973      (1,157)   
                
Total revenue  195   2,151   3   (1,157)  1,192 
                
                     
      Rest of World       
Interest Income Americas  Ireland  Other  Eliminations  Total 
Year ended December 31, 2008 US$‘000  US$‘000  US$‘000  US$’000  US$‘000 
                     
Interest Income Earned  1   62   2      65 
Inter-segment Interest Income     2,038      (2,038)   
                
Total revenue  1   2,100   2   (2,038)  65 
                

 

85


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
In December 2007, the Group announced its decision to focus on a smaller number of R&D projects, with a particular focus on projects which will make the greatest contribution to the strategic growth and development of the Group. Consequently, it was decided to terminate or suspend a number of projects. As a result, US$5,134,000 of development costs were written off for the year ended December 31, 2007. The write off of capitalised developments costs in 2007 related to a number of specific projects, the two most significant being the HIV over-the-counter (OTC) product and the development of the HIV Western Blot confirmatory test which accounts for US$2,772,000 of the total amount of capitalised development costs written off of US$5,134,000. The decision to suspend the HIV OTC project was based on an assessment of expected market size for this product. The Group’s market assessment, carried out in 2007, indicated that the market opportunity for this product was significantly less than was originally envisaged. The Group’s decision to suspend the development of its HIV Western Blot confirmatory test was also due to changes in the marketplace. The remaining development projects, which account for US$2,631,000 of the total capitalised development costs being written off in 2007 resulted from the strategic decision made by the Group in 2007 to focus on a smaller number of R&D projects.
Based on the decision to suspend a number of projects, US$439,000 was also written off for license costs which were capitalised in prior years. These license costs related to projects which have been written off in the year ended December 31, 2007.
A further of US$1,094,000 was written off technology intangible assets acquired from bioMerieux. This represented the portion of such assets which related to instruments and reagents which were being culled as part of the 2007 restructuring (see note 12).
(c)2. SEGMENT INFORMATION (CONTINUED)
                     
      Rest of World       
Interest Expense Americas  Ireland  Other  Eliminations  Total 
Year ended December 31, 2008 US$‘000  US$‘000  US$‘000  US$‘000  US$‘000 
                     
Interest Expense  5   2,147   8      2,160 
Inter-segment Interest Expense  330   1,708      (2,038)   
                
Total revenue  335   3,855   8   (2,038)  2,160 
                
k)The distribution of taxation (expense)/credit by geographical area was as follows:
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
Rest of World — Ireland  591   (1,023)  3,716 
Rest of World — Other  (815)  200   9 
Americas  (718)  (268)  167 
          
   (942)  (1,091)  3,892 
          
l)During 2010, 2009 and 2008 there were no customers generating 10% or more of total revenues.
m)The distribution of capital expenditure by geographical area was as follows:
         
  December 31, 2010  December 31, 2009 
  US$‘000  US$‘000 
Rest of World — Ireland  4,077   6,816 
Rest of World — Other  598   670 
Americas  3,923   3,071 
       
   8,598   10,557 
       
3.NET GAIN ON DIVESTMENT OF BUSINESS AND RESTRUCTURING EXPENSES
In May 2010, the Group sold its worldwide Coagulation business to Diagnostica Stago for US$89.9 million. Diagnostica Stago purchased the share capital of Trinity Biotech (UK Sales) Limited, Trinity Biotech GmbH and Trinity Biotech S.à.r.l, along with Coagulation assets of Biopool US Inc. and Trinity Biotech Manufacturing Limited. As part of the restructuring announced in December 2007, Trinity Biotech decided to close its manufacturing facility located in Umea, Sweden. This facility manufactured a portion of the Group’s Haemostasis products and was acquired as part of the Biopool AB acquisition in 2001. The manufacture of these products was transferred to the Group’s Irish and US facilities during 2008. As part of the closure of this facility,sale, the Group recognised an inventory write offalso transferred the leasing arrangements of US$147,000 and a write downone of property, plant and equipment of US$42,000. A total of US$448,000 was accrued at December 31, 2007 which consisted of termination payments of US$332,000, and lease obligations of US$116,000.
(d)The reductionits facilities in Bray, Ireland to Diagnostica Stago. Included in the numbersale are Trinity’s lists of products, the more focused R&D approachcoagulation customers and the closure of the Swedish operation enabled the Group to reduce its workforcesuppliers, all coagulation inventory, intellectual property and consequently total redundancy costs of US$1,470,000 were accrued for at December 31, 2007 (see note 22).developed technology.
4. FINANCIAL INCOME AND EXPENSESThe Group received consideration of US$67.4 million and interest on deferred consideration of US$1.0 million in 2010. These proceeds were used in part to repay the Group’s bank loans in 2010 and accordingly there were no bank loans outstanding at December 31, 2010. A further US$11.25 million will be received from Diagnostica Stago in May 2011 (see note 16) and the remaining US$11.25 million will be received in May 2012 (see note 14). These amounts are recognised net of deferred interest. No conditions or earnout provisions will apply to this deferred element of the consideration, which is supported by a bank guarantee.
                 
      December 31, 2008  December 31, 2007  December 31, 2006 
  Note  US$’000  US$’000  US$’000 
                 
Financial income:                
Interest income      65   457   1,164 
              
                 
Financial expense:                
Finance lease interest      (123)  (65)  (27)
Interest payable on interest bearing loans and borrowings  20   (1,912)  (2,834)  (2,167)
Convertible note interest  21         (278)
Other interest expense      (125)  (249)  (181)
              
       (2,160)  (3,148)  (2,653)
              
Net Financing Costs      (2,095)  (2,691)  (1,489)
              
Other interest expense recognised in 2008, 2007 and 2006 mainly comprises an interest expense arising from the discounting of the deferred consideration payable to bioMerieux, resulting from the acquisition of the haemostasis business during 2006, to reflect the present value of this additional consideration, see note 23.
IFRS 5 (Non-current Assets Held for Sale and Discontinued Operations) outlines the disclosures required for a discontinued operation. However, the coagulation business falls outside of these criteria, principally owing to the fact that it is not defined as a component of the Group. A component is defined by IFRS 5 as “operations and cashflows that can be clearly distinguished, operationally and for financial reporting purposes, from the rest of the entity.” The Group has determined that neither the operations nor the cashflows of the coagulation business could be clearly distinguished, operationally or from a financial reporting viewpoint and therefore, on that basis, the coagulation business does not meet the definition of a discontinued operation.

 

86


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
5.3. OTHER OPERATING INCOMENET GAIN ON DIVESTMENT OF BUSINESS AND RESTRUCTURING EXPENSES (CONTINUED)
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’000 
             
Rental income from premises  237   233   204 
Employment / training grants  936   180   71 
          
   1,173   413   275 
          
Accordingly, the Group has disclosed the Gain on Sale under the heading ‘Net gain on divestment of business and restructuring expenses’ in the income statement, where it is shown net of termination expenses of US$301,000 (see note 7). The Gain on divestment is also shown separately within the Segment Information note as required by IFRS 8 (Operating Segments) where appropriate (see note 2).
6. (LOSS)/ PROFIT BEFORE TAXThe gain on the divestment is summarised below according to the assets and liabilities which were divested in May 2010 as part of the sale. The assets and liabilities divested have been cross-referenced throughout this document in order to provide a clearer understanding of the movements which have occurred in the current financial year. The effect of the divestment is summarised as follows:
The following amounts were charged / (credited) to the statement of operations:
         
  2010  2010 
  US$’000  US$’000 
Total Consideration      89,923 
         
Property, plant and equipment (net book value)  6,775     
Goodwill and intangible assets  12,270     
Deferred tax assets  123     
Inventories (net)  21,528     
Trade and other receivables  6,211     
Cash and cash equivalents  427     
Interest bearing loans and borrowings  (2,825)    
Income tax payable  (70)    
Trade and other payables  (3,463)    
Deferred Tax Liabilities  (183)    
Net identifiable assets disposed  40,793   (40,793)
   
Other Costs associated with the Divestiture of Coagulation      (2,355)
Net gain on divestment of business
      46,775 
Restructuring Expenses*
      (301)
Net gain on divestment of business and restructuring expenses
      46,474 
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’000 
Directors’ emoluments (including non- executive directors):            
Remuneration  1,617   2,370   2,213 
Pension  241   147   119 
Compensation for loss of office  1,283       
Share based payments  776   920   732 
Other  44       
Auditors’ remuneration            
Audit fees  809   1,544   629 
Non audit fees  31   77   50 
Depreciation — leased assets  372   260   120 
Depreciation — owned assets  4,053   4,081   3,616 
Amortisation  3,616   3,418   2,687 
(Profit) / loss on the disposal of property, plant and equipment  (682)  16   (2)
Net foreign exchange differences  (224)  68   (240)
Operating lease rentals:            
Plant and machinery  31   38   85 
Land and buildings  4,421   3,798   2,838 
Other equipment  437   407   240 
7. PERSONNEL
*The Restructuring Expenses relate to termination payments resulting from a restructuring programme announced in 2010 (see note 7).
4.FINANCIAL INCOME AND EXPENSES
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’000 
             
Wages and salaries  48,755   48,385   42,113 
Social welfare costs  5,338   5,118   4,407 
Pension costs  1,442   1,388   987 
Share-based payments  1,166   1,403   1,141 
          
   56,701   56,294   48,648 
          
Personnel expenses are shown net of capitalisations. Total personnel expenses (wages and salaries, social welfare costs and pension costs), inclusive of amounts capitalised, for the year ended December 31, 2008 amounted to US$61,644,000 (2007: US$60,502,000) (2006: US$49,647,000). Total share based payments, inclusive of amounts capitalised in the balance sheet, amounted to US$1,193,000 for the year ended December 31, 2008 (2007: US$1,482,000) (2006: US$1,262,000). See note 19.
Included in personnel expenses for the year ended December 31, 2008 is US$589,000 which relates to termination payments resulting from the restructuring announced in December 2008 (see note 3).
               
    December 31, 2010  December 31, 2009  December 31, 2008 
  Note US$‘000  US$‘000  US$‘000 
Financial income:              
Interest income    910   8   65 
Other interest income    442       
            
     1,352   8   65 
            
               
Financial expense:              
Finance lease interest    (67)  (135)  (123)
Interest payable on interest bearing loans and borrowings 20  (425)  (1,053)  (1,912)
Other interest expense    (3)  (4)  (125)
            
     (495)  (1,192)  (2,160)
            
Net Financing Income/(expense)    857   (1,184)  (2,095)
            

 

87


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
The average number of persons employed by the Group in the financial year was 757 (2007: 802) (2006: 794) and is analysed into the following categories:
             
  December 31,  December 31,  December 31, 
  2008  2007  2006 
Research and development  57   51   44 
Administration and sales  261   268   246 
Manufacturing and quality  439   483   504 
          
   757   802   794 
          
8.4. PENSION SCHEMEFINANCIAL INCOME AND EXPENSES (CONTINUED)
The Group operates defined contribution pension schemes for certain of its full time employees. The benefits under these schemes are financed by both Group and employee contributions. Total contributions made by the Group in the financial year and charged against income amounted to US$1,442,000 (2007: US$1,388,000) (2006: US$987,000) (note 7). The pension accrual for the Group at December 31, 2008 was US$332,000 (2007: US$NIL), (2006: US$NIL).
Other interest income recognised in 2010 is entirely comprised of interest income relating to the deferred consideration of US$22,500,000 due to the Company as a result of the sale of the Coagulation product line in 2010. For further information, see Note 3.
Other interest expense recognised in 2008 mainly comprises an interest expense arising from the discounting of the deferred consideration payable to bioMerieux, resulting from the acquisition of the Coagulation business during 2006, to reflect the present value of this additional consideration.
5.OTHER OPERATING INCOME
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
             
Rental income from premises  213   222   237 
Employment / training grants  (50)  215   936 
Other income  1,453       
          
   1,616   437   1,173 
          
As part of the divestiture of the Coagulation business in May 2010, the Group entered into a Transitional Services Agreement (TSA) with Diagnostica Stago. The services provided by the Group to Stago under the TSA comprise mainly: accounting; information technology and logistics support and warehousing services.
Other income therefore, mainly comprises income recognised under the TSA. This income has not been treated as revenue since the TSA activities are incidental to the main revenue-generating activities of the Group.
6.PROFIT/(LOSS) BEFORE TAX
The following amounts were charged / (credited) to the statement of operations:
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
Directors’ emoluments (including non-executive directors):            
Remuneration  2,082   1,271   1,617 
Pension  127   105   241 
Share based payments  592   422   776 
Compensation for loss of office        1,283 
Other  39      44 
Auditors’ remuneration            
Audit fees  628   764   809 
Non audit fees  31   21   31 
Depreciation — leased assets  84   87   372 
Depreciation — owned assets  1,146   1,699   4,053 
Amortisation  1,589   1,959   3,616 
Gain on divestiture of Coagulation business  46,775       
Loss/(profit) on the disposal of property, plant and equipment  12   66   (682)
Net foreign exchange differences  1,119   32   (224)
Operating lease rentals:            
Plant and machinery  5   15   31 
Land and buildings  3,211   3,727   4,421 
Other equipment  130   339   437 
             

 

88


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
7.PERSONNEL EXPENSES
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
             
Wages and salaries  25,491   39,967   48,755 
Social welfare costs  2,279   4,237   5,338 
Pension costs  897   1,350   1,442 
Share-based payments  1,109   521   1,166 
          
   29,776   46,075   56,701 
          
Personnel expenses are shown net of capitalisations. Total personnel expenses (wages and salaries, social welfare costs and pension costs), inclusive of amounts capitalised, for the year ended December 31, 2010 amounted to US$32,506,000 (2009: US$50,459,000) (2008: US$61,644,000). Total share based payments, inclusive of amounts capitalised in the balance sheet, amounted to US$1,240,000 for the year ended December 31, 2010 (2009: US$599,000) (2008: US$1,193,000). See note 19.
Included in personnel expenses for the year ended December 31, 2010 is US$301,000 which relates to termination payments resulting from a restructuring programme announced in 2010. This programme involved a re-organisation of the Group’s HIV manufacturing activities and comprised termination payments for employees located in Ireland. This restructuring cost is included within Net gain on divestment of business and restructuring expenses, on the face of the income statement.
Included in personnel expenses for the year ended December 31, 2008 is US$589,000 which relates to termination payments resulting from the restructuring announced in December 2008 (see note 28).
The average number of persons employed by the Group in the financial year was 452 (2009: 676) (2008: 757) and is analysed into the following categories:
             
  December 31,  December 31,  December 31, 
  2010  2009  2008 
             
Research and development  37   61   57 
Administration and sales  130   189   261 
Manufacturing and quality  285   426   439 
          
   452   676   757 
          
The reduction in average headcount is mainly due to the fact that 321 employees transferred to the acquirer of the Coagulation business (Diagnostica Stago) in May 2010. These employees have been included in the average headcount numbers on a pro-rata basis up to their date of departure.
8.PENSION SCHEMES
The Group operates defined contribution pension schemes for certain of its full time employees. The benefits under these schemes are financed by both Group and employee contributions. Total contributions made by the Group in the financial year and charged against income amounted to US$897,000 (2009: US$1,350,000) (2008: US$1,442,000) (note 7). The pension accrual for the Group at December 31, 2010 was US$228,000 (2009: US$309,000), (2008: US$332,000).

89


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
9. INCOME TAX (CREDIT)EXPENSE / EXPENSE(CREDIT)
(a) The charge for tax based on the (loss)profit / profit(loss) comprises:
                        
 December 31, 2008 December 31, 2007 December 31, 2006  December 31, 2010 December 31, 2009 December 31, 2008 
 US$’000 US$’000 US$’000  US$‘000 US$‘000 US$‘000 
Current tax expense
  
Corporation tax at 12.5% 58 60 519  629 75 58 
Manufacturing relief    (49)
       
 58 60 470 
Overseas tax (a) 35 114 25  356 46 35 
Adjustment in respect of prior years (b)  (33)  (67)  (290)  (138)  (120)  (33)
              
Total current tax expense 60 107 205  847 1 60 
              
  
Deferred tax (credit) / expense(c)
 
Deferred tax expense / (credit)(c)
 
Origination and reversal of temporary differences (see note 13)  (3,858)  (1,042)  (107) 380 1,354  (3,858)
Origination and reversal of net operating losses (see note 13)  (94) 4,244  (2,922)  (285)  (264)  (94)
              
Total deferred tax (credit) / expense  (3,952) 3,202  (3,029)
Total deferred tax expense / (credit) 95 1,090  (3,952)
              
  
Total income tax (credit) / charge in income statement (d)  (3,892) 3,309  (2,824)
Total income tax charge / (credit) in income statement (d) 942 1,091  (3,892)
              
   
(a) The overseas tax charge in 2008, 20072010, 2009 and 20062008 relates primarily to US State Taxes.
 
(b) The credit in 2010 relates to the claim for Irish Research and Development Tax Credits (“R&D tax credits”) in respect of the year ended December 31, 2009. The credit in 2009 arises in respect of the finalisation of a claim for Irish Research and Development Tax Credits in respect of the year ended December 31, 2008 and the refund of US state taxes. The credit in 2008 relates primarily to the release of a provision for US State taxes at December 31, 2007 which was not considered to be required. The credit in 2007 principally arises in respect of the finalisation of a claim for Irish Research and Development Tax Credits (“R&D tax credits”) in respect of the year ended December 31, 2006. The credit in 2006 of US$290,000 relates primarily to the release of US$200,000 that had been provided at December 31, 2005 which was not considered to be required at December 31, 2006. The remaining US$90,000 principally arises in respect of the finalisation of a claim for R&D tax credits in respect of the year ended December 31, 2005.
 
(c) In 20082010 there was a deferred tax credit of US$1,093,000 (2009: US$1,015,000 charge; 2008: US$3,744,000 (2007: US$538,000)credit) recognised in respect of Ireland. In 2008 there wasIreland and a deferred tax creditcharge of US$1,188,000 (2009: US$75,000 charge; 2008: US$208,000 (2007: US$3,740,000 expense)credit) recognised in respect of overseas tax jurisdictions.
 
(d) In 2008 the impairment charge and restructuring charges had a significant impact on the income tax (credit)/charge in those financial years. The tax credit in 2008 includes a deferred tax credit of US$4,536,000 relating to the impairment and a deferred tax credit of US$215,000 relating to the restructuring (see note 3)28). The income tax charge in 2007 includes a deferred tax credit of US$1,584,000 relating to the restructuring (see note 3). The income tax charge in 2007 also includes a tax expense of US$3,780,000 relating to the derecognition of deferred tax assets previously recognised, which primarily arose on tax losses carried forward in the Group’s US operations. The derecognition of these deferred tax assets was considered appropriate in light of the increased tax losses caused by the restructuring and uncertainty over the timing of the utilisation of the tax losses.
             
  December 31, 2008  December 31, 2007  December 31, 2006 
Effective tax rate US$’000  US$’000  US$’000 
(Loss) / profit before taxation  (81,670)  (32,063)  452 
As a percentage of (loss) / profit before tax:            
Current tax  0.07%  (0.34%)  46.32%
Total (current and deferred)  4.76%  (10.32%)  (625.44)%

89


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
The following table reconciles the applicable Republic of Ireland statutory tax rate to the effective total tax rate for the Group:
             
  December 31, 2008  December 31, 2007  December 31, 2006 
Irish corporation tax  12.50%  12.50%  12.50%
Manufacturing relief        (10.76%)
Adjustments in respect of prior years  0.04%  0.21%  (64.15%)
Effect of tax rates on overseas earnings  1.67%  5.08%  (529.98%)
Effect of non deductible expenses  (6.48%)  (8.24%)  43.90%
Effect of current year net operating losses and temporary differences for which no deferred tax asset was recognised  (3.21%)  (9.00%)   
Effect of derecognition of deferred tax assets relating to loss carryforwards and temporary differences at the start of the period     (11.79%)   
Effect of benefit of loss carryforwards        (25.18%)
Effect of Irish income taxable at higher tax rate  (0.05%)  (0.13%)  2.44%
R&D tax credit  0.29%  1.05%  (54.21%)
          
Effective tax rate  4.76%  (10.32%)  (625.44%)
Deferred tax recognised directly in equity
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’000 
Relating to forward contracts as hedged instruments  26   23   4 
          
   26   23   4 
(b)The distribution of (loss)/profit before taxes by geographical area was as follows:
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’000 
Rest of World — Ireland  (59,917)  (23,143)  9,585 
Rest of World — Other  (4,395)  (2,182)  (1,855)
Americas  (17,358)  (6,738)  (7,278)
          
   (81,670)  (32,063)  452 
          
(c)At December 31, 2008, the Group had unutilised net operating losses as follows:
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’000 
USA  10,167   9,158   8,138 
France  1,812   1,085   264 
Germany  3,245   3,540   2,320 
Ireland  290   290   290 
UK  197   160   580 
          
   15,711   14,233   11,592 
          
The utilisation of these net operating loss carryforwards is limited to future profits in the USA, France, Germany, Ireland and the UK. The US net operating loss has a maximum carryforward of 20 years. US$3,043,000 of the net operating losses in the USA will expire by December 31, 2024, US$5,095,000 will expire by December 31, 2026, US$1,316,000 will expire by December 31, 2027 and US$713,000 will expire by December 31, 2028. The French, German, Irish and UK net operating losses can be carried forward indefinitely.
             
  December 31, 2010  December 31, 2009  December 31, 2008 
Effective tax rate US$‘000  US$‘000  US$‘000 
Profit/(loss) before taxation  61,360   12,915   (81,670)
As a percentage of profit/(loss) before tax:            
Current tax  1.38%  0.00%  0.07%
Total (current and deferred)  1.53%  8.45%  4.76%

 

90


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
At December 31, 2008, the Group recognised a deferred tax asset of US$133,000 (2007: US$203,000) in respect of net operating loss carryforwards in Germany and the UK, as there are sufficient taxable temporary differences relating to the same taxation authority and the same taxable entity which will result in taxable amounts against which the unused tax losses can be utilised before they expire. The utilisation of these net operating loss carryforwards is limited to future profits in Germany and the UK.
At December 31, 2008, the Group had unrecognised deferred tax assets in respect of unused tax losses, unused tax credits and deductible temporary differences as follows:
             
  December 31, 2008  December 31, 2007  December 31, 2006 
  US$’000  US$’000  US$’ 000 
USA — unused tax losses  4,126   3,717    
Germany — unused tax losses  866   945    
France — unused tax losses  598   290   87 
Ireland — unused tax losses  73   73    
USA — unused tax credits  346   314   185 
USA—deductible temporary differences  3,464   1,600     
          
Unrecognised Deferred Tax Asset  9,473   6,939   272 
          
A deferred tax asset of US$4,126,000 (2007: US$3,717,000) in respect of net operating losses in the USA, US$866,000 (2007: US$945,000) in respect of net operating losses in Germany, US$598,000 (2007: US$290,000) in respect of net operating losses in France and US$73,000 (2007: US$73,000) in respect of net operating losses in Ireland were not recognised at December 31, 2008 due to uncertainties regarding full utilisation of these losses in the related tax jurisdiction in future periods (see note 13). The Group has US state credit carryforwards of US$346,000 at December 31, 2008 (2007: US$314,000). A deferred tax asset of US$346,000 (2007: US$314,000) in respect of US state credit carryforwards was not recognised in 2008 due to uncertainties regarding future full utilisation of these state credit carryforwards in the related tax jurisdiction in future periods. Excepting state credit carryforwards of US$5,000 which expire by December 31, 2009, the balance of the state credits carry forward indefinitely.
(d)9. There are no incomeINCOME TAX EXPENSE / (CREDIT) (CONTINUED)
The following table reconciles the applicable Republic of Ireland statutory tax consequencesrate to the effective total tax rate for the Company attaching toGroup:
             
  December 31, 2010  December 31, 2009  December 31, 2008 
Irish corporation tax  12.50%  12.50%  12.50%
Adjustments in respect of prior years  (0.22%)  (0.93%)  0.04%
Effect of tax rates on overseas earnings  3.89%  25.30%  1.67%
Effect of non deductible expenses  0.32%  1.09%  (6.48%)
Effect of current year net operating losses and temporary differences for which no deferred tax asset was recognised  (5.55%)  (30.66%)  (3.21%)
R&D tax credit  (0.06%)     0.29%
          
Effect of Irish income taxable at higher tax rate (a)  (9.35%)  1.15%  (0.05%)
          
Effective tax rate  1.53%  8.45%  4.76%
(a)In 2010 the payment of dividends by Trinity Biotech plc to shareholdersIrish income taxable at a higher tax rate has a negative effect on the overall corporation tax rate. This is because the gain arising on sale of the Company.assets and liabilities of the coagulation business in Ireland, which is taxable at the higher tax rate of 25%, resulted in a capital loss and consequently no capital gains tax is payable. For further information see Note 3.
The effect of current year net operating losses and temporary differences for which no deferred tax asset was recognized is analyzed further in the table below (see also note 13). No deferred tax asset was recognized because there was no reversing deferred tax liability in the same jurisdiction reversing in the same period and no future taxable income in the same jurisdiction.
                 
  Effect in  Percentage  Effect in  Percentage 
  2010  effect in  2009  effect in 
Unrecognised deferred tax assets US$’000  2010  US$’000  2009 
Temporary differences arising in USA  (387)  (0.63%)  (3,076)  (23.83%)
Net operating losses arising in USA  (3,059)  (4.99%)  (1,055)  (8.16%)
Net operating losses arising in Ireland  104   0.17%      
Net operating losses arising in France  (89)  (0.14%)  263   2.03%
Net operating losses arising in Germany  26   0.04%  (588)  (4.55%)
             
   (3,405)  (5.55%)  (4,456)  (34.52%)
             
Group Unrecognised deferred tax assets  0   0.0%  348   2.69%
Change in tax rates  0   0.0%  149   1.15%
             
Total  (3,405)  (5.55%)  (3,959)  (30.66%)
             
Deferred tax recognised directly in equity
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
Relating to forward contracts as hedged instruments  6   3   26 
          
   6   3   26 

 

91


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
10.9. (LOSS)INCOME TAX EXPENSE / EARNINGS PER SHARE(CREDIT) (CONTINUED)
Basic (loss)/ earnings per ordinary share
Basic (loss)/ earnings per ordinary share for the Group is computed by dividing the loss after taxation of US$77,778,000 (2007: loss after tax of US$35,372,000) (2006: profit after tax of US$3,276,000) for the financial year by the weighted average number of ‘A’ ordinary and ‘B’ ordinary shares in issue of 81,394,075 (2007: 76,036,579) (2006: 70,693,753). 1,400,000 of the total weighted average shares used as the EPS denominator relate to the 700,000 ‘B’ ordinary shares in issue. In all respects these shares are treated the same as ‘A’ ordinary shares except for the fact that they have two voting rights per share, rights to participate in any liquidation or sale of the Group and to receive dividends as if each Class ‘B’ ordinary share were two Class ‘A’ ordinary shares. Hence the (loss)/ earnings per share for a ‘B’ ordinary share is exactly twice the (loss)/ earnings per share of an ‘A’ ordinary share.
             
  December 31,  December 31,  December 31, 
  2008  2007  2006 
             
‘A’ ordinary shares  79,994,075   74,636,579   69,293,753 
‘B’ ordinary shares (multiplied by 2)  1,400,000   1,400,000   1,400,000 
          
Basic (loss)/ earnings per share denominator  81,394,075   76,036,579   70,693,753 
          
             
Reconciliation to weighted average earnings per share denominator:
            
Number of A ordinary shares at January 1 (note 18)  74,756,765   73,601,497   60,041,521 
Number of B ordinary shares at January 1 (multiplied by 2)  1,400,000   1,400,000   1,400,000 
Weighted average number of shares issued during the year  5,237,310   1,035,082   9,252,232 
          
Basic (loss)/ earnings per share denominator  81,394,075   76,036,579   70,693,753 
          
The weighted average number of shares issued during the year is calculated by taking the number of shares issued by the number of days in the year each share is in issue divided by 365 days.
Diluted (loss)/ earnings per ordinary share
Diluted (loss)/ earnings per ordinary share is computed by dividing the loss after tax of US$77,778,000 (2007: loss after tax of US$35,372,000) (2006: profit after tax of US$3,276,000) for the financial year by the diluted weighted average number of ordinary shares in issue of 81,394,075 (2007: 76,036,579) (2006: 72,125,740).
The basic weighted average number of shares for the Group may be reconciled to the number used in the diluted (loss)/ earnings per ordinary share calculation as follows:
             
  December 31,  December 31,  December 31, 
  2008  2007  2006 
             
Basic (loss)/ earnings per share denominator (see above)  81,394,075   76,036,579   70,693,753 
Issuable on exercise of options and warrants        1,431,987 
          
Diluted (loss)/ earnings per share denominator *  81,394,075   76,036,579   72,125,740 
          
 a. The distribution of profit/(loss) before taxes by geographical area was as follows:
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
Rest of World — Ireland  38,161   5,240   (59,917)
Rest of World — Other  10,411   (1,206)  (4,395)
Americas  12,788   8,881   (17,358)
          
   61,360   12,915   (81,670)
          
*b. At December 31, 2008,2010, the numberGroup had unutilised net operating losses as follows:
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
USA  1,841   7,569   10,167 
Ireland  999   1,918   290 
France     2,368   1,812 
Germany     1,152   3,245 
UK     101   197 
          
   2,840   13,108   15,711 
          
The utilisation of shares issuablethese net operating loss carryforwards is limited to future profits in the USA and Ireland. The US net operating loss has a maximum carryforward of 20 years. US$847,000 will expire by December 31, 2026 and US$994,000 will expire by December 31, 2027. The Irish net operating losses can be carried forward indefinitely.
The unutilised net operating losses in France, Germany and UK were transferred to Diagnostica Stago on the exerciseApril 30, 2010 following their purchase of optionsTrinity Biotech S.à.r.l., Trinity Biotech GmbH and warrants is not dilutive.Trinity Biotech (UK Sales) Limited respectively. At December 31, 2007,2009, the numberGroup recognised a deferred tax asset of shares issuable onUS$96,000 (2008: US$133,000) in respect of net operating loss carryforwards in Germany and the exerciseUK, as there were sufficient taxable temporary differences relating to the same taxation authority and the same taxable entity which would result in taxable amounts against which the unused tax losses could be utilised before they expire.
At December 31, 2010, the Group had unrecognised deferred tax assets in respect of optionsunused tax losses, unused tax credits and warrants was anti-dilutive and hencedeductible temporary differences as follows:
             
  December 31, 2010  December 31, 2009  December 31, 2008 
  US$‘000  US$‘000  US$‘000 
USA — unused tax losses     3,071   4,126 
Germany — unused tax losses     427   866 
France — unused tax losses     861   598 
Ireland — unused tax losses  177   73   73 
USA — unused tax credits  358   346   346 
USA—deductible temporary differences     387   3,464 
          
Unrecognised Deferred Tax Asset  535   5,165   9,473 
          
The accounting policy for deferred tax is to calculate the diluted (loss)/ earnings per share was calculated excludingdeferred tax asset that is deemed recoverable, considering all sources for future taxable profits. The deferred tax assets in the number of shares issuable on the exercise of options and warrants. If the number of shares issuable on the exercise of options and warrants hadabove table have not been anti-dilutive, 1,854,825 shares issuable onrecognized due to uncertainty regarding the exercisefull utilization of options and warrants would have been includedthese losses in the diluted (loss)/ earnings per share denominatorrelated tax jurisdiction in 2007. The afterfuture periods. Only when it is probable that future profits will be available to utilize the forward losses or temporary differences is a deferred tax effect ofasset recognized. When there is a reversing deferred tax liability in that jurisdiction that reverses in the interest saving on convertible notessame period, the deferred tax asset is nil in 2007 asrestricted so that it equals the final interest payment on the convertibles notes was paid on January 2, 2007.reversing deferred tax liability.

 

92


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
The after tax effect of the interest saving on convertible notes for 2006 was anti-dilutive and hence the diluted earnings per share has been calculated excluding the after tax effect of the interest saving on the convertible notes of US$208,000 in 2006. If the after tax effect on interest saving on convertible notes had not been anti-dilutive, 2,209,506 shares issuable on the conversion of convertible notes would have been included in the diluted earnings per share denominator in 2006.
9.INCOME TAX EXPENSE / (CREDIT) (CONTINUED)
At December 31, 2009 a deferred tax asset of US $3,071,000 (2008 : US$4,126,000) in respect of net operating losses in the US and US$387,000 (2008: US$3,464,000) in respect of temporary differences in the US were not recognised because the deferred tax asset was restricted in order that it equalled the reversing deferred tax liability in the US. The net operating losses in the USA have reduced significantly in 2010, mainly due to the profit earned on the sale of the coagulation business. The reduction in net operating losses has resulted in the deferred tax asset being less than the reversing deferred tax liability. As a result, the unrecognised deferred tax assets in respect of unused tax losses and temporary differences have reduced to nil at December 31, 2010.
The Group has US state credit carryforwards of US$358,000 at December 31, 2010 (2009: US$346,000). A deferred tax asset of US$358,000 (2009: US$346,000) in respect of US state credit carryforwards was not recognised in 2010 due to uncertainties regarding future full utilisation of these state credit carryforwards in the related tax jurisdiction in future periods. Unused tax losses in respect of Germany and France have been transferred to Diagnostica Stago following their purchase of the Group’s German and French subsidiaries in 2010.
10.EARNINGS/(LOSS) PER SHARE
Basic earnings/(loss) per ordinary share
Basic earnings/(loss) per ordinary share for the Group is computed by dividing the profit after taxation of US$60,418,000 (2009: profit after tax of US$11,824,000) (2008: loss after tax of US$77,778,000) for the financial year by the weighted average number of ‘A’ ordinary and ‘B’ ordinary shares in issue of 84,734,378 (2009: 83,737,884) (2008: 81,394,075). 1,400,000 of the total weighted average shares used as the EPS denominator relate to the 700,000 ‘B’ ordinary shares in issue. In all respects these shares are treated the same as ‘A’ ordinary shares except for the fact that they have two voting rights per share, rights to participate in any liquidation or sale of the Group and to receive dividends as if each Class ‘B’ ordinary share were two Class ‘A’ ordinary shares. Hence the earnings/(loss) per share for a ‘B’ ordinary share is exactly twice the earnings/ (loss) per share of an ‘A’ ordinary share.
             
  December 31,  December 31,  December 31, 
  2010  2009  2008 
   
‘A’ ordinary shares  83,334,378   82,337,884   79,994,075 
‘B’ ordinary shares (multiplied by 2)  1,400,000   1,400,000   1,400,000 
          
Basic earnings/ (loss) per share denominator  84,734,378   83,737,884   81,394,075 
          
             
Reconciliation to weighted average earnings per share denominator:
            
Number of A ordinary shares at January 1 (note 18)  82,952,037   82,017,581   74,756,765 
Number of B ordinary shares at January 1 (multiplied by 2)  1,400,000   1,400,000   1,400,000 
Weighted average number of shares issued during the year  382,341   320,303   5,237,310 
          
Basic earnings/ (loss) per share denominator  84,734,378   83,737,884   81,394,075 
          
The weighted average number of shares issued during the year is calculated by taking the number of shares issued multiplied by the number of days in the year each share is in issue divided by 365 days.
Diluted earnings/ (loss) per ordinary share
Diluted earnings/ (loss) per ordinary share is computed by dividing the profit after tax of US$60,418,000 (2009: profit after tax of US$11,824,000) (2008: loss after tax of US$77,778,000) for the financial year by the diluted weighted average number of ordinary shares in issue of 86,661,535 (2009: 83,772,094) (2008: 81,394,075).

93


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
10.EARNINGS/(LOSS) PER SHARE (CONTINUED)
The basic weighted average number of shares for the Group may be reconciled to the number used in the diluted earnings/ (loss) per ordinary share calculation as follows:
             
  December 31,  December 31,  December 31, 
  2010  2009  2008 
   
Basic earnings/ (loss) per share denominator (see above)  84,734,378   83,737,884   81,394,075 
Issuable on exercise of options and warrants  1,927,157   34,210    
          
Diluted earnings/ (loss) per share denominator *  86,661,535   83,772,094   81,394,075 
          
*At December 31, 2010 and December 31, 2009 the number of shares issuable on the exercise of options and warrants was dilutive. At December 31, 2008, the number of shares issuable on the exercise of options and warrants was not dilutive.
Earnings per ADS
In June 2005, Trinity Biotech adjusted its ADS ratio from 1 ADS: 1 Ordinary Share to 1 ADS: 4 Ordinary Shares. Earnings per ADS for all periods presented have been restated to reflect this exchange ratio.
Basic (loss)/ earnings per ADS for the Group is computed by dividing the loss after taxation of US$77,778,000 (2007: loss after tax of US$35,372,000) (2006: profit after tax of US$3,276,000) for the financial year by the weighted average number of ADS in issue of 20,348,519 (2007: 19,009,144) (2006:17,673,438)
Basic earnings/ (loss) per ADS for the Group is computed by dividing the profit after taxation of US$60,418,000 (2009: profit after tax of US$11,824,000) (2008: loss after tax of US$77,778,000) for the financial year by the weighted average number of ADS in issue of 21,183,594 (2009: 20,934,471); (2008: 20,348,519).
            
 December 31, December 31, December 31,             
 2008 2007 2006  December 31, December 31, December 31, 
  2010 2009 2008 
‘A’ ordinary shares — ADS 19,998,519 18,659,144 17,323,438  20,833,594 20,584,471 19,998,519 
‘B’ ordinary shares — ADS 350,000 350,000 350,000  350,000 350,000 350,000 
              
Basic (loss)/ earnings per share denominator 20,348,519 19,009,144 17,673,438 
Basic earnings/ (loss) per share denominator 21,183,594 20,934,471 20,348,519 
              
Diluted (loss)/ earnings per ADS for the Group is computed by dividing the loss after taxation of US$77,778,000 (2007: loss after tax of US$35,372,000) (2006: profit after tax of US$3,276,000) for the financial year, by the diluted weighted average number of ADS in issue of 20,348,519 (2007: 19,009,144) (2006: 18,031,435)
Diluted earnings/ (loss) per ADS for the Group is computed by dividing the profit after taxation of US$60,418,000 (2009: profit after taxation of US$11,824,000) (2008: loss after tax of US$77,778,000) for the financial year, by the diluted weighted average number of ADS in issue of 21,665,383 (2009: 20,943,024) (2008: 20,348,519).
The basic weighted average number of ADS shares for the Group only may be reconciled to the number used in the diluted earnings per ADS share calculation as follows:
                        
 December 31,
2008
 December 31,
2007
 December 31,
2006
  December 31, December 31, December 31, 
Basic (loss)/ earnings per share denominator (see above) 20,348,519 19,009,144 17,673,438 
 2010 2009 2008 
Basic earnings/ (loss) per share denominator (see above) 21,183,594 20,934,471 20,348,519 
Issuable on exercise of options and warrants   357,997  481,789 8,553  
Issuable on conversion of convertible notes    
              
Diluted (loss)/ earnings per share denominator * 20,348,519 19,009,144 18,031,435  21,665,383 20,943,024 20,348,519 
              
   
* At December 31, 2010 and December 31, 2009, the number of shares issuable on the exercise of options and warrants was dilutive. At December 31, 2008, the number of ADSs issuable on the exercise of options and warrants iswas not dilutive. At December 31, 2007, the number of ADSs issuable on the exercise of options and warrants was anti-dilutive and hence the diluted (loss)/ earnings per share was calculated excluding the number of ADSs issuable on the exercise of options and warrants. If the number of ADSs issuable on the exercise of options and warrants had not been anti-dilutive, 463,706 ADSs issuable on the exercise of options and warrants would have been included in the diluted (loss)/ earnings per ADS denominator in 2007.
The after tax effect of the interest saving on convertible notes is nil in 2007 as the final interest payment on the convertibles notes was paid on January 2, 2007. The after tax effect of the interest saving on convertible notes for 2006 was anti-dilutive and hence the diluted earnings per ADS share has been stated excluding the after tax effect of the interest saving on the convertible notes of US$208,000 in 2006. If the after tax effect on interest saving on convertible notes had not been anti-dilutive, 552,377 ADSs issuable on the conversion of convertible notes would have been included in the diluted earnings per ADS denominator in 2006.

93


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
11.PROPERTY, PLANT AND EQUIPMENT
                     
          Computers,       
  Freehold land  Leasehold  fixtures and  Plant and    
  and buildings  improvements  fittings  equipment  Total 
  US$’000  US$’000  US$’000  US$’000  US$’000 
Cost
                    
At January 1, 2007  5,439   3,407   5,022   22,448   36,316 
Acquisitions through business combinations (note 26)           23   23 
Other additions  15   266   549   7,856   8,686 
Disposals / retirements        (52)  (1,107)  (1,159)
Exchange adjustments  382   2   9   446   839 
                
At December 31, 2007  5,836   3,675   5,528   29,666   44,705 
                
                     
At January 1, 2008  5,836   3,675   5,528   29,666   44,705 
Additions  34   41   313   3,551   3,939 
Disposals / retirements     (34)  (126)  (1,642)  (1,802)
Exchange adjustments  (154)     (9)  (185)  (348)
                
At December 31, 2008  5,716   3,682   5,706   31,390   46,494 
                
                     
Accumulated depreciation and impairment losses
                    
At January 1, 2007  (818)  (1,317)  (2,614)  (9,312)  (14,061)
Charge for the year  (119)  (347)  (799)  (3,076)  (4,341)
Disposals / retirements        52   430   482 
Restructuring write off           (133)  (133)
Exchange adjustments  (33)  (2)  (1)  (207)  (243)
                
At December 31, 2007  (970)  (1,666)  (3,362)  (12,298)  (18,296)
                
                     
At January 1, 2008  (970)  (1,666)  (3,362)  (12,298)  (18,296)
Charge for the year  (124)  (381)  (621)  (3,299)  (4,425)
Impairment loss     (1,149)  (1,185)  (10,761)  (13,095)
Disposals / retirements     35   81   944   1,060 
Exchange adjustments  17      6   94   117 
                
At December 31, 2008  (1,077)  (3,161)  (5,081)  (25,320)  (34,639)
                
Carrying amounts
                    
At December 31, 2008  4,639   521   625   6,070   11,855 
                
 
At December 31, 2007  4,866   2,009   2,166   17,368   26,409 
                
The annual impairment review performed at December 31, 2008, showed that the carrying value of the Group’s assets exceeded the amount to be recovered through use or sale of the assets by a total of US$97,126,000. The details of the impairment review are described in note 12. When an impairment loss is identified in a cash generating unit, it must be first allocated to reduce the carrying amount of any goodwill allocated to the cash generating unit and then to the other assets of the unit pro rata on the basis of the carrying amount of each asset in the unit. In this manner, an impairment loss of US$13,095,000 has been allocated to property, plant and equipment. The recoverable amount of property, plant and equipment was determined to be the value in use of each cash generating unit.

 

94


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
The impairment loss relating to property, plant and equipment arose in the following cash generating units:
11.PROPERTY, PLANT AND EQUIPMENT
                     
          Computers,       
  Freehold land  Leasehold  fixtures and  Plant and    
  and buildings  improvements  fittings  equipment  Total 
  US$‘000  US$‘000  US$‘000  US$‘000  US$‘000 
Cost
                    
                     
At January 1, 2009  5,716   3,682   5,706   31,390   46,494 
Additions  29   8   157   2,111   2,305 
Disposals / retirements        (322)  (933)  (1,255)
Exchange adjustments  81      5   117   203 
                
At December 31, 2009  5,826   3,690   5,546   32,685   47,747 
                
                     
At January 1, 2010  5,826   3,690   5,546   32,685   47,747 
Additions  11   188   453   1,644   2,296 
Disposals / retirements  (3,498)  (1,625)  (1,695)  (20,233)  (27,051)
Exchange adjustments  (259)     (14)  (156)  (429)
                
At December 31, 2010  2,080   2,253   4,290   13,940   22,563 
                
                     
Accumulated depreciation and impairment losses
                    
                     
At January 1, 2009  (1,077)  (3,161)  (5,081)  (25,320)  (34,639)
Charge for the year  (124)  (92)  (159)  (1,411)  (1,786)
Disposals / retirements        322   618   940 
Exchange adjustments  (10)     (5)  (73)  (88)
                
At December 31, 2009  (1,211)  (3,253)  (4,923)  (26,186)  (35,573)
                
                     
At January 1, 2010  (1,211)  (3,253)  (4,923)  (26,186)  (35,573)
Charge for the year  (146)  (79)  (144)  (861)  (1,230)
Disposals / retirements  571   1,396   1,331   16,929   20,227 
Exchange adjustments  5      1   6   12 
                
At December 31, 2010  (781)  (1,936)  (3,735)  (10,112)  (16,564)
                
Carrying amounts
                    
At December 31, 2010  1,299   317   555   3,828   5,999 
                
                     
At December 31, 2009  4,615   437   623   6,499   12,174 
                
  Included within disposals/retirements in 2010 is Property, Plant and Equipment with a net book value of US$6,775,000, which was disposed of as part of the divestiture of the Coagulation business in May 2010 (see note 3).
  US$’000
Trinity Biotech Manufacturing Limited9,709
Biopool US Inc2,821
Primus Corporation Inc377
Trinity Biotech France SARL179
Trinity Biotech (UK Sales) Limited9
13,095
The annual impairment review performed at December 31, 2010 and December 31, 2009, showed that the carrying value of the Group’s assets did not exceed the amount that could be recovered through their use or sale and, on that basis, there was no impairment in 2010 or 2009.
Assets held under operating leases (where the Company is the lessor)
Included in the carrying amount of property, plant and equipment are a number of assets included in plant and equipment which generate operating lease revenue for the Group. The net book value of these assets as at December 31, 2008 is US$768,000 (2007: US$3,913,000). Depreciation charged on these assets in 2008 amounted to US$1,082,000 (2007: US$1,527,000). Impairment charged on these assets amounted to US$2,373,000 in 2008.
Included in disposals/ retirements in 2008 is US$612,000 (2007: US$550,000) relating to the net book value of leased instruments reclassified as inventory on return from customers.
Assets held under finance leases
Included in the carrying amount of property, plant and equipment is an amount for capitalised leased assets of US$537,000 (2007: US$2,913,000). Impairment charged on these assets amounted to US$1,987,000 in 2008. The leased equipment secures the lease obligations (note 27). The depreciation charge in respect of capitalised leased assets for the year ended December 31, 2008 was US$372,000 (2007: US$260,000). This is split as follows:
                     
  Freehold      Computers,       
  land and  Leasehold  fixtures and  Plant and    
  buildings  improvements  fittings  equipment  Total 
At December 31, 2008 US$’000  US$’000  US$’000  US$’000  US$’000 
                     
Depreciation charge     43   46   283   372 
Impairment charge     168   280   1,539   1,987 
Carrying value
                    
At December 31, 2008     33   55   449   537 
                
                     
  Freehold      Computers,       
  land and  Leasehold  fixtures and  Plant and    
  buildings  improvements  fittings  equipment  Total 
At December 31, 2007 US$’000  US$’000  US$’000  US$’000  US$’000 
                     
Depreciation charge     43   46   171   260 
Carrying value
                    
At December 31, 2007     244   382   2,287   2,913 
                
Property, plant and equipment under construction
Included in plant and equipment at December 31, 2008 is an amount of US$148,000 (2007: US$92,000) relating to assets in the course of construction. A further US$56,000 was included as assets under construction in 2008, relating to plant and equipment which was not fully completed by December 31, 2008. These assets were not depreciated in 2008.

 

95


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
12.11. GOODWILLPROPERTY, PLANT AND INTANGIBLE ASSETSEQUIPMENT (CONTINUED)
Assets held under operating leases (where the Company is the lessor)
Included in the carrying amount of property, plant and equipment are a number of assets included in plant and equipment which generate operating lease revenue for the Group. The net book value of these assets as at December 31, 2010 is US$557,000 (2009: US$1,409,000). Depreciation charged on these assets in 2010 amounted to US$126,000 (2009: US$427,000).
                     
      Development  Patents and       
  Goodwill  costs  licences  Other  Total 
  US$’000  US$’000  US$’000  US$’000  US$’000 
Cost
                    
At January 1, 2007  76,617   18,240   10,093   23,719   128,669 
Acquisitions, through business combinations (note 26)  2,982         1,500   4,482 
Other additions     7,508      372   7,880 
Exchange adjustments     64      11   75 
                
At December 31, 2007  79,599   25,812   10,093   25,602   141,106 
                
                     
At January 1, 2008  79,599   25,812   10,093   25,602   141,106 
Additions     8,426      482   8,908 
Exchange adjustments     (26)     (6)  (32)
                
At December 31, 2008  79,599   34,212   10,093   26,078   149,982 
                
                     
Accumulated amortisation and Impairment losses
                    
At January 1, 2007     (950)  (2,123)  (3,828)  (6,901)
Charge for the year     (547)  (797)  (2,074)  (3,418)
Goodwill impairment  (19,156)           (19,156)
Restructuring write off (note 3)     (5,134)  (1,533)     (6,667)
Exchange adjustments     (31)     (5)  (36)
                
At December 31, 2007  (19,156)  (6,662)  (4,453)  (5,907)  (36,178)
                
                     
At January 1, 2008  (19,156)  (6,662)  (4,453)  (5,907)  (36,178)
Charge for the year     (750)  (627)  (2,239)  (3,616)
Impairment loss  (40,390)  (21,480)  (3,728)  (6,086)  (71,684)
Exchange adjustments     18      3   21 
                
At December 31, 2008  (59,546)  (28,874)  (8,808)  (14,229)  (111,457)
                
                     
Carrying amounts
                    
At December 31, 2008  20,053   5,338   1,285   11,849   38,525 
                
 
At December 31, 2007  60,443   19,150   5,640   19,695   104,928 
                
Included in disposals/retirements in 2010 is US$15,000 (2009: US$321,000) relating to the net book value of leased instruments reclassified as inventory on return from customers.
Assets held under finance leases
Included within development costs are costs of US$3,453,000 which were not amortised in 2008 (2007: US$12,333,000). These development costs are not being amortised as the projects to which the costs relate were not fully complete at December 31, 2008 or at December 31, 2007. As at December 31, 2008 these projects are expected to be completed during the period from January 1, 2009 to June 30, 2010 at an expected approximate further cost of US$5.0 million.
Included in the carrying amount of property, plant and equipment is an amount for capitalised leased assets of US$499,000 (2009: US$704,000). The leased equipment secures the lease obligations (note 20). The depreciation charge in respect of capitalised leased assets for the year ended December 31, 2010 was US$85,000 (2009: US$ US$87,000). This is split as follows:
Other intangible assets consist primarily of acquired customer and supplier lists, trade names, website and software costs.
                 
      Computers,       
  Leasehold  fixtures and  Plant and    
  improvements  fittings  equipment  Total 
At December 31, 2010 US$‘000  US$‘000  US$‘000  US$‘000 
                 
Depreciation charge        85   85 
Carrying value
                
At December 31, 2010        499   499 
Amortisation is charged to the statement of operations through the selling, general and administrative expenses line.
                 
      Computers,       
  Leasehold  fixtures and  Plant and    
  improvements  fittings  equipment  Total 
At December 31, 2009 US$‘000  US$‘000  US$‘000  US$‘000 
                 
Depreciation charge  7   7   73   87 
Carrying value
                
At December 31, 2009  26   48   630   704 
             
Property, plant and equipment under construction
There were no assets in the course of construction included in plant and equipment at December 31, 2010 (2009: US$9,000). The assets in the course of construction at December 31, 2009 were transferred to additions during the course of the year.

 

96


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
Included in other intangibles are the following indefinite lived assets:
12.GOODWILL AND INTANGIBLE ASSETS
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
Fitzgerald trade name  970   970 
RDI trade name  560   560 
Primus trade name  418   1,870 
       
   1,948   3,400 
       
No trade names were purchased as part of the 2007 or 2006 acquisitions (note 26). The trade name assets purchased as part of the acquisition of Primus and RDI in 2005 and Fitzgerald in 2004 were valued by an external valuer using the relief from royalty method and based on factors such as (1) the market and competitive trends and (2) the expected usage of the name. It was considered that these trade names will generate net cash inflows for the Group for an indefinite period.
Impairment testing for intangibles including goodwill and indefinite lived assets
Goodwill and other intangibles with indefinite lives are tested annually for impairment at each balance sheet date at a cash-generating unit (“CGU”) level, i.e. the individual legal entities. For the purpose of these annual impairment reviews goodwill is allocated to the relevant CGU.
The recoverable amount of goodwill and intangible assets contained in each of the Group’s CGU’s is determined based on the greater of the fair value less cost to sell and value in use calculations. The Group operates in one business segment and accordingly the key assumptions are similar for all CGU’s. The value in use calculations use cash flow projections based on the 2009 budget and projections for a further four years using a projected revenue growth rate of 3% and a cost growth rate of 3%. At the end of the five year forecast period, terminal values for each CGU, based on a long term growth rate are used in the value in use calculations. The cashflows and terminal values for the CGU’s are discounted using pre-tax discount rates which range from 8% to 41%.
The impairment review carried out at December 31, 2008 identified a total impairment loss of US$97,126,000 in six CGU’s. In other words, the carrying value of their net assets exceeded the discounted future cashflows by a total of US$97,126,000. The impairment loss arose from the impairment review performed on Trinity Biotech Manufacturing Limited, Biopool US Inc, Trinity Biotech (UK Sales) Limited, Primus Corporation, Clark Laboratories Inc. and Trinity Biotech France SARL.
In accordance with IAS 36,Impairment of Assets, the impairment loss for each CGU was first allocated to reduce the carrying amount of any goodwill allocated to the CGU, then to other assets of the unit pro rata on the basis of the carrying amount of each asset in the CGU. The full impairment loss for Biopool US Inc and Trinity Biotech France SARL could not be reflected in the 2008 financial statements for these entities because each of these entities had insufficient assets to write down after excluding those assets with a known recoverable amount. The amount of impairment loss that could not be recorded for Biopool US Inc and Trinity Biotech France SARL was US$10,279,000 and US$1,054,000 respectively. As a result, the impairment loss that was recorded in the 2008 financial statements was US$85,793,000.
The table below sets forth the impairment loss recorded for each of the CGU’s at December 31, 2008:
                     
      Development  Patents and       
  Goodwill  costs  licences  Other  Total 
  US$‘000  US$‘000  US$‘000  US$‘000  US$‘000 
Cost
                    
                     
At January 1, 2009  79,599   34,212   10,093   26,078   149,982 
Additions     7,845      407   8,252 
Disposals / retirements           (25)  (25)
Exchange adjustments     13      4   17 
                
At December 31, 2009  79,599   42,070   10,093   26,464   158,226 
                
                     
At January 1, 2010  79,599   42,070   10,093   26,464   158,226 
Additions     5,887   8   407   6,302 
Disposals / retirements  (32,345)  (20,113)  (3,675)  (7,169)  (63,302)
Exchange adjustments     (13)     (4)  (17)
                
At December 31, 2010  47,254   27,831   6,426   19,698   101,209 
                
                     
Accumulated amortisation and Impairment losses
                    
                     
At January 1, 2009  (59,546)  (28,874)  (8,808)  (14,229)  (111,457)
Charge for the year     (401)  (149)  (1,409)  (1,959)
Disposals / retirements           25   25 
Exchange adjustments     (10)     (3)  (13)
                
At December 31, 2009  (59,546)  (29,285)  (8,957)  (15,616)  (113,404)
                
                     
At January 1, 2010  (59,546)  (29,285)  (8,957)  (15,616)  (113,404)
Charge for the year     (297)  (86)  (1,206)  (1,589)
Disposals / retirements  30,120   11,824   3,184   5,904   51,032 
Exchange adjustments               
                
At December 31, 2010  (29,426)  (17,758)  (5,859)  (10,918)  (63,961)
                
                     
Carrying amounts
                    
At December 31, 2010  17,828   10,073   567   8,780   37,248 
                
                     
At December 31, 2009  20,053   12,785   1,136   10,848   44,822 
                
  Included within disposals/retirements in 2010 are intangible assets with a net book value of US$12,270,000, which were disposed of as part of the divestiture of the Coagulation business in May 2010 (see Note 3).
  Included within development costs are costs of US$’000
Trinity Biotech Manufacturing Limited57,889
Primus Corporation Inc.13,988
Biopool US Inc.8,649
Trinity Biotech (UK Sales) Limited3,036
Trinity Biotech France SARL1,973
Clark Laboratories Inc.258
Total impairment loss85,793
8,682,000 which were not amortised in 2010 (2009: US$4,564,000). These development costs are not being amortised as the projects to which the costs relate were not fully complete at December 31, 2010 or at December 31, 2009. As at December 31, 2010 these projects are expected to be completed during the period from January 1, 2011 to December 31, 2013 at an expected further cost of approximately US$6.5 million.

 

97


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
The table below sets forth the breakdown of the impairment loss for each class of asset at December 31, 2008:
12.GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
  The following represents the costs incurred during each period presented for each of the principal development projects:
         
  2010  2009 
Product Name US$’000  US$’000 
Premier Hb 9210 Instrument for Haemoglobin A1c testing  2,569   1,023 
Destiny Max coagulation instrument*  956   3,234 
Bordetella Pertussis Western Blot test  337   156 
Tristat point of care instrument  318   1,072 
Coagulation assays and intermediates*  312   1,010 
HIV Ag-Ab rapid test  247    
Legionella Urinary Antigen  198    
Syphilis Rapid point-of-care test  185    
Unigold Recombigen HIV Rapid enhancement  142   456 
Lyme assays     629 
Trinblot Scanner     72 
Other projects with spend less than $150,000  623   193 
       
Total capitalized development costs
  5,887   7,845 
       
   
* US$’000
Note that these projects ceased in May 2010 following the divestiture of the Coagulation Business.
Goodwill and other intangible assets71,684
Property, plant and equipment (see note 11)13,095
Prepayments (see note 16)1,014
  All of the development projects for which costs have been capitalized are judged to be technically feasible, commercially viable and likely to produce future economic benefits. In reaching this conclusion, many factors have been considered including the following:
 
Total impairment loss(a) 85,793The Group only develops products within its field of expertise. The R&D team is experienced in developing new products in this field and this experience means that only products which have a high probability of technical success are put forward for consideration as potential new products.
 (b) A technical feasibility study is undertaken in advance of every project. The feasibility study for each project is reviewed by the R&D team leader, and by other senior management depending on the size of the project. The feasibility study occurs in the initial research phase of the project and costs in this phase are not capitalized.
The impairment loss at December 31, 2008 allocated to goodwill arose on the following acquisitions:
(c)Nearly all of our new product developments involve the transfer of our existing product know-how to a new application. The Group does not engage in pure research. Every development project is undertaken with the intention of bringing a particular new product to market for which there is a known demand.
(d)The commercial feasibility of each new product is established prior to commencement of a project by ensuring it is projected to achieve an acceptable income after applying appropriate discount rates.
  
US$’000
bioMerieux19,886
Primus Corporation7,688
Biopool4,486
Sigma Clinical Chemistry4,005
Adaltis1,952
Sterilab Services905
Nephrotek SARL677
Other791
Total impairment loss allocated to goodwill40,390
intangible assets consist primarily of acquired customer and supplier lists, trade names, website and software costs.
The value in use calculation and the impairment charge arising therefrom are subject to significant estimation, uncertainty and accounting judgements and are particularly sensitive in the following areas. In the event that there was a variation of 10% in the assumed level of future growth in revenues, which would represent a reasonably likely range of outcomes, there would be the following impact on the level of the goodwill impairment loss recorded at December 31, 2008:
An increase in impairment of US$5.3 million in the event of a 10% decrease in the growth in revenues.
A decrease in impairment of US$5.0 million in the event of a 10% increase in the growth in revenues.
Similarly if there was a 10% variation in the discount rate used to calculate the potential goodwill impairment of the carrying values, which would represent a reasonably likely range of outcomes, there would be the following impact on the level of the goodwill impairment loss recorded at December 31, 2008:
An increase in impairment of US$4.8 million in the event of a 10% increase in the discount rate.
A decrease in impairment of US$4.7 million in the event of a 10% decrease in the discount rate.
Impairment loss arising on annual impairment review in 2007
Arising from the 2007 impairment review, an impairment loss of US$19,156,000 was recognised in the financial statements for the year ended December 31, 2007, representing the excess of the carrying value over the discounted future cashflows. This impairment loss arose in Trinity Biotech Manufacturing Limited, one of the Group’s CGU’s. Trinity Biotech Manufacturing Limited manufactures haemostasis, infectious diseases, point of care and clinical chemistry products at its plant in Bray, Ireland, which are then sold to third party distributors and other selling entities within the Group. The impairment loss was allocated entirely to goodwill and in particular to goodwill arising on the following acquisitions:
  
December 31, 2007
US$’000
Bartels7,340
Cambridge3,005
Ortho783
Dade8,028
19,156
Amortisation is charged to the statement of operations through the selling, general and administrative expenses line.

 

98


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
In 2007 this
12.GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
Included in other intangibles are the following indefinite lived assets:
         
  December 31, 2010  December 31, 2009 
  US$‘000  US$‘000 
Fitzgerald trade name  970   970 
RDI trade name  560   560 
Primus trade name  670   670 
       
   2,200   2,200 
       
The trade name assets purchased as part of the acquisition of Primus and RDI in 2005 and Fitzgerald in 2004 were valued by an external valuer using the relief from royalty method and based on factors such as (1) the market and competitive trends and (2) the expected usage of the name. It was considered that these trade names will generate net cash inflows for the Group for an indefinite period.
Impairment testing for intangibles including goodwill and indefinite lived assets
Goodwill and other intangibles with indefinite lives are tested annually for impairment at each balance sheet date at a cash-generating unit (“CGU”) level, i.e. the individual legal entities. For the purpose of these annual impairment reviews goodwill is allocated to the relevant CGU.
The recoverable amount of goodwill and intangible assets contained in each of the Group’s CGU’s is determined based on the greater of the fair value less cost to sell and value in use calculations. The Group operates in one market sector (namely diagnostics) and accordingly the key assumptions are similar for all CGU’s. The value in use calculations use cash flow projections based on the 2011 budget and projections for a further four years using projected revenue and cost growth rates of between 3% and 5%. At the end of the five year forecast period, terminal values for each CGU, based on a long term growth rate are used in the value in use calculations. The cashflows and terminal values for the CGU’s are discounted using pre-tax discount rates which range from 18% to 32%.
The value in use calculation is subject to significant estimation, uncertainty and accounting judgements and are particularly sensitive in the following areas. In the event that there was a variation of 10% in the assumed level of future growth in revenues, which would represent a reasonably likely range of outcomes, the following impairment loss/write back would be recorded at December 31, 2010:
No impairment loss was allocated toor reversal of impairment in the goodwill arising onevent of a 10% increase in the abovementioned acquisitions as sales of the products associated with each of these acquisitions are now static or declining.growth in revenues.
Impairment loss on bioMerieux technology asset
In December 2007, the Group announced a restructuring of its activities (see note 3). As part this restructuring, the Group decided to rationalise its three existing haemostasis product lines with a view to creating a single product line consisting of the best products from each line. As a direct consequence, a number of the Group’s haemostasis products were identified for culling, including a number of products acquired from bioMerieux in 2006. As a result, the Group recognised in 2007 a specificNo impairment loss or reversal of US$1,094,000 againstimpairment in the carrying valueevent of a 10% decrease in the technology assets acquired from bioMerieux. Thegrowth in revenues.
Similarly if there was a 10% variation in the discount rate used to calculate the potential impairment of the carrying values, which would represent a reasonably likely range of outcomes, there would be the following impairment loss/write back would be recorded at December 31, 2010:
No impairment loss represented 25%or reversal of impairment in the carrying valueevent of a 10% decrease in the technology assets atdiscount rate
No impairment loss or reversal of impairment in the dateevent of a 10% increase in the group restructuring, as the products being culled represent approximately 25% of sales of those products acquired from bioMerieux. The remaining useful economic life of the remaining 75% of the carrying value of the technology asset was unaffected and was amortised on a straight line basis, through December 31, 2008. No other assets were impaired in 2007 as a direct result of the product rationalisation.discount rate

 

99


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
13. DEFERRED TAX ASSETS AND LIABILITIES
Recognised deferred tax assets and liabilities
Deferred tax assets and liabilities of the Group are attributable to the following:
Recognised deferred tax assets and liabilities
                         
  Assets  Liabilities  Net 
  2010  2009  2010  2009  2010  2009 
  US$’000  US$’000  US$’000  US$’000  US$’000  US$’000 
                         
Property, plant and equipment  2,369   3,869   (581)  (1,187)  1,788   2,682 
Intangible assets        (6,031)  (6,343)  (6,031)  (6,343)
Inventories  955   1,253         955   1,253 
Provisions  294   118         294   118 
Other items  216      (578)  (680)  (362)  (680)
Tax value of loss carryforwards recognised  846   561          846   561 
                   
Deferred tax assets/(liabilities)  4,680   5,801   (7,190)  (8,210)  (2,510)  (2,409)
                   
Deferred tax assets and liabilities of the Group are attributable to the following:
The deferred tax asset in 2010 is due mainly to deductible temporary differences relating to property, plant and equipment, inventory and the elimination of unrealised intercompany inventory profit. The deferred tax asset decreased US$1,121,000 in 2010 principally due to a decrease in unrecognised deferred tax assets. The accounting policy for deferred tax is to calculate the deferred tax asset that is deemed recoverable, considering all sources for future taxable profits. However when there is a reversing deferred tax liability in that jurisdiction that reverses in the same period, the deferred tax asset is restricted so that it equals the reversing deferred tax liability.
                         
  Assets  Liabilities  Net 
  2008  2007  2008  2007  2008  2007 
  US$’000  US$’000  US$’000  US$’000  US$’000  US$’000 
                         
Property, plant and equipment  1,285   15   (885)  (1,618)  400   (1,603)
Intangible assets        (3,069)  (6,998)  (3,069)  (6,998)
Inventories  1,214   1,733         1,214   1,733 
Provisions  255   1,520         255   1,520 
Other items     466   (419)  (621)  (419)  (155)
Tax value of loss carryforwards recognised  297   203         297   203 
                   
Deferred tax assets/(liabilities)  3,051   3,937   (4,373)  (9,237)  (1,322)  (5,300)
                   
The deferred tax assets in Germany and UK were derecognised in 2010 following the divestiture of the German and UK subsidiaries to Diagnostica Stago (see Note 3 for further information on the divestiture of these subsidiaries). At December 31, 2009, the Group recognised a deferred tax asset of US$96,000 (2008: US$133,000) in respect of net operating loss carryforwards in Germany and the UK, as there were sufficient taxable temporary differences relating to the same taxation authority and the same taxable entity which would result in taxable amounts against which the unused tax losses could be utilised before they expire.
The deferred tax asset in 2008 is due mainly to deductible temporary differences and the elimination of unrealised intercompany inventory profit. The deferred tax asset decreased in 2008 principally due to an increase in unrecognised deferred tax assets. As deferred tax assets are only recognised where there is a reversing deferred tax liability in the same jurisdiction reversing in the same period, the recognised deferred tax asset decreases in line with the decrease in deferred tax liabilities.
The deferred tax liability is caused by the net book value of non-current assets being greater than the tax written down value of non-current assets, temporary differences due to the acceleration of the recognition of certain charges in calculating taxable income permitted in Ireland and the USA and deferred tax recognised on fair value asset uplifts in connection with business combinations. The deferred tax liability decreased US$1,020,000 in 2010, principally due to sale of property, plant and equipment and intangible assets to Diagnostica Stago and the resulting elimination of the temporary differences in respect of these assets.
At December 31, 2008, the Group recognised a deferred tax asset of US$133,000 (2007: US$203,000) in respect of net operating loss carryforwards in Germany and the UK, as there are sufficient taxable temporary differences relating to the same taxation authority and the same taxable entity which will result in taxable amounts against which the unused tax losses can be utilised before they expire. The utilisation of these net operating loss carryforwards is limited to future profits in Germany and the UK.
Deferred tax assets and liabilities are only offset when the entity has a legally enforceable right to set off current tax assets against current tax liabilities and where the intention is to settle current tax liabilities and assets on a net basis or to realise the assets and settle the liabilities simultaneously. At December 31, 2010 and at December 31, 2009 no deferred tax assets and liabilities are offset as it is not certain as to whether there is a legally enforceable right to set off current tax assets against current tax liabilities and it is also uncertain as to what current tax assets may be set off against current tax liabilities and in what periods.
Unrecognised deferred tax assets
The deferred tax liability is caused by the net book value of non current assets being greater than the tax written down value of non current assets, temporary differences due to the acceleration of the recognition of certain charges in calculating taxable income permitted in Ireland, the USA and Germany, and deferred tax recognised on fair value asset uplifts in connection with business combinations. The deferred tax liability decreased in 2008, principally due to the elimination of deferred tax recognised on fair value uplifts in connection with business combinations which were impaired in 2008.
Deferred tax assets have not been recognised by the Group in respect of the following items:
Deferred tax assets and liabilities are only offset when the entity has a legally enforceable right to set off current tax assets against current tax liabilities and where the intention is to settle current tax liabilities and assets on a net basis or to realise the assets and settle the liabilities simultaneously. At December 31, 2008 and at December 31, 2007 no deferred tax assets and liabilities are offset as it is not certain as to whether there is a legally enforceable right to set off current tax assets against current tax liabilities and it is also uncertain as to what current tax assets may be set off against current tax liabilities and in what periods.
Unrecognised deferred tax assets
Deferred tax assets have not been recognised by the Group in respect of the following items:
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
Deductible temporary differences  8,536   3,944 
Capital losses  6,138   6,138 
US state credit carryforwards  346   314 
Net operating losses  15,248   13,560 
       
   30,268   23,956 
       
No deferred tax asset is recognised in 2008 or 2007 in respect of a capital loss forward of US$6,138,000 in Ireland as it was not probable that there will be future capital gains against which to offset these capital losses.
         
  December 31, 2010  December 31, 2009 
  US$’000  US$’000 
Capital losses  8,513   6,138 
Net operating losses  704   11,720 
US state credit carryforwards  358   346 
Deductible temporary differences     954 
       
   9,575   19,158 
       

 

100


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
A deferred tax asset of US$4,126,000 (2007: US$3,717,000) in respect of net operating losses of US$10,167,000 (2007: US$9,158,000) in the US was not recognised due to uncertainties regarding the timing of the utilisation of these losses in the related tax jurisdiction in future periods. A deferred tax asset of US$3,464,000 (2007: US$1,600,000) in respect of deductible temporary differences of US$8,536,000 (2007: $3,944,000) in the US was not recognised due to uncertainties regarding the timing of the utilisation of these temporary differences in the related tax jurisdiction in future periods.
13.DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED)
A deferred tax asset of US$346,000 (2007: US$314,000) in respect of US state credit carryforwards was not recognised due to uncertainties regarding the timing of the utilisation of these state credit carryforwards in the related tax jurisdiction in future periods.
There was a decrease of US$9,583,000 in the unrecognised deferred tax assets during the year ended December 31, 2010. For comments on the uncertainty prompting less than full recognition refer to note 9. The movement in the unrecognised deferred tax assets during the year ended December 31, 2010 is analysed as follows:
A deferred tax asset of US$866,000 (2007: US$945,000) in respect of net operating losses of US$2,979,000 (2007: US$3,232,000) in Germany was not recognised due to uncertainties regarding the timing of the utilisation of these losses in the related tax jurisdiction in future periods.
             
  Increase/  Applicable    
  (decrease)  tax rate  Tax effect 
Movement in Unrecognised deferred tax assets US$’000  %  US$’000 
Deductible temporary differences  (954)  40.6%  (387)
Net operating losses Ireland  414   25.0%  104 
Net operating losses USA  (7,569)  40.6%  (3,071)
Net operating losses France to date of divestiture  (267)  33.0%  (89)
Net operating losses Germany to date of divestiture  79   34.0%  26 
US state credit carryforwards  12   n/a   12 
          
   (8,285)      (3,405)
Capital losses in Ireland  2,375   25.0%  594 
Net operating losses France eliminated on divestiture  (2,341)  33.0%  (773)
Net operating losses Germany eliminated on divestiture  (1,332)  34.0%  (453)
          
   (9,583)      (4,037)
A deferred tax asset of US$73,000 (2007: US$73,000) in respect of net operating losses of US$290,000 (2007: US$290,000) in Ireland was not recognised due to uncertainties regarding the timing of the utilisation of these losses in the related tax jurisdiction in future periods.
At December 31, 2009 net operating losses in the US of US$3,071,000 and temporary differences of $954,000 also in the US were not recognised because recognition would have resulted in the deferred tax asset exceeding the reversing deferred tax liability in the US. At December 31, 2010 the deferred tax asset in the US is less than the reversing deferred tax liability and therefore no restriction is required on the amount of net operating losses and temporary differences recognised as deferred tax assets.
A deferred tax asset of US$598,000 (2007: US$290,000) in respect of net operating losses of US$1,812,000 (2007: US$880,000)
A deferred tax asset of US$358,000 (2009: US$346,000) in respect of US state credit carryforwards was not recognised due to uncertainties regarding the timing of the utilisation of these state credit carryforwards in the related tax jurisdiction in future periods.
A deferred tax asset of US$177,000 (2009: US$73,000) in respect of net operating losses of US$704,000 (2009: US$290,000) in Ireland was not recognised due to uncertainties regarding the timing of the utilisation of these losses in the relevant entity in future periods.
A deferred tax asset of US$772,000 (2009: US$861,000) in respect of net operating losses of US$2,341,000 (2009: US$2,608,000) in France was not recognised up to the date of divestiture of the Group’s French subsidiary due to uncertainties regarding the timing of the utilisation of these losses in the related tax jurisdiction in future periods.
A deferred tax asset of US$453,000 (2009: US$427,000) in respect of net operating losses of US$1,332,000 (2009: US$1,253,000) in Germany and UK was not recognised up to the date of divestiture of the Group’s German and UK subsidiaries due to uncertainties regarding the timing of the utilisation of these losses in the related tax jurisdictions in future periods.
No deferred tax asset is recognised in respect of a capital loss forward of US$8,513,000 (2009: US$6,138,000) in Ireland as it is not probable that there will be future capital gains against which to offset these capital losses. The increase in the capital loss in 2010 is due to the divestiture of the assets and liabilities of the coagulation business in Ireland (see Note 3 for further information).
Unrecognised deferred tax liabilities
At December 31, 2008 and 2007,
At December 31, 2010 and 2009, there was no recognised or unrecognised deferred tax liability for taxes that would be payable on the unremitted earnings of certain of the Group’s subsidiaries. The Company is able to control the timing of the reversal of the temporary differences of its subsidiaries and it is probable that these temporary differences will not reverse in the foreseeable future.

101


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
13.DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED)
Movement in temporary differences during the year
                                    
 Balance Balance  Balance 
 January, 1 Recognised in Recognised on Recognised December 31,  Balance Recognised in Recognised December 31, 
 2008 income acquisitions in equity 2008  January, 1 2010 income in equity 2010 
 US$’000 US$’000 US$’000 US$’000 US$’000  US$’000 US$’000 US$’000 US$’000 
Property, plant and equipment  (1,603) 2,003   400  2,682  (894)  1,788 
Intangible assets  (6,998) 3,929    (3,069)  (6,343) 312   (6,031)
Inventories 1,733  (519)   1,214  1,253  (298)  955 
Provisions 1,520  (1,265)   255  118 176  294 
Other items  (155)  (290)  26  (419)  (680) 324  (6)  (362)
Tax value of loss carryforwards recognised 203 94   297  561 285  846 
                    
  (5,300) 3,952  26  (1,322)  (2,409)  (95)  (6)  (2,510)
                    
                     
  Balance              Balance 
  January, 1  Recognised in  Recognised on  Recognised  December 31, 
  2007  income  acquisitions  in equity  2007 
  US$’000  US$’000  US$’000  US$’000  US$’000 
Property, plant and equipment  (1,723)  120         (1,603)
Intangible assets  (6,285)  (428)  (285)     (6,998)
Inventories  1,886   (153)        1,733 
Provisions  1,055   465         1,520 
Other items  (1,170)  1,038      (23)  (155)
Tax value of loss carryforwards recognised  4,447   (4,244)        203 
                
   (1,790)  (3,202)  (285)  (23)  (5,300)
                

101


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
                 
              Balance 
  Balance  Recognised in  Recognised  December 31, 
  January, 1 2009  income  in equity  2009 
  US$’000  US$’000  US$’000  US$’000 
Property, plant and equipment  400   2,282      2,682 
Intangible assets  (3,069)  (3,274)     (6,343)
Inventories  1,214   39      1,253 
Provisions  255   (137)     118 
Other items  (419)  (264)  3   (680)
Tax value of loss carryforwards recognised  297   264      561 
             
   (1,322)  (1,090)  3   (2,409)
             
14. OTHER ASSETS
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
         
Finance lease receivables (see note 16)  776   773 
Other assets  101   123 
       
   877   896 
       
The Group leases instruments as part of its business. In 2008, the Group reclassified future minimum finance lease receivables with non-cancellable terms between one and five years of US$776,000 (2007: US$773,000) from trade and other receivables to other assets (see note 16).
         
  December 31, 2010  December 31, 2009 
  US$‘000  US$‘000 
      
Deferred Consideration  11,138    
Finance lease receivables (see note 16)  412   1,106 
Other assets  73   106 
       
   11,623   1,212 
       
15. INVENTORIESThe deferred consideration arises as a result of the sale of the coagulation business (see note 3) and comprises US$11,250,000 of a receivable due from Diagnostica Stago in May 2012 — shown net of US$112,000 of deferred interest income. A further US$11,250,000 (net US$10,804,000) is receivable in May 2011 and, as this falls due within one year, it is shown in Note 16, Trade and Other Receivables.
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
         
Raw materials and consumables  11,245   10,849 
Work-in-progress  11,033   9,243 
Finished goods  20,039   24,328 
       
   42,317   44,420 
       
All inventories are stated at the lower of cost or net realisable value. Total inventories for the Group are shown net of provisions of US$16,461,000 (2007: US$18,234,000).
The movement on the inventory provision for the three year period to December 31, 2008 is as follows:
             
  December 31,  December 31,  December 31, 
  2008  2007  2006 
  US$’000  US$’000  US$’000 
             
Opening provision at January 1  18,234   7,284   3,654 
Charged during the year  1,570   13,856   6,280 
Utilised during the year  (2,182)  (2,323)  (2,511)
Released during the year  (1,161)  (583)  (139)
          
Closing provision at December 31  16,461   18,234   7,284 
          
The Group leases instruments as part of its business. For details of future minimum finance lease receivables with non-cancellable terms, please refer to note 16.

 

102


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
15.INVENTORIES
         
  December 31, 2010  December 31, 2009 
  US$‘000  US$‘000 
     
Raw materials and consumables  4,516   9,191 
Work-in-progress  4,676   10,478 
Finished goods  8,384   19,529 
       
   17,576   39,198 
       
All inventories are stated at the lower of cost or net realisable value. Total inventories for the Group are shown net of provisions of US$6,400,000 (2009: US$12,566,000). Note 3 outlines the net inventories which were transferred to Diagnostica Stago during the year as part of the divestiture of the Coagulation business.
The movement on the inventory provision for the three year period to December 31, 2010 is as follows:
             
  December 31,  December 31,  December 31, 
  2010  2009  2008 
  US$‘000  US$‘000  US$‘000 
         
Opening provision at January 1  12,566   16,461   18,234 
Charged during the year  3,006   2,064   1,570 
Utilised during the year  (8,440)  (4,751)  (2,182)
Released during the year  (732)  (1,208)  (1,161)
          
Closing provision at December 31  6,400   12,566   16,461 
          
16. TRADE AND OTHER RECEIVABLES
                
 December 31, 2008 December 31, 2007  December 31, 2010 December 31, 2009 
 US$’000 US$’000  US$‘000 US$‘000 
  
Trade receivables, net of impairment losses 24,962 23,104  11,762 20,120 
Prepayments* 736 1,665 
Deferred consideration 10,804  
Prepayments 2,331 1,798 
Value added tax 195 108  204 67 
Finance lease receivables 439 388  229 692 
Other receivables 1,086 418  199 254 
          
 27,418 25,683  25,529 22,931 
          
Trade receivables for the Group are shown net of an impairment losses provision of US$619,000 (2007: US$657,000) (see note 29).
  The deferred consideration arises as a result of the sale of the coagulation business (see note 3) and comprises US$11,250,000 of a receivable due from Diagnostica Stago in May 2011 — shown net of US$446,000 of deferred interest income. A further US$11,250,000 (net US$11,138,000) is receivable in May 2012 and, as this falls due after one year, it is shown in Note 14, Other Assets.
* PrepaymentsTrade receivables are shown net of amounts written down as partan impairment losses provision of the impairment review of US$1,014,0001,443,000 (2009: US$855,000) (see note 3)27).
Leases as lessor
(i) Finance lease commitments — Group as lessor
The Group leases instruments as part of its business. Future minimum finance lease receivables with non-cancellable terms are as follows:
             
  December 31, 2008 
  US$’000 
          Minimum 
  Gross  Unearned  payments 
  investment  income  receivable 
             
Less than one year  764   325   439 
Between one and five years (note 14)  1,394   618   776 
          
   2,158   943   1,215 
          
             
  December 31, 2007 
  US$’000 
          Minimum 
  Gross  Unearned  payments 
  investment  income  receivable 
             
Less than one year  673   285   388 
Between one and five years (note 14)  1,448   675   773 
          
   2,121   960   1,161 
          
In 2008, the Group classified future minimum lease receivables between one and five years of US$776,000 (2007: US$773,000) to Other Assets, see note 14. Under the terms of the lease arrangements, no contingent rents are receivable.
(ii) Operating lease commitments — Group as lessor
The Group has leased a facility consisting of 9,000 square feet in Dublin, Ireland. This property has been sub-let by the Group. The lease contains a clause to enable upward revision of the rent charge on a periodic basis. The Group also leases instruments under operating leases as part of its business.

 

103


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
Future minimum rentals receivable under non-cancellable operating leases are as follows:
             
  December 31, 2008 
  US$’000 
  Land and       
  buildings  Instruments  Total 
Less than one year  223   1,160   1,383 
Between one and five years  892   1,552   2,444 
More than five years  613      613 
          
   1,728   2,712   4,440 
          
             
  December 31, 2007 
  US$’000 
  Land and       
  buildings  Instruments  Total 
Less than one year  232   2,198   2,430 
Between one and five years  929   3,566   4,495 
More than five years  871      871 
          
   2,032   5,764   7,796 
          
17.16. CASHTRADE AND CASH EQUIVALENTSOTHER RECEIVABLES (CONTINUED)
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
Cash at bank and in hand  3,182   4,193 
Short-term deposits  2,002   4,507 
       
Cash and cash equivalents in the statements of cash flows  5,184   8,700 
       
Leases as lessor
Cash relates to all cash balances which are readily available at year end. Cash equivalents relate to all cash balances on deposit, with a maturity of less than three months, which are not restricted. See note 27 (c).
(i)
Finance lease commitments — Group as lessor
The Group leases instruments as part of its business. Future minimum finance lease receivables with non-cancellable terms are as follows:
             
  December 31, 2010 
  US$‘000 
          Minimum 
  Gross  Unearned  Payments 
  investment  income  receivable 
Less than one year  367   138   229 
Between one and five years (note 14)  628   216   412 
          
   995   354   641 
          
             
  December 31, 2009 
  US$‘000 
          Minimum 
  Gross  Unearned  payments 
  investment  income  receivable 
Less than one year  1,002   310   692 
Between one and five years (note 14)  1,559   453   1,106 
          
   2,561   763   1,798 
          
In 2010, the Group classified future minimum lease receivables between one and five years of US$412,000 (2009: US$1,106,000) to Other Assets, see note 14. Under the terms of the lease arrangements, no contingent rents are receivable.
(ii)
Operating lease commitments — Group as lessor
The Group has leased a facility consisting of 9,000 square feet in Dublin, Ireland. This property has been sub-let by the Group. The lease contains a clause to enable upward revision of the rent charge on a periodic basis. The Group also leases instruments under operating leases as part of its business.
Future minimum rentals receivable under non-cancellable operating leases are as follows:
             
  December 31, 2010 
  US$’000 
  Land and       
  buildings  Instruments  Total 
Less than one year  209   1,759   1,968 
Between one and five years  838   689   1,527 
More than five years  157      157 
          
   1,204   2,448   3,652 
          
             
  December 31, 2009 
  US$’000 
  Land and       
  buildings  Instruments  Total 
Less than one year  228   1,992   2,220 
Between one and five years  911   852   1,763 
More than five years  399      399 
          
   1,538   2,844   4,382 
          

 

104


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
17.CASH AND CASH EQUIVALENTS
         
  December 31, 2010  December 31, 2009 
  US$’000  US$’000 
Cash at bank and in hand  2,449   4,711 
Short-term deposits  55,553   1,367 
       
Cash and cash equivalents in the statements of cash flows  58,002   6,078 
       
Cash relates to all cash balances which are readily available at year end. Cash equivalents relate to all cash balances on deposit, with a maturity of less than six months, which are not restricted. See note 25 (c).
18. CAPITAL AND RESERVES
                                     
  Share  Share                          
  capital  capital                  Convertible  (Accumulated    
  ‘A’  ‘B’                  notes —  deficit)/    
  ordinary  ordinary  Share  Translation  Warrant  Hedging  equity  retained    
  shares  shares  premium  reserve  reserve  reserves  component  earnings  Total 
  US$’000  US$’000  US$’000  US$’000  US$’000  US$’000  US$’000  US$’000  US$’000 
                                     
Balance at January 1, 2006  818   12   124,227   (1,622)  3,803   (64)  164   6,280   133,618 
Total recognised income and expense           1,347      64      3,276   4,687 
Share-based payments                       1,262   1,262 
Options exercised  2      212                  214 
Class A shares issued on conversion of convertible notes  20      3,624                  3,644 
Class A shares issued in private placement  126      24,879                  25,005 
Share issue expenses        (1,168)                 (1,168)
                            
Balance at December 31, 2006  966   12   151,774   (275)  3,803      164   10,818   167,262 
                                     
Balance at January 1, 2007  966   12   151,774   (275)  3,803      164   10,818   167,262 
Total recognised income and expense           1,072      201      (35,372)  (34,099)
Share-based payments                        1,482   1,482 
Options exercised  4      450                  454 
Class A shares issued on conversion of convertible notes  9      1,813                  1,822 
Convertible notes — transfer to retained earnings on maturity                    (164)  164    
Share issue expenses        (76)                 (76)
                            
Balance at December 31, 2007  979   12   153,961   797   3,803   201      (22,908)  136,845 
                            
                                     
Balance at January 1, 2008  979   12   153,961   797   3,803   201      (22,908)  136,845 
Total recognised income and expense           (806)     (226)     (77,778)  (78,810)
Share-based payments                       1,193   1,193 
Options exercised                           
Class A shares issued on conversion of convertible notes                           
Class A shares issued in private placement  79      7,037                  7,116 
Share issue expenses        (439)                 (439)
Fair Value of Warrants issued during the year        (695)     695             
                            
Balance at December 31, 2008  1,058   12   159,864   (9)  4,498   (25)     (99,493)  65,905 
                            

105


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008Share capital
         
  Class ‘A’ Ordinary shares  Class ‘A’ Ordinary shares 
In thousands of shares 2010  2009 
      
In issue at January 1  82,952   82,017 
Issued for cash  1,165   935 
       
         
In issue at December 31  84,117   82,952 
       
         
  Class ‘B’ Ordinary shares  Class ‘B’ Ordinary shares 
In thousands of shares 2010  2009 
      
In issue at January 1  700   700 
Issued for cash      
       
In issue at December 31  700   700 
       
18.CAPITAL AND RESERVES (Continued)
  
ShareThe Group had authorised share capital
of 200,000,000 ‘A’ ordinary shares of US$0.0109 each (2009: 200,000,000 ‘A’ ordinary shares of US$0.0109 each) and 700,000 ‘B’ ordinary shares of US$0.0109 each (2009: 700,000 ‘B’ ordinary shares of US$0.0109 each) as at December 31, 2010.
         
  Class ‘A’ Ordinary shares  Class ‘A’ Ordinary shares 
In thousands of shares 2008  2007 
         
In issue at January 1  74,757   73,602 
Issued for cash  7,260   285 
Issued for non cash (note 21)     870 
       
In issue at December 31  82,017   74,757 
       
         
  Class ‘B’ Ordinary shares  Class ‘B’ Ordinary shares 
In thousands of shares 2008  2007 
         
In issue at January 1  700   700 
Issued for cash      
       
In issue at December 31  700   700 
       
The Group had authorised share capital of 200,000,000 ‘A’ ordinary shares of US$0.0109 each (2007: 200,000,000 ‘A’ ordinary shares of US$0.0109 each) and 700,000 ‘B’ ordinary shares of US$0.0109 each (2007: 700,000 ‘B’ ordinary shares of US$0.0109 each) as at December 31, 2008.
(a) During 2008,2010, the Group issued 7,260,816 “A” Ordinary shares as part of a private placement. These shares were issued for a consideration of US$7,116,000, settled in cash. The Group incurred costs of US$439,000 in connection with the issue of shares.
(b)During 2007, the Group issued 285,2161,165,000 ‘A’ Ordinary shares from the exercise of warrants and employee options for a consideration of US$454,000,1,023,000 settled in cash. A further 870,052 shares (equivalent to US$1,821,000) were issued on a non cash basis as the Group made its final convertible debt repayment by way of shares during the year, which resulting in the release of the carrying amount of the convertible notes liability on the balance sheet (see note 21). In 2007, theThe Group incurred costs of US$76,000 (2006: US$1,168,000) (2005: US$317,000)64,000 in connection with the issue of shares.
(c)(b) In April 2006, Trinity Biotech completed a US$25,005,000 private placement of 11,593,840 of ClassDuring 2009, the Group issued 935,000 ‘A’ Ordinary Shares of the Group. The Group issued a further 145,156 shares from the exercise of employee options for a consideration of US$214,000. Transactions897,000 settled in cash. The Group incurred costs relating toof US$68,000 in connection with the private placement and the exerciseissue of employee options amounted to US$1,168,000. 1,821,980 shares (equivalent to US$3,644,000) were issued on a non cash basis as the Group made part of its convertible debt repayments by way of shares (see note 21).shares.
(d)(c) Since its incorporation the Group has not declared or paid dividends on its ‘A’ Ordinary Shares or ‘B’ Ordinary Shares. The Group anticipates, forIn 2011 the foreseeable future,Company announced that it intended to commence a dividend policy, to be paid once a year. In this regard, the Board have proposed a final dividend of 10 cent per ADR in respect of 2010 and this proposal will retain any future earnings in orderbe submitted to fund its business operations. The Group does not, therefore, anticipate paying any cash or share dividends on its ‘A’ Ordinary or ‘B’ Ordinary shares inshareholders for their approval at the foreseeable future.next Annual General Meeting of the Company. As provided in the Articles of Association of the Company, dividends or other distributions will beare declared and paid in US Dollars.
(e)(d) The Class ‘B’ Ordinary Shares have two votes per share and the rights to participate in any liquidation or sale of the Group and to receive dividends as if each Class ‘B’ Ordinary Share were two Class ‘A’ Ordinary Shares. In all other respects they rank pari passu with the ‘A’ ordinary shares.
Currency translation reserve
The currency translation reserve comprises all foreign exchange differences arising from the translation of the financial statements of foreign currency denominated operations of the Group since January 1, 2004.

 

106105


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
18.CAPITAL AND RESERVES (CONTINUED)
Warrant reserve
The warrant reserve comprises the equity component of share warrants issued by the Group for the purpose of fundraising. The Group calculates the fair value of warrants at the date of issue taking the amount directly to a separate reserve within equity. The fair value is calculated using the trinomial model. The fair value which is assessed at the grant date is calculated on the basis of the contractual term of the warrants.
In accordance with IFRS 2, 1,258,824 warrants with a fair value of US$3,803,000 (2007: 1,258,824 warrants with a fair value of US$3,803,000) have been classified as a separate reserve. A further 58,500 warrants were issued by the Group in 2001 and consequently they do not fall within scope of IFRS 2 and hence have not been fair valued. In 2008 the Group issued 2,178,244 warrants with a fair value of US$695,000. There were no new warrants issued by the Group in 2007.
In accordance with IFRS 2, 3,477,068 warrants with a fair value of US$4,529,000 (2009: 3,437,068 warrants with a fair value of US$4,498,000) have been classified as a separate reserve. There were no new warrants issued by the Group in 2009.
The following input assumptions were made to fair value the warrants issued by the Group during 2008:
The following input assumptions were made to fair value the warrants issued by the Group during 2010:
     
Fair value at date of measurement US$0.77
Share priceUS$1.50
Exercise priceUS$1.50
Expected volatility72.65%
Contractual life7 years
Risk free rate1.62%
Expected dividend yield
The following input assumptions were made to fair value the warrants issued by the Group during 2008:
Fair value at date of measurementUS$0.32
 
     
Share price US$0.91 
Exercise price US$1.39 
Expected volatility  51.31%
Contractual life 5 years 
Risk free rate  2.57%
Expected dividend yield   
The following input assumptions were made to fair value the warrants previously issued by the Group in 2004:Hedging reserve
  
FairThe hedging reserve comprises the effective portion of the cumulative net change in the fair value at date of measurementUS$3.02
Share priceUS$4.78
Exercise priceUS$5.25
Expected volatility78.31%
Contractual life5 years
Risk free rate3.26%
Expected dividend yieldcash flow hedging instruments related to hedged transactions entered into but not yet crystallised.
Hedging reserve
The hedging reserve comprises the effective portion of the cumulative net change in the fair value of cash flow hedging instruments related to hedged transactions entered into but not yet crystallised.
Convertible notes — equity component
Under IAS 32, the equity and liability elements of the convertible notes are recorded separately, with the equity component of the convertible notes being calculated as the excess of the issue proceeds over the present value of the future interest and principal repayments, discounted at the market rate of interest applicable to similar liabilities that do not have a conversion option. Transaction costs are allocated to the liability and equity components in proportion to the allocation of proceeds. On January 2, 2007, the maturity date of the convertible notes, the amount classified as equity of US$164,000 was reclassified from equity to retained earnings.

107


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
19. SHARE OPTIONS AND SHARE WARRANTS
Warrants
The Company granted warrants to purchase 940,405 Class ‘A’ Ordinary Shares in the Company to agents of the Company who were involved in the Company’s private placements in 1994 and 1995 and the debenture issues in 1997, 1999 and 2002. A further warrant to purchase 100,000 Class ‘A’ Ordinary Shares was also granted to a consultant of the Company. At December 31, 2008 there were no warrants outstanding under these awards. In January 2004, the Company completed a private placement of 5,294,118 Class ‘A’ Ordinary Shares of the Company at a price of US$4.25 per ‘A’ Ordinary share. The investors were granted five year warrants (vesting immediately) to purchase an aggregate of 1,058,824 Class ‘A’ Ordinary Shares in the Company at an exercise price of US$5.25 per share. The Company granted further warrants (vesting immediately) to purchase 200,000 Class ‘A’ Ordinary Shares in the Company to agents of the Company who were involved in this private placement in January 2004 at an exercise price of US$5.25. These warrants also have a term of five years. At December 31, 2008 there were warrants to purchase 1,258,824 ‘A’ Ordinary shares in the Company outstanding under this award.
The Company granted warrants to purchase 2,178,244 Class ‘A’ Ordinary Shares (vesting immediately) in April 2008. These warrants were issued at an exercise price of US$1.39 and have a term of five years.
The Company granted warrants to purchase 2,178,244 Class ‘A’ Ordinary Shares (vesting immediately) in April 2008. These warrants were issued at an exercise price of US$1.39 and have a term of five years.
The Company granted warrants to purchase 40,000 Class ‘A’ Ordinary Shares (vesting immediately) in April 2010. These warrants were issued at an exercise price of US$1.50 and have a seven year life.
         
  December 31, 2008  December 31, 2007 
Outstanding at beginning of year  1,258,824   1,317,324 
Granted  2,178,244    
Exercised     (10,000)
Forfeited     (48,500)
       
Outstanding at end of year  3,437,068   1,258,824 
       
Options
Under the terms of the Company’s Employee Share Option Plan, options to purchase 8,374,046 (excluding warrants of 3,437,068) ‘A’ Ordinary Shares were outstanding at December 31, 2008. Under the plan, options are granted to officers, employees and consultants of the Group at the discretion of the Compensation Committee (designated by the board of directors), under the terms outlined below.
The terms and conditions of the grants are as follows, whereby all options are settled by physical delivery of shares:
Vesting conditions
The options vest following a period of service by the officer or employee. The required period of service is determined by the Compensation Committee at the date of grant of the options (usually the date of approval by the Compensation Committee) and it is generally over a four year period. There are no market conditions associated with the share option grants.
Contractual life
The term of an option is determined by the Compensation Committee, provided that the term may not exceed seven years from the date of grant (some of the Group’s earlier plans had a ten year life). All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group (or one year after such termination because of death or disability) except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, the Compensation Committee may accelerate the exercisability and termination of the options up to a maximum of one year.
         
  December 31, 2010  December 31, 2009 
      
Outstanding at beginning of year  2,178,244   3,437,068 
Granted  40,000    
Exercised  (546,000)   
Forfeited     (1,258,824)
       
Outstanding at end of year  1,672,244   2,178,244 
       

 

108106


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
The number and weighted average exercise price of share options and warrants per ordinary share is as follows (as required by IFRS 2, this information relates to all grants of share options and warrants by the Group):
19.SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
             
      Weighted-    
      average    
  Options and  exercise price  Range 
  warrants  US$  US$ 
Outstanding January 1, 2006  8,848,457   2.35   0.81-5.25 
Granted  1,617,000   2.02   1.35-2.30 
Exercised  (145,155)  1.47   0.98-1.75 
Forfeited  (708,235)  2.15   0.81-5.00 
          
Outstanding at end of period  9,612,067   2.32   0.98-5.25 
          
             
Exercisable at end of year  5,605,469   2.50   0.98-5.25 
          
Outstanding January 1, 2007  9,612,067   2.32   0.98-5.25 
Granted  364,667   2.24   1.35-2.80 
Exercised  (285,210)  1.59   0.98-2.72 
Forfeited  (623,405)  2.07   0.98-4.00 
          
Outstanding at end of period  9,068,119   2.36   0.98-5.25 
          
             
Exercisable at end of year  6,417,223   2.48   0.98-5.25 
          
Outstanding January 1, 2008  9,068,119   2.36   0.98-5.25 
Granted  4,378,244   1.14   0.74-1.66 
Exercised         
Forfeited  (1,635,249)  1.58   0.74-4.50 
          
Outstanding at end of period  11,811,114   2.01   0.74-5.25 
          
             
Exercisable at end of year  8,670,013   2.27   0.74-5.25 
          
Options
There were no share options exercised in 2008. The weighted average share price per ‘A’ Ordinary share at the date of exercise for options exercised in 2007 was US$2.59 (2006: US$2.19).
Under the terms of the Company’s Employee Share Option Plans, options to purchase 9,281,427 (excluding warrants of 1,672,244) ‘A’ Ordinary Shares were outstanding at December 31, 2010. Under the Plans, options are granted to officers, employees and consultants of the Group at the discretion of the Compensation Committee (designated by the board of directors), under the terms outlined below.
The opening share price per ‘A’ Ordinary share at the start of the financial year was US$1.65 (2007: US$2.14) (2006: US$2.04) and the closing share price at December 31, 2008 was US$0.40 (2007: US$1.70) (2006: US$2.14). The average share price for the year ended December 31, 2008 was US$0.93.
The terms and conditions of the grants are as follows, whereby all options are settled by physical delivery of shares:
A summary of the range of prices for the Company’s stock options and warrants for the year ended December 31, 2008 follows:Vesting conditions
                         
  Outstanding  Exercisable 
          Weighted-          Weighted- 
          avg          avg 
        contractual        contractual 
      Weighted-  life      Weighted-  life 
Exercise price No. of  avg exercise  remaining  No. of  avg exercise  remaining 
range options/warrants  price  (years)  options/warrants  price  (years) 
                         
US$0.74-US$0.99  2,093,667  US$0.87   4.28   833,667  US$0.98   0.75 
                         
US$1.00-US$2.05  5,338,372  US$1.47   3.78   4,165,860  US$1.50   3.36 
                         
US$2.06-US$2.99  2,908,750  US$2.36   3.80   2,200,162  US$2.43   3.42 
                         
US$3.00-US$5.25  1,470,325  US$4.96   0.35   1,470,324  US$4.96   0.35 
                       
                         
   11,811,114           8,670,013         
                       
The options vest following a period of service by the officer or employee. The required period of service is determined by the Compensation Committee at the date of grant of the options (usually the date of approval by the Compensation Committee) and it is generally over a three to four year period. There are no market conditions associated with the share option grants.
Contractual life
The term of an option is determined by the Compensation Committee, provided that the term may not exceed seven years from the date of grant (some of the Group’s earlier Plans had a ten year life). All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group (or one year after such termination because of death or disability) except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, the Compensation Committee may accelerate the exercisability and termination of the options up to a maximum of one year.
The number and weighted average exercise price of share options and warrants per ordinary share is as follows (as required by IFRS 2, this information relates to all grants of share options and warrants by the Group):
             
      Weighted-    
      average    
  Options and  exercise price  Range 
  warrants  US$  US$ 
Outstanding January 1, 2008  9,068,119   2.36   0.98 - 5.25 
Granted  4,378,244  ��1.14   0.74 - 1.66 
Exercised         
Forfeited  (1,635,249)  1.58   0.74 - 4.50 
          
Outstanding at end of year  11,811,114   2.01   0.74 - 5.25 
          
             
Exercisable at end of year  8,670,013   2.27   0.74 - 5.25 
          
Outstanding January 1, 2009  11,811,114   2.01   0.74 - 5.25 
Granted  2,220,000   0.66   0.66 - 0.66 
Exercised  (934,456)  0.96   0.74 - 1.07 
Forfeited  (2,447,948)  3.52   0.87 - 5.25 
          
Outstanding at end of year  10,648,710   1.48   0.66 - 4.00 
          
             
Exercisable at end of year  6,915,952   1.84   0.74 - 4.00 
          
Outstanding January 1, 2010  10,648,710   1.48   0.66 - 4.00 
Granted  3,760,000   1.47   0.97 - 2.00 
Exercised  (1,410,156)  1.02   0.66 - 1.78 
Forfeited  (2,044,883)  1.96   0.87 - 4.00 
          
Outstanding at end of year  10,953,671   1.44   0.66 - 4.00 
          
             
Exercisable at end of year  5,226,413   1.70   0.66 - 4.00 
          
The weighted average share price per ‘A’ Ordinary share at the date of exercise for options exercised in 2010 was US$1.65 (2009: US$1.05). There were no share options exercised in 2008.

 

109107


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
The weighted-average remaining contractual life of options outstanding at December 31, 2008 was 3.45 years (2007: 3.21 years). The information above also includes outstanding warrants.
19.SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
A summary of the range of prices for the Company’s stock options and warrants for the year ended December 31, 2007 follows:
The opening share price per ‘A’ Ordinary share at the start of the financial year was US$1.04 (2009: US$0.40) (2008: US$1.68) and the closing share price at December 31, 2010 was US$2.20 (2009: US$1.01) (2008: US$0.40). The average share price for the year ended December 31, 2010 was US$1.54.
                         
  Outstanding  Exercisable 
          Weighted-          Weighted- 
          avg          avg 
         contractual         contractual 
      Weighted-  life      Weighted-  life 
Exercise price No. of  avg exercise  remaining  No. of  avg exercise  remaining 
range options  price  (years)  options  price  (years) 
                         
US$0.81-US$0.99  1,218,834  US$0.98   1.44   1,218,834  US$0.98   1.44 
                         
US$1.00-US$2.05  3,033,711  US$1.60   3.32   2,005,868  US$1.55   2.48 
                         
US$2.06-US$2.99  3,250,750  US$2.37   4.66   1,660,364  US$2.49   3.90 
                         
US$3.00-US$5.25  1,564,824  US$4.89   1.37   1,532,157  US$4.92   1.32 
                       
                         
   9,068,119           6,417,223         
                       
A summary of the range of prices for the Company’s stock options and warrants for the year ended December 31, 2010 follows:
The recognition and measurement principles of IFRS 2 have been applied to share options granted under the Company’s share options plans
                         
  Outstanding  Exercisable 
          Weighted-          Weighted- 
          avg          avg 
          contractual          contractual 
      Weighted-  life      Weighted-  life 
  No. of  avg exercise  remaining  No. of  avg exercise  remaining 
Exercise price range options/warrants  price  (years)  options/warrants  price  (years) 
US$0.66-US$0.99  2,761,677   0.72   5.21   638,336   0.72   4.88 
US$1.00-US$2.05  6,430,244   1.48   4.47   2,847,744   1.47   2.39 
US$2.06-US$2.99  1,733,250   2.41   1.59   1,711,833   2.41   1.57 
US$3.00-US$4.00  28,500   3.27   0.69   28,500   3.27   0.69 
                       
   10,953,671           5,226,413         
                       
The weighted-average remaining contractual life of options and warrants outstanding at December 31, 2009 was 4.19 years (2009: 3.88 years).
A summary of the range of prices for the Company’s stock options and warrants for the year ended December 31, 2009 follows:
                         
  Outstanding  Exercisable 
          Weighted-          Weighted- 
          avg          avg 
          contractual          contractual 
      Weighted-  life      Weighted-  life 
  No. of  avg exercise  remaining  No. of  avg exercise  remaining 
Exercise price range options  price  (years)  options  price  (years) 
US$0.66-US$0.99  3,275,000  US$0.70   6.12   196,666  US$0.74   5.72 
US$1.00-US$2.05  4,666,294  US$1.47   3.02   4,141,040  US$1.51   2.76 
US$2.06-US$2.99  2,551,916  US$2.38   2.74   2,422,746  US$2.39   2.66 
US$3.00-US$5.25  155,500  US$3.21   1.37   155,500  US$3.21   1.37 
                       
   10,648,710           6,915,952         
                       
The recognition and measurement principles of IFRS 2 have been applied to share options granted under the Company’s Share Option Plans since November 7, 2002 which have not vested by January 1, 2005 in accordance with IFRS 2.

108


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
19.SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
Charge for the year under IFRS 2
The charge for the year is calculated based on the fair value of the options granted which have not yet vested.
The fair value of the options is expensed over the vesting period of the option. US$1,166,000 was charged to the statement of operations in 2008, (2007: US$1,403,000) (2006: US$1,141,000) split as follows:
             
  December 31,  December 31,  December 31, 
  2008  2007  2006 
  US$’000 US$’000 US$’000
Share-based payments — cost of sales  51   71   89 
Share-based payments — research and development  48   108   36 
Share-based payments — selling, general and administrative  1,067   1,224   1,016 
          
             
Total  1,166   1,403   1,141 
          
The total share based payments charge for the year was US$1,193,000. However, a total of US$27,000 (2007: US$79,000) (2006: US$121,000) of research and development share based payments were capitalised in intangible development project assets during the year.

110


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
The charge for the year is calculated based on the fair value of the options granted which have not yet vested.
 The fair value of the options is expensed over the vesting period of the option. US$1,109,000 was charged to the statement of operations in 2010, (2009: US$521,000), (2008: US$1,166,000) split as follows:
The fair value of services received in return for share options granted are measured by reference to the fair value of share options granted. The estimate of the fair value of services received is measured based on a trinomial model. The following are the input assumptions used in determining the fair value of share options granted in 2008, 2007 and 2006:
             
  December 31,  December 31,  December 31, 
  2010  2009  2008 
  US$‘000  US$‘000  US$‘000 
Share-based payments — cost of sales  29   19   51 
Share-based payments — research and development  31   15   48 
Share-based payments — selling, general and administrative  1,049   487   1,067 
          
Total  1,109   521   1,166 
          
                         
  Key    Key      Key    
  management  Other  management  Other  management  Other 
  personnel  employees  personnel  employees  personnel  employees 
  2008  2008  2007  2007  2006  2006 
Weighted average fair value at measurement date US$0.47  US$0.39     US$0.96  US$1.17  US$0.97 
Total share options granted  1,665,000   535,000      364,667   860,000   757,000 
                   
                         
Weighted average share price US$0.89  US$0.92     US$2.28  US$2.09  US$1.95 
Weighted average exercise price US$0.89  US$0.92     US$2.28  US$2.09  US$1.95 
Weighted average expected volatility  51.61%  46.79%     47.41%  56.11%  54.88%
Weighted average expected life 6.36 years  4.60 years     4.18 years  5.73 years  4.47 years 
Weighted average risk free interest rate  2.77%  3.28%     4.35%  4.55%  4.83%
Expected dividend yield  0%  0%     0%  0%  0%
The total share based payments charge for the year was US$1,240,000. However, a total of US$131,000 (2009: US$78,000) (2008: US$27,000) of research and development share based payments were capitalised in intangible development project assets during the year.
No options were granted to the key management during 2007.
The fair value of services received in return for share options granted are measured by reference to the fair value of share options granted. The estimate of the fair value of services received is measured based on a trinomial model. The following are the input assumptions used in determining the fair value of share options granted in 2010, 2009 and 2008:
                         
  Key      Key      Key    
  management  Other  management  Other  management  Other 
  personnel  employees  personnel  employees  personnel  employees 
  2010  2010  2009  2009  2008  2008 
Weighted average fair value at measurement date US$0.86  US$0.72  US$0.38     US$0.47  US$0.39 
Total share options granted  2,500,000   1,220,000   2,220,000      1,665,000   535,000 
                   
                         
Weighted average share price US$1.53  US$1.34  US$0.66     US$0.89  US$0.92 
Weighted average exercise price US$1.53  US$1.34  US$0.66     US$0.89  US$0.92 
Weighted average expected volatility  64.86%  68.97%  63.31%     51.61%  46.79%
Weighted average expected life  5.34   4.33  5.73 years     6.36 years  4.60 years 
Weighted average risk free interest rate  2.04%  1.78%  2.47%     2.77%  3.28%
Expected dividend yield  0%  0%  0%     0%  0%
The expected life of the options is based on historical data and is not necessarily indicative of exercise patterns that may occur. The expected volatility is based on the historic volatility (calculated based on the expected life of the options). The Group has considered how future experience may affect historical volatility. The profile and activities of the Group are not expected to change in the immediate future and therefore Trinity Biotech would expect estimated volatility to be consistent with historical volatility.

109


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
20. INTEREST-BEARING LOANS AND BORROWINGS
  This note provides information about the contractual terms of the Group’s interest-bearing loans and borrowings. For more information about the Group’s exposure to interest rate and foreign currency risk, see note 29.27.
            
 December 31, 2008 December 31, 2007             
 Note US$’000 US$’000  December 31, 2010 December 31, 2009 
  Note US$’000 US$’000 
Current liabilities
  
Finance lease liabilities 430 657  162 791 
Bank loans, secured  27(c)   25(c) 
- Repayable by instalment 5,302 8,220   4,890 
- Repayable not by instalment 6,924 6,944   6,944 
          
 12,656 15,821  162 12,625 
            
  
Non-current liabilities
  
Finance lease liabilities 1,138 1,648  111 1,470 
Bank loans, secured  27(c)   25(c) 
- Repayable by instalment 22,327 24,664   17,761 
          
 23,465 26,312  111 19,231 
            
Bank loans
Trinity Biotech has a US$48,340,000 club banking facility with Allied Irish Bank plc and Bank of Scotland (Ireland) Limited (“the banks”). The facility consists
During 2010 the Group repaid in full all outstanding bank loans following the receipt of the proceeds from the sale of the Coagulation business (for further information, please refer to note 3). Before the repayment of these loans, Trinity Biotech had a US$48,340,000 club banking facility with Allied Irish Bank plc and Bank of Scotland (Ireland) Limited (“the banks”). This facility consisted of a US Dollar floating interest rate term loan of US$41,340,000 which runs until July 2012, and a one year revolver of US$7,000,000. Various covenants applied to these Group bank borrowings. At December 31, 2010, the total amount outstanding under this facility amounted to US$NIL (2009: US$29,327,000, net of unamortised funding costs of US$180,000).
Finance lease liabilities
Finance lease liabilities are payable as follows:
             
  December 31, 2010 
  US$’000 
  Minimum       
  lease       
  payments  Interest  Principal 
Less than one year  172   10   162 
In more than one year, but not more than two  113   2   111 
In more than two years but not more than five         
          
   285   12   273 
          
             
  December 31, 2009 
  US$’000 
  Minimum       
  lease       
  payments  Interest  Principal 
Less than one year  909   118   791 
In more than one year, but not more than two  904   66   838 
In more than two years but not more than five  665   32   633 
          
   2,478   216   2,262 
          
Under the terms of the lease arrangements, no contingent rents are payable.

 

111110


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
The facility was amended in October 2008, increasing the length of the term to July 2012, and amending the repayment schedule from $4,134,000 every January and July (originally commencing January 2007) to an amount of $1,072,000 in July 2008, $2,144,000 in January 2009, $3,215,000 in July 2009 and every six months thereafter. Hence, during 2008 amounts of $4,134,000 and $1,072,000 were paid in January and July respectively. The revolver loan element of the facility has remained at US$7,000,000. This facility is secured on the assets of the Group (see note 27 (c)).
Various covenants apply to the Group’s bank borrowings. At December 31, 2008, the total amount outstanding under the facility amounted to US$34,551,000, net of unamortised funding costs of US$315,000.
Finance lease liabilities
Finance lease liabilities are payable as follows:
             
  December 31, 2008
US$’000
 
  Minimum       
  lease      
  payments  Interest  Principal 
Less than one year  514   84   430 
In more than one year, but not more than two  477   58   419 
In more than two years but not more than five  757   38   719 
          
   1,748   180   1,568 
          
             
  December 31, 2008
US$’000
 
  Minimum       
  lease       
  payments  Interest  Principal 
             
Less than one year  779   122   657 
In more than one year, but not more than two  550   89   461 
In more than two years but not more than five  1,287   100   1,187 
          
   2,616   311   2,305 
          
Under the terms of the lease arrangements, no contingent rents are payable.
Promissory notes
During 2006, the Group issued a promissory note for the payment of deferred consideration to bioMerieux as part of the acquisition of their haemostasis business. However, these notes were non-interest bearing and are included under Other Financial Liabilities at December 31, 2007 (see note 23). The deferred consideration was paid in full in 2008 and accordingly, there is no liability at 31 December, 2008.
20.INTEREST-BEARING LOANS AND BORROWINGS (CONTINUED)
Terms and debt repayment schedule
The terms and conditions of outstanding interest bearing loans and borrowings at December 31, 2008 are as follows:
                             
      Nominal      Fair  Carrying  Fair  Carrying 
      interest  Year of  Value  Value  Value  Value 
Facility Currency  rate  maturity  December 31, 2008  December 31, 2007 
Fixed bank loans USD  5.00%  2009   2   2   19   20 
Floating (LIBOR) bank loans USD  2.74%  2009 – 2012   34,551   34,551   39,808   39,808 
Finance lease liabilities Euro  6.13%  2009 – 2012   1,551   1,524   2,153   2,142 
Finance lease liabilities GBP  7.54%  2009 – 2010   44   44   145   163 
                         
                             
Total interest-bearing loans and borrowings
              36,148   36,121   42,125   42,133 
                         

112


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
21.CONVERTIBLE NOTES — INTEREST BEARING
  
The terms and conditions of outstanding interest bearing loans and borrowings at December 31, 2008December 31, 2007
US$’000US$’000
Convertible notes
Due within one year
Total
2010 are as follows:
At December 31, 2008 and December 31, 2007 the balance outstanding on the convertible notes, resulting from the private placement of US$20,000,000 in July 2003 and a further US$5,000,000 in January 2004 was US$nil. The final principal repayment of US$1,822,000 was made by way of shares in January 2007. The final interest payment of US$14,000 was made in cash on the same date.
Under IAS 32, the equity and liability elements of the convertible notes were recorded separately, with the equity component of the convertible notes being calculated as the excess of the issue proceeds over the present value of the future interest and principal repayments, discounted at the market rate of interest applicable to similar liabilities that do not have a conversion option. Transaction costs were allocated to the liability and equity components in proportion to the allocation of proceeds. The corresponding interest expense recognised in the statement of operations is calculated using the effective interest rate method. The effective interest rate is the normal coupon rate of 3% adjusted for the effect of transaction costs and the amount classified as equity.
                             
      Nominal                 
      interest  Year of  Fair  Carrying  Fair  Carrying 
Facility Currency  rate  maturity  Value  Value  Value  Value 
           December 31, 2010  December 31, 2009 
                             
Fixed bank loans USD  5.00% - 6.00%  2010         268   268 
Floating (LIBOR) bank loans USD  2.53%  2010         29,327   29,327 
Finance lease liabilities Euro  5.16%  2010 -2012   273   273   2,268   2,257 
Finance lease liabilities GBP  7.72%  2010         5   5 
                         
                             
Total interest-bearing loans and borrowings
              273   273   31,868   31,857 
                         
20082007
US$’000US$’000
Proceeds from issue of convertible notes25,000
Transaction costs(1,307)
Net23,693
Converted to shares(17,355)
Cash repayments(7,288)
Amount classified as equity(297)
Accreted interest capitalised1,247
Carrying amount of liability at December 31
The amount of the convertible notes classified as equity on January 1, 2005 of US$297,000 is net of attributable transaction costs of US$16,000. Of the US$297,000, US$71,000 has been reclassified from equity to share capital and share premium following the share conversions in December 2003 and January 2004. On January 2, 2007, the maturity date of the convertible notes, the amount classified as equity of US$226,000 was stated net of the related deferred tax asset of US$62,000 and carried at US$164,000. The net balance of US$164,000 classified as equity at the date of maturity was reclassified from equity to retained earnings on maturity.
22.21. TRADE AND OTHER PAYABLES
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
Trade payables  11,585   8,454 
Payroll taxes  393   514 
Employee related social insurance  429   520 
Accrued restructuring expenses  1,144   2,016 
Accrued liabilities  7,506   11,821 
Deferred income  1,912   1,454 
       
   22,969   24,779 
       

113


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
         
  December 31, 2010  December 31, 2009 
  US$’000  US$’000 
       
Trade payables  3,267   3,693 
Payroll taxes  74   424 
Employee related social insurance  85   485 
Accrued liabilities  7,379   6,926 
Deferred income  642   1,316 
       
   11,447   12,844 
       
  
Accrued restructuring expenses
The restructuring accrual at the year endIncluded within accrued liabilities is an amount of US$89,000 which relates to contract termination costs and employee termination benefits associated with the restructuring announced in December2010 (see note 3)7).
Following the announcement of the restructuring in December 2007 (see note 3), the Group recognised an accrual of US$2,016,000 for expected restructuring costs. Of the total restructuring accrual of US$2,016,000, US$1,470,000 related to costs accrued for contract termination costs and employee termination benefits and included US$332,000 for termination payments accrued as part of the closure of the Swedish operation. US$116,000 related to a building lease and other non-redundancy obligations arising from the closure of the Swedish manufacturing operation.
23.OTHER FINANCIAL LIABILITIES
December 31, 2008December 31, 2007
US$’000US$’000
Consideration
Due within 1 year2,725
2,725
Consideration
In June 2006, the Group acquired the haemostasis business of bioMerieux for a cash consideration of US$38.2 million. In addition bioMerieux was entitled to deferred consideration up to a maximum of US$6.2 million, payable in June 2007 and up to an additional US$5.3 million, payable in June 2008, depending on the performance of the business during 2006. At December 31, 2006, it was determined that the deferred consideration of US$3.2 million and US$2.8 million would be payable in July 2007 and July 2008 respectively. Deferred consideration of US$3,208,000 was paid in July 2007. In accordance with the Group’s policy these deferred consideration amounts have been discounted to reflect their fair value at the date of acquisition. At December 31, 2007, the fair value of the deferred consideration still outstanding amounted to US$2,725,000 (2006: US$5,688,000). In June 2008, the final portion of the deferred consideration of US$2,802,000 was paid and accordingly, there was no liability at December 31, 2008.
24.22. PROVISIONS
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
Provisions  50   100 
       
         
  December 31, 2010  December 31, 2009 
  US$’000  US$’000 
      
Provisions  50   50 
       
  Movement on provisions during the year is as follows:
        
         December 31, 2010 December 31, 2009 
 December 31, 2008 December 31, 2007  US$’000 US$’000 
 US$’000 US$’000  
Balance at January 1 100 100  50 50 
Provisions released during the year  (50)     
          
Balance at December 31 50 100  50 50 
          
  During 20082010 the Group experienced no significant product warranty claims. However, the Group believes that it is appropriate to retain a product warranty provision to cover any future claims. The provision at December 31, 20082010 represents the estimated cost of product warranties, the exact amount which cannot be determined. US$50,000 represents management’s best estimate of these obligations at December 31, 2008.2010.
25.OTHER PAYABLES
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
Other payables  59   74 
       

 

114111


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
26.23.OTHER PAYABLES DUE AFTER ONE YEAR
         
  December 31, 2010  December 31, 2009 
  US$’000  US$’000 
Other payables  30   59 
       
   30   59 
       
24. BUSINESS COMBINATIONS
Acquisitions 2008 — 2010
2008Acquisitions
  There were no acquisitions made by the Group in the current financial year.between 2008 and 2010.
2007 Acquisitions
2007Acquisitions
  In September 2007, the Group acquired the immuno technology business of Cortex Biochem Inc (“Cortex”) for a total cash consideration of US$2,925,000, consisting of cash consideration of US$2,887,000 and acquisition expenses of US$38,000.
  In October 2007, the Group acquired certain components relating to the distribution business of Sterilab Services UK (“Sterilab”), a distributor of Infectious Diseases products, for a total of US$1,489,000, consisting of cash consideration of US$1,480,000 and acquisition expenses of US$9,000.
  The results for both acquisitions in 2007 are incorporated from the date of acquisition in the consolidated statement of operations for the year ended December 31, 2007.
             
  Cortex  Sterilab  Total 
  US$’000  US$’000  US$’000 
Property, plant and equipment     23   23 
Inventories  41   88   129 
Trade and other receivables  152      152 
Intangible assets  844   656   1,500 
          
   1,037   767   1,804 
          
             
Deferred tax liability (see note 13)  102   183   285 
Trade and other payables  45      45 
          
   147   183   330 
          
             
Fair value of net assets  890   584   1,474 
Goodwill arising on acquisition  2,035   905   2,940 
          
   2,925   1,489   4,414 
          
             
Consideration:            
Cash payments  2,887   1,480   4,367 
Costs associated with the acquisition  38   9   47 
          
   2,925   1,489   4,414 
          

 

115112


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
24.BUSINESS COMBINATIONS (CONTINUED)
  Goodwill capitalised during 2007 in respect of the Cortex and Sterilab acquisitions amounted to US$2,940,000 and comprised:
                     
      Fair value          
  Book values  adjustments  Fair value  Consideration  Goodwill 
  US$’000  US$’000  US$’000  US$’000  US$’000 
Cortex
                    
Trade and other receivables  152      152         
Inventories  218   (177)  41         
Intangible assets     844   844         
                  
   370   667   1,037         
                  
                     
Deferred tax liability     102   102         
Trade and other payables  45      45         
                
   325   565   890   2,925   2,035 
                
                     
Sterilab
                    
Property, plant and equipment  23      23         
Inventories  99   (11)  88         
Intangible assets     656   656         
                  
   122   645   767         
                  
                     
Deferred tax liability     183   183         
Trade and other payables                 
                
   122   462   584   1,489   905 
                
Impact of the acquisition on the statement of operations and cashflow
Impact of the acquisition on the statement of operations and cashflow
  Due to their size, the impact of the acquisition of Cortex and Sterilab does not have a significant impact on the statement of operations and cashflow in 2007.
  The following represents the increases to goodwill which took place in 2007.
     
  US$’000 
Goodwill recognised with respect to 2007 acquisitions    
- Cortex  2,035 
- Sterilab  905 
Goodwill recognised with respect to 2006 acquisitions    
- bioMerieux  42 
    
Total goodwill movement in 2007  2,982 
    
2006Acquisitions
In June 2006, Trinity Biotech acquired the haemostasis business of bioMerieux Inc. (“bioMerieux”) for a total consideration of US$44.4 million, consisting of cash consideration of US$38.2 million, deferred consideration of US$5.5 million (net of discounting) and acquisition expenses of US$0.7 million. At December 31, 2006, Trinity Biotech had accrued US$5,688,000 for the deferred consideration to be paid in June 2007 and June 2008 (see note 23). Deferred consideration of US$3,208,000 (US$3,120,000 net of discounting) was paid to bioMerieux in June 2007. At December 31, 2007, the Group had accrued deferred consideration US$2,725,000 to be paid in June 2008. A payment of $2,802,000 was paid to bioMerieux in June 2008 in respect of the final portion of this deferred consideration and accordingly there is no liability at December 31, 2008.

 

116


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
In October, 2006, Trinity Biotech acquired the French distribution business of Laboratoires Nephrotek SARL (“Nephrotek”) for a total consideration of US$1,175,000, consisting of cash consideration of US$1,060,000 and acquisition expenses of US$115,000.
The results of these acquisitions for 2006 are incorporated from the date of acquisition in the consolidated statement of operations for the year ended December 31, 2006. The fair value of the identifiable assets and liabilities were as follows:
             
  bioMerieux  Nephrotek  Total 
  US$’000  US$’000  US$’000 
Property, plant and equipment  2,354   64   2,418 
Inventories  12,529   345   12,874 
Intangible assets  11,150   235   11,385 
          
   26,033   644   26,677 
          
             
Deferred tax liability (see note 13)  1,293   77   1,370 
Trade and other payables  1,319   69   1,388 
          
   2,612   146   2,758 
          
             
Fair value of net assets  23,421   498   23,919 
Goodwill arising on acquisition  21,002   677   21,679 
          
   44,423   1,175   45,598 
          
             
Consideration:            
Cash payments  38,157   821   38,978 
Deferred consideration  5,511   239   5,750 
Costs associated with the acquisition  755   115   870 
          
   44,423   1,175   45,598 
          
Goodwill capitalised during 2006 in respect of the acquired haemostasis business from bioMerieux and the acquired distribution business from Nephrotek amounted to US$21,679,000 and comprises:
                     
      Fair value          
  Book values  adjustments  Fair value  Consideration  Goodwill 
  US$’000  US$’000  US$’000  US$’000  US$’000 
bioMerieux
                    
Property, plant and equipment  2,659   (305)  2,354         
Inventories (including prepayments)  12,848   (319)  12,529         
Intangible assets     11,150   11,150         
                  
   15,507   10,526   26,033         
                  
                     
Deferred tax liability     1,293   1,293         
Trade and other payables  1,219   100   1,319         
                
   14,288   9,133   23,421   44,423   21,002 
                
                     
Nephrotek
                    
Property, plant and equipment  96   (32)  64         
Inventories  394   (49)  345         
Intangible assets     235   235         
                  
   490   154   644         
                  
                     
Deferred tax liability     77   77         
Trade and other payables  40   29   69         
                
   450   48   498   1,175   677 
                

117113


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
During the period, following the acquisition, fair value adjustments were made to recognise intangible assets acquired in 2006. The inventory acquired under the acquisition of the haemostasis business of bioMerieux was provided to Trinity Biotech on a phased basis over the 12 month period after the acquisition date. Consequently, at December 31, 2006, the fair valuation of inventory had been assessed on a provisional basis and the fair value exercise was completed in 2007. The final fair valuation of inventory resulted in a write down during 2007 of inventory acquired of US$42,000. The fair value of all other assets and liabilities was complete at December 31, 2006.
                 
  Provisional  Adjustments  Adjustments  Final 
  fair value  to net assets  to costs  fair value 
  2006  2007  2007  2007 
  US$’000 US$’000 US$’000 US$’000
bioMerieux
                
Intangible assets  11,150         11,150 
Working capital  14,883   (42)     14,841 
             
   26,033   (42)     25,991 
             
                 
Deferred tax liability  1,293         1,293 
Trade and other payables  1,319         1,319 
             
   23,421   (42)     23,379 
             
                 
Consideration and costs  44,423         42,423 
             
27.25. COMMITMENTS AND CONTINGENCIES
(a) 
Capital Commitments
  The Group has no capital commitments authorised and contracted for as at December 31, 2008 (2007:2010 (2009: US$Nil).
(b) 
Leasing Commitments
  The Group leases a number of premises under operating leases. The leases typically run for periods up to 25 years. Lease payments are reviewed periodically (typically on a 5 year basis) to reflect market rentals. Operating lease commitments payable during the next 12 months amount to US$4,438,000 (2007:2,411,000 (2009: US$4,943,000)4,289,000) payable on leases of buildings at Dublin and Bray, Ireland, Berkshire, UK, Paris, France, Jamestown, New York, Kansas City, Missouri, New Jersey, Concord,Acton, Massachusetts and Carlsbad, California and motor vehicles and equipment in the UK and Germany.California. US$181,000 (2007:42,000 (2009: US$170,000)415,000) of these operating lease commitments relates to leases whose remaining term will expire within one year, US$902,000 (2007:172,000 (2009: US$1,084,000)406,000) relates to leases whose remaining term expires between one and two years, US$350,000 (2007:345,000 (2009: US$574,000)395,000) between two and five years and the balance of US$3,005,000 (2007:1,852,000 (2009: US$3,115,000)3,073,000) relates to leases which expire after more than five years. See note 2826 for related party leasing arrangements.

118


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
  Future minimum operating lease commitments with non-cancellable terms in excess of one year are as follows:
        
 Year ended  Year ended 
 2008  2010 
 Operating leases  Operating leases 
 US$’000  US$’000 
  
2009 4,438 
2010 3,972 
2011 3,491  2,411 
2012 3,164  2,299 
2013 3,030  2,228 
2014 2,221 
2015 2,099 
Later years 39,595  25,298 
      
  
Total lease obligations 57,690  36,556 
   
        
 Year ended  Year ended 
 2007  2009 
 Operating leases  Operating leases 
 US$’000  US$’000 
  
2008 4,943 
2009 4,370 
2010 3,680  4,289 
2011 3,298  3,743 
2012 3,138  3,486 
2013 3,482 
2014 3,317 
Later years 43,122  35,503 
      
  
Total lease obligations 62,551  53,820 
   
  
For future minimum finance lease commitments, in respect of which the lessor has a charge over the related assets, see note 20.
(c) 
Bank Security
  
The Group repaid in full its bank borrowings in May 2010. In 2009 the Group’s bank borrowings (note 20) arewere secured by a fixed and floating charge over the assets of Group entities, including specific charges over the shares in the subsidiaries and the Group’s patents. Various covenants apply toThese charges were released following the Group’s bank borrowings with respect to profitability, interest cover, capital expenditure, working capital and locationrepayment of assets. As at December 31, 2008 the Group wasloans in breach of one of these covenants which had been waived by the banks. The covenant which was breached concerned minimum tangible net worth for the year end December 31, 2008 (see note 29).
May 2010.

114


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
25. COMMITMENTS AND CONTINGENCIES (CONTINUED)
(d) 
Section 17 Guarantees
  Pursuant to the provisions of Section 17, Irish Companies (Amendment) Act, 1986, the Company has guaranteed the liabilities of Trinity Biotech Manufacturing Limited, Trinity Biotech Manufacturing Services Limited, Trinity Research Limited, Benen Trading Limited and Trinity Biotech Financial Services Limited and Trinity Biotech Sales Limited subsidiary undertakings in the Republic of Ireland, for the financial year to December 31, 20082010 and, as a result, these subsidiary undertakings have been exempted from the filing provisions of Section 17, Irish Companies (Amendment) Act, 1986. Where the Company enters into these guarantees of the indebtedness of other companies within its Group, the Company considers these to be insurance arrangements and accounts for them as such. The Company treats the guarantee contract as a contingent liability until such time as it becomes probable that the company will be required to make a payment under the guarantee. The Company does not enter into financial guaranteeguarantees with third parties.

119


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
(e) 
Government Grant Contingencies
  The Group has received training and employment grant income from Irish development agencies. Subject to existence of certain conditions specified in the grant agreements, this income may become repayable. No such conditions existed as at December 31, 2008.2010. However if the income were to become repayable, the maximum amounts repayable as at December 31, 20082010 would amount to US$1,997,000 (2007:3,373,000 (2009: US$644,000)3,646,000).
(f)
Litigation
 In 2010, Laboratoires Nephrotek, formerly a distributor for Trinity Biotech, took a legal action in France against the Group, claiming damages of US$0.8 million. They claim that certain instruments supplied by Trinity Biotech did not operate properly in the field. No court hearings have occurred in relation to this case yet. Trinity Biotech will be defending the claim. There are also a small number of legal cases being brought against the Group by certain of its former employees in the previously owned French subsidiary, Trinity Biotech France S.à.r.l. The ultimate resolution of the aforementioned proceedings is not expected to have a material adverse effect on our financial position, results of operations or cash flows.
28.26. RELATED PARTY TRANSACTIONS
  The Group has related party relationships with its subsidiaries, and with its directors and executive officers.
Leasing arrangements with related parties
Leasing arrangements with related parties
  The Group has entered into various arrangements with JRJ Investments (“JRJ”), a partnership owned by Mr O’Caoimh and Dr Walsh, directors of the Company, to provide for current and potential future needs to extend its premises at IDA Business Park, Bray, Co. Wicklow, Ireland.
  
In July 2000, Trinity Biotech entered into an agreement with JRJ pursuant to which the Group took a lease of a 25,000 square foot premises adjacent to the existing facility for a term of 20 years at a rent of 7.62€7.62 per square foot for an annual rent of 190,000€190,000 (US$279,000)254,000). During 2006, the rent on this property was reviewed and increased to 11.00€11.00 per square foot, resulting in an annual rent of 275,000€275,000 (US$404,000)367,000).
The lease on this property was assigned to Diagnostica Stago in May, 2010 following the divestiture of the Coagulation business.
  
In November 2002, the Group entered into an agreement for a 25 year lease with JRJ for offices that have been constructed adjacent to its premises at IDA Business Park, Bray, Co. Wicklow, Ireland. The annual rent of 381,000€381,000 (US$560,000)509,000) is payable from January 1, 2004.
There was a rent review performed on this premises in 2009 and further to this review, there was no change to the annual rental charge.
  
In December 2007, the Group entered into an agreement with Mr. O’Caoimh and Dr Walsh pursuant to which the Group took a lease on an additional 43,860 square foot manufacturing facility in Bray, Ireland at a rate of 17.94€17.94 per square foot (including fit out) giving a total annual rent of 787,000€787,000 (US$1,158,000)1,051,000).
  Trinity Biotech and its directors (excepting Mr O’Caoimh and Dr Walsh who express no opinion on this point) believe that the arrangements entered into represent a fair and reasonable basis on which the Group can meet its ongoing requirements for premises.
Compensation of key management personnel of the Group
At December 31, 2008, the key management personnel of the Group is made up of three key personnel, the two executive directors and the Chief Financial Officer/Company Secretary, Mr Kevin Tansley. Mr Brendan Farrell served as Chief Executive Officer until October 2008 and, accordingly, his remuneration up to that date has been included in the analysis below.
At December 31, 2007, the key management personnel of the Group was made up of five key personnel, the four executive directors and the Chief Financial Officer/Company Secretary. On November 1, 2007, Mr Kevin Tansley became an executive officer on his appointment to Chief Financial Officer and Company Secretary.
Compensation for the year ended December 31, 2008 of these personnel is detailed below:
         
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
Short-term employee benefits  1,789   2,293 
Compensation for loss of office  1,283    
Post-employment benefits  277   149 
Equity compensation benefits  736   853 
       
   4,085   3,295 
       

 

120115


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
26.RELATED PARTY TRANSACTIONS (CONTINUED)
Compensation of key management personnel of the Group
At December 31, 2010 the key management personnel of the Group were made up of four key personnel: the three executive directors; Mr. Ronan O’Caoimh, Mr. Rory Nealon and Dr. Jim Walsh and Mr. Kevin Tansley, our Chief Financial Officer/Company Secretary. At December 31, 2009 the key management personnel of the Group were made up of three key personnel: the two executive directors; Mr. Ronan O’Caoimh and Mr. Rory Nealon and the Chief Financial Officer/Company Secretary, Mr Kevin Tansley.
Compensation for the year ended December 31, 2010 of these personnel is detailed below:
         
  December 31, 2010  December 31, 2009 
  US$’000  US$’000 
Short-term employee benefits  1,299   1,244 
Performance related bonus  1,050    
Post-employment benefits  155   136 
Equity compensation benefits  828   367 
       
   3,332   1,747 
       
Total director emoluments includedcharged to the statement of operations shown in note 6 is net of amounts capitalised of US$137,000 and includes non executive directors’ fees and other compensation of US$200,000 (2007:357,000 (2009: US$130,000)313,000) and equity compensation benefits of US$39,000 (2007:122,000 (2009: US$67,000)55,000) and excludes the compensation costs of the Chief Financial Officer comprising total remuneration of US$408,000.613,000 (2009: US$317,000) and equity compensation of US$221,000 (2009: US$107,000). Total directors’ remuneration is also included in “personnel expenses” (note 7).
Directors’ and executive officersCompany Secretary’s interests in the Company’s shares and share option plan
         
  ‘A’ Ordinary Shares  Share options 
At January 1, 2008  5,881,205   4,977,083 
Exercised      
Granted     1,665,000 
Additions /(Removals)*  (589,135)  (1,885,000)
Expired Options     (642,998)
Shares sold      
Shares purchased  1,482,000    
       
At December 31, 2008  6,774,070   4,114,085 
       
         
  ‘A’ Ordinary Shares  Share options 
At January 1, 2010  5,671,106   5,667,086 
Exercised     (566,664)
Granted     2,500,000 
Expired Options     (248,333)
Shares purchased/(sold) during the year  (140,000)   
       
At December 31, 2010  5,531,106   7,352,089 
       
*The amounts removed are wholly attributable to shares and share options held by Mr Brendan Farrell as Mr. Farrell was not an executive officer at the year end.
         
  ‘A’ Ordinary Shares  Share options 
At January 1, 2007  5,881,205   4,812,083 
Exercised      
Granted      
Additions     165,000 
Shares sold      
Shares purchased      
       
At December 31, 2007  5,881,205   4,977,083 
       
         
  ‘A’ Ordinary Shares  Share options 
At January 1, 2009  5,520,110   4,114,085 
Exercised     (471,955)
Granted     2,220,000 
Expired Options     (195,044)
Shares purchased  150,996    
       
At December 31, 2009  5,671,106   5,667,086 
       
Rayville Limited, an Irish registered company, which is wholly owned by the two executive directors and certain other executives of the Group, owns all of the ‘B’ non-voting Ordinary Shares in Trinity Research Limited, one of the Group’s subsidiaries. The ‘B’ shares do not entitle the holders thereof to receive any assets of the company on a winding up. All of the ‘A’ voting ordinary shares in Trinity Research Limited are held by the Group. Trinity Research Limited may, from time to time, declare dividends to Rayville Limited and Rayville Limited may declare dividends to its shareholders out of those amounts. Any such dividends paid by Trinity Research Limited are ordinarily treated as a compensation expense by the Group in the consolidated financial statements prepared in accordance with IFRS, notwithstanding their legal form of dividends to minority interests, as this best represents the substance of the transactions.
In February 2008, Dr. Walsh advanced a loan to Trinity Biotech Manufacturing Limited amounting to 650,000 (US$956,000) at an annual interest rate of 5.68%. The company repaid the loan to Dr. Walsh prior to the year end. There were no other director loans advanced during 2008 and there were no loan balances payable to2010 or receivable from directors at January 1, 2008 and at December2009.

116


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008.2010
26.RELATED PARTY TRANSACTIONS (CONTINUED)
In December 2006, the Remuneration Committee ofJune 2009, the Board approved the payment of a dividend of US$5,331,000$2,830,000 by Trinity Research Limited to Rayville Limited on the ‘B’ shares held by it. This amount was then lent back by Rayville to Trinity Research Limited. This loan was partially used to fund executive compensation in 2007 and will fund future executive compensation over the next number of years under the arrangement described above, with the amount of such funding being reflected in compensation expense over the corresponding period. As the dividend payment is matched by a loan from Rayville Limited to Trinity Research Limited which is repayable solely at the discretion of the Remuneration Committee of the Board and is unsecured and interest free, the Group netted the dividend paid to Rayville Limited against the corresponding loan from Rayville Limited in the 2007 and 20062009 & 2010 consolidated financial statements.

121


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
The amount of payments to Rayville included in compensation expense was US$1,911,000,1,866,000, US$2,061,0001,071,000 and US$1,866,0002,149,000 for 2006, 20072008, 2009 and 20082010 respectively, of which US$1,779,000,1,610,000, US$1,867,000887,000 and US$1,609,9051,431,000 respectively related to the key management personnel of the Group. There were no dividends payable to Rayville Limited as of December 31, 2010 or 2009. Dividends payable to Rayville at December 31, 2008 amounted to US$60,000. There were no dividends payable to Rayville Limited as of December 31, 2006 or 2007. Of the US$1,866,0002,149,000 of payments made to Rayville Limited in 2008,2010, US$386,000565,000 represented repayments of the loan to Trinity Research Limited referred to above.
29.27. DERIVATIVES AND FINANCIAL INSTRUMENTS
The Group uses a range of financial instruments (including cash, bank borrowings, convertible notes, promissory notes, finance leases, receivables, payables and derivatives) to fund its operations. These instruments are used to manage the liquidity of the Group in a cost effective, low-risk manner. Working capital management is a key additional element in the effective management of overall liquidity. The Group does not trade in financial instruments or derivatives. The main risks arising from the utilisationutilization of these financial instruments are interest rate risk, liquidity risk and credit risk.
Effective interest rate and repricing analysis
The following table sets out all interest-earning financial assets and interest bearing financial liabilities held by the Group at December 31, indicating their effective interest rates and the period in which they re-price:
                                                        
As at December 31,              Effective           
2008 Effective Total 6 mths or less 6 – 12 mths 1–2 years 2–5 years 
2010 interest Total 6 mths or less 6-12 mths 1-2 years 2-5 years 
US$’000 Note interest rate US$’000 US$’000 US$’000 US$’000 US$’000  Note rate US$’000 US$’000 US$’000 US$’000 US$’000 
Cash and cash equivalents 17  2.16% 5,184 5,184     17  3.24% 58,002 58,002    
Deferred Consideration 14/16  3.1% 21,942 10,804  11,138 
Secured bank loans — floating 20  2.74%  (34,551)  (34,551)     20       
Secured bank loans — fixed 20  5%  (2)  (2)     20       
Finance lease liabilities — fixed 20  6.98%  (1,568)   (16)  (28)  (1,524) 20  5.08%  (273)    (273)  
                      
 
Total  (30,937)  (29,369)  (16)  (28)  (1,524) 79,671 68,806  10,865  
                      

117


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
                             
As at December 31,                      
2007     Effective  Total  6 mths or less  6 – 12 mths  1–2 years  2–5 years 
US$’000 Note  interest rate  US$’000  US$’000  US$’000  US$’000  US$’000 
Cash and cash equivalents  18   4.54%  8,700   8,700          
Secured bank loans — floating  21   6.99%  (39,808)  (39,808)         
Secured bank loans — fixed  21   5%  (20)        (20)   
Finance lease liabilities — fixed  21   6.32%  (2,305)  (6)  (39)  (221)  (2,039)
                        
Total          (33,433)  (31,114)  (39)  (241)  (2,039)
                        
27.DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
                             
As at December 31,                         
2009     Effective  Total  6 mths or less  6-12 mths  1-2 years  2-5 years 
US$’000 Note  interest rate  US$’000  US$’000  US$’000  US$’000  US$’000 
Cash and cash equivalents  17   0.2%  6,078   6,078          
Secured bank loans — floating  20   2.53%  (29,327)  (29,327)         
Secured bank loans — fixed  20   6.00%  (268)           (268)
Finance lease liabilities — fixed  20   6.61%  (2,261)  (5)     (305)  (1,951)
                        
Total          (25,778)  (23,254)     (305)  (2,219)
                        
The effective interest rate on all loans and borrowings is the same as the actual interest rates.

122


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
Interest rate risk
The Group borrows in US dollarsdollars. At December 31, 2010 all of the Group borrowings were at floatingfixed rates of interest. At December 31, 2009 Group borrowings were at both fixed and fixedfloating rates of interest. Year-end borrowings totalled US$36,121,000 (2007:273,000 (2009: US$42,133,000)31,856,000), (net of cash: surplus of US$30,937,000 (2007:57,729,000), (2009: deficit of US$33,433,000))25,778,000), at interest rates ranging from 2.74%5.02% to 6.98% (2007: 5.0%5.29% (2009: 2.53% to 6.99%6.61%).
The total year-endYear-end borrowings consistsconsist entirely of fixed rate debt of US$1,570,000 (2007:273,000 (2009: US$2,325,000)2,529,000) at interest rates ranging from 5%5.02% to 6.98% (2007: 5%5.29% (2009: 6% to 6.32%6.61%) and. There was no floating rate debt ofat December 31, 2010 (2009: US$34,551,000 (2007:US$39,808,000)29,327,000 at an interest rate of 2.74% (2007: 6.49% to 6.99%2.53%). In broad terms, a one-percentage point increase in interest rates would increase interest income by US$52,000 (2007:580,000 (2009: US$87,000)61,000) and increasewould not affect the interest expense byin 2010 (2009: US$349,000 (2007: US$401,000)295,000) resulting in an increase in interest income of US$580,000 (2009: increase in the net interest charge of US$297,000 (2007: increase by US$314,000)234,000).
Interest rate profile of financial liabilities
The interest rate profile of financial assets/liabilities of the Group waswere as follows:
                
 December 31, 2008 December 31, 2007  December 31, 2010 December 31, 2009 
 US$ ’000 US$ ’000  US$‘000 US$‘000 
Fixed rate instruments
  
Fixed rate financial liabilities  (1,570)  (2,325)  (273)  (2,529)
Financial assets 21,942  
  
Variable rate instruments
  
Financial assets 5,184 8,700  58,002 6,078 
Floating rate financial liabilities  (34,551)  (39,808)   (29,327)
          
  (30,937)  (33,433) 79,671  (25,778)
          
Fixed rate instrumentfinancial liabilities comprise fixed rate borrowings and finance lease obligations. The weighted average interest rate and weighted average period for which the rate is fixed is as follows:
                
 December 31, 2008 December 31, 2007  December 31, 2010 December 31, 2009 
Fixed rate financial liabilities
  
Weighted average interest rate  6.16%  6.09%  5.08%  6.21%
Weighted average period for which rate is fixed 3.56 years 4.44 years  1.59 years 2.82 years 
Financial assets comprise of cash and cash equivalents at December 31, 20082010 and at December 31, 20072009 (see note 17) and deferred consideration at December 31, 2010 (see note 14 & 16).
Floating rate financial liabilities in 2009 comprise other borrowings that bearbore interest at a rate of 2.74%2.53%. These borrowings arewere provided by lenders at a margin of 2.25% over inter-bank rates.

118


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
27.DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
Fair value sensitivity analysis for fixed rate instruments
The Group does not account for any fixed rate financial liabilities at fair value through the statement of operations. Therefore a change in interest rates at December 31, 20082010 would not affect profit or loss.
Cash flow sensitivity analysis for variable rate instruments
A change of 100 basis points in interest rates at the reporting date would have no effect on profit or loss for the period. This assumes that all other variables, in particular foreign currency rates, remain constant.

123


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
Fair Values
The table below sets out the Group’s classification of each class of financial assets/liabilities and their fair values:
                                                
 Cash flow Liabilities at Total    Cash flow Total   
 Loans and hedge amortised carrying Fair  Loans and hedge Assets/(Liabilities) carrying Fair 
 Note receivables derivatives cost amount Value  Note receivables derivatives at amortised cost amount Value 
December 31, 2008
 
December 31, 2010
 
  
Trade receivables 16 24,962   24,962 24,962  16 11,762   11,762 11,762 
Cash and cash equivalents 17 5,184   5,184 5,184  17 58,002   58,002 58,002 
Finance lease receivable 14, 16 1,215   1,215 1,215  14, 16 641   641 641 
Forward contracts used for hedging   (27)   (27)  (27)
Net Deferred Consideration Receivable 14, 16 21,942   21,942 21,942 
Grant income receivable 1,008   1,008 1,008  167   167 167 
Secured bank loans 20    (34,553)  (34,553)  (34,553)
Finance lease liabilities 20    (1,568)  (1,568)  (1,595) 20    (273)  (273)  (273)
Trade and other payables (excluding deferred revenue)    (21,057)  (21,057)  (21,057)    (11,318)  (11,318)  (11,318)
Other payables 25    (59)  (59)  (59) 23    (30)  (30)  (30)
Provisions 24    (50)  (50)  (50) 22    (50)  (50)  (50)
                      
 32,369  (27)  (57,287)  (24,945)  (24,972) 92,514   (11,671) 80,843 80,843 
                      
                                                
 Cash flow Liabilities at Total    Cash flow Liabilities at Total   
 Loans and hedge amortised carrying Fair  Loans and hedge amortised carrying Fair 
 Note receivables derivatives cost amount Value  Note receivables derivatives cost amount Value 
December 31, 2007
 
December 31, 2009
 
  
Trade receivables 16 23,104   23,104 23,104  16 20,120   20,120 20,120 
Cash and cash equivalents 18 8,700   8,700 8,700  17 6,078   6,078 6,078 
Finance lease receivable 13, 16 1,161   1,161 1,161  14, 16 1,798   1,798 1,798 
Forward contracts used for hedging  224  224 224    (58)   (58)  (58)
Grant income receivable 285   285 285  201   201 201 
Secured bank loans 21    (39,828)  (39,828)  (39,827) 20    (29,595)  (29,595)  (29,595)
Finance lease liabilities 21    (2,305)  (2,305)  (2,298) 20    (2,261)  (2,261)  (2,273)
Trade and other payables (excluding deferred revenue)    (23,327)  (23,327)  (23,327)    (11,528)  (11,528)  (11,528)
Other financial liabilities 24    (2,725)  (2,725)  (2,725)
Other payables 26    (74)  (74)  (74) 23    (59)  (59)  (59)
Provisions 25    (100)  (100)  (100) 22    (50)  (50)  (50)
                      
 33,250 224  (68,359)  (34,885)  (34,877) 28,197  (58)  (43,493)  (15,354)  (15,366)
                      

 

124119


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
27.DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
Interest rates used for determining fair value
The interest rates used to discount estimated cash flows, where applicable, based on observable market rates plus a premium which reflects the risk profile of the Group at the reporting date, were as follows:
         
  December 31, 20082010  December 31, 20072009 
         
Deferred Consideration3.10%
Loans and borrowings  2.74%  6.74% – 6.992.53%
Leases  5.02% – 5.14- 5.29%  5.84% – 7.205.66% - 5.82%
There was no significant difference between the fair value and carrying value of the Group’s trade receivables and trade and other payables at December 31, 20082010 and December, 31 20072009 as all fell due within 6 months.
Liquidity risk
The Group’s operations are cash generating. Short-term flexibility is achieved through the management of the group’s short-term deposits and through the use of a US$7,000,000 revolver loan facility.deposits.
The following are the contractual maturities of financial liabilities, including estimated interest payments:
                                                
 Carrying Contractual 6 mths or 6 mths –      Carrying Contractual 6 mths or 6 mths-     
As at December 31, 2008 amount cash flows less 12 mths 1–2 years 2–5 years 
As at December 31, 2010 amount cash flows less 12 mths 1-2 years 2-5 years 
US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000  US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 
Financial liabilities
  
Secured bank loans — floating 34,551 36,289 9,614 3,463 6,817 16,395        
Secured bank loans — fixed 2 2 2           
Finance lease liabilities — fixed 1,568 1,748 260 254 477 757  273 285 86 86 113  
Trade & other payables 22,969 22,969 22,969     11,447 11,447 11,447    
                          
  
 59,090 61,008 32,845 3,717 7,294 17,152  11,720 11,732 11,533 86 113  
                          
                         
  Carrying  Contractual  6 mths or  6 mths-       
As at December 31, 2009 amount  cash flows  less  12 mths  1-2 years  2-5 years 
US$’000 US$’000  US$’000  US$’000  US$’000  US$’000  US$’000 
Financial liabilities
                        
Secured bank loans — floating  29,327   30,268   9,660   2,592   6,549   11,467 
Secured bank loans — fixed  268   288   56   56   112   64 
Finance lease liabilities —fixed  2,261   2,478   457   452   898   671 
Trade & other payables  12,844   12,844   12,844          
                   
                         
   44,700   45,878   23,017   3,100   7,559   12,202 
                   
Trinity Biotech hashad a US$48,340,000 club banking facility with AIB plc and Bank of Scotland (Ireland) Limited (“the banks”). which was utilised until May 2010; at which point the bank loans were repaid in their entirety and the facility ceased. The facility consistsconsisted of a five year term loan of US$41,340,000 and a one year revolver of US$7,000,000. At December 31, 2008,2009, the total amount outstanding under the facility amounted to US$34,553,000.29,327,000, net of unamortised funding costs of US$180,000. Various covenants applyapplied to these borrowings. In the event that the Group breaches these covenants, this may result in the borrowings becoming payable immediately. As at December 31, 20082009 the Group was in breach of one of these covenants which had beenwas waived by the banks. The covenant which was breached concerned minimum tangible net worththe level of earnings before interest, tax, depreciation, amortisation and share option expense for the year end December 31, 2008.2009. The margin applied to the loan facility has remained consistent atwas 2.25% above LIBOR.

 

125120


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 20082010
                         
  Carrying  Contractual  6 mths or  6 mths –       
As at December 31, 2007 amount  cash flows  less  12 mths  1–2 years  2–5 years 
US$’000 US$’000  US$’000  US$’000  US$’000  US$’000  US$’000 
Financial liabilities
                        
Secured bank loans — floating  39,808   44,309   12,537   4,942   9,484   17,346 
Secured bank loans — fixed  20   21   9   9   3    
Finance lease liabilities — fixed  2,305   2,616   408   371   550   1,287 
Trade & other payables  24,779   24,779   24,779          
                   
                         
   66,912   71,725   37,733   5,322   10,037   18,633 
                   
27.DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
Foreign exchange risk
The majority of the Group’s activities are conducted in US Dollars. The primary foreign exchange risk arises from the fluctuating value of the Group’s euroEuro denominated expenses as a result of the movement in the exchange rate between the US Dollar and the euro.Euro. Arising from this, where considered necessary, the Group pursues a treasury policy which aims to sell US Dollars forward to match a portion of its uncovered euroEuro expenses at exchange rates lower than budgeted exchange rates. These forward contracts are primarily cashflow hedging instruments whose objective is to cover a portion of these euroEuro forecasted transactions. All of the forwardForward contracts normally have maturities of less than one year after the balance sheet date. All of theThere were no forward contracts in place at December 31, 2008 have a maturity of less than one year after the balance sheet date. Where necessary, these forward contracts will be rolled over at maturity.2010.
Euro denominated sales remained relatively consistent with the prior year, in percentage terms. The Group had foreign currency denominated cash balances equivalent to US$1,257,000215,000 at December 31, 2008 (2007:2010 (2009: US$1,659,000)518,000).
The Group states its forward exchange contracts at fair value in the balance sheet. The Group classifies its forward exchange contracts as hedging forecasted transactions and thus accounts for them as cash flow hedges. During 20082010 and 2007,2009, changes in the fair value of these contracts were recognized in equity and then in the case of contracts which were exercised during 20082010 and 2007,2009, the cumulative gain or losses were transferred to the statement of operations.
At December 31, 2008 the fair value of the2010 there were no forward exchange contractcontracts in place amounted to a(2009: liability of US$27,000 (2007: asset of US$224,000)58,000).
The following are the contractual maturities of the forward contracts used for hedging in place at December 31, 2008, which crystallize in 2009:
                 
  Carrying  Contractual cash  6 mths or  6 mths – 12 
As at December 31, 2008 amount  flows  less  mths 
US$’000 US$’000  US$’000  US$’000  US$’000 
Forward contract used for hedging:
                
Outflow  (27)  (3,900)  (2,700)  (1,200)
Inflow     3,896   2,694   1,202 
             
   (27)  (4)  (6)  2 
             

126


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
Sensitivity analysis
A 10% strengthening of the US dollar against the following currencies at December 31, 20082010 would have increased/ (decreased) profit or loss and other equity by the amounts shown below. This analysis assumes that all other variables, in particular interest rates, remain constant.
                
 Other equity  Other equity 
 Profit or loss movements  Profit or loss movements 
 US$’000 US$’000  US$’000 US$’000 
December 31, 2008
 
December 31, 2010
 
Euro  (1,806)  
 
December 31, 2009
 
Euro 1,808 2  2,009 5 
Pound Sterling  (24)   (416)  
 
December 31, 2007
 
Euro 1,991  (20)
Pound Sterling  (580)  
Swedish Kroner 9  
A 10% weakening of the US dollar against the above currencies at December 31, 20082010 and December 31, 20072009 would have the equal but opposite effect on the above currencies to the amounts shown above, on the basis that all other variables remain constant.
Credit Risk
The Group has no significant concentrations of credit risk. Exposure to credit risk is monitored on an ongoing basis. The Group maintains specific provisions for potential credit losses. To date such losses have been within management’s expectations. Due to the large number of customers and the geographical dispersion of these customers, the Group has no significant concentrations of accounts receivable.
With respect to credit risk arising from the other financial assets of the Group, which comprise cash and cash equivalents and forward contracts,deferred consideration, the Group’s exposure to credit risk arises from default of the counter-party, with a maximum exposure equal to the carrying amount of these instruments.
The Group maintains cash and cash equivalents and enters into forward contracts, when necessary, with various financial institutions. These financial institutions are located in a number of countries and Group policy is designed to limit exposure to any one institution. The Group performs periodicregular and detailed evaluations of thethese financial institutions to assess their relative credit standing of those financial institutions.standing. The carrying amount reported in the balance sheet for cash and cash equivalents and forward contracts approximate their fair value.

121


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
27.DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
Exposure to credit risk
The carrying amount of financial assets represents the maximum credit exposure. The maximum exposure to credit risk is as follows:
         
  Carrying Value  Carrying Value 
  December 31, 2008  December 31, 2007 
  US$’000  US$’000 
         
Third party trade receivables  24,962   23,104 
Finance lease income receivable  1,215   1,161 
Cash & cash equivalents  5,184   8,700 
Grant income receivable  1,008   285 
Forward exchange contracts used for hedging     224 
       
   32,369   33,474 
       

127


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
         
  Carrying Value  Carrying Value 
  December 31, 2010  December 31, 2009 
  US$’000  US$’000 
         
Third party trade receivables  11,762   20,120 
Finance lease income receivable  641   1,798 
Cash & cash equivalents  58,002   6,078 
Net Deferred Consideration  21,942    
Grant income receivable  167   201 
       
   92,514   28,197 
       
The maximum exposure to credit risk for trade receivables and finance lease income receivable by geographic location is as follows:
        
         Carrying Value Carrying Value 
 Carrying Value Carrying Value  December 31, 2010 December 31, 2009 
 December 31, 2008 December 31, 2007  US$’000 US$’000 
 US$’000 US$’000  
United States 11,310 11,137  6,175 10,187 
Euro-zone countries 4,006 3,969  2,652 3,215 
UK 950 1,749  701 599 
Other European countries 1,866 583  106 732 
Other regions 8,045 6,827  2,769 7,185 
          
 26,177 24,265  12,403 21,918 
          
The maximum exposure to credit risk for trade receivables and finance lease income receivable by type of customer is as follows:
                
 Carrying Value Carrying Value  Carrying Value Carrying Value 
 December 31, 2008 December 31, 2007  December 31, 2010 December 31, 2009 
 US$’000 US$’000  US$’000 US$’000 
  
End-user customers 11,404 11,974  6,366 11,524 
Distributors 12,623 11,723  5,497 9,742 
Non-governmental organisations 2,150 568  540 652 
          
 26,177 24,265  12,403 21,918 
          
Due to the large number of customers and the geographical dispersion of these customers, the Group has no significant concentrations of accounts receivable.

122


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
27.DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
Impairment Losses
The ageing of trade receivables at December 31, 20082010 is as follows:
                                
 Gross Impairment Gross Impairment  Gross Impairment Gross Impairment 
In thousands of US$ 2008 2008 2007 2007  2010 2010 2009 2009 
  
Not past due 16,916 97 14,288 151  6,099 35 13,388 102 
Past due 0-30 days 4,274 15 5,208 65  3,459 19 3,817 6 
Past due 31-120 days 2,011 89 3,365 35  2,039 25 962 29 
Greater than 120 days 2,380 418 900 406  1,608 1,364 2,808 718 
                  
 25,581 619 23,761 657  13,205 1,443 20,975 855 
                  
The movement in the allowance for impairment in respect of trade receivables during the year was as follows:
                        
In thousands of US$ 2008 2007 2006  2010 2009 2008 
  
Balance at January 1 657 1,074 587  855 619 657 
Charged to costs and expenses 544 578 896  717 302 544 
Amounts recovered during the year  (82)  (190)  (100)  (13)  (22)  (82)
Amounts written off during the year  (500)  (805)  (309)  (116)  (44)  (500)
              
Balance at December 31 619 657 1,074  1,443 855 619 
              
The allowance for impairment in respect of trade receivables is used to record impairment losses unless the Group is satisfied that no recovery of the account owing is possible. At this point the amount is considered irrecoverable and is written off against the financial asset directly.

128


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
Capital Management
The Group’s policy is to maintain a strong capital base so as to maintain investor, creditor and market confidence and to sustain future development of the business. The Board of Directors monitors earnings per share as a measure of performance, which the Group defines as profit after tax divided by the weighted average number of shares in issue.
The Board of Directors have a policy to maintain a capital structure consisting of both debt and equity and constantly monitorsFollowing the mix of long term debt to equity. This approach is of particular importance with respect to the acquisition strategydivestiture of the Coagulation product line in 2010, the Group wherebynow has significant cash reserves and has eliminated all bank debt. In the past, the Group has funded recent acquisitions using both equity and long term debt depending on the size of the acquisition and the capital structure in place at the time of the acquisition.
TheAlthough at December 31, 2010 the Group has no debt, it maintains a long term lending facilityrelationship with a number of lending banks (see note 20) and Trinity Biotech is listed on the NASDAQ which allows the Group to raise funds through equity financing where necessary.
The Board of Directors is authorised to purchase its own shares on the market on the following conditions;
the aggregate nominal value of the shares authorised to be acquired shall not exceed 10% of the aggregate nominal value of the issued share capital of the Company at the close of business on the date of the passing of the resolution:
the minimum price (exclusive of taxes and expenses) which may be paid for a share shall be the nominal value of that share:
the maximum price (exclusive of taxes and expenses) which may be paid for a share shall not be more than the average of the closing bid price on NASDAQ in respect of the ten business days immediately preceding the day on which the share is purchased.
ThereCapital management in the Group has been assisted by the sale of the Coagulation product line to Stago in 2010. The sale allowed the Group to eliminate bank debt and increases cash reserves. These cash reserves are monitored closely and cash deposits are aligned to mature with the capital requirements of the Group.

123


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
28.2008 IMPAIRMENT CHARGES AND RESTRUCTURING EXPENSES
In the year ended December 31, 2008, asset impairment charges totalling US$85,793,000 were no changesrecognised in the statement of operations. No impairment charge was recognised in the statement of operations for the year ended December 31, 2010 or December 31, 2009.
In accordance with IAS 36,Impairment of Assets, the Group carries out an annual impairment review of the asset valuations. The Group carries out its impairment review on 31 December each year. In determining whether a potential asset impairment exists, the Group considered a range of internal and external factors. One such factor was the relationship between the Group’s market valuation and the book value of its net assets. Trinity Biotech’s market capitalization at the end of 2008 was significantly below the book value of its net assets. In such circumstances given the accounting standard guidance, the Group decided to recognize at December 31, 2008 a non-cash impairment charge of US$81.3 million after tax. The impairment was taken against goodwill and other intangible assets, property, plant and equipment and prepayments. The tax impact of the impairment charges is described in note 9.
The Board of Directors announced a restructuring of the business in December 2008. The restructuring aimed to reduce costs through improved operational efficiency within the Group. As a result of the restructuring, there was a reduction in the size of the workforce, mainly affecting the sales, marketing and administration functions. Termination payments and other restructuring costs resulted in an after tax charge of US$1.9 million in the current year. Included in this amount is US$1.5 million relating to the Group’s approachresignation of Brendan Farrell as Chief Executive Officer in October 2008.
The impact of the above items on the statement of operations for the year ended December 31, 2008 was as follows:
                 
      Impairment  Restructuring  Total 
      US$’000  US$’000  US$‘000 
                 
Selling, general & administration expenses
                
Impairment of PP&E      13,095      13,095 
Impairment of goodwill and other intangible assets      71,684      71,684 
Impairment of prepayments      1,014      1,014 
                 
Employee termination payments  (a)      589   589 
Director’s compensation for loss of office and share option expense  (b)      1,465   1,465 
Other restructuring expenses         35   35 
              
Total impairment loss and restructuring expenses before tax
      85,793   2,089   87,882 
              
                 
Income tax impact of impairment loss and restructuring expenses (note 9)      (4,536)  (215)  (4,751)
              
Total impairment loss and restructuring expenses after tax
      81,257   1,874   83,131 
              
(a)Under the restructuring plan announced in December 2008, the Group’s workforce was reduced by about 10%. The redundancies occurred in the Group’s US, Irish and German operations. The total redundancy costs amounted to US$589,000, of which an amount of US$156,000 is accrued at December 31, 2008.
(b)An expense of US$1,465,000 was recorded in 2008 in relation to the resignation of the former Chief Executive Officer, Brendan Farrell. Mr. Farrell left the company in October 2008. The expense comprises termination payments of US$1,283,000, of which US$988,000 is included in accrued restructuring expenses at December 31, 2008, and an accelerated share option expense of US$182,000.

124


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
29.POST BALANCE SHEET EVENTS
Acquisition of Phoenix Bio-tech Corp.
On January 4, 2011, the Group purchased 100% of the common stock of Phoenix Bio-tech Corporation for US$2.5 million. Phoenix Bio-tech manufactures and sells products for the detection of syphilis. This acquisition has not been reflected in the financial statements for the year ended December 31, 2010 as it was completed subsequent to the financial year end. The fair values of the acquired assets and liabilities have not been established yet.
Phoenix Bio-tech was founded in 1992 and is based in Toronto, Canada. It sells its products under the TrepSure and TrepCheck labels. Phoenix’s annual revenues are approximately US$1.25 million. Prior to the acquisition, Trinity Biotech distributed Phoenix Bio-tech’s syphilis products on a non-exclusive basis in the USA.
The key terms of the acquisition are as follows:
Consideration of US$2,500,000. US$1,000,000 was payable on closing and the remaining US$1,500,000 is payable in four instalments in the period April 2011 to January 2012.
The consideration of US$2,500,000 includes acquired net working capital management duringof approximately US$500,000.
As the year.initial accounting and fair value assessment for the business combination is incomplete at the time that these financial statements were authorised for issue the following disclosures cannot be made but will be reported if relevant in the Form 20-F for the period ended December 31, 2011:
Neither
A qualitative description of the factors that make up the goodwill to be recognised,
Details of the indemnification assets,
Details of acquired receivables,
The amounts recognised as of the acquisition date for each major class of asset acquired and liability assumed,
Details of contingent liabilities recognised; and
The total amount of goodwill that is expected to be deductible for tax purposes.
Dividend
In 2011 the Company nor anyannounced that it intended to commence a dividend policy, to be paid once a year. In this regard, the Board of its subsidiariesDirectors has proposed a final dividend of 10 cent per ADR in respect of 2010 and this proposal will be submitted to shareholders for their approval at the next Annual General Meeting of the Company. As provided in the Articles of Association of the Company, dividends or other distributions are subject to externally imposed capital requirements.declared and paid in US Dollars.
30. ACCOUNTING ESTIMATES AND JUDGEMENTS
The preparation of these financial statements requires the Group to make estimates and judgements that affect the reported amount of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
On an on-going basis, the Group evaluates these estimates, including those related to intangible assets, contingencies and litigation. The estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Key sources of estimation uncertainty
Note 12 contains information about the assumptions and the risk factors relating to goodwill impairment. Note 19 outlines information regarding the valuation of share options and warrants. In note 29,27, detailed analysis is given about the interest rate risk, credit risk, liquidity risk and foreign exchange risk of the Group.

125


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
30.ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED)
Critical accounting judgements in applying the Group’s accounting policies
Certain critical accounting judgements in applying the group’s accounting policies are described below:
Research and development expenditure
Under IFRS as adopted by the EU, we write-off research and development expenditure as incurred, with the exception of expenditure on projects whose outcome has been assessed with reasonable certainty as to technical feasibility, commercial viability and recovery of costs through future revenues. Such expenditure is capitalised at cost within intangible assets and amortised over its expected useful life of 15 years, which commences when commercial production starts.
Factors which impact our judgement to capitalise certain research and development expenditure include the degree of regulatory approval for products and the results of any market research to determine the likely future commercial success of products being developed. We review these factors each year to determine whether our previous estimates as to feasibility, viability and recovery should be changed.

129


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
Impairment of intangible assets and goodwill
Definite lived intangible assets are reviewed for indicators of impairment annually while goodwill and indefinite lived assets are tested for impairment annually, individually or at the cash generating unit level.
Factors considered important, as part of an impairment review, include the following:
Significant underperformance relative to expected historical or projected future operating results;
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;
Obsolescence of products;
Significant decline in our stock price for a sustained period; and
Our market capitalisation relative to net book value.
Significant underperformance relative to expected historical or projected future operating results;
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;
Obsolescence of products;
Significant decline in our stock price for a sustained period; and
Our market capitalisation relative to net book value.
When we determine that the carrying value of intangibles, non-current assets and related goodwill may not be recoverable based upon the existence of one or more of the above indicators of impairment, any impairment is measured based on our estimates of projected net discounted cash flows expected to result from that asset, including eventual disposition. Our estimated impairment could prove insufficient if our analysis overestimated the cash flows or conditions change in the future.
Allowance for slow-moving and obsolete inventory
We evaluate the realisability of our inventory on a case-by-case basis and make adjustments to our inventory provision based on our estimates of expected losses. We write-off any inventory that is approaching its “use-by” date and for which no further re-processing can be performed. We also consider recent trends in revenues for various inventory items and instances where the realisable value of inventory is likely to be less than its carrying value.
Allowance for impairment of receivables
We make judgements as to our ability to collect outstanding receivables and where necessary make allowances for impairment. Such impairments are made based upon a specific review of all significant outstanding receivables. In determining the allowance, we analyse our historical collection experience and current economic trends. If the historical data we use to calculate the allowance for impairment of receivables does not reflect the future ability to collect outstanding receivables, additional allowances for impairment of receivables may be needed and the future results of operations could be materially affected.

126


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
30.ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED)
Accounting for income taxes
Significant judgement is required in determining our worldwide income tax expense provision. In the ordinary course of a global business, there are many transactions and calculations where the ultimate tax outcome is uncertain. Some of these uncertainties arise as a consequence of revenue sharing and cost reimbursement arrangements among related entities, the process of identifying items of revenue and expense that qualify for preferential tax treatment and segregation of foreign and domestic income and expense to avoid double taxation. In addition, we operate within multiple taxing jurisdictions and are subject to audits in these jurisdictions. These audits can involve complex issues that may require an extended period of time for resolution. Although we believe that our estimates are reasonable, no assurance can be given that the final tax outcome of these matters will not be different than that which is reflected in our historical income tax provisions and accruals. Such differences could have a material effect on our income tax provision and profit in the period in which such determination is made. In management’s opinion, adequate provisions for income taxes have been made.
Deferred tax assets and liabilities are determined for the effects of net operating losses and temporary differences between the book and tax bases of assets and liabilities, using tax rates projected to be in effect for the year in which the differences are expected to reverse. While we have considered future taxable income and ongoing prudent and feasible tax planning strategies in assessing whether deferred tax assets can be recognised, there is no assurance that these deferred tax assets may be realisable. The extent to which recognised deferred tax assets are not realisable could have a material adverse impact on our income tax provision and net income in the period in which such determination is made.

130


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
Item 18, noteNote 13 to the consolidated financial statements outlines the basis for the deferred tax assets and liabilities and includes details of the unrecognized deferred tax assets at year end. The Group derecognized deferred tax assets arising on unused tax losses except to the extent that there are sufficient taxable temporary differences relating to the same taxation authority and the same taxable entity which will result in taxable amounts against which the unused tax losses can be utilisedutilized before they expire. The derecognition of these deferred tax assets was considered appropriate in light of the increased tax losses caused by the restructuring and uncertainty over the timing of the utilisationutilization of the tax losses. Except for the derecognition of deferred tax assets there were no material changes in estimates used to calculate the income tax expense provision during 2008, 20072010, 2009 or 2006.2008.

127


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
31. GROUP UNDERTAKINGS
The consolidated financial statements include the financial statements of Trinity Biotech plc and the following principal subsidiary undertakings:
         
    Principal Country of   
    incorporation and   
Name and registered office Principal activity operation Group % holding 
Trinity Biotech plc
IDA Business Park, Bray,
Co. Wicklow, Ireland
 Investment and holding company Ireland Holding company
IDA Business Park, Bray, company
  
Co. Wicklow, Ireland
         
Trinity Biotech Manufacturing Limited
IDA Business Park, Bray,
Co. Wicklow, Ireland
 Manufacture and sale of diagnostic test kits Ireland  100%
IDA Business Park, Bray,
Co. Wicklow, Ireland
 diagnostic test kits
         
Trinity Research Limited
IDA Business Park, Bray,
Co. Wicklow, Ireland
 Research and development Ireland  100%
IDA Business Park, Bray,
Co. Wicklow, Ireland
 
         
Benen Trading Limited
IDA Business Park, Bray,
Co. Wicklow, Ireland
 Trading Ireland  100%
IDA Business Park, Bray,
Co. Wicklow, Ireland
 
         
Trinity Biotech Manufacturing Services Limited
IDA Business Park, Bray,
Co. Wicklow, Ireland
 Engineering services Ireland  100%
IDA Business Park, Bray,
Co. Wicklow, Ireland
 
         
Trinity Biotech Financial Services Limited
IDA Business Park, Bray,
Co Wicklow, Ireland
 Provision of financial services Ireland  100%
IDA Business Park, Bray,
Co Wicklow, Ireland
 services
         
Trinity Biotech Inc
Girts Road, Jamestown, NY 14702, USA
 Holding Company U.S.A.  100%
Girts Road, Jamestown, NY 14702, USA 
         
Clark Laboratories Inc
Trading as Trinity Biotech (USA)
Girts Road, Jamestown
NY14702, USA
 Manufacture and sale of diagnostic test kits U.S.A.  100%
Trading as Trinity Biotech (USA) diagnostic test kits
Girts Road, Jamestown
NY14702, USA

131


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2008
31.GROUP UNDERTAKINGS (Continued)
         
Principal Country of
incorporation and
Name and registered officePrincipal activityoperationGroup % holding
Mardx Diagnostics Inc
5919 Farnsworth Court
Carlsbad
CA 92008, USA
 Manufacture and sale of diagnostic test kits U.S.A.  100%
5919 Farnsworth Court Carlsbad diagnostic test kits
CA 92008, USA
         
Fitzgerald Industries International, IncManagement services companyU.S.A.100%

2711 Centerville Road, Suite 400
Wilmington, New Castle
Delaware, 19808, USA
 Management services companyU.S.A.   100%
  
         
Biopool US Inc (trading as Trinity Biotech Distribution)
Girts Road, Jamestown
NY14702, USA
 Sale of diagnostic test kits U.S.A.  100%
Trinity Biotech Distribution)
Girts Road, Jamestown
NY14702, USA
         
Primus Corporation
4231 E 75th Terrace
Kansas City,
MO 64132, USA
 Manufacture and sale of diagnostic test kits and instrumentation U.S.A.  100%
4231 E 75th Terracediagnostic test kits and
Kansas City,instrumentation
MO 64132, USA
Trinity Biotech (UK Sales) LimitedSale of diagnostic test kitsUK 100%
54 Queens Road
Reading RG1 4A2, England
Trinity Biotech GmbHManufacture of diagnosticGermany100%
Lehbrinksweg 59,instrumentation and
32657 Lemgo, Germanysale of diagnostic test kits
Biopool ABManufacture andSweden100%
S-903 47 Umeasale of diagnostic test kits
Sweden
Trinity Biotech France SARLSale of diagnostic test kitsFrance100%
300A Rue Marcel Paul
21 Des Grands Godets
93 500 Champigny sur marne France

128


NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
32. AUTHORISATION FOR ISSUE
These Group consolidated financial statements were authorised for issue by the Board of Directors on April 7, 2009.14, 2011.

 

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Signatures
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorised the undersigned to sign this annual report on its behalf.
TRINITY BIOTECH PLC
     
 TRINITY BIOTECH PLC
 
By:By: RONAN O’CAOIMH
Mr Ronan O’Caoimh
Director/Chief Executive Officer

Date: April 7, 2009 
  
   
 By:  Director/KEVIN TANSLEY  
  Mr Kevin TansleyChief Executive Officer  
  
Date: April 14, 2011
By:KEVIN TANSLEY
Mr Kevin Tansley
Company secretary/
Chief Financial Officer

Date: April 7, 200914, 2011  

 

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Item 19
Exhibits
     
Exhibit No. Description of Exhibit
10cPurchase and Sale Agreement of the Diagnostic Coagulation Business
     
 12.1  Certification by Chief Executive Officer Pursuant to Section 302 of the Sarbanes- Oxley Act of 2002.
     
 12.2  Certification by Chief Financial Officer Pursuant to Section 302 of the Sarbanes- Oxley Act of 2002.
     
 13.1  Certification by Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
 13.2  Certification by Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
 15.1  Consent of Independent Registered Public Accounting Firm (KPMG)(GT)

 

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