FORM 20-F
(MARK ONE)
[ ] REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g)
OF THE SECURITIES EXCHANGE ACT OF 1934
OR
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
[X] FOR THE FISCAL YEAR ENDED: DECEMBER 31, 2004
COMMISSION FILE NUMBER: 0-22320
TRINITY BIOTECH PLC
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(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
IRELAND
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(JURISDICTION OF INCORPORATION OR ORGANISATION)
IDA BUSINESS PARK, BRAY, CO. WICKLOW, IRELAND
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(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)
SECURITIES REGISTERED OR TO BE REGISTERED PURSUANT TO SECTION 12 (b) OF THE ACT:
NONE
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(TITLE OF CLASS)
NAME OF EACH EXCHANGE ON WHICH REGISTERED:
NONE
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(TITLE OF CLASS)
SECURITIES REGISTERED OR TO BE REGISTERED PURSUANT TO SECTION 12 (g) OF THE ACT:
AMERICAN DEPOSITORY SHARES
(REPRESENTING 'A' ORDINARY SHARES, PAR VALUE US$0.0109)
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(TITLE OF EACH CLASS)
SECURITIES FOR WHICH THERE IS A REPORTING OBLIGATION PURSUANT TO
SECTION 15 (d) OF THE ACT:
NONE
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(TITLE OF EACH CLASS)
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: 54,904,318 CLASS 'A' ORDINARY SHARES AND
700,000 CLASS 'B' ORDINARY SHARES.
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 REQUIED TO FILE SUCH REPORTS), AND (2) HAS BEEN
SUBJECT TO SUCH FILING REQUIREMENTS FOR THE PAST 90 DAYS.
YES [X] NO [ ]
INDICATE BY CHECK MARK WHICH FINANCIAL STATEMENT ITEM THE REGISTRANT HAS
ELECTED TO FOLLOW:
ITEM 17 [ ] ITEM 18 [X]
This annual report on Form 20-F was not prepared for filing in Ireland in
compliance with Irish law or the listing rules of the Irish Stock Exchange.
Unless otherwise provided herein or required by the context, references to "we",
"us", "Trinity Biotech" or the "Company" in this annual report shall mean
Trinity Biotech plc and its world-wide subsidiaries, collectively.
We have a secondary listing on the Irish Stock Exchange. For this reason, we are
not subject to the same ongoing regulatory requirements as those which would
apply to an Irish company with a primary listing on the Irish Stock Exchange,
including the requirement that certain transactions require the approval of
shareholders. For further information, shareholders should consult their own
financial advisor.
Our financial statements are presented in US Dollars and are prepared in
accordance with accounting principles generally accepted in the Republic of
Ireland which differ in certain respects from US generally accepted accounting
principles (see note 25) to the consolidated financial statements. All
references in this annual report to "Dollars" and "$" are to US Dollars, and all
references to "Euro" or "(euro)" are to European Union 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.
ITEM 1 IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not Applicable
ITEM 2 OFFER STATISTICS AND EXPECTED TIMETABLE
Not Applicable
ITEM 3 SELECTED CONSOLIDATED FINANCIAL DATA
The following selected consolidated financial data of Trinity Biotech as at
December 31, 2004 and 2003, and for each of the years ended December 31, 2004,
December 31, 2003 and December 31, 2002, 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, 2002, December 31, 2001 and
December 31, 2000, and for each of the years ended December 31, 2001 and 2000
are derived from the audited consolidated financial statements not appearing in
this annual report. The data should be read in conjunction with the financial
statements, related notes, and other financial information included elsewhere
herein.
Consolidated Statement of Income Data
Year Ended Year Ended Year Ended Year Ended Year Ended
Dec 31, 2004 Dec 31, 2003 Dec 31, 2002 Dec 31,2001 Dec 31,2000
------------ ------------ ------------ ------------ ------------
US$'000 US$'000 US$'000 US$'000 US$'000
Revenues 79,944 65,675 51,978 37,076 29,743
Cost of sales (39,688) (32,877) (25,689) (18,050) (15,410)
Administrative expenses (27,304) (17,063) (12,849) (11,196) (6,013)
Research & development expenses (4,641) (5,210) (4,471) (2,780) (2,682)
Amortisation (2,570) (856) (2,386) (2,002) (1,191)
------------ ------------ ------------ ------------ ------------
Operating profit
- Continuing operations 4,632 9,669 6,524 5,817 3,201
- Acquisitions 1,109 - 59 (2,769) 1,246
- Disposals - - - - -
------------ ------------ ------------ ------------ ------------
5,741 9,669 6,583 3,048 4,447
Interest income 302 173 103 142 466
Interest expense (824) (792) (704) (538) (758)
------------ ------------ ------------ ------------ ------------
Net profit before tax and share of
operating loss in associate &
impairment 5,219 9,050 5,982 2,652 4,155
Share of operating loss in
associate & impairment - (1,067) (317) (269) (30)
------------ ------------ ------------ ------------ ------------
Net profit before tax 5,219 7,983 5,665 2,383 4,125
Tax on profit on ordinary activities (53) (2,186) (768) (16) (1)
------------ ------------ ------------ ------------ ------------
Net profit after tax 5,166 5,797 4,897 2,367 4,124
============ ============ ============ ============ ============
Profit from operations per ordinary
share (US Dollars) 0.10 0.22 0.16 0.08 0.12
Profit from continuing operations per
ordinary share (US Dollars) 0.08 0.22 0.16 0.14 0.09
Basic earnings per ordinary share
(US Dollars) 0.09 0.13 0.12 0.06 0.11
Diluted earnings per ordinary share
(US Dollars) 0.09 0.12 0.12 0.06 0.10
Weighted average number of shares
used in computing basic EPS 55,132,024 43,093,146 40,550,367 40,408,978 37,131,692
Weighted average number of shares
used in computing diluted EPS 63,935,138 50,583,247 42,486,227 41,120,060 40,540,494
2
Consolidated Balance Sheet Data
As at As at As at As at As at
Dec 31, 2004 Dec 31, 2003 Dec 31, 2002 Dec 31, 2001 Dec 31, 2000
------------ ------------ ------------ ------------ ------------
US$'000 US$'000 US$'000 US$'000 US$'000
Working capital 55,426 45,630 20,424 17,117 15,755
Long-term liabilities 13,119 17,517 7,745 7,805 2,266
Total assets 150,828 118,091 89,798 77,072 66,900
Capital stock 776 670 610 603 603
Shareholders' equity 116,138 80,262 62,537 56,412 53,892
Amounts Adjusted for US GAAP
Consolidated Statement of Income Data
Year Ended Year Ended Year Ended Year Ended Year Ended
Dec 31, 2004 Dec 31, 2003 Dec 31, 2002 Dec 31,2001 Dec 31,2000
------------ ------------ ------------ ------------ ------------
US$'000 US$'000 US$'000 US$'000 US$'000
Net profit 4,048 5,146 5,043 710 1,108
Basic earnings
per ordinary share (US Dollars) 0.07 0.12 0.12 0.02 0.03
Diluted earnings
per ordinary share (US Dollars) 0.07 0.11 0.12 0.02 0.03
Consolidated Balance Sheet Data
As at As at As at As at As at
Dec 31, 2004 Dec 31, 2003 Dec 31, 2002 Dec 31,2001 Dec 31,2000
------------ ------------ ------------ ------------ ------------
US$'000 US$'000 US$'000 US$'000 US$'000
Total assets 158,869 128,650 99,067 83,240 75,859
Shareholders' equity 122,033 87,234 70,944 63,463 62,899
No dividends were declared in any of the periods from December 31, 2000 to
December 31, 2004.
3
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 with all of the other information included in this annual report before
you decide to purchase our shares.
TRINITY BIOTECH'S OPERATING RESULTS MAY BE SUBJECT TO FLUCTUATIONS.
o Trinity Biotech's operating results may fluctuate as a result of many
factors related to our business, including the competitive conditions in the
industry, 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 size and timing of orders and general economic
conditions.
TRINITY BIOTECH'S REVENUES DEPEND TO A HIGH DEGREE ON ITS RELATIONSHIP WITH
WAMPOLE LABORATORIES, A FORMER AFFILIATE OF CARTER WALLACE, INC.
o During the financial years ended December 31, 2004, December 31, 2003 and
December 31, 2002, approximately 7%, 12% and 20% respectively of Trinity
Biotech's revenues were derived from a distribution agreement by and among
our subsidiary, Trinity Biotech (USA) Corp. (trading name of Clark
Laboratories, Inc) and Carter-Wallace, Inc ("Carter-Wallace") and its
affiliate Wampole Laboratories ("Wampole"). In 2001, Wampole was acquired by
Medpointe, Inc and was subsequently acquired by Inverness Medical
Innovations, Inc ("Inverness Medical") in 2002. In 2002, the Company
negotiated an amendment to the distribution agreement whereby the
exclusivity of Inverness Medical's right to sell our products in the US
would be removed in stages throughout 2004. During 2003, the Company
experienced declining sales revenues under the distribution agreement which
it believes is due to Inverness Medical attempting to convert customers from
the Trinity Biotech product to an alternative product. Accordingly, in
December 2003, the Company filed legal action against Inverness Medical and
Wampole for declaratory judgment and breach of contract. In January 2004,
Inverness Medical and Wampole countersued and sought a preliminary
injunction to prevent the Company from selling direct in the US any of its
products which are competitive with products sold by Inverness Medical and
sourced by other suppliers. The Superior Court of Middlesex County,
Massachusetts, denied the motion for preliminary injunction on January 28,
2004. In April of 2004, Trinity amended its complaint to add additional
claims alleging breaches of the distribution agreement by the Defendants. In
May of 2004, the Defendants amended their counterclaims to add claims
alleging, among other things, that Trinity was selling certain products
without a licence. Following the expiration of the Defendants' exclusive
distribution rights under the distribution agreement on October 1, 2004,
Trinity moved to amend its complaint to eliminate the declaratory judgement
claims and add additional claims for breach of the distribution agreement
and tortious interference with advantageous business relations that had
arisen after December 2003. The Defendants filed a cross-motion to amend
their complaint. There has been no ruling by the court on either party's
motion. The case is currently in the discovery phase. For further
information relating to this matter please refer to Item 8 "Legal
Proceedings". The Company has decided to sell its products directly in the
US and has increased its direct sales force. Any inability to recapture lost
sales from Inverness Medical may have a material adverse effect on the
Company.
A NEED FOR CAPITAL MIGHT ARISE IN THE FUTURE IF TRINITY BIOTECH'S CAPITAL
REQUIREMENTS INCREASE OR REVENUES DECREASE.
o Up to now Trinity Biotech has funded its operations through the sale of its
shares and securities convertible into shares, revenues from operations and
bank borrowings. Trinity Biotech expects that the proceeds of recent equity
financings, bank borrowings, current working capital and sales revenues will
fund its existing operations and payment obligations for the future.
However, if our capital requirements are greater than expected, or if our
revenues are not sufficient 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.
THE DIAGNOSTICS INDUSTRY IS HIGHLY COMPETITIVE, AND TRINITY BIOTECH'S RESEARCH
AND DEVELOPMENT COULD BE RENDERED OBSOLETE BY TECHNOLOGICAL ADVANCES OF
COMPETITORS.
o 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
significantly 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
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principal products with which Trinity Biotech competes) are Dade-Behring
(Sysmex(R) CA, D-Dimer plus, Enzygnost(R)), bioMerieux (MDA(R), VIDAS(TM)),
Zeus Scientific Inc. (Zeus EIA, IFA), Diasorin Inc. (ETI(TM)), Abbott
Diagnostics (AxSYM(TM), IMx(TM)), Diagnostic Products Corp. - DPC
(Immulite(TM)), Bio-Rad (ELISA & WB), Roche Diagnostics (COBAS AMPLICOR(TM),
Ampliscreen(TM), Accutrend(TM)) and OraSure Technologies, Inc (OraQuick(R)).
TRINITY BIOTECH IS HIGHLY DEPENDENT ON SUITABLE DISTRIBUTORS WORLDWIDE.
o Revenue and earnings stability and growth are directly dependent on the
effectiveness of advertising, marketing and promotional programmes. Trinity
Biotech currently distributes its product portfolio through distributors in
over 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.
o The healthcare 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 ACQUISITION STRATEGY MAY BE LESS SUCCESSFUL THAN EXPECTED, AND
THEREFORE, GROWTH MAY BE LIMITED.
o 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 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.
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 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.
o We are committed to significant expenditure on research and development.
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 market new products but this work 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.
o Even when products are successfully developed and marketed, Trinity
Biotech's ownership of the technology behind these products has a finite
life. In general, generic competition, which can arise after the expiration
of a patent, can have a detrimental effect on a product's revenue,
profitability and market share. There can be no guarantee that the net
income and financial position of Trinity Biotech 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 to 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.
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.
o The following table sets forth the US patents Trinity Biotech currently
owns. The table provides the relevant patent number, a brief description and
the remaining life time for each patent:
5
PATENT LIFE REMAINING FROM
PATENT NUMBER DESCRIPTION FEBRUARY 28, 2005
------------- ---------------------------------- --------------------------
5,006,474 Bi-Directional Lateral 3 years 2 months
Chromatography Test Device
5,114,845 Improved Assays for Plasminogen 2 years 5 months
Activator Inhibitor and Soluble
Fibrin
5,175,087 Method of Performing Tissue 2 years 5 months
Plasminogen Activator Assay
5,985,582 Thrombin-Based Assay for 12 years 10 months
Antithrombin - III
6,194,394 Coagulation controls for 13 years 5 months
Prothrombin Time (PT) and
Activated Partial Thromboplastin
Time (APTT) Assays
6,528,273 Methods for quality control of 13 years 9 months
Prothrombin Time (PT) and
Activated Partial Thromboplastin
Time (APTT) Assays Using
Coagulation Controls
6,391,609 Thromboplastin Reagents and 14 years 8 months
Methods for Preparing and Using
Such Reagents
6,653,066 Device and method for detecting 18 years and 9 months
polyvalent substances
In addition to these US patents, Trinity Biotech owns a total of 24
non-US patents.
o 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.
o 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.
o 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'S BUSINESS IS HEAVILY REGULATED, AND COMPLIANCE WITH APPLICABLE
REGULATIONS COULD REDUCE REVENUES AND PROFITABILITY.
o Our manufacturing and marketing 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
6
certainty that such approval will be granted or, even once granted, will
not be revoked during the continuing review and monitoring process.
o 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.
TRINITY BIOTECH'S SUCCESS IS DEPENDENT ON CERTAIN KEY MANAGEMENT PERSONNEL.
o Trinity Biotech's success is dependent on certain key management
personnel. Our key employees are Ronan O'Caoimh, our CEO and Chairman,
Brendan Farrell, our President, Dr Jim Walsh, our COO, and Rory Nealon,
our CFO and Secretary, with all of which we have entered into employment
contracts. We carry a life assurance policy for Mr O'Caoimh in the
amount of (euro)533,000. Competition for qualified employees among
biotechnology companies is intense, and the loss of such personnel or
the inability to attract and retain the additional highly skilled
employees required for the expansion of our activities, could adversely
affect our business. In the US, Germany and Sweden we were able to
attract and retain qualified staff. In Ireland, we have experienced some
difficulties in attracting and retaining staff due to competition from
other employers in our industry and due to the strength of the Irish
economy.
TRINITY BIOTECH IS DEPENDENT ON ITS SUPPLIERS FOR THE PRIMARY RAW MATERIALS
REQUIRED FOR ITS TEST KITS.
o 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
specificity and sensitivity 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.
TRINITY BIOTECH MAY BE SUBJECT TO LIABILITY RESULTING FROM ITS PRODUCTS OR
SERVICES.
o Trinity Biotech may be subject to claims for personal injuries or other
damages resulting from its products or services. Trinity Biotech has
product liability insurance in place for its US manufacturing
subsidiaries up to a maximum of US$4,000,000 for any one accident,
limited to a maximum of US$4,000,000 in any one year period of
insurance. A separate policy is in place for non-US subsidiaries, which
are also covered up to a maximum of (euro)4,000,000 (US$5,456,000) for
any one accident, limited to a maximum of (euro)4,000,000 (US$5,456,000)
in any one year period of insurance. A deductible of US$25,000 is
applicable to each insurance event. 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.
CURRENCY FLUCTUATIONS MAY ADVERSELY AFFECT OUR EARNINGS AND ASSETS.
o Trinity Biotech records its transactions in Euro, US Dollars and Swedish
Kroner and prepares its financial statements in US Dollars. A
substantial portion of our expenses is denominated in Euro. However,
Trinity Biotech's revenues are primarily denominated in US Dollars. As a
result, we are affected by fluctuations in currency exchange rates,
especially the exchange rate between the US dollar and the Euro.
Fluctuations between these and other exchange rates may adversely affect
our earnings and assets. The percentage of 2004 consolidated revenue
denominated in US Dollars was approximately 67%. Of the remaining 33%
revenue, the breakdown was as follows: Euro (27%), Sterling (5%) and Yen
and Swedish Kroner (1%). Thus, a 10% decrease in the value of each of
the Euro, Yen, Sterling and Swedish Kroner 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 was 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. As part
of a managed hedging policy, Trinity Biotech has identified the extent
of this Euro mismatch and implemented a forward currency hedging policy
which aims to cover a portion of this mismatch through the use of
forward contracts. Trinity Biotech entered into a series of forward
contracts to sell US Dollars forward for Euro. These contracts remain in
place until late 2005. Trinity Biotech continues to monitor its exposure
to foreign currency movements. 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.
7
PENNY STOCK REGULATIONS IMPOSE SALES PRACTICE LIMITATIONS ON BROKER-DEALERS WHO
SELL OUR SHARES.
o SEC regulations concerning "penny stock" apply to Trinity Biotech's
shares. These regulations impose sales practice requirements on
broker-dealers who sell our shares to persons other than established
customers and "accredited investors" as defined in SEC regulations. For
transactions covered by the regulations, broker-dealers must make a
suitability determination and receive a written agreement from the
purchaser prior to the sale. These regulations may affect the ability of
broker-dealers to sell our shares in the secondary market and thus
adversely affect our share price.
THE CONVERSION OF OUR OUTSTANDING CONVERTIBLE NOTES AND WARRANTS WOULD DILUTE
THE OWNERSHIP INTEREST OF EXISTING SHAREHOLDERS.
o The convertible notes described in Item 18, Note 9 (e), and the warrants
described in Item 18, Note 10, issued in 2004, are convertible into ADRs
representing our Class "A" Ordinary Shares. Conversion of the remainder
of the notes and exercise of the warrants will likely occur only when
the conversion price is below the trading price of our ADRs and will
dilute the ownership interests of existing shareholders. For instance,
should the holders of the Series A Convertible Notes decide to convert
the balance of the US$20,000,000 total principal amount of US$11,896,000
and the holders of the Series B Convertible Notes decide to convert the
balance of the US$5,000,000 total principal amount of US$4,500,000 into
ADRs at conversion prices of US$3.55 and US$4 respectively, and should
the 1,317,324 warrants be exercised, Trinity Biotech would have to issue
5,793,239 additional ADRs. On the basis of 55,588,050 outstanding shares
at February 28, 2005, this would effectively dilute the ownership
interest of the existing shareholders by approximately 9.4%. Management
also has the option of repaying these debentures in ordinary shares. Any
such repayment would effectively dilute the ownership interest of the
existing shareholders. In addition, any sales in the public market of
the ADRs issuable upon conversion of the notes could adversely affect
prevailing market prices of our ADRs.
IT COULD BE DIFFICULT FOR US HOLDERS OF ADRS TO ENFORCE ANY SECURITIES LAWS
CLAIMS AGAINST TRINITY BIOTECH, ITS OFFICERS OR DIRECTORS IN IRISH COURTS.
o 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 Court will recognise the United States judgement. The
originating court must have been a court of competent jurisdiction, the
judgement may not be recognised 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.
TRINITY BIOTECH IS EXPOSED TO POTENTIAL RISKS AND INCREASED COSTS FROM THE
REQUIREMENTS OF SECTION 404 OF THE SARBANES OXLEY ACT OF 2002 TO EVALUATE
INTERNAL CONTROLS OVER FINANCIAL REPORTING.
o Section 404 of the Sarbanes Oxley Act of 2002 requires that the Company
evaluates and reports on the internal controls over financial reporting
and have an auditor attest to such evaluation. The Company has prepared
an internal plan for compliance and is in the process of documenting and
testing the system of internal controls to provide the basis for this
report for the year ended December 31, 2006. Due to ongoing evaluation
and testing of the Company's internal controls and the uncertainties of
the interpretation of these new requirements, the Company cannot assure
that there may not be significant deficiencies or material weaknesses
that would be required to be reported. In the event that significant
deficiencies or material weaknesses are reported, investor perceptions
may be adversely affected and could cause a decline in the market price
of our stock.
The Company is spending increased costs and an increased amount of
management time and external resources in order to comply with the above
legislation by the end of 2006. The process of documenting and testing
the internal control systems and procedures and considering improvements
has required the Company to hire additional personnel and outside
advisory services, resulting in additional accounting and consultancy
expenses.
8
ITEM 4 INFORMATION ON THE COMPANY
HISTORY AND DEVELOPMENT OF THE COMPANY
Trinity Biotech plc ("Trinity Biotech" or "the Company") 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
coagulation disorders and autoimmune disorders. The Company is also a
significant provider of raw materials to the life sciences industry. The Company
markets over 500 different diagnostic products in approximately 80 countries.
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 Company
has expanded its product base through internal development and acquisitions into
product categories that primarily test for infectious, sexually transmitted and
autoimmune diseases. In addition, arising from the acquisition of the Biopool
haemostasis business in December 2001 and the haemostasis division of Sigma
Diagnostics, part of Sigma Aldrich, in August 2002, Trinity Biotech has expanded
its product range to include test kits that diagnose blood coagulation and
related disorders, and a haemostasis instrumentation portfolio. The acquisition
of the speciality clinical chemistry business of Sigma Diagnostics in November
2002 means that Trinity Biotech now participates in this important market
segment. In 2004, Trinity Biotech further expanded its product range through the
acquisition of the assets of Fitzgerald Industries International Inc
(Fitzgerald) a distributor of immunodiagnostic products and the acquisition of
the assets of Adaltis US, Inc through which Trinity has obtained distribution
rights to Adaltis's open-ended mircoplate analytical instrumentation. Trinity
Biotech markets its products in the US and in approximately 80 countries
worldwide through a combination of direct selling and a network of national and
international distributors. Trinity Biotech has manufacturing facilities in
Bray, Ireland, Umea, Sweden and Lemgo, Germany, in Europe, and in Jamestown, New
York, and Carlsbad, California in the US.
In the period 2000 to 2003, Trinity Biotech made six acquisitions of diagnostic
businesses. Three of these acquisitions were of Enzyme Immunoassay ("EIA")
businesses, two were haemostasis businesses, and the sixth was a speciality
clinical chemistry business. Two further acquisitions, a distributor of
immunodiagnostic products and a distributor of infectious diseases
instrumentation and reagents, were undertaken in 2004. A further acquisition, a
provider of immunodiagnostic products, was completed in March 2005. Details of
all of these acquisitions are set out below. In July 2001, Trinity Biotech
established a direct sales operation in Germany which commenced trading in
October 2001, and in 2002 the Company established a small direct sales operation
in the United Kingdom. Through these acquisitions and new products added through
in-house research and development, Trinity Biotech now has a comprehensive
portfolio of over 500 products, including 5 rapid tests.
ACQUISITION OF RESEARCH DIAGNOSTICS INC
In March 2005, Trinity Biotech purchased the assets of Research Diagnostics Inc
("RDI") for US$4.2 million in cash. RDI provides a comprehensive range of
immunodiagnostic products to pharmaceutical companies, diagnostic manufacturers
and research facilities worldwide.
ACQUISITION OF THE ASSETS OF ADALTIS US, INC
In April 2004, Trinity acquired the assets of Adaltis US, Inc for US$2,852,000
in cash. Adaltis US, Inc is the US distribution arm for Adaltis, Inc. As part of
the transaction, Trinity has obtained exclusive distribution rights to Adaltis'
open-end microplate analytical instrumentation in the US and non-exclusive
distribution rights in the rest of the world, except China.
ACQUISITION OF THE ASSETS OF FITZGERALD INDUSTRIES INTERNATIONAL INC
In April 2004, Trinity also completed the acquisition of the assets of
Fitzgerald Industries International Inc for US$16 million. Fitzgerald provides a
comprehensive range of immunodiagnostic products to pharmaceutical companies,
reference laboratories, diagnostic manufacturers and research facilities
worldwide.
ACQUISITION OF THE SPECIALITY CLINICAL CHEMISTRY PRODUCT LINE OF SIGMA
DIAGNOSTICS
In November 2002, Trinity Biotech acquired the speciality clinical chemistry
product line from Sigma Diagnostics for a total consideration of US$4.4 million
satisfied in cash and deferred consideration. The deferred consideration of
US$1.8 million was paid in 2003. The speciality clinical chemistry business
consists of several specialised products that are clearly differentiated in the
marketplace, including ACE, Bile Acids, Lactate, Oxalate and G6PDH.
ACQUISITION OF THE HAEMOSTASIS DIVISION OF SIGMA DIAGNOSTICS
In August 2002, Trinity Biotech purchased the haemostasis division of Sigma
Diagnostics for a total consideration of US$1.4 million. The consideration was
satisfied in cash. The Sigma diagnostics business comprises a comprehensive
portfolio of reagents manufactured in St. Louis, Missouri and the Amelung range
of automated and semi-automated instruments manufactured in Lemgo, Germany. The
Sigma Diagnostics haemostasis reagents comprise more than 50 tests covering both
routine and speciality assays. The Amelung range of instruments comprises the
smaller KC1 and KC4
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products, the mid-size AMAX 200 and the large throughput AMAX 400. Since
acquisition Trinity Biotech also received FDA clearance for a new haemostasis
analyser the AMAX Destiny(TM).
ACQUISITION OF THE ASSETS OF THE BIOPOOL HAEMOSTASIS BUSINESS
In December 2001, Trinity Biotech acquired the assets of the Biopool haemostasis
business for a consideration of US$6.4 million before costs comprising US$3.8
million in cash and US$2.6 million in deferred consideration. The deferred
consideration was payable in three instalments of US$0.9 million, US$1.2 million
and US$0.5 million on December 21, 2002, 2003 and 2004 respectively. The
outstanding deferred consideration has been fully settled as part of a
settlement agreement with Xtrana Inc. Biopool develops, manufactures and markets
a comprehensive range of test kits which assess and diagnose disorders of blood
coagulation, thrombotic risk factors, fibrinolysis, platelet function and the
vascular system. These products are sold to hospitals, clinical laboratories,
commercial reference laboratories and research institutions on a worldwide
basis. Sales in the US are made through a direct sales force and OEM partners,
while international sales are handled through a direct sales force in Germany
and a network of national distributors elsewhere.
ACQUISITION OF THE AMERLEX HORMONE BUSINESS OF ORTHO CLINICAL DIAGNOSTICS
On October 19, 2001 Trinity Biotech acquired the assets of the Amerlex hormone
business of Ortho Clinical Diagnostics for a consideration of US$0.9 million.
The consideration was satisfied in cash. The Amerlex hormone business
manufactures and sells a range of tests which diagnose hormone disorders. This
business has been fully integrated into the Bray manufacturing facility.
ACQUISITION OF BARTELS INC
In December 2000, Trinity Biotech acquired the assets of Bartels Inc
("Bartels"), for a consideration of US$9.5 million comprising US$3.2 million in
stock, US$0.4 million in the form of a promissory note and the balance of US$5.9
million in cash. Bartels is a leading manufacturer of cell dependent organism
diagnostics and its product range includes antigen detection kits for Herpes
Simplex Virus, and respiratory viruses such as Influenza A and B, Parainfluenza
Viruses 1, 2 and 3 and Respiratory Syncital Virus.
ACQUISITION OF MARDX DIAGNOSTICS INC
In March 2000, Trinity Biotech acquired all the outstanding share capital of
MarDx Diagnostics Inc (MarDx) of Carlsbad, California for a consideration of
US$4.2 million. MarDx is a world leader in the development and manufacture of
diagnostic products, known as Western Blots, which confirm the primary diagnosis
of certain infectious diseases. Their principal product is a Western Blot test
for Lyme disease, which is an infection carried by deer ticks. The disease
manifests itself as a multi-system inflammatory disease that affects the skin,
joints and nervous system. If diagnosed and treated early with antibiotics, Lyme
disease is readily cured.
The MarDx test was the first Lyme Western Blot assay to receive FDA clearance
and remains the leading selling test for Lyme disease in the US. The acquisition
of MarDx gave Trinity Biotech a strong position in the Western Blot segment of
the infectious disease market. Western Blot confirmatory testing is a natural
extension to Trinity Biotech's EIA products and the Company intends to extend
the MarDx Western Blot technology and manufacturing capability to other
confirmatory tests.
INVESTMENT IN HIBERGEN LIMITED
On October 2, 2000, the Company acquired 33% of the ordinary share capital of
HiberGen for a total consideration of US$1.4 million. On July 2, 2001 the
Company increased its shareholding in HiberGen to 40% at a cost of US$0.3
million. On April 3, 2002 the Company increased its shareholding to 42.9% by the
acquisition of a further 165,000 Ordinary Shares in HiberGen Limited. The
consideration of US$202,000 was satisfied by the issue of 156,189 'A' Ordinary
Shares in Trinity Biotech plc. In November 2003, the Company announced that a
fundraising process undertaken by HiberGen had not been successful and that
HiberGen had ceased trading. The Company wrote-off its remaining investment in
quarter four of the 2003 financial year.
ESTABLISHMENT OF UK SUBSIDIARY, TRINITY BIOTECH (UK SALES) LTD
In 2002 Trinity Biotech opened a sales and marketing office in Oxfordshire, UK
employing five sales professionals who market the haemostasis and clinical
chemistry products from Trinity Biotech.
ESTABLISHMENT OF GERMAN SUBSIDIARY, TRINITY BIOTECH GMBH
In October 2001, Trinity Biotech established a direct sales operation in
Germany. After the US and Japan, Germany, with a population of 83 million, is
the third largest market in the world for in-vitro diagnostics, accounting for
7% ((euro)1.6 billion) of the total world market of (euro)22.5 billion. In the
past Trinity Biotech had serviced the market through five independent
distributors who handled a small proportion of the Company's product portfolio
whereas the new German
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direct sales force markets all of Trinity Biotech's current products. In 2002
Trinity Biotech purchased the haemostasis business of Sigma Diagnostics. The
German part of this business was taken over by Trinity Biotech GmbH.
PRE MARKET APPLICATION ("PMA") AND CLINICAL LABORATORY IMPROVEMENTS AMENDMENTS
OF 1988 "CLIA" WAIVER APPROVALS FOR UNIGOLD HIV TEST
In March 2001, the US Food and Drug Administration's Centre for Biologics
Evaluation and Research (CBER) approved an Investigational Device Exemption
(IDE) for treatment use for Trinity Biotech's UniGold HIV test. This IDE allows
Trinity Biotech's UniGold HIV test to be used in a limited number of hospitals
throughout the US, to provide patients with the results of tests, conducted
during ongoing clinical trials.
The product is used to provide diagnostic test results in ten minutes, in
situations involving needle stick injuries and pregnant women at high risk of
HIV presenting themselves for delivery. In these circumstances, the ability to
diagnose HIV status rapidly provides the opportunity to make potentially crucial
medical decisions and to administer appropriate medication.
The granting of the IDE application acknowledged that the clinical protocol for
the IDE was appropriate and that Trinity Biotech's proposed clinical trials
under the treatment IDE met FDA standards for human safety and confidentiality.
During 2001, representatives from Trinity Biotech were informed by the FDA that
the FDA required that additional clinical trials be conducted to ensure that the
results which have been obtained to date are statistically significant. This
means that the results which have been presented to the FDA in the PMA filing
must be reproduced on a larger population of samples. The resulting product
clinical trials have now been conducted at sites in Houston, Texas and
Baltimore, Maryland. Approximately 9,000 samples were collected and tested on
Trinity Biotech's UniGold HIV test. This data along with extensive information
on the manufacturing process for Trinity Biotech's UniGold HIV test were
presented to the FDA. The FDA completed a plant inspection of the Irish
manufacturing facility in mid September 2003. On December 23, 2003, the FDA
issued approval for the sale of the UniGold HIV test for use with venipuncture
blood (whole blood, serum and plasma). In early 2004, an IDE submission was made
to the FDA to define data requirements to expand the use of the product to test
fingerstick (blood taken directly from finger) samples. Clinical trials were
completed by the end of May 2004 and the application in the form of a PMA
supplement made to the FDA on June 10, 2004. Three months later on September 21,
2004, the FDA issued approval for the sale of the Unigold HIV test for use with
fingerstick samples. This allows for the use of the Unigold HIV test in further
settings where venipuncture samples may not be taken.
In the US, laboratories are classed under The Clinical Laboratory Improvements
Amendments of 1988 ("CLIA") regulations in to one of three categories: Waived,
Moderate and High. Accreditation by CLIA is required by laboratories to use
moderate and high complexity classified tests. No laboratory accreditation is
required for use of CLIA waived tests (see 'other FDA regulations' below).
Throughout 2004, trials were completed to support a CLIA waiver for the UniGold
HIV test. The application for CLIA waiver for use in venipuncture whole blood
was made in April 2004. A CLIA waiver approval was granted for venipuncture
whole blood in June 2004 and approval for finger stick whole blood was granted
in November 2004. This allows for the sale of the Unigold HIV test into clinical
laboratories throughout the United States testing the following blood samples;
serum, plasma, fingerstick and venipuncture whole blood.
PRINCIPAL MARKETS
The primary market for Trinity Biotech's tests remains the US. During fiscal
2004, the Company sold 52% (US$41.4 million) (2003: 55% or US$36.3 million;
2002: 64% or US$33.5 million) of product in the US. Sales to non-US (principally
European and Asian) countries represented 48% (US$38.6 million) during fiscal
2004 (2003: 45% or US$29.4 million; 2002: 36% or US$18.5 million).
For a more comprehensive segmental analysis please refer to Item 5, "Results of
Operations" and Note 12 "Analysis of Revenue, Operating Income, Major Customers
and Assets" of the Notes to the Consolidated Financial Statements contained in
Item 18 "Financial Statements".
PRINCIPAL PRODUCTS
The Company develops, acquires, manufactures and markets a wide range of
diagnostic products based on the technology of immunoassay. Immunoassays harness
the body's own natural defence mechanisms. Faced with invasion by a foreign
agent, known as an antigen, the body defends itself by producing antibodies.
Each type of antibody produced is a highly specific response to the invading
antigen. The antibodies bind and neutralise the antigen. It is this highly
specific binding of antigen to antibody, which forms the basis for all
immunoassay tests.
11
Trinity Biotech's products can test for foreign agents such as viruses, bacteria
and parasites, and for naturally occurring conditions such as cancer cells and
hormones. The Company's manufacturing processes utilise biotechnology techniques
involving the in-house production of recombinant proteins, synthetic peptides
and monoclonal antibodies.
Trinity Biotech's product areas can be broken down under the headings of the six
key technologies which are sold under the following brand names:
Enzyme Immunoassays (EIA)
Bartels(R)
CAPTIA(TM)
MarDx(R)
MicroTrak(TM)
Recombigen(R)
Fluorescence Assays (IFA/DFA)
Bartels(R)
MarDx(R)
MicroTrak(TM)
Western Blot (WB)
MarDx(R)
Rapid Assays
Capillus(TM)
SeroCard(TM)
UniGold(TM)
Haemostasis
Biopool(R)
Amax
Clinical Chemistry
EZ HDL
EZ LDL
ENZYME IMMUNOASSAYS
The Company's wide range of Enzyme Immunoassay (EIA) products includes over 90
assays utilising different formats to accommodate the most demanding of
laboratories to the most basic. This type of test is the mainstay of standard
clinical laboratories around the world and forms the backbone of the Trinity
Biotech product list of over 500 products. Trinity Biotech currently sells over
100 EIA tests of various configurations in many countries around the world. Of
these, over 70 are cleared by the FDA for distribution within the US.
These tests are performed on plates that allow for up to 96 simultaneous samples
and can be performed manually or more typically on automated equipment. Trinity
Biotech also offers a range of equipment for these types of assays as well as
validating the Trinity Biotech range for use on the most popular types of
analysers, used by most medical laboratories.
In essence, each well is coated with antigen or antibody depending upon the
analyte being tested for. When the test is run, the first step would be to add
the sample and a reaction will bind any antibodies or antigens (if present) to
the well wall. After removal of interfering substances through washing steps, a
colour-forming reagent is added and the intensity of colour is read on an
instrument indicating the result. EIA's can aid in providing the clinician with
accurate information to assist in the diagnosis of a variety of disorders such
as autoimmune diseases, hormonal imbalances, sexually transmitted diseases,
enteric infections, respiratory infections, cardiovascular diseases, and a wide
range of other diseases.
HAEMOSTASIS
The second largest range of assays in Trinity Biotech's portfolio is the
haemostasis assays. Arising from the acquisition of the Biopool and Sigma
haemostasis businesses, Trinity Biotech now has an extensive range of
haemostasis diagnostic kits, offering laboratories the ability to maximise
testing. Biopool is a well-known leader and innovator in the worldwide market
for haemostasis and fibrinolysis reagents. Strengthening the Biopool reagent
portfolio is the addition of the former Sigma Amelung instrumentation and
reagents. This strategic combination enables Trinity Biotech to provide the
market
12
with a complete line of haemostasis products that permit customised testing.
With the increasing demand to elucidate a wide range of coagulapathies in the
aging population, haemostasis testing is quickly advancing to the requirements
of today's complexities.
Trinity Biotech's full range of test kits assess and diagnose disorders of blood
coagulation, thrombotic risk factors, fibrinolysis, platelet function and the
vascular system. Included in the product range is the range of D-dimer assays.
Employing latex technology, Trinity Biotech can offer superior sensitivity and
NPV (Negative Predictive Value) for D-dimer testing. Alongside D-dimer are
Trinity Biotech's comprehensive routine and speciality assays.
This extensive haemostasis product line is sold to hospitals, clinical
laboratories, commercial reference laboratories and research institutions on a
worldwide basis.
FLUORESCENCE ASSAYS
Another large range of diagnostic assays in Trinity Biotech's portfolio are the
fluorescence assays that are also typically performed in medium to large sized
hospital laboratories around the world. Trinity Biotech offers 33 fluorescence
assays, of which 25 are cleared by the FDA for distribution within the US, with
many variations in kit presentation to suit the customer's needs.
There are two distinct technologies employed, namely Direct Fluorescence Assays
(DFA) and Immunofluorescence Assays (IFA). Trinity Biotech offers 24 IFA's with
the vast majority forming the comprehensive range of tests to diagnose
autoimmune disorders. The remainder of the assays are used to assist in the
diagnosis of infectious diseases such as Legionnaires disease, Lyme disease and
many others. Of the nine DFA's Trinity Biotech offers, the largest range are FDA
cleared for detecting causative agents of sexually transmitted diseases (STD's),
principally Chlamydia and Herpes, and forms one of Trinity Biotech's most
popular selling product groups.
The principle of the IFA test can be summarised as the introduction of patient's
serum to a specially prepared slide containing the specific antigen to which the
antibody is directed. The antibody, if present, binds to the antigen and after a
series of washing steps and addition of a conjugate, will emit fluorescence when
viewed through a microscope equipped with an ultra-violet light source.
The principle of DFA, however, can best be described as the fixation of a
patient sample to a microscope slide, which is then introduced to an antibody
conjugated to a fluorescent dye, to stain and thereby identify the antigen to
which the antibody is directed.
RAPID ASSAYS
Trinity Biotech has developed a range of membrane and latex based rapid assays
to cater for point of care ('POC') and over-the-counter ('OTC') markets. This
range of five tests facilitates fast and often very important treatment for the
patient and can avoid further costly testing. The UniGold(TM) range of tests
does not require refrigeration which is very important for the OTC and POC
markets, and in less developed countries.
Tests for HIV are available in the UniGold(TM), SeroCard(TM) and Capillus(TM)
formats. SeroCard(TM) is a self-encased, flow-through rapid EIA device where
results are obtained by visual interpretation of a colour change, whereas
Capillus(TM) utilises latex agglutination enhanced by capillary slide
technology.
These types of rapid tests give a definitive qualitative answer, indicating the
presence or absence of antigens or antibodies (test dependent) as an aid in the
diagnosis of infection or other clinical conditions. Rapid diagnostic tests
provide information that is essential in allowing key decisions to be made
regarding cost effective treatment options.
WESTERN BLOT ASSAYS
Trinity Biotech's extensive range of 18 Western Blot test systems includes the
first Lyme Western Blot assay to receive FDA clearance for distribution within
the US. Other Western Blot kits in the range include assays to aid in the
diagnosis of autoimmune disorders and more typically infectious diseases such as
Syphilis, Epstein Barr Virus (EBV), H. pylori and others.
Western Blot assays are typically used in reference or speciality laboratories
for confirming the presence, or absence, of antibodies. This can be an essential
part of routine practice for some laboratory investigations for conditions such
as Lyme disease, whereby the confirmation of antibody status is the only means
to obtain an accurate diagnosis. The principle of these types of tests is that a
membrane containing electrophoretically separated proteins of a particular
organism are incubated with a patient's serum sample. If specific antibodies to
individual proteins are present, they will bind to the corresponding antigen
bands. After various washing steps and conjugation, the strip is finally reacted
with a precipitating
13
colour developing solution which deposits a visible precipitate on antibody
reacted antigen bands. Bands can then be visualised, scored for intensity,
relative to a band of a weakly reactive control, and recorded.
CLINICAL CHEMISTRY
Trinity Biotech acquired the Speciality Clinical Chemistry business of Sigma
Diagnostics. This business consists of several specialised products that are
clearly differentiated in the marketplace, including ACE, Bile Acids, Lactate,
Oxalate and G6PDH.
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. EZ HDL
and EZ LDL cholesterol assays broke new ground when they were introduced by
Sigma as the first homogenous, non-precipitating liquid reagents for determining
HDL and LDL.
DISTRIBUTION AGREEMENT BETWEEN TRINITY BIOTECH USA AND CARTER WALLACE Clark
Laboratories, Inc ("Clark") entered into a distribution agreement with
Carter-Wallace Inc ("Carter-Wallace") on December 18, 1995 for an initial period
of five years and, thereafter, for an indefinite period subject to termination
provisions outlined in the distribution agreement. Under the original terms of
the agreement, Carter-Wallace had the exclusive right to sell and distribute
Clark's ELISA products in the US and Puerto Rico (the "Territory") through its
affiliate Wampole Laboratories ("Wampole"). As part of the agreement, Clark
obtained from Carter-Wallace the exclusive right to manufacture for
Carter-Wallace certain products that Carter-Wallace was obtaining from
Bio-Whittaker (the "BW Products"). In 1997, Trinity Biotech, plc ("Trinity" or
the "Company") acquired Clark, and succeeded to Clark's rights and obligations
under the distribution agreement. In 2002, the Company negotiated an amendment
to the distribution agreement with Inverness Medical Innovations, Inc
("Inverness Medical"), the successor to Carter-Wallace's rights under the
distribution agreement, whereby the Inverness Medical's exclusive distribution
rights would be subject to certain limitations, and would expire in their
entirety on October 1, 2004. In 2002, the Company also entered into a letter
agreement with Inverness Medical whereby, among other things, Inverness Medical
agreed to grant to Trinity a licence to all the granted patents relating to
Lateral Flow devices that it owned and to which it had the right to grant
licences in exchange for certain royalty payments.
In December 2003, the Company initiated legal proceedings in the Superior Court
of Middlesex County, Massachusetts against Inverness Medical and its affiliate
Wampole (collectively, Defendants) for declaratory judgment, breach of contract
and unfair and deceptive business practices in connection with the Defendants'
performance under the distribution agreement. Among other things, the suit
requested a judgement declaring that Trinity was entitled to sell certain
products directly in the Territory before October 1, 2004 under the terms of the
2002 amendment to the distribution agreement and due to breaches of the
distribution agreement by the Defendants. The suit also alleged that the
Defendants were attempting to convert customers from Trinity's products to
products manufactured by a competitor (which were modified to look like the
Trinity products) by misrepresenting to the customers that the Trinity product
was unavailable and was being discontinued. In January 2004, the Defendants
countersued alleging, among other things, various breaches of the distribution
agreement and the letter agreement (which they alleged was repudiated and
rescinded, if ever valid), and sought a preliminary injunction to prevent
Trinity from selling directly in the Territory any of its products which are
competitive with products sold by the Defendants and sourced from other
suppliers. The Superior Court of Middlesex County, Massachusetts, denied this
motion for a preliminary injunction on January 28, 2004. In April of 2004,
Trinity amended its complaint to add additional claims alleging breaches of the
distribution agreement by Defendants. In May of 2004, the Defendants amended
their counterclaims to add claims alleging, among other things, that Trinity was
selling the BW Products directly without a licence. Following the expiration of
the Defendants' exclusive distribution rights under the distribution agreement
on October 1, 2004, Trinity moved to amend its complaint to eliminate the
declaratory judgment claims and add additional claims for breach of the
distribution agreement and tortious interference with advantageous business
relations that had arisen after December 2003. The Defendants filed a
cross-motion to amend their complaint. There has been no ruling by the court on
either party's motion. The case is currently in the discovery phase. Please see
also Item 8 "Legal Proceedings".
The Company is currently selling its products directly in the US and has
increased its direct sales force to approximately one hundred staff. The
inability to recapture lost sales from the Defendants may have a material
adverse effect on the Company. In addition, an adverse ruling by the court or
adverse jury verdict with respect to Trinity's direct sales and/or the validity
of the letter agreement and Trinity's licence to the Lateral Flow devices may
have a material adverse effect on the Company.
SALES AND MARKETING
Trinity Biotech sells its product through its own direct sales-force in three
countries: the United States, Germany and the United Kingdom. In the United
States there are approximately 100 sales and marketing professionals responsible
for the
14
sale of haemostasis reagents and instrumentation, clinical chemistry and
infectious disease products. The sales force of 20 people in Germany is
responsible for selling the full range of Trinity Biotech products including
haemostasis, infectious disease, clinical chemistry and radioimmunoassay. In
2002, Trinity Biotech opened a sales and marketing office in Oxfordshire, UK
which now employs 5 sales professionals who market the haemostasis and clinical
chemistry products from Trinity Biotech. In addition to our direct sales
operations, Trinity Biotech also operates in 78 countries, through over 300
independent distributors and strategic partners.
MANUFACTURING AND 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 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. Many of these companies have substantially greater capital resources and
have marketing and business organisations of substantially greater size than
Trinity Biotech. Many companies have been working on immunodiagnostic reagents
and products, including some products believed to be similar to those currently
marketed or under development by the Company, for a longer period of time than
has the Company. The Company's competition includes several large companies such
as Roche, Abbott, Johnson & Johnson, Bayer and Dade-Behring.
PATENTS AND LICENCES
Patents
Trinity Biotech's SeroCardTM diagnostic tests are based on Trinity Biotech Inc's
patent for its "Bi-Directional Lateral Chromatography Test Device". On April 9,
1991, a patent was issued to Trinity Biotech Inc (formerly Disease Detection
International Inc) by the US Patent and Trademark Office covering this device.
The patent expires in 2008. This patented technology allows Trinity Biotech to
concentrate and detect antibodies or antigens using a whole blood specimen in
addition to serum, urine, saliva and other fluid samples.
In February 1993, Trinity Biotech filed a patent application with the Irish
Patents Office under the title "Device for the Processing of Saliva for use in
an Immunoassay". The patent describes a saliva collection system for collecting
and analysing immunoglobulins extracted from the oral cavity. This patent was
granted in May 1993. The Company was granted a second patent covering the
mechanics of its Saliva Collection Device in June 1994. Management believes that
these two patents, which expire in 2010, will help protect Trinity Biotech's
SalivaCardTM test from being copied by a competitor.
In January 1999, Trinity Biotech filed a patent application with the Irish
Patents Office describing a device used in the detection of Strep A in Trinity
Biotech's Rapid Strep A test. This patent was granted in February 2000.
In December 2002, Trinity Biotech filed a patent application with the Irish
Patents Office under the title "A test for detection of antibodies to HIV". The
patent describes a method relating to the preparation of a test to detect
anti-HIV antibodies in serum, plasma or whole blood. This patent was
subsequently granted in October 2003. In April 2002, Trinity Biotech filed a
patent application with the Irish Patents Office under the title "A method and
apparatus for drying a coated microtitre plate after rinsing" which was also
granted in 2003. In December 2002, the Company also filed a patent application
with the Irish Patents Office under the title "A cyanide-free reagent for
measuring haemoglobin in blood, and a method for measuring haemoglobin" which
has been granted.
Many of the Company's tests are not protected by specific patents, due to the
significant cost of putting patents in place for the Company's wide range of
products. However, the Company 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
15
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 licence 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
In 2002, the Company obtained the Unipath and Carter Wallace lateral flow
licences under agreement with Inverness Medical Innovations.
On December 20, 1999 the Company 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.
The Company has also entered into a number of licence/supply agreements for key
raw materials used in the manufacture of its products.
GOVERNMENT REGULATION
The preclinical and clinical testing, manufacture, labelling, distribution, and
promotion of the Company's products are subject to extensive and rigorous
government regulation in the United States and in other countries in which the
Company'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" or the "agency") in the US, the Irish Medicines Board (as
the authority over Trinity Biotech in Europe) and Health Canada. Recently, a
European Directive has been implemented allowing one approval system to be
applicable throughout Europe, CE marking. Canada has also amended its
regulations where it is now mandatory to hold an externally accredited quality
system to a very exacting standard.
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 52% of Trinity Biotech's 2004 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;
labelling; storage; premarket clearance or approval; advertising and promotion;
and sales and distribution.
Access to US Market. Each medical device that the Company may wish to
commercially distribute in the US will likely require either 510(k) clearance or
premarket 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). Devices deemed to pose
relatively less risk are placed in either class I or II, which requires the
manufacturer to submit a premarket notification requesting permission for
commercial distribution; this is known as 510(k) clearance. Some low risk
devices are exempted from this requirement. Devices deemed by the FDA to pose
the greatest risk, such as life-sustaining, life-supporting or implantable
devices, or devices deemed not substantially equivalent to a previously 510(k)
cleared device or a "preamendment" class III device (i.e., in commercial
distribution since prior to May 28, 1976) for which PMA applications have not
been called, are placed in class III requiring PMA approval. Recently, the FDA
have introduced fees for the review of 510(k) and PMA applications. The fee for
a PMA application is in excess of US$250,000.
510(k) Clearance Pathway. To obtain 510(k) clearance, the Company must submit a
premarket 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 4 to 12 months, but it can
last longer. After a device receives 510(k) clearance, any modification that
could significantly affect its safety or
16
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 labelling. 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. 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, it's
labeling or its manufacturing process. The FDA has recently implemented
substantial fees for the submission and review of PMA applications.
BLA approval pathway., BLA approval is required for CBER regulated products
intended for use in a blood bank environment, where the blood screening using
these products may be administered to an individual following processing. This
approval pathway involves even more stringent review of the product, its
supporting clinical data and site inspection, than that of a PMA application.
The BLA application pathway is more costly, lengthy and uncertain than the PMA
clearance process.
Clinical Studies. A clinical study is generally required to support a PMA
application and is sometimes required for a 510(k) premarket 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. In vitro diagnostic
devices ("IVD's"), however, are generally exempt from IDE requirements, provided
that the testing (i) does not require an invasive sampling procedure that
presents a significant risk; (ii) does not by design or intention introduce
energy into a subject; and (iii) is not used for a diagnostic determination
without confirmation of the diagnosis by another, medically established
diagnostic device or procedure.
IVD manufacturers also must establish distribution controls to assure that IVD's
distributed for the purpose of conducting research or clinical investigations
are used only for that purpose and are not commercialised. Pursuant to current
FDA policy, manufacturers of IVD's labelled for research use only ("RUO") or
investigational use only ("IUO") are strongly encouraged by the FDA to establish
a certification program under which investigational IVD's are distributed to or
utilised only by individuals, laboratories, or health care facilities that have
provided the manufacturer with a written certification of compliance indicating
that the RUO or IUO product will be restricted in use and will, among other
things, meet Institutional Review Board approval and informed consent
requirements.
FDA Approval for Unigold HIV Test. The Company's complete PMA application for
the UniGold HIV Test was filed on March 27, 2003. The PMA application was
supported by clinical data involving 9,000 samples. The FDA issued PMA approval
for the device on December 23, 2003. This approval allows for the use of serum,
plasma and venipuncture whole blood in clinical settings. Early in 2004, an IDE
submission was made to the FDA to define the data requirements to expand the use
of the product to test fingerstick (blood taken directly from the finger)
samples. Clinical tests were completed by the end of May 2004 and the
application in the form of a PMA supplement made to the FDA on June 10, 2004.
Three months later, on September 21, 2004, the FDA issued approval for the sale
of the Unigold HIV test for use with fingerstick samples. This allows for the
use of the Unigold HIV test in further settings where venipuncture samples may
not be taken.
Postmarket 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 elaborate testing, control, documentation
and other quality assurance procedures during the manufacturing process;
labelling 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.
The Company 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
17
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 Company. Any failure to comply with applicable QSR or other
regulatory requirements could have a material adverse effect on the Company's
revenues, earnings and financial standing. There can be no assurances that the
Company 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 Company's revenues, earnings and financial standing.
Other FDA Regulation
Purchasers of the Company'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. CLIA
requirements may prevent some clinical laboratories from using any or all of the
Company's diagnostic products. There can be no assurance that the CLIA
regulations and future administrative interpretations of CLIA will not have a
material adverse impact on the Company by limiting the potential market for the
Company's products. Regarding the company's Unigold HIV test, CLIA waiver was
granted for venipuncture whole blood in June 2004 and approval for fingerstick
whole blood was granted in November 2004. This allows for the sale of the
Unigold HIV test into clinical laboratories throughout the United States testing
the following blood samples; serum, plasma, fingerstick and venipuncture whole
blood.
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 authorisation 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 the Company 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 the Company'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 the Company'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 the Company will receive on a timely basis, if at all, any
foreign government approval necessary for marketing its products.
ORGANISATIONAL STRUCTURE
Trinity Biotech plc and its subsidiaries ("the Group") is a manufacturer of
diagnostic test kits 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 GmbH, based in Lemgo, Germany, and at Trinity Biotech
(USA), MarDx Diagnostics Inc and Biopool US Inc based in Jamestown, New York
State, Carlsbad, California and St. Louis, Missouri respectively. The Group's
newly acquired distributor of immunodiagnostic products, Fitzgerald is in
Boston, Massachusetts and Bray, Co.Wicklow, Ireland.
For a more comprehensive schedule of the subsidiary and associated undertakings
of the Company please refer to Note 26 of the Notes to the Consolidated
Financial Statements "Group Undertakings" contained in Item 18 "Financial
Statements" of this Form 20-F.
18
PROPERTY, PLANT AND EQUIPMENT
Trinity Biotech has five manufacturing sites worldwide, two in the US
(Jamestown, NY and Carlsbad, CA), one in Bray, Co. Wicklow, Ireland, one in
Umea, Sweden and one in Lemgo, Germany. The US and Irish facilities are each
FDA, EN and ISO approved facilities. As part of its ongoing commitment to
quality, Trinity Biotech was granted the latest ISO 9001: 2000 and ISO 13485:
1996 certification in February 2003. This certificate was granted by the
Underwriters Laboratory, an internationally recognised notified body. It serves
as external verification that Trinity Biotech has an established and 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 requirements of the ISO 9001:
2000.
Trinity Biotech's manufacturing and research and development facilities
consisting of approximately 45,000 square feet are located at IDA Business Park,
Bray, Co. Wicklow, Ireland. This facility is ISO 9001 approved and was purchased
in December 1997. The facilities include 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 out the
facility. In December 1999, the Company sold the facility for net proceeds 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 at (euro)392,000
(US$535,000). In July 2000, the Company entered into a 20 year lease for a
25,000 square foot warehouse adjacent to the existing facility at an annual rent
of (euro)191,000 (US$261,000). The Company also envisaging that further premises
may potentially be required by it entered into a four years eleven month lease
at (euro)13,000 (US$18,000) per annum over adjacent lands. On November 20, 2002
the Company entered into an agreement for lease with the lessor for 16,700
square feet of offices at an annual rent of (euro)381,000 (US$520,000), payable
from 2004. (See Item 7 - Major Shareholders and Related Party 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$55,000.
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
July 2001, at an annual rental cost of US$240,000. The second adjacent facility
comprises 14,500 square feet and is the subject of a five year lease, renewed in
July 2001, at an annual rental cost of US$142,000.
Arising from the acquisition of the Biopool haemostasis business, Trinity
Biotech currently operates from an additional facility located in Umea, Sweden.
The Umea facility is 8,712 square feet and the annual rental is US$127,000. The
lease, renewed in December 2003, expires in December 2006.
Arising from the acquisition of the Sigma haemostasis division in 2002, Trinity
Biotech acquired a manufacturing/office facility of 55,000 square feet in Lemgo,
Germany. This facility is owned by Trinity Biotech GmbH.
Arising from the acquisition of Adaltis the Company leases a 9,600 square foot
premises in Allentown, Pennsylvania with an annual rental of US$120,000. This
lease is due to be expire in August 2005 and is not expected to be renewed.
Additional office space is leased by the Company in Ireland, Darmstadt, St,
Louis, Missouri, Boston Massachusetts and New Jersey at an annual cost of
US$125,000, US$75,000, US$87,000, US$64,000 and US$120,000 respectively.
ITEM 5 OPERATING AND FINANCIAL REVIEW AND PROSPECTS
OPERATING RESULTS
Trinity Biotech's consolidated financial statements include the attributable
results of eight trading entities: - Trinity Biotech Manufacturing Limited
(Ireland), Clark Laboratories Inc (trading as Trinity Biotech (USA)), Biopool US
Inc, MarDx Diagnostics Inc, Biopool AB, Trinity Biotech (UK Sales) Limited,
Trinity Biotech GmbH (Germany) and Benen Trading Limited (trading as Fitzgerald
Industries International). These entities are engaged in the manufacture and
sale of diagnostic test kits and related instrumentation. The consolidated
financial statements for 2003 and 2002 also include a share of the loss of the
associate undertaking, HiberGen. This discussion covers the years ended December
31, 2004, December 31, 2003 and December 31, 2002 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 Irish GAAP which differs from US GAAP as indicated
in Note 25 to the consolidated financial statements.
19
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 coagulation disorders and autoimmune disorders. The
Company is also a significant provider of raw materials to the life sciences
industry. The Company markets over 500 different diagnostic products in
approximately 80 countries. In addition, the Company manufactures its own and
distributes third party haemostasis and infectious diseases diagnostic
instrumentation.
Trinity Biotech was incorporated in Ireland in January 1992. The Company was
organised to acquire, develop and market technologies for rapid in-vitro blood
and saliva diagnostics for HIV and other infectious diseases. In October 1992,
Trinity Biotech completed an initial public offering in the United States in
which it raised net proceeds in excess of US$5 million. In October 1993, Trinity
Biotech took a controlling interest in DDI and in October 1994, merged Trinity
Biotech's wholly-owned US subsidiary into DDI so that DDI became a wholly-owned
subsidiary of Trinity Biotech. DDI was the surviving legal entity in the merger
and was subsequently renamed Trinity Biotech Inc ("TBI"). In December 1994,
Trinity Biotech acquired the remaining 50% of FHC which its subsidiary TBI did
not own. During 1995, Trinity Biotech raised net proceeds in excess of US$6
million as a result of a private placement of the Company's shares. In February
1997, the Company purchased the entire share capital of Clark Laboratories Inc
("Clark"), which now trades as Trinity Biotech USA, and in June 1997, the
Company purchased the entire share capital of Centocor UK Holdings Ltd
("Centocor"). In 1998, the Company made four product line acquisitions: the
acquisition of the Microzyme and Macra Lp(a) product lines in June 1998 and the
acquisition of the MicroTrak and Cambridge Diagnostics HIV product lines in
September 1998. The manufacture of these product lines has been transferred to
the Company's Jamestown, NY and Bray, Co. Wicklow, Ireland manufacturing
facilities. In March 2000, the Company purchased 100% of the share capital of
MarDx Diagnostics Inc ("MarDx") and in December 2000, the assets of Bartels Inc
were acquired. The Bartels plant in Seattle closed in June 2001 and production
has been transferred to the Californian, New York and Irish factories. In
October 2001, the Company purchased the Amerlex hormone business of Ortho
Clinical Diagnostics and in December 2001 the Company acquired the assets of the
Biopool haemostasis business. In October 2001, Trinity Biotech established a
direct sales operation in Germany, Trinity Biotech GmbH. In August 2002, Trinity
Biotech acquired the haemostasis division of Sigma Diagnostics, part of
Sigma-Aldrich. The Sigma diagnostics haemostasis business comprised a
comprehensive portfolio of reagents manufactured in St Louis, Missouri and the
Amelung range of automated and semi-automated instruments manufactured in Lemgo,
Germany. During 2003, Trinity Biotech completed the transfer of the Sigma
haemostasis test manufacturing from St. Louis to the Irish facility. On
September 30, 2002, Trinity Biotech closed the haemostasis manufacturing
facility in Ventura, California which it had acquired from Xtrana, (Biopool),
and has integrated these operations into the Wicklow manufacturing facility in
Ireland. Trinity Biotech also acquired the speciality clinical chemistry
business from Sigma Diagnostics in December 2002. This business consists of
several specialised products that are clearly differentiated in the marketplace,
including ACE, Bile Acids, Lactate, Oxalate and G6PDH. During 2002, Trinity
Biotech established a small direct sales operation in the United Kingdom to
handle the Sigma haemostasis and clinical chemistry product lines. In April
2004, Trinity Biotech acquired the assets of Fitzgerald Industries International
Inc, a provider of immunodiagnostic products to pharmaceutical companies,
reference laboratories, diagnostic manufacturers and research facilities
worldwide. Also in April 2004, Trinity acquired the assets of Adaltis US, Inc,
the US distribution arm for Adaltis, Inc thus obtaining exclusive distribution
rights to Adaltis's open-end microplate analytical instrumentation in the US and
non-exclusive distribution rights in the rest of the world, except China. For
further information about the company's principal products and principal markets
please refer to Item 4, "Information on the Company".
In October 2000, Trinity Biotech subscribed for a 33% shareholding in HiberGen
Limited ("HiberGen"). In July 2001 the Company subscribed for a further 300,000
Ordinary Shares in HiberGen, increasing its shareholding to 40%. On April 3,
2002, the Company increased its shareholding to 42.9% by the acquisition of a
further 165,000 Ordinary Shares in HiberGen Limited. The consideration of
US$202,000 was satisfied by the issue of 156,189 'A' Ordinary Shares in Trinity
Biotech plc. During 2003, HiberGen Limited was unsuccessful in raising
additional funds and on November 14, 2003, the Board of HiberGen Limited decided
to cease trading.
In May 1999 Trinity Biotech obtained a secondary listing on the Irish Stock
Exchange and in April 2000 raised US$13.4 million by the issue of 4 million
Class 'A' Ordinary Shares to institutional investors.
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.
20
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. For further information about the
company'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 accounting principles generally accepted in Ireland ("Irish
GAAP"). 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.
Research and development expenditure
Under Irish GAAP, 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,15
years.
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.
Under US GAAP, we write off all research and development costs as incurred.
Impairment of intangible assets
We assess the impairment of identifiable intangibles and related goodwill
whenever events or changes in circumstances indicate that the carrying value may
not be recoverable.
Factors considered important, which could trigger an impairment review, include
the following:
o significant underperformance relative to expected historical or
projected future operating results;
o significant changes in the manner of our use of the acquired assets or
the strategy for our overall business;
o obsolescence of products whose development costs we have capitalised;
o 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, long-lived 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.
Under US GAAP, following our adoption of SFAS 142 on January 1, 2002, we have
ceased to amortise goodwill. In lieu of amortisation, we were required to
perform an annual impairment review of the carrying value of our goodwill and
indefinite-lived intangible assets. On January 1, 2002 the Group performed the
required impairment review of goodwill and indefinite-lived intangible assets
and determined that there was no impairment. On December 31, 2002, December 31,
2003 and December 31, 2004 the Group performed further impairment tests of
goodwill and indefinite-lived intangible assets and concluded that there was no
impairment in the carrying value of these assets at those dates.
21
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 reserve 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 doubtful debts
We make judgements as to our ability to collect outstanding receivables and
provide allowances for the portion of receivables when collection becomes
doubtful. Provisions are made based upon a specific review of all significant
outstanding receivables. In determining the provision, we analyse our historical
collection experience and current economic trends. If the historical data we use
to calculate the allowance provided for doubtful debts does not reflect the
future ability to collect outstanding receivables, additional provisions for
doubtful accounts may be needed and the future results of operations could be
materially affected.
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.
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 net
income in the period in which such determination is made. Deferred tax assets
and liabilities are determined using enacted tax rates for the effects of net
operating losses and temporary differences between the book and tax bases of
assets and liabilities. We record a valuation allowance to reduce our deferred
tax assets to the amount of future tax benefit that is more likely than not to
be realised. While we have considered future taxable income and ongoing prudent
and feasible tax planning strategies in assessing the need for the valuation
allowance, there is no assurance that the valuation allowance would not need to
be increased to cover additional deferred tax assets that may not be realisable.
Any increase in the valuation allowance 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.
IMPACT OF RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
Share-Based Payment
In December 2004, the FASB issued SFAS No. 123 (revised 2004) "Share-Based
Payment" ("SFAS 123R"). This Statement replaces FASB Statement No. 123,
"Accounting for Stock-Based Compensation" and supersedes APB Opinion No. 25,
"Accounting for Stock Issued to Employees", and its related implementation
guidance.
This Statement establishes standards for the accounting for transactions in
which an entity exchanges its equity instruments for goods or services. It also
addresses transactions in which an entity incurs liabilities in exchange for
goods or services that are based on the fair value of the entity's equity
instruments or that may be settled by the issuance of those equity instruments.
This Statement focuses primarily on accounting for transactions in which an
entity obtains employee services in share-based payment transactions. This
Statement does not change the accounting guidance for share-based payment
transactions with parties other than employees provided in Statement 123 as
originally issued and EITF Issue No. 96-18, "Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services". This Statement does not address the accounting for
employee share ownership plans, which are subject to AICPA Statement of Position
93-6, "Employers' Accounting for Employee Stock Ownership Plans".
This Statement requires a public entity to measure the cost of employee services
received in exchange for an award of equity instruments based on the grant-date
fair value of the award (with limited exceptions). That cost will be recognised
over the period during which an employee is required to provide service in
exchange for the award--the requisite service period (usually the vesting
period). No compensation cost is recognised for equity instruments for which
employees do not render the requisite service. Employee share purchase plans
will not result in recognition of compensation cost if certain conditions are
met; those conditions are much the same as the related conditions in Statement
123. A public entity will initially measure the cost of employee services
received in exchange for an award of liability instruments based on its current
fair value; the fair value of that award will be remeasured subsequently at each
reporting date through the settlement date. Changes in fair value during the
requisite service period will be recognised as compensation cost over that
22
period. If an equity award is modified after the grant date, incremental
compensation cost will be recognised in an amount equal to the excess of the
fair value of the modified award over the fair value of the original award
immediately before the modification. The proforma disclosures previously
permitted under Statement 123 no longer will be an alternative to financial
statement recognition
This Statement eliminates the alternative to use Opinion 25's intrinsic value
method of accounting that was provided in Statement 123 as originally issued.
Under Opinion 25, issuing stock options to employees generally resulted in
recognition of no compensation cost. This Statement is effective for public
entities that do not file as small business issuers as of the beginning of the
first interim or annual reporting period that begins after June 15, 2005. Under
SFAS 123R, the Company must determine the appropriate fair value model to be
used for valuing share-based payments, the amortisation method for compensation
cost and the transition method to be used at date of adoption. The transition
methods include prospective and retroactive adoption options. Under the
retroactive option, prior periods may be restated either as of the beginning of
the year of adoption or for all periods presented. The prospective method
requires that compensation expense be recorded for all unvested stock option and
restricted stock at the beginning of the first quarter of adoption of SFAS 123R,
while the retroactive methods would record compensation expense for all unvested
stock options and restricted stock beginning with the first period restated. The
Company is evaluating the requirements of SFAS 123R and expects that the
adoption of SFAS 123R will have a material impact on the Company's consolidated
results of operations and earnings per share. The Company has not determined the
method of adoption or the effect of adopting SFAS 123R, and it has not
determined whether the adoption will result in amounts that are similar to the
current proforma disclosures under Statement 123.
The adoption or future adoption of the following recent accounting
pronouncements have not or are not expected to have a material impact on the
Company's results of operations and financial condition.
Consolidation of Variable Interest Entities
The Financial Accounting Standards Board issued FASB Interpretations No. 46,
"Consolidation of Variable Interest Entities", ("FIN 46") in January 2003. This
interpretation clarifies the application of Accounting Research Bulletin No.51,
"Consolidated Financial Statements", to certain entities in which equity
investors do not have the characteristics of a controlling financial interest or
do not have sufficient equity at risk for the entity to finance its activities
without additional subordinated financial support from other parties. The
provisions of FIN 46 were revised in December 2003 through the issue of FASB
Interpretation No. 46(R) ("FIN46R"), "Consolidation of Variable Interest
Entities - An Interpretation of ARB No. 51" to be effective for financial
statement periods ended after March 15, 2004. The adoption of FIN 46R is not
expected to have a material impact on the consolidated financial statements of
the Company as the company has a controlling interest in all of its
subsidiaries.
Inventory Costs
The Financial Accounting Standards Board ("FASB") issued SFAS No. 151 "Inventory
Costs - an amendment of ARB No. 43, Chapter 4" in November 2004. This standard
amends the guidance in ARB No. 43, Chapter 4, "Inventory Pricing", to clarify
the accounting for abnormal amounts of idle facility expense, freight, handling
costs, and wasted material (spoilage). Paragraph 5 of ARB 43, Chapter 4,
previously stated that "under some circumstances, items such as idle facility
expense, excessive spoilage, double freight, and rehandling costs may be so
abnormal as to require treatment as current period charges..." The amendment
removes the ambiguity and requires that all abnormal amounts of idle facility
expense, freight, rehandling costs, and wasted material (spoilage) be treated as
current period costs. In addition, this statement requires that allocation of
fixed production overheads to the costs of conversion be based on the normal
capacity of the production facilities. The provisions of this Statement shall be
effective for inventory costs incurred during fiscal years beginning after June
15, 2005.
Exchanges of Nonmonetary Assets--an amendment of APB Opinion No. 29
The FASB issued Financial Accounting Statement No. 153 "Exchanges of Nonmonetary
Assets - an amendment of APB Opinion No. 29" in December 2004. The guidance in
APB Opinion No. 29, "Accounting for Nonmonetary Transactions", is based on the
principle that exchanges of nonmonetary assets should be measured based on the
fair value of the assets exchanged. The guidance in that Opinion, however,
included certain exceptions to that principle. This Statement amends Opinion 29
to eliminate the exception for nonmonetary exchanges of similar productive
assets and replaces it with a general exception for exchanges of nonmonetary
assets that do not have commercial substance. A nonmonetary exchange has
commercial substance if the future cash flows of the entity are expected to
change significantly as a result of the exchange. The provisions of this
statement shall be effective for non-monetary asset exchanges occurring in
fiscal periods beginning after June 15, 2005.
RESULTS OF OPERATIONS
Year ended December 31, 2004 compared to the year ended December 31, 2003.
23
The following compares our results in the year ended December 31, 2004 to those
of the year ended December 31, 2003. Our analysis is divided as follows:
1. Overview
2. Revenues
3. Operating Expenses
4. Retained Profit
1. OVERVIEW
In US Dollars, consolidated revenues increased by 22% through a combination of
increased sales of existing products (11%) and sales from acquisitions (11%).
Geographically, 52% of sales were generated in the USA, 28% in Europe and 20% in
the rest of the world.
The gross margin for the year ended December 31, 2004 was 50.4% compared to
49.9% for the year ended December 31, 2003. The increase in gross margin is
primarily explained by higher margins from the sale of Fitzgerald products since
its acquisition in April 2004.
Operating profit fell by 41%, primarily due to the cost impact of the increased
sales force in the USA and increasing costs in the Irish operations. The impact
of these factors was partially offset by the operating profit earned from new
acquisitions. The combination of the above factors caused the operating margin
to fall from 14.7% in 2003 to 7.2% in 2004.
Retained profit for the period decreased by 11% (compared to 41% for operating
profit). The lower decrease in retained profit is due to the impact of the share
of operating losses and impairment of an investment in an associated company in
2003 and a lower effective rate of taxation in 2004.
2. REVENUES
The Company's revenues consist primarily 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 is predominantly recognised on the
basis of shipment to customers. The only exception to this is for bill and hold
transactions, whereby revenue is recognised once all of the company's
obligations have been fulfilled. There were no instances of bill and hold
transactions at December 31, 2003 and 2004. The Company ships its products on a
variety of freight terms, including ex-works and CIF (carriage including
freight), depending on the specific terms agreed with customers.
No right of return exists in relation to product sales except in instances where
demonstrable product defects occur. The Company has defined procedures for
dealing with customer complaints associated with such product defects as they
arise.
A small number of sales transactions are made on extended credit terms. This
revenue is recognised in the financial statements at the date of shipment.
However, under US GAAP alternative treatment is required (see note 25 to the
financial statements for treatment under US GAAP).
The Company also derives a portion of its revenues from leasing haemostasis
diagnostic instrumentation to customers. In cases where the risks and rewards of
ownership pass to the customer the non-financing portion of the revenue is
recognised at the time of sale. In the case of operating leases, revenue is
recognised over the term of the lease. In certain markets, the company also
earns revenue from servicing the haemostasis diagnostic instrumentation located
at customer premises.
24
Revenues by Product Line
The following table sets forth selected sales data for each of the periods
indicated.
YEAR ENDED DECEMBER 31,
-----------------------
2004 2003 % CHANGE
---------- ---------- ----------
(US$ '000) (US$ '000)
REVENUES
Infectious diseases 31,638 30,678 3
Rapids 9,807 4,449 120
Haemostasis 26,772 24,435 10
Other 11,727 6,113 92
TOTAL 79,944 65,675 22
Trinity Biotech's consolidated revenues for the year ended December 31, 2004
were US$79,944,000 compared to consolidated revenues of US$65,675,000 for the
year ended December 31, 2003.
Infectious diseases
Sales of infectious diseases products have increased by US$960,000 primarily due
to increased sales of Lyme kits (US$1,366,000), EIA instruments (US$510,000) and
MMV products (US$203,000) as offset by reductions in the sales of Respiratory
Laboratory (US$729,000) and Hormone products (US$507,000).
The above increases and decreases are stated after the impact of a US$2,625,000
decrease in revenues resulting from declining sales under the distribution
agreement with Carter-Wallace, Inc ("Carter-Wallace") and its affiliate Wampole
Laboratories ("Wampole"), now owned by Inverness Medical Innovations, Inc
("Inverness Medical"). The Company believes this is due to Inverness Medical and
Wampole attempting to convert customers from the Trinity Biotech product to an
alternative product. Accordingly, in December 2003, the Company filed legal
action against Inverness Medical and Wampole for declaratory judgment and breach
of contract. In January 2004, Inverness Medical countersued and sought a
preliminary injunction to prevent the Company from selling direct in the US any
of its products which are competitive with products sold by Inverness Medical
and sourced by other suppliers. The Superior Court of Middlesex County,
Massachusetts, denied the motion for preliminary injunction on January 28, 2004.
In April of 2004, Trinity amended its complaint to add additional claims
alleging breaches of the distribution agreement by the Defendants. In May of
2004, the Defendants amended their counterclaims to add claims alleging, among
other things, that Trinity was selling certain products without a licence.
Following the expiration of the Defendants' exclusive distribution rights under
the distribution agreement on October 1, 2004, Trinity moved to amend its
complaint to eliminate the declaratory judgment claims and add additional claims
for breach of the distribution agreement and tortious interference with
advantageous business relations that had arisen after December 2003. The
Defendants filed a cross-motion to amend their complaint. There has been no
ruling by the court on either party's motion. The case is currently in the
discovery phase.
For further information relating to this matter please refer to Item 8 "Legal
Proceedings". The Company decided to sell its products directly in the US and
has increased its direct sales force in 2004 in the US to approximately 100
staff.
Rapids
Sales of Rapids have increased by US$5,358,000 which is primarily attributable
to increased sales of rapid HIV products to Africa.
Haemostasis Revenues
The increase in haemostasis revenues of US$2,337,000 is attributable to
increased sales of the Company's Biopool/Amax range of products. This increase
in sales occurred predominantly in the Company's European market.
Other Revenues
Additional other revenues of US$5,614,000 were earned in 2004 due to a
combination of sales of immunodiagnostic products by Fitzgerald (US$4,765,000)
and increased sales of the Amax speciality clinical chemistry product line,
originally acquired from Sigma in 2002 (US$849,000).
25
Revenues by Geographical Region
The following table sets forth selected sales data, analysed by geographic
region:
YEAR ENDED DECEMBER 31,
-----------------------
2004 2003 % CHANGE
---------- ---------- ----------
(US$ '000) (US$ '000)
REVENUES
USA 41,380 36,299 14
Europe 22,654 19,983 13
Middle East /Africa 11,550 6,248 85
Other overseas 4,360 3,145 39
TOTAL 79,944 65,675 22
The US$5,081,000 increase in the US is primarily attributable to the inclusion
of sales from Fitzgerald (US$2,751,000) and Adaltis (US$2,283,000) since their
acquisition in April 2004. Sales of existing product ranges (excluding sales to
Wampole) have increased by US$2,672,000. This is partially offset by the
US$2,625,000 reduction in sales to Wampole discussed above.
The US$2,671,000 increase in Europe is primarily due to higher sales of the
Company's Biopool/Amax range of products (US$1,833,000) and sales of Fitzgerald
products (US$876,000).
The US$5,302,000 increases in Middle East/Africa is primarily attributable to
increased sales of rapid HIV products to Africa (US$4,863,000) and Haemostasis
products (US$283,000).
The US$1,215,000 increase in sales to other overseas countries is principally
due to the inclusion of sales of Fitzgerald products to the Far East since its
acquisition in April 2004 (US$1,138,000).
For further information about the company's principal products, principal
markets and competition please refer to Item 4, "Information on the Company".
3. OPERATING EXPENSES
The following table sets forth the company's operating expenses.
YEAR ENDED DECEMBER 31,
-----------------------
2004 2003 % CHANGE
---------- ---------- ----------
(US$ '000) (US$ '000)
Revenues 79,944 65,675 22
Cost of sales (39,688) (32,877) 21
Research & development (4,641) (5,210) (11)
Administrative expenses (29,874) (17,919) 67
Operating profit 5,741 9,669 (41)
Cost of sales
Trinity Biotech's consolidated cost of sales increased 21% or by US$6,811,000
from US$32,877,000 for the year ended December 31, 2003 to US$39,688,000 for the
year ended December 31, 2004. The increase in cost of sales is primarily
attributable to incremental cost of sales associated with the newly acquired
Fitzgerald and Adaltis product ranges (US$4,064,000). The remaining US$2,747,000
is attributable to the increased cost of sales associated with higher sales
levels of the company's existing product ranges. See Revenues section above for
details on movements in revenues during 2004.
Research and development
Research and development ("R&D") expenditure decreased to US$4,641,000 in 2004.
This represents 5.8% of consolidated revenues compared to expenditure of
US$5,210,000 or 7.9% of consolidated revenues in 2003. For a consideration of
the various R&D projects see "Research and Products under Development" in Item
5.
Administrative expenses
Overall normal administrative expenses account for 37% of consolidated revenues
in 2004 which compares with 27% in 2003. The following table outlines the
breakdown of administrative expenses compared to a similar breakdown for 2003.
26
YEAR ENDED DECEMBER 31,
-----------------------
2004 2003 INCREASE % CHANGE
---------- ---------- ---------- ----------
US$'000 US$'000 US$'000
SG&A 27,304 17,063 10,241 60
Amortisation 2,570 856 1,714 200
TOTAL 29,874 17,919 11,955 67
SG&A
Administrative expenses increased 60% or by US$10,240,000 from US$17,063,000 to
US$27,304,000, which compares to revenue growth of 22% during the same period.
The higher growth is primarily attributable to the strengthening of the
company's sales force in the US during the year, increased costs in the Irish
operations and the inclusion of additional SG&A expenditure associated with the
Fitzgerald and Adaltis acquisitions.
A detailed analysis of this increase in SG&A expenses of US$10,241,000 in 2004
is as follows:
o An increase of US$3,735,000 in the company's US direct sales operation,
principally attributable to expansion of the Group's sales and marketing
capability within the US in order to reflect the Group's expanding
product range. This includes the impact of increasing the sales force in
the US to approximately 100 people. The key objectives of the expanded
sales force in the US are to grow sales of the Unigold rapid HIV test,
to significantly increase our market share in the coagulation market, to
recover business from our US distributor and to expand our presence in
the infectious disease market.
o Increased SG&A costs in the Irish operations of US$2,845,000. This is
due to a combination of
(i) foreign exchange caused by the strengthening of the Euro
versus the US Dollar.
(ii) increased royalties and commissions principally
associated with the significant increase in the sales of
rapid HIV products.
(iii) increased central administration costs in Bray, Ireland
reflecting the first full year of the significantly
increased level of activity now being undertaken at Bray
following the transfer of the Sigma and Biopool lines to
Bray during 2003.
o Increased SG&A expenditure in relation to the Fitzgerald acquisition
(US$936,000) and Adaltis acquisition (US$320,000).
o An increase of US$172,000 in the UK principally due an increased sales
force. The UK direct sales operation which was established in 2002 was
further expanded during 2004.
o A reduction in foreign exchange gains in 2004 compared to 2003
(US$1,565,000).
o The remaining increase of US$667,000 which represents 3.9% of the prior
year SG&A costs is principally due to general inflation across the
Group.
Amortisation
The increase in amortisation of US$1,714,000 from US$856,000 to US$2,570,000 is
largely attributable to the release of a lower level of negative goodwill of
US$620,000 (2003: US$1,572,000) arising from the Sigma haemostasis acquisition
in 2002. The remaining increase of US$762,000 is mainly attributable to goodwill
amortisation in relation to the acquisitions for Fitzgerald and Adaltis during
2004 (US$575,000) and increased amortisation of other non-current intangible
assets (US$279,000).
4. RETAINED PROFIT
The following table sets forth selected income statement data for each of the
periods indicated.
YEAR ENDED DECEMBER 31,
-----------------------
2004 2003 % CHANGE
---------- ---------- ----------
(US$ '000) (US$ '000)
OPERATING INCOME 5,741 9,669 (41)
Net interest charge (522) (619) (16)
PROFIT BEFORE TAX AND SHARE
OF OPERATING LOSS IN
ASSOCIATED COMPANY AND 5,219 9,050 (42)
IMPAIRMENT
Share of operating loss in
associated company and
impairment - (1,067) (100)
PROFIT BEFORE TAX 5,219 7,983 (35)
Tax (53) (2,186) (98)
RETAINED PROFIT 5,166 5,797 (11)
27
Net interest charge
Net interest decreased to US$522,000 in 2004 compared to US$619,000 in 2003. The
decreased level of interest reflects the Company's lower level of net debt
during the year, mainly attributable to higher level of deposit interest being
earned on cash deposits following the Company's fund raising activities during
2004. Please refer to "Liquidity and Capital Resources" later in this section
for information on Trinity Biotech's use of debt.
Share of loss in associated company and impairment
On October 2, 2000, the Company acquired 33% of the share capital of HiberGen
Limited for a total consideration of US$1,372,000. On July 2, 2001 the Company
subscribed for a further 300,000 Ordinary Shares of (euro)0.0127 each in
HiberGen Limited, increasing its shareholding to 40%, at a cost of US$309,000.
On April 3, 2002 the Company increased its shareholding to 42.9% by the
acquisition of a further 165,000 Ordinary Shares in HiberGen Limited. The
consideration of US$202,000 was satisfied by the issue of 156,189 'A' Ordinary
Shares in Trinity Biotech plc. During 2003 HiberGen Limited was unsuccessful in
raising additional funds and on November 14, 2003, the Board of HiberGen Limited
decided to cease trading. The company wrote off its investment in HiberGen in
2003, thus there is no impact on the results for 2004.
Taxation
A tax charge of US$53,000 was incurred in the year ended December 31, 2004. The
comparable charge for 2003 was US$2,186,000. This represented a decrease in
current tax in absolute terms of US$1,091,000 and a decrease in deferred tax of
US$1,042,000. The decrease in current tax is primarily attributable to a
reduction in overseas taxation as a result of the current year losses in the US.
This also had the impact of increasing the deferred tax asset thus decreasing
the deferred tax charge. For further details on the Group's tax charge please
refer to Note 8 "Deferred Tax" and Note 14 "Income Taxes" of the Notes to the
Consolidated Financial Statements contained in Item 18 "Financial Statements".
Retained Profit
Retained profit for the period decreased by US$631,000, from US$5,797,000 to
US$5,166,000. As a percentage of consolidated revenues this represents a
decrease to 6.5% from 8.8%. This decrease is principally due to the higher costs
associated with strengthening the sales force in the US more than offsetting the
increased gross margins earned from higher sales levels, the impact of reduced
taxation charge in 2004 and the share of losses and the impairment of the
investment in an associated company in 2003.
RESULTS OF OPERATIONS
Year ended December 31, 2003 compared to the year ended December 31, 2002. The
following compares our results in the year ended December 31, 2003 to those of
the year ended December 31, 2002. Our analysis is divided as follows:
1. Overview
2. Revenues
3. Operating Expenses
4. Retained Profit
1. OVERVIEW
In US Dollars, our consolidated revenues increased by 26%; operating income grew
by 47%; retained profit increased by 18% and cash flow from operating activities
increased by 17%.
Geographically, 55% of our sales were generated in the USA, 30% in Europe and
15% in the rest of the world.
The gross margin for the year ended December 31, 2003 was 49.9% compared to
50.6% for the year ended December 31, 2002. The decrease in gross margin is
partly explained by the weakening of the US Dollar, causing the margin to drop
by 0.7%.
Our operating margin in 2003 was 14.7% of sales, an increase of 2% over the
12.7% of sales of the previous year. This is due to the increase in turnover,
primarily attributable to a full year's revenues of the Sigma haemostasis and
Sigma speciality clinical chemistry product lines in 2003. This is partially
offset by (i) the increase in cost of sales arising from
28
these product lines of US$8,710,000 and (ii) the increase in administration
expenses due to the expansion of sales and marketing activities.
As a result of these factors, operating income increased by US$3,086,000 to
US$9,669,000.
2. REVENUES
The following table sets forth selected sales data for each of the periods
indicated.
YEAR ENDED DECEMBER 31,
-----------------------
2003 2002 % CHANGE
---------- ---------- ----------
(US$ '000) (US$ '000)
REVENUES
Infectious diseases
- infectious disease
(excl rapids) 30,678 33,939 (10)
- rapids 4,449 3,890 14
Haemostasis 24,435 13,780 77
Clinical Chemistry 6,113 369 1,557
TOTAL 65,675 51,978 26
Trinity Biotech's consolidated revenues for the year ended December 31, 2003
were US$65,675,000 compared to consolidated revenues of US$51,978,000 for the
year ended December 31, 2002.
US$2,200,000 of the decrease of US$2,702,000 in infectious diseases revenues
resulted from declining sales under the distribution agreement with
Carter-Wallace, Inc ("Carter-Wallace") and its affiliate Wampole Laboratories
("Wampole"), now owned by Inverness Medical Innovations, Inc ("Inverness
Medical"). The Company believes this is due to Inverness Medical and Wampole
attempting to convert customers from the Trinity Biotech product to an
alternative product. Accordingly, in December 2003, the Company filed legal
action against Inverness Medical and Wampole for declaratory judgement and
breach of contract. In January 2004, Inverness Medical countersued and sought a
preliminary injunction to prevent the Company from selling direct in the US any
of its products which are competitive with products sold by Inverness Medical
and sourced by other suppliers. The Superior Court of Middlesex County,
Massachusetts, denied the motion for preliminary injunction on January 28, 2004.
For further information relating to this matter please refer to Item 8 "Legal
Proceedings.
Additional revenues of US$5,744,000 were earned on clinical chemistry products
in 2003 due to the contribution of a full year's sales of the Sigma speciality
clinical chemistry product line in 2003. This compares to one month's revenues
from the same product line in 2002.
The increase in haemostasis revenues of US$10,655,000 is principally
attributable to a full year's revenues of the Sigma haemostasis product line in
2003 as compared to five month's revenues, from August to December, in 2002.
For further information about the company's principal products, principal
markets and competition please refer to Item 4, "Information on the Company".
The following table sets forth selected sales data, analysed by geographic
region:
YEAR ENDED DECEMBER 31,
-----------------------
2003 2002 % CHANGE
---------- ---------- ----------
(US$ '000) (US$ '000)
REVENUES
USA 36,299 33,512 8
Europe 19,982 11,899 68
Middle East /Africa 6,249 4,396 42
Other overseas 3,145 2,171 45
TOTAL 65,675 51,978 26
29
The US$2,787,000 increase in the US is attributable to the increase in
haemostasis and clinical chemistry sales of US$5,300,000 due to the inclusion of
a full year's revenues of the Sigma haemostasis and Sigma speciality clinical
chemistry product lines. This is partially offset by the US$2,200,000 reduction
in sales from Wampole discussed above.
The US$8,083,000, US$1,853,000 and US$974,000 increases in the Europe, Middle
East/Africa and other overseas segments, respectively, are primarily driven by
the inclusion of a full year's revenues of the Sigma haemostasis and Sigma
speciality clinical chemistry product lines.
3. OPERATING EXPENSES
The following table sets forth our operating expenses.
YEAR ENDED DECEMBER 31,
-----------------------
2003 2002 % CHANGE
---------- ---------- ----------
(US$ '000) (US$ '000)
Revenues 65,675 51,978 26
Cost of sales (32,877) (25,690) 28
Research & development (5,210) (4,471) 17
Administrative expenses (17,919) (15,234) 18
Operating profit 9,669 6,583 47
Cost of sales
Trinity Biotech's consolidated cost of sales increased 28% or by US$7,187,000
from US$25,690,000 for the year ended December 31, 2002 to US$32,877,000 for the
year ended December 31, 2003. The increase in cost of sales is primarily
attributable to (i) the Sigma haemostasis and speciality clinical chemistry
product lines which contributed an additional US$8,710,000 to cost of sales, and
(ii) the decrease in cost of sales associated with the decrease in revenues for
infectious diseases sales categories of US$1,523,000.
Research and development
Research and development ("R&D") expenditure increased to US$5,210,000 in 2003.
This represents 7.9% of consolidated revenues and is comparable to R&D spend in
2002 of US$4,471,000 or 8.6% of consolidated revenues. For a consideration of
the various R&D projects see "Research and Products under Development" in Item 5
of the 20-F.
Administrative expenses
Overall normal administrative expenses account for 27% of consolidated revenues
in 2003 which compares with 29% in 2002. The following table outlines the
breakdown of administrative expenses compared to a similar breakdown for 2002.
YEAR ENDED DECEMBER 31,
----------------------- INCREASE/
2003 2002 (DECREASE) % CHANGE
---------- ---------- ---------- ----------
US$'000 US$'000 US$'000
SG&A 17,063 12,849 4,214 33
Amortisation 856 2,386 (1,530) (64)
TOTAL 17,919 15,235 2,684 18
SG&A
Administrative expenses increased 33% or by US$4,214,000 from US$12,849,000 to
US$17,063,000, this compares to revenue growth of 26% during the same period.
The higher growth is attributable to the strengthening of the Group's sales and
marketing and administrative functions following the acquisitions of the Sigma
haemostasis product line in August 2002 and the Sigma clinical chemistry product
line in November 2002. In April 2002 Sigma Aldrich announced plans to sell the
assets of its diagnostics business. When the Group took on these businesses in
August and November 2002 a significant selling effort was required to retain the
customer base.
Specifically the Group (i) opened a new sales and marketing facility in St.
Louis, Missouri in October 2002, (ii) opened a direct sales and marketing
operation in the UK in October 2002, and (iii) expanded its sales and marketing
operations in Germany and Ireland to cater for the new product lines acquired in
these acquisitions. This expansion occurred in Quarter 4,
30
2002 and 2003 represented the first full year's operation of these expanded
sales and marketing and administrative functions.
The effect of these acquisitions was to significantly expand the haemostasis
product line into instruments, consumables and a wider range of reagents, and to
introduce a new product line in clinical chemistry. Accordingly the focus of the
sales and marketing effort changed from infectious disease and the Biopool
haemostasis reagents to encompass a broader haemostasis range and clinical
chemistry. This expansion in the volume and complexity of our product range
necessitated a substantial increase in the level of sales and marketing effort
and a redirection and retraining of our existing salesforce and distributors.
A detailed analysis of this increase in SG&A expenses of US$4,214,000 in 2003 is
as follows:
o An increase of US$1,691,000 in the Group's US operations, principally
attributable to expansion of the Group's sales and marketing capability
within the US in order to reflect the Group's expanding product range as
noted above. 2003 represented the first full year of the Group's central
sales and marketing facility in St. Louis which was established in
October 2002.
o An increase in SG&A expenses of US$1,613,000 in the Group's operations
in Germany. This is principally attributable to the inclusion of a full
year's SG&A expenses incurred at the Group's haemostasis instrument
manufacturing facility in Lemgo versus four months of such costs in
2002. This plant was acquired as part of the acquisition of the
haemostasis business line from Sigma in August 2002.
o An increase of US$458,000 due to the inclusion of a full year of SG&A
costs in the UK, compared to three months in 2002 following the
establishment of a UK sales office in Oxfordshire in October 2002.
o The remaining increase of US$452,000 is principally attributable to;
(i) a strengthening of the Group's central sales and
marketing function, located in Bray, Ireland, in line
with the broadening of the Group's product range
(US$1,392,000);
(ii) increased central administrative costs (US$895,000) in
Bray, Ireland reflecting the significant increase in
level of activity now being undertaken at Bray following
the transfer of the manufacture of the Sigma and Biopool
product lines to Bray during 2003 and increase in head
office administrative functions reflective of the
increasing size of the Group and the level of
fundraising and acquisition activities; and,
(iii) an offset by foreign exchange gains of US$1,835,000
incurred by the Group which arose during the year.
Amortisation
The decrease in amortisation of US$1,530,000 from US$2,386,000 to US$856,000 is
largely attributable to the release of negative goodwill of US$1,572,000 arising
from the Sigma haemostasis acquisition in 2002. Following the completion of the
fair value exercises in 2003 in respect of the Sigma Haemostasis and Sigma
Clinical Chemistry acquisitions made during 2002, amendments have been made to
the fair values reported in the 2002 financial statements. The amendments relate
to the identification of additional obligations of US$929,000 assumed on the
acquisition of the Sigma Haemostasis business, the completion of the fair value
exercise on inventory acquired in both acquisitions resulting in the recognition
of additional value of US$3,031,000 and the recognition of additional costs of
US$68,000 relating to the Sigma Hemostasis acquisition and US$97,000 relating to
the Clinical Chemistry acquisition. In accordance with Irish GAAP, negative
goodwill has been released to the profit and loss account as the related assets
are utilised. Please refer to Note 19 "Acquisition of Businesses" in Item 18,
"Financial Statements", for full disclosure of these acquisitions and fair value
adjustments.
4. RETAINED PROFIT
The following table sets forth selected income statement data for each of the
periods indicated.
YEAR ENDED DECEMBER 31,
-----------------------
2003 2002 % CHANGE
---------- ---------- ----------
(US$ '000) (US$ '000)
OPERATING INCOME 9,669 6,583 47
Net interest charge (619) (601) 3
PROFIT BEFORE TAX
AND SHARE OF OPERATING
LOSS IN ASSOCIATED COMPANY
AND IMPAIRMENT 9,050 5,982 51
Share of operating loss in
associated company and impairment (1,067) (317) 237
PROFIT BEFORE TAX 7,983 5,665 41
Tax (2,186) (768) 185
RETAINED PROFIT 5,797 4,897 18
31
Net interest charge
Net interest increased to US$619,000 in 2003 compared to US$601,000 in 2002. The
increased level of interest reflects the Company's higher level of net debt
during the year, mainly attributable to the completion of the US$10 million club
banking facility with Allied Irish Banks plc and Bank of Scotland (Ireland) Ltd
in June 2003 and the private placement of US$20 million of 3% convertible notes
in July 2003. Please refer to "Liquidity and Capital Resources" later in this
section for information on Trinity Biotech's use of debt.
Share of loss in associated company and impairment
From 2000 to 2002, the Company acquired 42.9% of the share capital of Hibergen
Limited. During 2003, Hibergen Limited was unsuccessful in raising additional
funds and on November 14, 2003, the board of Hibergen Limited decided to cease
trading. The carrying value of the Company's investment in Hibergen was written
off in 2003.
Taxation
A tax charge of US$2,186,000 was incurred in the year ended December 31, 2003.
The comparable charge for 2002 was US$767,000. This represented an increase in
current tax in absolute terms of US$1,279,000 and an increase in deferred tax of
US$140,000. The increase in current tax is primarily attributable to a higher
corporation tax charge in Ireland in 2003 as the level of relief for losses
carried forward enjoyed by the Company in previous years is no longer available.
The utilisation of losses carried forward also helped to increase the Group net
deferred tax charge. For further details on the Group's tax charge please refer
to Note 8 "Deferred Taxation" and Note 14 "Income Taxes" of the notes to the
consolidated financial statements contained in Item 18 "Financial Statements" of
this Form 20-F.
Retained Profit
Retained profit increased by US$900,000, from US$4,897,000 to US$5,797,000. As a
percentage of consolidated revenues this represents a decrease from 9.4% to
8.8%, principally due to the write-off of the investment in HiberGen.
LIQUIDITY AND CAPITAL RESOURCES
FINANCING
During 2003, US$1,000,000 principal amount of 6% convertible debentures was
converted into 666,667 Class 'A' Ordinary Shares of the Company.
On April 3, 2002, the Company increased its shareholding in Hibergen Limited, an
associate company, from 40% to 42.9% by the acquisition of 165,000 Ordinary
Shares in HiberGen Limited. The consideration of US$202,000 was satisfied by the
issue of 156,189 'A' Ordinary Shares in Trinity Biotech plc.
In December 2001, the Company acquired the assets of the Biopool haemostasis
business for a total consideration of US$6,409,000, after costs, satisfied in
cash and deferred consideration. The deferred consideration of US$2,591,000 was
payable in three instalments of US$855,000, US$1,166,000 and US$570,000 on
December 21, 2002, 2003 and 2004 respectively. The deferred consideration was
not conditional on any future event and has been fully settled.
On August 27, 2002, Trinity Biotech purchased the haemostasis division of Sigma
Diagnostics for a total consideration of US$1,428,000. The consideration was
satisfied in cash. On November 27, 2002, the Company also acquired the
speciality clinical chemistry product line from Sigma Diagnostics for a total
consideration of US$4,412,000 satisfied in cash and deferred consideration. The
cash consideration was partly financed by the issue of US$2.5 million of
convertible debentures. The deferred consideration of US$1,810,000 was paid
during 2003.
In November 2002, the Company completed a private placement of (i) US$2,500,000
principal amount of 5.25% convertible debentures and (ii) 50,000 warrants (the
"Second Warrants") to purchase 'A' Ordinary Shares of the
32
Company. The debentures bore interest at a rate of 5.25% per annum and were
convertible into Class 'A' Ordinary Shares of the Company at a price of US$1.50.
During 2003, the debenture was fully converted into 1,666,667 Class 'A' Ordinary
Shares of the Company.
In December 1999, the Company completed a private placement of (i) US$3,500,000
principal amount of 7.5% Convertible Debentures and (ii) 483,701 warrants to
purchase 'A' Ordinary shares of the Company (the "First Warrants"), which
resulted in aggregate gross proceeds to the Company of US$3,500,000. In relation
to the First Warrants, 333,701 were each exercisable to purchase one 'A'
Ordinary Share of the Company at US$1.74 per share and the remaining 150,000
were each exercisable to purchase one 'A' Ordinary Share of the Company at
US$1.80 per share. 100,000 of these warrants were exercised to purchase 'A'
Ordinary Shares in the Company in 2000. The balance of these 150,000 warrants
expired unexercised on June 25, 2002. During 2003, 133,701 of the remaining
First Warrants were exercised and the final 200,000 were exercised in 2004. The
Second Warrants are each exercisable to purchase one 'A' Ordinary Share of the
Company at US$1.50 and will expire in November 2007. None of the Second Warrants
have been exercised.
In June 2003, Trinity Biotech completed a new US$10,000,000 club banking
facility with Allied Irish Bank plc and Bank of Scotland (Ireland) Ltd. The new
facility consists of a five year term loan of US$6,000,000 and a one year
revolver of US$4,000,000. This facility was partly used to repay existing loans
and the loan notes payable to Xtrana, Inc. During 2004 the Company repaid
US$1,200,000 of the term loan. At December 31, 2004, the term loan outstanding
was US$4,800,000. During 2004 US$1,000,000 of the revolver was repaid leaving
US$2,000,000 outstanding at December 31, 2004.
In July 2003, the Company completed a private placement of US$20,000,000
principal amount of 3% convertible debentures. The debentures bear interest at a
rate of 3% per annum, convertible into Class 'A' Ordinary Shares of the Company
at a price of US$3.55. In December 2003, US$6,355,000 of the US$20,000,000
principal amount of the debentures was converted into 1,790,141 Class 'A'
Ordinary Shares of the Company, a further US$44,500 of accrued interest was
settled by the issue of 12,535 Class 'A' Ordinary Shares of the Company at
US$3.55 per share. In 2004, a further US$427,500 of the principal amount of the
debenture was converted into 120,423 Class 'A' Ordinary Shares of the Company.
As part of the July 2003 placement, convertible notes in the aggregate principal
amount of up to US$5,000,000 could be issued at the option of the investors by
the later of January 9, 2004 and the three month anniversary of the effective
date of the registration statement. In March 2004, the investors exercised this
option in full and the Company completed a further placement of US$5,000,000
principal amount of 3% convertible debentures. The debentures bear interest at a
rate of 3% per annum and are convertible into Class 'A' Ordinary Shares of the
Company at a price of US$4. All of above debentures are unsecured and are
repayable in ten equal instalments on a quarterly basis commencing October 2004.
Under the terms of the agreement, the Company has the right to satisfy each
repayment either in cash or in shares. In October 2004, the first principal
repayment of $1,822,000 was made to the debenture holders in cash. At 31
December 2004, the total amount of debentures outstanding amounted to
US$15,819,000. The debt is stated net of unamortised issue costs of US$576,000.
In January 2004, the Company has completed a private placement of 5,294,118 of
Class 'A' Ordinary Shares of the Company at a price of US$4.25 per share. The
investors were granted five year warrants to purchase an aggregate of 1,058,824
Class 'A' Ordinary Shares of the Company at an exercise price of US$5.25 per
share. Under the terms of the placement, investors were also granted the right
to purchase an additional 2,647,059 Class 'A' Ordinary Shares of the Company at
a price of US$4.25 per share for a period of up to 30 days after the closing of
the transaction. An additional 431,617 Class 'A' Ordinary Shares of the Company
were issued within the 30 day period following the closing of the transaction to
investors who exercised this option.
CASH MANAGEMENT
As at December 31, 2004, Trinity Biotech's consolidated cash and cash
equivalents were US$22,287,000. This compares to cash and cash equivalents of
US$20,563,000 at December 31, 2003. The increase is due to cash inflow of
US$2,348,000 from operations, the issue of share capital, and the issue of
convertible debentures, offset by the repayment of bank borrowings and cash
payments for the purchase of businesses and fixed assets. This resulted in an
increase in cash and liquid resources of US$1,723,000 during the year.
A significant portion of the Company's activities are conducted in US Dollars.
The primary foreign exchange risk arises from the fluctuating value of the
Company's Euro expenses as a result of the movement in the exchange rate between
the US Dollar and the Euro. Arising from this, the Company pursues a treasury
policy which aims to sell US Dollars forward to match a portion of its uncovered
Euro expenses at exchange rates lower than budgeted exchange rates. The
Company's current hedging policy is to cover a portion of its expenses forward.
The Company expects that its forward contracts as at December 31, 2004 will have
a positive impact on the cashflows of the business. At December 31, 2004 forward
contracts with a carrying value of US$Nil had a fair value of US$418,000.
33
As at December 31, 2004, year end borrowings were US$24,011,000 and cash in hand
was US$22,287,000. For a more comprehensive discussion of the Company's level of
borrowings at the end of 2004, the maturity profile of the borrowings, the
company's use of financial instruments, its currency and interest rate structure
and its funding and treasury policies please refer to Item 11 "Qualitative and
Quantitative Disclosures about Market Risk".
CONTRACTUAL OBLIGATIONS
The following table summarises our minimum contractual obligations and
commercial commitments, as of December 31, 2004:
CONTRACTUAL OBLIGATIONS PAYMENTS DUE BY PERIOD
-------------------------------------------------- ---------------------------------------------------------
less than more than 5
Total 1 year 1-3 Years 3-5 Years years
------- --------- --------- --------- -----------
US$'000 US$'000 US$'000 US$'000 US$'000
Bank loans 6,731 3,150 3,581 - -
Financial liabilities from unconnected third party 669 669 - - -
Capital (finance) lease obligations 792 238 554 - -
Operating lease obligations 28,753 2,648 3,977 3,216 18,912
Other long-term liabilities reflected on the 15,819 7,031 7,321 1,467 -
company's balance sheet under Irish GAAP
Total 52,764 13,736 15,433 4,683 18,912
Trinity Biotech incurs debt to pursue its policy of growth through acquisition.
Trinity Biotech believes that, with further funds generated from operations, it
will have sufficient funds to meet its capital commitments and continue existing
operations for the foreseeable future. If operating margins on sales were to
decline substantially, if the Company's increased investment in its US direct
sales force was not to generate comparable margins in sales or if the Company
was to make a large and unanticipated cash outlay, the Company 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 Company
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.
IMPACT OF INFLATION
Although Trinity Biotech's operations are influenced by general economic trends,
Trinity Biotech does not believe that inflation had a material effect on its
operations for the periods presented. Management believes, however, that
continuing national wage inflation in Ireland and the impact of inflation on
costs generally will result in a sizeable increase in the Irish facility's
operating costs in 2005.
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.
Trinity Biotech's revenues are primarily denominated in US Dollars, its expenses
are incurred principally in Euro and US Dollars. The recent weakening of the US
Dollar could have an adverse impact on future profitability. Management are
actively seeking to increase the size of the Euro revenue base 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.
EXCHANGE RATES
Fluctuations in the exchange rate between the Euro and the US Dollar may impact
on the Company's Euro monetary assets and liabilities and on Euro expenses and
consequently the Company's earnings.
OFF-BALANCE SHEET ARRANGEMENTS
Not applicable.
RESEARCH AND PRODUCTS UNDER DEVELOPMENT
HISTORY
Trinity Biotech has invested considerable funds in research and development over
the past number of years. It has developed a platform technology for its rapid
UniGold tests and, arising from this, the Company has focused on
34
developing rapid tests for certain infectious diseases utilising this platform.
The Company continues to expand and improve its product offerings in other areas
including EIAs, immunofluorescent assays and Western Blots.
DEVELOPMENT GROUPS
The Company has research and development groups focusing separately on
microtitre based tests, rapid tests, western blot products and immunofluorescent
assays. These groups are located in Dublin and the US. The Company sub-contracts
some research and development to independent researchers based in the US and
from time to time sponsors various projects in universities. Each of these
research and development groups is currently involved in the following projects:
Microtitre Plate Development Group
Development of type specific microtitre plate assay for the detection of HSV-1
and HSV-2 The Company has developed HSV-1 and HSV-2 specific tests to complement
its HSV-1/2 tests. HSV-2 causes more serious complications to pregnant women and
HSV-2 positive patients are more susceptible to contracting HIV. These type
specific tests utilise recombinant proteins rather than the less specific viral
lysates in the older generations of these products. This work was completed in
the latter half of 2003 and the Company received FDA approval for these tests
from the FDA on July 13, 2004.
Development of microtitre plate assay for the detection of EU Lyme IgG and IgM
Prompted by the company's successful Lyme Western Blots and the company's
successful domestic (US) Lyme IgG and IgM EIAs, development has commenced on two
new elisas to specifically detect EU Lyme IgG and IgM. It is anticipated that
development should be completed and the products launched on the market by mid
2005.
One Plate IgMs
The Company has a repertoire of IgM EIA products against various infectious
agents. These were originally in a two plate format but a program was initiated
to convert these to a one plate format. Work on converting Rubella IgM, Toxo
IgM, VZV IgM, Measles IgM and Mumps IgM was completed in 2003. The conversion of
HSV 1 IgM, HSV 2 IgM and CMV IgM assays to a one plate format commenced in 2004
and is expected to be completed in 2005.
Rapid Development Group
Development of UniGold Recombigen HIV (2000-2003)
This represents a modification of Trinity Biotech's original UniGold HIV Test
using recombinant protein antigens rather than peptides in the test. It is a
single use rapid test for the detection of antibodies to HIV-1 in plasma, serum
and whole blood. The test is intended for use as an aid in diagnosis, in
settings where the rapid diagnosis of HIV infection can ensure early initiation
of antiretroviral therapy. The test can be performed in ten minutes, enabling
health care providers to supply preliminary results to patients at the time of
testing, potentially increasing the overall effectiveness of counselling and
testing programs.
The recombinant proteins are manufactured by Trinity Biotech and allow the
UniGold HIV Test to be produced in a more cost-effective manner. Clinical and
non-clinical trials demonstrated that the test has a sensitivity of 100% and a
specificity of 99.7%.
On December 23, 2003, the FDA issued approval for the sale of the UniGold HIV
test for use with vennipuncture blood (whole blood, serum and plasma). Early in
2004, an IDE submission was made to the FDA to define the data requirements to
expand the use of the product to test fingerstick (blood taken directly from the
finger) samples. Clinical trials were completed by the end of May 2004 and the
application in the form of a PMA supplement made to the FDA on June 10, 2004.
Three months later on September 21, 2004 the FDA issued approval for the sale of
the UniGold HIV test for use with fingerstick samples. This allows for the use
of the UniGold HIV test in further settings where vennipuncture samples may not
be taken.
Throughout 2004 trials were completed to support CLIA waiver applications for
the UniGold HIV test. The application for CLIA waiver for use with vennipuncture
whole blood was made in April 2004. CLIA waiver approval was granted for whole
blood on June 23, 2004. An additional waiver approval was submitted for
fingerstick blood in September 2004 and approval granted in November 2004. This
allows for sale of the UniGold HIV test into clinical laboratories throughout
the United States testing the following blood sample types: serum, plasma,
fingerstick and venipuncture whole blood.
35
Western Blot Development Group
HIV Western Blot
Trinity Biotech has developed a western blot test for detecting antibodies to
HIV for use as a diagnostic and confirmatory product in blood banks. The
products had been designed and developed at the Trinity Biotech plc facility in
Carlsbad California where the company has established a long history in Western
Blot products. The development work on the Recombigen(R) HIV-1 Western Blot was
completed during the first half of 2004. An Investigational New Drug (IND)
application was completed and submitted to the CBER division of the FDA on July
20, 2004. Approval for this application was granted by the FDA on September 24,
2004. This application outlined the manufacturing processes for the product and
defined the clinical trials to be performed on the product to support a BLA
application. Clinical trials and product validation are planned for 2005. Once
all trials are complete a BLA application will be made. This product is
available for evaluation use outside of the US.
Immunofluorescent Assay Development Group
Research is also ongoing on redesigning various immunofluorescent assays from
indirect assays to direct assays. This redevelopment will make the products more
user friendly and reduce assay time.
VRK DFA kit
This is a test for the detection of Influenza A and B, RSV (Respiratory
syncytial virus), Para and Adenovirus in both patient specimens and culture
samples. It employs a one step method with a total test time of 15 minutes,
allowing the differentiation of various viruses responsible for respiratory
system infections. Such a product will complement the existing RSV DFA kit. This
product is due to be completed and launched (ROW) in 2005 and submitted for
510(k) approval in 2006.
For the 12 months ended December 31, 2004, the Company spent US$4,641,000 on
research and development. This expenditure is broken down into salary costs,
reagents, consultancy fees and other related costs. This is broadly comparable
with the net expenditure in previous two years (2003: US$5,210,000, 2002
US$4,471,000).
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.
ITEM 6
DIRECTORS AND SENIOR MANAGEMENT
DIRECTORS AND EXECUTIVE OFFICERS
Name Age Title
-------------------------------------- --- ----------------------------------------------------
Ronan O'Caoimh 49 Chairman of the Board of Directors
Chief Executive Officer
Brendan K. Farrell 57 Director, President
Jim Walsh Ph.D. 46 Director, Chief Operating Officer
Rory Nealon 37 Director, Chief Financial Officer, Company Secretary
Denis R. Burger, Ph.D. 61 Non Executive Director
Peter Coyne 45 Non Executive Director
BOARD OF DIRECTORS
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 has been Chairman since May 1995. 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.
BRENDAN FARRELL, PRESIDENT, joined Trinity Biotech in July 1994. He was
previously Marketing Director of B.M. Browne Limited, a company involved in the
marketing and distribution of medical and diagnostic products. Prior to that
36
he was Chief Executive of Noctech Limited, an Irish based diagnostics company,
following six years with Baxter Healthcare where he was Director of European
Business Development. Mr Farrell has a Masters degree in Biochemistry from
University College Cork.
RORY NEALON, CHIEF FINANCIAL OFFICER, joined Trinity Biotech as Chief Financial
Officer and Company Secretary in January 2003. 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.
JIM WALSH, PHD, CHIEF OPERATING OFFICER, joined Trinity Biotech in October 1995.
Prior to joining the Company, 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 and a PhD in Microbiology from University
College Galway.
DENIS R. BURGER, PHD, NON-EXECUTIVE DIRECTOR, co-founded Trinity Biotech in June
1992 and acted as Chairman from June 1992 to May 1995. He is currently a
non-executive director of the Company. Dr Burger is Chairman, Chief Executive
Officer and a director of AVI Biopharma Inc, an Oregon based biotechnology
company. Dr Burger is also a 50% partner in Sovereign Ventures, a healthcare
consulting and funding firm based in Portland, Oregon. He was 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 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. He
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.
COMPENSATION OF DIRECTORS AND OFFICERS
The remuneration committee is responsible for determining the remuneration of
the executive directors. The basis for the executive directors' remuneration and
level of annual bonuses is determined by the remuneration committee of the
board. In all cases, performance 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 and Mr Ronan O'Caoimh. 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 outside the normal duties of a director 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.
Performance Defined
Salary/ related contribution Total Total
Director Benefits bonus pension 2004 2003
------------------------------- -------- ----------- ------------ --------- ---------
US$,000 US$'000 US$'000 US$'000 US$'000
Ronan O'Caoimh 325 120 63 508 423
Brendan Farrell 240 73 28 341 294
Rory Nealon 196 23 18 237 145
Jim Walsh 240 48 63 351 294
-------- ----------- ------------ --------- ---------
1,001 264 172 1,437 1,156
-------- ----------- ------------ --------- ---------
37
Total Total
Non-executive director Fees 2004 2003
------------------------------- -------- --------- ---------
US$,000 US$'000 US$'000
Denis R. Burger 28 28 20
Peter Coyne 28 28 20
-------- --------- ---------
56 56 40
-------- --------- ---------
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.
In accordance with the Articles of Association of the Company, Mr. Peter Coyne
will retire by rotation and, being eligible, offer himself for re-election at
the Annual General Meeting of the Company.
The board has established audit and remuneration committees. The functions and
membership of the remuneration committee is described above. The audit committee
is responsible to the board for the review of the quarterly and annual reports
and ensuring that an effective system of internal controls is maintained. 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 the two independent non-executive directors of the Company,
Mr Peter Coyne (committee chairman) and Dr Denis Burger. Nasdaq Rule
4350(d)(2)(A) requires each Nasdaq-listed company to have an independent audit
committee of three members. Foreign private issuers are required to comply with
Nasdaq Rule 4350(d) by July 31, 2005. The audit committee of Trinity Biotech plc
currently consists of only two members.
EMPLOYEES
As of December 31, 2004, Trinity Biotech had 675 employees (2003: 624)
consisting of a research director and 40 research scientists and technicians,
411 manufacturing and quality assurance employees, and 223 finance,
administration and marketing staff (2003: a research director and 40 research
scientists and technicians, 430 manufacturing and quality assurance employees,
and 153 finance, administration and marketing staff). Trinity Biotech's future
hiring levels will depend on the growth of revenues.
The geographic spread of the Company's employees was as follows: 319 in Bray,
Co. Wicklow, Ireland, 93 in Germany, 10 in Sweden, 5 in the United Kingdom and
248 in its US operations.
STOCK OPTION PLAN
The board of directors has adopted the Employee Share Option Plan 2003 (the
"Plan"), the purpose of which 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 is
administered by a compensation committee designated by the board of directors.
The aggregate maximum number of 'A' Ordinary shares of Trinity Biotech available
for awards under the Plan is 3,000,000 subject to adjustments to reflect changes
in Trinity Biotech's capitalisation. Options under the Plan may be awarded only
to employees, officers, directors and consultants of Trinity Biotech.
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 the options. As of February 28, 2005, 6,108,541 of the options outstanding
were held by directors and officers of Trinity Biotech.
38
As of February 28, 2005 the following options were outstanding:
Number of 'A' Ordinary Shares Range of
Subject to Option Exercise Price
per Share
Total options outstanding 8,617,517 US$0.81-US$5.00
In addition, the Company granted warrants to purchase 940,405 Class 'A' Ordinary
Shares at prices ranging from $1.50 to $2.75 to agents who were involved in the
Company's private placements in 1994, 1995 and 1999 and the debenture issues in
1997, 1999 and 2002. A further warrant to purchase 100,000 Class 'A' Ordinary
Shares was granted to a consultant of the Company. In January 2004, the Company
has completed a private placement, as part of this the investors were granted
five year warrants to purchase an aggregate of 1,058,824 Class 'A' Ordinary
Shares of the Company at an exercise price of US$5.25 per share and the agent
received 200,000 warrants to purchase 200,000 Class 'A' Ordinary Shares of the
Company at an exercise price of US$5.25. As of February 28, 2005 there were
warrants to purchase 1,317,324 Class 'A' Ordinary Shares in the Company
outstanding.
ITEM 7
MAJOR SHAREHOLDERS AND
RELATED PARTY TRANSACTIONS
As of February 28, 2005 Trinity Biotech has outstanding 55,588,050 'A' Ordinary
shares and 700,000 'B' Ordinary shares. Such totals exclude 9,934,841 shares
issuable upon the exercise of outstanding options and warrants.
The following table sets forth, as of February 28, 2005, 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 officer of Trinity Biotech, and (iii) all officers and
directors 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 Company is not controlled by another corporation or government.
Number of Number of
'A' Ordinary Percentage 'B' Ordinary Percentage Percentage
Shares Outstanding Shares Outstanding Total
Beneficially 'A' Ordinary Beneficially 'B' Ordinary Voting
Owned Shares Owned Shares Power
------------ ------------ ------------ ------------ ------------
Ronan O'Caoimh 2,087,988(1) 3.7% 0 0 3.6%
Brendan Farrell 1,264,135(2) 2.2% 0 0 2.2%
Rory Nealon 200,000(3) 0.4% 0 0 0.3%
Jim Walsh 1,299,615(4) 2.3% 0 0 2.2%
Denis R. Burger 67,000(5) 0.1% 0 0 0.1%
Peter Coyne 43,333(6) 0.1% 0 0 0.1%
Potenza Investments, Inc 0 0 500,000(7) 71.4% 1.8%
("Potenza")
Statenhof Building, Reaal 2A
23 50AA Leiderdorp, Netherlands
Officers and Directors
as a group (6 persons) 4,925,071(1)(2) 8.4% 0 0 8.2%
(3)(4)
(5)(6)
(1) Includes 1,217,333 shares issuable upon exercise of options.
(2) Includes 1,211,875 shares issuable upon exercise of options.
(3) Includes 200,000 shares issuable upon exercise of options.
(4) Includes 880,000 shares issuable upon exercise of options.
39
(5) Includes 30,000 shares issuable upon exercise of options.
(6) Includes 43,333 shares issuable upon exercise of options.
(7) Includes shares beneficially owned by SRL (350,000 'B') and Brindisi
Investments Inc (150,000 'B'). SRL has previously advised Trinity Biotech
that Potenza owns a majority of SRL's common stock. These 'B' shares have
two votes per share.
RELATED PARTY TRANSACTIONS
The Company 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. It has entered into an agreement with
JRJ pursuant to which the Company has taken a lease of premises adjacent to the
existing facility for a term of 20 years at a rent of (euro)7.62 per square foot
("the Current Extension"). The lease commenced on the newly completed 25,000
square foot building in July 2000. The Company also envisages that a further
premises may potentially be required by it and, for that purpose, has entered
into a four years eleven month lease at (euro)13,000 per annum over adjacent
lands with JRJ. On November 20, 2002, the Company entered into an agreement for
a 25 year lease with JRJ for offices that have been constructed on part of these
lands. The annual rent of (euro)381,000 (US$520,000) is payable from 2004.
Independent valuers have advised the Company that the rent fixed in respect of
the Current Extension, the agreement for the lease and the lease of adjacent
lands represents a fair market rent. The rent for any future property
constructed will be set at the then open market value. The Company 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 Company can meet its ongoing requirements for
premises.
ITEM 8
FINANCIAL STATEMENTS
LEGAL PROCEEDINGS
DISPUTE REGARDING THE ACQUISITION FROM XTRANA INC
In December 2002, the Company filed an action against Xtrana Inc relating to the
purchase of the Biopool business from Xtrana in 2001. The Company was seeking
US$1,200,000 in damages and US$3,000,000 in punitive damages alleging breach of
contract and other damages regarding the sale of an individual product line. On
January 17, 2003 Xtrana countersued seeking US$57,000,000 in damages.
On June 16, 2003 Trinity Biotech and Xtrana settled this litigation. Pursuant to
the terms of the settlement agreement entered into between the parties, Trinity
Biotech agreed to pay Xtrana the amounts due on two promissory notes of
US$1,166,000 and US$570,000, together with interest thereon as provided in the
notes, less US$225,000, and less US$24,000, which represented the amount due and
owing by Xtrana to Trinity Biotech as of May 31, 2003 pursuant to a letter
agreement, dated December 20, 2001, between Trinity Biotech and Xtrana, relating
to a third party. The total amount of the settlement payment made by Trinity
Biotech to Xtrana was US$1,506,000.
The parties also agreed that, following Xtrana's receipt of the settlement
payment, they would cause the litigation to be dismissed with prejudice and
without costs to any party. The parties also released each other from any claims
arising from or in connection with the notes due from Trinity Biotech to Xtrana,
the litigation, the security agreements entered into between the parties, the
asset purchase agreement made as of November 9, 2001 and any other matter
whatsoever, except for the parties executory obligations as set forth in the
settlement agreement.
DISPUTE REGARDING THE DISTRIBUTION AGREEMENT WITH INVERNESS MEDICAL
INNOVATIONS INC
In December 2003, the Company initiated legal proceedings in the Superior Court
of Middlesex County, Massachusetts against Inverness Medical and its affiliate
Wampole (collectively, Defendants) for declaratory judgment, breach of contract
and unfair and deceptive business practices in connection with the Defendants'
performance under a distribution agreement initially entered into in 1995 by
Clark Laboratories Inc (now part of the Trinity Biotech Group) and subsequently
amended in 2002. Inverness Medical, through its affiliate, Wampole Laboratories,
has acted as exclusive distributor for certain of Trinity Biotech's infectious
disease products in the US. This exclusivity ended on September 30, 2004, at
which time it had been agreed that both Trinity Biotech and Inverness Medical
would sell the products under
40
their respective labels. Among other things, the suit requested a judgement
declaring that Trinity was entitled to sell certain products directly in the US
and Puerto Rico before October 1, 2004 under the terms of the 2002 amendment to
the distribution agreement and due to breaches of the distribution agreement by
the Defendants. The suit also alleged that the Defendants were attempting to
convert customers from Trinity's products to products manufactured by a
competitor (which were modified to look like the Trinity products) by
misrepresenting to the customers that the Trinity product was unavailable and
was being discontinued. In January 2004, the Defendants countersued alleging,
among other things, various breaches of the distribution agreement and
subsequent amendments, and sought a preliminary injunction to prevent Trinity
from selling directly in the Territory any of its products which are competitive
with products sold by the Defendants and sourced from other suppliers. The
Superior Court of Middlesex County, Massachusetts, denied this motion for a
preliminary injunction on January 28, 2004. In April of 2004, Trinity amended
its complaint to add additional claims alleging breaches of the distribution
agreement by the Defendants. In May of 2004, the Defendants amended their
counterclaims to add claims alleging, among other things, that Trinity was
selling certain products without a license. Following the expiration of the
Defendants' exclusive distribution rights under the distribution agreement on
October 1, 2004, Trinity moved to amend its complaint to eliminate the
declaratory judgment claims and add additional claims for breach of the
distribution agreement and tortious interference with advantageous business
relations that had arisen after December 2003. The Defendants filed a
cross-motion to amend their complaint. There has been no ruling by the court on
either party's motion. The case is currently in the discovery phase. Please see
also Item 4, "Distribution Agreement between Trinity Biotech USA and Carter
Wallace".
ITEM 9 THE OFFER AND LISTING
Trinity Biotech's American Depository Shares ("ADS's") are listed on the NASDAQ
Small Cap Market under the symbol "TRIB". The Company's Class B Warrant (symbol
"TRIZF"), expired on February 28, 1999. Each ADS represents one 'A' Ordinary
Share of the Company. The Company's 'A' Ordinary Shares are also listed and
trade on the Irish Stock Exchange. The Company's depository bank for the ADS's
is The Bank of New York. On February 28, 2005, the reported closing sale price
of the ADS's was US$2.56 per ADS. The following tables set forth the range of
quoted high and low sale prices of Trinity Biotech's ADS, and Class B Warrants
for (a) the years ended December 31, 2000, 2001, 2002, 2003 and 2004; (b) the
quarters ended March 31, June 30, September 30 and December 31, 2003; March 31,
June 30, September 30 and December 31, 2004; and (c) the months of March, April,
May, June, July, August, September, October, November and December 2004 and
January and February 2005 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.
ADS's
------------------
High Low
------- -------
YEAR ENDED DECEMBER 31
2000 $ 7.59 $ 1.69
2001 $ 3.22 $ 0.97
2002 $ 1.86 $ 0.89
2003 $ 6.72 $ 1.25
2004 $ 5.99 $ 2.36
2003
Quarter ended March 31 $ 2.44 $ 1.25
Quarter ended June 30 $ 3.50 $ 2.09
Quarter ended September 30 $ 4.01 $ 2.26
Quarter ended December 31 $ 6.72 $ 2.61
2004
Quarter ended March 31 $ 5.99 $ 3.52
Quarter ended June 30 $ 3.81 $ 2.70
Quarter ended September 30 $ 3.42 $ 2.36
Quarter ended December 31 $ 3.18 $ 2.60
MONTH ENDED
March 31, 2004 $ 4.47 $ 3.52
April 30, 2004 $ 3.81 $ 2.81
May 31, 2004 $ 3.15 $ 2.70
June 30, 2004 $ 3.62 $ 2.80
July 31, 2004 $ 3.42 $ 2.36
August 31, 2004 $ 3.10 $ 2.51
September 30, 2004 $ 3.23 $ 2.69
October 31, 2004 $ 3.18 $ 2.60
November 30, 2004 $ 3.15 $ 2.66
December 31, 2004 $ 2.99 $ 2.61
January 31, 2005 $ 3.02 $ 2.65
February 28, 2005 $ 2.83 $ 2.50
41
The number of record holders of Trinity Biotech's ADS's as at February 28, 2005
amounts to 1,681, inclusive of those brokerage firms and/or clearing houses
holding Trinity Biotech's securities for their clientele (with each such
brokerage house and/or clearing house being considered as one holder).
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 Company). 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 Company, the
giving of any security or indemnity to a third party in respect of a debt or
obligation of the Company 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 Company to borrow money but it is
obliged to restrict these borrowings to ensure that the aggregate amount
outstanding of all monies borrowed by the Company 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 Company
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.
42
Directors are not required to retire upon reaching any specific age and are not
required to hold any shares in the capital of the Company. 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.
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 2003
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
43
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 2003 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 2003 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.
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.
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
44
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.
MATERIAL CONTRACTS
See Item 4 "History and Development of the Company" regarding acquisitions made
by the Company.
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
depository receipts of Irish companies such as Trinity Biotech, and dividends
and redemption proceeds, subject to the withholding where appropriate of
withholding tax as described under Item 10, are 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 of Finance of the Republic of Ireland to make provision
for the restriction of financial transfers between the Republic of Ireland and
other countries. Financial transfers are broadly defined and include all
transfers, which would be movements of funds within the meaning of the treaties
governing the European Communities. The acquisition or disposal of ADS's
representing shares issued by an Irish incorporated company and associated
payments may fall 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
the Financial Transfers Act, 1992 will have a material effect on its business.
For the purposes of the orders relating to Iraq and the Federal Republic 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.
Any transfer of, or payment for, an ordinary share or ADS involving the
government of any country which is currently the subject of United Nations
sanctions, any person or body controlled by any government or country under
United Nations sanctions or any persons or body controlled acting on behalf of
these governments of countries, may be subject to restrictions required under
these sanctions as implemented into Irish law.
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 ADRs.
45
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 ADRs 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 ADRs may vary
depending upon each holder's own particular situation.
Prospective purchasers of Trinity Biotech ADRs 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 ADRs.
US FEDERAL INCOME TAX CONSEQUENCES TO US HOLDERS
The following is a summary of the material US federal income tax consequences
that generally would apply with respect to the ownership and disposition of
Trinity Biotech ADRs, in the case of a purchaser of such ADRs who is a US Holder
(as defined below) and who holds the ADRs 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.
For US federal income tax purposes, US Holders of Trinity Biotech ADRs will be
treated as owning the underlying Class 'A' Ordinary Shares, or ADSs, represented
by the ADRs 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
ADRs 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 ADRs, 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 ADRs 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 income or, in the case of certain US Holders,
financial services income for US foreign tax credit purposes. US Holders should
note that recently enacted legislation eliminates the "financial services
income" category with respect to taxable years beginning after December 31,
2006. Under this legislation, the foreign tax credit limitation categories will
be limited to "passive category income" and "general category income." 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.
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 30-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, 2008
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
46
under the income tax treaty between the United States and Ireland (the "Treaty")
or (ii) the ADRs 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 ADRs 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 ADRs, the US Holder must have held such ADRs 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 ADRs should consult their own tax advisors regarding the effect of these
rules in their particular circumstances.
Upon a sale or exchange of ADRs, 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 ADRs 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 ADRs sold or exchanged for more than one year
at the time of the sale or exchange.
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 ADRs
would be required to allocate to each day in the holding period for such
holder's ADRs 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
ADRs 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 ADRs). Any
portion of an excess distribution that is treated as allocable to one or more
taxable years prior to the year of distribution 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 ADRs, 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".
For US federal income tax purposes, a foreign corporation is treated as a
"foreign personal holding company" (or FPHC) in any taxable year in which (i)
five or fewer individuals who are citizens or residents of the United States own
directly or by attribution more than 50%, by vote or value, of the shares of the
corporation and (ii) at least 60% of the corporation's gross income consists of
foreign personal holding company income. Based on the composition of its share
ownership and the nature of its business operations and gross income at the
present time, Trinity Biotech believes that it was not subject to treatment as
an FPHC for 2004.
If Trinity Biotech were classified as a FPHC, each US Holder of Trinity Biotech
ADRs on the last day of any taxable year in which Trinity Biotech is a FPHC
would have to include in the holder's gross income for that year the holder's
pro rata share of Trinity Biotech's "undistributed foreign personal holding
company income." The amount so included would not qualify for taxation at the
15% reduced tax rate applicable to dividend income, and thus would be subject to
US federal income tax at regular ordinary income rates. If Trinity Biotech were
to distribute in a subsequent tax year any
47
undistributed foreign person holding company income so taxed, the amount so
distributed would not be counted as part of an "excess distribution" under the
PFIC rules discussed above.
The FPHC rules are repealed for tax years beginning after December 31, 2004.
For US federal income tax purposes, a foreign corporation is treated as a
"controlled foreign corporation" (or CFC) in any taxable year in which one or
more US Shareholders, each of whom owns (directly or by attribution) at least
10% of the voting power of all classes of the corporation's stock (a "US
Ten-Percent Shareholder"), own, in the aggregate, more than 50% of the
corporation's stock, by vote or value.
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.
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 ADR's. 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 ADRs, the FPHC rules and 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 ADRs 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 ADRs. . US Holders of ADRs should consult
their own tax advisers as to the applicability and effect of any such taxes.
REPUBLIC OF IRELAND TAXATION
For the purposes of this summary, an "Irish Holder" means a holder of ordinary
shares or ADSs evidenced by ADRs 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 ADRs 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 and does
not perform independent personal services through a permanent establishment or
fixed base in Ireland.
48
The Board of Directors does not expect to pay dividends for the foreseeable
future. Should Trinity Biotech begin paying dividends, such dividends will
generally be subject to a 20% withholding tax (DWT). Under current legislation,
where DWT applies Trinity Biotech will be responsible for withholding it at
source. DWT will not apply 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 to us 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 tax (currently either 20% or 42% depending
on the individual's circumstances). 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 health levy of 2% and pay related social insurance contribution of
up to 3% in respect of their dividend income.
Shareholders who are individuals resident in the US (and certain other
countries) and who are not resident or ordinarily resident in Ireland may
receive dividends free of DWT where the shareholder has provided the Company
with the relevant declaration and residency certificate required by legislation.
Corporate shareholders that are not resident in Ireland and who are 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
country with which Ireland has a double tax treaty, which includes the United
States) or resident in a member state of the European Union other than Ireland
which are not controlled by Irish residents or whose principal class of shares
or its 75% parent's principal class of shares are substantially or regularly
traded on a recognised stock exchange in a country with which Ireland has a tax
treaty, may receive dividends free of DWT where they provide Trinity Biotech
with the relevant declaration, auditors' certificate and Irish Revenue
Commissioners' certificate as required by Irish law.
US resident holders of ordinary shares (as opposed to ADRs) should note that
these documentation requirements may be burdensome. As described below, these
documentation requirements do not apply in the case of holders of ADRs. US
resident holders who do not comply with the documentation requirements or
otherwise do not qualify for an exemption may be able 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.
Special DWT arrangements are available in the case of shares held by US resident
holders in Irish companies through American depository banks using ADRs who
enter into intermediary agreements with the Irish Revenue Commissioners. Under
such agreements, American depository banks who receive dividends from Irish
companies and pay the dividends on to the US resident ADR holders are allowed to
receive and pass on a dividend from the Irish company on a gross basis (without
any withholding) if:
o the depository bank's ADR register shows that the direct beneficial
owner has a US address on the register, or
o 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 ADRs,
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.
49
Under the Irish Taxes Consolidation Act 1997, non-Irish shareholders may, unless
exempted, be liable to Irish income tax on dividends received from Trinity
Biotech. Such a shareholder will not have an Irish income tax liability on
dividends if the shareholder is:
o 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
o a corporation that is not resident in Ireland and which is ultimately
controlled by persons resident in the US (or certain other countries);
or
o 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
o is otherwise entitled to an exemption from DWT.
Disposals of Ordinary Shares or ADRs
Irish Holders that acquire ordinary shares or ADRs will generally be considered,
for Irish tax purposes, to have acquired their ordinary shares or ADRs at a base
cost equal to the amount paid for the ordinary shares or ADRs. On subsequent
dispositions, ordinary shares or ADRs 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 ADRs acquired at a later time.
Irish Holders that dispose of their ordinary shares or ADRs 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 ADRs disposed
of and any incidental expenses. The current rate of CGT is 20%. Indexation of
the base cost of the ordinary shares or ADRs will only be available up to
December 31, 2002, and only in respect of ordinary shares or ADRs 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 ADRs.
An annual exemption allows individuals to realise chargeable gains of up to
(euro)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 Euro they must be
translated into Euro amounts to calculate the amount of any chargeable gain or
loss. Similarly, acquisition costs denominated in a currency other than euro
must be translated at the date of acquisition in Euro amounts.
Irish Holders that realise a loss on the disposition of ordinary shares or ADRs
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 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
US Holders will not be subject to Irish capital gains tax (CGT) on the disposal
of ordinary shares or ADRs provided that such ordinary shares or ADRs are quoted
on a stock exchange at the time of disposition. A stock exchange for this
purpose includes, among others, the Irish Stock Exchange (the ISE) or the Nasdaq
National Market (NASDAQ). While it is our intention to continue the quotation of
our ordinary shares on the ISE and the quotation of ADRs on NASDAQ, no
assurances can be given in this regard.
If, for any reason, our ADRs cease to be quoted on NASDAQ and our ordinary
shares cease to be quoted on the ISE, US Holders will not be subject to CGT on
the disposal of their ordinary shares or ADRs provided that the ordinary shares
or ADRs 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 or ADRs will 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 capital acquisitions tax is charged at a rate of 20% on
the taxable value of the gift or inheritance above a tax-free threshold. This
tax-free threshold is determined by the amount of the current benefit and of
previous benefits, received
50
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 to (euro)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.
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 ADRs 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 (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 minimum stamp duty of (euro)1.00 will apply to a transfer of
ordinary shares. Where the consideration for a sale is expressed in a currency
other than Euro, the duty will be charged on the Euro 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 of (euro)12.50 will apply.
Transfers of ADRs are exempt from Irish stamp duty as long as the ADRs 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 ADRs for the purposes of withdrawing the underlying ordinary
shares from the ADS/ADR system, and transfers of ordinary shares to the
Depositary or the Depositary's custodian for the purposes of transferring
ordinary shares onto the ADS/ADR 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 of (euro)12.50.
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.
DIVIDEND POLICY
Since its inception Trinity Biotech has not declared or paid dividends on its
'A' Ordinary Shares. Trinity Biotech anticipates, for the foreseeable future,
that it will retain any future earnings in order to fund the business operations
of the Company. The Company does not, therefore, anticipate paying any cash or
share dividends on its 'A' Ordinary Shares in the foreseeable future.
Any cash dividends or other distributions, if made, are expected to be made in
US Dollars, as provided for by the Articles of Association.
ITEM 11
QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK
QUALITATIVE INFORMATION ABOUT MARKET RISK
51
The Company'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 Company making use of spot and forward
foreign exchange markets.
Trinity Biotech uses a range of financial instruments (including cash, bank
borrowings, convertible debentures and finance leases) to fund its operations.
These instruments are used to manage the liquidity of the Company in a cost
effective, low-risk manner. Working capital management is a key additional
element in the effective management of overall liquidity. The Company 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.
The Company'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 Company borrows in appropriate currencies at fixed and floating rates of
interest. Year-end borrowings, net of cash, totalled US$1,723,000 (2003:
US$5,707,000) at interest rates ranging from 3% to 5.5% and including
US$16,680,000 of fixed rate debt at interest rates ranging from 3% to 5.50%
(2003: US$14,135,000 at interest rates ranging from 5% to 7.50%). In broad
terms, a one-percentage point increase in interest rates would decrease the net
interest charge by US$150,000 (2003: decrease by US$83,000).
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, 46% of gross debt fell due for repayment within one
year.
A significant portion of the Company's activities are conducted in US Dollars.
The primary foreign exchange risk arises from the fluctuating value of the
Company's Euro expenses as a result of the movement in the exchange rate between
the US Dollar and the Euro. Arising from this, the Company pursues a treasury
policy which aims to sell US Dollars forward to match a portion of the uncovered
Euro expenses at exchange rates lower than budgeted exchange rates. The
Company's current hedging policy is to cover forward a portion of its exposure
for a minimum of three months. Under US GAAP, US$126,000 was recognised in the
income statement in respect of gains on the fair value of derivative instruments
(2003: US$68,000). Given the recent weakening of the US Dollar, the Company's
objective is to mitigate this exposure by increasing the level of Euro
denominated sales and the Company anticipates that, over the next three years, a
higher proportion of its non-US Dollar expenses will be matched by non-US Dollar
revenues. The Company had foreign currency denominated cash balances equivalent
to US$874,000 at December 31, 2004.
QUANTITATIVE INFORMATION ABOUT MARKET RISK
INTEREST RATE SENSITIVITY
The Company 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 Company 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.
The Company estimates that the maximum effect of a rise of one percentage point
in one of the principal interest rates to which the Company is exposed, without
making any allowance for the potential impact of such a rise on exchange rates,
would be an increase in profit before tax for 2004 of less than 3%.
The table below provides information about the Company's long term debt
obligations that are sensitive to changes in interest rates. 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 the
Company's reporting currency. The actual currencies of the instruments are as
indicated.
52
MATURITY AFTER FAIR
BEFORE DECEMBER 31 2006 2007 2008 2009 2010 TOTAL VALUE*
----------------------- ------ ------ ------ ------ ------- -------- --------
LONG-TERM DEBT
Variable rate - US$000 1,176 1,176 1,175 - - 3,527 3,527
Average interest rate 3.37% 3.37% 3.37% 3.37% 3.37%
Fixed rate - US$000 7,558 1,660 177 2 - 9,396 9,396
Average interest rate 3.06% 3.21% 4.79% 5.0% - 3.12%
*Represents the net present value of the expected cash flows discounted at
current market rates of interest which approximate the total average interest
rates.
EXCHANGE RATE SENSITIVITY
At year-end 2004, approximately 11% of the Company's US$116,138,000 net worth
(shareholders' equity) was denominated in currencies other than the US Dollar,
principally the Euro.
A strengthening or weakening of the US Dollar by 10% against all the other
currencies in which the Company operates would not materially reduce the
Company's 2004 year-end net worth.
ITEM 12
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
Not applicable.
PART II
ITEM 13
DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
Not applicable.
ITEM 14
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.
ITEM 15
CONTROL AND PROCEDURES
During the annual report period, we carried out an evaluation, under the
supervision and with the participation of our senior management, including Chief
Executive Officer, Ronan O'Caoimh, and Chief Financial Officer, Rory Nealon, of
the effectiveness of the design and operation of our disclosure controls and
procedures pursuant to Rule 13(a)-14(c) of the Securities Exchange Act of 1934.
Disclosure controls and procedures are designed to ensure that the material
financial and non-financial information required to be disclosed in this Form
20-F filed with the SEC is recorded, processed, summarised and reported timely.
In designing and evaluating the disclosure controls and procedures, management
recognised that any controls and procedures, no matter how well designed and
operated, can provide only reasonable, rather than absolute, assurance of
achieving the desired control objectives, and management necessarily was
required to apply its judgement in evaluating the cost-benefit relationship of
possible controls and procedures. Based upon that evaluation, our management,
including the Chief Executive Officer and Chief Financial Officer, concluded
that our disclosure controls and procedures, are effective in timely alerting
them to material information relating to us required to be included in the our
periodic SEC filings, except as indicated below.
During the audit of the 2004 financial statements the Company's auditors
identified a material weakness relating to the Company's interpretation and
appropriate application of generally accepted accounting principles. Two of the
more significant examples of which are described below.
o The inappropriate recognition of revenue on a bill and hold arrangement
with a customer who was arranging their own courier to collect the
goods. While the Company followed its own internal procedures in this
regard these procedures did not address all of the criteria necessary to
permit the recognition of revenue in this instance as outlined in SAB
104. These procedures are being amended to include requirements to
ensure that in such cases fixed delivery schedules are provided by
customers and to consider further the basis for bill and hold customer
requests.
o In response to market forces existing in some jurisdictions the Company
in certain circumstances sells instruments to customers at a price which
is less than manufacturing cost with a view to recouping those initial
discounts from the future sale of reagents and consumables which can
only be utilised on those instruments. The Company's original
interpretation of Irish GAAP determined that it was appropriate to defer
these initial discounts with a plan to amortise over a three year period
being reflective of the period over which the Company anticipates the
sale of such reagents and consumables. The auditors concluded that the
discounts deferred did not meet the definition of an asset.
As part of the process to design its program for complying with Section 404 of
the Sarbanes Oxley Act of 2002 the Company will evaluate and enhance its
procedures where the interpretation of GAAP is involved and will expand its
external consultative process in advance of implementing new accounting
procedures. The interpretation issues have been accounted for correctly in the
preparation of the financial statements set out in Item 18.
Except for the matters referred to above, there have been no significant changes
in our internal controls over financial reporting or other factors, which could
significantly affect internal controls over financial reporting subsequent to
the date of the evaluation.
ITEM 16
AUDIT COMMITTEE FINANCIAL EXPERT
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.
53
CODE OF ETHICS
We have adopted a code of ethics for executive and financial officers, a code of
ethics that applies to our chief executive officer, chief financial officer,
corporate controller and other finance 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 corporate controller, we will disclose the nature of
such amendment or waiver on our website.
PRINCIPAL ACCOUNTING FEES AND SERVICES
Fees Paid to Independent Public Accountants
The following table sets forth, for each of the years indicated, the fees paid
to our independent public accountants and the percentage of each of the fees out
of the total amount paid to the accountants.
YEAR ENDED DECEMBER 31,
--------------------------------------------------------------
2003 2004
---------------------------- ------------------------------
SERVICES RENDERED FEES PERCENTAGES FEES PERCENTAGES
----------------- -------------- ----------- -------------- -----------
(US$'000) (US$'000)
Audit 421 66% 419 91%
Audit-related *209 33% 25 5%
Tax 5 1% 17 4%
Other - -
-------------- --------------
Total 635 461
-------------- --------------
* includes capitalised costs of acquisition and costs of finance relating to
fundraising activities.
PRE-APPROVAL POLICIES AND PROCEDURES
Our Audit Committee has adopted a policy and procedures for the pre-approval of
audit and non-audit services rendered by our independent public accountants,
Ernst & Young. 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. 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.
EXEMPTIONS FROM THE LISTING REQUIREMENTS AND STANDARDS FOR AUDIT COMMITTEE
Not applicable.
PURCHASE OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATES AND PURCHASERS
The following table sets forth, for each of the months indicated, the total
number of shares purchased by us or on our behalf or any affiliated purchaser,
the average price paid per share, the number of shares purchased as part of a
publicly announced repurchase plan or program, the maximum number of shares or
approximate US Dollar value that may yet be purchased under the plans or
programs.
54
TOTAL NUMBER OF
SHARES PURCHASED AS MAXIMUM NUMBER OF
PART OF PUBLICLY SHARES THAT MAY YET
TOTAL NUMBER OF AVERAGE PRICE PAID ANNOUNCED PLANS OR BE PURCHASED UNDER
PERIOD IN 2004 SHARES PURCHASED PER SHARE PROGRAMS THE PLANS OR PROGRAMS
------------------- ---------------- ------------------ ------------------- ----------------------
January - - - 4,183,462
February - - - 4,183,462
March - - - 4,183,462
April - - - 4,183,462
May - - - 5,186,266
June - - - 5,186,266
July - - - 5,186,266
August - - - 5,186,266
September - - - 5,186,266
October - - - 5,186,266
November - - - 5,186,266
December - - - 5,186,266
PART III
ITEM 17
FINANCIAL STATEMENTS
The registrant has responded to Item 18 in lieu of responding to this item.
ITEM 18
FINANCIAL STATEMENTS
55
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To: The Board of Directors of Trinity Biotech plc
We have audited the accompanying consolidated balance sheets of Trinity Biotech
plc ("the Company") as of December 31, 2004 and 2003, and the related
consolidated statements of income, total recognised gains and losses, movement
in shareholders' equity and cash flows for each of the three years in the period
ended December 31, 2004. Our audits also included the financial statement
schedule included at Item 18. These financial statements and schedule are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements and schedule based on our audits.
We conducted our audits in accordance with Auditing Standards issued by the
Auditing Practices Board for use in Ireland and 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. We were not engaged to perform an
audit of the Company's internal control over financial reporting. Our audit
included consideration of internal control over financial reporting as a basis
for designing audit procedures that are appropriate in the circumstances but not
for the purpose of expressing an opinion on the effectiveness of the Company's
internal control over financial reporting. Accordingly we express no such
opinion. An audit also includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by management, and
evaluating the overall financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the consolidated financial position of Trinity Biotech
plc at December 31, 2004 and 2003, and the consolidated results of its
operations and its cash flows for each of the three years in the period ended
December 31, 2004, in conformity with accounting principles generally accepted
in the Republic of Ireland, which differ in certain respects from U.S. generally
accepted accounting principles (see note 25 of Notes to the Consolidated
Financial Statements). Also, in our opinion, the related financial statement
schedule, when considered in relation to the basic financial statements taken as
a whole, presents fairly in all material respects the information set forth
therein.
Dublin, Ireland Ernst & Young
March 30, 2005
56
CONSOLIDATED BALANCE SHEETS
As at As at
December 31 December 31
Notes 2004 2003
----- ------------ ------------
US$'000 US$'000
ASSETS
Inventories 2 37,519 30,555
Accounts receivable, net and prepayments 3 15,880 13,913
Cash and cash equivalents 22,287 20,562
------------ ------------
75,686 65,030
Intangible assets, net 4 57,870 38,851
Property, plant and equipment, net 5 15,942 13,660
Other assets 3 1,330 550
------------ ------------
TOTAL ASSETS 150,828 118,091
------------ ------------
LIABILITIES & SHAREHOLDERS' EQUITY
Accounts payable and accrued expenses 6 20,260 19,401
Provisions for liabilities and charges (deferred tax) 8 1,311 911
Long-term liabilities 7 13,119 17,517
SHAREHOLDERS' EQUITY
Called up share capital
Class 'A' Ordinary shares 9 764 658
Class 'B' Ordinary shares 9 12 12
Share premium account 120,444 87,596
Currency adjustment (3,975) (4,091)
Profit and loss reserve 11 997 (4,169)
Other reserves (2,104) 256
------------ ------------
SHAREHOLDERS' EQUITY - (all equity interests) 116,138 80,262
------------ ------------
Total Liabilities and Shareholders' Equity 150,828 118,091
------------ ------------
See Notes to the Consolidated Financial Statements
57
CONSOLIDATED STATEMENTS OF INCOME
Year ended December 31
--------------------------------------------
Notes 2004 2003 2002
----- ------------ ------------ ------------
US$'000 US$'000 US$'000
Revenues
- Continuing operations 72,896 65,675 47,447
- Acquisitions 19 7,048 - 4,531
------------ ------------ ------------
12 79,944 65,675 51,978
Cost of sales (39,688) (32,877) (25,689)
------------ ------------ ------------
Gross profit 40,256 32,798 26,289
Research and development expenses (4,641) (5,210) (4,471)
Administrative expenses (29,874) (17,919) (15,235)
------------ ------------ ------------
Operating profit
- Continuing operations 4,632 9,669 6,524
- Acquisitions 1,109 - 59
------------ ------------ ------------
12 5,741 9,669 6,583
Interest receivable and similar income 302 173 103
Interest payable and similar charges 12 (824) (792) (704)
------------ ------------ ------------
Profit on ordinary activities before taxation
and share of operating loss in associate
company and impairment 5,219 9,050 5,982
Share of operating loss in associate company
and impairment 13 - (1,067) (317)
------------ ------------ ------------
Profit on ordinary activities before taxation 13 5,219 7,983 5,665
Tax on profit on ordinary activities 14 (53) (2,186) (768)
------------ ------------ ------------
Retained profit for the financial period 5,166 5,797 4,897
------------ ------------ ------------
Basic earnings per ordinary share (US Dollars) 15 0.09 0.13 0.12
Diluted earnings per ordinary share (US Dollars) 15 0.09 0.12 0.12
Movements on reserves are shown in the "Consolidated Statements of Movement in
Shareholders' Equity".
CONSOLIDATED STATEMENTS OF TOTAL RECOGNISED GAINS AND LOSSES
Year ended December 31
-------------------------------
2004 2003 2002
-------- -------- --------
US$'000 US$'000 US$'000
Profit for the financial period attributable to company shareholders
excluding share of operating loss in associate company
and impairment 5,166 6,864 5,214
Share of operating loss in associate company
and impairment - (1,067) (317)
Currency adjustment 116 175 356
-------- -------- --------
Total recognised gains and losses for the period 5,282 5,972 5,253
-------- -------- --------
See Notes to the Consolidated Financial Statements
58
CONSOLIDATED STATEMENTS OF MOVEMENT IN SHAREHOLDERS' EQUITY
Class 'A' Ordinary Shares Class 'B' Ordinary Shares
-----------------------------------------------------
Share Share
capital capital
Number of US$0.0109 Number of US$0.0109 Share
shares each shares each premium
---------- ---------- --------- ---------- ---------
US$'000 US$'000 US$'000
Authorised 75,000,000 817 700,000 12
---------- ---------- --------- ----------
Issued:
Balance as at December 31, 2001 39,016,746 591 700,000 12 75,242
---------- ---------- --------- ---------- ---------
Shares issued for cash 443,900 5 - - 540
Options exercised 12,334 - (*) - - 14
Class 'A' shares issued for financial asset 156,189 2 - - 200
Share issue expenses - - - - (8)
Currency adjustment - - - - -
Retained profit - - - - -
Stock compensation - - - - -
---------- ---------- --------- ---------- ---------
Balance as at December 31, 2002 39,629,169 598 700,000 12 75,988
---------- ---------- --------- ---------- ---------
Shares issued for cash 10,279 - (*) - - 44
Options and warrants exercised 1,397,717 15 - - 2,229
Class 'A' shares issued on conversion of debentures 4,123,475 45 - - 9,810
Share issue expenses - - - - (475)
Currency adjustment - - - - -
Retained profit - - - - -
Stock compensation - - - - -
---------- ---------- --------- ---------- ---------
Balance as at December 31, 2003 45,160,640 658 700,000 12 87,596
---------- ---------- --------- ---------- ---------
Options and warrants exercised 1,113,538 12 - - 1,968
Class 'A' shares issued on conversion of debenture 120,423 1 - - 426
Class 'A' shares issued in private placing 5,725,733 63 - - 24,272
Class 'A' shares issued to fund acquisition 2,783,984 30 - - 7,691
Share issue expenses - - - - (1,509)
Currency adjustment - - - - -
Retained profit - - - - -
Stock compensation - - - - -
Issued share capital unpaid (note 9(g)) - - - - -
---------- ---------- --------- ---------- ---------
Balance as at December 31, 2004 54,904,318 764 700,000 12 120,444
---------- ---------- --------- ---------- ---------
Retained Currency Goodwill Other
profit adjustment reserve reserve Total
--------- ---------- -------- -------- ---------
US$'000 US$'000 US$'000 US$'000 US$'000
Authorised
Issued:
Balance as at December 31, 2001 6,913 (4,622) (21,777) 52 56,411
--------- ---------- -------- -------- ---------
Shares issued for cash - - - - 545
Options exercised - - - - 14
Class 'A' shares issued for financial asset - - - - 202
Share issue expenses - - - - (8)
Currency adjustment - 356 - - 356
Retained profit 4,897 - - - 4,897
Stock compensation - - - 120 120
--------- ---------- -------- -------- ---------
Balance as at December 31, 2002 11,810 (4,266) (21,777) 172 62,537
--------- ---------- -------- -------- ---------
Shares issued for cash - - - - 44
Options and warrants exercised - - - - 2,244
Class 'A' shares issued on conversion of debentures - - - - 9,855
Share issue expenses - - - - (475)
Currency adjustment - 175 - - 175
Retained profit 5,798 - - - 5,798
Stock compensation - - - 84 84
--------- ---------- -------- -------- ---------
Balance as at December 31, 2003 17,608 (4,091) (21,777) 256 80,262
--------- ---------- -------- -------- ---------
Options and warrants exercised - - - - 1,980
Class 'A' shares issued on conversion of debenture - - - - 427
Class 'A' shares issued in private placing - - - - 24,335
Class 'A' shares issued to fund acquisition - - - - 7,721
Share issue expenses - - - - (1,509)
Currency adjustment - 116 - - 116
Retained profit 5,166 - - - 5,166
Stock compensation - - - 13 13
Issued share capital unpaid (note 9(g)) - - - (2,373) (2,373)
--------- ---------- -------- -------- ---------
Balance as at December 31, 2004 22,774 (3,975) (21,777) (2,104) 116,138
--------- ---------- -------- -------- ---------
(*) Amount less than US$1,000
See Notes to Consolidated Financial Statements
59
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year ended December 31
--------------------------------------
Notes 2004 2003 2002
-------- ---------- ---------- ----------
US$'000 US$'000 US$'000
Net cash inflow from operating activities 17 2,348 4,176 3,581
---------- ---------- ----------
Returns on investments and servicing of finance
Interest received 291 174 57
Interest paid (884) (566) (695)
Finance interest paid (47) (23) (9)
---------- ---------- ----------
Net cash outflow from returns on investments and servicing of finance (640) (415) (647)
---------- ---------- ----------
Taxation
Taxation (paid) (1,666) (157) (404)
Capital expenditure and financial investment
Purchase of tangible fixed assets 16 (3,689) (3,856) (2,517)
Disposal/ retirement of fixed assets 31 - -
Purchase of intangible fixed assets (3,295) (1,846) (469)
---------- ---------- ----------
Net cash outflow from investing activities (6,953) (5,702) (2,986)
---------- ---------- ----------
Acquisitions and disposals
Payments to acquire trades or businesses (19,090) (763) (4,409)
Deferred consideration paid - (4,374) -
---------- ---------- ----------
Net cash outflow from acquisitions and disposals (19,090) (5,137) (4,409)
---------- ---------- ----------
Net cash outflow before use of liquid resources and financing (26,001) (7,235) (4,865)
---------- ---------- ----------
Management of liquid resources 16 2,158 (15,296) 553
---------- ---------- ----------
Financing
Repayment of loan from unconnected third party - (57) (163)
Repayment of minority interest - (309) -
Issue of shares 31,708 2,252 559
Expenses paid in respect of share issues and debt financing (2,238) (1,123) -
Movement in finance leases (267) (131) 4
(Decrease)/ increase in long term debt (2,214) 2,450 (1,804)
(Decrease)/ increase in other financial liabilities (2,675) (1,093) 4,108
Issue of convertible debentures, net 3,178 20,000 2,500
---------- ---------- ----------
Net cash inflow from financing 27,492 21,989 5,204
---------- ---------- ----------
Increase/ (decrease) in cash 3,649 (542) 892
========== ========== ==========
Reconciliation of net cash flow to movement in net debt
Increase/ (decrease) in cash in the year 3,649 (542) 892
Decrease/ (increase) in long term debt 2,214 (2,450) 1,804
Decrease/ (increase) in other financial liabilities 2,675 1,150 (4,042)
Issue of convertible debentures, net (3,178) (20,000) (2,500)
(Decrease)/ increase in liquid resources (2,158) 15,296 (553)
Decrease in finance leases 267 131 17
Expenses paid in respect of debt financing 251 650 -
---------- ---------- ----------
Change in net debt resulting from cash flows 3,720 (5,765) (4,382)
---------- ---------- ----------
New finance leases - (671) -
Finance leases acquired - (201) -
Conversion of debentures 427 9,834 -
Exchange movements on net debt (79) (392) (88)
Non cash exchange movement 233 1 95
(Release)/ deferral of debt issue costs (317) 131 21
---------- ---------- ----------
264 8,702 28
Movement in net debt in the year 3,984 2,937 (4,354)
Net debt at January 1 (5,707) (8,644) (4,290)
---------- ---------- ----------
Net debt at December 31 18 (1,723) (5,707) (8,644)
---------- ---------- ----------
60
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2004
1. BASIS OF PREPARATION AND ACCOUNTING POLICIES
The consolidated financial statements have been prepared in United
States Dollars under the historical cost convention and are in
accordance with accounting principles generally accepted in Ireland.
The principal accounting policies adopted by Trinity Biotech plc and its
subsidiaries ("the Group") are as follows:
(a) Basis of Consolidation
The consolidated financial statements include the financial statements
of Trinity Biotech plc ("Trinity Biotech" and/or "the Company") and its
subsidiary and associated undertakings in Ireland, the United States,
the United Kingdom, Sweden and Germany made up to the end of the
financial year. Where a subsidiary undertaking or interest in an
associated undertaking is acquired during the financial year the Group
financial statements include the attributable results from the date of
acquisition up to the end of the financial year. All inter-company
transactions and balances have been eliminated in the preparation of
these consolidated financial statements. Associated undertakings are
consolidated using the equity method of accounting.
(b) Goodwill
With effect from January 1, 1998, goodwill arising on consolidation
(representing the excess of the fair value of consideration over the
fair value of the separable net assets acquired), at the date of
acquisition of subsidiary and associated undertakings, is capitalised in
the balance sheet and amortised over an appropriate period. Goodwill
arising prior to that date was written-off against reserves and has not
been reinstated in the Group balance sheet.
(c) Tangible Fixed Assets
Tangible fixed assets are stated at cost less accumulated depreciation.
Depreciation is provided on a straight line basis to write off the cost
of the assets over their expected useful lives as follows:
Leasehold improvements 5 - 10 years Computer equipment 3 - 5 years
Office equipment and fittings 10 years Plant and equipment 5 - 10 years
Buildings 50 years
The carrying value of tangible assets is reviewed for impairment if
events or changes in circumstances indicate that the carrying value may
not be recoverable. Impairment is assessed by comparing the carrying
value of an asset with its recoverable amount (being the higher of net
realisable value and value in use). Net realisable value is defined as
the amount at which an asset could be disposed of net of any direct
selling costs. Value in use is defined as the present value of the
future cash flows obtainable through continued use of an asset including
those anticipated to be realised on its eventual disposal.
(d) Intangible Assets
Patents and licences are stated at cost and are amortised over the
lesser of their expected useful lives or their statutory lives which
range between 6 and 15 years. Certain trade names acquired are deemed
to have an indefinite useful life. The carrying value of intangibles is
reviewed annually by the directors to determine whether there should be
a reduction to reflect any impairment in value.
Research and development expenditure is written-off 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, 15 years. With effect from
January 1, 1998, goodwill on acquisition of businesses and product lines
is capitalised in the balance sheet and is amortised over a period of 20
years. Negative goodwill is included in intangible assets and is to be
released over the period of release of the related non-monetary assets.
This is also subject to an annual impairment review by the directors and
any diminution in value is immediately taken to the profit and loss
account.
(e) Inventories
Inventories are stated at the lower of cost or net realisable value on a
first-in, first-out basis. Cost 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 activity. Net realisable value is
the estimated selling price of inventory on hand less all further costs
to completion and costs expected to be incurred in marketing,
distribution and selling.
(f) Taxation
Taxation, which is based on the results for the year, is reduced where
appropriate by manufacturing companies' relief. Deferred taxation, the
estimated future tax consequences of transactions and events recognised
in the financial statements of the current and previous years, is
provided on all material timing differences using the tax rates
substantively enacted at the balance sheet date which are expected to
apply in the periods in which the
61
timing differences are expected to reverse. Timing differences between
the Group's taxable profits and its results as stated in the financial
statements arise from the inclusion of gains and losses in tax
assessments in periods different from those in which they are recognised
in the financial statements. Deferred tax is measured on a non-
discounted basis. Deferred tax assets are recognised to the extent that
the directors consider that it is more likely than not that there will
be suitable taxable profits from which the future reversal of the
underlying timing differences can be deducted.
(g) Sales and Revenue Recognition
Sales of products are recorded as of the date of shipment. Sales
represent the value of goods supplied to external customers and exclude
sales taxes and discounts.
(h) Pension Costs
The Group operates a defined contribution pension scheme. Contributions
to the scheme are expensed as incurred.
(i) Leases
Where tangible assets are financed by leasing agreements which give
rights approximating to ownership ("finance leases"), they are treated
as if they had been purchased outright at the present values of the
minimum lease payments; the corresponding obligations are shown in the
balance sheet as obligations under finance leases. The present value of
the minimum payments under a lease is derived by discounting those
payments at the interest rate implicit in the lease, and is normally the
price at which the asset could be acquired in an arm's length
transaction.
Amortisation is calculated in order to write-off the amounts capitalised
over the estimated useful lives of the assets 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
income statement in proportion to the amount outstanding under the
lease.
Leases other than finance leases are classified as "operating leases",
and the rentals thereunder are charged to the income statement on a
straight line basis over the periods of the leases.
(j) Government Grants
Research and development, employment and training grants are credited to
the income statement against related expenditure in the period in which
the expenditure is incurred.
(k) Foreign Currency
A majority of the revenue of the Company and its subsidiaries is
generated in US Dollars. The Company's management believes that the US
dollar is the primary currency of the economic environment in which the
Company and its subsidiaries (with the exception of the Company's
subsidiaries in Germany and Sweden) principally operate. Thus the
functional currency of the Company and its subsidiaries (other than
those in Germany and Sweden) is the US Dollar. The functional currency
of the German and Swedish subsidiaries is the Euro and the Swedish
Kroner respectively. The reporting currency of the Company is the US
Dollar.
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. Adjustments arising on translation of the results of
these subsidiary undertakings and on restatement of the opening net
assets at closing rates, are dealt with in reserves.
Foreign currency transactions are translated at the rates of exchange
ruling at the dates of the transactions. 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 income statement.
(l) Liquid Resources
Liquid resources are current asset investments, which are held as
readily disposable stores of value. Liquid resources comprise short term
deposits.
(m) Use of Estimates
The preparation of financial statements in conformity with accounting
principles generally accepted in the Republic of Ireland requires
management to make estimates and assumptions that affect the amounts
reported in the financial statements and accompanying notes. Actual
results could differ from these estimates.
(n) Companies Acts, 1963 to 2003
The financial information relating to the Company and its subsidiaries
included in this document does not comprise full group accounts as
referred to in Regulation 40 of the European Communities (Companies:
Group Accounts) Regulations 1992, copies of which are required by that
Act to be annexed to the Company's annual return. The auditors have made
reports without qualification under Section 193 of the Companies Act,
62
1990 in respect of the group financial statements for the years ended
December 31, 2003 and 2002. Copies of full group accounts for each of
the years ended December 31, 2003 and 2002 have been annexed together to
the relevant annual returns, and a copy of the full group accounts for
the year ended December 31, 2004 together with the report of the
auditors thereon will in due course be annexed to the relevant annual
return, which will be filed after the annual general meeting of the
Company in 2005.
(o) Cost of Sales
Cost of sales comprises the product cost including shipping, handling
and packaging costs.
(p) Provision for Bad Debts
The Group sells its products to companies in various markets throughout
the world. The Group maintains reserves for potential credit losses. To
date such losses have been within management's expectations. The Group
had an allowance for doubtful accounts of approximately US$462,000,
US$478,000, and US$496,000 as at December 31, 2004, 2003 and 2002,
respectively.
(q) Financial Instruments
Financial instruments include (i) borrowings; (ii) cash deposits and
liquid resources; and, (iii) interest and forward contracts.
Derivatives, principally forward foreign exchange contracts, are used to
manage the working capital requirements of the Group in a cost
effective, low-risk manner. Working capital management is a key element
in the effective management of overall liquidity. Where derivatives are
used to hedge cross-currency cash flows arising from trading activities,
the underlying transaction is ultimately recorded at the contract rate
upon settlement.
(r) Employee Stock Compensation
Options may be issued to employees to purchase ordinary shares with
exercise prices which are less than the market value of the ordinary
shares at the date of grant. In such cases the excess of the market
value over the exercise price for the total number of options so issued
is treated as compensation expense and recorded in the consolidated
statements of income over the vesting period, with an appropriate credit
to other reserves.
2. INVENTORIES December 31 December 31
2004 2003
----------- -----------
US$'000 US$'000
Raw materials 9,239 11,713
Work-in-progress 10,520 9,207
Finished goods 17,760 9,635
----------- -----------
37,519 30,555
----------- -----------
The replacement cost of inventory is not materially different from the
cost stated above.
3. ACCOUNTS RECEIVABLE AND PREPAYMENTS December 31 December 31
(Amounts falling due within one year) 2004 2003
----------- -----------
US$'000 US$'000
Accounts receivable, net 10,879 11,603
Prepayments 1,908 825
Value added tax 70 74
Called up share capital not paid 158 253
Grants receivable - 182
Other receivables 902 282
Deferred costs 447 139
Deferred tax asset (see note 8) 1,516 555
----------- -----------
15,880 13,913
----------- -----------
OTHER ASSETS December 31 December 31
(Amounts falling due after more 2004 2003
than one year) ----------- -----------
US$'000 US$'000
Deferred costs 875 410
Other assets 455 140
----------- -----------
1,330 550
----------- -----------
63
4. INTANGIBLE ASSETS December 31 December 31
2004 2003
----------- -----------
US$'000 US$'000
Cost
Product licence and development costs 11,327 7,069
Goodwill (see note 19) 56,889 39,643
------ ------
68,216 46,712
Less accumulated amortisation (10,346) (7,861)
----------- -----------
57,870 38,851
----------- -----------
5. PROPERTY, PLANT AND EQUIPMENT December 31 December 31
2004 2003
----------- -----------
US$'000 US$'000
Cost
Land and buildings 5,504 5,133
Leasehold improvements 2,699 2,444
Computer and office equipment 4,642 3,839
Plant and equipment 12,014 9,164
----------- -----------
24,859 20,580
Less accumulated depreciation (8,917) (6,920)
----------- -----------
15,942 13,660
----------- -----------
Included in the net book value of tangible fixed assets is an amount for
capitalised leased assets of US$1,354,000 (2003: US$1,538,000). The
amortisation charge in respect of capitalised leased assets for the year
ended December 31, 2004 was US$184,000 (2003: US$118,000 and 2002:
US$110,000).
6. ACCOUNTS PAYABLE AND ACCRUED EXPENSES December 31 December 31
(Amounts falling due within one year) 2004 2003
----------- -----------
US$'000 US$'000
Accounts payable 3,328 3,519
Income tax deducted under PAYE 244 138
Employee related social insurance 366 140
Corporate income taxes 542 1,574
Accrued liabilities 3,995 4,895
Accrued royalties 697 224
Obligations under finance leases 238 264
Financial liabilities from unconnected
third party 669 3,309
Bank loans - current portion (see note 7) 3,150 4,176
3% convertible debentures (see note 7) 7,031 1,162
----------- -----------
20,260 19,401
----------- -----------
As at December 31, 2004, the undrawn portion of existing banking
facilities amounted to US$2,000,000.
7. LONG-TERM LIABILITIES
(Amounts falling due after more December 31 December 31
than one year) 2004 2003
----------- -----------
US$'000 US$'000
3% convertible debentures 8,788 11,875
Bank loans (secured, see note 20(e)) 3,581 4,734
Lease creditors 554 750
Corporate income taxes 161 158
Other creditors 35 -
----------- -----------
13,119 17,517
----------- -----------
64
The age profile of the Group's long-term liabilities, excluding
obligations under finance leases, is as follows:
December 31 December 31
2004 2003
----------- -----------
US$'000 US$'000
In more than one year, but not more
than two 8,578 6,462
In more than two years, but not more
than three 2,706 6,480
In more than three years, but not more
than four 1,256 2,562
In more than four years, but not more
than five 13 1,255
In more than five years 12 8
----------- -----------
12,565 16,767
----------- -----------
In June 2003, Trinity Biotech completed a new US$10,000,000 club banking
facility with Allied Irish Bank plc and Bank of Scotland (Ireland) Ltd.
The facility consists of a five year term loan of US$6,000,000 and a one
year revolver of US$4,000,000. This facility is secured by the assets of
the Group. The term loan is repayable in ten equal biannual instalments
which commenced on January 2, 2004. At December 31, 2004, the total
amount outstanding on the term loan amounted to US$4,800,000 and the
drawn portion of the revolver loan amounted to US$2,000,000. The debt is
stated net of unamortised issue costs of US$138,000.
In July 2003, the Company completed a private placement of US$20,000,000
principal amount of 3% convertible debentures. The debentures bear
interest at a rate of 3% per annum, convertible into Class 'A' Ordinary
Shares of the Company at a price of US$3.55. In December 2003,
US$6,355,000 of the US$20,000,000 principal amount of the debentures and
US$44,000 of the related accrued interest was converted into 1,802,676
Class 'A' Ordinary Shares of the Company. In January 2004, a further
US$427,000 of the principal amount of the debenture was converted into
120,423 Class 'A' Ordinary Shares of the Company. As part of the July
2003 placement, convertible notes in the aggregate principal amount of
up to US$5,000,000 could be issued at the option of the investors by the
later of January 9, 2004 and the three month anniversary of the
effective date of the registration statement. In March 2004, the
investors exercised this option in full and the Company completed a
further placement of US$5,000,000 principal amount of 3% convertible
debentures. The debentures bear interest at a rate of 3% per annum and
are convertible into Class 'A' Ordinary Shares of the Company at a price
of US$4. All of the above debentures are unsecured and are repayable in
ten equal instalments on a quarterly basis. Under the terms of the
agreement, the Company has the right to satisfy each repayment either in
cash or in shares. In October 2004, the first principal repayment of
US$1,822,000 was made to the debenture holders in cash. At December 31,
2004, the total debentures cost outstanding was US$15,819,000. The debt
is stated net of unamortised issue costs of US$576,000.
As at December 31, 2004 payments falling due under finance leases of
less than one year's duration amounted to US$238,000 (2003: US$264,000).
As at December 31, 2004 obligations under finance leases of between two
and five years' duration amounted to US$554,000 (2003: US$750,000).
There were no payments falling due extending beyond five years.
8. DEFERRED TAX December 31 December 31
2004 2003
----------- -----------
US$'000 US$'000
Movement in Deferred Tax Asset
At beginning of year 555 419
Charge to profit and loss account
(see note 14) (455) (307)
Credit to profit and loss account
(see note 14) 1,416 443
----------- -----------
At end of year 1,516 555
----------- -----------
65
Movement in Deferred Tax Liability
At beginning of year 911 294
Charge to profit and loss account
(see note 14) 683 632
Credit to profit and loss account
(see note 14) (283) (15)
----------- -----------
At end of year 1,311 911
----------- -----------
The deferred tax asset is due to timing differences created by net
operating losses and state credit carryforwards, the tax written-down
value of fixed assets being greater than the related net book value and
the elimination of unrealised intercompany profit. The deferred tax
asset increased in 2004 due to the tax effect of the excess of the tax
written-down value of fixed assets over the net book value, the
elimination of unrealised intercompany profit and the availability of
net operating losses for offset against future profits. The higher level
of increase in 2004 compared to 2003 is due principally to the
availability of higher net operating losses carrying forward in the
Company's US entities. In 2003, the deferred tax asset increased as the
tax effect of the excess of tax written-down value of fixed assets over
the net book value and the elimination of unrealised profit exceeded the
tax consequences of the utilisation of net operating loss carryforwards.
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Net operating loss carryforwards 845 41 488
Other timing differences 973 693 62
----------- ----------- -----------
Total deferred tax assets 1,818 734 550
Valuation allowance (302) (179) (131)
----------- ----------- -----------
Net deferred tax assets 1,516 555 419
----------- ----------- -----------
At December 31, 2004, the Company recognised a deferred tax asset of
US$845,000 in respect of net operating loss carryforwards in the US and
the UK. The utilisation of these net operating loss carryforwards is
limited to the future profitable operations of these entities. These
losses carry forward indefinitely. Valuation allowances have been
provided against state credit carryforwards for uncertainties regarding
future full utilisation of these credits in the related tax jurisdiction
in future periods.
The deferred tax liability is caused by the net book value of fixed
assets being greater than the tax written down value of fixed assets and
timing differences due to the acceleration of the recognition of certain
charges in calculating taxable income permitted in Ireland. The deferred
tax liability increased in 2004 and 2003 as the excess of the net book
value of fixed assets over the tax written down value increased and the
Company was able to recognise an upfront charge in the calculation of
its taxable income in Ireland.
9. CALLED UP SHARE CAPITAL
(a) During 2003 US$1,000,000 principal amount of 6% convertible debentures
was converted into 666,667 Class 'A' Ordinary Shares of the Company.
(b) On April 3, 2002, the Company acquired a further 165,000 Ordinary Shares
in its then associate HiberGen Limited. The consideration of US$202,000
was satisfied by the issue of 156,189 'A' Ordinary Shares in Trinity
Biotech plc.
(c) In November 2002, the Company completed a private placement of
US$2,500,000 principal amount of 5.25% convertible debentures. The
debentures bore interest at a rate of 5.25% per annum and were
convertible into Class 'A' Ordinary Shares of the Company at a price of
US$1.50. During 2003 these debentures were converted into 1,666,667
Class 'A' Ordinary Shares of the Company.
(d) In December 2002, Enterprise Ireland subscribed for 443,900 'A' Ordinary
Shares in the Company.
(e) In July 2003, the Company completed a private placement of US$20,000,000
principal amount of 3% convertible debentures. The debentures bear
interest at a rate of 3% per annum, convertible into Class 'A'
66
Ordinary Shares of the Company at a price of US$3.55. In December 2003,
US$6,355,000 of the US$20,000,000 principal amount of the debentures was
converted into 1,790,141 Class 'A' Ordinary Shares of the Company, a
further US$44,000 of accrued interest was settled by the issue of 12,535
Class 'A' Ordinary Shares of the Company at US$3.55 per share. In 2004,
a further US$427,000 of the principal amount of the debenture was
converted into 120,423 Class 'A' Ordinary Shares of the Company. As part
of the July 2003 placement, convertible notes in the aggregate principal
amount of up to US$5,000,000 could be issued at the option of the
investors by the later of January 9, 2004 and the three month
anniversary of the effective date of the registration statement. In
March 2004, the investors exercised this option in full and the Company
completed a further placement of US$5,000,000 principal amount of 3%
convertible debentures. The debentures bear interest at a rate of 3% per
annum and are convertible into Class 'A' Ordinary Shares of the Company
at a price of US$4. All of above debentures are unsecured and are
repayable in ten equal instalments on a quarterly basis commencing in
October 2004. Under the terms of the agreement, the Company has the
right to satisfy each repayment either in cash or in shares. In October
2004, the first principal repayment of US$1,822,000 was made to the
debenture holders in cash. At December 31, 2004, the total amount of
debentures outstanding amounted to US$15,819,000. The debt is stated net
of unamortised issue costs of US$576,000.
(f) In January 2004, the Company completed a US$22.5m private placement of
5,294,118 of Class 'A' Ordinary Shares of the Company at a price of
US$4.25 per share. The investors were granted five year warrants to
purchase an aggregate of 1,058,824 Class 'A' Ordinary Shares of the
Company at an exercise price of US$5.25 per share. Under the terms of
the placement, investors were also granted the right to purchase an
additional 2,647,059 Class 'A' Ordinary Shares of the Company at a price
of US$4.25 per share for a period of up to 30 days after the closing of
the transaction. An additional 431,617 Class 'A' Ordinary Shares of the
Company, amounting to US$1,834,000, were issued within the 30 day period
following the closing of the transaction to investors who exercised this
option.
(g) In April 2004, Trinity completed the acquisition of the assets of
Fitzgerald Industries International Inc (Fitzgerald) for US$16,000,000
in cash. The acquisition was partly funded by the issue of 2,783,984 'A'
Ordinary Shares of the Company. As at December 31, 2004, 817,470 shares
with a value of US$2,373,000 remain unpaid (see the consolidated
statements of movement in shareholders' equity).
(h) The Class `B' Ordinary Shares have two votes per share and the rights to
participate in any liquidation or sale of the Company and to receive
dividends as if each Class `B' Ordinary Share were two Class 'A'
Ordinary Shares.
(i) Since its incorporation the Company has not declared or paid dividends
on its 'A' Ordinary Shares. The Company anticipates, for the foreseeable
future, that it will retain any future earnings in order to fund its
business operations. The Company does not, therefore, anticipate paying
any cash or share dividends on its 'A' Ordinary Shares in the
foreseeable future.
As provided in the Articles of Association of the Company, dividends or
other distributions will be declared and paid in US Dollars.
(j) In March 1998 Benen Trading Limited ("Benen") received an injection of
funds under the Business Expansion Scheme. In order to present a true
and fair view of the consolidated financial statements, the substance of
this transaction, as distinct from its strict legal form, was considered
in determining its true nature and the appropriate accounting treatment.
In particular, the option which is incorporated within the transaction,
and the most likely exercise of it, determined the substance of the
transaction. It was considered that the injection of funds was in the
nature of quasi equity. The Company had obligations to transfer economic
benefits at the end of the investment period limited to a maximum of
(euro)330,200 and accordingly consolidated Benen as a 100% subsidiary
undertaking and the proceeds of the investment were credited to minority
interest. On April 4, 2003 this option was exercised and the shares of
Benen were purchased by Trinity Biotech plc.
10. SHARE OPTIONS AND WARRANTS
Under the terms of the Company's Employee Share Option Plan options to
purchase 8,629,017 Class 'A' Ordinary Shares were outstanding at
December 31, 2004. Under the plan, options are granted to officers,
employees and consultants of the Group at the discretion of the board.
In addition, 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. In January 2004, the Company completed a private placement
of 5,294,118 of Class 'A' Ordinary Shares of the Company at a price of
US$4.25 per share. The investors were granted five year warrants 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 further
granted warrants to purchase 200,000 Class 'A' Ordinary Shares in the
Company
67
to agents of the Company who were involved in this private placement at
an exercise price of US$5.25. At December 31, 2004 there were warrants
to purchase 1,317,324 Class 'A' Ordinary shares in the Company
outstanding.
The share options and warrants outstanding at December 31, 2004 were as
follows:
Options & Warrants
--------------------------
Range
Outstanding Shares US$
------------------- ---------- -----------
January 1, 2002 7,975,703 0.81-5.00
Granted 2,243,500* 0.98-1.50
Exercised (12,334) 1.13
Cancelled (741,420) 0.98-2.78
---------- -----------
December 31, 2002 9,465,449 0.81-5.00
Granted 1,340,500 0.98- 3.11
Granted over value 155,000 1.80
Exercised (1,397,717) 0.81- 2.75
Cancelled (1,235,838) 0.98- 2.60
---------- -----------
December 31, 2003 8,327,394 0.81-5.00
---------- -----------
Granted 3,162,824* 2.33 - 5.25*
Exercised (1,113,538) 0.98 - 2.75
Cancelled (430,339) 0.98 - 4.00
---------- -----------
December 31, 2004 9,946,341 0.81 - 5.25
---------- -----------
* Amounts adjusted for previously issued stock options
11. PROFIT AND LOSS RESERVE
December 31 December 31
Profit and loss reserve 2004 2003
----------- -----------
US$'000 US$'000
Accumulated surplus 22,774 17,608
Goodwill reserve (21,777) (21,777)
----------- -----------
997 (4,169)
----------- -----------
12. ANALYSIS OF REVENUE, OPERATING INCOME, MAJOR CUSTOMERS AND ASSETS
a) The Group operates in one business segment, the market for diagnostic
tests for a range of diseases and other medical conditions, and in two
reportable segments, the United States and the Rest of World, which are
based on a geographical split. Information on assets is maintained by
location analysed between the United States and the Rest of World. The
information presented below relates to these operating segments and is
presented in a manner consistent with information presented to the
Group's chief operating decision maker. The basis of accounting for each
segment is the same basis as used in the preparation of the consolidated
financial statements.
b) The distribution of revenue by geographical area was as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Rest of World 51,007 46,527 23,968
United States 28,937 19,148 28,010
----------- ----------- -----------
79,944 65,675 51,978
----------- ----------- -----------
68
Revenue is attributed to geographical area based on where customer
orders are satisfied from.
c) The distribution of revenue by customers' geographical area was as
follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
United States 41,380 36,299 33,512
Europe 22,654 19,983 11,899
Asia/Africa 11,550 6,248 4,396
Other overseas 4,360 3,145 2,171
----------- ----------- -----------
79,944 65,675 51,978
----------- ----------- -----------
d) The distribution of revenue by major product group was as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Infectious diseases 31,638 30,678 33,939
Haemostasis 26,772 24,435 13,780
Rapids 9,807 4,449 3,890
Other 11,727 6,113 369
----------- ----------- -----------
79,944 65,675 51,978
----------- ----------- -----------
This analysis of revenue is provided for information purposes but does
not form the basis of information provided to or used by the Group's
chief operating decision maker in making strategic or operational
decisions.
e) The distribution of intersegmental sales was as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Rest of World 20,502 25,481 21,448
Rest of World - intersegmental sales 9,773 15,964 18,366
United States 56,427 37,120 28,010
Less intercompany sales (6,758) (12,890) (15,846)
----------- ----------- -----------
79,944 65,675 51,978
----------- ----------- -----------
Sales of product between companies in the Group are made on commercial
terms (cost plus a mark-up) which reflect the nature of the relationship
between the relevant companies.
69
f) The distribution of operating income by geographical area was as
follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Rest of World 11,111 7,947 3,755
United States (5,370) 1,722 2,828
-------- -------- --------
Total operating income 5,741 9,669 6,583
-------- -------- --------
g) The distribution of consolidated total assets by geographical area was
as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Rest of World 117,069 85,178 62,074
United States 33,759 32,913 27,724
----------- ----------- -----------
Total assets 150,828 118,091 89,798
----------- ----------- -----------
h) The distribution of consolidated long-lived assets by geographical area
was as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Rest of World 66,951 42,894 38,742
United States 8,191 10,167 11,721
----------- ----------- -----------
Total long-lived assets 75,142 53,061 50,463
----------- ----------- -----------
i) In 2004 there were no customers with 10% or more of total revenues.
However, in prior periods one customer did exceed 10% of total revenue
as shown below:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
Customer A n/a 12% 20%
----------- ----------- -----------
j) The distribution of depreciation and amortisation by geographical area
was as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Rest of World 3,405 1,267 2,406
United States 984 956 1,098
----------- ----------- -----------
Total depreciation and amortisation 4,389 2,223 3,504
----------- ----------- -----------
k) The analysis of interest expense by geographical area was as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Rest of World (812) (728) (608)
United States (12) (64) (96)
----------- ----------- -----------
Total interest (824) (792) (704)
----------- ----------- -----------
70
l) The analysis of taxation charge by geographical area was as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Rest of World 1,153 1,409 231
United States (1,100) 777 537
----------- ----------- -----------
53 2,186 768
----------- ----------- -----------
13. PROFIT ON ORDINARY ACTIVITIES December 31 December 31 December 31
BEFORE TAXATION 2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
The profit on ordinary activities
before taxation is stated after
charging/(crediting):
Directors' emoluments:
Remuneration 1,321 1,092 1,165
Pension 172 104 95
Auditors' remuneration:
Audit fees 419 455 190
Non audit fees 17 18 20
Depreciation 1,819 1,367 1,118
Amortisation 2,570 856 2,386
Operating lease rentals:
Plant and machinery 19 - 26
Other 1,975 1,687 1,445
Employment grants (135) (307) (214)
Settlement of litigation
(see note below) - (225) -
----------- ----------- -----------
On June 16, 2003 Trinity Biotech and Xtrana entered into a settlement
agreement. Pursuant to the terms of the Settlement Agreement entered
into between the parties, Trinity Biotech agreed to pay Xtrana the
amounts due on two promissory notes of US$1,166,000 and US$5,700,000,
together with interest thereon as provided in the notes, less
US$225,000, and less US$24,000, which represented the amount due and
owing by Xtrana to Trinity Biotech.
From 2000 to 2002, the Company acquired 42.9% of the share capital of
Hibergen Limited. During 2003, Hibergen Limited was unsuccessful in
raising additional funds and on November 14, 2003, the board of Hibergen
Limited decided to cease trading. The carrying value of the Company's
investment in Hibergen was written off in 2003.
71
14. INCOME TAXES
(a) The charge for taxation based on the profit on ordinary activities,
comprises:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Current tax
Corporation tax at 12.5%
(2003: 12.5%, 2002: 16%) 1,111 1,532 9
Manufacturing relief (144) (195) -
----------- ----------- -----------
967 1,337 9
Overseas tax* (139) 368 482
Relief in respect of prior year (214) - (64)
----------- ----------- -----------
Total current tax 614 1,705 427
Deferred tax charge/(credit)
Movement in deferred tax asset
(see note 8) (961) (136) 190
Movement in deferred tax liability
(see note 8) 400 617 151
----------- ----------- -----------
Total taxation on profit on ordinary
activities 53 2,186 768
----------- ----------- -----------
Effective tax rate
Profit on ordinary activities
before taxation 5,219 7,983 5,665
As a percentage of profit before
tax
Current tax 11.8% 21.4% 7.5%
Total tax (current and deferred) 1.0% 27.4% 13.5%
* The credit in 2004 of US$139,000 primarily arises as a result of
expected refunds relating to a loss carry-back claim in respect of the
current year US loss.
The following table relates the applicable Republic of Ireland statutory
tax rate to the effective current tax rate of the Group:
2004 2003 2002
% of profit % of profit % of profit
before taxation before taxation before taxation
--------------- --------------- ---------------
Irish corporation tax 12.5 12.5 16.0
Manufacturing relief (2.8) (2.4) (0.0)
Tax rates on overseas
(losses)/earnings (13.4) 1.2 4.0
Relief in respect of prior year (4.1) - (1.1)
Effect of non-taxable costs in PBT 20.0 6.2 -
Other including benefit of loss
carryforwards (0.4) 3.9 (11.4)
--------------- --------------- ---------------
Current tax 11.8 21.4 7.5
Deferred tax (10.8) 6.0 6.0
--------------- --------------- ---------------
Total tax (current and deferred) 1.0 27.4 13.5
--------------- --------------- ---------------
(b) The distribution of profit on ordinary activities before taxes by
geographical area was as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
Ireland 10,599 5,772 2,934
Overseas (5,380) 2,211 2,731
----------- ----------- -----------
Total profits before taxation 5,219 7,983 5,665
----------- ----------- -----------
(c) The tax effects of temporary differences that give rise to significant
portions of deferred tax assets relate principally to the elimination of
unrealised intercompany profit and net operating losses and state credit
carryforwards. The valuation allowance for deferred tax assets at
December 31, 2004, 2003 and 2002 was US$302,000, US$179,000 and
US$131,000 respectively.
(d) At December 31, 2004, the Group had net operating losses of
approximately US$2,517,000 (2003: approximately US$332,000). The
utilisation of these net operating loss carryforwards is limited to
offset against the future profits earned by the Group arising from the
same trade and in the company in which they arose.
72
15. EARNINGS PER ORDINARY SHARE
Basic earnings per ordinary share Earnings per ordinary share is
computed by dividing the profit on ordinary activities after taxation of
US$5,166,000 (December 31, 2003, US$5,797,000 and December 31, 2002,
US$4,897,000) for the financial year by the weighted average number of
ordinary shares in issue of 55,132,024 (December 31, 2003: 43,093,146
and December 31, 2002: 40,550,367).
Diluted earnings per ordinary share Diluted earnings per ordinary share
is computed by dividing the profit on ordinary activities after taxation
of US$5,166,000 (December 31, 2003, US$5,797,000 and December 31, 2002,
US$4,897,000) for the financial year, adjusted for debenture interest
saving of US$514,000 (December 31, 2003, US$344,000 and December 31,
2002, US$86,000) by the diluted weighted average number of ordinary
shares in issue of 63,935,138 (December 31, 2003, 50,583,247 and
December 31, 2002, 42,486,227). The basic weighted average number of
shares may be reconciled to the number used in the diluted earnings per
ordinary share calculation as follows:
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
Basic earnings per share denominator 55,132,024 43,093,146 40,550,367
Issuable on exercise of options 4,158,159 4,106,791 1,214,703
Issuable on conversion of debentures 4,644,955 3,383,310 721,157
----------- ----------- -----------
Diluted earnings per share denominator 63,935,138 50,583,247 42,486,227
----------- ----------- -----------
16. SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
December 31 December 31 December 31
2004 2003 2002
----------- ----------- -----------
US$'000 US$'000 US$'000
(a) Additions to tangible fixed assets 3,689 4,527 2,517
Less new finance leases - (671) -
----------- ----------- -----------
3,689 3,856 2,517
----------- ----------- -----------
(b) Management of liquid resources
Cash flows of US$2,158,000 from the use of liquid resources in 2004
arose from the movement of fixed deposit accounts to cash. Cash flows of
US$15,296,000 from the use of liquid resources in 2003 arose from the
movement of cash to fixed deposit accounts. Cash flows of US$553,000
from the use of liquid resources in 2002 arose from the movement of cash
from fixed deposit accounts.
(c) Impact of acquisitions on cash flow headings
There were two acquisitions in 2004. The cash outflow of US$19,090,000
in 2004 was partly funded by the issue of 2,783,983 'A' Ordinary Shares.
As at December 31, 2004, 817,470 shares with a value of US$2,373,000
remained unpaid. The operating results of Adaltis and Fitzgerald
acquired on April 7 and April 15 respectively contributed US$1,109,000
to the operating profit of the group. The net cash inflow from operating
activities for Fitzgerald for the period from April 15, 2004 (the date
of acquisition) to December 31, 2004 was US$1,212,000. The acquisition
of Fitzgerald did not have a material impact on any other headings of
the consolidated statement of cashflows. As the working capital of
Adaltis was fully integrated into the Group's existing US operations by
December 31, 2004 post operating cashflows were not obtainable.
There were no acquisitions in 2003. Additional costs incurred and
obligations assumed from the acquisitions completed in 2002 resulted in
cash outflows to the Group of US$763,000 during 2003. Deferred
consideration of US$1,810,000 relating to the purchase of the speciality
clinical chemistry product line from Sigma Diagnostics was paid during
2003.
73
The cash outflow of US$4,409,000 from the acquisition of businesses and
product lines in 2002 was partly funded by the issue of US$2,500,000 of
convertible debentures in November 2002 (see note 9(c)). As the working
capital of the acquired businesses was fully integrated within the Group
by December 31, 2002 post acquisition operating cash flows were not
readily obtainable. The operating results of the haemostasis division
and the speciality clinical chemistry product line of Sigma Diagnostics
acquired on August 27 and November 27, 2002 respectively contributed
US$59,000 to the operating profit of the Group.
17. RECONCILIATION OF OPERATING December 31 December 31 December 31
PROFIT TO NET CASH INFLOW 2004 2003 2002
FROM OPERATING ACTIVITIES ----------- ----------- -----------
US$'000 US$'000 US$'000
Operating profit 5,741 9,669 6,583
Depreciation and amortisation 4,389 2,224 3,504
Exceptional administrative expenses - - (2,835)
Decrease/ (increase) in receivables
and prepayments 484 (65) (4,251)
(Decrease)/ increase in accounts
payable (2,419) (2,561) 2,875
Increase in inventory (5,883) (6,005) (2,415)
Non cash compensation expense 13 84 120
Foreign exchange (gains)/ losses on
non-operating cashflows (131) 485 -
Loss on disposal/ retirement of
fixed assets 14 186 -
Other non-cash items 140 159 -
----------- ----------- -----------
Net cash inflow from operating
activities 2,348 4,176 3,581
----------- ----------- -----------
18. ANALYSIS OF NET DEBT
December 31 Acquisitions/ Non-cash Exchange December 31
2003 Cash flow disposals changes movements 2004
----------- ----------- ----------- ----------- ----------- -----------
US$'000 US$'000 US$'000 US$'000 US$'000 US$'000
Cash 2,553 3,649 - - 233 6,435
Liquid resources 18,010 (2,158) - - - 15,852
----------- ----------- ----------- ----------- ----------- -----------
20,563 1,491 - - 233 22,287
Long-term debt
- current portion (4,176) 1,067 - (41) - (3,150)
Long-term debt (4,734) 1,153 - - - (3,581)
Other financial liabilities (3,309) 2,675 - - (35) (669)
Finance leases (1,014) 267 - - (44) (791)
Convertible debentures (13,037) (2,933) - 151 - (15,819)
----------- ----------- ----------- ----------- ----------- -----------
Net debt (5,707) 3,720 - 110 154 (1,723)
----------- ----------- ----------- ----------- ----------- -----------
December 31 Acquisitions/ Non-cash Exchange December 31
2002 Cash flow disposals changes movements 2003
----------- ----------- ----------- ----------- ----------- -----------
US$'000 US$'000 US$'000 US$'000 US$'000 US$'000
Cash 3,094 (542) - - 1 2,553
Liquid resources 2,714 15,296 - - - 18,010
----------- ----------- ----------- ----------- ----------- -----------
5,808 14,754 - - 1 20,563
Long-term debt
- current portion (1,978) (2,198) - - - (4,176)
Long-term debt (4,656) (79) - - - (4,735)
Other financial liabilities (4,108) 1,150 - - (351) (3,309)
Finance leases (231) 131 (201) (671) (41) (1,013)
Convertible debentures (3,479) (19,523) - 9,965 - (13,037)
----------- ----------- ----------- ----------- ----------- -----------
Net debt (8,644) (5,765) (201) 9,294 (391) (5,707)
----------- ----------- ----------- ----------- ----------- -----------
74
December 31 Acquisitions/ Non-cash Exchange December 31
2001 Cash flow disposals changes movements 2002
----------- ----------- ----------- ----------- ----------- -----------
US$'000 US$'000 US$'000 US$'000 US$'000 US$'000
Cash 2,107 892 - - 95 3,094
Liquid resources 3,267 (553) - - - 2,714
----------- ----------- ----------- ----------- ----------- -----------
5,374 339 - - 95 5,808
Long-term debt
- current portion (2,410) 432 - - - (1,978)
Long-term debt (6,028) 1,372 - - - (4,656)
Other financial liabilities - (4,042) - - (66) (4,108)
Finance leases (227) 17 - - (21) (231)
Convertible debentures (1,000) (2,500) - 21 - (3,479)
----------- ----------- ----------- ----------- ----------- -----------
Net debt (4,291) (4,382) - 21 8 (8,644)
----------- ----------- ----------- ----------- ----------- -----------
19. ACQUISITION OF BUSINESSES
2004 Acquisitions
In April, 2004, the Company acquired the business of Fitzgerald
Industries International, Inc ("Fitzgerald") for US$16 million in cash.
Acquisition expenses amounted to US$152,000. Fitzgerald provides a
comprehensive range of immunodiagnostic products to pharmaceutical
companies, reference laboratories, diagnostic manufacturers and research
facilities worldwide. The acquisition of Fitzgerald places the Company
in the life sciences market with significant potential for future
growth. In April 2004, the Company also acquired the assets of Adaltis
US, Inc for US$2,852,000 in cash. Adaltis US, Inc is the distribution
arm for Adaltis Inc. Acquisition costs amounted to US$112,000. As part
of the transaction, Trinity obtained exclusive distribution rights to
Adaltis' open-end microplate analytical instrumentation in the US and
non-exclusive distribution rights in the rest of the world, excluding
China. This acquisition gives Trinity access to the existing installed
base of instruments in the US and provides an opportunity for Trinity to
place its own reagents on this installed base of instruments. The
results of these acquisitions for 2004 are incorporated from the date of
acquisition in the consolidated statement of income for the year ended
December 31, 2004.
Fitzgerald Adaltis Total
---------- ------- -------
US$'000 US$'000 US$'000
Tangible fixed assets 35 237 272
Working capital 193 332 525
Intangible fixed assets 1,073 - 1,073
---------- ------- -------
Net assets at fair value 1,301 569 1,870
Goodwill 14,851 2,395 17,246
---------- ------- -------
Consideration 16,152 2,964 19,116
---------- ------- -------
Satisfied by:
Cash payments including costs 16,152 2,964 19,116
---------- ------- -------
Goodwill capitalised during 2004 in respect of acquired businesses
amounted to US$17,246,000 and comprises:
75
Fair
Book Value Fair
Values Adjustment Value Consideration Goodwill
------- ---------- ------- ------------- --------
US$'000 US$'000 US$'000 US$'000 US$'000
FITZGERALD
Tangible fixed assets 35 - 35
Working capital 210 (17) 193
Intangible fixed assets 33 1,040 1,073
------- ---------- ------- ------------- --------
278 1,023 1,301 (16,152) 14,851
------- ---------- ------- ------------- --------
ADALTIS
Tangible fixed assets 237 - 237
Working capital 327 5 332
------- ---------- ------- ------------- --------
564 5 569 (2,964) 2,395
------- ---------- ------- ------------- --------
Total 842 1,028 1,870 (19,116) 17,246
------- ---------- ------- ------------- --------
During the period, following the acquisitions, initial fair value
adjustments were made to the acquired working capital of Fitzgerald
(US$17,000 decrease) and Adaltis (US$5,000 increase). In addition a fair
value adjustment was made to recognise an indefinite lived intangible
asset representing the trade name acquired of US$970,000 and other
intangibles of US$70,000. These fair value adjustments were made
following an assessment of the carrying value of the assets acquired.
Due to the material size of the acquisition, the following unaudited
financial information for Fitzgerald for the period during 2004 prior to
its acquisition by the Company (i.e. from January 1, 2004 to April 14,
2004) is provided:
Fitzgerald
----------
US$'000
Turnover 1,471
----------
Operating Profit 646
----------
Profit before tax 649
Tax -
----------
Profit after tax 649
----------
There were no gains or loss during the period from January 1, 2004 to
the April 14, 2004 other than those recognised through the statement of
income.
The profit after tax for Fitzgerald for the year ended December 31, 2003
was US$3,153,000.
2002 Acquisitions
On August 27, 2002 Trinity Biotech purchased the haemostasis division of
Sigma Diagnostics for a total consideration of US$1,428,000. The
consideration was satisfied in cash. Acquisition expenses amounted to
US$79,000. The division comprises a portfolio of reagents manufactured
in St. Louis, Missouri and the Amelung range of instruments manufactured
in Lemgo, Germany. During 2003 and 2004 Trinity transferred the
production of these reagents to Bray, Ireland.
On November 27, 2002 the Company also acquired the speciality clinical
chemistry product line from Sigma Diagnostics for a total consideration
of US$4,444,000 satisfied in cash and deferred consideration with a fair
value of US$4,412,000. The cash consideration was partly financed by the
issue of US$2.5 million of convertible debentures (see note 9(c)). The
deferred consideration of US$1,810,000 was paid in two instalments of
US$1,010,000 and US$800,000 on May 27 and November 27, 2003,
respectively. The fair value of deferred consideration at November 27,
2002 was US$1,778,000. Total acquisition expenses amounted to US$94,000.
During 2003 and 2004 Trinity Biotech transferred production of the
product line from St. Louis, Missouri to Bray, Ireland. Goodwill arising
on acquisition of US$4 million after fair value adjustments represents
the value of the expected synergies created by combining production
within Trinity Biotech's existing manufacturing operations. (The results
of these acquisitions for 2002 are incorporated from the date of
acquisition in the consolidated statement of income for the year ended
December 31, 2002.)
The Company did not allocate any value to trademarks of the Sigma
acquired entities as part of the purchase price allocation as the
Company re-branded the products acquired under a Trinity Biotech label.
The Company
76
did not allocate any value to customer relationships or customer lists
obtained as part of these acquisitions as these are not considered
proprietary to the acquired entities and the Company is already in
possession of such customer lists and has existing relationships with
customers of acquired entities given its existing position in the
diagnostics industry.
Sigma
Sigma Clinical
Haemostasis Chemistry Total
----------- --------- -------
US$'000 US$'000 US$'000
Tangible fixed assets 2,500 - 2,500
Working capital 206 625 831
----------- --------- -------
Net assets at fair value 2,706 625 3,331
Goodwill (1,278) 3,787 2,509
----------- --------- -------
Consideration 1,428 4,412 5,840
----------- --------- -------
Satisfied by:
Cash payments including costs 1,428 2,634 4,062
----------- --------- -------
Net cashflow 1,428 2,634 4,062
Deferred consideration - 1,778 1,778
----------- --------- -------
Consideration 1,428 4,412 5,840
----------- --------- -------
Goodwill capitalised during 2002 in respect of acquired businesses
amounted to US$2,509,000 and comprises:
Fair
Book Value Fair
Values Adjustment Value Consideration Goodwill
------- ---------- ------- ------------- --------
US$'000 US$'000 US$'000 US$'000 US$'000
SIGMA HAEMOSTASIS
Tangible fixed assets 1,322 1,178* 2,500
Working capital 8,458 (8,252)* 206
------- ---------- ------- ------------- --------
9,780 (7,074) 2,706 (1,428) 1,278
------- ---------- ------- ------------- --------
SIGMA CLINICAL CHEMISTRY
Working capital 1,490 (865)* 625
------- ---------- ------- ------------- --------
1,490 (865) 625 (4,412) (3,787)
------- ---------- ------- ------------- --------
Total 11,270 (7,939) 3,331 (5,840) (2,509)
------- ---------- ------- ------------- --------
The book values of the assets shown above have been taken from
management accounts and other information of the acquired businesses at
the dates of acquisitions.
The fair value adjustments above principally arise for the following
reasons:
* Revaluation of fixed assets and inventories following an assessment of
the continuing economic contribution of fixed assets and the realisable
value of inventories.
Following the completion of the fair value exercises in 2003 in respect
of the acquisitions made during 2002, amendments have been made to the
fair values reported in the 2002 financial statements. The amendments
relate to the identification of additional obligations assumed on the
acquisition of the Sigma Haemostasis business, the fair valuation of
inventory acquired and the recognition of additional costs in both the
Sigma Haemostasis and Clinical Chemistry acquisitions. The difference
has been taken as an adjustment to goodwill on acquisition. Provisional
and final values of net assets acquired and consideration paid are as
follows:
77
Provisional Adjustments Adjustments Final
fair value to net assets to costs fair value
2002 2003 2003 2003
----------- ------------- ----------- -----------
US$'000 US$'000 US$'000 US$'000
SIGMA HAEMOSTASIS
Tangible fixed assets 2,500 - - 2,500
Working capital 206 2,240 - 2,446
----------- ------------- ----------- -----------
Net assets 2,706 2,240 - 4,946
----------- ------------- ----------- -----------
Consideration and costs (1,428) - (68) (1,496)
----------- ------------- ----------- -----------
SIGMA CLINICAL CHEMISTRY
Working capital 625 (137) - 488
----------- ------------- ----------- -----------
Consideration and costs (4,412) - (98) (4,510)
----------- ------------- ----------- -----------
2001 Acquisitions
On December 21, 2001 the Group acquired the assets of the Biopool
haemostasis business for a total consideration of US$6,409,000 satisfied
in cash and deferred consideration. The deferred consideration of
US$2,591,000 was payable in three instalments of US$855,000,
US$1,166,000 and US$570,000 on December 21, 2002, 2003 and 2004
respectively. At December 31, 2002, US$2,021,000 of the deferred
consideration was included in current liabilities under deferred
consideration. In December 2002, the Company filed an action against
Xtrana Inc relating to the purchase of the Biopool business from Xtrana
in 2001. On June 16, 2003 Trinity Biotech and Xtrana settled this
litigation. Pursuant to the terms of the settlement agreement entered
into between the parties, Trinity Biotech agreed to pay Xtrana the
remaining amount due on the deferred consideration. This debt was
settled in full in 2003. Total acquisition expenses amounted to
US$159,000. This business comprises a range of test kits which assess
and diagnose disorders of blood coagulation, thrombotic risk factors,
fibrinolysis, platelet function and the vascular system. As part of the
acquisition the Company assumed the workforce in Ventura, California and
Umea, Sweden. In the ten months after acquisition the Company learnt the
production techniques associated with this product range and transferred
the Ventura production facility together with a number of key employees
to the Bray, Ireland facility. The Company has maintained the Umea
operation and will continue to benefit from the expertise associated
with this assumed workforce. Goodwill arising on acquisition of US$5.1
million after fair value adjustments represents the value of the
expected synergies created by combining production within the Company's
existing manufacturing operations in Ireland together with the
specialist product knowledge acquired with the assumed workforce in
Ventura and Umea.
Following the completion of the fair value exercise in 2002 in respect
of the Biopool acquisition made during 2001, amendments have been made
to the fair values reported in the 2001 financial statements. The
difference has been taken as an adjustment to goodwill on acquisition.
Provisional and final values of net assets acquired and consideration
paid are as follows:
Provisional Adjustments Adjustments Final
fair value to net assets to costs fair value
2001 2002 2002 2002
----------- ------------- ----------- ----------
US$'000 US$'000 US$'000 US$'000
Working capital (136) 1,551 - 1,415
----------- ------------- ----------- ----------
Consideration and costs (6,409) - (68) (6,477)
----------- ------------- ----------- ----------
20. COMMITMENTS AND CONTINGENCIES
(a) Capital Commitments
There were no capital commitments contracted for or authorised at
December 31, 2004, 2003 or 2002
(b) Operating lease commitments payable during the next 12 months amount to
US$2,648,000 (2003: US$2,182,000) payable on leases of buildings at
Dublin and Bray, Ireland, Darmstadt, Germany, Umea, Sweden, St. Louis,
Missouri, upstate New York and Carlsbad, California and cars and
equipment in the UK and Lemgo,
78
Germany. US$206,000 of the operating lease commitments total relates to
leases whose remaining term will expire within one year, US$630,000
relates to leases whose remaining term expires between one and two
years, US$253,000 between two and five years and the balance of
US$1,559,000 relates to leases which expire after more than five years.
Future minimum operating and finance lease commitments with
non-cancellable terms in excess of one year are as follows:
Operating Leases Finance Leases
---------------- --------------
US$'000 US$'000
2005 2,648 268
2006 2,200 241
2007 1,777 188
2008 1,632 163
2009 1,584 -
Later years 18,912 -
---------------- --------------
Total minimum payments 28,753 860
Less amounts representing interest - (68)
---------------- --------------
Total lease obligations 28,753 792
---------------- --------------
(c) In June 2003, Trinity Biotech completed a new US$10,000,000 club banking
facility with Allied Irish Banks plc and Bank of Scotland (Ireland) Ltd,
this facility is guaranteed by the subsidiaries of the company. At
December 2004, US$6,800,000 of this balance was drawn down by the
company.
(d) Pursuant to the provisions of Section 17, Companies (Amendment) Act,
1986, the Company has guaranteed the liabilities of Trinity Biotech
Manufacturing Limited, Trinity Research Limited, Benen Trading Limited,
Trinity Biotech Sales Limited, Flambelle Limited and Reddinview Limited,
subsidiary undertakings in the Republic of Ireland, for the financial
year to December 31, 2004 and, as a result, these subsidiary
undertakings have been exempted from the filing provisions of Section 7,
Companies (Amendment) Act, 1986.
(e) The Company's bank borrowings are secured by a fixed and floating charge
over the assets of the Company.
(f) In December 2003, the Company initiated legal proceedings in the
Superior Court of Middlesex County, Massachusetts against Inverness
Medical and its affiliate Wampole (collectively, Defendants) for
declaratory judgment, breach of contract and unfair and deceptive
business practices in connection with the Defendants' performance under
a distribution agreement initially entered into in 1995 by Clark
Laboratories Inc (now part of the Trinity Biotech Group) and
subsequently amended in 2002. Inverness Medical, through its affiliate,
Wampole Laboratories, has acted as exclusive distributor for certain of
Trinity Biotech's infectious disease products in the US. This
exclusivity ended on September 30, 2004, at which time it had been
agreed that both Trinity Biotech and Inverness Medical would sell the
products under their respective labels. Among other things, the suit
requested a judgement declaring that Trinity was entitled to sell
certain products directly in the US and Puerto Rico before October 1,
2004 under the terms of the 2002 amendment to the distribution agreement
and due to breaches of the distribution agreement by the Defendants. The
suit also alleged that the Defendants were attempting to convert
customers from Trinity's products to products manufactured by a
competitor (which were modified to look like the Trinity products) by
misrepresenting to the customers that the Trinity product was
unavailable and was being discontinued. In January 2004, the Defendants
countersued alleging, among other things, various breaches of the
distribution agreement and subsequent amendments, and sought a
preliminary injunction to prevent Trinity from selling directly in the
Territory any of its products which are competitive with products sold
by the Defendants and sourced from other suppliers. The Superior Court
of Middlesex County, Massachusetts, denied this motion for a preliminary
injunction on January 28, 2004. In April of 2004, Trinity amended its
complaint to add additional claims alleging breaches of the distribution
agreement by the Defendants. In May of 2004, the Defendants amended
their counterclaims to add claims alleging, among other things, that
Trinity was selling certain products directly without a license.
Following the expiration of the Defendants' exclusive distribution
rights under the distribution agreement on October 1, 2004, Trinity
moved to amend its complaint to eliminate the declaratory judgment
claims and add additional claims for breach of the
79
distribution agreement and tortious interference with advantageous
business relations that had arisen after December 2003. The Defendants
filed a cross-motion to amend their complaint. There has been no ruling
by the court on either party's motion. It is possible that the Company
will incur a loss arising out of this legal case. However, it is
currently not possible to quantify the amount of this potential loss.
21. SIGNIFICANT CONCENTRATIONS AND BUSINESS RISKS
The Group maintains cash and cash equivalents 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 Company performs periodic evaluations of the relative
credit standing of those financial institutions.
The carrying amount reported in the balance sheet for cash and cash
equivalents approximates its fair value.
Due to the large numbers of customers and the geographical dispersion of
these customers, the Group has no significant concentrations of accounts
receivable.
22. PENSION SCHEME
The Group operates a defined contribution pension scheme for its
full-time employees. The benefits under this scheme 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$450,000
(December 31, 2003, US$400,000 and December 31, 2002, US$523,000). This
represents the total cost to the Group of the pension scheme for the
financial year and as such it was not necessary to accrue or prepay
pension contributions at the year end.
23. RELATED PARTY TRANSACTIONS
The Company 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. It has
entered into an agreement with JRJ pursuant to which the Company has
taken a lease of premises adjacent to the existing facility for a term
of 20 years at a rent of (euro)7.62 per square foot ("the Current
Extension"). The lease commenced on the newly completed 25,000 square
foot building in July 2000. The Company also envisages that further
premises may potentially be required by it and, for that purpose, has
entered into a four years eleven month lease at (euro)13,000 per annum
over adjacent lands with JRJ. On November 20, 2002, the Company entered
into an agreement for a 25 year lease with JRJ for offices that have
been constructed on part of these lands. The annual rent of
(euro)381,000 (US$520,000) is payable from January 1, 2004. Independent
valuers have advised the Company that the rent fixed in respect of the
current extension, the agreement for lease and the adjacent lands
represents a fair market rent. The rent for any future property
constructed will be set at the then open market value. The Company 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 Company can meet its ongoing
requirements for premises.
24. DERIVATIVES AND FINANCIAL INSTRUMENTS
The Group uses a range of financial instruments (including cash, bank
borrowings, convertible debentures 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. The Group 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.
INTEREST RATE RISK
The Group borrows in appropriate currencies at floating and fixed rates
of interest. Year-end borrowings, net of cash, totalled US$1,723,000
(2003: US$5,707,000) at interest rates ranging from 3.0% to 5.5% and
including US$16,680,000 of fixed rate debt at interest rates ranging
from 3% to 5.50% (2003: US$14,135,000 at interest rates ranging from 3%
to 5.50%). In broad terms, a one-percentage point increase in interest
rates would reduce the net interest charge by US$150,000 (2003: decrease
by US$83,000).
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 its revolver facility.
80
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 Euro expenses as a result of the movement in the exchange rate
between the US Dollar and the Euro. Arising from this, the Group pursues
a treasury policy which aims to sell US Dollars forward to match a
portion of its uncovered Euro expenses at exchange rates lower than
budgeted exchange rates. With an increasing level of Euro denominated
sales, the Group anticipates that, over the next three years, a higher
proportion of its non-US Dollar expenses will be matched by non-US
Dollar revenues. The Group had foreign currency denominated cash
balances equivalent to US$874,000 at December 31, 2004.
The disclosures below exclude short term accounts receivable and payable
INTEREST RATE PROFILE OF FINANCIAL LIABILITIES
The interest rate profile of financial liabilities of the Group was as
follows:
December 31 December 31
2004 2003
----------- -----------
US$'000 US$'000
Floating rate financial liabilities 7,331 12,135
Fixed rate financial liabilities 16,680 14,135
----------- -----------
24,011 26,270
----------- -----------
Floating rate financial liabilities comprise other borrowings that bear
interest at rates of between 3.33% and 4.86%. These borrowings are
provided by financial institutions at margins ranging from 1% to 2.25%
over interbank rates.
December 31 December 31
Fixed rate financial liabilities 2004 2003
----------- -----------
- weighted-average interest rate 3.20% 3.28%
- weighted-average period for which rate
is fixed 2.15 years 3.24 years
MATURITY OF FINANCIAL LIABILITIES
The maturity profile of the Group's financial liabilities was as
follows:
December 31 December 31
2004 2003
----------- -----------
US$'000 US$'000
In one year or less, or on demand 11,088 8,912
In more than one year, but not more
than two 8,733 6,654
In more than two years, but not more
than five 4,190 10,705
In more than five years - -
----------- -----------
24,011 26,271
----------- -----------
FAIR VALUES OF FINANCIAL ASSETS AND LIABILITIES
There is no significant difference between the fair value and the
carrying value of the Group's financial assets and liabilities as at
December 31, 2004. At December 31, 2004 forward contracts with a
carrying value of US$Nil had a fair value of US$418,000.
81
25. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN IRELAND
AND IN THE UNITED STATES
The Consolidated Financial Statements are prepared in accordance with
accounting principles generally accepted in the Republic of Ireland
("Irish GAAP"), which differ in certain significant respects from US
generally accepted accounting principles ("US GAAP"). These differences
relate principally to the following items and the necessary adjustments
are shown in the table set out below:
(a) Goodwill:
In prior years under Irish GAAP, goodwill was either written-off
immediately on completion of the acquisition against shareholders'
equity, or capitalised in the balance sheet and amortised through the
statement of income on a systematic basis over its useful economic
life. From 1998, goodwill must be capitalised and amortised over the
period of its expected useful life, however, historic goodwill
continues to remain an offset against shareholders' equity. Under US
GAAP, accounting for goodwill as an offset against shareholders' equity
is not permitted. Prior to January 1, 2002 goodwill was amortised under
US GAAP, except for goodwill arising on acquisitions after June 30,
2001, over the period of its expected useful life, subject to a maximum
write off period of 40 years, through the income statement. A useful
life of 10 years was adopted for the purposes of the reconciliation.
In June 2001, the Financial Accounting Standards Board ("FASB")
issued Statement of Financial Accounting Standard ("SFAS") 141,
"Business Combinations", and SFAS 142, "Goodwill and Other Intangible
Assets", both of which are effective for fiscal years beginning after
December 15, 2001. Under the new rules, goodwill is no longer amortised
under US GAAP, but is subject to annual impairment tests in accordance
with SFAS 142 and when conditions of impairment are present. On January
1, 2002 the Group performed the required impairment review of goodwill
and indefinite-lived intangible assets upon the adoption of SFAS 142
and determined that there was no impairment. On December 31, 2003 and
December 31, 2004, the Group performed further impairment tests of
goodwill and indefinite-lived intangible assets, and concluded that
there was no impairment in the carrying value of these assets at those
dates.
There has not been a disposal of all or a portion of a reporting unit
in the three years to December 31, 2004. The aggregate amount of
goodwill relating to acquisitions during the period for the Group and
for each reportable segment for each of the periods presented including
goodwill arising on acquisition of interest in associate, net of fair
value adjustments, is as follows:
2004 2003 2002
US$'000 US$'000 US$'000
Rest of World 8,728 (1,937) 1,181
United States - - -
----- ------ -----
Total 8,728 (1,937) 1,181
----- ------- -----
Goodwill of US$17,246,000 arises on the 2004 acquisitions of Fitzgerald
Industries International Inc, ("Fitzgerald") and Adaltis US, Inc under
Irish GAAP. Under US GAAP, US$10,050,000 representing the allocated
value of US$8,690,000 for customer relationships and US$700,000 for
supplier relationships in respect of the Fitzgerald acquisition and
US$660,000 for customer relationships in respect of the Adaltis US, Inc
acquisition have been accounted for as intangible assets under US GAAP.
Irish GAAP does not permit the separate recognition of such assets.
Such goodwill is amortised under Irish GAAP on a straight-line basis
over 20 years. The separately identified intangible assets have been
amortised on a straight-line basis over 13 years and 11 years for
customer relationships and supplier relationships, respectively, in
respect of the Fitzgerald acquisition and over 10 years for customer
lists in respect of the Adaltis US, Inc acquisition under US GAAP.
In 2003, the Group's investment in its associate, including unamortised
goodwill of US$1,659,000, was written-off.
Negative goodwill arises when the net amounts assigned to assets
acquired and liabilities assumed exceed the cost of an acquired entity.
Under Irish GAAP, negative goodwill arising on acquisitions is
recognised as a negative asset, within intangible fixed assets, and
recognised in the profit and loss account in the periods in which the
non-monetary assets acquired are depreciated or sold. Any negative
goodwill in excess of the fair values of the non-monetary assets
acquired is recognised in the profit and loss account in the periods
expected to benefit. Under US GAAP, negative goodwill would be allocated
to reduce proportionately the values assigned to the acquired
non-current assets. Any excess remaining negative goodwill is recognised
in US GAAP income as an extraordinary gain for periods beginning after
December 15, 2001. In 2004 negative goodwill of US$620,000 was released
to the statement of income under Irish GAAP as the related non-monetary
assets acquired were depreciated and sold. Under US GAAP there is no
release of negative goodwill to the statement of income in 2004 as the
balance of US$951,000 remaining after the gross negative goodwill of
US$2,500,000 was reduced from property, plant and equipment under US
GAAP would have been recognised as an extraordinary gain in 2003.
Similarly at December 31, 2004 gross negative goodwill of US$2,500,000
within intangible fixed assets under Irish GAAP would be disclosed as a
reduction from property, plant and equipment under US GAAP. Depreciation
of US$63,000 (2003: US$76,000), under Irish GAAP, on property, plant and
equipment acquired would not be recognised under US GAAP as the value of
the acquired building has been fully offset by the negative goodwill
arising on the acquisition.
82
Following the completion of the fair value exercises in 2003 in respect
of the Sigma Haemostasis and Sigma Clinical Chemistry acquisitions made
during 2002, amendments have been made to the fair values reported in
the 2002 financial statements. The amendments relate to the
identification of additional obligations of US$929,000 assumed on the
acquisition of the Sigma Haemostasis business, the completion of the
fair value exercise on inventory acquired in both acquisitions
resulting in the recognition of additional value of US$3,031,000 and
the recognition of additional costs of US$68,000 relating to the Sigma
Haemostasis acquisition and US$98,000 relating to the Clinical
Chemistry acquisition. The difference has been taken as an adjustment
to goodwill on acquisition.
Identifiable intangible assets comprise goodwill, which is not
amortisable and certain other non-current intangible assets, which are
amortisable. Other non-current asset amortisation under US GAAP for the
years ended December 31, 2004, 2003 and 2002 was US$715,000, US$154,000,
and US$139,000, respectively. Other non-current amortisation of
identifiable intangible assets under US GAAP is estimated to be
approximately US$954,000 in 2005, US$947,000 in 2006, US$941,000 in
2007, US$937,000 in 2008, US$924,000 in 2009 and US$4,703,000
thereafter.
The net book value of goodwill at December 31, 2004 was US$57,126,000.
(b) Cash Flow Statements:
The consolidated statement of cash flows prepared under Irish GAAP
presents substantially the same information as required under US GAAP by
SFAS 95, "Statement of Cash Flows". This standard differs, however, with
regard to the classification of items within the statements and as
regards the definition of cash equivalents. Under US GAAP, cash
equivalents would not include bank overdrafts. The movements on such
bank overdrafts are required to be included in financing activities
under SFAS 95. Under US GAAP short term investments with a maturity of
three months or less at the date of acquisition are included in cash
equivalents. Under Irish GAAP, movements in short-term investments are
classified as management of liquid resources. Under Irish GAAP, cash
flows are presented separately for operating activities, returns on
investments and servicing of finance, dividends received from associated
undertakings, taxation, capital expenditure and financial investment,
acquisitions and disposals, equity dividends paid, management of liquid
resources and financing. US GAAP, however, requires only three
categories of cash flow activity to be reported: operating, investing
and financing. Cash flows from taxation and returns on investments and
servicing of finance shown under Irish GAAP would, with the exception of
preference dividends paid, be included as operating activities under US
GAAP. The payment of dividends would be included as a financing activity
under US GAAP. Under US GAAP, capitalised interest is treated as part of
the cost of the asset to which it relates and is thus included as part
of investing cash flows; under Irish GAAP all interest is treated as
part of returns on investments and servicing of finance.
(c) Share Capital Not Paid:
Under Irish GAAP, unpaid share capital is classified as a receivable
under current assets. Under US GAAP, share capital receivable should be
reported as a reduction to Shareholders' Equity. Unpaid share capital at
December 31, 2004 is US$158,000 (2003: US$253,000).
(d) Statement of Comprehensive Income:
The Company prepares a "Statement of Total Recognised Gains and Losses"
which is essentially the same as the "Statement of Comprehensive Income"
required under US GAAP, except for the recognition of unrealised gains
and losses on qualified derivative hedging transactions, which are
recognised in US GAAP Comprehensive Income. SFAS 130 requires disclosure
of the cumulative amounts of other comprehensive income.
(e) Sale and Leaseback:
Under Irish GAAP, the Company's sale and leaseback transaction which
took place in December 1999 was treated as a disposal of assets with the
gain on the disposal of US$1,014,000 being credited to the profit and
loss account in the period of the transaction. Under US GAAP, this
amount is deferred and released to the profit and loss account over the
period of the lease (20 years).
83
(f) Sales on Extended Credit Terms:
In 2003 and 2004 the Company made certain sales on extended credit
terms. Under US GAAP, SAB 104, "Revenue Recognition in Financial
Statements", such sales on extended credit terms would not be
recognisable as revenue until the subsequent year, when the cash is
actually received. No similar provisions exist under Irish GAAP to
preclude revenue recognition. Sales were not made on extended credit
terms in 2002.
(g) Restructuring Costs:
Under Irish GAAP, certain provisions made for restructuring costs
incurred upon and related to acquisitions of acquired companies
(principally payments to employees and certain facilities costs) and
expensed immediately would not be recognisable under US GAAP, because
EITF 95-3, "Recognition of Liabilities in Connection with a Purchase
Business Combination", requires costs that meet certain criteria be
treated as part of the purchase price allocation. Certain termination
costs not determined on the basis of length of service or other exit
costs which are not incremental to the acquired company, even if they
provide a reduced economic benefit, are considered period costs which
are expensed when incurred. Certain facilities costs amounting to
US$270,000 representing post-closure lease commitments for a facility
acquired in 2001 were originally capitalised. These costs were
subsequently excluded as a fair value adjustment in 2002 as the facility
was not closed within a year of the acquisition. A decision to maintain
the facility for certain operations was subsequently taken in 2003.
(h) Product Development Costs:
US GAAP, as set forth in SFAS 2, "Accounting for Research and
Development Costs", requires development costs to be written-off in the
year of expenditure. Under Irish GAAP, development expenditure on
projects whose outcome can be assessed with reasonable certainty as to
technical feasibility, commercial viability and recovery of costs
through future revenues, are capitalised at cost within intangible
assets.
(i) Derivatives and Financial Instruments:
In June 1998, the FASB issued SFAS 133, "Accounting for Derivative
Instruments and Hedging Activities". SFAS 133 requires that all
derivatives be recognised on the balance sheet at fair value.
Derivatives which are not hedges or where hedge correlation cannot be
demonstrated must be adjusted to fair value through income. Under Irish
GAAP derivatives are not recognised until settled. Realised gains and
losses on transactions where derivatives are used to hedge
cross-currency cashflows are ultimately recorded in the income statement
on settlement.
As part of a managed hedging policy Trinity Biotech has entered into a
series of forward contracts to sell US Dollars forward for Euro. These
contracts were entered into by the Company to mitigate its foreign
exchange risk. The principal exchange risk identified by Trinity Biotech
was with respect to fluctuations in the Euro as a substantial portion of
its expenses is denominated in Euro but its revenues are primarily
denominated in US Dollars. These forward contracts are cashflow hedging
instruments whose objective is to cover a portion of this Euro mismatch.
In the medium term, the Company's objective is to increase the level of
non-US Dollar denominated revenue, thus creating a natural hedge of its
non-US Dollar expenditure.
During 2001 Trinity Biotech began documenting its hedging transactions
in accordance with the requirements of SFAS 133. In 2004 an unrealised
loss of US$54,000 (2003: loss of US$791,000, 2002 gain of US$1,178,000)
was taken to comprehensive income in respect of such contracts in
accordance with the standard.
During the year ended December 31, 2004 US$868,000 (2003: US$2,374,000)
of foreign exchange gains were recognised in the Income Statement. This
included realised foreign exchange gains of US$126,000 (2003: US$68,000,
2002: US$162,000) on the exercise of forward contracts under US GAAP,
relating to contracts entered into during the year which had not been
designated as hedging instruments. At December 31, 2004 contracts with a
fair value of US$47,000 are recorded in other comprehensive income which
the Company anticipates will be reclassified into earnings on the
exercise of forward contracts in the year ending December 31, 2005. The
last of the Company's forward contracts expires in December 2005.
(j) Deferred Tax:
Deferred tax differences arise between Irish GAAP and US GAAP due to the
impact of the nature and timing of the reconciling items arising.
84
CUMULATIVE EFFECT ON December 31 December 31 December 31
SHAREHOLDERS' EQUITY 2004 2003 2002
US$'000 US$'000 US$'000
Total shareholders' equity before
minority interests under Irish GAAP 116,138 80,262 62,537
US GAAP adjustments:
Goodwill
- Gross (a) 11,727 21,777 21,777
- Gross (b) 1,532 - -
- Aggregate amortisation (7,717) (9,854) (11,412)
Intangible assets
- Gross (c) 10,050 - -
- Aggregate amortisation (532) - -
Product development costs
- Gross (8,441) (4,668) (2,328)
- Aggregate amortisation 251 - -
Property, plant and equipment 139 77 -
Share capital not paid (158) (253) (260)
Adjustment for sale and leaseback (760) (811) (862)
Adjustment for sales on extended credit (80) (144) -
Adjustment for fair value of derivative instruments 418 346 1,069
Deferred tax
- Fair value intangible assets (1,455) - -
- Other 921 502 423
------- ------ --------
Shareholders' equity under US GAAP 122,033 87,234 70,944
------- ------ --------
(a) Includes pre -1998 goodwill written-off against shareholders' equity
under Irish GAAP of US$21,777,000.
(b) Deferred tax liability recognised on identifiable intangible assets
from Fitzgerald and Adaltis US, Inc acquisitions.
(c) Intangible assets of US$10,050,000 arising on 2004 acquisitions
under US GAAP are accounted for as goodwill under Irish GAAP.
At December 31, 2004 the cumulative total fair value of derivative
instruments in other comprehensive income was US$47,000, (2003:
US$101,000). At December 31, 2004 the total accumulated translation
reserve in other comprehensive income was (US$3,975,000),
(2003: (US$4,091,000)).
EFFECT ON NET PROFIT December 31 December 31 December 31
For the year ended 2004 2003 2002
US$'000 US$'000 US$'000
Profit on ordinary activities after taxation
under Irish GAAP 5,166 5,797 4,897
US GAAP adjustments:
Goodwill amortisation 2,136 1,559 2,265
Intangible amortisation (532) - -
Adjustment for property, plant and equipment 63 76 -
Adjustment for sale and leaseback 51 51 51
Adjustment for sales on extended credit 64 (144) -
Adjustment for restructuring costs - - (2,835)
Adjustment for product development costs
- Cost (3,773) (2,340) (417)
- Amortisation 251 - -
Adjustment for fair value of derivative instruments 126 68 162
Deferred tax 496 79 920
------- -------- --------
Profit under US GAAP 4,048 5,146 5,043
-------- -------- --------
Profit per ordinary share (US Dollars) 0.07 0.12 0.12
Diluted profit per ordinary share (US Dollars) 0.07 0.11 0.12
Weighted-average number of ordinary shares used
in computing basic profit per ordinary share 55,132,024 43,093,146 40,550,367
Diluted weighted-average number of ordinary shares
used in computing diluted profit per ordinary share 63,935,138 50,583,247 42,486,227
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
December 31 December 31 December 31
For the year ended 2004 2003 2002
US$'000 US$'000 US$'000
Profit under US GAAP 4,048 5,146 5,043
Translation adjustment 116 175 356
Fair value of derivative instruments (54) (791) 1,178
-------- -------- --------
Total comprehensive income 4,110 4,530 6,577
-------- -------- --------
85
CHANGES IN US GAAP EQUITY FOR THE YEARS ENDED DECEMBER 31 2004,
DECEMBER 31 2003 AND DECEMBER 31 2002
December 31 December 31 December 31
2004 2003 2002
US$'000 US$'000 US$'000
US GAAP Shareholders' Equity at January 1 87,234 70,944 63,463
Net profit for the period 4,048 5,146 5,043
'A' shares issued for cash 24,335 44 545
'A' shares issued for conversion of debenture 427 9,855 -
'A' shares issued on conversion of warrant 348 233 -
Options exercised 1,632 2,011 14
Stock-based compensation - additional paid-in capital 13 84 120
'A' shares issued as consideration for acquisition 7,721 - -
'A' shares issued for financial asset - - 202
Share issue expenses (1,509) (475) (8)
Share proceeds outstanding (2,373) - -
Share capital not paid in previous periods no longer payable 95 8 31
Other comprehensive income:
Translation adjustment 116 175 356
Fair value of derivative instruments (54) (791) 1,178
------- ------ ------
US GAAP Shareholders' Equity at December 31 122,033 87,234 70,944
------- ------ ------
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the year ended
-----------------------------------------------------
December 31 December 31 December 31
2004 2003 2002
US$'000 US$'000 US$'000
Operating Activities
Retained profit under Irish GAAP 5,166 5,797 4,897
Adjustments to reconcile net profit to cash
provided by operating activities:
Depreciation 1,819 1,367 1,118
Amortisation 2,570 856 2,385
Taxation (paid) (1,666) (157) (404)
Share of operating loss in associate - 254 317
Write off of investment in associate - 814 -
Provision for corporation tax charge 53 2,186 768
Net interest payable accrual (118) 159 (46)
Exceptional administrative expenses - - (2,835)
Decrease/ (increase) in accounts receivable and prepayments 484 (65) (4,251)
(Decrease) /increase in accounts payable and accrued expenses (2,419) (2,561) 2,875
Increase in inventory (5,883) (6,005) (2,415)
Non-cash compensation expense 13 84 120
Foreign exchange losses on non-operating cash flows (131) 485 -
Loss on disposal/retirement of fixed assets 14 186 -
Non cash settlement of interest - 45 -
Other non-cash items 140 160 -
------- ------- ------
Net cash inflow from operating activities 42 3,605 2,529
-- ------- ------
Investing activities
Payments to acquire trades or businesses (19,090) (763) (4,409)
Deferred consideration paid - (4,374) -
Payment for intangible fixed assets (3,295) (1,846) (469)
Disposal of fixed assets 31 - -
Payment for tangible fixed assets (3,689) (3,856) (2,517)
------- ------- ------
Net cash outflow from investing activities (26,043) (10,839) (7,395)
-------- -------- ------
Financing activities
Repayment of loan from unconnected third party - (57) (163)
Repayment of minority interest - (309) -
Issue of ordinary share capital including premium 31,708 2,252 559
Expenses paid in connection with share issue and debt financing (2,238) (1,123) -
Increase / (decrease) in long-term debt (2,214) 2,450 (1,804)
Movement in finance leases (267) (131) 4
Issue /(settlement) of convertible debentures, net 3,178 20,000 2,500
(Decrease) / increase in other financial liabilities (2,675) (1,093) 4,108
------- ------- ------
Net cash inflow from financing 27,492 21,989 5,204
------- ------- ------
Increase in cash and cash equivalents 1,491 14,755 339
Effects of exchange rate movements on cash 233 1 95
Cash and cash equivalents at beginning of year 20,563 5,808 5,374
------- ------- ------
Cash and cash equivalents at end of year 22,287 20,564 5,808
------- ------- ------
86
NON CASH TRANSACTIONS
In December 2001, the Group acquired the assets of the Biopool haemostasis
business for a total consideration of US$6,409,000 satisfied in cash and
deferred consideration. The deferred consideration was payable in three
instalments of US$855,000, US$1,166,000 and US$570,000 on December 21, 2002,
2003 and 2004, respectively. The deferred consideration was not conditional on
any future event and has been fully settled. This transaction relates to the
Rest of World reportable segment.
In November 2002, the Company acquired the speciality clinical chemistry product
line from Sigma Diagnostics for a total consideration of US$4,412,000 satisfied
in cash and deferred consideration. The cash consideration was partly financed
by the issue of US$2,500,000 of 5.25% convertible debentures. The debentures
bear interest at a rate of 5.25% per annum and are convertible into Class 'A'
Ordinary Shares of the Company at a price of US$1.50. The Company also issued
50,000 warrants (the "Second Warrants") in November 2002. The deferred
consideration of US$1,810,000 was paid in full in 2003. This transaction relates
to the Rest of World reportable segment.
On April 3, 2002, the Company acquired a further 165,000 Ordinary Shares in its
associate HiberGen Limited. The consideration of US$202,000 was satisfied by the
issue of 156,189 'A' Ordinary Shares in Trinity Biotech plc. During 2003,
HiberGen Limited was unsuccessful in raising additional funds and on November
14, 2003, the Board of HiberGen Limited decided to cease trading. The Company
wrote off its remaining investment in quarter four of the 2003 financial year.
This transaction relates to the Rest of World reportable segment.
In December 1999, the Company completed a private placement of (i) US$3,500,000
principal amount of 7.5% Convertible Debentures and (ii) 483,701 warrants to
purchase 'A' Ordinary shares of the Company (the "First Warrants"), which
resulted in aggregate gross proceeds to the Company of US$3,500,000.
In relation to the First Warrants, 333,701 were each exercisable to purchase one
'A' Ordinary Share of the Company at US$1.74 per share and the remaining 150,000
were each exercisable to purchase one 'A' Ordinary Share of the Company at
US$1.80 per share. 100,000 of these warrants were exercised to purchase 'A'
Ordinary Shares in the Company in 2000. The balance of these 150,000 warrants
expired unexercised on June 25, 2002. During 2003, 133,701 of the remaining
First Warrants were exercised and the final 200,000 were exercised in 2004. The
Second Warrants are each exercisable to purchase one 'A' Ordinary Share of the
Company at US$1.50 and will expire in November 2007. To date none of the Second
Warrants have been exercised.
In July 2003, the Company completed a private placement of US$20,000,000
principal amount of 3% convertible debentures. The debentures bear interest at a
rate of 3% per annum and are convertible into Class 'A' Ordinary Shares of the
Company at a price of US$3.55. In December 2003, US$6,355,000 of the
US$20,000,000 principal amount of the debenture was converted into 1,790,141
Class 'A' Ordinary Shares of the Company. In January 2004, a further US$427,500
of the principal amount of the debenture has been converted into 120,423 Class
'A' Ordinary Shares of the Company. As part of the July placement, convertible
notes in the aggregate principal amount of up to US$5,000,000 could be issued at
the option of the investors by the later of January 9, 2004 and the three month
anniversary of the effective date of the registration statement. In March 2004,
the investors exercised this option in full and the Company completed a further
placement of US$5,000,000 principal amount of 3% convertible debentures. The
debentures bear interest at a rate of 3% per annum and are convertible into
Class 'A' Ordinary Shares of the Company at a price of US$4. The debentures are
unsecured and are repayable in ten equal instalments. Under the terms of the
agreement, the Company has the right to satisfy each repayment either in cash or
in shares. In October 2004, the first principal repayment of US$1,822,000 was
made to the debenture holders in cash. At December 31, 2004, total debentures
outstanding were US$15,819,000. The debt is stated net of unamortised issue
costs of US$576,000.
In January 2004, the Company has completed a private placement of 5,294,118 of
Class 'A' Ordinary Shares of the Company at a price of US$4.25 per share. The
investors were granted five year warrants to purchase an aggregate of 1,058,824
Class 'A' Ordinary Shares of the Company at an exercise price of US$5.25 per
share. The Company further granted warrants to purchase 200,000 Class 'A'
Ordinary Shares in the Company to agents of the Company who were involved in
this private placement at an exercise price of US$5.25. Under the terms of the
placement, investors were also granted the right to purchase an additional
2,647,059 Class 'A' Ordinary Shares of the Company at a price of US$4.25 per
share for a period of up to 30 days after the closing of the transaction. An
additional 431,617 Class 'A' Ordinary Shares of the Company were issued within
the 30 day period following the closing of the transaction to investors who
exercised this option.
In April 2004, Trinity completed the acquisition of the assets of Fitzgerald
Industries International Inc (Fitzgerald) for US$16,000,000 in cash. The
acquisition was partly funded by the issue of 2,783,984 'A' Ordinary Shares of
the Company. As at December 31, 2004, 817,470 shares with a value of
US$2,373,000 remain unpaid (see the consolidated statements of movement in
shareholders' equity).
87
SHARE OPTION SCHEME - ADDITIONAL INFORMATION REQUIRED BY SFAS 123 The Company
has elected to follow Accounting Principles Board Opinion No. 25, "Accounting
for Stock Issued to Employees" ("APB 25") and related interpretations in
accounting for its employee stock options because, as discussed below, the
alternative fair value accounting provided for under SFAS 123, "Accounting for
Stock-Based Compensation," requires use of option valuation models that were not
developed for use in valuing employee stock options. Under APB 25, where the
exercise price of the Company's employee stock options is less than the market
price of the underlying stock on the grant date, compensation expense is
recognised in the income statement over the vesting period.
Proforma information regarding net income and earnings per share is required by
SFAS 123, and has been determined as if the Company had accounted for its
employee stock options under the fair value method of that statement. The fair
value for these options was estimated at the date of grant using a Black-Scholes
option pricing model with the following weighted-average assumptions:
2004 2003 2002
Expected option (in years) 4.0 4.0 4.0
Risk-free weighted-average interest rate 4.25% 4.25% 2.3%
Stock price volatility 0.398 0.855 0.411
Dividend yield 0% 0% 0%
The Black-Scholes option valuation model was developed for use in estimating the
fair value of traded options which have no vesting restrictions and are fully
transferable. In addition, option valuation models require the input of highly
subjective assumptions including the expected stock price volatility. Because
the Company's employee stock options have characteristics significantly
different from those of traded options, and because changes in the subjective
input assumptions can materially affect the fair value estimate, in management's
opinion, the existing models do not necessarily provide a reliable single
measure of the fair value of its employee stock options.
The information required by SFAS 148, "Accounting for Stock-Based Compensation",
is as follows:
December 31 December 31 December 31
2004 2003 2002
US$'000 US$'000 US$'000
Net income as reported 4,048 5,146 5,043
Add: Total stock-based employee compensation
expense included in reported net income,
net of related tax effects 13 84 120
Deduct: Total stock based employee compensation
under fair value based method
for all awards, net of related
tax effects (1,408) (1,808) (1,425)
------- ------- -------
Proforma net income 2,653 3,422 3,738
Earnings per share:
Basic - as reported (US Dollars) 0.07 0.12 0.12
Diluted - as reported (US Dollars) 0.07 0.11 0.12
Basic - proforma (US Dollars) 0.05 0.08 0.09
Diluted - proforma (US Dollars) 0.05 0.07 0.09
A summary of the Company's stock option activity, and related information, for
the years ended December 31 follows:
2004 Weighted-Average 2003 Weighted-Average 2002 Weighted-Average
Options Exercise Price Options Exercise Price Options Exercise Price
Outstanding-beginning of year 8,327,394 US$1.44 9,465,449 US$1.44 7,975,703 US$1.57
Granted 3,162,824* US$3.68 1,495,500 US$1.90 2,243,500* US$1.10
Exercised (1,113,538) US$1.82 (1,397,717) US$1.61 (12,334) US$1.13
Forfeited (430,339) US$1.66 (1,235,838) US$1.82 (741,420) US$1.80
-------- ---------- --------
Outstanding at end of year 9,946,341 US$2.10 8,327,394 US$1.44 9,465,449 US$1.44
Exercisable at end of year 5,693,844 US$2.20 3,995,076 US$1.48 3,927,771 US$1.56
Weighted-average fair value
of options granted during the year US$0.99 US$1.09 US$0.58
* Amounts adjusted for previously issued stock options.
88
The weighted-average remaining contractual life of options outstanding at
December 31, 2004 is 4.39 years. The information above also includes outstanding
warrants.
A summary of the range of prices for the Company's stock options for the year
ended December 31 2004 follows:
Outstanding Exercisable
Option price range No. of Shares Weight.-Av. Weight.-Av. No. of Shares Weight.-Av. Weight.-Av.
exercise price contractual exercise price contractual
life remaining life remaining
US$0.81 - US$0.99 2,947,530 US$0.94 3.92 years 1,756,863 US$0.92 3.45 years
US$1.00 - US$1.99 2,999,677 US$1.35 3.89 years 2,195,344 US$1.33 3.65 years
US$2.00 - US$2.99 2,315,310 US$2.55 5.69 years 386,513 US$2.39 2.05 years
US$3.00 - US$5.25 1,683,824 US$4.84 4.36 years 1,355,124 US$5.21 3.90 years
CAPITAL SHARES RESERVED FOR FUTURE ISSUANCE
The following table sets forth the shares of common stock reserved for
future issuance:
------------------------------------------------------------------------
YEAR ENDED
DECEMBER 31, 2004
------------------------------------------------------------------------
------------------------------------------------------------------------
Shares issuable on conversion of debentures 4,475,915
------------------------------------------------------------------------
Shares underlying outstanding stock options 8,629,017
------------------------------------------------------------------------
Shares available for grant under option plans 1,033,339
------------------------------------------------------------------------
Shares issuable upon exercise of warrants 1,317,324
---------
------------------------------------------------------------------------
15,455,595
==========
------------------------------------------------------------------------
INVESTMENTS
The Company had no trading securities as at December 31, 2004 or
December 31, 2003.
The gross realised gains on sales of trading securities during 2004 was
US$Nil (2003: US$Nil, 2002: US$Nil).
The Company had no "available-for-sale" or "held to maturity securities"
as at December 31, 2004 or December 31, 2003.
FAIR VALUES OF FINANCIAL INSTRUMENTS
The following methods and assumptions were used by the Company in
estimating its fair value disclosures for financial instruments:
Cash and cash equivalents, trade accounts receivable and trade accounts
payable: The carrying amount reported in the balance sheet for cash and
cash equivalents, trade accounts receivable and trade accounts payable
approximates their fair value.
Long and short-term debt: The carrying amounts of the Company's
borrowings approximate their fair value as substantially all of the debt
bears interest at market rates.
Forward contracts: The Company marks its forward contracts to market in
determining fair value.
The carrying amounts and fair values of the Company's financial
instruments at December 31, 2004 and 2003 are as follows:
December 31, 2004 December 31, 2003
------------------------- --------------------------
Carrying Fair Carrying Fair
Amount Value Amount Value
US$'000 US$'000 US$'000 US$'000
Cash and cash equivalents 22,287 22,287 20,563 20,563
Trade accounts receivable 10,799 10,799 11,459 11,459
Trade accounts payable 3,328 3,328 3,519 3,519
Short-term debt 11,088 11,410 8,911 9,153
Long-term debt 12,923 13,316 17,359 17,899
Forward contracts 418 418 346 346
89
ADDITIONAL UNAUDITED PROFORMA INFORMATION FOR ACQUISITIONS MADE IN 2004
The information below presents the proforma effect of the acquisitions
made in 2004 as if they had occurred on January 1, 2004 and
January 1, 2003.
December 31 December 31
2004 2003
US$'000 US$'000
Proforma revenues 82,241 79,236
Proforma income before extraordinary items 4,227 3,682
Proforma net income 4,227 4,633
Proforma earnings per share (US Dollars) 0.08 0.08
Proforma diluted earnings per share (US Dollars) 0.07 0.08
The proforma information was compiled using a combination of available
financial information or where unavailable, extrapolations of the
results of Adaltis and Fitzgerald both of which were acquired during
2004. There were no acquisitions in 2003.
ADDITIONAL UNAUDITED PROFORMA INFORMATION FOR ACQUISITIONS MADE IN 2002
The information below presents the proforma effect of the acquisitions
in 2002, as if they had occurred on January 1, 2002.
December 31
2002
US$'000
Proforma revenues 63,351
Proforma net income 6,446
Proforma earnings per share (US Dollars) 0.16
Proforma diluted earnings per share (US Dollars) 0.15
The proforma information was compiled using extrapolations of the
results for the haemostasis division and speciality clinical chemistry
product line acquired from Sigma Diagnostics during 2002.
RESTRUCTURING COSTS
In December 2001, the Company purchased Biopool and decided to
consolidate its operation into the Bray facility.
Restructuring provisions were determined based on estimates prepared at
the time the restructuring actions were approved by management. An
analysis of the movement on the Company's restructuring plan reserves
for 2002 and 2003 is as follows:
Provision for Restructuring Costs 2002 2003
(under Irish GAAP) US$'000 US$'000
Opening provision 2,835 315
Incurred (2,290) (315)
Write back of provision (230) -
------ ----
Closing provision 315 -
------ ----
Date of completion
The anticipated and actual date of closure of the Biopool facility at
Ventura, CA was September 30, 2002. The anticipated date of completion
of the transfer of operations from the Biopool facility at Umea, Sweden
was also September 30, 2002. However, in 2003 the Company made a
decision to maintain the operations of the Umea facility at a reduced
level with a staff of approximately eight employees and the transfer of
certain other operations did not occur until 2003. 15 employees were
only terminated in January 2003 and 15 further employees in July, 2003.
54 employees were involuntarily terminated consequent to the Biopool
Ventura facility closure.
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IMPACT OF RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
Share-Based Payment
In December 2004, the FASB issued SFAS No. 123 (revised 2004)
"Share-Based Payment" ("SFAS 123R"). This Statement replaces FASB
Statement No. 123, "Accounting for Stock-Based Compensation" and
supersedes APB Opinion No. 25, "Accounting for Stock Issued to
Employees", and its related implementation guidance.
This Statement establishes standards for the accounting for
transactions in which an entity exchanges its equity instruments for
goods or services. It also addresses transactions in which an entity
incurs liabilities in exchange for goods or services that are based on
the fair value of the entity's equity instruments or that may be
settled by the issuance of those equity instruments. This Statement
focuses primarily on accounting for transactions in which an entity
obtains employee services in share-based payment transactions. This
Statement does not change the accounting guidance for share-based
payment transactions with parties other than employees provided in
Statement 123 as originally issued and EITF Issue No. 96-18,
"Accounting for Equity Instruments That Are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or
Services". This Statement does not address the accounting for employee
share ownership plans, which are subject to AICPA Statement of Position
93-6, "Employers' Accounting for Employee Stock Ownership Plans".
This Statement requires a public entity to measure the cost of employee
services received in exchange for an award of equity instruments based
on the grant-date fair value of the award (with limited exceptions).
That cost will be recognised over the period during which an employee
is required to provide service in exchange for the award--the requisite
service period (usually the vesting period). No compensation cost is
recognized for equity instruments for which employees do not render the
requisite service. Employee share purchase plans will not result in
recognition of compensation cost if certain conditions are met; those
conditions are much the same as the related conditions in Statement
123. A public entity will initially measure the cost of employee
services received in exchange for an award of liability instruments
based on its current fair value; the fair value of that award will be
remeasured subsequently at each reporting date through the settlement
date. Changes in fair value during the requisite service period will be
recognised as compensation cost over that period. If an equity award is
modified after the grant date, incremental compensation cost will be
recognized in an amount equal to the excess of the fair value of the
modified award over the fair value of the original award immediately
before the modification. The proforma disclosures previously permitted
under Statement 123 no longer will be an alternative to financial
statement recognition.
This Statement eliminates the alternative to use Opinion 25's intrinsic
value method of accounting that was provided in Statement 123 as
originally issued. Under Opinion 25, issuing stock options to employees
generally resulted in recognition of no compensation cost. This
Statement is effective for public entities that do not file as small
business issuers as of the beginning of the first interim or annual
reporting period that begins after June 15, 2005. Under SFAS 123R, the
Company must determine the appropriate fair value model to be used for
valuing share-based payments, the amortisation method for compensation
cost and the transition method to be used at date of adoption. The
transition methods include prospective and retroactive adoption
options. Under the retroactive option, prior periods may be restated
either as of the beginning of the year of adoption or for all periods
presented. The prospective method requires that compensation expense be
recorded for all unvested stock option and restricted stock at the
beginning of the first quarter of adoption of SFAS 123R, while the
retroactive methods would record compensation expense for all unvested
stock options and restricted stock beginning with the first period
restated. The Company is evaluating the requirements of SFAS 123R and
expects that the adoption of SFAS 123R will have a material impact on
the Company's consolidated results of operations and earnings per
share. The Company has not determined the method of adoption or the
effect of adopting SFAS 123R, and it has not determined whether the
adoption will result in amounts that are similar to the current
proforma disclosures under Statement 123.
91
The adoption or future adoption of the following recent accounting
pronouncements have not or are not expected to have a material impact
on the Company's results of operations and financial condition.
Consolidation of Variable Interest Entities
The Financial Accounting Standards Board issued FASB Interpretations
No. 46, "Consolidation of Variable Interest Entities", ("FIN 46") in
January 2003. This interpretation clarifies the application of
Accounting Research Bulletin No.51, "Consolidated Financial
Statements," to certain entities in which equity investors do not have
the characteristics of a controlling financial interest or do not have
sufficient equity at risk for the entity to finance its activities
without additional subordinated financial support from other parties.
The provisions of FIN 46 were revised in December 2003 through the
issue of FASB Interpretation No. 46(R) ("FIN46R"), "Consolidation of
Variable Interest Entities - An Interpretation of ARB No. 51" to be
effective for financial statement periods ended after March 15, 2004.
The adoption of FIN 46R is not expected to have a material impact on
the consolidated financial statements of the Company as the Company has
a controlling interest in all of its subsidiaries.
Inventory Costs
The Financial Accounting Standards Board ("FASB") issued SFAS 151,
"Inventory Costs - an amendment of ARB No. 43, Chapter 4", in November
2004. This standard amends the guidance in ARB No. 43, Chapter 4,
"Inventory Pricing", to clarify the accounting for abnormal amounts of
idle facility expense, freight, handling costs, and wasted material
(spoilage). Paragraph 5 of ARB 43, Chapter 4, previously stated that
"under some circumstances, items such as idle facility expense,
excessive spoilage, double freight, and rehandling costs may be so
abnormal as to require treatment as current period charges..." The
amendment removes the ambiguity and requires that all abnormal amounts
of idle facility expense, freight, rehandling costs, and wasted
material (spoilage) be treated as current period costs. In addition,
this statement requires that allocation of fixed production overheads
to the costs of conversion be based on the normal capacity of the
production facilities. The provisions of this Statement shall be
effective for inventory costs incurred during fiscal years beginning
after June 15, 2005.
Exchanges of Nonmonetary Assets - an amendment of APB Opinion No. 29
The FASB issued SFAS 153, "Exchanges of Nonmonetary Assets - an
amendment of APB Opinion No. 29", in December 2004. The guidance in APB
Opinion No. 29, "Accounting for Nonmonetary Transactions", is based on
the principle that exchanges of nonmonetary assets should be measured
based on the fair value of the assets exchanged. The guidance in that
Opinion, however, included certain exceptions to that principle. This
Statement amends Opinion 29 to eliminate the exception for nonmonetary
exchanges of similar productive assets and replaces it with a general
exception for exchanges of nonmonetary assets that do not have
commercial substance. A nonmonetary exchange has commercial substance if
the future cash flows of the entity are expected to change significantly
as a result of the exchange. The provisions of this statement shall be
effective for non-monetary asset exchanges occurring in fiscal periods
beginning after June 15, 2005.
92
26. GROUP UNDERTAKINGS
Principal Country
Name and of incorporation Group
registered office Principal activity and operation % holding
Trinity Biotech plc Investment
IDA Business Park and holding Holding
Bray, Co. Wicklow, Ireland company Ireland Company
Trinity Biotech Manufacturing Limited Manufacture and sale Ireland 100%
IDA Business Park of diagnostic test kits
Bray
Co. Wicklow, Ireland
Trinity Research Limited Research and Ireland 100%
IDA Business Park development
Bray
Co. Wicklow, Ireland
Trinity Biotech Sales Limited Non - trading Ireland 100%
IDA Business Park, Bray
Co. Wicklow, Ireland
Flambelle Limited Non-trading Ireland 100%
16 Fitzwilliam Place
Dublin, Ireland
Benen Trading Ltd Trading Ireland 100%
IDA Business Park, Bray
Co. Wicklow, Ireland
Reddinview Ltd Dormant company Ireland 100%
IDA Business Park, Bray
Co. Wicklow, Ireland
Trinity Biotech Inc Holding Company U.S.A. 100%
(Formerly Disease Detection
International Inc)
Girts Road
Jamestown
NY 14702, USA
Clark Laboratories Inc Manufacture and sale U.S.A. 100%
Trading as Trinity Biotech (USA) of diagnostic test kits
Girts Road
Jamestown
NY 14702, USA
FHC Corporation Non-trading U.S.A. 100%
Girts Road
Jamestown
NY 14702, USA
MarDx Diagnostics Inc Manufacture and U.S.A. 100%
5919 Farnsworth Court sale of diagnostic
Carlsbad test kits
CA 92008, USA
Fitzgerald Industries International, Inc Management services U.S.A. 100%
2711 Centerville Road, Suite 400 company
Wilmington, New Castle
Delaware, 19808
Biopool US Inc Manufacture and U.S.A. 100%
Girts Road sale of diagnostic
Jamestown test kits
NY 14702, USA
Eastcourt Limited Non-trading UK 100%
Chichester House
278/282, High Holborn
London, UK
Trinity Biotech UK Holdings Ltd Holding company UK 100%
(Formerly Centocor UK Holdings Ltd)
Shalford
Guildford, Surrey, UK
Trinity Biotech UK Ltd In voluntary UK 100%
(Formerly Centocor UK Ltd) liquidation
Shalford
Guildford, Surrey, UK
Trinity Biotech (UK Sales) Limited Sales of UK 100%
54 Queens Road diagnostic
Reading RG1 4A2, England test kits
Trinity Biotech GmbH Manufacture of diagnostic Germany 100%
Otto Hesse Str 19 instrumentation and
64293 Darmstadt, Germany sale of diagnostic test kits
Biopool AB Manufacture and Sweden 100%
S-903 47 Umea sale of diagnostic
Sweden test kits
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27. EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE
In January 2005, Trinity made the second repayment on the total
convertible debenture principal amount outstanding. Under the terms of
the agreement, the Company has the right to satisfy each repayment
either in cash or in shares. The amount due to be paid was US$1,822,000
and this repayment was satisfied by the issue of 672,232 shares on
January 4, 2005. At February 28, 2005, the total amount of convertible
debt outstanding was US$13,997,000.
In March 2005, Trinity Biotech purchased the assets of Research
Diagnostics Inc ("RDI") for US$4.2 million in cash. RDI provides a
comprehensive range of immunodiagnostic products to pharmaceutical
companies, diagnostic manufacturers and research facilities worldwide
and earned revenues of US$5,054,000 (unaudited) in 2004.
As part of the acquisition of RDI the Company acquired working capital
of approximately US$176,000 (unaudited). As a formal valuation of the
intangible assets acquired has not been completed it is not practical to
provide any further details of the net assets acquired on acquisition.
94
SCHEDULE II
TRINITY BIOTECH PLC
VALUATION AND QUALIFYING ACCOUNTS
DOUBTFUL DEBTS Balance at Charged to Charged to Balance
beginning costs and other at end
of period expenses accounts Deductions of period
US$'000 US$'000 US$'000 US$'000 US$'000
(a) (b)
2004 478 180 (143) (53) 462
2003 496 262 (38) (242) 478
2002 30 466 - - 496
(a) Amounts recovered during the year
(b) Amounts written-off during the year
VALUATION ALLOWANCE FOR INCOME TAXES Balance at Provided Reductions Balance
beginning at end
of period of period
US$'000 US$'000 US$'000 US$'000
(a) (b)
2004 179 302 (179) 302
2003 131 179 (131) 179
2002 273 - (142) 131
(a) Increase in valuation allowance associated with deferred tax asset.
(b) Reduction in valuation of allowance associated with deferred tax
asset.
95
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
By: RONAN O'CAOIMH
--------------
Mr Ronan O'Caoimh
Director/
Chief Executive Officer
Date: March 31, 2005
By: RORY NEALON
-----------
Mr Rory Nealon
Director/
Chief Financial Officer
Date: March 31, 2005
96
ITEM 19
EXHIBITS
EXHIBIT NO. DESCRIPTION OF EXHIBIT
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.
97