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
FOR THE FISCAL YEAR ENDED: DECEMBER 31, 2002
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 ORGANIZATION)
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: 39,629,169 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 REQUIRED TO FILE SUCH REPORTS), AND (2) HAS BEEN SUBJECT TO SUCH
FILING REQUIREMENTS FOR THE PAST 90 DAYS.
YES..........X.............. NO.....................
INDICATE BY CHECK MARK WHICH FINANCIAL STATEMENT ITEM THE REGISTRANT HAS
ELECTED TO FOLLOW:
ITEM 17....................... ITEM 18......X.........
page 1
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 plc
("Trinity" and/or the "Company") as at December 31, 2002 and 2001 and for each
of the years ended December 31, 2002, December 31, 2001 and December 31, 2000,
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, 2000,
December 31, 1999 and December 31, 1998 and for each of the years ended December
31, 1999 and 1998 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, 2002 Dec 31, 2001 Dec 31,2000 Dec 31,1999 Dec 31, 1998
------------- ------------- ------------- ------------- -------------
US$ US$ US$ US$ US$
Revenues 51,979,756 37,064,573 29,742,942 26,104,623 23,169,520
Cost of sales (26,368,693) (18,146,765) (15,401,257) (14,521,619) (15,176,056)
Administrative expenses (12,277,487) (12,128,677) (5,141,214) (3,072,322) (2,271,247)
R & D expenses (4,470,745) (2,779,729) (2,681,220) (2,448,372) (2,559,490)
Amortization (2,404,521) (1,829,135) (1,303,290) (896,913) (178,846)
------------- ------------- ------------- ------------- -------------
Operating profit/(loss)
- Continuing Operations 6,399,283 4,989,119 3,969,890 5,165,397 1,648,881
- Acquisitions 59,027 (2,808,852) 1,246,071 -- 602,831
- Disposals -- -- -- -- 732,169
------------- ------------- ------------- ------------- -------------
6,458,310 2,180,267 5,215,961 5,165,397 2,983,881
Interest expense (705,625) (472,283) (704,847) (723,312) (466,902)
Interest income 57,133 142,364 466,151 69,284 71,011
Share of operating loss in associate (300,000) (195,000) (30,000) -- --
Profit/(loss) on assets -- -- -- 404,328 (37,397)
------------- ------------- ------------- ------------- -------------
Net profit before tax 5,509,818 1,655,348 4,947,265 4,915,697 2,550,593
Tax on profit on ordinary
activities (499,501) (206,000) (123,800) -- --
------------- ------------- ------------- ------------- -------------
Net profit after tax 5,010,317 1,449,348 4,823,465 4,915,697 2,550,593
------------- ------------- ------------- ------------- -------------
Profit from operations
per ordinary share (US cents) 15.93 5.40 14.05 18.34 11.66
Profit from continuing operations
per ordinary share (US cents) 15.78 12.35 10.69 18.34 6.44
Basic earnings
per ordinary share (US cents) 12.36 3.59 12.99 17.46 9.97
Diluted earnings
per ordinary share (US cents) 11.99 3.52 12.20 16.96 9.65
Weighted average number of shares
used in computing basic EPS 40,550,367 40,408,978 37,131,692 28,158,184 25,586,050
Weighted average number of shares
used in computing diluted EPS 42,486,227 41,120,930 40,540,494 28,990,725 26,437,695
2
Consolidated Balance Sheet As at As at As at As at As at
Data Dec 31, 2002 Dec 31, 2001 Dec 31,2000 Dec 31,1999 Dec 31,1998
------------ ------------ ------------ ------------ ------------
US$ US$ US$ US$ US$
Working Capital 20,011,370 16,616,454 16,736,469 6,017,656 9,073
Long-term Liabilities 7,745,442 7,805,237 2,266,425 8,086,232 12,263,521
Total Assets 89,267,571 77,029,213 67,230,672 45,042,295 45,013,047
Capital Stock 610,095 603,420 602,807 460,290 425,299
Shareholders' Equity 62,598,296 56,221,625 54,732,703 22,954,066 14,624,196
Amounts Adjusted for US GAAP
Consolidated Statement Year Ended Year Ended Year Ended Year Ended Year Ended
of Income Dec 31, 2002 Dec 31, 2001 Dec 31,2000 Dec 31,1999 Dec 31,1998
------------ ------------ ------------ ------------ ------------
US$ US$ US$ US$ US$
Net profit 5,225,804 293,816 1,667,958 988,792 625,088
Basic earnings
per ordinary share (US cents) 12.89 0.73 4.49 3.51 2.44
Diluted earnings
per ordinary share (US cents) 12.50 0.71 4.11 3.41 2.36
Consolidated Balance Sheet As at As at As at As at As at
Data Dec 31, 2002 Dec 31, 2001 Dec 31, 2000 Dec 31, 1999 Dec 31, 1998
------------ ------------ ------------ ------------ ------------
US$ US$ US$ US$ US$
Total Assets 97,183,227 83,839,373 75,448,105 55,620,414 60,177,621
Shareholders' Equity 70,990,056 64,364,902 63,859,198 33,729,185 29,818,770
No dividends were declared in any of the periods from December 31, 1998 to
December 31, 2002.
RISK FACTORS
POTENTIAL FLUCTUATIONS IN RESULTS
Trinity's operating results may fluctuate as a result of many factors including
size and timing of orders, the competitive conditions in the industry, loss of
significant customers, delays in the development of new products, currency
fluctuations and general economic conditions.
FUTURE NEED FOR CAPITAL
Up to now Trinity has funded its operations through the sale of its shares and
securities convertible into shares, revenues from operations and bank
borrowings. Trinity expects that the proceeds of recent equity financings, bank
borrowings, current working capital and sales revenues will fund its current
operations and payment obligations for the foreseeable future. However, if the
Company's capital requirements are greater than expected, or if its revenues are
not sufficient to fund its operations, Trinity 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 the Company's current shareholders or
the price of its shares in general.
MARKET COMPETITION AND TECHNOLOGICAL OBSOLESCENCE
The diagnostics industry is extremely competitive. Trinity is competing directly
with companies which have greater capital resources and larger marketing and
business organisations than Trinity. Trinity'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. The Company has significantly invested in research and development
("R&D") but there can be no guarantees that its R&D programmes will not be
rendered technologically obsolete or financially non-viable by the technological
advances of its competitors.
SOURCING OF SUITABLE DISTRIBUTORS
Revenue and earnings stability and growth are directly dependent on the
effectiveness of advertising, marketing and promotional programmes. Trinity
currently distributes its product portfolio through distributors in over 80
countries worldwide. The Company's continuing economic success and financial
security is dependent on its ability to secure effective channels of
distribution on favourable trading terms with suitable distributors.
3
CHANGING MARKET CONDITIONS
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 the Company 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.
DEPENDENCE UPON SALES TO MAJOR CUSTOMER
During the financial years ended December 31, 2002, December 31, 2001 and
December 31, 2000, approximately 20%, 27% and 30% respectively of Trinity's
revenues were derived from a distribution agreement between the Company's
subsidiary, Trinity Biotech USA (formerly Clark Laboratories, Inc.) and Carter
Wallace, Inc. In 2001, Carter Wallace, Inc was acquired by Medpointe, Inc which
was subsequently acquired by Inverness Medical in 2002. In 2002 the Company
negotiated an amendment to the distribution agreement whereby the exclusivity
will be removed in stages throughout 2004. Any material reduction in sales
arising from the distribution agreement whether caused by the above amendment to
the distribution agreement or due to the loss or interruption of the
distribution agreement with Carter Wallace, Inc could be expected to have a
material adverse effect on Trinity.
ACQUISITION OF BUSINESSES
The Company 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. The Company's 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 the
Company's existing business.
RESEARCH AND DEVELOPMENT RISK AND EXPIRATION OF PATENTS
The Company is 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. The Company's
organic growth and long-term success is dependent on its 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 the Company's growth
and disadvantage its market share.
Even when products are successfully developed and marketed, the Company'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
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's planned products, Trinity would be
obliged to seek licences to use this technology and, in the event of being
unable to obtain such a licence or it being obtainable on grounds that would be
materially disadvantageous to Trinity, the Company would be precluded from
marketing such products, which could adversely impact its revenues, sales and
financial position.
PATENT PROTECTION
We can provide no assurance that the patents Trinity may apply for will be
obtained or that existing patents will not be challenged. The patents owned by
Trinity 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.
Also, our technologies could be subject to claims of infringement of patents or
proprietary technology owned by others. The cost of enforcing our patent and
technology rights against infringers or defending our patents and technologies
against infringement charges by others may be high and could adversely affect
our business.
Trade secrets and confidential know-how are important to our scientific and
commercial success. Although we seek to protect our proprietary information
through confidentiality agreements and other contracts, we can provide no
assurance that others will not independently develop the same or similar
information or gain access to our proprietary information.
REGULATION
The Company's manufacturing and marketing of diagnostic test kits is subject to
government regulation in the United States of America ("USA") by the Food and
Drug Administration ("FDA"), and by comparable regulatory authorities in other
jurisdictions. The approval process for the Company's products, while variable
across countries, is generally lengthy, time
4
consuming, detailed and expensive. The Company's continued success is dependent
on its ability to develop and market new products, some of which are currently
awaiting approval from these regulatory authorities. There is no certainty that
such approval will be granted or, even once granted, will not be revoked during
the continuing review and monitoring process.
A PMA for the UniGold HIV Test is undergoing FDA review. No assurance can be
given that the FDA will grant PMA approval to the UniGold HIV test on a timely
basis or at all. A delay or failure to receive such approval could have a
material adverse effect on the Company's revenues, earnings and financial
standing.
The Company is required to comply with extensive postmarket 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.
DEPENDENCE ON KEY PERSONNEL
Trinity's success is dependent on certain key management personnel. Competition
for qualified employees among biotechnology companies is intense, and the loss
of key personnel or the inability to attract and retain the additional highly
skilled employees required for the expansion of the Company's activities, could
adversely affect its business.
DEPENDENCE UPON SUPPLIERS
The primary raw materials required for Trinity's test kits consist of
antibodies, antigens and other reagents, glass fibre and packaging materials
which are acquired from third parties. Although Trinity 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 may not be
available. Such unavailability could affect the quality of the Company's
products and its ability to meet orders for specific products.
RISK OF PRODUCT LIABILITY
Trinity may be subject to claims for personal injuries or other damages
resulting from its products or services. There can be no assurance that its
product liability insurance is sufficient to protect the Company against
liability that could have a material adverse effect on its business.
RISK OF FOREIGN EXCHANGE FLUCTUATIONS
Trinity records its transactions in Euro and US dollars and prepares its
financial statements in US dollars. A substantial portion of its expenses is
denominated in Euro. However, Trinity's revenues are primarily denominated in US
dollars. As a result, the Company is 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 the
Company's earnings and assets.
PENNY STOCK REGULATIONS AND RESTRICTIONS ON MARKETABILITY
SEC regulations concerning a "penny stock" apply to Trinity's shares. These
regulations impose sales practice requirements on broker-dealers who sell the
Company's 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 the Company's shares in the
secondary market and thus adversely affect its share price.
ITEM 4
INFORMATION ON THE COMPANY
HISTORY AND DEVELOPMENT OF THE COMPANY
Trinity 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, primarily, infectious diseases, sexually
transmitted diseases, blood coagulation disorders and autoimmune disorders. The
Company markets over 500 different diagnostic products in approximately 80
countries.
Trinity 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 USA. 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
hemostasis business in December 2001 and the hemostasis division of Sigma
Diagnostics, part of Sigma Aldrich, in August 2002, Trinity has expanded its
product range to include test kits that diagnose blood coagulation and related
disorders, and a hemostasis instrumentation portfolio. The acquisition of the
speciality clinical chemistry business of Sigma Diagnostics in November 2002
means that Trinity now
5
participates in this important market segment. Trinity markets its products in
the USA and in approximately 80 countries worldwide through a combination of
direct selling and a network of national and international distributors. Trinity
has manufacturing facilities in Bray, Ireland, and Lemgo, Germany, in Europe,
and in Jamestown, New York, and Carlsbad, California in the USA.
Over the past four years, Trinity has made six acquisitions of diagnostic
businesses the details of which are set out below. Three of these acquisitions
have been of Enzyme Immunoassay ("EIA") businesses, two were hemostasis
businesses and the sixth was a speciality clinical chemistry business. In
October 2000, the Company also subscribed for 33% of the share capital of
HiberGen Limited ("HiberGen"), an Irish-based genomics company. In July 2001,
the Company further increased its shareholding in HiberGen to 40% and in April
2002 increased it further to 42.9%. In July 2001, Trinity 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 now has a comprehensive portfolio of over 500 products,
including 14 rapid tests.
ACQUISITION OF THE SPECIALITY CLINICAL CHEMISTRY PRODUCT LINE OF SIGMA
DIAGNOSTICS
In November 2002, Trinity acquired the speciality clinical chemistry product
line from Sigma Diagnostics for a total consideration of US$4.4m satisfied in
cash and deferred consideration. The deferred consideration is payable in two
instalments. The first instalment of US$1m was paid on May 27, 2003. The second
instalment of US$0.8m is payable on November 27, 2003. The deferred
consideration is not conditional on any future event. 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 HEMOSTASIS DIVISION OF SIGMA DIAGNOSTICS
In August 2002, Trinity Biotech purchased the hemostasis division of Sigma
Diagnostics for a total consideration of US$1.4m. 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 hemostasis reagents comprise more than fifty tests covering
both routine and speciality assays. The Amelung range of instruments comprises
the smaller KC1 and KC4 products, the mid-size AMAX 200 and the large throughput
AMAX 400. Trinity also received FDA clearance recently for its new hemostasis
analyser the AMAX Destiny(TM).
ACQUISITION OF THE ASSETS AND GOODWILL OF THE BIOPOOL HEMOSTASIS BUSINESS
In December 2001, Trinity acquired the assets and goodwill of the Biopool
hemostasis business for a consideration of US$6.3m before costs comprising
US$3.7m in cash and US$2.6m in deferred consideration. The deferred
consideration was payable in three instalments of US$0.9m, US$1.1m and US$0.6m
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 USA
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 acquired the assets and goodwill of the Amerlex
hormone business of Ortho Clinical Diagnostics for a consideration of US$0.9m.
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.
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$1.4m. On July 2, 2001 the Company
increased its shareholding in HiberGen to 40% at a cost of US$0.3m. 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$201,874 was satisfied by the issue of 156,189 'A' Ordinary Shares in Trinity
Biotech plc.
ACQUISITION OF BARTELS INC
In December 2000, Trinity acquired the assets and goodwill of Bartels Inc
("Bartels"), for a consideration of US$9.5m comprising US$3.2m in stock, US$0.4m
in the form of a promissory note and the balance of US$5.9m 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.
6
ACQUISITION OF MARDX DIAGNOSTICS INC
On February 29, 2000, Trinity 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 USA. The
acquisition of MarDx gave Trinity a strong position in the Western Blot segment
of the infectious disease market. Western Blot confirmatory testing is a natural
extension to Trinity's EIA products and the Company intends to extend the MarDx
Western Blot technology and manufacturing capability to other confirmatory
tests.
ESTABLISHMENT OF UK SUBSIDIARY, TRINITY BIOTECH (UK SALES) LTD
In 2002 Trinity opened a sales and marketing office in Oxfordshire, UK employing
three sales professionals who market the hemostasis and clinical chemistry
products from Trinity Biotech.
ESTABLISHMENT OF GERMAN SUBSIDIARY, TRINITY BIOTECH GMBH
On July 10, 2001, Trinity established a direct sales operation in Germany which
commenced trading in October. After the USA and Japan, Germany, with a
population of 83m, is the third largest market in the world for in-vitro
diagnostics, accounting for 7% (E.1.6bn) of the total world market of
E.22.5bn. In the past Trinity had serviced the market through five
independent distributors who handled a small proportion of the Company's product
portfolio whereas the new German direct sales force markets all of Trinity's
current products. In 2002 Trinity purchased the hemostasis business of Sigma
Diagnostics. This business was taken over by Trinity Biotech GmbH.
PMA APPLICATION 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's UniGold HIV test. This IDE allows
Trinity's UniGold HIV test to be used in a limited number of hospitals
throughout the USA, to provide patients with the results of tests, conducted
during ongoing clinical trials.
The product is used to provide diagnostic test results in less than fifteen
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's proposed clinical trials under the
treatment IDE met FDA standards for human safety and confidentiality.
During 2001, representatives from Trinity 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's
UniGold HIV test. This data along with extensive information on the
manufacturing process for Trinity's UniGold HIV test have been presented to the
FDA. The FDA is currently reviewing the data and Trinity is in active
communication with them. Trinity last met with the FDA on June 23, 2003. The
Company has been asked to clarify several issues and will be responding to the
FDA before the end of July 2003.
PRINCIPAL MARKETS
The primary market for Trinity's tests remains the USA. During fiscal 2002, the
Company sold 65% (US$33.5m) (2001: 68% or US$25.1m; 2000: 58% or US$17.3m) of
product in the USA. Sales to non-USA (principally European and Asian) countries
represented 35% (US$18.5m) during fiscal 2002 and 32% (US$12m) during fiscal
2001. The comparable figure in 2000 was 42% (US$12.5m).
For a more comprehensive segmental analysis please refer to Note 13 "Analysis of
Revenue, Operating Income, Major Customers and Assets" of the Notes to the
Consolidated Financial Statements contained in Item 18 "Financial Statements".
7
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 neutralize the antigen. It is this highly
specific binding of antigen to antibody which forms the basis for all
immunoassay tests.
Trinity'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 utilize biotechnology techniques
involving the in-house production of recombinant proteins, synthetic peptides
and monoclonal antibodies.
Trinity'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)
Hemostasis
Biopool(R)
Amelung
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
product list of over 500 products. Trinity currently sells 95 EIA tests of
various configurations in many countries around the world. Of these, 68 are
cleared by the FDA for distribution within the USA.
These tests are performed on plates that allow for up to 96 simultaneous tests
and can be performed manually or more typically on automated equipment. Trinity
also offers a modest range of equipment for these types of assays as well as
validating the Trinity 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.
8
HEMOSTASIS
The second largest range of assays in Trinity's portfolio is the hemostasis
assays. Arising from the acquisition of the Biopool and Sigma hemostasis
businesses, Trinity now has an extensive range of hemostasis diagnostic kits,
offering laboratories the ability to maximize testing. Biopool is a well-known
leader and innovator in the worldwide market for hemostasis and fibrinolysis
reagents. Strengthening the Biopool reagent portfolio is the addition of the
former Sigma Amelung instrumentation and reagents. This strategic combination
enables Trinity to provide the market with a complete line of hemostasis
products that permit customized testing. With the increasing demand to elucidate
a wide range of coagulapathies in the aging population, hemostasis testing is
quickly advancing to the requirements of today's complexities.
From routine PTs to the esoteric aPC, Trinity'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 can
offer superior sensitivity and NPV (Negative Predictive Value) for D-dimer
testing. Alongside D-dimer are Trinity's comprehensive routine and speciality
assays.
This extensive hemostasis 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's portfolio are the
fluorescence assays that are also typically performed in medium to large sized
hospital laboratories around the world. Trinity offers 33 fluorescence assays,
of which 25 are cleared by the FDA for distribution within the USA, 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 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 9 DFA's Trinity 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'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. 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 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 14
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,
especially in developing countries.
Tests for HIV are also 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's extensive range of 18 Western Blot test systems includes the first
Lyme Western Blot assay to receive FDA clearance for distribution within the
USA. 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
9
bands. After various washing steps and conjugation, the strip is finally reacted
with a precipitating 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 USA AND CARTER WALLACE
Trinity Biotech USA ("Trinity USA") entered into a distribution agreement with
Carter Wallace Inc 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 terms of the agreement, Carter Wallace
has exclusive rights to Trinity USA's products in the USA and Puerto Rico.
Trinity USA and Trinity may market certain Trinity USA products in the USA and
Puerto Rico, which Carter Wallace has chosen not to market in those territories.
In addition, Trinity and Trinity USA may market all of Trinity USA's products in
all territories outside of the USA and Puerto Rico. As part of the agreement,
Carter Wallace paid Trinity USA an amount of US$2.0m for the rights to the
Trinity USA products in the territories of the USA and Puerto Rico. In 2002 the
Company negotiated an amendment to the distribution agreement whereby the
exclusivity will be removed in stages throughout 2004.
SALES AND MARKETING
Trinity 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 over thirty-five sales and marketing professionals responsible for the sale
of hemostasis reagents and instrumentation, clinical chemistry and infectious
disease products. The sales force of sixteen people in Germany is responsible
for selling the full range of Trinity Biotech products including hemostasis,
infectious disease, clinical chemistry and radioimmunoassay. In 2002, Trinity
opened a sales and marketing office in Oxfordshire, UK employing three sales
professionals who market the hemostasis and clinical chemistry products from
Trinity Biotech. In addition to our direct sales operations, Trinity also
operates in seventy-eight countries, through over three hundred independent
distributors and strategic partners.
MANUFACTURING AND RAW MATERIALS
The primary raw materials required for Trinity'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 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 may not be available. Such unavailability
could affect the quality of its products and its ability to meet orders for
specific products, if such orders are obtained. Trinity'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'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 organizations of substantially greater size than
Trinity. 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 Chiron and Dade Behring. The Company
expects competition within the industry to intensify.
10
PATENTS AND LICENCES
Patents
Trinity's SeroCard(TM) 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 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 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's
SalivaCardTM test from being copied by a competitor.
In January 1999, Trinity filed a patent application with the Irish Patents
Office describing a device used in the detection of Strep A in Trinity's Rapid
Strep A test. This patent was granted in February 2000.
Many of the Company's tests are not protected by specific patents. 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 operates. In the event that any of such claims relate
to its planned products, Trinity intends to evaluate such claims and, if
appropriate, seek a licence to use the protected technology. There can be no
assurance that Trinity would, firstly, be able to obtain licences to use such
technology or, secondly, obtain such licences on satisfactory commercial terms.
If Trinity or its suppliers are unable to licence any such protected technology
that might be used in Trinity's products, Trinity 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's products
should be found to infringe protected technology, Trinity could also be required
to pay damages to the infringed party.
Licences
In 2003, 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 USA 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 categorization 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 USA, the Paul Erhlich Institute in
Germany and the Agence Francaise de Securite Sanitaire des Produits de Sante in
France. Recently, a European Directive has been implemented allowing one
approval system to be applicable throughout Europe, CE marking.
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 65% of Trinity's 2002 revenues were
generated in the USA and the USA represents approximately 43% of the worldwide
diagnostics market, an overview of FDA regulation has been included below.
11
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 U.S. Market: Each medical device that the Company may wish to
commercially distribute in the U.S. will likely require either 510(k) clearance
or premarket application ("PMA") approval prior to commercial distribution.
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.
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 four to 12 months, but it can
last longer. After a device receives 510(k) clearance, any modification that
could significantly affect its safety or effectiveness, or that would constitute
a major change in its intended use, requires a new 510(k) clearance or could
even require a PMA approval.
PMA Approval Pathway: A device that does not qualify for 510(k) clearance
generally will be placed in class III and required to obtain PMA approval, which
requires proof of the safety and effectiveness of the device to the FDA's
satisfaction. A PMA application must provide extensive preclinical and clinical
trial data and also information about the device and its components regarding,
among other things, device design, manufacturing and labeling. In addition, an
advisory committee made up of clinicians and/or other appropriate experts is
typically convened to evaluate the application and make recommendations to the
FDA as to whether the device should be approved. Although the FDA is not bound
by the advisory panel decision, the panel's recommendation is important to the
FDA's overall decision making process. The PMA approval pathway is more costly,
lengthy and uncertain than the 510(k) clearance process. It generally takes from
one to three years or even longer. After approval of a PMA, a new PMA or PMA
supplement is required in the event of a modification to the device, its
labeling or its manufacturing process.
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 commercialized. Pursuant to current
FDA policy, manufacturers of IVD's labeled 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
utilized 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.
The Company has developed tests, software and instrument systems that it
distributes in the United States on an RUO or IUO basis. Failure of the Company
or recipients of the Company's RUO and IUO devices to comply with the regulatory
limitations on the distribution and use of such devices could result in
enforcement action by the FDA that would adversely affect the Company's ability
to distribute the tests prior to obtaining FDA clearance or approval. Such
restrictions could have a material adverse effect on the Company's revenues,
earnings and financial standing.
Product under FDA Review: The Company's complete PMA application for the UniGold
HIV Test was filed as of March 27, 2003. The PMA application was supported by
clinical data involving 9,000 samples. The FDA is reviewing the PMA application
and clinical data. No assurance can be given that the necessary PMA approval for
the UniGold HIV Test will be granted on a timely basis, if at all. Delays in the
receipt of, or a failure to receive, such PMA approval could have a material
adverse effect on the Company's revenues, earnings and financial standing.
12
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 design, 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 and market surveillance by the FDA to
determine compliance with regulatory requirements. If the FDA finds any failure
to comply, the agency can institute a wide variety of enforcement actions,
ranging from a public warning letter to more severe sanctions such as: fines,
injunctions, and civil penalties; recall or seizure of products; the issuance of
public notices or warnings; operating restrictions, partial suspension or total
shutdown of production; refusing requests for 510(k) clearance or PMA approval
of new products; withdrawing 510(k) clearance or PMA approvals already granted;
and criminal prosecution.
Some clinical laboratories prepare their own finished diagnostic tests using
purchased reagents. In the past, the FDA did not generally exercise regulatory
authority over these individual reagents or such finished tests. In November
1997, the FDA issued special rules for these reagents, individually termed an
analyte specific reagent ("ASR"), that apply a regulatory framework to them,
including restrictions on sales or promotional claims that could be made about
these products and the restriction of sales to clinical laboratories certified
under the Clinical Laboratory Improvements Amendments of 1988 ("CLIA") as high
complexity testing laboratories. The Company sells individual reagents that fall
within the ASR regulatory framework and is therefore subject to the labelling
and restriction of sales requirements set forth therein.
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 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, 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.
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 authorization 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
13
assurance that the Company will receive on a timely basis, if at all, any
foreign government approval necessary for marketing its products.
ORGANIZATIONAL STRUCTURE
Trinity Biotech plc and its subsidiaries ("the Group") is a manufacturer of
diagnostic test kits for sale and distribution worldwide. Trinity'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.
For a more comprehensive schedule of the subsidiary and associated undertakings
of the Company please refer to Note 29 of the Notes to the Consolidated
Financial Statements "Group Undertakings" contained in Item 18 "Financial
Statements" of this Form 20-F.
PROPERTY, PLANT AND EQUIPMENT
Trinity has four manufacturing sites worldwide, two in the USA (Jamestown, NY
and Carlsbad, CA), one in Bray, Co. Wicklow, Ireland and one in Lemgo, Germany.
The US and Irish facilities are each an FDA, EN and ISO approved facility. As
part of its ongoing commitment to quality, Trinity is actively working on
achieving the latest ISO/9001/2000 certification.
Trinity's executive offices and 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 spent US$4.2m buying and fitting out the facility.
In December 1999, the Company sold the facility for net proceeds of US$5.2m and
leased it back from the purchaser for 20 years. The current annual rent which is
reviewed every 5 years is set at E.392,337 (US$389,687). 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 E.190,455 (US$189,167). 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
E.28,568 (US$28,375) per annum over adjacent lands. On November 20, 2002 the
Company signed an agreement for lease with the lessor for offices that are
currently being constructed on part of these lands. The lease is expected to
commence in quarter three 2003 on terms similar to that for the warehouse. (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 USA in
1994. Additional warehousing space is also leased in upstate New York at an
annual rental charge of US$34,642.
MarDx operates from two facilities in Carlsbad, California. The first facility
comprises 21,500 sq feet and is the subject of a 5 year lease, renewed in July
2001, at an annual rental cost of US$212,640. The second adjacent facility
comprises 14,500 square feet and is the subject of a 5 year lease, renewed in
July 2001, at an annual rental cost of US$130,200.
Arising from the acquisition of the Biopool hemostasis business, Trinity
currently operates from an additional facility located in Umea, Sweden. The Umea
facility is 12,500 square feet and the annual rental is US$170,000. The lease
expires in December 2004.
Arising from the acquisition of the Sigma hemostasis division in 2002, Trinity
acquired a manufacturing/office facility of 55,000 sq ft in Lemgo, Germany. This
facility is owned by Trinity Biotech GmbH.
Additional office space is leased by the Company in Ireland and St, Louis,
Missouri at an annual cost of US$114,249 and US$78,089 respectively.
ITEM 5 OPERATING AND FINANCIAL REVIEW
AND PROSPECTS
GENERAL
Trinity 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
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 took a controlling
interest in DDI and in October 1994, merged Trinity's wholly-owned US subsidiary
into DDI so that DDI
14
became a wholly-owned subsidiary of Trinity. DDI was the surviving legal entity
in the merger and was subsequently renamed Trinity Biotech Inc ("TBI"). In
December 1994, Trinity acquired the remaining 50% of FHC which its subsidiary
TBI did not own. During 1995, Trinity 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 and goodwill 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 and goodwill of the Biopool hemostasis business. In October 2001, Trinity
established a direct sales operation in Germany, Trinity Biotech GmbH. In August
2002, Trinity acquired the hemostasis division of Sigma Diagnostics, part of
Sigma-Aldrich. The Sigma diagnostics hemostasis 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. Trinity intends to transfer the Sigma hemostasis test manufacturing
from St. Louis to the Irish facility, with the transfer scheduled for completion
in Q3 2003. On September 30, 2002, Trinity closed the hemostasis 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 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
established a small direct sales operation in the United Kingdom to handle the
Sigma hemostasis and clinical chemistry product lines.
In October 2000, Trinity subscribed for a 33.3% 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$201,874 was
satisfied by the issue of 156,189 'A' Ordinary Shares in Trinity Biotech plc.
In May 1999 Trinity obtained a secondary listing on the Irish Stock Exchange and
in April 2000 raised US$13.4m by the issue of 4 million Class 'A' Ordinary
Shares to institutional investors.
Trinity's financial statements include the attributable results of seven trading
entities - Trinity Biotech Manufacturing Limited, Trinity Biotech (USA), Biopool
US Inc, MarDx Diagnostics Inc, Biopool AB, Trinity Biotech (UK Sales) Limited
and Trinity Biotech GmbH which are engaged in the manufacture and sale of
diagnostic test kits, and a share of the loss of the associate undertaking,
HiberGen. This discussion covers the years ended December 31, 2002, December 31,
2001 and December 31, 2000 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 28 to the Consolidated
Financial Statements.
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 judgments 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 judgments 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 capitalized at
cost within intangible assets and amortized over 10 years.
15
Factors which impact our judgement to capitalize 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
capitalized;
o significant decline in our stock price for a sustained period;
and our market capitalization 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 and SFAS 144 on January 1,
2002, we have ceased to amortize goodwill. In lieu of amortization, we are
required to perform an initial impairment review of our goodwill. 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 the Group performed a further impairment test of goodwill
and indefinite-lived intangible assets and concluded that there was no
impairment in the carrying value of these assets at this date.
Allowance for slow-moving and obsolete inventory
We evaluate the realizability 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. We also
consider recent trends in revenues for various inventory items and instances
where the realizable 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 analyze 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 income sharing and cost
reimbursement arrangements among related entities, the process of identifying
items of income 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 that period in which such determination is made.
Impairment or disposal of long-lived assets
In August 2001, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 144, Accounting for the Impairment or
Disposal of Long-Lived Assets (SFAS 144), which addresses financial accounting
and reporting for the impairment or disposal of long-lived assets and supersedes
SFAS No. 121, Accounting for the Impairment of Long-Lived Assets and for
Long-Lived Assets to be Disposed Of, and the accounting and reporting provisions
of APB Opinion No. 30, Reporting the Results of Operations for a disposal of a
Segment of a Business. SFAS 144 is effective for fiscal years beginning after
December 15, 2001, with earlier application encouraged. The Company has adopted
SFAS 144 as of January 1, 2002. It has had no material impact on the results
of the Company.
16
RESULTS OF OPERATIONS
Year Ended December 31, 2002 Compared to the Year Ended December 31, 2001
Trinity's consolidated revenues for the year ended December 31, 2002 were
US$51,979,756 compared to consolidated revenues of US$37,064,573 for the year
ended December 31, 2001. The growth in revenues of 40% was due to a combination
of factors including organic growth of existing product lines, the full
integration of the Biopool acquisition which was acquired in December 2001, the
added contribution from the Sigma hemostasis product line from August 2002 and
the introduction of the Sigma speciality clinical chemistry product line with
effect from December 2002.
The gross margin for the year ended December 31, 2002 was 49.3% compared to 51%
for the year ended December 31, 2001. The decrease in gross margin is partly
explained by differing product mixes and the inefficiencies associated with
transferring acquisitions. The quarter four margin increased to 52.3% from 51.6%
in the comparative period last year.
Net interest increased to US$648,492 in 2002 compared to US$329,919 in 2001. The
increased level of interest reflects the Company's higher level of net debt
during the year.
Research and development ("R&D") expenditure increased to US$4,470,745 in 2002.
This represents 8.6% of consolidated revenues and is comparable to the R&D spend
in 2001 of US$2,779,729 or 7.5% of consolidated revenues. The increase in
relative terms is in part explained by the inclusion of a full year's R&D
expenditure for the acquisitions made in 2001 and a part year's spend for the
2002 acquisitions. Normal administrative expenses for the year ended December
31, 2002 amounted to US$14,682,008 compared to US$10,307,812 for the year ended
December 31, 2001. SG&A costs in normal administrative expenses amount to
US$12,277,487 in 2002, an increase from US$8,478,677 in 2001. This is a 45%
increase in the absolute level of these costs and reflects the significant
increase in the size of the direct sales force in the USA, Germany and the UK.
In relative terms the indirect cost base is 23.6% of consolidated revenues which
is comparable with the ratio attained in 2001. Amortization increased to
US$2,404,521 in 2002 compared to US$1,829,135 in 2001 as a result of the
inclusion of a full year's amortization charge on the goodwill relating to the
Biopool acquisition completed in December 2001 and the commencement of
amortization on the Sigma clinical chemistry product line in quarter four 2002.
There was no exceptional administrative charge recognised in 2002. An
exceptional administrative expense of US$3,650,000 was recognised in 2001. Of
this charge US$2,850,000 relates to commitments made on the acquisition of the
assets and goodwill of the Biopool hemostasis business on December 21, 2001
primarily to make payments to employees for redundancy, and plant closure costs,
including commitments for onerous leasing arrangements. The Biopool facility in
Ventura, California was closed in September 2002. The balance of the exceptional
charge of US$800,000 relates to the acquisition of Bartels Inc on December 8,
2000. This charge comprised payments to employees so as to ensure the effective
transfer of the business from Seattle to other facilities. The restructuring
programme at Bartels was implemented during the first two quarters of 2001 and
the Seattle facility was closed on June 8, 2001.
A tax charge of US$499,501 was incurred in the year which reflects the
continuing movement of the Company into a tax paying position as net operating
losses carried forward are offset by profits.
As a result of the above profit after tax and exceptionals in 2002 amounted to
US$5,010,317 compared to US$1,449,348 in 2001. The profit before exceptionals in
2001 was US$5,099,348.
Increase in turnover in the Irish reportable segment during 2002 of
US$10,451,486 is attributable to additional revenues generated from (i) the
inclusion of the first full year of the manufacture of the Bartels product line
following its transfer to the Irish manufacturing facility and (ii) the
acquisition of the Sigma and Biopool hemostasis businesses in August 2002 and
December 2001 respectively. Increased revenues and overhead synergies achieved
from the above acquisitions, exceeded the direct costs of transferring the
product lines to Ireland, resulting in operating income in this reportable
segment of US$3,729,361 for the year ended 31 December 2002 as compared to an
operating loss of US$179,902 for the year ended 31 December 2001. Inclusion of a
full year's revenues generated from the Biopool and Sigma hemostasis businesses
has contributed to the increase in revenues of US$4,463,597 during 2002 in the
US reportable segment. The indirect costs associated with the acquired product
lines, principally the cost of the direct sales force in the US, has been offset
by the benefit of additional revenues generated during the year, resulting in an
overall increase in operating income of US$368,780 in the US reportable segment
in the financial year ended 31 December 2002.
Year Ended December 31, 2001 Compared to the Year Ended December 31, 2000
Trinity's consolidated revenues for the year ended December 31, 2001 were
US$37,064,573 compared to consolidated revenues of US$29,742,942 for the year
ended December 31, 2000. The growth in revenues of 25% was attributable to both
organic and acquisition-led growth.
The gross margin for the year ended December 31, 2001 was 51% compared to 48%
for the year ended December 31, 2000. This improvement was due to both a better
mix of sales during the year and the increased level of higher margin sales
arising from the US acquisitions completed during 2000.
Net interest increased to US$329,919 in 2001 compared to US$238,696 in 2000. The
increased level of interest reflects the Company's higher level of net debt
during the year.
Normal administrative expenses for the year ended December 31, 2001 amounted to
US$10,307,812 compared to US$5,157,504 for the year ended December 31, 2000.
This significant increase reflects the costs incurred in these areas by the
companies acquired in 2000 and 2001 plus the direct sales investment in Germany
and the USA. Amortization increased to US$1,829,135 compared to US$1,303,290 in
2000 as a result of the commencement of amortization on certain product lines
and the new acquisitions. An exceptional administrative expense of US$3,650,000
was recognised in the figures for 2001. This was described in more detail in the
preceding paragraphs detailing the Company's performance in 2001.
A tax charge of US$206,000 was incurred in the year which reflects the movement
of the Company into a tax paying position as net operating losses carried
forward are offset by profits.
17
As a result of the above, profit after tax amounted to US$5,099,348 (before
exceptionals) compared to US$6,110,465 (before exceptionals) in 2000. Profit
after tax and exceptionals in 2001 amounted to US$1,449,348 compared to
US$4,823,465 in 2000.
There was no significant movement in revenues in the Irish reportable segment
during 2001. The decrease in revenue for the Irish reportable segment for the
year ended 2001 compared to 2000 was a result of greater emphasis on the
acquired businesses and a small decrease in revenue generated by an older
product line. Operating loss incurred in the Irish reportable segment during
2001 resulted from the inclusion of costs associated with the acquisitions
completed in 2000 and the higher level of inflation in Ireland in 2001 as
compared to 2000. Significant increase in sales revenues in the US reportable
segment in 2001 as compared to 2000 resulted from the successful acquisition and
integration of Bartels Inc acquired in December 2000. The benefit of additional
revenues from this business was noted during the financial year ended December
2002. Significant costs associated with the reorganization and transfer of this
business were incurred during 2001. Transfer costs resulted in a decrease in
operating income to US$2,360,169 during 2001 in the US reportable segment as
compared to US$3,309,179 in 2000. The Company recognized an exceptional
administrative charge of US$2,850,000 in the year ended 2001 relating to the
transfer of the Biopool facility, and an additional charge of US$800,000
relating to the transfer of the Bartels business from Seattle, Washington to
Bray, Ireland. The comparable charge in 2000 was US$1,287,000 relating to the
transfer of the Bartels business.
LIQUIDITY AND CAPITAL RESOURCES
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 (the
"First Warrants") to purchase 'A' Ordinary Shares of the Company, which resulted
in aggregate gross proceeds to the Company of US$3,500,000. The debentures were
convertible into 'A' Ordinary Shares of the Company at a price of US$1.80.
During 2000, US$1,875,000 of the US$3,500,000 principal amount of the debenture
was converted into 1,041,667 Class 'A' Ordinary Shares of the Company. During
2001, US$625,000 of the remaining balance of the debenture was redeemed. The
remaining balance of the principal amount was rolled over in November 2002 at an
annual interest rate of 6% and a conversion price of US$1.50. Since the year end
the debenture has been fully converted into 666,667 Class 'A' Ordinary Shares of
the Company.
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 to
purchase 'A' Ordinary Shares of the Company (see Item 18 "Financial
Statements"). 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.
Since the year end, the debenture has been fully converted into 1,666,667 Class
'A' Ordinary Shares of the Company.
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 warrants expired
unexercised on June 25, 2002. The Second Warrants are each exercisable to
purchase one 'A' Ordinary Shares of the Company at US$1.50.
In March 2000, Trinity paid US$4,208,279 for 100% of the share capital of MarDx.
This acquisition was funded through the issuance of shares to the value of
US$2,163,287 and cash of US$2,044,992. In October 2000, the Company acquired 33%
of the share capital of HiberGen for a consideration of US$1,371,642 which was
satisfied by cash of US$1,185,197 and shares to the value of US$186,445. In July
2001, the Company subscribed for a further 300,000 Ordinary Shares in HiberGen,
increasing its shareholding to 40% at a cost of US$309,399. In December 2000,
the assets and goodwill of Bartels Inc were acquired for a consideration of
US$9,463,974 which was satisfied with shares to the value of US$3,190,000, a
promissory note of US$350,000 and cash of US$5,923,974. The promissory note was
settled in 2001.
In October 2001, Trinity purchased the Amerlex hormone business of Ortho
Clinical Diagnostics for a total consideration of US$877,797. The consideration
was satisfied in cash. In December 2001, the Company acquired the assets and
goodwill of the Biopool hemostasis business for a total consideration of
US$6,409,329, after costs, satisfied in cash and deferred consideration. The
deferred consideration of US$2,591,500 was payable in three instalments of
US$855,200, US$1,166,200 and US$570,100 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 hemostasis division of Sigma
Diagnostics for a total consideration of US$1,422,802. 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$4,436,188 satisfied in cash and deferred consideration. The
cash consideration was partly financed by the issue of US$2.5m of convertible
debentures. The first instalment of US$1,010,000 of the deferred consideration
was paid on May 27, 2003. The second instalment of US$800,000 is payable on
November 27, 2003.
As at December 31, 2002, Trinity's consolidated cash and cash equivalents were
US$5,768,401. This compares to cash and cash equivalents of US$5,281,976 at
December 31, 2001. The increase is due to a cash inflow of US$3,873,391 from
operations, the issue of share capital, the drawdown of financial facilities 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 net cash inflows of US$486,425 during the year.
A significant portion of the Company's activities are conducted in US Dollars.
The primary foreign exchange risk arises from the fluctuating value of the
Company's Euro expenses as a result of the movement in the exchange rate between
the US Dollar and the Euro. Arising from this, the Company pursues a formalised
treasury policy which aims to sell US Dollars forward to match uncovered Euro
expenses at exchange rates lower than budgeted exchange rates. The Company's
current hedging policy is to cover forward for a minimum of six months. The
Company expects that its forward contracts as at December 31, 2002 will have a
positive impact on the cashflows of the business. At December 31, 2002 forward
contracts with a carrying value of US$Nil had a fair value of US$711,352.
As at December 31, 2002, year end borrowings were US$14,175,446 and cash in hand
was US$5,768,401. For a more comprehensive discussion of the Company's level of
borrowings at the end of 2002, 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". In June 2003, Trinity completed a
new US$10,000,000 club banking facility with Allied Irish Bank plc
and Bank of Scotland (Ireland) Ltd. The new
18
facility consists of a five year term loan of US$5,000,000 and a one year
revolver of US$5,000,000. This facility was partly used to repay existing loans
and the loan notes payable to Xtrana, Inc. Trinity believes that, with further
funds generated from operations, it will have sufficient funds to meet its
capital commitments and continue operations for the foreseeable future. If
operating margins on sales were to decline substantially or 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's operations are influenced by general economic trends, Trinity
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 2003.
IMPACT OF CURRENCY FLUCTUATION
Trinity's revenue and expenses are affected by fluctuations in currency exchange
rates especially the exchange rate between the US Dollar and the Euro. Trinity'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 holds most of its cash assets in US dollars. As Trinity 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.
RESEARCH AND PRODUCTS UNDER DEVELOPMENT
HISTORY
Trinity has invested considerable funds in research and development over the
past number of years. It has developed a platform technology for its rapid
UniGold(TM) tests and, arising from this, the Company has focused on developing
rapid tests for certain infectious diseases utilizing this platform. The
following tests have already been successfully developed:
Hepatitis B
HIV (recombinant protein format)
H. pylori
Malaria
Strep A (CLIA Waivable)
A research project is presently underway to develop a rapid test for influenza A
and B using the UniGold(TM) technology.
The Company has also developed numerous tests utilising the microtitre well
format platform technology for its laboratory-based business. For example, the
Company has developed EIA plate tests for Adenovirus, Rotavirus, C. difficile,
Cryptosporidium and Mycoplasma. Many of Trinity's EIA plate products are
undergoing re-optimisation in order to make them compatible with automated assay
processing systems.
DEVELOPMENT GROUPS
The Company has four 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 USA. The Company
sub-contracts some research and development to independent researchers based in
the USA. In addition, the Company sponsors various projects in universities in
Ireland, the UK and the USA. Each of these research and development groups is
currently involved in the following projects:
19
Microtitre Plate Development Group
Development of microtitre plate assay for the detection of HSV-1 and HSV-2
The Company is developing 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 will utilize recombinant proteins rather than the less specific
viral lysates in the older generations of these products.
Adaptation of assays to Microtrak XL units
During 1998, Trinity acquired the Microtrak Chlamydia business from Dade Behring
Inc. As a result of the acquisition, Trinity acquired instruments to run
Microtitre plate tests. These instruments only ran Chlamydia EIA tests and
Trinity is now adapting its other Microtitre plate assays so that they can be
run on this instrument. The Microtrak XL instruments are placed in a number of
laboratories in the USA and around the rest of the world. The development of
more tests using these instruments will enhance Trinity's ability to sell these
tests.
Redevelopment of the Captia Products
The Syphilis IgG product has been re-developed making these kits more user
friendly and compatible with automated assay systems. These re-optimizations
include the introduction of a one step tracer, the addition of a stop solution
and including a stable one component, ready to use substrate.
Rapid Development Group
Development of Recombinant HIV UniGold(TM) Test
This represents a modification of Trinity's UniGold HIV Test using recombinant
proteins as opposed to peptides for the test. These recombinant proteins are
manufactured by Trinity and allow the UniGold(TM) HIV Test to be produced in a
more cost-effective manner. Development of this product has been completed. All
clinical and non-clinical trials have been concluded and Trinity's PMA
(pre-market application) modules have been submitted to the FDA.
CLIA Waived Strep A test
Trinity has already developed a rapid Strep A test for the doctor's office
market. However, smaller doctors' practices are not entitled to use the test as
it is considered to be moderately complex under the CLIA regulations. Trinity
has developed a simpler form of the test, which will enable it to be sold to
doctors' offices in the USA. The worldwide market for this Strep A test was 90
million tests in 1998, of which 40 million tests were in the USA. This product
has been 510(k) approved and the objective is to achieve the CLIA waiver.
Western Blot Development Group
European Lyme IgG and IgM Western Blots
Development has been completed on two new western blots that have been designed
specifically for the detection of European Lyme. Both products are in pilot
production and on completion of this phase of the project extensive trials will
be performed in order to ensure compliance with CE requirements.
HIV 1 / 2 Western Blot
Trinity has developed a western blot test for detecting antibodies to HIV 1 and
HIV 2 that is presently undergoing clinical trials in Africa and the USA. The
product is now available for sale outside the USA.
Immunofluorescent Assay Development Group
The development department in Trinity has recently been expanded to include a
group that will work exclusively on redesigning various immunofluorescent assays
from indirect assays to direct assays. This redevelopment will make the products
more user friendly and reduce assay time.
For the 12 months ended December 31, 2002, the Company spent US$4,470,745 on
research and development. This expenditure is broken down into salary costs,
reagents, consultancy fees and other related costs. The comparable net
expenditure in 2001 and 2000 was US$2,779,729 and US$2,681,220 respectively.
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.
20
ITEM 6
DIRECTORS AND SENIOR MANAGEMENT
DIRECTORS AND EXECUTIVE OFFICERS
Name Age Title
Ronan O'Caoimh 47 Chairman of the Board of Directors
Chief Executive Officer
Brendan K. Farrell 55 Director, President
James Walsh Ph.D. 44 Director, Chief Operating Officer
Rory Nealon 35 Director, Chief Financial Officer, Company Secretary
Denis R. Burger, Ph.D. 59 Non Executive Director
Peter Coyne 44 Non Executive Director
BOARD OF DIRECTORS
RONAN O'CAOIMH, CHAIRMAN AND CHIEF EXECUTIVE OFFICER, co-founded Trinity 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, 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 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 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 as Chief Financial Officer
and Company Secretary in January 2003. Prior to joining Trinity, 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.
Mr. Nealon replaces Mr. Maurice Hickey who resigned from the board in December
2002.
JIM WALSH, PH.D., CHIEF OPERATING OFFICER, joined Trinity 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 Ph.D. in Microbiology from University College,
Galway.
DENIS BURGER, PH.D., NON-EXECUTIVE DIRECTOR, was Chairman of Trinity from June
1992 to May 1995 and is currently a non-executive director. Dr. Burger is
President, 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 Ph.D. in 1969 in Microbiology and Immunology from the University
of Arizona.
PETER COYNE, NON-EXECUTIVE DIRECTOR, joined the board of Trinity 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.
21
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
Director Salary/ related contribution Total Total
US$ Benefits bonus pension 2002 2001
------------ ------------ ------------ ------------ ------------
Ronan O'Caoimh 303,675 70,175 48,092 421,942 356,555
Brendan Farrell 224,068 50,125 23,699 297,892 251,794
Maurice Hickey 191,110 31,339 13,186 235,635 140,088
Jim Walsh 224,554 50,125 9,729 284,408 252,684
------------ ------------ ------------ ------------ ------------
943,407 201,764 94,706 1,239,877 1,001,121
------------ ------------ ------------ ------------ ------------
Total Total
Non-executive director Fees 2002 2001
US$ ---------- ---------- ----------
Denis R. Burger 10,000 10,000 10,000
Peter Coyne 10,000 10,000 1,877
---------- ---------- ----------
20,000 20,000 11,877
---------- ---------- ----------
BOARD PRACTICES
The Articles of Association of Trinity provide that one third of the directors
in office (other than the Managing Director or a director holding an executive
office with Trinity) 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
retired by rotation and, being eligible, offered himself for re-election and was
re-elected as a director at the Annual General Meeting of the Company held on
May 23, 2003. Furthermore, Mr. Rory Nealon, who was co-opted to the board during
the year following the resignation of Mr. Maurice Hickey, and who retired in
accordance with the Articles of Association, was also re-elected.
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, and Mr. Rory Nealon,
Chief Financial Officer.
22
EMPLOYEES
As of December 31, 2002, Trinity had 580 employees consisting of a research
director and 40 research scientists and technicians, 389 manufacturing and
quality assurance employees, and 150 finance, administration and marketing
staff. Trinity's future hiring levels will depend on the growth of revenues.
The geographic spread of the Company's employees was as follows: 263 in Bray,
Co. Wicklow, Ireland, 96 in Germany, 22 in Sweden, 3 in the United Kingdom and
196 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's employees, consultants,
officers and directors with additional incentives to improve Trinity's ability
to attract, retain and motivate individuals upon whom Trinity'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 available for awards under the Plan is 3,000,000
subject to adjustments to reflect changes in Trinity's capitalization. Options
under the Plan may be awarded only to employees, officers, directors and
consultants of Trinity.
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 (or one year after such termination because
of death or disability). Under certain circumstances involving a change in
control of Trinity, the committee may accelerate the exercisability and
termination of the options. As of May 31, 2003, 5,141,875 of the options
outstanding were held by directors and officers of Trinity.
As of May 31, 2003 the following options were outstanding:
Number of 'A' Ordinary Shares Range of
Subject to Option Exercise Price
per Share
Total Options Outstanding 8,842,840 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. As of May 31, 2003 there were
warrants to purchase 392,201 Class 'A' Ordinary Shares in the Company
outstanding.
ITEM 7
MAJOR SHAREHOLDERS AND
RELATED PARTY TRANSACTIONS
As of May 31, 2003 Trinity has outstanding 41,750,169 'A' Ordinary shares and
700,000 'B' Ordinary shares. Such totals exclude 9,235,041 shares issuable upon
the exercise of outstanding options and warrants.
The following table sets forth, as of May 31, 2003, the Trinity 'A' Ordinary
Shares and 'B' Ordinary Shares beneficially held by (i) each person known by
Trinity to beneficially hold 5% or more of such shares, (ii) each director and
officer of Trinity, 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.
23
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 2,060,432 (1) 4.7% 0 0 4.5%
Brendan Farrell 1,352,043 (2) 3.1% 0 0 3.0%
Rory Nealon 0 (3) 0% 0 0 0%
Jim Walsh 1,232,948 (4) 2.8% 0 0 2.7%
Denis R. Burger 685,000 (5) 1.6% 0 0 1.5%
Peter Coyne 0 (6) 0% 0 0 0
Potenza Investments, Inc 0 0 500,000 (7) 71.4% 2.2%
("Potenza")
Statenhof Building, Reaal 2A
23 50AA Leiderdorp, Netherlands
The Tailwind Fund Limited 2,373,701 (8) 5.7% 0 0 5.6%
Officers and Directors
as a group (6 persons) 5,330,423(1)(2)(3)(4)(5)(6) 12.1% 0 0 11.7%
(1) Includes 689,777 shares issuable upon exercise of options.
(2) Includes 845,208 shares issuable upon exercise of options.
(3) None of options presently held have vested
(4) Includes 513,333 shares issuable upon exercise of options.
(5) Includes 50,000 of 100,000 owned by Sovereign Ventures, a general
partnership owned 50% by Denis Burger which are included in the shares
deemed owned by Dr. Burger, and 294,000 shares issuable upon exercise
of options.
(6) None of options presently held have vested
(7) Includes shares beneficially owned by SRL (350,000 'B') and Brindisi
Investments Inc. (150,000 'B'). SRL has advised Trinity that Potenza
owns a majority of SRL's common stock. These 'B' shares have two votes
per share.
(8) Based on Schedule 13G filed by The Tail Wind Fund Ltd. on January 8,
2003
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 E.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 E.28,568 per annum over adjacent
lands with JRJ. On November 20, 2002, the Company signed an agreement for lease
with JRJ for offices that are currently being constructed on part of these
lands. The lease is expected to commence in quarter three on terms similar to
that for the Current Extension. 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
ITEM 8
FINANCIAL STATEMENTS
LEGAL PROCEEDINGS
DISPUTE REGARDING THE ACQUISITION FROM XTRANA INC.
On December 19, 2002, Trinity filed a lawsuit against Xtrana, Inc. ("Xtrana") in
the United States District Court for the Southern District of New York in
connection with an Asset Purchase Agreement entered into between Trinity and
Xtrana as of November 9, 2001. After the Asset Purchase Agreement was finalised,
Xtrana entered into a consent judgement with Instrumentation Laboratories ("IL")
in which it admitted that one of the products listed in the Asset Purchase
Agreement (identified as "Bioclot") infringed on patents held by IL. Trinity
asserted claims against Xtrana for breach of contract, breach of the implied
covenant of good faith and fair dealing, unjust enrichment, common law fraud,
negligent misrepresentation and violation of the Delaware Consumer Fraud Act as
a result of misrepresentations made by Xtrana regarding the IL lawsuit and for
entering into the consent judgement. The Company sought damages of not less than
US$1,200,000 from Xtrana and punitive damages of not less than US$3,000,000.
On or about January 17, 2003 Xtrana filed an answer to the complaint filed by
the Company and counterclaims against the Company for tortuous interference with
prospective economic advantage, breach of contract for failure to pay promissory
notes in connection with the Asset Purchase Agreement, breach of covenant of
good faith and fair dealing and seeking a declaratory judgement that the Company
is obligated to make payments under the promissory notes. Xtrana sought not less
than US$27,000,000 for each of its claims and punitive damages of not less than
US$30,000,000 on its claims for tortuous interference and breach of covenant of
good faith and fair dealing.
On June 16, 2003 Trinity and Xtrana settled this litigation. Pursuant to the
terms of the Settlement Agreement entered into between the parties, Trinity
agreed to pay Xtrana the amounts due on two promissory notes of US$1,166,200 and
US$570,100, together with interest thereon as provided in the notes, less
US$225,000, and less US$24,148.03, which represented the amount due and owing by
Xtrana to Trinity as of May 31, 2003 pursuant to a Letter Agreement, dated
December 20, 2001, between Trinity and Xtrana, relating to a third party. The
total amount of the settlement payment made by Trinity to Xtrana was
US$1,505,942.10.
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 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.
ITEM 9
THE OFFER AND LISTING
Trinity'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 May 30, 2003, the reported closing sale price of the
ADS's was US$2.39 per ADS. The following tables set forth the range of quoted
high and low sale prices of Trinity's ADS, and Class B Warrants for (a) the
years ended December 31, 1998, 1999, 2000, 2001 and 2002; (b) the quarters ended
March 31, June 30, September 30 and December 31, 2001; March 31, June 30,
September 30 and December 31, 2002, and the quarter ended March 31, 2003; and
(c) the months of December 2002, and January, February, March, April and May
2003 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 Class B
High Low High Low
YEAR ENDED DECEMBER 31
1998 $ 2.56 $ 0.47 $ 0.63 $ 0.28
1999 $ 2.47 $ 1.16 $ 0.12 $ 0.03
2000 $ 7.59 $ 1.69
2001 $ 3.22 $ 0.97
2002 $ 1.86 $ 0.89
25
ADS's
High Low
2001
Quarter ended March 31 $ 3.22 $ 2.00
Quarter ended June 30 $ 2.50 $ 1.67
Quarter ended September 30 $ 1.91 $ 0.97
Quarter ended December 31 $ 1.84 $ 1.20
2002
Quarter ended March 31 $ 1.86 $ 1.41
Quarter ended June 30 $ 1.64 $ 1.24
Quarter ended September 30 $ 1.49 $ 0.89
Quarter ended December 31 $ 1.67 $ 0.93
2003
Quarter ended March 31 $ 2.44 $ 1.25
MONTH ENDED
December 31, 2002 $ 1.67 $ 1.27
January 31, 2003 $ 1.65 $ 1.25
February 28, 2003 $ 1.97 $ 1.52
March 31, 2003 $ 2.44 $ 1.77
April 30, 2003 $ 2.83 $ 2.09
May 31, 2003 $ 2.73 $ 2.20
The number of record holders of Trinity's ADS's as at May 31, 2003 amounts to
1,703, inclusive of those brokerage firms and/or clearing houses holding
Trinity'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.
26
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 two
times 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.
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
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 2001
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 authorize 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.
27
ACTION NECESSARY TO CHANGE THE RIGHTS OF SHAREHOLDERS
In order to change the rights attaching to any class of shares, a special
resolution passed at a class meeting of the holders of such shares is required.
The provisions in relation to general meetings apply to such class meetings
except the quorum shall be two persons holding or representing by proxy at least
one third in nominal amount of the issued shares of that class. In addition, in
order to amend any provisions of the Articles of Association in relation to
rights attaching to shares, a special resolution of the shareholders as a whole
is required.
CALLING OF AGM'S AND EGM'S OF SHAREHOLDERS
The Company must hold a general meeting as its annual general meeting each year.
Not more than 15 months can elapse between annual general meetings. The annual
general meetings are held at such time and place as the directors determine and
all other general meetings are called extraordinary general meetings. Every
general meeting shall be held in Ireland unless all of the members entitled to
attend and vote at it consent in writing to it being held elsewhere or a
resolution providing that it be held elsewhere was passed at the preceding
Annual General Meeting. The directors may at any time call an extraordinary
general meeting and such meetings may also be convened on such requisition, or
in default may be convened by such requisitions, as is provided by the Companies
Acts, 1963 to 2001 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 7 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 2001 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 USA 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.
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, 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.
28
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 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. Angola and Iraq are currently the
subject of United Nations sanctions.
TAXATION
The following discussion is based on US and Republic of Ireland tax law,
statutes, treaties, regulations, rulings and decisions now in effect, all of
which are subject to change. No representation is or can be made as to whether
such laws, statutes, treaties, regulations, rulings and decisions will change,
or what impact if any such changes will have on the statements contained in this
summary. This summary does not discuss all aspects of Irish and US federal
income taxation that may be relevant to a particular stockholder in light of the
stockholder's circumstances or to certain types of investors subject to special
treatment under the 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. This
description is for general information only and is based on the Internal Revenue
Code of 1986, as amended. The tax treatment of a holder of Trinity ADS's and/or
'A' Ordinary Shares ("Trinity Stock") may vary depending upon his or her
particular situation. Holders or prospective purchasers of Trinity Stock are
advised to consult their own tax advisors as to the Irish or other tax
consequences of the purchase, ownership and disposition of this stock.
UNITED STATES FEDERAL INCOME TAXATION
Under the Income Tax Treaty currently in effect between the USA and Ireland (the
"Treaty"), Trinity will not be subject to US federal income tax (other than
withholding tax imposed on US source dividends and certain interest) unless it
engages in a trade or business in the USA through a permanent establishment in
the USA. Trinity's ownership of its US subsidiaries does not, in itself,
constitute a permanent establishment.
Trinity expects to be able to conduct its activities in a manner that will not
result in it being considered to be engaged in a trade or business or to have a
permanent establishment in the USA for US federal income tax purposes. The law
is unclear, however, as to what constitutes being engaged in a trade or business
or a US permanent establishment, so there can be no assurance that Trinity will
not be held to be in a trade or business or to have a US permanent establishment
(in which case Trinity would generally be subject to US federal income tax on
such of its net income as is effectively connected to the permanent
establishment). Trinity's US subsidiaries, as US corporations, are subject to US
taxation.
FEDERAL INCOME TAX CONSEQUENCES TO US INVESTORS
Holders of ADS's will be treated as the owners of the underlying Trinity Stock
for US federal income tax purposes. The gross amount of distributions, including
the amount of Irish taxes, if any, withheld therefrom, to ADS holders from
Trinity will be treated for US tax purposes as dividends to the extent of
Trinity's current and accumulated earnings and profits as determined for US
federal income tax purposes. Distributions in excess of current and accumulated
earnings and profits will be applied against
29
and reduce a holder's basis in its ADS's. The excess, if any, of the
distribution remaining after the basis has been reduced to zero will constitute
capital gain.
Dividends paid by Trinity generally will not qualify for the dividends received
deduction otherwise available to US corporate shareholders.
Irish withholding tax imposed on dividends, if any, will be a foreign income tax
eligible for credit against a holder's U.S. federal income tax liability,
subject to certain limitations set out in the Internal Revenue Code (or,
alternatively, for deduction against income in determining such tax liability).
The rules relating to the determination of the foreign tax credit are complex,
and holders should consult with their personal tax advisors to determine whether
and to what extent they would be entitled to this credit.
If a holder sells or otherwise disposes of ADS's, the holder will recognize gain
or loss for U.S. federal income tax purposes in an amount equal to the
difference between the amount realized on the sale or other disposition and the
adjusted tax basis in ADS's. Such gain or loss generally will be capital gain or
loss and will be long-term capital gain or loss if the holder has held the ADS's
for more than one year at the time of the sale or other disposition.
Under recently enacted tax legislation, dividends received by individual holders
from certain foreign corporations, and long-term capital gain realized by
individual holders, generally are subject to a reduced maximum tax rate of 15
percent through December 31, 2008. Dividends received with respect to ADS's
should qualify for the 15 percent rate. The reduced rate on capital gains
applies to sales and exchanges on or after May 6, 2003 and the reduced rates on
dividend income to dividends received after December 31, 2002. The rate
reduction does not apply to dividends received in respect of certain short-term
or hedged positions in the common stock or in certain other situations. The
legislation contains special rules for computing the foreign tax credit
limitation of a taxpayer who receives dividends subject to the rate reduction.
Holders should consult their own tax advisors regarding the implications of
these rules in light of their particular circumstances.
Payments in respect of ADS's may be subject to information reporting to the U.S.
Internal Revenue Service and to U.S. 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
the fact 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 holder's U.S. tax liability, and a
Holder may obtain a refund of any excess amounts withheld under the backup
withholding rules by filing the appropriate claim for refund with the IRS.
Any holder who holds 10% or more in vote or value of Trinity will be subject to
certain additional United States information reporting requirements.
STATE AND LOCAL TAX CONSEQUENCES TO US SHAREHOLDERS
The ownership of the ADS's may result in state or local taxes to US investors.
Republic of Ireland Taxation
TAXATION OF TRINITY
For Irish tax purposes, the residence of a company is in the jurisdiction where
the central management and control of the company is located. Subject to certain
exceptions, all Irish incorporated companies are deemed to be tax resident in
Ireland. Companies which are tax resident in Ireland are subject to Irish
corporation tax on their total profits (wherever arising and, generally, whether
or not remitted to Ireland). The question of residence, by virtue of management
and control, is essentially one of fact. While there can be no certainty that
Trinity will continue to be Irish resident it is the present intention of
Trinity's management to manage and control the business from Ireland, so that
Trinity will be tax resident in Ireland.
Until December 31, 2010, Trinity is entitled to the 10 per cent. rate of
corporation tax from the sale of product manufactured by Trinity in Ireland.
In addition, section 234 of the Taxes Consolidation Act, 1997 ("TCA 1997")
provides that a resident of Ireland shall be entitled to have any qualifying
income from a qualifying patent disregarded for income taxation purposes. It
should be noted that there are restrictions on the exemption where patent income
is received from a connected party. A qualifying patent means a patent in
30
respect of which the research, planning, processing, experimenting, testing,
devising, designing, developing or similar activities leading to the invention
which is the subject of the patent, was carried out in Ireland. Accordingly,
Trinity or its subsidiaries' qualifying income from such qualifying patents is
disregarded for corporation tax purposes in Ireland.
Any other taxable income will be taxed at the standard rates. The standard rate
of corporation tax on trading income is currently 12.5 per cent. and on
non-trading income is 25 per cent.
Although Trinity has no reason to believe that the Republic of Ireland intends
to change its method of taxation as it relates to patent licensing, royalty,
trading or manufacturing income, there can be no assurance that such changes
will not actually occur. Irish capital duty, a tax on the issuance of share
capital by companies, is payable at the rate of one percent of proceeds received
in exchange for such issuance.
TAXATION OF DIVIDENDS
The board of directors does not expect to pay dividends for the foreseeable
future. Should Trinity begin paying dividends, such dividends will generally be
subject to a 20 per cent. withholding tax (DWT). Under current legislation,
where DWT applies Trinity will be responsible for withholding it at source. DWT
will not apply where an exemption applies and where Trinity has received all
necessary documentation from the recipient prior to payment of the dividend.
DWT EXEMPTIONS FOR US RESIDENT SHAREHOLDERS
Shareholders who are individuals resident in the USA (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 USA (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 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
per cent. parent's principal class of shares are substantially or regularly
traded on a recognized stock exchange in a country with which Ireland has a tax
treaty, may receive dividends free of DWT where they provide Trinity with the
relevant declaration, auditor's certificate and Irish Revenue Commissioners'
certificate as required by Irish law.
US resident holders of ordinary shares (as opposed to ADS's) should note that
these documentation requirements may be burdensome. As described below, these
documentation requirements do not apply in the case of holders of ADS's. 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.
DWT EXEMPTIONS FOR US RESIDENT HOLDERS OF ADS'S
Special DWT arrangements are available in the case of shares held by US resident
holders in Irish companies through American depository banks using ADS's 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 USA.
IRISH INCOME TAX FOR NON-IRISH RESIDENT SHAREHOLDERS
Under the TCA 1997, non-Irish shareholders may, unless exempted, be liable to
Irish income tax on dividends received from Trinity. Such a shareholder will not
have an Irish income tax liability on dividends if the shareholder is:
o an individual resident in the USA (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 USA (or certain other countries);
or
o a corporation that is not resident in Ireland and whose principal class
of shares (or its 75 per cent. parent's principal class of shares) are
substantially or regularly traded on a recognized stock exchange; or
o is otherwise entitled to an exemption from DWT.
31
IRISH INCOME TAX FOR IRISH RESIDENT SHAREHOLDERS
As explained in "Taxation of Dividends" above, DWT applies with some exceptions
to dividends which Trinity pays to shareholders, including individual
shareholders resident or ordinarily resident in Ireland. Irish individual
shareholders are subject to income tax on the gross dividend, which is the
dividend received plus DWT, at their marginal rate of tax but are entitled to a
credit for the DWT deducted against their income tax liability. Irish individual
shareholders may also be subject to the Irish health levy of 2 per cent. in
respect of this dividend income. Irish individual shareholders may claim to have
the withheld tax refunded by the Irish tax authorities to the extent that it
exceeds the shareholder's Irish income tax liability.
DWT does not apply to dividends paid to various Irish resident companies,
pension funds and charities where the shareholder has provided Trinity with the
relevant declaration required by Irish law. Pursuant to section 129 TCA1997
Irish resident companies are not subject to corporation tax on dividends or
distributions received from other Irish resident companies.
IRISH TAXATION OF CAPITAL GAINS
Irish holders will be liable to Irish capital gains tax ("CGT") on the disposal
of ordinary shares or ADS's to the extent that the proceeds realized from such
disposition exceed the indexed base cost of the ordinary shares or ADS's
disposed of and any incidental expenses.
Irish holders will generally be considered, for Irish tax purposes, to have
acquired their ordinary shares or ADS's at a base cost equal to the amount paid
for the ordinary shares or ADS's. On subsequent dispositions, ordinary shares or
ADS's 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 ADS's acquired at a later time. The current rate of CGT is 20 per
cent.. Indexation of the base cost of the ordinary shares or ADS's was only
available up to December 31, 2002, and only in respect of ordinary shares or
ADS's held for more than 12 months prior to their disposal.
Irish holders that have unutilized capital losses from other sources in the
current, or any previous tax year, can generally apply such losses to reduce
gains realized on the disposal of the ordinary shares or ADS's.
An annual exemption allows individuals to realize chargeable gains of up to
E.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 realize a loss on the disposition of ordinary shares or ADS's
will generally be entitled to offset such allowable losses against capital gains
realized 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.
A person who is not an Irish holder will not be subject to Irish capital gains
tax on the disposal of ordinary shares or ADS's provided that the ordinary
shares or ADS's are quoted on a recognized stock exchange. NASDAQ and the ISEQ
are recognized stock exchanges.
IRISH CAPITAL ACQUISITIONS TAX
A gift or inheritance of ordinary shares or ADS's 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 per
cent. 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 since December 5, 1991, 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 E.3,000 can be received each
year from any given individual without triggering a charge to capital
acquisitions tax. Where a charge to Irish capital gains tax and capital
acquisitions tax arises on the same event, capital acquisitions tax payable on
the event can be reduced by the amount of the capital gains tax 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
32
inheritance of ordinary shares or ADS's 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--ORDINARY SHARES
Irish stamp duty, which is a tax on certain documents, may be payable on all
transfers of Trinity ordinary shares (other than between spouses) wherever the
document of transfer is executed. Where the transfer is attributable to a sale,
stamp duty will be charged at a rate of 1 per cent, rounded down to the nearest
E.1 (the ad valorem rate), of the amount or value of the purchase price or
market value if higher. Where the consideration for the 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. In
the case of a transfer by way of gift (other than to a spouse, which is exempt)
or for a consideration less than the market value of the ordinary shares
transferred, stamp duty will be charged at the ad valorem rate on such market
value.
Transfers of ordinary shares between associated companies will be relieved from
stamp duty in Ireland provided certain conditions are met. Transfers of ordinary
shares where no beneficial interest passes (e.g. a transfer of shares from a
beneficial owner to his nominee), will generally be exempt from stamp duty if
they contain the appropriate certificate, otherwise a flat rate of E.12.50
(the nominal rate) will apply.
IRISH STAMP DUTY--ADS'S REPRESENTING ORDINARY SHARES
A transfer by a shareholder to the Depository of ordinary shares for deposit
under the Deposit Agreement in return for ADS's, and a transfer of ordinary
shares from the Depository upon surrender of ADS's for the purposes of
withdrawal of the underlying ordinary shares in accordance with the terms of the
Deposit Agreement, will be stampable at the ad valorem rate if the transfer
relates to a sale or contemplated sale or any other change in the beneficial
ownership of such ordinary shares, and at the nominal rate where the transfer
merely relates to a transfer where no change in the beneficial ownership in the
underlying ordinary shares is effected.
Transfers of ADS's are exempt from Irish stamp duty as long as the ADS's are
quoted on the NASDAQ National Market or any recognized stock exchange in the USA
or Canada.
The person accountable for payment of stamp duty is the transferee or, in the
case of a transfer by way of gift or for a 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 has not declared or paid dividends on its 'A'
Ordinary Shares. Trinity 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
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 audit. These
activities include the Company making use of spot and forward foreign exchange
markets.
Trinity 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 utilization of these financial instruments are
interest rate risk, liquidity risk and foreign exchange risk.
33
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 Group borrows in appropriate currencies at fixed and floating rates of
interest. Year-end borrowings, net of cash, totalled US$8,407,045 (2001:
US$4,375,840) at interest rates ranging from 2.30% to 7.41% and including
US$3,985,362 of fixed rate debt at interest rates ranging from 5% to 7.50%
(2001: US$1,309,607 at 7.50%). In broad terms, a one-percentage point increase
in interest rates would increase the net interest charge by US$101,329 (2001:
US$81,000).
Long-term borrowing requirements are met by funding in the USA and Ireland.
Short-term borrowing requirements are primarily drawn under committed bank
facilities. At the year-end, 50% of gross debt fell due for repayment within one
year. The Company continues to comply with all of its borrowing covenants, none
of which represents a restriction on funding or investment policy in the
foreseeable future.
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 formalised
treasury policy which aims to sell US Dollars forward to match uncovered Euro
expenses at exchange rates lower than budgeted exchange rates. The Company's
current hedging policy is to cover forward for a minimum of six months. 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 Group had foreign
currency denominated cash balances equivalent to US$2,050,827 at December 31,
2002.
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 a reduction in profit before tax for 2002 of less than two per cent.
The table below provides information about the Company's debt obligations that
are sensitive to changes in interest rates. For long-term debt obligations, the
table presents principal cash flows and related weighted average interest rates
by expected maturity dates. Weighted average variable rates are based on rates
set at the balance sheet date. The information is presented in US Dollars, which
is the Company's reporting currency. The actual currencies of the instruments
are as indicated.
MATURITY AFTER FAIR
BEFORE DECEMBER 31 2003 2004 2005 2006 2007 2007 TOTAL* VALUE**
---------------------------- --------- --------- --------- --------- --------- --------- --------- ---------
US$000 (except percentages)
LONG-TERM DEBT
Variable rate - US$000 10,190 10,190 10,190
Average interest rate 4.2% 4.2%
Fixed rate - US$000 3,903 13 15 16 16 22 3,985 3,985
Average interest rate 5.6% 5.0% 5.0% 5.0% 5.0% 5.0% 5.6%
* Represents the maturity profile as at June 17, 2003 of the Company's
long-term debt as at December 31, 2002.
** Represents the net present value of the expected cash flows discounted
at current market rates of interest.
EXCHANGE RATE SENSITIVITY
At year-end 2002, less than 1% of the Company's US$62,908,242 net worth
(shareholders' equity and minority interest) was denominated in currencies other
than the US Dollar, principally the Euro.
A strengthening of the US Dollar by 10% against all the other currencies in
which the Company operates would not materially reduce the Company's 2002
year-end net worth.
34
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 PROCEDURES
Within the 90 days prior to the date of the filing of this annual report, 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, summarized and reported timely. In designing and evaluating the
disclosure controls and procedures, management recognized 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 judgment 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.
There have been no significant changes in our internal controls or other
factors, which could significantly affect internal controls subsequent to the
date of the evaluation. Therefore, no corrective actions were taken.
ITEM 16
RESERVED
PART III
ITEM 17
FINANCIAL STATEMENTS
The registrant has responded to Item 18 in lieu of responding to this item.
ITEM 18
FINANCIAL STATEMENTS
35
ITEM 19
EXHIBITS
EXHIBIT NO. DESCRIPTION OF EXHIBIT
----------- ----------------------
1.1 Certification by Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
1.2 Certification by Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
1.3 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.
1.4 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.
36
EXHIBIT 1.1
CERTIFICATION PURSUANT TO
SECTION 302(a) OF THE SARBANES-OXLEY ACT OF 2002
I, Ronan O'Caoimh, certify that:
1. I have reviewed this annual report on Form 20-F of Trinity Biotech plc;
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this annual
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this annual report;
4. The registrant's other certifying officers and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this annual report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls and
procedures as of a date within 90 days prior to the filing date of this annual
report (the "Evaluation Date"); and
c) presented in this annual report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of the
Evaluation Date;
5. The registrant's other certifying officers and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit committee of
registrant's board of directors (or persons performing the equivalent function):
a) all significant deficiencies in the design or operation of internal controls
which could adversely affect the registrant's ability to record, process,
summarize and report financial data and have identified for the registrant's
auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal controls; and
6. The registrant's other certifying officers and I have indicated in this
annual report whether or not there were significant changes in internal controls
or in other factors that could significantly affect internal controls subsequent
to the date of our most recent evaluation, including any corrective actions with
regard to significant deficiencies and material weaknesses.
Date: June 30, 2003
/s/ Ronan O'Caoimh*
-----------------------
Ronan O'Caoimh
Chief Executive Officer
* The originally executed copy of this Certification will be maintained at the
Company's offices and will be made available for inspection upon request.
EXHIBIT 1.2
CERTIFICATION PURSUANT TO
SECTION 302(a) OF THE SARBANES-OXLEY ACT OF 2002
I, Rory Nealon, certify that:
1. I have reviewed this annual report on Form 20-F of Trinity Biotech plc;
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this annual
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this annual report;
4. The registrant's other certifying officers and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this annual report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls and
procedures as of a date within 90 days prior to the filing date of this annual
report (the "Evaluation Date"); and
c) presented in this annual report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of the
Evaluation Date;
5. The registrant's other certifying officers and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit committee of
registrant's board of directors (or persons performing the equivalent function):
a) all significant deficiencies in the design or operation of internal controls
which could adversely affect the registrant's ability to record, process,
summarize and report financial data and have identified for the registrant's
auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal controls; and
6. The registrant's other certifying officers and I have indicated in this
annual report whether or not there were significant changes in internal controls
or in other factors that could significantly affect internal controls subsequent
to the date of our most recent evaluation, including any corrective actions with
regard to significant deficiencies and material weaknesses.
Date: June 30, 2003
/s/ Rory Nealon *
-----------------------
Rory Nealon
Chief Financial Officer
* The originally executed copy of this Certification will be maintained at the
Company's offices and will be made available for inspection upon request.
EXHIBIT 1.3
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of Trinity Biotech plc (the "Company") on
Form 20-F for the period ending December 31, 2002 as filed with the Securities
and Exchange Commission on the date hereof (the "Report"), I, Ronan O'Caoimh,
Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002,
that:
(1) The Report fully complies with the requirements of section 13(a) or
15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all
material respects, the financial condition and result of operations of the
Company.
/s/ Ronan O'Caoimh *
-----------------------
Ronan O'Caoimh
Chief Executive Officer
June 30, 2003
*The originally executed copy of this Certification will be maintained at the
Company's offices and will be made available for inspection upon request.
EXHIBIT 1.4
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of Trinity Biotech plc (the "Company") on
Form 20-F for the period ending December 31, 2002 as filed with the Securities
and Exchange Commission on the date hereof (the "Report"), I, Rory Nealon, Chief
Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or
15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all
material respects, the financial condition and result of operations of the
Company.
/s/ Rory Nealon *
-----------------------
Rory Nealon
Chief Financial Officer
June 30, 2003
*The originally executed copy of this Certification will be maintained at the
Company's offices and will be made available for inspection upon request.
REPORT OF INDEPENDENT AUDITORS
To: The Board of Directors of Trinity Biotech plc
We have audited the consolidated balance sheets of Trinity Biotech plc as of
December 31, 2002 and 2001 and the related consolidated statements of income,
total recognized gains and losses, movement in shareholders' equity and cash
flows for each of the three years in the period ended December 31, 2002. Our
audits also included the financial statement schedule listed in the Index 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 Irish Auditing Standards issued by
the Auditing Practices Board and auditing standards in the United States. Those
standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free from material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the consolidated financial position of Trinity
Biotech plc at December 31, 2002 and 2001, and the consolidated results of its
operations and its cash flows for each of the three years in the period ended
December 31, 2002, in conformity with accounting principles generally accepted
in the Republic of Ireland, which differ in certain respects from those followed
in the United States (see note 28 of Notes to 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 /s/ Ernst & Young
April 17, 2003 Ernst & Young
Registered Auditors
37
CONSOLIDATED BALANCE SHEETS
As at As at
December 31 December 31
2002 2001
Notes US$ US$
----- ----------- -----------
ASSETS
Inventories 2 20,362,389 16,342,308
Accounts receivable and prepayments 3 12,494,467 7,684,575
Cash and cash equivalents 5,768,401 5,281,976
----------- -----------
38,625,257 29,308,859
Intangible assets, net 4 39,605,251 40,402,394
Property, plant & equipment, net 5 9,878,818 5,967,443
Financial assets 6 1,158,245 1,350,517
----------- -----------
TOTAL ASSETS 89,267,571 77,029,213
----------- -----------
LIABILITIES & SHAREHOLDERS' EQUITY
Accounts payable and accrued expenses 7 18,350,165 12,570,405
Provisions for liabilities and charges (Deferred tax) 263,722 122,000
Long term liabilities 8 7,745,442 7,805,237
SHAREHOLDERS' EQUITY
Called up share capital
Class 'A' Ordinary shares 10 597,840 591,165
Class 'B' Ordinary shares 10 12,255 12,255
Share premium account 75,886,015 75,132,118
Currency adjustment (4,448,404) (5,054,186)
Profit and loss reserve 12(a) (9,449,410) (14,459,727)
----------- -----------
Shareholders' equity - (all equity interests) 62,598,296 56,221,625
Minority interest - (all equity interests) 12(b) 309,946 309,946
----------- -----------
62,908,242 56,531,571
----------- -----------
Total Liabilities and Shareholders' Equity 89,267,571 77,029,213
----------- -----------
See Notes to Consolidated Financial Statements
38
CONSOLIDATED STATEMENTS OF INCOME
Year ended December 31
2002 2001 2000
Notes US$ US$ US$
----- ----------- ----------- -----------
Revenues
- Continuing operations 47,448,756 36,662,278 25,017,178
- Acquisitions 15 4,531,000 402,295 4,725,764
----------- ----------- -----------
13 51,979,756 37,064,573 29,742,942
Cost of sales (26,368,693) (18,146,765) (15,401,257)
----------- ----------- -----------
Gross profit 25,611,063 18,917,808 14,341,685
Research & development expenses (4,470,745) (2,779,729) (2,681,220)
Administrative expenses - normal (14,682,008) (10,307,812) (5,157,504)
Administrative expenses - exceptional 16 -- (3,650,000) (1,287,000)
----------- ----------- -----------
Operating profit
- Continuing operations 6,399,283 4,989,119 3,969,890
- Acquisitions 59,027 (2,808,852) 1,246,071
----------- ----------- -----------
13 6,458,310 2,180,267 5,215,961
Share of operating loss in associate (300,000) (195,000) (30,000)
Interest receivable and similar income 57,133 142,364 466,151
Interest payable and similar charges (705,625) (472,283) (704,847)
----------- ----------- -----------
Profit on ordinary activities before taxation 14 5,509,818 1,655,348 4,947,265
Tax on profit on ordinary activities 17 (499,501) (206,000) (123,800)
----------- ----------- -----------
Retained profit for the financial period 5,010,317 1,449,348 4,823,465
----------- ----------- -----------
Basic earnings per ordinary share (US cents) 18 12.36 3.59 12.99
Diluted earnings per ordinary share (US cents) 18 11.99 3.52 12.20
Movements on reserves are shown in the "Consolidated Statements of Movement in
Shareholders' Equity".
CONSOLIDATED STATEMENTS OF TOTAL RECOGNISED GAINS AND LOSSES
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Profit for the financial period attributable to
group shareholders excluding share of loss in associate 5,310,317 1,644,348 4,853,465
Share of operating loss in associate (300,000) (195,000) (30,000)
Currency adjustment 605,782 148,951 (565,653)
----------- ----------- -----------
Total recognised gains and losses for the period 5,616,099 1,598,299 4,257,812
----------- ----------- -----------
See Notes to Consolidated Financial Statements
39
CONSOLIDATED STATEMENTS OF MOVEMENT IN SHAREHOLDERS' EQUITY
Class 'A' Ordinary Shares Class 'B' Ordinary Shares
Share Share
capital capital
US$0.0109 US$0.0109 Share
Number of each Number of each premium
shares US$ shares US$ US$
---------- --------- --------- --------- -----------
Authorised 75,000,000 817,500 700,000 12,255
---------- ------- ------- ------
Issued:
Balance as at December 31, 1999 28,905,832 447,974 700,000 12,255 47,863,861
---------- ------- ------- ------ -----------
Class 'A' shares issued for cash 4,239,198 59,755 -- -- 13,825,122
Class 'A' shares issued on conversion of debenture 1,041,667 14,839 -- -- 1,860,161
Class 'A' shares issued on exercise of warrant 100,000 1,425 -- -- 178,576
Options exercised 2,784,496 39,667 -- -- 7,476,347
Class 'A' shares issued as consideration in
business acquisition 1,834,431 26,131 -- -- 5,327,156
Class 'A' shares issued for financial asset 67,872 761 -- -- 185,684
Share issue expenses -- -- -- -- (1,474,799)
Currency adjustment -- -- -- -- --
Retained profit -- -- -- -- --
---------- ------- ------- ------ -----------
Balance as at December 31, 2000 38,973,496 590,552 700,000 12,255 75,242,108
---------- ------- ------- ------ -----------
Options exercised 43,250 613 -- -- 73,531
Share issue expenses -- -- -- -- (183,521)
Currency adjustment -- -- -- -- --
Retained profit -- -- -- -- --
---------- ------- ------- ------ -----------
Balance as at December 31, 2001 39,016,746 591,165 700,000 12,255 75,132,118
---------- ------- ------- ------ -----------
Shares issued for cash 443,900 4,839 -- -- 539,984
Options exercised 12,334 134 -- -- 13,741
Class 'A' shares issued for financial asset 156,189 1,702 -- -- 200,172
Currency adjustment -- -- -- -- --
Retained profit -- -- -- -- --
---------- ------- ------- ------ -----------
Balance as at December 31, 2002 39,629,169 597,840 700,000 12,255 75,886,015
---------- ------- ------- ------ -----------
Retained Currency Goodwill
profit adjustment reserve Total
US$ US$ US$ US$
---------- ---------- ----------- -----------
Authorised
Issued:
Balance as at December 31, 1999 1,044,143 (4,637,484) (21,776,683) 22,954,066
---------- ---------- ----------- -----------
Class 'A' shares issued for cash -- -- -- 13,884,877
Class 'A' shares issued on conversion of debenture -- -- -- 1,875,000
Class 'A' shares issued on exercise of warrant -- -- -- 180,001
Options exercised -- -- -- 7,516,014
Class 'A' shares issued as consideration in 5,353,287
business acquisition -- -- -- 186,445
Class 'A' shares issued for financial asset -- -- -- (1,474,799)
Share issue expenses -- -- -- (565,653)
Currency adjustment -- (565,653) -- 4,823,465
Retained profit 4,823,465 -- --
---------- ---------- ----------- -----------
Balance as at December 31, 2000 5,867,608 (5,203,137) (21,776,683) 54,732,703
---------- ---------- ----------- -----------
Options exercised -- -- -- 74,144
Share issue expenses -- -- -- (183,521)
Currency adjustment -- 148,951 -- 148,951
Retained profit 1,449,348 -- -- 1,449,348
---------- ---------- ----------- -----------
Balance as at December 31, 2001 7,316,956 (5,054,186) (21,776,683) 56,221,625
---------- ---------- ----------- -----------
Shares issued for cash -- -- -- 544,823
Options exercised -- -- -- 13,875
Class 'A' shares issued for financial asset -- -- -- 201,874
Currency adjustment -- 605,782 -- 605,782
Retained profit 5,010,317 -- -- 5,010,317
---------- ---------- ----------- -----------
Balance as at December 31, 2002 12,327,273 (4,448,404) (21,776,683) 62,598,296
---------- ---------- ----------- -----------
See Notes to Consolidated Financial Statements
40
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year ended December 31
2002 2001 2000
Notes US$ US$ US$
----- ------------ ---------- -----------
Net cash inflow from operating activities 20 3,873,391 5,630,748 3,224,126
------------ ---------- -----------
Returns on investments and servicing of finance
Interest received 57,133 142,364 466,149
Interest paid (695,489) (369,312) (663,466)
Finance interest paid (9,037) (23,424) (41,381)
------------ ---------- -----------
Net cash outflow from returns on investments and servicing of finance (647,393) (250,372) (238,698)
------------ ---------- -----------
Taxation
Taxation (paid)/refund (403,935) (319,510) 36,000
------------ ---------- -----------
Capital expenditure and financial investment
Purchase of tangible fixed assets 19 (2,516,982) (1,343,370) (1,173,921)
Purchase of intangible fixed assets (468,941) (986,502) (1,360,032)
------------ ---------- -----------
Net cash outflow from investing activities (2,985,923) (2,329,872) (2,533,953)
------------ ---------- -----------
Acquisitions and disposals
Acquisition of subsidiary undertakings -- (4,777,388) --
Payments to acquire trades or businesses (4,408,692) -- (7,822,352)
Purchase of associate undertaking -- (309,399) (1,185,197)
Deferred consideration paid -- -- (4,096,006)
------------ ---------- -----------
Net cash outflow for acquisitions and disposals (4,408,692) (5,086,787) (13,103,555)
------------ ---------- -----------
Net cash outflow before use of liquid resources and financing (4,572,552) (2,355,793) (12,616,080)
------------ ---------- -----------
Management of liquid resources 19 553,310 (2,373,316) 77,815
Financing
Loan from unconnected third party (163,213) (73,336) (1,071,014)
Issue of shares 558,698 74,144 21,580,892
Expenses paid in respect of share issues -- (183,521) (1,474,799)
Capital element of finance lease repayments (17,350) (310,076) (291,838)
(Decrease)/increase in long term debt (1,803,466) 4,829,963 (4,916,009)
(Decrease) in promissory note -- (350,000) --
Increase in other financial liabilities 3,984,308 -- --
Increase/(decrease) in convertible debentures 2,500,000 (625,000) --
------------ ---------- -----------
Net cash inflow from financing 5,058,977 3,362,174 13,827,232
------------ ---------- -----------
Increase/(decrease) in cash 1,039,735 (1,366,935) 1,288,967
------------ ---------- -----------
Reconciliation of net cash flow to movement in net debt
Increase/(decrease) in cash in the year 1,039,735 (1,366,935) 1,288,967
Decrease/(increase) in long term debt 1,803,466 (4,829,963) 4,916,009
Increase in other financial liabilities (3,984,308) -- --
(Issue)/redemption of convertible debentures (2,500,000) 625,000 --
Long term debt acquired -- -- (1,300,000)
(Decrease)/increase in liquid resources (553,310) 2,373,316 (77,815)
Capital element of finance lease repayments 17,350 310,076 291,838
------------ ---------- -----------
Change in net debt resulting from cash flows (4,177,067) (2,888,506) 5,118,999
------------ ---------- -----------
New finance leases -- -- (175,659)
Conversion of debentures -- -- 1,875,000
Promissory notes paid/(issued) -- 350,000 (350,000)
------------ ---------- -----------
Movement in net debt in the year (4,177,067) (2,538,506) 6,468,340
Net debt at January 1 (4,382,293) (1,843,787) (8,312,127)
------------ ---------- -----------
Net debt at December 31 21 (8,559,360) (4,382,293) (1,843,787)
------------ ---------- -----------
41
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002
1. ACCOUNTING POLICIES
The financial statements have been prepared in United States Dollars
under the historical cost convention and are in accordance with
generally accepted accounting principles 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" and/or "the Company") and its
subsidiary 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 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.
(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 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 3 and 20 years. The carrying value of intangibles is
reviewed annually by the directors to determine whether there should be
a reduction to reflect any permanent diminution 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 10 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 and 15 years
respectively. Negative goodwill 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) Investments
The Company classifies long and short term marketable investment
securities and certain investments as either "held to maturity",
"trading" or "available for sale". Realised gains and losses are
determined using specific identification. Debt securities which the
Company has the positive intent and ability to hold to maturity are
classified as "held to maturity" securities and reported at amortised
cost. Equity securities which the Company has the positive intent and
ability to hold for the long term are classified as "long-term
securities" and reported at cost.
Debt and equity securities which are bought and held principally for
the purpose of selling them in the near term are classified as
"trading" securities and reported at fair value, with realised gains
and losses included in income for the period.
Debt and equity securities not classified as either "held to maturity"
or "trading" securities are classified as "available for sale"
securities and reported at fair value, with unrealised gains or losses
reported in a separate component of shareholders' equity.
42
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
1. ACCOUNTING POLICIES (Continued)
(f) Inventories
Inventories are stated at the lower of cost and 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.
(g) 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 average tax rates
substantially enacted at the balance sheet date which are expected to
apply in the periods in which the 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
liabilities are not discounted
(h) 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.
(i) Pension Costs
The Group operates a defined contribution pension scheme. Contributions
to the scheme are expensed as incurred.
(j) 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.
Depreciation 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 "operating leases" and the rentals
thereunder are charged to the income statement on a straight line basis
over the periods of the leases.
(k) 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.
(l) Foreign Currency
The functional currency of the Company is the United States Dollar. As
of January 1 1998, the Company changed its functional currency from the
Irish Pound to the United States 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.
(m) Liquid Resources
Liquid resources are current asset investments, which are held as
readily disposable stores of value. Liquid resources include
investments in equity investments and short term deposits.
(n) Use of estimates
The preparation of financial statements in conformity with generally
accepted accounting principles 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.
43
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
1. ACCOUNTING POLICIES (Continued)
(o) Companies Acts, 1963 to 2001
The financial information relating to the Company and its subsidiary
undertakings included in this document does not comprise statutory
financial statements as referred to in Section 19 of the Companies
(Amendment) Act, 1986, copies of which are required by that Act to be
annexed to the Company's annual return lodged with the Registrar of
Companies. The auditors have made reports without qualification under
Section 193 of the Irish Companies Act, 1990 in respect of all such
financial statements. Copies of statutory financial statements of
Trinity Biotech plc for years up to and including the year ended
December 31, 2001 have been so annexed to the relevant annual returns.
(p) Cost of Sales
Cost of sales comprises the product cost including shipping, handling
and packaging costs.
(q) 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$236,859,
US$30,000 and US$31,850 as at December 31, 2002, 2001 and 2000
respectively.
(r) Financial instruments
Financial instruments include (i) borrowings, (ii) cash deposits and
liquid resources and (iii) interest and forward contracts.
Derivatives, principally forward foreign exchange contracts, are used
to manage the working capital requirements of the Group in a cost
effective, low-risk manner. Working capital management is a key element
in the effective management of overall liquidity.
Where derivatives are used to hedge cross-currency cash flows arising
from trading activities, the underlying transaction is recorded at the
contract rate.
2. INVENTORIES
December 31 December 31
2002 2001
US$ US$
----------- -----------
Raw materials 5,930,871 5,120,345
Work in progress 6,360,177 7,014,487
Finished goods 8,071,341 4,207,476
---------- ----------
20,362,389 16,342,308
---------- ----------
The replacement cost of inventory is not materially different from the
cost stated above.
3. ACCOUNTS RECEIVABLE AND PREPAYMENTS
(Amounts falling due within one year)
December 31 December 31
2002 2001
US$ US$
----------- -----------
Accounts receivable 9,953,528 5,247,014
Prepayments 1,032,038 973,135
Value Added Tax 159,736 155,858
Called up share capital not paid 260,203 291,211
Grants receivable 504,480 290,389
Other receivables 121,482 187,568
Deferred tax asset (see note 9) 463,000 539,400
---------- ----------
12,494,467 7,684,575
---------- ----------
44
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
4. INTANGIBLE ASSETS
December 31 December 31
2002 2001
US$ US$
----------- -----------
Cost
Patents and licenses 4,889,791 4,420,850
Goodwill (see note 22) 41,632,292 40,588,001
----------- -----------
46,522,083 45,008,851
Less accumulated amortisation (6,916,832) (4,606,457)
----------- -----------
39,605,251 40,402,394
----------- -----------
5. PROPERTY, PLANT AND EQUIPMENT
December 31 December 31
2002 2001
Cost US$ US$
----------- -----------
Land & buildings 4,229,485 1,636,350
Leasehold improvements 1,213,153 677,234
Computer & office equipment 2,740,273 1,825,634
Plant and equipment 8,194,774 7,221,485
----------- -----------
16,377,685 11,360,703
Less accumulated depreciation (6,498,867) (5,393,260)
----------- -----------
9,878,818 5,967,443
----------- -----------
A mortgage amounting to US$167,406 is secured by a charge over the
plant in Jamestown, New York.
Included in the net book value of tangible fixed assets is an amount
for capitalised leased assets of US$944,352 (2001: US$826,127). The
depreciation charge in respect of capitalised leased assets for the
year ended December 31, 2002 was US$110,345 (2001: US$111,512).
6. FINANCIAL ASSETS
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Investment in associate (see below) 1,158,245 1,350,517 1,341,642
--------- --------- ---------
On October 2, 2000, the Company acquired 33% of the share capital of
HiberGen Limited for a total consideration of US$1,371,642. On July 2,
2001 the Company subscribed for a further 300,000 Ordinary Shares of
E.0.0127 each in HiberGen Limited, increasing its shareholding to
40%, at a cost of US$309,399. 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$201,874
was satisfied by the issue of 156,189 'A' Ordinary Shares in Trinity
Biotech plc.
The carrying amount of the investment in the associate is split as
follows:
December 31 December 31
2002 2001
US$ US$
----------- -----------
Share of net assets of associate on acquisition 118,220 71,883
Goodwill arising on acquisition 1,764,695 1,609,158
Accumulated amortisation (199,670) (105,524)
Share of operating loss in associate (525,000) (225,000)
---------- ----------
1,158,245 1,350,517
---------- ----------
45
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
7. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
(Amounts falling due within one year)
December 31 December 31
2002 2001
US$ US$
----------- -----------
Accounts payable 2,979,095 1,713,775
Income tax deducted under PAYE 81,810 57,441
Employee related social insurance 81,960 56,539
Corporate income taxes 305,134 427,690
Accrued liabilities 3,321,626 2,385,205
Accrued exceptional charges -- 2,850,000
Accrued royalties 532,621 408,812
Obligations under finance leases 196,858 185,575
Financial liabilities from unconnected third party - current portion 4,041,506 220,411
Long term debt - current portion 1,978,155 2,409,757
Deferred consideration - current portion 3,831,400 855,200
6.0/7.5% convertible debenture (see note 8) 1,000,000 1,000,000
---------- ----------
18,350,165 12,570,405
---------- ----------
In December 2001, the Company acquired the assets and goodwill of the
Biopool hemostasis business. Under the terms of the purchase agreement
US$2,591,500 of the total consideration of US$6,409,329 has been
deferred. The deferred consideration of US$2,591,500 was payable in
three instalments of US$855,200, US$1,166,200 and US$570,100 on
December 21, 2002, 2003 and 2004 respectively. At December 31, 2002,
US$2,021,400 of the deferred consideration for the Biopool hemostasis
business is included in current liabilities under deferred
consideration.
In November 2002, the Company acquired the speciality clinical
chemistry product line from Sigma Diagnostics for a total consideration
of US$4,436,188 satisfied in cash and deferred consideration. This
deferred consideration of US$1,810,000 is payable in two instalments of
US$1,010,000 and US$800,000 on May 27 and November 27, 2003
respectively and is included in current liabilities under deferred
consideration.
As at December 31, 2002 the undrawn portion of existing banking
facilities amounted to US$2,170,242.
8. LONG TERM LIABILITIES
(Amounts falling due after more than one year)
December 31 December 31
2002 2001
US$ US$
----------- -----------
5.25% convertible debenture 2,500,000 --
Bank loans (secured, see note 23(h)) 4,655,785 6,027,649
Deferred consideration 570,100 1,736,300
Lease creditors 12,655 41,288
Other creditors 6,902 --
--------- ---------
7,745,442 7,805,237
--------- ---------
The age profile of the Group's long-term debt, excluding obligations
under finance leases, is as follows:
December 31 December 31
2002 2001
US$ US$
----------- -----------
In more than one year, but not more than two 2,065,750 2,919,734
In more than two years, but not more than three 1,466,965 2,019,898
In more than three years, but not more than four 1,055,071 1,422,726
In more than four years, but not more than five 3,073,491 1,254,776
In more than five years 71,510 146,815
--------- ---------
7,732,787 7,763,949
--------- ---------
In December 1999, the Company completed a private placement of
US$3,500,000 principal amount of 7.5% convertible debentures. The
debentures bore interest at a rate of 7.5% per annum which was payable
semi-annually. The debentures were convertible, at the option of the
holder, into Class 'A' Ordinary Shares of the Company at a price of
US$1.80. During 2000, US$1,875,000 of the US$3,500,000 principal amount
of the debenture was converted into 1,041,667 Class 'A' Ordinary Shares
of the Company. During 2001, US$625,000 of the remaining balance of the
debenture was redeemed. The remaining balance of the principal amount
was rolled over in November 2002 at an annual interest rate
46
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
8. LONG TERM LIABILITIES (Continued)
of 6% and a conversion price of US$1.50. The convertible debenture
matures on December 31, 2005 and is payable on demand from May 31,
2003.
In November 2002, the Company completed a private placement of
US$2,500,000 principal amount of 5.25% convertible debentures (see Note
22). 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. Since the year end, US$1,800,000 of the US$2,500,000 of the
principal amount of the debentures was converted into 1,200,000 Class
'A' Ordinary Shares of the Company. The balance of the convertible
debentures is repayable from January 2004 and matures on July 2, 2007.
As at December 31, 2002 payments falling due under finance leases of
less than one year's duration amounted to US$196,858 (2001:
US$185,575). As at December 31, 2002 obligations under finance leases
of between two and five years' duration amounted to US$12,655 (2001:
US$41,288). There were no payments falling due extending beyond five
years.
9. DEFERRED TAXATION
December 31 December 31
2002 2001
US$ US$
----------- -----------
At beginning of year (417,000) (240,000)
Charge to profit and loss account (see note 17) 217,722 122,000
Credit to profit and loss account (see note 17) -- (299,000)
-------- --------
At end of year (199,278) (417,000)
-------- --------
Deferred taxation represents the following:
Capital allowances in excess of related depreciation 281,433 217,000
Other timing differences (480,711) (634,000)
-------- --------
(199,278) (417,000)
-------- --------
10. CALLED UP SHARE CAPITAL (Refer to Consolidated Statements of Movement
in Shareholders' Equity)
(a) In December 1999, the Company completed a private placement of
US$3,500,000 principal amount of 7.5% convertible debentures. During
2000, US$1,875,000 of the US$3,500,000 principal amount of the
debentures was converted into 1,041,667 Class 'A' Ordinary Shares of
the Company. During 2001, US$625,000 of the remaining balance of the
debenture was redeemed. The remaining balance of the principal amount
was rolled over in November 2002 at an annual interest rate of 6% and a
conversion price of US$1.50. The convertible debenture matures on
December 31, 2005 and is payable on demand from May 31, 2003.
(b) In November 2002, the Company completed a private placement of
US$2,500,000 principal amount 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. Since the year end, US$1,800,000 of the US$2,500,000 of the
principal amount of the debentures was converted into 1,200,000 Class
'A' Ordinary Shares of the Company. The balance of the convertible
debentures matures on July 2, 2007.
(c) On April 3, 2002, the Company acquired a further 165,000 Ordinary
Shares in its associate HiberGen Limited. The consideration of
US$201,874 was satisfied by the issue of 156,189 'A' Ordinary Shares in
Trinity Biotech plc.
(d) In December 2002, Enterprise Ireland subscribed for 443,900 'A'
Ordinary Shares in the Company (see note 23(e)).
(e) 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.
(f) The AGM held on May 28, 2001, approved a resolution for the
renominalisation of the Company's share capital from Irish Pound
0.01 each to US$0.0109 each.
47
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
10. CALLED UP SHARE CAPITAL (Continued)
(g) Since its incorporation the Company has not declared or paid dividends
on its 'A' Ordinary Shares. The Company anticipates, for the
foreseeable future, that it will retain any future earnings in order to
fund its business operations. The Company does not, therefore,
anticipate paying any cash or share dividends on its 'A' Ordinary
Shares in the foreseeable future.
As provided in the Articles of Association of the Company, dividends or
other distributions will be declared and paid in US Dollars.
11. SHARE OPTIONS AND WARRANTS
Under the terms of the Company's Employee Share Option Plan options to
purchase 8,781,174 Class 'A' Ordinary Shares were outstanding at
December 31, 2002. Under the plan, options are granted to officers,
employees and consultants of the Group at the discretion of the
remuneration committee of the board. In addition, the Company granted
warrants to purchase 940,405 Class 'A' Ordinary Shares in the Company
to agents of the Company who were involved in the Company's private
placements in 1994 and 1995 and the debenture issues in 1997, 1999 and
2002. A further warrant to purchase 100,000 Class 'A' Ordinary Shares
was also granted to a consultant of the Company. At December 31, 2002
there were warrants to purchase 553,525 Class 'A' Ordinary Shares in
the Company outstanding.
The share options and warrants outstanding at December 31, 2002 were as
follows:
Options & Warrants
Shares Range
Outstanding US$
---------- ---------
January 1, 2000 4,884,472 0.81-5.00
Granted 4,112,194 1.75-4.00
Exercised (2,884,496) 0.81-4.00
Cancelled (243,467) 1.00-4.00
---------- ---------
December 31, 2000 5,868,703 0.81-5.00
Granted 2,039,500 0.98-1.20
Exercised (43,250) 1.00-2.00
---------- ---------
December 31, 2001 7,864,953 0.81-5.00
Granted 2,223,500 0.98-1.50
Exercised (12,334) 1.13
Cancelled (741,420) 0.98-2.78
---------- ---------
December 31, 2002 9,334,699 0.81-5.00
---------- ---------
12. PROFIT AND LOSS RESERVE/MINORITY INTEREST
(a) Profit and loss reserve
December 31 December 31
2002 2001
US$ US$
----------- -----------
Accumulated surplus 12,327,273 7,316,956
Goodwill reserve (21,776,683) (21,776,683)
----------- -----------
(9,449,410) (14,459,727)
----------- -----------
Due to the adoption of Financial Reporting Standard No. 10 by the
Company, the goodwill reserve is disclosed as part of the profit and
loss reserve on the face of the balance sheet. This adoption does not
affect the potential distributable reserves of the Company.
48
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
12. PROFIT AND LOSS RESERVE/MINORITY INTEREST (Continued)
(b) Minority interest
December 31 December 31
2002 2001
US$ US$
----------- -----------
Minority interest 309,946 309,946
------- -------
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, is
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. Since the year end this option has
been exercised.
In these circumstances it is considered that the injection of these
funds is in the nature of quasi equity. The Group does have obligations
to transfer economic benefits at the end of the investment period. This
obligation is limited to a maximum of E.330,200 being E.1.32 per
share. Accordingly, the Group has continued to consolidate Benen as a
100% subsidiary undertaking and the proceeds (after deducting share
issue costs and expenses) of the investment have been credited to
minority interest.
13. 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
three reportable segments, Ireland, the United States and the rest of
Europe, which are based on a geographical split. 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
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Ireland 23,969,561 13,518,075 14,410,284
United States 28,010,195 23,546,498 15,332,658
---------- ---------- ----------
51,979,756 37,064,573 29,742,942
---------- ---------- ----------
Revenue is attributed to geographic 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
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
U.S.A 33,512,898 25,046,609 17,282,005
Europe 11,899,290 6,879,597 7,197,185
Middle East/Africa 4,396,270 3,900,154 4,047,205
Other overseas 2,171,298 1,238,213 1,216,547
---------- ---------- ----------
51,979,756 37,064,573 29,742,942
---------- ---------- ----------
d) It is not deemed practical to present an analysis of revenue by major
product group.
49
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
13. ANALYSIS OF REVENUE, OPERATING INCOME, MAJOR CUSTOMERS AND ASSETS
(Continued)
e) The distribution of intersegmental sales was as follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Ireland 21,449,346 12,178,904 11,918,545
Ireland - intersegmental sales 18,365,780 13,732,096 12,224,323
United States 28,010,195 23,546,498 15,332,659
Less intercompany sales (15,845,565) (12,392,925) (9,732,585)
----------- ----------- -----------
51,979,756 37,064,573 29,742,942
----------- ----------- -----------
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.
f) The distribution of operating income by geographical area was as
follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- ----------
Ireland 3,729,361 (179,902) 1,906,242
United States 2,728,949 2,360,169 3,309,719
--------- ---------- ---------
Total operating income 6,458,310 2,180,267 5,215,961
--------- ---------- ---------
g) The distribution of consolidated total assets by geographical area was
as follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- ----------
Ireland 55,432,377 54,468,833 46,520,110
Rest of Europe 5,876,572 --
United States 27,958,622 22,353,480 20,710,562
---------- ---------- ----------
Total assets 89,267,571 77,029,213 67,230,672
---------- ---------- ----------
h) The distribution of consolidated long-lived assets by geographical
area was as follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Ireland 36,145,378 36,066,960 29,311,638
Rest of Europe 2,776,911 --
United States 11,720,835 11,597,729 11,260,967
---------- ---------- ----------
Total long-lived assets 50,643,124 47,720,354 40,572,605
---------- ---------- ----------
50
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
13. ANALYSIS OF REVENUE, OPERATING INCOME, MAJOR CUSTOMERS AND ASSETS
(Continued)
i) The concentrations of revenues to customers representing 10% or more of
total revenues was as follows:
December 31 December 31 December 31
2002 2001 2000
----------- ----------- -----------
Customer A 20% 27% 30%
j) The distribution of depreciation and amortisation by geographical area
was as follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Ireland 2,392,874 1,908,221 1,224,478
Rest of Europe 19,220 2,655 --
United States 1,098,034 763,445 736,248
--------- --------- ---------
Total depreciation and amortisation 3,510,128 2,674,321 1,960,726
--------- --------- ---------
k) The distribution of unusual items by geographical area was as follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Europe -- -- --
United States -- (3,650,000) (1,287,000)
------- ---------- ----------
Total unusual items -- (3,650,000) (1,287,000)
------- ---------- ----------
l) The analysis of interest by geographical area was as follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Ireland (608,915) (244,759) (305,569)
United States (96,710) (227,524) (399,278)
-------- -------- --------
Total interest (705,625) (472,283) (704,847)
-------- -------- --------
51
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
14. PROFIT ON ORDINARY ACTIVITIES
BEFORE TAXATION
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
The profit on ordinary activities before taxation is stated
after charging/(crediting)
Directors' emoluments:
Remuneration 1,165,171 953,841 949,116
Pension 94,706 59,157 56,456
Auditors' remuneration:
Audit fees 170,000 170,000 84,000
Non audit fees 20,000 25,377 --
Depreciation 1,105,607 845,186 657,436
Amortisation 2,404,521 1,829,135 1,303,290
Operating lease rentals:
Plant and machinery 26,048 -- --
Other 1,444,623 942,495 773,837
Research and development grants -- -- (18,467)
Employment grants (214,091) -- --
Settlement of litigation (see note below) -- (1,360,971) --
Transfer technology fee provision -- 555,000 --
Other non-recurring charges -- 357,447 --
---------- ---------- ----------
Trinity and Selfcare entered into a settlement in 2001 whereby Selfcare
paid Trinity US$1,500,000 and Trinity (i) conveyed to Selfcare its
rights in an HIV I/II RTD product licence and (ii) agreed to supply
certain antigens at cost for a ten-year period, pursuant to an Antigen
Supply Agreement.
15. ACQUISITIONS
On August 27, 2002 Trinity Biotech purchased the Hemostasis division of
Sigma Diagnostics and on November 27, 2002 the Company also acquired
the speciality clinical chemistry product line from Sigma Diagnostics.
The results of these acquisitions for 2002 are incorporated from the
date of acquisition in the profit and loss account for the year ended
December 31, 2002.
On October 19, 2001 Trinity Biotech purchased the Amerlex hormone
business of Ortho Clinical Diagnostics and on December 21, 2001 the
Company acquired the assets and goodwill of the Biopool Hemostasis
business. The results of these acquisitions for 2001 are incorporated
from the date of acquisition in the profit and loss account for the
year ended December 31, 2001.
On December 8, 2000, the Group purchased the assets and goodwill of
Bartels Inc, based in Seattle, Washington. As no audited financial
statements were available for the acquired business in the period prior
to the acquisition, the directors used the fair values established at
the time of the acquisition to derive the following approximate results
of the entity from the date of acquisition to December 31, 2000. The
results of Bartels are incorporated into continuing operations in the
years ended December 31, 2001 and 2002.
December 31
2000
US$
-----------
Sales 465,871
Cost of sales (82,000)
--------
383,871
========
52
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
16. ADMINISTRATIVE EXPENSES - EXCEPTIONAL ITEMS
An exceptional charge of US$2,850,000 was incurred during 2001 relating
to the acquisition of the assets and goodwill of the Biopool hemostasis
business on December 21, 2001. The principal components of this charge
were commitments on the acquisition of the assets and goodwill of the
Biopool hemostasis business to make payments to employees.
An exceptional charge of US$800,000 was also incurred during 2001
relating to the acquisition of Bartels Inc on December 8, 2000. This
charge comprised payments to employees so as to ensure the effective
transfer of the business from Seattle to Dublin. A similar exceptional
charge of US$1,287,000 arose in 2000 relating to commitments on
acquisition to make payments to employees. There were no exceptional
charges recognised in 2002.
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Administrative expenses
-Exceptional -- 3,650,000 1,287,000
----------- ----------- -----------
17. INCOME TAXES
(a) The charge for taxation based on the profit on ordinary
activities, comprises:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Current tax
Corporation tax at 16% (2001: 20%, 2000: 24%) 49,662 380,000 129,120
Manufacturing relief (18,623) (190,000) (75,320)
----------- ----------- -----------
31,039 190,000 53,800
Overseas tax 597,862 193,000 310,000
Overprovision in respect of prior year (347,122) -- --
----------- ----------- -----------
Total current tax 281,779 383,000 363,800
Deferred tax
Origination and reversal of timing differences 217,722 (177,000) (240,000)
----------- ----------- -----------
Total taxation on profit on ordinary activities 499,501 206,000 123,800
----------- ----------- -----------
Effective tax rate
Profit on ordinary activities before taxation 5,509,818 1,655,348 4,947,265
As a percentage of profit before tax
Current tax 5.1% 23.1% 7.4%
Total tax (current and deferred) 9.1% 12.4% 2.5%
The following table relates the applicable Republic of Ireland
statutory tax rate to the effective current tax rate of the Group:
2002 2001 2000
% of profit % of profit % of profit
before taxation before taxation before taxation
--------------- --------------- ---------------
Irish corporation tax 16.0 20.0 24.0
Manufacturing relief (0.3) (11.5) (1.5)
Tax rates on overseas earnings 5.1 3.9 1.3
Overprovision in respect of prior year (6.3) -- --
Other mainly expenses not deductible for tax purposes (9.4) 10.7 (16.4)
------------- ------------- -------------
5.1 23.1 7.4
------------- ------------- -------------
(b) The distribution of profit on ordinary activities before taxes by
geographical area was as follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Ireland 2,383,053 (330,612) 2,036,824
United States 2,644,968 2,200,662 2,910,441
Rest of Europe 481,797 (214,702) --
----------- ----------- -----------
Total profits before taxation 5,509,818 1,655,348 4,947,265
----------- ----------- -----------
53
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
17. INCOME TAXES (Continued)
(c) The tax effects of temporary differences that give rise to
significant portions of deferred tax assets relate principally to
net operating losses. There was no valuation allowance for
deferred tax assets at December 31, 2002, 2001 or 2000.
(d) At December 31, 2002, the Group had Irish net operating losses of
approximately US$382,000 (2001: approximately US$382,000). The
utilisation of these net operating loss carryforwards was limited
to offset against the future profits earned by the Group arising
from the same trade and in the tax jurisdiction in which they
arose.
At December 31, 2002, the Group had U.S. net operating loss
carryforwards of approximately US$775k for US federal income tax
purposes, which will expire in 2008 if not previously utilised.
Utilisation of the U.S. net operating loss carryforward may be
subject to an annual limitation due to the change in ownership
rules provided by the Internal Revenue Code of 1986. This
limitation and other restrictions provided by the Internal Revenue
Code of 1986 may reduce the net operating loss carryforward such
that it would not be available to offset future taxable income of
the US subsidiaries.
18. EARNINGS PER ORDINARY SHARE
(a) Basic earnings per ordinary share
Earnings per ordinary share is computed by dividing the profit on
ordinary activities after taxation of US$5,010,317 (December 31, 2001,
US$1,449,348 and December 31, 2000, US$4,823,465) for the financial
year by the weighted average number of ordinary shares in issue of
40,550,367 (December 31, 2001 - 40,408,978 and December 31, 2000 -
37,131,692).
(b) Diluted earnings per ordinary share
Diluted earnings per ordinary share is computed by dividing the profit
on ordinary activities after taxation of US$5,010,317 (December 31,
2001, US$1,449,348 and December 31, 2000, US$4,823,465) for the
financial year, adjusted for debenture interest saving of US$85,829
(December 31, 2001 US$nil and December 31, 2000 US$121,875) by the
diluted weighted average number of ordinary shares in issue of
42,486,227 (December 31, 2001, 41,120,930 and December 31, 2000,
40,540,494). The basic weighted average number of shares may be
reconciled to the number used in the diluted earnings per ordinary
share calculation as follows:
December 31 December 31 December 31
2002 2001 2000
----------- ----------- -----------
Basic earnings per share denominator 40,550,367 40,408,978 37,131,692
Issuable on exercise of options 1,214,703 711,952 2,506,024
Issuable on conversion of debentures 721,157 -- 902,778
----------- ----------- -----------
Diluted earnings per share denominator 42,486,227 41,120,930 40,540,494
----------- ----------- -----------
No adjustment is included for debenture conversion for 2001 as the
impact would have been anti-dilutive.
19. SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
(a) Purchase of tangible fixed assets
Additions to tangible fixed assets 2,516,982 1,343,370 1,349,580
Less new finance leases -- -- (175,659)
--------- --------- ---------
2,516,982 1,343,370 1,173,921
--------- --------- ---------
(b) Management of liquid resources
Cash flows from the use of liquid resources in 2002 arose from the
movement of cash from fixed deposit accounts.
Cash flows from the use of liquid resources in 2001 arose from the
movement of cash to fixed deposit accounts.
Cash flows from the use of liquid resources in 2000 arose from the sale
of equity investments of US$127,500, less the purchase of equity
investments of US$49,685.
(c) Impact of acquisitions on cash flow headings
As the working capital of the acquired businesses was fully integrated
within the Group at year end, post acquisition operating cash flows are
not readily obtainable. The operating results of the hemostasis
division and the speciality clinical chemistry product line of Sigma
Diagnostics acquired on August 27 and November 27, 2002 respectively
contributed US$59,027 to the operating profit of the Group.
54
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
19. SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION (Continued)
The cash outflow of US$4,408,692 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 10).
The operating results of the Amerlex hormone business of Ortho Clinical
Diagnostics acquired on October 19, 2001 contributed US$41,148 to the
net cash inflow from operating activities of the Group.
20. RECONCILIATION OF OPERATING December 31 December 31 December 31
PROFIT TO NET CASH INFLOW 2002 2001 2000
FROM OPERATING ACTIVITIES US$ US$ US$
----------- ----------- -----------
Operating profit 6,458,310 2,180,267 5,215,961
Depreciation and amortisation 3,510,128 2,674,321 1,960,726
Disposal of investments -- -- (37,465)
Exceptional administrative expenses (2,850,000) 2,850,000 1,287,000
(Increase)/decrease in receivables and prepayments (4,137,160) 1,525,800 1,074,798
Increase/(decrease) in accounts payable 2,381,143 (1,818,268) (1,209,806)
Increase in inventory (2,094,812) (1,930,323) (4,501,435)
Translation adjustments 605,782 148,951 (565,653)
----------- ----------- -----------
Net cash inflow from operating activities 3,873,391 5,630,748 3,224,126
=========== =========== ===========
21. ANALYSIS OF NET DEBT
December 31 Cash flow Acquisitions/ Non-cash Exchange December 31
2001 disposals changes movements 2002
US$ US$ US$ US$ US$ US$
----------- ----------- ------------- ----------- ----------- -----------
Cash 2,014,844 1,039,735 -- -- -- 3,054,579
Liquid resources 3,267,132 (553,310) -- -- -- 2,713,822
----------- ----------- ----------- ----------- ----------- -----------
5,281,976 486,425 -- -- -- 5,768,401
Long term debt
- current portion (2,409,757) 431,602 -- -- -- (1,978,155)
Long term debt (6,027,649) 1,371,864 -- -- -- (4,655,785)
Other financial liabilities -- (3,984,308) -- -- -- (3,984,308)
Finance leases (226,863) 17,350 -- -- -- (209,513)
Convertible debentures (1,000,000) (2,500,000) -- -- -- (3,500,000)
----------- ----------- ----------- ----------- ----------- -----------
Net debt (4,382,293) (4,177,067) -- -- -- (8,559,360)
----------- ----------- ----------- ----------- ----------- -----------
December 31 Cash flow Acquisitions/ Non-cash Exchange December 31
2000 disposals changes movements 2001
US$ US$ US$ US$ US$ US$
----------- ----------- ------------ ----------- ----------- -----------
Cash 3,381,779 (1,366,935) -- -- -- 2,014,844
Liquid resources 893,816 2,373,316 -- -- -- 3,267,132
----------- ----------- ----------- ----------- ----------- -----------
f 4,275,595 1,006,381 -- -- -- 5,281,976
Long term debt
- current portion (2,574,185) 164,428 -- -- -- (2,409,757)
Long term debt (1,033,258) (4,994,391) -- -- -- (6,027,649)
Finance leases (536,939) 310,076 -- -- -- (226,863)
Convertible debentures (1,625,000) 625,000 -- -- -- (1,000,000)
Promissory note (350,000) 350,000 -- -- -- --
----------- ----------- ----------- ----------- ----------- -----------
Net debt (1,843,787) (2,538,506) -- -- -- (4,382,293)
----------- ----------- ----------- ----------- ----------- -----------
55
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
21. ANALYSIS OF NET DEBT (Continued)
December 31 Cash flow Acquisitions/ Non-cash Exchange December 31
1999 disposals changes movements 2000
US$ US$ US$ US$ US$ US$
----------- ----------- ------------- ----------- ----------- -----------
Cash 2,092,812 1,288,967 -- -- -- 3,381,779
Liquid resources 971,631 (77,815) -- -- -- 893,816
----------- ----------- ----------- ----------- ----------- -----------
3,064,443 1,211,152 -- -- -- 4,275,595
Long term debt
- current portion (2,967,595) 737,160 (343,750) -- -- (2,574,185)
Long term debt (4,255,857) 4,178,849 (956,250) -- -- (1,033,258)
Finance leases (653,118) 291,838 -- (175,659) -- (536,939)
Convertible debentures (3,500,000) -- -- 1,875,000 -- (1,625,000)
Promissory note -- -- -- (350,000) -- (350,000)
----------- ----------- ----------- ----------- ----------- -----------
Net debt (8,312,127) 6,418,999 (1,300,000) 1,349,341 -- (1,843,787)
----------- ----------- ----------- ----------- ----------- -----------
22. ACQUISITION OF BUSINESSES
On August 27, 2002 Trinity Biotech purchased the hemostasis division of
Sigma Diagnostics for a total consideration of US$1,422,802. The
consideration was satisfied in cash. Acquisition expenses amounted to
US$73,499. On November 27, 2002 the Company also acquired the
speciality clinical chemistry product line from Sigma Diagnostics for a
total consideration of US$4,436,188 satisfied in cash and deferred
consideration. The cash consideration was partly financed by the issue
of US$2.5m of convertible debentures (see note 10). The deferred
consideration of US$1,810,000 is payable in two instalments of
US$1,010,000 and US$800,000 on May 27 and November 27, 2003
respectively. The deferred consideration is not conditional on any
future event. Total acquisition expenses amounted to US$86,188.
Sigma Sigma Total
Hemostasis Clinical
Chemistry
US$ US$ US$
---------- --------- ---------
Tangible fixed assets 2,500,000 -- 2,500,000
Working capital 206,462 625,269 831,731
---------- --------- ---------
Net assets at fair value 2,706,462 625,269 3,331,731
Goodwill (1,283,660) 3,810,919 2,527,259
---------- --------- ---------
Consideration 1,422,802 4,436,188 5,858,990
---------- --------- ---------
Satisfied by:
Cash payments including costs 1,422,802 2,626,188 4,048,990
---------- --------- ---------
Net cash outflow 1,422,802 2,626,188 4,048,990
Deferred consideration -- 1,810,000 1,810,000
---------- --------- ---------
Consideration 1,422,802 4,436,188 5,858,990
---------- --------- ---------
56
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
22. ACQUISITION OF BUSINESSES (Continued)
Goodwill capitalised during the year in respect of acquired businesses
amounted to US$2,527,259 and comprises:
Fair
Book Value Fair
Values Adjustment Value Consideration Goodwill
US$ US$ US$ US$ US$
----------- ---------- ---------- ------------- ----------
SIGMA HEMOSTASIS
Tangible fixed assets 1,321,652 1,178,348* 2,500,000
Working capital 8,457,883 (8,251,421)* 206,462
----------- ---------- ---------- ---------- ----------
9,779,535 (7,073,073) 2,706,462 (1,422,802) 1,283,660
----------- ---------- ---------- ---------- ----------
SIGMA CLINICAL CHEMISTRY
Working capital 1,490,593 (865,324)* 625,269
----------- ---------- ---------- ---------- ----------
1,490,593 (865,324) 625,269 (4,436,188) (3,810,919)
----------- ---------- ---------- ---------- ----------
Total 11,270,128 (7,938,397) 3,331,731 (5,858,990) (2,527,259)
----------- ---------- ---------- ---------- ----------
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.
On October 19, 2001 the Group purchased the Amerlex hormone business of
Ortho Clinical Diagnostics for a total consideration of US$877,797. The
consideration was satisfied in cash. Acquisition expenses amounted to
US$94,860. On December 21, 2001 the Group acquired the assets and
goodwill of the Biopool hemostasis business for a total consideration
of US$6,409,329 satisfied in cash and deferred consideration. The
deferred consideration of US$2,591,500 is payable in three instalments
of US$855,200, US$1,166,200 and US$570,100 on December 21, 2002, 2003
and 2004 respectively. The deferred consideration is not conditional on
any future event. Total acquisition expenses amounted to US$159,329.
Ortho Biopool Total
US$ US$ US$
---------- ---------- ----------
Working capital -- (136,000) (136,000)
---------- ---------- ----------
Net assets/(liabilities) at fair value -- (136,000) (136,000)
Goodwill 877,797 6,545,329 7,423,126
---------- ---------- ----------
Consideration 877,797 6,409,329 7,287,126
---------- ---------- ----------
Satisfied by:
Cash payments including costs 877,797 3,817,829 4,695,626
---------- ---------- ----------
Net cash outflow 877,797 3,817,829 4,695,626
Deferred consideration -- 2,591,500 2,591,500
---------- ---------- ----------
Consideration 877,797 6,409,329 7,287,126
---------- ---------- ----------
57
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
22. ACQUISITION OF BUSINESSES (Continued)
Goodwill capitalised during 2001 in respect of acquired businesses
amounted to US$7,423,126 and comprises:
Fair
Book Value Fair
Values Adjustment Value Consideration Goodwill
US$ US$ US$ US$ US$
---------- ---------- ---------- ------------- ----------
ORTHO
-- -- -- (877,797) (877,797)
---------- ---------- ---------- ---------- ----------
BIOPOOL
Working capital 3,022,000 (3,158,000)* (136,000)
---------- ---------- ---------- ---------- ----------
3,022,000 (3,158,000) (136,000) (6,409,329) (6,545,329)
---------- ---------- ---------- ---------- ----------
Total 3,022,000 (3,158,000) (136,000) (7,287,126) (7,423,126)
---------- ---------- ---------- ---------- ----------
The book values of the assets and liabilities 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:
* Write-down of inventories and receivables following an assessment of
the realisable value of inventories and the collectability of
receivables.
On February 29, 2000 the Group purchased Mardx Diagnostics Inc for a
total consideration of US$4,208,279. The consideration was satisfied by
cash and the issue of 'A' Ordinary Shares. Acquisition expenses
amounted to US$244,992. On December 8, 2000 the Group acquired the
assets and goodwill of Bartels Inc for a total consideration of
US$9,463,974 satisfied by cash, the issue of 'A' Ordinary Shares and a
promissory note. Total acquisition expenses amounted to US$158,874.
Mardx Bartels Total
US$ US$ US$
---------- ----------- -----------
Tangible fixed assets 72,306 -- 72,306
Working capital 660,458 750,000 1,410,458
Long-term debt (956,250) -- (956,250)
---------- ----------- -----------
Net assets/(liabilities) at fair value (223,486) 750,000 526,514
Goodwill 4,431,765 8,713,974 13,145,739
---------- ----------- -----------
Consideration 4,208,279 9,463,974 13,672,253
---------- ----------- -----------
Satisfied by:
Cash payments including costs 2,044,992 5,923,974 7,968,966
---------- ----------- -----------
Net cash outflow 2,044,992 5,923,974 7,968,966
Promissory Note -- 350,000 350,000
Issue of 'A' Ordinary Shares 2,163,287 3,190,000 5,353,287
---------- ----------- -----------
Consideration 4,208,279 9,463,974 13,672,253
---------- ----------- -----------
58
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
22. ACQUISITION OF BUSINESSES (Continued)
Goodwill capitalised during 2000 in respect of acquired businesses
amounted to US$13,145,739 and comprised:
Fair
Book Value Fair
Values Adjustment Value Consideration Goodwill
US$ US$ US$ US$ US$
----------- ----------- ----------- ------------- -----------
MARDX
Tangible fixed assets 572,306 (500,000)* 72,306
Working capital 910,458 (250,000)* 660,458
Long-term debt (956,250) -- (956,250)
----------- ----------- -----------
526,514 (750,000) (223,486) (4,208,279) (4,431,765)
----------- ----------- ----------- ----------- -----------
BARTELS
Working capital 959,478 (209,478)* 750,000
----------- ----------- -----------
959,478 (209,478) 750,000 (9,463,974) (8,713,974)
----------- ----------- ----------- ----------- -----------
Total 1,485,992 (959,478) 526,514 (13,672,253) (13,145,739)
----------- ----------- ----------- ----------- -----------
The book value of the assets and liabilities shown above have been
taken from management accounts and other information of the acquired
businesses at the date of acquisition.
* The fair value adjustments above principally arise for the following
reasons: Write-down of fixed assets, inventories and receivables
following an assessment of the continuing economic contribution of
fixed assets, the realisable value of inventories and the
collectability of accounts receivable.
Following the completion of the fair value exercises in 2001 in respect
of the acquisitions made during 2000, amendments have been made to the
fair values reported in the 2000 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
2000 2001 2001 2001
US$ US$ US$ US$
----------- ------------- ----------- -----------
MARDX
Tangible fixed assets 72,306 -- -- 72,306
Working Capital 660,458 -- -- 660,458
Long-term debt (956,250) -- -- (956,250)
----------- ----------- ----------- -----------
Net assets (223,486) -- -- (223,486)
----------- ----------- ----------- -----------
Consideration and costs (4,208,279) -- -- (4,208,279)
----------- ----------- ----------- -----------
BARTELS
Working capital 750,000 127,090 -- 877,090
----------- ----------- ----------- -----------
Consideration and costs (9,463,974) -- (81,762) (9,545,736)
----------- ----------- ----------- -----------
59
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
23. COMMITMENTS AND CONTINGENCIES
(a) Capital Commitments
The capital commitments of the Group were as follows:
31 December 31 December 31 December
2002 2001 2000
US$ US$ US$
----------- ----------- -----------
Contracted for -- -- --
Authorised, not contracted for -- -- 400,000
----------- ----------- -----------
-- -- 400,000
----------- ----------- -----------
(b) Operating lease commitments payable during the next twelve months
amount to US$1,529,849 (2001: US$936,101) payable on leases of
buildings at Dublin and Bray, Ireland, Umea, Sweden, St. Louis,
Missouri, upstate New York and Carlsbad, California and plant and
machinery in Lemgo, Germany. US$30,452 of the operating lease
commitments total relates to leases whose remaining term will expire
within one year, US$149,845 relates to leases whose remaining term
expires between one and two years, US$711,425 between two and five
years and the balance of US$638,127 relates to leases which expire
after more than five years.
Future minimum operating and finance lease commitments with non
cancellable terms in excess of one year are as follows:
Operating Leases Finance Leases
US$ US$
---------------- --------------
2003 1,529,849 196,858
2004 1,571,874 12,655
2005 1,365,166 --
2006 954,445 --
Later years 8,239,907 --
Interest element of finance leases -- --
----------- -----------
13,661,241 209,513
----------- -----------
(c) Under agreements between the Group and Enterprise Ireland, grants
amounting to US$504,480 (2001: US$290,389) are receivable which may be
revoked, cancelled or abated in certain circumstances.
(d) Under agreements between the Group and Enterprise Ireland, a loan
amounting to US$57,198 (2001: US$220,411) is payable which may be
required to be repaid immediately in certain circumstances.
(e) Under an agreement reached in November 2000, between the Group and
Enterprise Ireland, grants of US$605,680 are payable in the event of
predefined employment targets being achieved. As part of this
agreement, Enterprise Ireland could subscribe for 'A' Ordinary Shares
of the Company up to a value of E.1,097,054 at a share price 10%
below the market price of the Company's shares. In December 2000
Enterprise Ireland subscribed E.548,527 of this amount for 239,198
'A' Ordinary Shares of the Company. In December 2002 Enterprise Ireland
subscribed the remaining E.548,527 for 443,900 'A' Ordinary Shares
of the Company.
(f) At December 31, 2002 the Company has guaranteed the borrowings of
subsidiary undertakings to the amount of US$2,776,343.
(g) Pursuant to the provisions of Section 17, Companies (Amendment) Act,
1986, the Company has guaranteed the liabilities of Trinity Biotech
Manufacturing Limited, a subsidiary undertaking in the Republic of
Ireland, for the financial year to December 31, 2002 and, as a result,
this subsidiary undertaking has been exempted from the filing
provisions of Section 7, Companies (Amendment) Act, 1996.
(h) The Company's bank borrowings are secured by a fixed and floating
charge over the assets of the Company. The Company has also given
security over certain US assets, subordinate to other banking
arrangements, to Xtrana Inc relating to the deferred consideration due
as part of the acquisition of the Biopool hemostasis business.
60
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
23. COMMITMENTS AND CONTINGENCIES (Continued)
(i) 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 is seeking US$1.2m in damages and US$3m 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$57m in damages. The Company believes that this countersuit is
without merit and is vigorously pursuing its litigation against Xtrana.
24. 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 Company 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.
25. 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$522,797 (December 31, 2001, US$583,065 and December 31, 2000,
US$547,475). 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.
26. 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 E7.62 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 E28,568 per annum
over adjacent lands with JRJ. On November 20, 2002 the Company signed
an agreement for lease with JRJ for offices that are currently being
constructed on part of these lands. The lease is expected to commence
in quarter three 2003 on terms similar to that for the current
extension. 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.
27. 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 utilization 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$8,407,045
(2001: US$4,375,840) at interest rates ranging from 2.30% to 7.41% and
including US$3,985,362 of fixed rate debt at interest rates ranging
from 5% to 7.50% (2001: US$1,309,607 at interest rates ranging from 5%
to 7.50%). In broad terms, a one-percentage point increase in interest
rates would increase the net interest charge by US$101,329 (2001:
US$81,000).
61
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
27. DERIVATIVES AND FINANCIAL INSTRUMENTS (Continued)
LIQUIDITY RISK
The Group's operations are cash generating. Short term flexibility is
achieved with overdraft facilities.
FOREIGN EXCHANGE RISK
The vast bulk 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 formalised treasury policy which aims to sell US Dollars
forward to match 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$2,050,827 at December 31, 2002.
The disclosures below exclude short term accounts receivable and
payable
INTEREST RATE PROFILE OF FINANCIAL LIABILITIES
The interest rate profile of financial liabilities of the Group was as
follows:
December 31 December 31
2002 2001
US$ US$
----------- -----------
Financial liabilities on which no interest is paid 57,198 220,411
Floating rate financial liabilities 10,132,886 8,127,798
Fixed rate financial liabilities 3,985,362 1,309,607
----------- -----------
14,175,446 9,657,816
----------- -----------
Financial liabilities, on which no interest is paid, comprise loans
from unconnected third parties and have a weighted average period until
maturity of 1 year.
Floating rate financial liabilities comprise overdrafts and other
borrowings that bear interest at rates of between 2.30% and 7.41%.
These overdrafts and borrowings are provided by financial institutions
at margins ranging from 1% to 3.50% over interbank rates.
December 31 December 31
Fixed rate financial liabilities 2002 2001
----------- -----------
- weighted average interest rate 5.50% 7.26%
- weighted average period for which rate is fixed 3.78 years 1.72 years
MATURITY OF FINANCIAL LIABILITIES
The maturity profile of the Group's financial liabilities was as
follows:
December 31 December 31
2002 2001
US$ US$
----------- -----------
In one year or less, or on demand 7,019,661 3,630,167
In more than one year, but not more than two 1,488,748 1,753,534
In more than two years, but not more than five 5,595,527 4,127,300
In more than five years 71,510 146,815
----------- -----------
14,175,446 9,657,816
----------- -----------
FAIR VALUES OF FINANCIAL 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, 2002. At December 31, 2002 forward contracts with a
carrying value of US$Nil had a fair value of US$711,352.
28. 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
accounting principles generally accepted in the United States ("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
income statement on a systematic basis over its useful economic life.
From 1998, goodwill must be capitalised and amortised over the
62
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN IRELAND AND IN THE UNITED STATES (Continued)
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,
except for goodwill arising on acquisitions after 30 June 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 US 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 will no longer be
amortised under US GAAP, but will be subject to annual impairment tests
in accordance with the statements. 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 the Group performed a further
impairment test of goodwill and indefinite-lived intangible assets and
concluded that there was no impairment in the carrying value of these
assets at this date.
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. Under US GAAP,
negative goodwill would be allocated to reduce proportionately the
values assigned to the acquired non-current assets.
Net Income and earnings per share for the years ended December 31,
2002, 2001 and 2000, adjusted to exclude amortization of goodwill is as
follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
Reported net income under US GAAP 5,225,804 293,816 1,667,958
SFAS No.142 effect - Goodwill -- 3,775,136 3,417,858
-------------- -------------- -------------
Adjusted net income 5,225,804 4,068,952 5,085,816
Reported basic earnings per share (US cents) 12.89 0.73 4.49
SFAS No.142 effect - Goodwill -- 9.34 9.20
-------------- -------------- -------------
Adjusted basic earnings per share (US cents) 12.89 10.07 13.69
Reported diluted earnings per share (US cents) 12.50 0.71 4.11
SFAS No.142 effect - Goodwill -- 8.99 8.43
-------------- -------------- -------------
Adjusted diluted earnings per share (US cents) 12.50 9.70 12.54
Identifiable intangible assets comprise goodwill, which is not
amortizable and certain intangible other non-current assets, which are
amortizable. Other non-current asset amortization under US GAAP for the
years ended December 31, 2002, 2001 and 2000 was US$138,886, US$115,175
and US$27,367 respectively. Other non-current amortization under US
GAAP is estimated to be approximately US$138,022 in 2003, US$203,978 in
2004, US$199,152 in 2005, US$193,358 in 2006, and US$185,714 in 2007,
and US$839,599 thereafter.
63
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN IRELAND AND IN THE UNITED STATES (Continued)
(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, 2002, is US$260,203 (2001 : US$291,211).
(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. 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$1,014,080 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).
(f) Minority Interests:
Under Irish GAAP, minority interests are included as a portion of
Shareholders' Equity. Under US GAAP, minority interests are excluded
from Shareholders' Equity.
(g) Sales on Extended Credit Terms:
In 2000 the Company made certain sales on extended credit terms.
Under US GAAP, SAB 101 "Revenue Recognition in Financial
Statements", such sales on extended credit terms would not be
recognisable as revenue until 2001. No similar provisions exist
under Irish GAAP to preclude revenue recognition. Sales were not
made on extended credit terms in 2001 or 2002.
64
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN IRELAND AND IN THE UNITED STATES (Continued)
(h) Restructuring Costs:
Under Irish GAAP, certain provisions made for restructuring costs
(principally payments to employees) incurred as a result of
acquisitions and expensed immediately would not be recognisable
under US GAAP, because EITF 95-3, "Recognition of Liabilities in
Connection with a Purchase Business Combination", would also not
permit such costs to be included in the purchase price allocation
but contains more stringent criteria for expense recognition, and
such restructuring costs will be expensed in the subsequent period.
(i) Research and Development:
Under US GAAP, 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.
(j) Stock-based compensation expense:
US GAAP, as set forth in APB 25 and SFAS 123 "Accounting for
Stock-Based Compensation", and FIN 44 "Accounting for Certain
Transactions Involving Stock Compensation" requires stock options
issued to non-employees to be valued at fair value and compensation
cost to be recognised based on that fair value.
(k) Derivatives and financial instruments
In June 1998, the FASB issued SFAS No 133 "Accounting for Derivative
Instruments and Hedging Activities". SFAS 133 requires that (for US
GAAP purposes only) 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.
65
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN IRELAND AND IN THE UNITED STATES (Continued)
CUMULATIVE EFFECT ON SHAREHOLDERS' EQUITY December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
Total shareholders' equity before
minority interests under Irish GAAP 62,598,296 56,221,625 54,732,703
US GAAP adjustments:
Goodwill 10,503,303 8,098,782 10,265,482
Share capital not paid (260,203) (291,211) (278,525)
Adjustment for sale and leaseback (861,968) (912,672) (963,376)
Adjustment for sales on extended credit -- -- (35,000)
Adjustment for restructuring costs -- 2,850,000 1,222,203
Adjustment for research and development costs (2,327,444) (1,910,083) (1,028,373)
Adjustment for fair value of derivative instruments 711,352 14,585 --
Deferred tax 626,720 293,876 (55,916)
------------- ------------- -------------
Shareholders' equity under US GAAP 70,990,056 64,364,902 63,859,198
------------- ------------- -------------
EFFECT ON NET PROFIT December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
Profit on ordinary activities after taxation
under Irish GAAP 5,010,317 1,449,348 4,823,465
US GAAP adjustments:
Goodwill amortisation 2,404,521 (2,166,700) (2,141,935)
Adjustment for sale and leaseback 50,704 50,704 50,704
Adjustment for sales on extended credit -- 35,000 (35,000)
Adjustment for restructuring costs (2,850,000) 1,627,797 1,222,203
Adjustment for research and development costs (417,361) (881,710) (1,028,373)
Adjustment for stock compensation -- -- (909,062)
Adjustment for fair value of derivative instruments (14,585) 14,585 --
Deferred tax 1,042,208 164,792 (314,044)
------------ ------------ ------------
Profit under US GAAP 5,225,804 293,816 1,667,958
------------ ------------ ------------
Profit per ordinary share (US cents) 12.89 0.73 4.49
Diluted profit per ordinary share (US cents) 12.50 0.71 4.11
Weighted average number of ordinary shares used
in computing basic earnings per ordinary share 40,550,367 40,408,978 37,131,692
Diluted weighted average number of ordinary shares
used in computing diluted profit per ordinary share 42,486,227 41,120,930 40,540,494
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
Profit under US GAAP 5,225,804 293,816 1,667,958
Translation adjustment 605,782 148,951 (565,653)
Fair value of derivative instruments 711,352 -- --
------------- ------------- -------------
Total Comprehensive Income 6,542,938 442,767 1,102,305
------------- ------------- -------------
66
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002(CONTINUED)
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN IRELAND AND IN THE UNITED STATES (Continued)
Year ended
Consolidated Statements of Cash Flows December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
Operating Activities
Net profit under Irish GAAP 5,010,317 1,449,348 4,823,465
Adjustments to reconcile net profit to cash
provided by operating activities:
Depreciation and amortisation 3,510,128 2,674,321 1,960,726
Taxation (paid)/refund (403,935) (319,510) 36,000
Share of operating loss in associate 300,000 195,000 30,000
Provision for corporation tax charge 499,501 206,000 123,800
Net interest payable accrual 1,099 79,545 --
Disposal of investments -- -- (37,465)
Exceptional administrative expenses (2,850,000) 2,850,000 1,287,000
(Increase)/decrease in accounts receivable and prepayments (4,137,160) 1,525,800 1,074,798
Increase/(decrease) in accounts payable & accrued expenses 2,381,143 (1,818,268) (1,209,806)
Increase in inventory (2,094,812) (1,930,323) (4,501,435)
Translation adjustments 605,782 148,951 (565,653)
------------ ------------ ------------
Net cash inflow from operating activities 2,822,063 5,060,864 3,021,430
------------ ------------ ------------
Investing activities
Acquisition of subsidiary undertakings -- (4,777,388) --
Payments to acquire trades or businesses (4,408,692) -- (7,822,352)
Purchase of associate undertaking -- (309,399) (1,185,197)
Deferred consideration paid -- -- (4,096,006)
Payment for patents and deferred development costs (468,941) (986,502) (1,360,032)
Payment for tangible fixed assets (2,516,982) (1,343,370) (1,173,921)
------------ ------------ ------------
Net cash outflow from investing activities (7,394,615) (7,416,659) (15,637,508)
------------ ------------ ------------
Financing Activities
Loan from unconnected third party (163,213) (73,336) (1,071,014)
Issue of ordinary share capital including premium 558,698 74,144 21,580,892
Expenses paid in connection with share issue -- (183,521) (1,474,799)
(Decrease)/increase in long term debt (1,803,466) 4,829,963 (4,916,009)
Capital element of finance lease payments (17,350) (310,076) (291,838)
Increase/(decrease) in convertible debentures 2,500,000 (625,000) --
Decrease in promissory note -- (350,000) --
Increase in other financial liabilities 3,984,308 -- --
------------ ------------ ------------
Net cash inflow from financing 5,058,977 3,362,174 13,827,232
------------ ------------ ------------
Increase in cash and cash equivalents 486,425 1,006,379 1,211,154
Cash and cash equivalents at beginning of year 5,281,976 4,275,597 3,064,443
------------ ------------ ------------
Cash and cash equivalents at end of year 5,768,401 5,281,976 4,275,597
------------ ------------ ------------
67
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN IRELAND AND IN THE UNITED STATES (Continued)
NON CASH TRANSACTIONS
In December 2000, the Group acquired the assets and goodwill of Bartels
Inc, for a consideration of US$9,463,974 comprising US$3,190,000 in
stock, US$5,923,974 in cash and the balance of US$350,000 in the form
of a promissory note. This promissory note was settled in full during
the second quarter of 2001. This transaction relates to the Irish
reportable segment.
In December 2001, the Group acquired the assets and goodwill of the
Biopool hemostasis business for a total consideration of US$6,409,329
satisfied in cash and deferred consideration. The deferred
consideration was payable in three instalments of US$855,200,
US$1,166,200 and US$570,100 on December 21, 2002, 2003 and 2004
respectively. The deferred consideration is not conditional on any
future event. This transaction relates to the Irish reportable segment.
In November 2002, the Company acquired the speciality clinical
chemistry product line from Sigma Diagnostics for a total consideration
of US$4,436,188 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.
On April 3, 2002, the Company acquired a further 165,000 Ordinary
Shares in its associate HiberGen Limited. The consideration of
US$201,874 was satisfied by the issue of 156,189 'A' Ordinary Shares in
Trinity Biotech plc.
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.
The debentures bear interest at the rate of 7.5% per annum, payable
quarterly. US$2,500,000 of the principal amount originally matured on
December 18, 2001 with the remaining US$1,000,000 maturing on December
18, 2002. The debentures are convertible into 'A' Ordinary Shares of
the Company at a price of US$1.80. During 2000, US$1,875,000 of the
US$3,500,000 principal amount of the debentures was converted into
1,041,667 Class 'A' Ordinary Shares of the Company. During 2001,
US$625,000 of the remaining balance of the debentures was redeemed. The
remaining balance of the principal amount was rolled over in November
2002 at an annual interest rate of 6% and a conversion price of
US$1.50.
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. The balance of
these warrants expired unexercised on June 25 2002. The Second Warrants
are each exercisable to purchase one 'A' Ordinary Share in the Company
at US$1.50 per share. The Second Warrants expire in November 2007.
68
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN IRELAND AND IN THE UNITED STATES (Continued)
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 FASB Statement No. 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 US GAAP reconciliation over
the vesting period.
Proforma information regarding net income and earnings per share is
required by Statement 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:
2002 2001 2000
Expected option life (years) 4.0 3.0 4.2
Risk-free weighted average interest rate 2.3% 4.5% 5.5%
Stock price volatility 0.411 0.620 0.869
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
For purposes of proforma disclosures, the estimated fair value of the
options is amortised to expense over the options' vesting period. The
Company's proforma information follows:
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
Proforma net profit/(loss) 3,800,456 (955,903) (220,421)
Proforma earnings/(loss) per share (US cents) 9.37 (2.37) (0.59)
Proforma diluted earnings/(loss) per share (US cents) 9.15 (2.37) (0.59)
69
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN IRELAND AND IN THE UNITED STATES (Continued)
A summary of the Company's stock option activity, and related
information, for the years ended December 31 follows:
2002 Weighted-Average 2001 Weighted-Average 2000 Weighted-Average
Options Exercise Price Options Exercise Price Options Exercise Price
Outstanding-beginning of year 7,864,953 $1.57 5,868,703 $1.78 4,884,472 $1.39
Granted 2,223,500 $1.10 2,039,500 $1.02 4,112,194 $2.88
Exercised (12,334) $1.13 (43,250) $1.71 (2,884,496) $2.73
Forfeited (741,420) $1.80 -- -- (243,467) $3.02
Outstanding-end of year 9,334,699 $1.44 7,864,953 $1.57 5,868,703 $1.78
Exercisable at end of year 3,927,771 $1.56 2,899,339 $1.37 1,873,029 $1.34
Weighted average fair value
of options granted during the year $0.58 $0.56 $1.43
The weighted average remaining contractual life of options outstanding
at December 31, 2002 is 4.6 years.
A summary of the range of prices for the Company's stock options for
the year ended December 31 2002 follows:
OUTSTANDING EXERCISABLE
Weight. Av. Weight. Av.
Weight. Av. contractual Weight. Av. contractual
Option price range No. of Shares exercise price life remaining No. of Shares exercise price life remaining
$0.81 - $0.99 3,942,530 $0.94 5.3 years 825,030 $0.81 1.1 years
$1.00 - $1.99 3,646,534 $1.40 4.3 years 1,986,368 $1.35 3.5 years
$2.00 - $2.99 1,150,567 $2.35 2.8 years 808,017 $2.30 1.9 years
$3.00 - $5.00 595,068 $3.25 3.7 years 308,356 $3.99 2.7 years
INVESTMENTS
The Company had no trading securities as at December 31, 2002 or
December 31, 2001.
The gross realised gains on sales of trading securities during 2002 was
US$Nil (2001: US$Nil, 2000: US$37,465).
The Company had no "available for sale" or "held to maturity
securities" as at December 31, 2002 or December 31, 2001.
FAIR VALUES OF FINANCIAL INSTRUMENTS
The following methods and assumptions were used by the Company in
estimating its fair value disclosures for financial instruments:
Cash and cash equivalents: The carrying amount reported in the balance
sheet for cash and cash equivalents approximates its fair value.
Long and short-term debt: The carrying amounts of the Company's
borrowings approximate their fair value as substantially all of the
debt bears interest at market rates. In addition, debt originally due
for repayment over an average period of 3.78 years, has been
predominantly settled in 2003.
70
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN IRELAND AND IN THE UNITED STATES (Continued)
The carrying amounts and fair values of the Company's financial
instruments at December 31, 2002 and 2001 are as follows:
December 31, 2002 December 31, 2001
Carrying Fair Carrying Fair
Amount Value Amount Value
US$ US$ US$ US$
Cash and cash equivalents 5,768,401 5,768,401 5,281,978 5,281,978
Short term debt 7,216,519 7,216,519 3,630,167 3,630,167
Long term debt 7,168,440 7,168,440 6,027,649 6,027,649
Forward contracts -- 711,352 -- 14,585
ADDITIONAL PROFORMA INFORMATION FOR ACQUISITIONS MADE IN 2001 AND 2002
The information below presents the proforma effect of the acquisitions
made in 2000 as if they had occurred on January 1, 2000, the proforma
effect of the acquisitions made in 2001, as if they had occurred on
January 1, 2000 and the proforma effect of the acquisitions made in
2002, as if they had occurred on January 1, 2001.
December 31 December 31 December 31
2002 2001 2000
US$ US$ US$
Proforma revenues 63,352,500 63,585,202 49,524,670
Proforma net income 6,561,656 1,931,112 1,561,407
Proforma earnings per share (US cents) 16.18 4.78 4.21
Proforma diluted earnings per share (US cents) 15.65 4.70 3.85
The proforma information was compiled using extrapolations of the
results for the hemostasis division and speciality clinical chemistry
product line acquired from Sigma Diagnostics during 2002.
ACCOUNTING PRONOUNCEMENTS
Impairment or disposal of long-lived assets
In August 2001, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards No. 144, "Accounting for
the Impairment or Disposal of Long-Lived Assets" ("SFAS 144"), which
addresses financial accounting and reporting for the impairment or
disposal of long-lived assets and supersedes SFAS No. 121, "Accounting
for the Impairment of Long-Lived Assets and for Long-Lived Assets to be
Disposed Of", and the accounting and reporting provisions of APB
Opinion No. 30, "Reporting the Results of Operations for a Disposal of
a Segment of a Business". SFAS 144 is effective for fiscal years
beginning after December 15, 2001, with earlier application encouraged.
The Company has adopted SFAS 144 as of January 1, 2002. There was no
material impact to the Company from the adoption of this standard.
Business combinations/Goodwill and Other Intangible Assets
The impact of adoption of these pronouncements is discussed at Note
28(a)
Stock Compensation
In December 2002, the Financial Accounting Standards Board (FASB)
issued SFAS No. 148, "Accounting for Stock-Based Compensation", to
provide alternative methods of transition for a voluntary change to the
fair value based method of accounting for stock-based employee
compensation. In addition, SFAS 148 amends the disclosure requirements
of SFAS 123 to require prominent disclosures in both annual and interim
financial statements about the method of accounting for stock-based
employee compensation and of the effect of the method used on reported
results. The provisions of SFAS 148 are effective in fiscal years
ending after December 15, 2002 and interim periods beginning after
December 15, 2002. As of December 31, 2002, the Company has elected not
to change to the fair value based method of accounting for stock-based
employee compensation.
71
29. GROUP UNDERTAKINGS
Principal Country
Name and of incorporation Group
registered office Principal activity and operation % holding
Holding Company
Trinity Biotech plc Investment
IDA Business Park and holding
Bray, company Ireland
Co. Wicklow, Ireland
Subsidiary and Associate Undertakings
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
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
MarDx Diagnostics Inc Manufacture and U.S.A. 100%
5919 Farnsworth Court sale of diagnostic
Carlsbad test kits
CA 92008, USA
Flambelle Limited Non-trading Ireland 100%
16 Fitzwilliam Place
Dublin, Ireland
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
72
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2002 (CONTINUED)
29. GROUP UNDERTAKINGS (Continued)
Principal Country
Name and of incorporation Group
registered office Principal activity and operation % holding
Subsidiary and Associate Undertakings continued
Benen Trading Ltd Manufacture and Ireland 10%
IDA Business Park, Bray sale of diagnostic
Co. Wicklow, Ireland test kits
Reddinview Ltd Dormant company Ireland 100%
IDA Business Park, Bray
Co. Wicklow, Ireland
HiberGen Limited Genetic Variation Ireland 42.9%
IDA Business Park, Bray Detection
Co. Wicklow, Ireland
Trinity Biotech GmbH Sale of diagnostic Germany 100%
Otto Hesse Str 19 test kits
64293 Darmstadt, Germany
Biopool US Inc Manufacture and U.S.A. 100%
Girts Road sale of diagnostic
Jamestown test kits
NY 14702, USA
Biopool AB Manufacture and Sweden 100%
S-903 47 Umea sale of diagnostic
Sweden test kits
30. EVENTS SUBSEQUENT TO DATE OF AUDITORS' REPORT - UNAUDITED
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 and Xtrana settled this litigation. Pursuant
to the terms of the Settlement Agreement entered into between the
parties, Trinity agreed to pay Xtrana the amounts due on two promissory
notes of US$1,166,200 and US$570,100, together with interest thereon as
provided in the notes, less US$225,000, and less US$24,148.03, which
represented the amount due and owing by Xtrana to Trinity as of May 31,
2003 pursuant to a Letter Agreement, dated December 20, 2001, between
Trinity and Xtrana, relating to a third party. The total amount of the
settlement payment made by Trinity to Xtrana was US$1,505,942.10.
The parties also agreed that, following Xtrana's receipt of the
settlement payment, they would cause the litigation to be dismissed
with prejudice and without costs to any party. The parties also
released each other from any claims arising from or in connection with
the notes due from Trinity to Xtrana, the litigation, the security
agreements entered into between the parties, the Asset Purchase
Agreement made as of November 9, 2001 and any other matter whatsoever,
except for the parties executory obligations as set forth in the
settlement agreement.
73
SCHEDULE 2
TRINITY BIOTECH PLC.
VALUATION AND QUALIFYING ACCOUNTS
Balance at Charged to Charged to Balance
beginning costs and other at end
of period expenses accounts Deductions of period
US$ US$ US$ US$ US$
(a) (b)
2002
Doubtful debts 30,000 206,859 -- -- 236,859
2001
Doubtful debts 31,850 30,000 -- (31,850) 30,000
2000
Doubtful debts 88,822 31,850 -- (88,822) 31,850
(a) Amounts recovered during the year
(b) Amounts written off during the year
74
CONSENT OF ERNST & YOUNG INDEPENDENT AUDITORS
We consent to the incorporation by reference in the Registration Statements
(Form F-3 No. 333-13080, Form F-3 No. 333-7044, Form F-3 No. 333-11360 and the
Form F-3 No 333-103033 and the related prospectuses, of Trinity Biotech plc, and
in the Registration Statements (Form S-8 No. 33-76384 and Form S-8 No. 333-220)
pertaining to the Employee Share Option Plan of Trinity Biotech plc of our
report dated April 17, 2003 with respect to the consolidated financial
statements of Trinity Biotech plc included in the Annual Report (Form 20-F) for
the year ended December 31, 2002.
Dublin, Ireland /s/ Ernst & Young
June 30, 2003 Ernst & Young
Registered Auditors
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 authorized the undersigned to sign
this annual report on its behalf.
TRINITY BIOTECH PLC
By: /s/ RONAN O'CAOIMH
-------------------------------
Mr. Ronan O'Caoimh
Director/
Chief Executive Officer
Date: June 30, 2003
By: /s/ RORY NEALON
-------------------------------
Mr. Rory Nealon
Director/
Chief Financial Officer
Date: June 30, 2003
75