FORM 20-F
(Mark One)
|_| REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g)
OF THE SECURITIES EXCHANGE ACT OF 1934
OR
|X| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
|X|For the fiscal year ended: December 31, 2003
Commission file number: 0-22320
Trinity Biotech plc
...............................................................................
(Exact name of Registrant as specified in its charter)
Ireland
...............................................................................
(Jurisdiction of incorporation or organization)
IDA Business Park, Bray, Co. Wicklow, Ireland
.................................................................................
(Address of principal executive offices)
Securities registered or to be registered pursuant to Section 12 (b) of the Act:
None
.................................................................................
(Title of Class)
Name of each exchange on which registered:
None
.................................................................................
(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)
................................................................................
(Title of each class)
Securities for which there is a reporting obligation pursuant to Section 15 (d)
of the Act:
None
................................................................................
(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: 45,160,640 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...
This annual report on Form 20-F was not prepared for filing in Ireland in
compliance with Irish law or the listing rules of the Irish Stock Exchange.
Unless otherwise provided herein or required by the context, references to "we",
"us", "Trinity Biotech" or the "Company" in this annual report shall mean
Trinity Biotech plc and its world-wide subsidiaries, collectively.
We have a secondary listing on the Irish Stock Exchange. For this reason, we are
not subject to the same ongoing regulatory requirements as those which would
apply to an Irish company with a primary listing on the Irish Stock Exchange,
including the requirement that certain transactions require the approval of
shareholders. For further information, shareholders should consult their own
financial advisor.
Our financial statements are presented in U.S. dollars and are prepared in
accordance with accounting principles generally accepted in the Republic of
Ireland which differ in certain respects from accounting principles generally
accepted in the United States of America (see note 28 to the consolidated
financial statements. All references in this annual report to "dollars" and "$"
are to U.S. dollars, and all references to "euro" or "(euro)" are to European
Union euro. Except as otherwise stated herein, all monetary amounts in this
annual report have been presented in dollars.
Item 1 Identity of Directors, Senior Management and Advisers
Not Applicable
Item 2 Offer Statistics and Expected Timetable
Not Applicable
Item 3 Selected Consolidated Financial Data
The following selected consolidated financial data of Trinity Biotech as at
December 31, 2003 and 2002, and for each of the years ended December 31, 2003,
December 31, 2002 and December 31, 2001, 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, 2001, December 31, 2000 and
December 31, 1999, and for each of the years ended December 31, 2000 and 1999
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, 2003 Dec 31, 2002 Dec 31, 2001 Dec 31,2000 Dec 31,1999
------------ ------------ ------------ ----------- -----------
US$ US$ US$ US$ US$
Revenues 65,675,398 51,978,422 37,075,573 29,742,942 25,719,623
Cost of sales (32,876,951) (25,689,879) (18,049,765) (15,410,257) (14,562,619)
Administrative expenses (17,063,451) (12,849,416) (11,195,884) (6,013,064) (2,955,078)
Research & Development
expenses (5,210,039) (4,470,745) (2,779,729) (2,681,220) (2,448,372)
Amortization (856,355) (2,385,521) (2,002,135) (1,191,290) (896,913)
------- ------- ------- ------- -------
Operating profit
- Continuing Operations 9,668,602 6,523,834 5,816,912 3,201,040 4,856,641
- Acquisitions - 59,027 (2,768,852) 1,246,071 -
- Disposals - - - - -
-------- -------- -------- ------- -------
9,668,602 6,582,861 3,048,060 4,447,111 4,856,641
Interest income 174,117 103,133 142,364 466,151 69,284
Interest expense (792,353) (704,460) (538,401) (757,852) (761,501)
Profit on assets - - - - 404,328
2
Net profit before tax and ------ -------- --------- -------- ---------
Share of operating loss in
Associate & impairment 9,050,366 5,981,534 2,652,023 4,155,410 4,568,752
Share of operating loss in
Associate & impairment (1,067,262) (317,113) (268,870) (30,000) -
------- ------- ------- ------- -------
Net profit before tax 7,983,104 5,664,421 2,383,153 4,125,410 4,568,752
Tax on profit on ordinary
activities (2,185,630) (767,510) (15,876) (1,000) 10,000
-------- -------- -------- --------- -------
Net profit after tax 5,797,474 4,896,911 2,367,277 4,124,410 4,578,752
------- ------- ------- ------- -------
Profit from operations
per ordinary share (US dollars) 0.22 0.16 0.08 0.12 0.17
Profit from continuing operations
per ordinary share (US dollars) 0.22 0.16 0.14 0.09 0.17
Basic earnings
per ordinary share (US dollars) 0.13 0.12 0.06 0.11 0.16
Diluted earnings
per ordinary share (US dollars) 0.12 0.12 0.06 0.10 0.16
Weighted average number of shares
used in computing basic EPS 43,093,146 40,550,367 40,408,978 37,131,692 28,158,184
Weighted average number of shares
used in computing diluted EPS 50,583,247 42,486,227 41,120,060 40,540,494 28,990,725
Consolidated Balance Sheet As at As at As at As at As at
---------------------------
Data Dec 31, 2003 Dec 31, 2002 Dec 31, 2001 Dec 31, 2000 Dec 31, 1999
---- ------------ ------------ ------------ ------------ ------------
US$ US$ US$ US$ US$
Working Capital 45,629,978 20,423,522 17,117,172 15,755,495 5,439,566
Long-term Liabilities 17,517,713 7,745,442 7,805,237 2,266,425 8,086,232
Total Assets 118,091,489 89,798,458 77,072,043 66,900,229 44,433,295
Capital Stock 670,388 610,095 603,420 602,807 460,229
Shareholders' Equity 80,261,927 62,537,284 56,411,625 53,891,729 22,372,976
Amounts Adjusted for US GAAP
Consolidated Statement
---------------------- Year Ended Year Ended Year Ended Year Ended Year Ended
of Income Data Dec 31, 2003 Dec 31, 2002 Dec 31, 2001 Dec 31,2000 Dec 31,1999
-------------- ------------ ------------ ------------ ----------- -----------
US$ US$ US$ US$ US$
Net profit 5,145,594 5,042,943 710,151 1,108,114 651,847
Basic earnings
per ordinary share (US dollars) 0.12 0.12 0.02 0.03 0.02
Diluted earnings
per ordinary share (US dollars) 0.11 0.12 0.02 0.03 0.02
Consolidated Balance Sheet
--------------------------- As at As at As at As at As at
Data Dec 31, 2003 Dec 31, 2002 Dec 31, 2001 Dec 31,2000 Dec 31,1999
---- ------------ ------------ ------------ ----------- -----------
US$ US$ US$ US$ US$
Total Assets 128,649,751 99,067,410 83,239,531 75,858,813 55,696,411
Shareholders' Equity 87,233,925 70,944,268 63,463,291 62,899,307 33,121,515
No dividends were declared in any of the periods from December 31, 1999 to
December 31, 2003.
3
Risk Factors
Before you invest in our shares, you should be aware that there are
various risks, which are described below. You should consider carefully these
risks together with all of the other information included in this annual report
before you decide to purchase our shares.
Trinity Biotech's operating results may be subject to fluctuations.
o Trinity Biotech's operating results may fluctuate as a result of many
factors related to our business, including the competitive conditions
in the industry, loss of significant customers, delays in the
development of new products and currency fluctuations, as described in
more detail below, and general factors such as size and timing of
orders and general economic conditions.
Trinity Biotech's revenues depend to a high degree on its relationship with
Wampole Laboratories, a former affiliate of Carter Wallace, Inc.
o During the financial years ended December 31, 2003, December 31, 2002
and December 31, 2001, approximately 12%, 20% and 27% respectively of
Trinity Biotech's revenues were derived from a distribution agreement
by and among our subsidiary, Trinity Biotech (USA) Corp. (trading name
of Clark Laboratories, Inc.) and Carter-Wallace, Inc.
("Carter-Wallace") and its affiliate Wampole Laboratories ("Wampole").
In 2001, Wampole was acquired by Medpointe, Inc. and was subsequently
acquired by Inverness Medical Innovations, Inc. ("Inverness Medical")
in 2002. In 2002, the Company negotiated an amendment to the
distribution agreement whereby the exclusivity of Inverness Medical's
right to sell our products in the US would be removed in stages
throughout 2004. During 2003, the Company experienced declining sales
revenues under the distribution agreement which it believes is due to
Inverness Medical attempting to convert customers from the Trinity
Biotech product to an alternative product. Accordingly, in December
2003, the Company filed legal action against Inverness Medical and
Wampole for declaratory judgment and breach of contract. In January
2004, Inverness Medical and Wampole countersued and sought a
preliminary injunction to prevent the Company from selling direct in
the US any of its products which are competitive with products sold by
Inverness Medical and sourced by other suppliers. The Superior Court of
Middlesex County, Massachusetts, denied the motion for preliminary
injunction on January 28, 2004. For further information relating to
this matter please refer to Item 8 "Legal Proceedings". The Company has
decided to sell its products directly in the US and has increased its
direct sales force. Any inability to recapture lost sales from
Inverness Medical may have a material adverse effect on the Company.
A need for capital might arise in the future if Trinity Biotech's capital
requirements increase or revenues decrease.
o Up to now Trinity Biotech has funded its operations through the sale of
its shares and securities convertible into shares, revenues from
operations and bank borrowings. Trinity Biotech expects that the
proceeds of recent equity financings, bank borrowings, current working
capital and sales revenues will fund its operations and payment
obligations for the future. However, if our capital requirements are
greater than expected, or if our revenues are not sufficient to fund our
operations, we may need to find additional financing which may not be
available on attractive terms or at all. Any future financing could have
an adverse effect on our current shareholders or the price of our shares
in general.
The diagnostics industry is highly competitive, and Trinity Biotech's research
and development could be rendered obsolete by technological advances of
competitors.
o The diagnostics industry is extremely competitive. Trinity Biotech is
competing directly with companies which have greater capital resources
and larger marketing and business organizations than Trinity Biotech.
Trinity Biotech's ability to grow revenue and earnings may be adversely
impacted by competitive product and pricing pressures and by its
inability to gain or retain market share as a result of the action of
competitors. We have significantly invested in research and development
("R&D") but there can be no guarantees that our R&D programmes will not
be rendered technologically obsolete or financially non-viable by the
technological advances of our competitors, which would also adversely
affect our existing product lines and inventory. The main competitors of
Trinity Biotech (and their principal products with which Trinity Biotech
competes) are Dade-Behring (Sysmex(R) CA, D-Dimer plus, Enzygnost(R)),
bioMerieux (MDA(R), VIDAS(TM)), Zeus Scientific Inc. (Zeus EIA, IFA),
Diasorin Inc. (ETI(TM)), Abbott Diagnostics (AxSYM(TM), IMx(TM)),
Diagnostic Products Corp. - DPC (Immulite(TM)), Bio-Rad (ELISA & WB),
Roche Diagnostics (COBAS AMPLICOR(TM), Ampliscreen(TM), Accutrend(TM))
and OraSure Technologies, Inc. (OraQuick(R)).
4
Trinity Biotech is highly dependent on suitable distributors worldwide.
o Revenue and earnings stability and growth are directly dependent on the
effectiveness of advertising, marketing and promotional programmes.
Trinity Biotech currently distributes its product portfolio through
distributors in over 80 countries worldwide. Our continuing economic
success and financial security is dependent on our ability to secure
effective channels of distribution on favourable trading terms with
suitable distributors.
Trinity Biotech's business could be adversely affected by changing market
conditions resulting in the reduction of the number of institutional customers.
o The healthcare industry is in transition with a number of changes that
affect the market for diagnostic test products. Changes in the
healthcare industry delivery system have resulted in major consolidation
among reference laboratories and in the formation of multi-hospital
alliances, reducing the number of institutional customers for diagnostic
test products. There can be no assurance that we will be able to enter
into and/or sustain contractual or other marketing or distribution
arrangements on a satisfactory commercial basis with these institutional
customers.
Trinity Biotech's acquisition strategy may be less successful than expected, and
therefore, growth may be limited.
o Trinity Biotech has historically grown organically and through the
acquisition of, and investment in, other companies, product lines and
technologies. There can be no guarantees that recent or future
acquisitions can be successfully assimilated or that projected growth in
revenues or synergies in operating costs can be achieved. Our ability to
integrate future acquisitions may also be adversely affected by
inexperience in dealing with new technologies, and changes in regulatory
or competitive environments. Additionally, even during a successful
integration, the investment of management's time and resources in the
new enterprise may be detrimental to the consolidation and growth of our
existing business.
Trinity Biotech's long-term success depends on its ability to develop new
products subject to stringent regulatory control. Even if new products are
successfully developed, Trinity Biotech's patents have a limited life time and
are thereafter subject to competition with generic products. Also, competitors
might claim an exclusive patent for products Trinity Biotech plans to develop.
o We are committed to significant expenditure on research and development.
However, there is no certainty that this investment in research and
development will yield technically feasible or commercially viable
products. Our organic growth and long-term success is dependent on our
ability to develop and market new products but this work is subject to
very stringent regulatory control and very significant costs in
research, development and marketing. Failure to introduce new products
could significantly slow our growth and adversely affect our market
share.
o Even when products are successfully developed and marketed, Trinity
Biotech's ownership of the technology behind these products has a finite
life. In general, generic competition, which can arise after the
expiration of a patent, can have a detrimental effect on a product's
revenue, profitability and market share. There can be no guarantee that
the net income and financial position of Trinity Biotech will not be
adversely affected by competition from generic products. Conversely, on
occasion, certain companies have claimed exclusive patent, copyright and
other intellectual property rights to technologies in the diagnostics
industry. If these technologies relate to Trinity Biotech's planned
products, Trinity Biotech would be obliged to seek licenses to use this
technology and, in the event of being unable to obtain such licenses or
it being obtainable on grounds that would be materially disadvantageous
to Trinity Biotech, we would be precluded from marketing such products,
which could adversely impact our revenues, sales and financial position.
Trinity Biotech's patent applications could be rejected or the existing patents
could be challenged; our technologies could be subject to patent infringement
claims; and trade secrets and confidential know-how could be obtained by
competitors.
The following table sets forth the US patents Trinity Biotech currently owns.
The table provides the relevant patent number, a brief description and the
remaining life time for each patent:
5
------------------- --------------------------------------------------------- ------------------------------------------------
Patent Number Description Patent life remaining from February 29, 2004
------------------- --------------------------------------------------------- ------------------------------------------------
------------------- --------------------------------------------------------- ------------------------------------------------
5,006,474 Bi-Directional Lateral Chromatography Test Device 4 years 2 months
------------------- --------------------------------------------------------- ------------------------------------------------
5,114,845 Improved Assays for Plasminogen Activator Inhibitor and 3 years 5 months
Soluble Fibrin
------------------- --------------------------------------------------------- ------------------------------------------------
5,175,087 Method of Performing Tissue Plasminogen Activator Assay 3 years 5 months
------------------- --------------------------------------------------------- ------------------------------------------------
5,985,582 Thrombin-Based Assay for Antithrombin - III 13 years 10 months
------------------- --------------------------------------------------------- ------------------------------------------------
6,194,394 Coagulation controls for Prothrombin Time (PT) and 14 years 5 months
Activated Partial Thromboplastin Time (APTT) Assays
------------------- --------------------------------------------------------- ------------------------------------------------
6,528,273 Methods for quality control of Prothrombin Time (PT) 14 years 9 months
and Activated Partial Thromboplastin Time (APTT) Assays
Using Coagulation Controls
------------------- --------------------------------------------------------- ------------------------------------------------
6,391,609 Thromboplastin Reagents and Methods for Preparing and 15 years 8 months
Using Such Reagents
------------------- --------------------------------------------------------- ------------------------------------------------
6,653,066 Device and method for detecting polyvalent substances 19 years and 9 months
------------------- --------------------------------------------------------- ------------------------------------------------
In addition to these US patents, Trinity Biotech owns a total of 24
non-US patents.
o We can provide no assurance that the patents Trinity Biotech may apply
for will be obtained or that existing patents will not be challenged.
The patents owned by Trinity Biotech and its subsidiaries may be
challenged by third parties through litigation and could adversely
affect the value of our patents. We can provide no assurance that our
patents will continue to be commercially valuable.
o Also, our technologies could be subject to claims of infringement of
patents or proprietary technology owned by others. The cost of
enforcing our patent and technology rights against infringers or
defending our patents and technologies against infringement charges by
others may be high and could adversely affect our business.
o Trade secrets and confidential know-how are important to our scientific
and commercial success. Although we seek to protect our proprietary
information through confidentiality agreements and other contracts, we
can provide no assurance that others will not independently develop the
same or similar information or gain access to our proprietary
information.
Trinity Biotech's business is heavily regulated, and compliance with applicable
regulations could reduce revenues and profitability.
o Our manufacturing and marketing diagnostic test kits are subject to
government regulation in the United States of America by the Food and
Drug Administration ("FDA"), and by comparable regulatory authorities
in other jurisdictions. The approval process for our products, while
variable across countries, is generally lengthy, time consuming,
detailed and expensive. Our continued success is dependent on our
ability to develop and market new products, some of which are currently
awaiting approval from these regulatory authorities. There is no
certainty that such approval will be granted or, even once granted,
will not be revoked during the continuing review and monitoring
process.
6
o We are required to comply with extensive post market regulatory
requirements. Non-compliance with applicable regulatory requirements of
the FDA or comparable foreign regulatory bodies can result in
enforcement action which may include recalling products, ceasing
product marketing, paying significant fines and penalties, and similar
actions that could limit product sales, delay product shipment, and
adversely affect profitability.
Trinity Biotech's success is dependent on certain key management personnel.
o Trinity Biotech's success is dependent on certain key management
personnel. Our key employees are Ronan O'Caoimh, our CEO and Chairman,
Brendan Farrell, our President, Dr. Jim Walsh, our COO, and Rory
Nealon, our CFO and Secretary, with all of which we have entered into
employment contracts. We carry a life assurance policy for Mr O'Caoimh
in the amount of (euro)533,289. Competition for qualified employees
among biotechnology companies is intense, and the loss of such
personnel or the inability to attract and retain the additional highly
skilled employees required for the expansion of our activities, could
adversely affect its business. In the USA, Germany and Sweden we were
able to attract and retain qualified staff. In Ireland, we have
experienced some difficulties in attracting and retaining staff due to
competition from other employers in our industry and due to the
strength of the Irish economy. We are not aware of any plans by
qualified staff to retire or leave Trinity Biotech in the near future.
Trinity Biotech is dependent on its suppliers for the primary raw materials
required for its test kits.
o The primary raw materials required for Trinity Biotech's test kits
consist of antibodies, antigens or other reagents, glass fibre and
packaging materials which are acquired from third parties. Although
Trinity Biotech does not expect to be dependent upon any one source for
these raw materials, alternative sources of antibodies with the
specificity and sensitivity desired by Trinity Biotech may not be
available. Such unavailability could affect the quality of our products
and our ability to meet orders for specific products.
Trinity Biotech may be subject to liability resulting from its products or
services.
o Trinity Biotech may be subject to claims for personal injuries or other
damages resulting from its products or services. Trinity Biotech has
product liability insurance in place for its US manufacturing
subsidiaries up to a maximum of US$2,000,000 for any one accident,
limited to a maximum of US$2,000,000 in any one year period of
insurance. A separate policy is in place for non-US subsidiaries, which
are also covered up to a maximum of (euro)4,000,000 (US$5,020,710) for
any one accident, limited to a maximum of (euro)4,000,000
(US$5,020,710) in any one year period of insurance. A deductible of
US$25,000 is applicable to each insurance event. There can be no
assurance that our product liability insurance is sufficient to protect
us against liability that could have a material adverse effect on our
business.
Currency fluctuations may adversely affect our earnings and assets.
o Trinity Biotech records its transactions in Euro and US dollars and
prepares its financial statements in US dollars. A substantial portion
of our expenses is denominated in Euro. However, Trinity Biotech's
revenues are primarily denominated in US dollars. As a result, we are
affected by fluctuations in currency exchange rates, especially the
exchange rate between the US dollar and the Euro. Fluctuations between
these and other exchange rates may adversely affect our earnings and
assets. The percentage of 2003 consolidated revenue denominated in US$
was approximately 67%. Of the remaining 33% revenue, the breakdown was
as follows: Euro (29%), Yen (1%) and Sterling and Swedish Kroner (3%).
Thus, a 10% decrease in the value of each of the Euro, Yen, Sterling
and Swedish Kroner would have approximately a 3% adverse impact on
consolidated revenues. As part of the process of mitigating foreign
exchange risk, the principal exchange risk identified by Trinity
Biotech was with respect to fluctuations in the Euro. This is
attributable to the level of Euro denominated expenses exceeding the
level of Euro denominated revenues thus creating a Euro deficit. As
part of a managed hedging policy, Trinity Biotech has identified the
extent of this Euro mismatch and implemented a forward currency hedging
policy which aims to cover a portion of this mismatch through the use
of forward contracts. Trinity Biotech entered into a series of forward
contracts to sell US$ forward for Euro. These contracts remain in place
until late 2005. Trinity Biotech continues to monitor its exposure to
foreign currency movements. In the medium term, our objective is to
increase the level of non-US$ denominated revenue, thus creating a
natural hedge of the non-US$ expenditure.
7
Penny Stock Regulations impose sales practice limitations on broker-dealers who
sell our shares.
o SEC regulations concerning "penny stock" apply to Trinity Biotech's
shares. These regulations impose sales practice requirements on
broker-dealers who sell our shares to persons other than established
customers and "accredited investors" as defined in SEC regulations. For
transactions covered by the regulations, broker-dealers must make a
suitability determination and receive a written agreement from the
purchaser prior to the sale. These regulations may affect the ability
of broker-dealers to sell our shares in the secondary market and thus
adversely affect our share price.
The conversion of our outstanding convertible notes and warrants would dilute
the ownership interest of existing shareholders.
o The convertible notes described in Item 18, Note 10 (e) and the
warrants described in Item 18, Note 11, issued since year end, are
convertible into ADRs representing our Class "A" Ordinary Shares.
Conversion of the remainder of the notes and exercise of the warrants
will likely occur only when the conversion price is below the trading
price of our ADRs and will dilute the ownership interests of existing
shareholders. For instance, should the holders of the Series A
Convertible Notes decide to convert the balance of the US$20,000,000
total principal amount of US$13,217,500 and the holders of the Series B
Convertible Notes decide to convert the total principal amount of
US$5,000,000 into ADRs at conversion prices of US$3.55 and US$4
respectively, and should the 1,258,824 warrants be exercised, Trinity
Biotech would have to issue 6,232,063 additional ADRs. On the basis of
51,766,449 outstanding shares at February 29, 2004, this would
effectively dilute the ownership interest of the existing shareholders
by approximately 11%. In addition, any sales in the public market of
the ADRs issuable upon conversion of the notes could adversely affect
prevailing market prices of our ADRs.
It could be difficult for US holders of ADRs to enforce any securities laws
claims against Trinity Biotech, its officers or directors in Irish Courts.
o At present, no treaty exists between the United States and Ireland for
the reciprocal enforcement of foreign judgments. The laws of Ireland do
however, as a general rule, provide that the judgments of the courts of
the United States have in Ireland the same validity as if rendered by
Irish Courts. Certain important requirements must be satisfied before
the Irish Court will recognize the United States judgment. The
originating court must have been a court of competent jurisdiction, the
judgment may not be recognized if it is based on public policy, was
obtained by fraud or its recognition would be contrary to Irish public
policy. Any judgment obtained in contravention of the rules of natural
justice will not be enforced in Ireland.
Item 4
Information on the Company
History and Development of the Company
Trinity Biotech Plc ("Trinity Biotech" or "the Company") develops, manufactures
and markets diagnostic test kits used for the clinical laboratory and
point-of-care ("POC") segments of the diagnostic market. These test kits are
used to detect infectious diseases, sexually transmitted diseases, blood
coagulation disorders and autoimmune disorders. The Company markets over 500
different diagnostic products in approximately 80 countries.
Trinity Biotech was incorporated as a public limited company (plc) registered in
Ireland in 1992. The Company commenced operations in 1992 and, in October 1992,
completed an initial public offering of its securities in the 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
haemostasis business in December 2001 and the haemostasis division of Sigma
Diagnostics, part of Sigma Aldrich, in August 2002, Trinity Biotech has expanded
its product range to include test kits that diagnose blood coagulation and
related disorders, and a haemostasis instrumentation portfolio. The acquisition
of the speciality clinical chemistry business of Sigma Diagnostics in November
2002 means that Trinity Biotech now participates in this important market
segment. Trinity Biotech 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 Biotech has manufacturing
facilities in Bray, Ireland, Umea, Sweden and Lemgo, Germany, in Europe, and in
Jamestown, New York, and Carlsbad, California in the USA.
Over the past four years, Trinity Biotech 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
haemostasis businesses and the sixth was a speciality clinical chemistry
business. In July 2001, Trinity Biotech established a direct sales operation in
Germany which commenced trading in October 2001, and in 2002 the Company
established a small direct sales operation in the United Kingdom. Through these
acquisitions and new products added through in-house research and development,
Trinity Biotech now has a comprehensive portfolio of over 500 products,
including 7 rapid tests.
8
Acquisition of the speciality clinical chemistry product line of Sigma
Diagnostics
In November 2002, Trinity Biotech acquired the speciality clinical chemistry
product line from Sigma Diagnostics for a total consideration of US$4.4m
satisfied in cash and deferred consideration. The deferred consideration of
US$1.8m was paid in 2003. The speciality clinical chemistry business consists of
several specialised products that are clearly differentiated in the marketplace,
including ACE, Bile Acids, Lactate, Oxalate and G6PDH.
Acquisition of the haemostasis division of Sigma Diagnostics
In August 2002, Trinity Biotech purchased the haemostasis division of Sigma
Diagnostics for a total consideration of US$1.4m. 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 haemostasis 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 Biotech also received FDA clearance recently for its new
haemostasis analyser the AMAX Destiny(TM).
Acquisition of the assets of the Biopool haemostasis business In December 2001,
Trinity Biotech acquired the assets of the Biopool haemostasis business for a
consideration of US$6.4m before costs comprising US$3.8m in cash and US$2.6m in
deferred consideration. The deferred consideration was payable in three
instalments of US$0.9m, US$1.2m 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 Biotech acquired the assets 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.
Acquisition of Bartels Inc
In December 2000, Trinity Biotech acquired the assets 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.
Acquisition of MarDx Diagnostics Inc
In March 2000, Trinity Biotech acquired all the outstanding share capital of
MarDx Diagnostics Inc. (MarDx) of Carlsbad, California for a consideration of
US$4.2 million. MarDx is a world leader in the development and manufacture of
diagnostic products, known as Western Blots, which confirm the primary diagnosis
of certain infectious diseases. Their principal product is a Western Blot test
for Lyme disease, which is an infection carried by deer ticks. The disease
manifests itself as a multi-system inflammatory disease that affects the skin,
joints and nervous system. If diagnosed and treated early with antibiotics, Lyme
disease is readily cured.
The MarDx test was the first Lyme Western Blot assay to receive FDA clearance
and remains the leading selling test for Lyme disease in the USA. The
acquisition of MarDx gave Trinity Biotech a strong position in the Western Blot
segment of the infectious disease market. Western Blot confirmatory testing is a
natural extension to Trinity Biotech's EIA products and the Company intends to
extend the MarDx Western Blot technology and manufacturing capability to other
confirmatory tests.
Investment in HiberGen Limited
On October 2, 2000, the Company acquired 33% of the ordinary share capital of
HiberGen for a total consideration of US$1.4m. 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. In November 2003, the Company announced that the recent fundraising
process undertaken by HiberGen had not been successful and that HiberGen had
ceased trading. The Company wrote-off its remaining investment in quarter four
of the 2003 financial year.
9
Establishment of UK subsidiary, Trinity Biotech (UK Sales) Ltd
In 2002 Trinity Biotech opened a sales and marketing office in Oxfordshire, UK
employing three sales professionals who market the haemostasis and clinical
chemistry products from Trinity Biotech.
Establishment of German subsidiary, Trinity Biotech GmbH
In October 2001, Trinity Biotech established a direct sales operation in
Germany. After the USA and Japan, Germany, with a population of 83m, is the
third largest market in the world for in-vitro diagnostics, accounting for 7%
((euro)1.6bn) of the total world market of (euro)22.5bn. In the past Trinity
Biotech had serviced the market through five independent distributors who
handled a small proportion of the Company's product portfolio whereas the new
German direct sales force markets all of Trinity Biotech's current products. In
2002 Trinity Biotech purchased the haemostasis business of Sigma Diagnostics.
The German part of this business was taken over by Trinity Biotech GmbH.
Pre Market Application ("PMA") 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 Biotech's UniGold HIV test. This IDE allows
Trinity Biotech's UniGold HIV test to be used in a limited number of hospitals
throughout the 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 Biotech's proposed clinical trials
under the treatment IDE met FDA standards for human safety and confidentiality.
During 2001, representatives from Trinity Biotech were informed by the FDA that
the FDA required that additional clinical trials be conducted to ensure that the
results which have been obtained to date are statistically significant. This
means that the results which have been presented to the FDA in the PMA filing
must be reproduced on a larger population of samples. The resulting product
clinical trials have now been conducted at sites in Houston, Texas and
Baltimore, Maryland. Approximately 9,000 samples were collected and tested on
Trinity Biotech's UniGold HIV test. This data along with extensive information
on the manufacturing process for Trinity Biotech's UniGold HIV test were
presented to the FDA. The FDA completed a plant inspection of the Irish
manufacturing facility in mid September. On December 29, 2003, the FDA issued
approval for the sale of the UniGold HIV test. This allows for sale of the
UniGold HIV test into clinical laboratories throughout the United States testing
the following blood sample types:, serum, plasma and venipuncture whole blood.
In the US laboratories are classed under The Clinical Laboratory Improvements
Amendments of 1988 ("CLIA") regulations in to one of three categories: Waived,
Moderate and High. Accreditation by CLIA is required by laboratories to use
moderate and high complexity classified tests. No laboratory accreditation is
required for use of CLIA waived tests (see 'other FDA regulations' below).
Trials are currently underway to support a CLIA waiver for the UniGold HIV test.
Should CLIA waiver be granted; the use of the UniGold HIV test will be expanded
to Point of Care settings. Early in 2004, an IDE submission was made to the FDA
to define the data requirements to expand the use of the product to test finger
stick (blood taken directly from the finger) samples.
Principal Markets
The primary market for Trinity Biotech's tests remains the USA. During fiscal
2003, the Company sold 55% (US$36.3) (2002: 64% or US$33.5m; 2001: 68% or
US$25.0m) of product in the USA. Sales to non-USA (principally European and
Asian) countries represented 45% (US$29.4m) during fiscal 2003 and 36%
(US$18.5m) during fiscal 2002. The comparable figure in 2001 was 32% (US$12.1m).
For a more comprehensive segmental analysis please refer to Item 5, "Results of
Operations" and 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".
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.
10
Trinity Biotech's products can test for foreign agents such as viruses, bacteria
and parasites, and for naturally occurring conditions such as cancer cells and
hormones. The Company's manufacturing processes utilize biotechnology techniques
involving the in-house production of recombinant proteins, synthetic peptides
and monoclonal antibodies.
Trinity Biotech's product areas can be broken down under the headings of the six
key technologies which are sold under the following brand names:
Enzyme Immunoassays (EIA)
Bartels(R)
CAPTIA(TM)
MarDx(R)
MicroTrak(TM)
Recombigen(R)
Fluorescence Assays (IFA/DFA)
Bartels(R)
MarDx(R)
MicroTrak(TM)
Western Blot (WB)
MarDx(R)
Rapid Assays
Capillus(TM)
SeroCard(TM)
UniGold(TM)
Haemostasis
Biopool(R)
Amax
Clinical Chemistry
EZ HDL
EZ LDL
Enzyme Immunoassays
The Company's wide range of Enzyme Immunoassay (EIA) products includes over 90
assays utilising different formats to accommodate the most demanding of
laboratories to the most basic. This type of test is the mainstay of standard
clinical laboratories around the world and forms the backbone of the Trinity
Biotech product list of over 500 products. Trinity Biotech currently sells 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 samples
and can be performed manually or more typically on automated equipment. Trinity
Biotech also offers a modest range of equipment for these types of assays as
well as validating the Trinity Biotech range for use on the most popular types
of analysers, used by most medical laboratories.
In essence, each well is coated with antigen or antibody depending upon the
analyte being tested for. When the test is run, the first step would be to add
the sample and a reaction will bind any antibodies or antigens (if present) to
the well wall. After removal of interfering substances through washing steps, a
colour-forming reagent is added and the intensity of colour is read on an
instrument indicating the result. EIA's can aid in providing the clinician with
accurate information to assist in the diagnosis of a variety of disorders such
as autoimmune diseases, hormonal imbalances, sexually transmitted diseases,
enteric infections, respiratory infections, cardiovascular diseases, and a wide
range of other diseases.
Haemostasis
The second largest range of assays in Trinity Biotech's portfolio is the
haemostasis assays. Arising from the acquisition of the Biopool and Sigma
haemostasis businesses, Trinity Biotech now has an extensive range of
haemostasis diagnostic kits, offering laboratories the ability to maximize
testing. Biopool is a well-known leader and innovator in the worldwide market
for haemostasis and fibrinolysis reagents. Strengthening the Biopool reagent
portfolio is the addition of the former Sigma Amelung instrumentation and
reagents. This strategic combination enables Trinity Biotech to provide the
market with a complete line of haemostasis products that permit customized
testing. With the increasing demand to elucidate a wide range of coagulapathies
in the aging population, haemostasis testing is quickly advancing to the
requirements of today's complexities.
11
Trinity Biotech's full range of test kits assess and diagnose disorders of blood
coagulation, thrombotic risk factors, fibrinolysis, platelet function and the
vascular system. Included in the product range is the range of D-dimer assays.
Employing latex technology, Trinity Biotech can offer superior sensitivity and
NPV (Negative Predictive Value) for D-dimer testing. Alongside D-dimer are
Trinity Biotech's comprehensive routine and speciality assays.
This extensive haemostasis product line is sold to hospitals, clinical
laboratories, commercial reference laboratories and research institutions on a
worldwide basis.
Fluorescence Assays
Another large range of diagnostic assays in Trinity Biotech's portfolio are the
fluorescence assays that are also typically performed in medium to large sized
hospital laboratories around the world. Trinity Biotech offers 33 fluorescence
assays, of which 25 are cleared by the FDA for distribution within the 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 Biotech offers 24 IFA's with
the vast majority forming the comprehensive range of tests to diagnose
autoimmune disorders. The remainder of the assays are used to assist in the
diagnosis of infectious diseases such as Legionnaires disease, Lyme disease and
many others. Of the 9 DFA's Trinity Biotech offers, the largest range are FDA
cleared for detecting causative agents of sexually transmitted diseases (STD's),
principally Chlamydia and Herpes, and forms one of Trinity Biotech's most
popular selling product groups.
The principle of the IFA test can be summarised as the introduction of patient's
serum to a specially prepared slide containing the specific antigen to which the
antibody is directed. Antibody, if present, binds to the antigen and after a
series of washing steps and addition of a conjugate, will emit fluorescence when
viewed through a microscope equipped with an ultra-violet light source.
The principle of DFA, however, can best be described as the fixation of a
patient sample to a microscope slide, which is then introduced to an antibody
conjugated to a fluorescent dye, to stain and thereby identify the antigen to
which the antibody is directed.
Rapid Assays
Trinity Biotech has developed a range of membrane and latex based rapid assays
to cater for point of care ('POC') and over-the-counter ('OTC') markets. This
range of 7 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 Biotech's extensive range of 18 Western Blot test systems includes the
first Lyme Western Blot assay to receive FDA clearance for distribution within
the 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
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.
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Clinical Chemistry
Trinity Biotech acquired the Speciality Clinical Chemistry business of Sigma
Diagnostics. This business consists of several specialised products that are
clearly differentiated in the marketplace, including ACE, Bile Acids, Lactate,
Oxalate and G6PDH.
These products are suitable for both manual and automated testing and have
proven performance in the diagnosis of many disease states from liver and kidney
disease to G6PDH deficiency which is an indicator of haemolytic anaemia. EZ HDL
and EZ LDL cholesterol assays broke new ground when they were introduced by
Sigma as the first homogenous, non-precipitating liquid reagents for determining
HDL and LDL.
Distribution Agreement between Trinity Biotech USA and Carter Wallace
Trinity Biotech USA ("Trinity USA") entered into a distribution agreement with
Carter-Wallace Inc. ("Carter-Wallace") on December 18, 1995 for an initial
period of five years and, thereafter, for an indefinite period subject to
termination provisions outlined in the distribution agreement. Under the terms
of the agreement, Carter-Wallace has the exclusive right to sell and distribute
Trinity USA's products in the USA and Puerto Rico through its affiliate Wampole
Laboratories ("Wampole"). Under the distribution agreement, the Company retained
the right to market certain Trinity USA products in the USA and Puerto Rico,
which Carter-Wallace has chosen not to market in those territories. In addition,
the Company 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 with Inverness Medical Innovations, Inc.
("Inverness Medical"), the successor to Carter-Wallace's rights under the
distribution agreement, whereby the exclusivity would be removed in stages
throughout 2004. In December 2003, the Company initiated legal proceedings
against Inverness Medical for declaratory judgment and breach of contract. The
suit alleges that Inverness Medical is attempting to convert customers from the
Trinity Biotech product to a product manufactured by a competitor by claiming
that the Trinity Biotech product is unavailable and is being discontinued. In
January 2004, Inverness Medical countersued and sought a preliminary injunction
to prevent Trinity Biotech from selling direct in the US any of its products
which are competitive with products sold by Inverness Medical and sourced by
other suppliers. The Superior Court of Middlesex County, Massachusetts, denied
this motion for a preliminary injunction on January 28, 2004. For further
information relating to this matter please refer to Item 8 "Legal Proceedings".
The Company has decided to sell its products directly in the US and has
increased its direct sales force to approximately seventy staff. Any inability
to recapture lost sales from Wampole may have a material adverse effect on the
Company.
Sales and Marketing
Trinity Biotech sells its product through its own direct sales-force in three
countries: the United States, Germany and the United Kingdom. In the United
States there are approximately seventy sales and marketing professionals
responsible for the sale of haemostasis reagents and instrumentation, clinical
chemistry and infectious disease products. The sales force of twenty people in
Germany is responsible for selling the full range of Trinity Biotech products
including haemostasis, infectious disease, clinical chemistry and
radioimmunoassay. In 2002, Trinity Biotech opened a sales and marketing office
in Oxfordshire, UK employing three sales professionals who market the
haemostasis and clinical chemistry products from Trinity Biotech. In addition to
our direct sales operations, Trinity Biotech also operates in seventy-eight
countries, through over three hundred independent distributors and strategic
partners.
Manufacturing and Raw Materials
The primary raw materials required for Trinity Biotech's test kits consist of
antibodies, antigens, human plasma, latex beads, rabbit brain phospholipids,
bovine source material, other reagents, glass fibre and packaging materials. The
reagents used as raw materials have been acquired for the most part from third
parties. Although Trinity Biotech is not dependent upon any one source for such
raw materials, alternative sources of antibodies and antigens with the
specificity and sensitivity desired by Trinity Biotech may not be available.
Such unavailability could affect the quality of its products and its ability to
meet orders for specific products, if such orders are obtained. Trinity
Biotech's growth may be limited by its ability to obtain or develop the
necessary quantity of antibodies or antigens required for specific products.
Thus, Trinity Biotech's strategy is, whenever possible, to establish alternative
sources of supply of antibodies.
Competition
The diagnostic industry is very competitive. There are many companies, both
public and private, engaged in diagnostics-related research and development,
including a number of well-known pharmaceutical and chemical companies.
Competition is based primarily on product reliability, customer service and
price. Many of these companies have substantially greater capital resources and
have marketing and business organizations of substantially greater size than
Trinity Biotech. Many companies have been working on immunodiagnostic reagents
and products, including some products believed to be similar to those currently
marketed or under development by the Company, for a longer period of time than
has the Company. The Company's competition includes several large companies such
as Roche, Abbott, Johnson & Johnson, Bayer, Chiron and Dade-Behring.
13
Patents and Licences
Patents
Trinity Biotech'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
Biotech to concentrate and detect antibodies or antigens using a whole blood
specimen in addition to serum, urine, saliva and other fluid samples.
In February 1993, Trinity Biotech filed a patent application with the Irish
Patents Office under the title "Device for the Processing of Saliva for use in
an Immunoassay". The patent describes a saliva collection system for collecting
and analysing immunoglobulins extracted from the oral cavity. This patent was
granted in May 1993. The Company was granted a second patent covering the
mechanics of its Saliva Collection Device in June 1994. Management believes that
these two patents, which expire in 2010, will help protect Trinity Biotech's
SalivaCardTM test from being copied by a competitor.
In January 1999, Trinity Biotech filed a patent application with the Irish
Patents Office describing a device used in the detection of Strep A in Trinity
Biotech's Rapid Strep A test. This patent was granted in February 2000.
In December 2002, Trinity Biotech filed a patent application with the Irish
Patents Office under the title "A test for detection of antibodies to HIV". The
patent describes a method relating to the preparation of a test to detect
anti-HIV antibodies in serum, plasma or whole blood. This patent was
subsequently granted in October 2003. In April 2002, Trinity Biotech filed a
patent application with the Irish Patents Office under the title "A method and
apparatus for drying a coated microtitre plate after rinsing" which was also
granted in 2003. In December 2002, the Company also filed a patent application
with the Irish Patents Office under the title "A cyanide-free reagent for
measuring haemoglobin in blood, and a method for measuring haemoglobin" which
has been granted.
Many of the Company's tests are not protected by specific patents, due to the
significant cost of putting patents in place for the Company's wide range of
products. However, the Company believes that substantially all of its tests are
protected by proprietary know-how, manufacturing techniques and trade secrets.
From time-to-time, certain companies have asserted exclusive patent, copyright
and other intellectual property rights to technologies that are important to the
industry in which Trinity Biotech operates. In the event that any of such claims
relate to its planned products, Trinity Biotech intends to evaluate such claims
and, if appropriate, seek a licence to use the protected technology. There can
be no assurance that Trinity Biotech would, firstly, be able to obtain licences
to use such technology or, secondly, obtain such licences on satisfactory
commercial terms. If Trinity Biotech or its suppliers are unable to licence any
such protected technology that might be used in Trinity Biotech's products,
Trinity Biotech could be prohibited from marketing such products. It could also
incur substantial costs to redesign its products or to defend any legal action
taken against it. If Trinity Biotech's products should be found to infringe
protected technology, Trinity Biotech could also be required to pay damages to
the infringed party.
Licences
In 2002, the Company obtained the Unipath and Carter Wallace lateral flow
licences under agreement with Inverness Medical Innovations.
On December 20, 1999 the Company obtained a non-exclusive commercial licence
from the National Institute of Health ("NIH") in the 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 Irish Medicines Board (as
the authority over Trinity Biotech in Europe) and Health Canada. Recently, a
European Directive has been implemented allowing one approval system to be
applicable throughout Europe, CE marking. Canada has also recently amended their
regulations where it is now mandatory to hold an externally accredited quality
system to a very exacting standard.
14
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 55% of Trinity Biotech's 2003 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.
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, it's
labeling or its manufacturing process. The FDA has recently implemented
substantial fees for the submission and review of PMA applications.
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.
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 issued PMA approval for the
device on December 29, 2003. This approval allows for the use of serum, plasma
and venipuncture whole blood in clinical settings. The company is actively
pursuing the expansion of the product use to point of care setting and the use
of blood taken directly from the finger.
15
Postmarket Regulation
After the FDA permits a device to enter commercial distribution, numerous
regulatory requirements apply, including: the Quality System Regulation ("QSR"),
which requires manufacturers to follow elaborate testing, control, documentation
and other quality assurance procedures during the manufacturing process;
labeling regulations; the FDA's general prohibition against promoting products
for unapproved or "off-label" uses; and the Medical Device Reporting ("MDR")
regulation, which requires that manufacturers report to the FDA if their device
may have caused or contributed to a death or serious injury or malfunctioned in
a way that would likely cause or contribute to a death or serious injury if it
were to recur.
The Company is subject to inspection by the FDA to determine compliance with
regulatory requirements. If the FDA finds any failure to comply, the agency can
institute a wide variety of enforcement actions, ranging from a public warning
letter to more severe sanctions such as: fines, injunctions, and civil
penalties; recall or seizure of products; the issuance of public notices or
warnings; operating restrictions, partial suspension or total shutdown of
production; refusing requests for 510(k) clearance or PMA approval of new
products; withdrawing 510(k) clearance or PMA approvals already granted; and
criminal prosecution.
Unanticipated changes in existing regulatory requirements or adoption of new
requirements could have a material adverse effect on the Company. Any failure to
comply with applicable QSR or other regulatory requirements could have a
material adverse effect on the Company's revenues, earnings and financial
standing. There can be no assurances that the Company will not be required to
incur significant costs to comply with laws and regulations in the future or
that laws or regulations will not have a material adverse effect upon the
Company's revenues, earnings and financial standing.
Other FDA Regulation
Purchasers of the Company's clinical diagnostic products in the United States
may be regulated under The Clinical Laboratory Improvements Amendments of 1988
("CLIA") and related federal and state regulations. CLIA is intended to ensure
the quality and reliability of clinical laboratories in the United States by
mandating specific standards in the areas of personnel qualifications,
administration and participation in proficiency testing, patient test
management, quality control, quality assurance and inspections. The regulations
promulgated under CLIA established three levels of diagnostic tests ("waived",
"moderately complex" and "highly complex") and the standards applicable to a
clinical laboratory depend on the level of the tests it performs. CLIA
requirements may prevent some clinical laboratories from using any or all of the
Company's diagnostic products. There can be no assurance that the CLIA
regulations and future administrative interpretations of CLIA will not have a
material adverse impact on the Company by limiting the potential market for the
Company's products.
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
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 Biotech's
executive offices are located at Bray, Co. Wicklow, Ireland while its research
and development, manufacturing and marketing activities are principally
conducted at Trinity Biotech Manufacturing Limited, based in Bray, Co. Wicklow,
Ireland, Trinity Biotech GmbH, based in Lemgo, Germany, and at Trinity Biotech
(USA), MarDx Diagnostics Inc and Biopool US Inc based in Jamestown, New York
State, Carlsbad, California and St. Louis, Missouri respectively.
16
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 Biotech has five manufacturing sites worldwide, two in the USA
(Jamestown, NY and Carlsbad, CA), one in Bray, Co. Wicklow, Ireland, one in
Umea, Sweden and one in Lemgo, Germany. The US and Irish facilities are each
FDA, EN and ISO approved facilities. As part of its ongoing commitment to
quality, Trinity Biotech was granted the latest ISO 9001: 2000 and ISO 13485:
1996 certification in February 2003. This certificate was granted by the
Underwriters Laboratory, an internationally recognised notified body. It serves
as external verification that Trinity Biotech has an established and effective
quality system in accordance with an internationally recognised standard. By
having an established quality system there is a presumption that Trinity Biotech
will consistently manufacture products in a controlled manner. To achieve this
certification Trinity Biotech performed an extensive review of the existing
quality system and implemented any additional requirements of the ISO 9001:
2000.
Trinity Biotech's manufacturing and research and development facilities
consisting of approximately 45,000 square feet are located at IDA Business Park,
Bray, Co. Wicklow, Ireland. This facility is ISO 9001 approved and was purchased
in December 1997. The facilities include offices, research and development
laboratories, production laboratories, cold storage and drying rooms and
warehouse space. Trinity Biotech spent US$4.2m 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 (euro)392,349 (US$492,468). In
July 2000, the Company entered into a 20 year lease for a 25,000 square foot
warehouse adjacent to the existing facility at an annual rent of (euro)190,500
(US$239,111). The Company also envisages that further premises may potentially
be required by it and, for that purpose, has entered into a four years eleven
month lease at (euro)12,860 (US$16,142) per annum over adjacent lands. On
November 20, 2002 the Company entered into an agreement for lease with the
lessor for 16,000 square foot of offices that have recently been constructed on
part of these lands. The annual rent of (euro)365,760 (US$459,094) is payable
from January 1, 2004. (See Item 7 - Major Shareholders and Related Party
Transactions).
Trinity Biotech USA operates from a 24,000 square foot FDA and ISO 9001 approved
facility in Jamestown, New York. The facility was purchased by Trinity Biotech
USA in 1994. Additional warehousing space is also leased in upstate New York at
an annual rental charge of US$48,144.
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$213,600. 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$134,985.
Arising from the acquisition of the Biopool haemostasis business, Trinity
Biotech currently operates from an additional facility located in Umea, Sweden.
The Umea facility is 8,712 square feet and the annual rental is US$116,054. The
lease, renewed in December 2003, expires in December 2006.
Arising from the acquisition of the Sigma haemostasis division in 2002, Trinity
Biotech acquired a manufacturing/office facility of 55,000 sq ft in Lemgo,
Germany. This facility is owned by Trinity Biotech GmbH.
Additional office space is leased by the Company in Ireland, Darmstadt and St,
Louis, Missouri at an annual cost of US$114,773, US$53,497 and US$78,089
respectively. The Company is currently negotiating the lease of additional
office space in New Jersey.
Item 5 Operating and Financial Review
and Prospects
Operating Results
Trinity Biotech's consolidated financial statements include the attributable
results of seven trading entities: - Trinity Biotech Manufacturing Limited
(Ireland), Clark Laboratories Inc. (trading as Trinity Biotech (USA)), Biopool
US Inc., MarDx Diagnostics Inc, Biopool AB, Trinity Biotech (UK Sales) Limited
and Trinity Biotech GmbH (Germany). These entities are engaged in the
manufacture and sale of diagnostic test kits. The consolidated financial
statements also include a share of the loss of the associate undertaking,
HiberGen. This discussion covers the years ended December 31, 2003, December 31,
2002 and December 31, 2001 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.
17
Overview
Trinity Biotech develops, manufactures and markets diagnostic test kits used for
the clinical laboratory and point-of-care ("POC") segments of the diagnostic
market. These test kits are used to detect infectious diseases, sexually
transmitted diseases, blood coagulation disorders and autoimmune disorders. The
Company markets over 500 different diagnostic products in approximately 80
countries.
Trinity Biotech was incorporated in Ireland in January 1992. The Company was
organised to acquire, develop and market technologies for rapid in-vitro blood
and saliva diagnostics for HIV and other infectious diseases. In October 1992,
Trinity Biotech completed an initial public offering in the United States in
which it raised net proceeds in excess of US$5 million. In October 1993, Trinity
Biotech took a controlling interest in DDI and in October 1994, merged Trinity
Biotech's wholly-owned US subsidiary into DDI so that DDI became a wholly-owned
subsidiary of Trinity Biotech. DDI was the surviving legal entity in the merger
and was subsequently renamed Trinity Biotech Inc ("TBI"). In December 1994,
Trinity Biotech acquired the remaining 50% of FHC which its subsidiary TBI did
not own. During 1995, Trinity Biotech raised net proceeds in excess of US$6
million as a result of a private placement of the Company's shares. In February
1997, the Company purchased the entire share capital of Clark Laboratories Inc
("Clark"), which now trades as Trinity Biotech USA, and in June 1997, the
Company purchased the entire share capital of Centocor UK Holdings Ltd
("Centocor"). In 1998, the Company made four product line acquisitions: the
acquisition of the Microzyme and Macra Lp(a) product lines in June 1998 and the
acquisition of the MicroTrak and Cambridge Diagnostics HIV product lines in
September 1998. The manufacture of these product lines has been transferred to
the Company's Jamestown, NY and Bray, Co. Wicklow, Ireland manufacturing
facilities. In March 2000, the Company purchased 100% of the share capital of
MarDx Diagnostics Inc ("MarDx") and in December 2000, the assets of Bartels Inc
were acquired. The Bartels plant in Seattle closed in June 2001 and production
has been transferred to the Californian, New York and Irish factories. In
October 2001, the Company purchased the Amerlex hormone business of Ortho
Clinical Diagnostics and in December 2001 the Company acquired the assets of the
Biopool haemostasis business. In October 2001, Trinity Biotech established a
direct sales operation in Germany, Trinity Biotech GmbH. In August 2002, Trinity
Biotech acquired the haemostasis division of Sigma Diagnostics, part of
Sigma-Aldrich. The Sigma diagnostics haemostasis business comprised a
comprehensive portfolio of reagents manufactured in St Louis, Missouri and the
Amelung range of automated and semi-automated instruments manufactured in Lemgo,
Germany. During 2003, Trinity Biotech completed the transfer of the Sigma
haemostasis test manufacturing from St. Louis to the Irish facility. On
September 30, 2002, Trinity Biotech closed the haemostasis manufacturing
facility in Ventura, California which it had acquired from Xtrana, (Biopool),
and has integrated these operations into the Wicklow manufacturing facility in
Ireland. Trinity Biotech also acquired the speciality clinical chemistry
business from Sigma Diagnostics in December 2002. This business consists of
several specialised products that are clearly differentiated in the marketplace,
including ACE, Bile Acids, Lactate, Oxalate and G6PDH. During 2002, Trinity
Biotech established a small direct sales operation in the United Kingdom to
handle the Sigma haemostasis and clinical chemistry product lines. For further
information about the company's principal products and principal markets please
refer to Item 4, "Information on the Company".
In October 2000, Trinity Biotech subscribed for a 33% shareholding in HiberGen
Limited ("HiberGen"). In July 2001 the Company subscribed for a further 300,000
Ordinary Shares in HiberGen, increasing its shareholding to 40%. On April 3,
2002, the Company increased its shareholding to 42.9% by the acquisition of a
further 165,000 Ordinary Shares in HiberGen Limited. The consideration of
US$201,874 was satisfied by the issue of 156,189 `A' Ordinary Shares in Trinity
Biotech plc. During 2003, HiberGen Limited was unsuccessful in raising
additional funds and on November 14, 2003, the Board of HiberGen Limited decided
to cease trading.
In May 1999 Trinity Biotech obtained a secondary listing on the Irish Stock
Exchange and in April 2000 raised US$13.4m by the issue of 4 million Class 'A'
Ordinary Shares to institutional investors.
Factors affecting our results
The global diagnostics market is growing rapidly due to, among other reasons,
the ageing population and the increasing demand for rapid tests in a clinical
environment.
Our revenues are directly related to our ability to identify high potential
products while they are still in development and to bring them to market quickly
and effectively. Efficient and productive research and development is crucial in
this environment as we, like our competitors, search for effective and
cost-efficient solutions to diagnostic problems. The growth in new technology
will almost certainly have a fundamental effect on the diagnostics industry as a
whole and upon our future development. For further information about the
company's principal products, principal markets and competition please refer to
Item 4, "Information on the Company".
18
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.
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 on January 1, 2002, we have
ceased to amortize goodwill. In lieu of amortization, we were required to
perform an annual impairment review of the carrying value of our goodwill and
indefinite-lived intangible assets. On January 1, 2002 the Group performed the
required impairment review of goodwill and indefinite-lived intangible assets
and determined that there was no impairment. On December 31, 2002 and December
31, 2003 the Group performed further impairment tests of goodwill and
indefinite-lived intangible assets and concluded that there was no impairment in
the carrying value of these assets at those dates.
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 and for which
no further re-processing can be performed. We also consider recent trends in
revenues for various inventory items and instances where the realizable value of
inventory is likely to be less than its carrying value.
19
Allowance for doubtful debts
We make judgments 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 judgment is required in determining our worldwide income tax expense
provision. In the ordinary course of a global business, there are many
transactions and calculations where the ultimate tax outcome is uncertain. Some
of these uncertainties arise as a consequence of revenue sharing and cost
reimbursement arrangements among related entities, the process of identifying
items of revenue and expense that qualify for preferential tax treatment and
segregation of foreign and domestic income and expense to avoid double taxation.
Although we believe that our estimates are reasonable, no assurance can be given
that the final tax outcome of these matters will not be different than that
which is reflected in our historical income tax provisions and accruals. Such
differences could have a material effect on our income tax provision and net
income in the period in which such determination is made. Deferred tax assets
and liabilities are determined using enacted tax rates for the effects of net
operating losses and temporary differences between the book and tax bases of
assets and liabilities. We record a valuation allowance to reduce our deferred
tax assets to the amount of future tax benefit that is more likely than not to
be realized. While we have considered future taxable income and ongoing prudent
and feasible tax planning strategies in assessing the need for the valuation
allowance, there is no assurance that the valuation allowance would not need to
be increased to cover additional deferred tax assets that may not be realizable.
Any increase in the valuation allowance could have a material adverse impact on
our income tax provision and net income in the period in which such
determination is made. In addition, we operate within multiple taxing
jurisdictions and are subject to audits in these jurisdictions. These audits can
involve complex issues that may require an extended period of time for
resolution. In management's opinion, adequate provisions for income taxes have
been made.
Asset Retirement Obligations
The Company is responsible for certain costs of restoring leased premises to
their original condition. The terms of such obligations vary. Generally, a
maximum obligation is not explicitly stated. Because the obligated amounts of
these types of agreements often are not explicitly stated, the overall maximum
amount of the obligations cannot be reasonably estimated. Historically, the
Company has not been obligated to make significant payments for these
obligations, and no liabilities have been recorded for these obligations on its
balance sheet as of December 31, 2003 and 2002.
Recent 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 was effective for fiscal years beginning after December 15,
2001, with earlier application encouraged. The Company adopted SFAS 144 as of
January 1, 2002. Such adoption had no material impact on the results of the
Company.
Costs Associated with Exit or Disposal Activities
The Financial Accounting Standards Board issued Statement No. 146, "Accounting
for Costs Associated with Exit or Disposal Activities" ("SFAS 146") in June
2002. SFAS 146 provides guidance on the recognition and measurement of
liabilities associated with exit or disposal activities and requires that such
liabilities be recognized when incurred. In many cases, those costs will be
recognized as liabilities in periods following a commitment to a plan, not at
the date of commitment. SFAS 146 also changes the recognition of one-time
termination benefits, such as severance pay or other termination indemnities,
whenever the benefit arrangement requires employees to render future service
beyond a "minimum retention period." SFAS 146 also addresses the accounting for
other costs associated with an exit or disposal activity, such as costs to
consolidate or close facilities and relocate employees. A liability for such
costs has to be recognized and measured at its fair value in the period in which
it is incurred. SFAS 146 is effective for exit or disposal activities that are
initiated after December 31, 2002. Application of SFAS 146 had no material
impact on the consolidated financial statements of the Company as it had no exit
costs in 2003.
Guarantor's Accounting and Disclosure Requirements for Guarantees, Including
Indirect Guarantees of Indebtedness of Others
The Financial Accounting Standards Board issued FASB Interpretation No. 45
"Guarantor's Accounting and Disclosure Requirements for Guarantees, Including
Indirect Guarantees of Indebtedness of Others", ("FIN 45") in November 2002. FIN
45 requires a guarantor to recognize, at the inception of a guarantee, a
liability for the fair value of the obligation undertaken by it in issuing the
guarantee. It also expands the disclosure requirements in the financial
statements of the guarantor with respect to its obligations under certain
guarantees that it has issued. The Company is required to adopt the initial
recognition and initial measurement accounting provisions of this interpretation
on a prospective basis to guarantees issued or modified after December 31, 2002.
The disclosure requirements are required to have been adopted as of December 31,
2002. Application of FIN 45 had no material impact on the consolidated financial
statements of the Company as, in the normal course of business, the Company does
not issue guarantees to third parties and the Company had no guarantees in 2003.
20
Consolidation of Variable Interest Entities
The Financial Accounting Standards Board issued FASB Interpretations No. 46,
"Consolidation of Variable Interest Entities", ("FIN 46") in January 2003. This
interpretation clarifies the application of Accounting Research Bulletin No. 51,
"Consolidated Financial Statements," to certain entities in which equity
investors do not have the characteristics of a controlling financial interest or
do not have sufficient equity at risk for the entity to finance its activities
without additional subordinated financial support from other parties. The
provisions of FIN 46 were revised in December 2003 to be effective for financial
statement periods ended after March 15, 2004. The adoption of FIN 46 is not
expected to have a material impact on the consolidated financial statements of
the Company as the company has a controlling interest in all of its
subsidiaries.
Derivative Instruments and Hedging Activities
The Financial Accounting Standards Board issued Statement No. 149, " Amendment
of Statement 133 on Derivative Instruments and Hedging Activities", ("SFAS 149")
in April 2003. SFAS 149 amends and clarifies financial accounting and reporting
for derivative instruments, including certain derivative instruments embedded in
other contracts (collectively referred to as "derivatives") and for hedging
activities under SFAS No. 133, "Accounting for Derivative Instruments and
Hedging Activities". This statement requires contracts with comparable
characteristics be accounted for similarly. In particular, this Statement (a)
clarifies under what circumstances a contract with an initial net investment
meets the characteristic of a derivative as discussed in SFAS No. 133, (b)
clarifies when a derivative contains a financing component and (c) amends the
definition of an "underlying" to conform it to language used in FASB
Interpretation No. 45, "Guarantor's Accounting and Disclosure Requirements for
Guarantees, Including Indirect Guarantees of Indebtedness of Others". This
Statement is effective for contracts entered into or modified after June 30,
2003 and for hedging relationships designated after June 30, 2003. The adoption
of the new rules had no material impact on the consolidated financial statements
of the Company.
Accounting for Certain Financial Instruments with Characteristics of both
Liabilities and Equity
The Financial Accounting Standards Board issued SFAS No. 150, "Accounting for
Certain Financial Instruments with Characteristics of both Liabilities and
Equity", ("SFAS 150") in May 2003. SFAS 150 establishes standards for how an
issuer classifies and measures certain financial instruments with
characteristics of both liabilities and equity. It requires that an issuer
classify a financial instrument that is within its scope as a liability (or an
asset in some circumstances). Many of those instruments were previously
classified as equity. SFAS 150 is effective for financial instruments entered
into or modified after May 31, 2003. Application of SFAS 150 had no material
impact on the consolidated financial statements of the Company as it had no such
financial instruments in 2003.
Results of Operations
Year ended December 31, 2003 compared to the Year Ended December 31, 2002
The following compares our results in the year ended December 31, 2003 to those
of the year ended December 31, 2002. Our analysis is divided as follows:
1. Overview
2. Revenues
3. Operating Expenses
4. Retained Profit
1. Overview
In US dollars, our consolidated revenues increased by 26%; operating income grew
by 47%; retained profit increased by 18% and cash flow from operating activities
increased by 17%.
Geographically, 55% of our sales were generated in the USA, 30% in Europe and
15% in the rest of the world.
The gross margin for the year ended December 31, 2003 was 49.9% compared to
50.6% for the year ended December 31, 2002. The decrease in gross margin is
partly explained by the weakening of the dollar, causing the margin to drop by
0.7%.
21
Our operating margin in 2003 was 14.7% of sales, an increase of 2% over the
12.7% of sales of the previous year. This is due to the increase in turnover,
primarily attributable to a full year's revenues of the Sigma haemostasis and
Sigma speciality clinical chemistry product lines in 2003. This is partially
offset by (i) the increase in cost of sales arising from these product lines of
US$8,710,000 and (ii) the increase in administration expenses due to the
expansion of sales and marketing activities.
As a result of these factors, operating income increased by US$3,086,000 to
US$9,669,000.
2. Revenues
The following table sets forth selected sales data for each of the periods
indicated.
----------------------- ----------------------------------------
Year ended December 31,
----------------------- ----------------------------------------
2003 2002
----------------------- ----------- ------------ -------------
(US$ '000) (US$ '000) % Change
----------------------- ----------- ------------ -------------
Revenues
----------------------- ----------- ------------ -------------
Infectious diseases 35,127 37,829 (7)
----------------------- ----------- ------------ -------------
Haemostasis 24,435 13,780 77
----------------------- ----------- ------------ -------------
Clinical Chemistry 6,113 369 1,557
----------------------- ----------- ------------ -------------
Total 65,675 51,978 26
----------------------- ----------- ------------ -------------
Trinity Biotech's consolidated revenues for the year ended December 31, 2003
were US$65,675,000 compared to consolidated revenues of US$51,978,000 for the
year ended December 31, 2002.
US$2,200,000 of the decrease of US$2,702,000 in infectious diseases revenues
resulted from declining sales under the distribution agreement with
Carter-Wallace, Inc. ("Carter-Wallace") and its affiliate Wampole Laboratories
("Wampole"), now owned by Inverness Medical Innovations, Inc. ("Inverness
Medical"). The Company believes this is due to Inverness Medical and Wampole
attempting to convert customers from the Trinity Biotech product to an
alternative product. Accordingly, in December 2003, the Company filed legal
action against Inverness Medical and Wampole for declaratory judgment and breach
of contract. In January 2004, Inverness Medical countersued and sought a
preliminary injunction to prevent the Company from selling direct in the US any
of its products which are competitive with products sold by Inverness Medical
and sourced by other suppliers. The Superior Court of Middlesex County,
Massachusetts, denied the motion for preliminary injunction on January 28, 2004.
For further information relating to this matter please refer to Item 8 "Legal
Proceedings". The Company has decided to sell its products directly in the US
and has increased its direct sales force in 2004 in the US to approximately 70
staff.
Additional revenues of US$5,744,000 were earned on clinical chemistry products
in 2003 due to the contribution of a full year's sales of the Sigma speciality
clinical chemistry product line in 2003. This compares to one month's revenues
from the same product line in 2002.
The increase in haemostasis revenues of US$10,655,000 is principally
attributable to a full year's revenues of the Sigma haemostasis product line in
2003 as compared to five month's revenues, from August to December, in 2002.
For further information about the company's principal products, principal
markets and competition please refer to Item 4, "Information on the Company".
The following table sets forth selected sales data, analysed by geographic
region:
---------------------- ------------------------------------------
Year ended December 31,
---------------------- ------------------------------------------
2003 2002
---------------------- ------------- ------------ -------------
(US$ '000) (US$ '000) % Change
---------------------- ------------- ------------ -------------
Revenues
---------------------- ------------- ------------ -------------
USA 36,299 33,512 8
---------------------- ------------- ------------ -------------
Europe 19,982 11,899 68
---------------------- ------------- ------------ -------------
Middle East /Africa 6,249 4,396 42
---------------------- ------------- ------------ -------------
Other overseas 3,145 2,171 45
---------------------- ------------- ------------ -------------
Total 65,675 51,978 26
---------------------- ------------- ------------ -------------
22
The US$2,787,000 increase in the US is attributable to the increase in
haemostasis and clinical chemistry sales of US$5,300,000 due to the inclusion of
a full year's revenues of the Sigma haemostasis and Sigma speciality clinical
chemistry product lines. This is partially offset by the US$2,200,000 reduction
in sales from Wampole discussed above.
The US$8,083,000, US$1,853,000 and US$974,000 increases in the Europe, Middle
East/Africa and other overseas segments, respectively, are primarily driven by
the inclusion of a full year's revenues of the Sigma haemostasis and Sigma
speciality clinical chemistry product lines.
3. Operating Expenses
The following table sets forth our operating expenses.
------------------------- -----------------------------------------
Year ended December 31,
------------------------- --------------------------- -------------
2003 2002
------------------------- ------------ ------------- -------------
(US$ '000) (US$ '000) % Change
------------------------- ------------ ------------- -------------
------------------------- ------------ ------------- -------------
Revenues 65,675 51,978 26
------------------------- ------------ ------------- -------------
Cost of sales (32,877) (25,690) 28
------------------------- ------------ ------------- -------------
Research & development (5,210) (4,471) 17
------------------------- ------------ ------------- -------------
Administrative expenses (17,919) (15,234) 18
------------------------- ------------ ------------- -------------
Operating profit 9,669 6,583 47
------------------------- ------------ ------------- -------------
Cost of sales
Trinity Biotech's consolidated cost of sales increased 28% or by US$7,187,000
from US$25,690,000 for the year ended December 31, 2002 to US$32,877,000 for the
year ended December 31, 2003. The increase in cost of sales is primarily
attributable to (i) the Sigma haemostasis and speciality clinical chemistry
product lines which contributed an additional US$8,710,000 to cost of sales, and
(ii) the decrease in cost of sales associated with the decrease in revenues for
infectious diseases sales categories of US$1,523,000.
Research and development
Research and development ("R&D") expenditure increased to US$5,210,000 in 2003.
This represents 7.9% of consolidated revenues and is comparable to R&D spend in
2002 of US$4,471,000 or 8.6% of consolidated revenues. For a consideration of
the various R&D projects see "Research and Products under Development" in Item 5
of the 20-F.
Administrative expenses
Overall normal administrative expenses account for 27% of consolidated revenues
in 2003 which compares with 29% in 2002. The following table outlines the
breakdown of administrative expenses compared to a similar breakdown for 2002.
-------------- --------------------------------------------------------
Year ended December 31,
-------------- --------------------- ------------------- ------------
2003 2002 Increase/(decrease) % Change
US$'000 US$'000 US$'000
-------------- --------- ---------- ------------------- ------------
SG&A 17,063 12,848 4,215 33
-------------- --------- ---------- ------------------- ------------
Amortization 856 2,386 (1,530) (64)
-------------- --------- ---------- ------------------- ------------
Total 17,919 15,234 2,685 18
-------------- --------- ---------- ------------------- ------------
SG&A
Administrative expenses increased 33% or by US$4,215,000 from US$12,848,000 to
US$17,063,000, this compares to revenue growth of 26% during the same period.
The higher growth is attributable to the strengthening of the Group's sales and
marketing and administrative functions following the acquisitions of the Sigma
haemostasis product line in August 2002 and the Sigma clinical chemistry
product line in November 2002. In April 2002 Sigma Aldrich announced plans to
sell the assets of its diagnostics business. When the Group took on these
businesses in August and November 2002 a significant selling effort was
required to retain the customer base.
Specifically the Group (i) opened a new sales and marketing facility in St.
Louis, Missouri in October 2002, (ii) opened a direct sales and marketing
operation in the UK in October 2002, and (iii) expanded its sales and marketing
operations in Germany and Ireland to cater for the new product lines acquired in
these acquisitions. This expansion occurred in Quarter 4, 2002 and 2003
represented the first full year's operation of these expanded sales and
marketing and administrative functions.
The effect of these acquisitions was to significantly expand the haemostasis
product line into instruments, consumables and a wider range of reagents, and to
introduce a new product line in clinical chemistry. Accordingly the focus of the
sales and marketing effort changed from infectious disease and the Biopool
haemostasis reagents to encompass a broader haemostasis range and clinical
chemistry. This expansion in the volume and complexity of our product range
necessitated a substantial increase in the level of sales and marketing effort
and a redirection and retraining of our existing salesforce and distributors.
A detailed analysis of this increase in SG&A expenses of $4,215,000 in 2003 is
as follows:
o An increase of $1,691,000 in the Group's US operations,
principally attributable to expansion of the Group's sales and
marketing capability within the US in order to reflect the
Group's expanding product range as noted above. 2003
represented the first full year of the group's central sales
& marketing facility in St. Louis which was established in
October 2002.
23
o An increase in SG&A expenses of $1,613,000 in the Group's
operations in Germany. This is principally attributable to the
inclusion of a full year's SG&A expenses incurred at the
Group's haemostasis instrument manufacturing facility in Lemgo
versus four months of such costs in 2002. This plant was
acquired as part of the acquisition of the haemostasis
business line from Sigma in August 2002.
o An increase of $459,000 due to the inclusion of a full year of
SG&A costs in the UK, compared to three months in 2002
following the establishment of a UK sales office in
Oxfordshire in October 2002.
o The remaining increase of $452,000 is principally attributable
to;
(i) a strengthening of the Group's central sales and
marketing function, located in Bray, Ireland, in line
with the broadening of the Group's product range
($1,392,000);
(ii) increased central administrative costs ($895,000) in
Bray, Ireland reflecting the significant increase in
level of activity now being undertaken at Bray
following the transfer of the manufacture of the
Sigma and Biopool product lines to Bray during 2003
and increase in head office administrative functions
reflective of the increasing size of the Group and
the level of fundraising and acquisition activities;
and,
(iii) As offset by foreign exchange gains of US$1,835,000
incurred by the Group which arose during the year.
Amortization
The decrease in amortisation of US$1,530,000 from US$2,386,000 to US$856,000 is
largely attributable to the release of negative goodwill of US$1,572,000 arising
from the Sigma haemostasis acquisition in 2002. Following the completion of the
fair value exercises in 2003 in respect of the Sigma Haemostasis and Sigma
Clinical Chemistry acquisitions made during 2002, amendments have been made to
the fair values reported in the 2002 financial statements. The amendments relate
to the identification of additional obligations of US$928,881 assumed on the
acquisition of the Sigma Haemostasis business, the completion of the fair value
exercise on inventory acquired in both acquisitions resulting in the recognition
of additional value of US$3,031,420 and the recognition of additional costs of
US$67,595 relating to the Sigma Hemostasis acquisition and US$97,479 relating to
the Clinical Chemistry acquisition. In accordance with Irish GAAP, negative
goodwill has been released to the profit and loss account as the related assets
are utilised. Please refer to Note 22 "Acquisition of Businesses" in Item 18,
"Financial Statements", for full disclosure of these acquisitions and fair value
adjustments.
4. Retained Profit
The following table sets forth selected income statement data for each of the
periods indicated.
--------------------------------- ---------------------------------------------
Year ended December 31,
--------------------------------- ------------------------------- ------------
2003 2002
--------------------------------- -------------- --------------- ------------
(US$ '000) (US$ '000) % Change
--------------------------------- -------------- --------------- ------------
Operating Income 9,669 6,583 47
--------------------------------- -------------- --------------- ------------
Net interest charge (619) (601) 3
--------------------------------- -------------- --------------- ------------
Profit before tax and Share 9,050 5,982 51
of operating loss in associated
company and impairment
--------------------------------- -------------- --------------- ------------
--------------------------------- -------------- --------------- ------------
Share of operating loss in (1,067) (317) 237
associated company
and impairment
--------------------------------- -------------- --------------- ------------
--------------------------------- -------------- --------------- ------------
Profit before tax 7,983 5,665 41
--------------------------------- -------------- --------------- ------------
--------------------------------- -------------- --------------- ------------
Tax (2,186) (768) 185
--------------------------------- -------------- --------------- ------------
--------------------------------- -------------- --------------- ------------
Retained profit 5,797 4,897 18
--------------------------------- -------------- --------------- ------------
Net interest charge
Net interest increased to US$619,000 in 2003 compared to US$601,000 in 2002. The
increased level of interest reflects the Company's higher level of net debt
during the year, mainly attributable to the completion of the US$10 million club
banking facility with Allied Irish Banks plc and Bank of Scotland (Ireland) Ltd
in June 2003 and the private placement of US$20 million of 3% convertible notes
in July 2003. Please refer to "liquidity and Capital Resources" later in this
section for information on Trinity Biotech's use of debt.
24
Share of loss in associated company and impairment
On October 2, 2000, the Company acquired 33% of the share capital of HiberGen
Limited for a total consideration of US$1,371,642. On July 2, 2001 the Company
subscribed for a further 300,000 Ordinary Shares of (euro)0.0127 each in
HiberGen Limited, increasing its shareholding to 40%, at a cost of US$309,399.
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. During 2003 HiberGen Limited was unsuccessful in
raising additional funds and on November 14, 2003, the Board of HiberGen Limited
decided to cease trading.
Taxation
A tax charge of US$2,186,000 was incurred in the year ended December 31, 2003.
The comparable charge for 2002 was US$768,000. This represented an increase in
current tax in absolute terms of US$1,278,000 and an increase in deferred tax of
US$140,000. The increase in current tax is primarily attributable to a higher
corporation tax charge in Ireland in 2003 as the level of relief for losses
carried forward enjoyed by the Company in previous years is no longer available.
The utilization of losses carried forward also helped to increase the Group net
deferred tax charge. For further details on the Group's tax charge please refer
to Note 9 "Deferred Taxation" and Note 17 "Income Taxes" of the Notes to the
Consolidated Financial Statements contained in Item 18 "Financial Statements" of
this Form 20-F.
Retained Profit
Retained profit increased by US$900,000, from US$4,897,000 to US$5,797,000. As a
percentage of consolidated revenues this represents a decrease from 9.4% to
8.8%, principally due to the write-off of the investment in HiberGen.
Year Ended December 31, 2002 Compared to the Year Ended December 31, 2001
The following compares our results in the year ended December 31, 2002 to those
of the year ended December 31, 2001. Our analysis is divided as follows:
1. Overview
2. Revenues
3. Operating Expenses
4. Retained Profit
1. Overview
In US dollars, our consolidated revenues increased by 40%; operating income grew
by 116%; retained profit increased by 107% and cash flow from operating
activities decreased by 37%.
Geographically, 64% of our sales were generated in the USA, 23% in Europe and
13% in the rest of the world.
The gross margin for the year ended December 31, 2002 was 50.6% compared to
51.3% 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.
Our operating margin in 2002 was 12.7% of sales, an increase of 4.5% over the
8.2% of sales of the previous year. This is due to the increase in turnover,
primarily attributable to the full integration of the Biopool acquisition and
the additional contributions from the Sigma haemostasis and Sigma speciality
clinical chemistry product lines, of US$14,149,000. This is partially offset by
(i) the increase in cost of sales arising from these product lines of
US$7,093,000; (ii) the increase in research and development of US$1,691,000
mainly arising from the acquisitions made in 2001 and 2002 and (iii) the
increase in administration costs due to the increase in the direct sales force
in the US, Germany and the UK.
As a result of these factors, operating income increased by US$3,535,000 to
US$6,583,000.
25
2. Revenues
The following table sets forth selected sales data for each of the periods
indicated.
------------------------- --------------------------------------------
Year ended December 31,
------------------------- --------------------------------------------
2002 2001
------------------------- -------------- ------------- -------------
(US$ '000) (US$ '000) % Change
------------------------- -------------- ------------- -------------
Revenues
------------------------- -------------- ------------- -------------
Infectious diseases 37,829 37,076 2
------------------------- -------------- ------------- -------------
Haemostasis 13,780 - -
------------------------- -------------- ------------- -------------
Clinical Chemistry 369 - -
------------------------- -------------- ------------- -------------
Total 51,978 37,076 40
------------------------- -------------- ------------- -------------
Trinity Biotech's consolidated revenues for the year ended December 31, 2002
were US$51,978,000 compared to consolidated revenues of US$37,076,000 for the
year ended December 31, 2001.
The growth in revenues of 40% was due to a combination of factors including
additional revenue of US$753,000 from the organic growth of existing product
lines, US$9,618,000 from the full integration of the Biopool acquisition which
was acquired in December 2001, the added contribution of US$4,162,000 from the
Sigma haemostasis product line from August 2002 and US$369,000 from the
introduction of the Sigma speciality clinical chemistry product line with effect
from December 2002.
The following table sets forth selected sales data, analysed by geographic
region:
----------------------- ---------------------------------------
Year ended December 31,
----------------------- ---------------------------------------
2002 2001
----------------------- ------------ ------------ -----------
(US$ '000) (US$ '000) % Change
----------------------- ------------ ------------ -----------
Revenues
----------------------- ------------ ------------ -----------
USA 33,512 25,058 34
----------------------- ------------ ------------ -----------
Europe 11,899 6,880 73
----------------------- ------------ ------------ -----------
Middle East /Africa 4,396 3,900 13
----------------------- ------------ ------------ -----------
Other overseas 2,171 1,238 75
----------------------- ------------ ------------ -----------
Total 51,978 37,076 40
----------------------- ------------ ------------ -----------
The major segmental changes occurred in the US and Europe regions, with
increases of US$8,454,000 and US$5,019,000 respectively. These increases are
largely attributable to the increase in haemostasis revenues following the
inclusion of a full year's revenues from the Biopool product line and five
months of revenue from the Sigma haemostasis product line, acquired in August
2002.
3. Operating Expenses
The following table sets forth our operating expenses.
------------------------------------- -----------------------------------
Year ended December 31,
------------------------------------- -----------------------------------
2002 2001
------------------------------------- ---------- ---------- -----------
(US$ '000) (US$ '000) % Change
------------------------------------- ---------- ---------- -----------
------------------------------------- ---------- ---------- -----------
Revenues 51,978 37,076 40
------------------------------------- ---------- ---------- -----------
Cost of sales (25,690) (18,050) 42
------------------------------------- ---------- ---------- -----------
Research & development (4,471) (2,780) 61
------------------------------------- ---------- ---------- -----------
Administrative expenses - normal (15,234) (9,563) 59
------------------------------------- ---------- ---------- -----------
Administrative expenses - exceptional - (3,635) (100)
------------------------------------- ---------- ---------- -----------
Operating profit 6,583 3,048 116
------------------------------------- ---------- ---------- -----------
Cost of Sales
Trinity Biotech's consolidated cost of sales increased by US$7,640,000 from
US$18,050,000 for the year ended December 31, 2001 to US$25,690,000 for the year
ended December 31, 2002. The increase in cost of sales is primarily attributable
to (i) the Biopool acquisition which added US$4,832,000 to cost of sales, (ii)
the Sigma haemostasis and speciality clinical chemistry product lines which
contributed an additional US$2,261,000 to cost of sales, and (iii) the increased
cost of sales from organic sales growth which contributed an additional
US$516,000 to cost of sales in 2002. The balance of the increase of US$31,000 is
attributable to increased overhead costs and is principally driven by inflation.
26
RESEARCH AND DEVELOPMENT
Research and development ("R&D") expenditure increased to US$4,471,000 in 2002.
This represents 8.6% of consolidated revenues and is comparable to the R&D spend
in 2001 of US$2,780,000 or 7.5% of consolidated revenues. The increase in
absolute 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.
ADMINISTRATIVE EXPENSES
Normal administrative expenses for the year ended December 31, 2002 amounted to
US$15,234,000 compared to US$9,563,000 for the year ended December 31, 2001. The
following table outlines the breakdown of administrative expenses compared to a
similar breakdown for 2001.
------------------------- -----------------------------------------------------
Year ended December 31,
------------------------- -----------------------------------------------------
2002 2001 Increase/(decrease) % Change
US$'000 US$'000 US$'000
------------------------- --------- --------- ------------------- ----------
SG&A - normal 12,848 7,561 5,287 70
------------------------- --------- --------- ------------------- ----------
Amortization 2,386 2,002 384 19
------------------------- --------- --------- ------------------- ----------
Administrative expenses - - 3,635 (3,635) (100)
exceptional
------------------------- --------- --------- ------------------- ----------
Total 15,234 13,198 2,036 15
------------------------- --------- --------- ------------------- ----------
SG&A
SG&A costs in normal administrative expenses amount to US$12,848,000 in 2002,
an increase from US$7,561,000 in 2001. This is a 70% 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 and an expansion of our sales
and marketing effort in Ireland. As described above this was necessitated by
the acquisitions of the Sigma product lines completed in August 2002 and
November 2002.
Amortization
Amortization increased to US$2,386,000 in 2002 compared to US$2,002,000 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.
Administrative Expenses - Exceptional
There was no exceptional administrative charge recognised in 2002. An
exceptional administrative expense of US$3,635,000 was recognised in 2001. Of
this charge US$2,835,000 relates to commitments made on the acquisition of the
assets of the Biopool haemostasis 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$800,000 relates to the acquisition of Bartels Inc on December 8, 2000.
This charge comprised payments to employees. The restructuring programme at
Bartels was implemented during the first two quarters of 2001 and the Seattle
facility was closed on June 8, 2001.
27
4. Retained Profit
The following table sets forth selected income statement data for each of the
periods indicated.
-------------------------------- --------------------------------------
Year ended December 31,
-------------------------------- --------------------------------------
2002 2001
-------------------------------- ---------- ----------- -------------
US$ '000) (US$ '000) % Change
-------------------------------- ---------- ----------- -------------
Operating Income 6,583 3,048 116
-------------------------------- ---------- ----------- -------------
Net interest charge (601) (396) 52
-------------------------------- ---------- ----------- -------------
Profit before tax and
share of operating loss
in associated company 5,982 2,652 126
-------------------------------- ---------- ----------- -------------
-------------------------------- ---------- ----------- -------------
Share of operating loss
in associated company (317) (269) 18
-------------------------------- ---------- ----------- -------------
-------------------------------- ---------- ----------- -------------
Profit before tax 5,665 2,383 138
-------------------------------- ---------- ----------- -------------
-------------------------------- ---------- ----------- -------------
Tax (768) (16) 4,700
-------------------------------- ---------- ----------- -------------
-------------------------------- ---------- ----------- -------------
Retained profit 4,897 2,367 107
-------------------------------- ---------- ----------- -------------
Net Interest Charge
Net interest increased to US$601,000 in 2002 compared to US$396,000 in 2001. The
increased level of interest reflects the Company's higher level of net debt
during the year.
Taxation
A tax charge of US$768,000 was incurred in the year ended December 31, 2002. The
comparable charge for 2001 was US$16,000. The tax charge in previous years has
been low due to the effect of net operating losses forward. In 2002 the
effective rate of tax was 13.5%. The Group enjoys the benefit of a 10% tax rate
in Ireland and also had some operating losses forward which were utilised during
the year. For further details on the Group's tax charge please refer to Note 9
"Deferred Taxation" and Note 17 "Income Taxes" of the Notes to the Consolidated
Financial Statements contained in Item 18 "Financial Statements" of this Form
20-F.
Retained profit
Retained profit as a percentage of consolidated revenues increased from 6.4% to
9.4%, principally due to the acquisition of the Sigma haemostasis and Sigma
speciality clinical chemistry product lines and the full integration of the
Biopool haemostasis product lines.
Liquidity and Capital Resources
Financing
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. During 2003 these
debentures were fully converted into 666,667 Class `A' Ordinary Shares of the
Company.
In March 2000, Trinity Biotech 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. 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 December 2000, the assets 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.
28
In October 2001, Trinity Biotech 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 of the
Biopool haemostasis 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 haemostasis division of Sigma
Diagnostics for a total consideration of US$1,428,001. The consideration was
satisfied in cash. On November 27, 2002, the Company also acquired the
speciality clinical chemistry product line from Sigma Diagnostics for a total
consideration of US$4,412,372 satisfied in cash and deferred consideration. The
cash consideration was partly financed by the issue of US$2.5m of convertible
debentures. The deferred consideration of US$1,810,000 was paid during 2003.
In November 2002, the Company completed a private placement of (i) US$2,500,000
principal amount of 5.25% convertible debentures and (ii) 50,000 warrants (the
"Second Warrants") to purchase 'A' Ordinary Shares of the 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. During 2003, the debenture was 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 150,000 warrants
expired unexercised on June 25, 2002. During 2003 133,701 of the remaining First
Warrants were exercised and since year end a further 100,000 of these warrants
have been exercised, the balance of these warrants expire in December 2004. The
Second Warrants are each exercisable to purchase one 'A' Ordinary Share of the
Company at US$1.50 and will expire in November 2007.
In June 2003, Trinity Biotech completed a new US$10,000,000 club banking
facility with Allied Irish Bank plc and Bank of Scotland (Ireland) Ltd. The new
facility consists of a five year term loan of US$6,000,000 and a one year
revolver of US$4,000,000. This facility was partly used to repay existing loans
and the loan notes payable to Xtrana, Inc. At December 31, 2003, the term loan
was fully drawn and US$3,000,000 of the revolver had been drawn down.
In July 2003, the Company completed a private placement of US$20,000,000
principal amount of 3% convertible debentures. The debentures bear interest at a
rate of 3% per annum and are convertible into Class 'A' Ordinary Shares of the
Company at a price of US$3.55. In December 2003, US$6,355,000 of the
US$20,000,000 principal amount of the debenture was converted into 1,790,141
Class 'A' Ordinary Shares of the Company. Since the year end, a further
US$427,500 of the principal amount of the debenture has been converted into
120,423 Class 'A' Ordinary Shares of the Company. As part of the July placement,
convertible notes in the aggregate principal amount of up to US$5,000,000 could
be issued at the option of the investors by the later of January 9, 2004 and the
three month anniversary of the effective date of the registration statement. In
March 2004, the investors exercised this option in full and the Company
completed a further placement of US$5,000,000 principal amount of 3% convertible
debentures. The debentures bear interest at a rate of 3% per annum and are
convertible into Class 'A' Ordinary Shares of the Company at a price of US$4.
Since the year end, the Company has completed a private placement of 5,294,118
of Class 'A' Ordinary Shares of the Company at a price of US$4.25 per share. The
investors were granted five year warrants to purchase an aggregate of 1,058,824
Class 'A' Ordinary Shares of the Company at an exercise price of US$5.25 per
share. Under the terms of the placement, investors were also granted the right
to purchase an additional 2,647,059 Class 'A' Ordinary Shares of the Company at
a price of US$4.25 per share for a period of up to 30 days after the closing of
the transaction. An additional 431,617 Class 'A' Ordinary Shares of the Company
were issued within the 30 day period following the closing of the transaction to
investors who exercised this option.
Cash management
As at December 31, 2003, Trinity Biotech's consolidated cash and cash
equivalents were US$20,563,000. This compares to cash and cash equivalents of
US$5,808,000 at December 31, 2002. The increase is due to cash inflow of
US$4,176,000 from operations, the issue of share capital, the drawdown of
financial facilities and the issue of US$20 million convertible debentures,
offset by the repayment of bank borrowings and cash payments for the purchase of
businesses and fixed assets. This resulted in an increase in cash and liquid
resources of US$14,755,000 during the year.
29
A significant portion of the Company's activities are conducted in US Dollars.
The primary foreign exchange risk arises from the fluctuating value of the
Company's Euro expenses as a result of the movement in the exchange rate between
the US Dollar and the Euro. Arising from this, the Company pursues a treasury
policy which aims to sell US Dollars forward to match a portion of its uncovered
Euro expenses at exchange rates lower than budgeted exchange rates. The
Company's current hedging policy is to cover a portion of its expenses forward
for a minimum of three months. The Company expects that its forward contracts as
at December 31, 2003 will have a positive impact on the cashflows of the
business. At December 31, 2003 forward contracts with a carrying value of US$Nil
had a fair value of US$3,121,000 (asset) and US$2,775,000 (liability)
respectively.
As at December 31, 2003, year end borrowings were US$26,271,000 and cash in hand
was US$20,563,000. For a more comprehensive discussion of the Company's level of
borrowings at the end of 2003, the maturity profile of the borrowings, the
company's use of financial instruments, its currency and interest rate structure
and its funding and treasury policies please refer to Item 11 "Qualitative and
Quantitative Disclosures about Market Risk".
Contractual obligations
The following table summarizes our minimum contractual obligations and
commercial commitments, as of December 31, 2003:
Contractual Obligations Payments due by Period
----------------------- -----------------------------------------------------------------------
less than 1 more than 5
Total year 1-3 Years 3-5 Years years
----------- --------------- ---------- --------- -----------
US$'000 US$'000 US$'000 US$'000 US$'000
----------- --------------- ---------- --------- -----------
Long-term debt obligations 8,911 4,177 2,355 2,379 -
Capital (finance) lease obligations 1,014 264 425 325 -
Operating lease obligations 26,906 2,182 3,798 2,688 18,238
Other long-term liabilities
reflected on the company's balance sheet
under Irish GAAP 13,225 1,191 10,587 1,439 8
Total 50,056 7,814 17,165 6,831 18,246
Trinity Biotech incurs debt to pursue its policy of growth through acquisition.
Trinity Biotech believes that, with further funds generated from operations, it
will have sufficient funds to meet its capital commitments and continue
operations for the foreseeable future. If operating margins on sales were to
decline substantially, if the Company's increased investment in its US direct
sales force was not to generate comparable margins in sales or if the Company
was to make a large and unanticipated cash outlay, the Company would have
further funding requirements. If this were the case, there can be no assurance
that financing will be available at attractive terms, or at all. The Company
believes that success in raising additional capital or obtaining profitability
will be dependent on the viability of its products and their success in the
market place.
Impact of Inflation
Although Trinity Biotech's operations are influenced by general economic trends,
Trinity Biotech does not believe that inflation had a material effect on its
operations for the periods presented. Management believes, however, that
continuing national wage inflation in Ireland and the impact of inflation on
costs generally will result in a sizeable increase in the Irish facility's
operating costs in 2004.
Impact of Currency Fluctuation
Trinity Biotech's revenue and expenses are affected by fluctuations in currency
exchange rates especially the exchange rate between the US Dollar and the Euro.
Trinity Biotech's revenues are primarily denominated in US Dollars, its expenses
are incurred principally in Euro and US Dollars. The recent weakening of the US
Dollar could have an adverse impact on future profitability. Management are
actively seeking to increase the size of the Euro revenue base to mitigate this
risk. The revenues and costs incurred by US subsidiaries are denominated in US
Dollars.
Trinity Biotech holds most of its cash assets in US dollars. As Trinity Biotech
reports in US Dollars, fluctuations in exchange rates do not result in exchange
differences on these cash assets.
Exchange Rates
Fluctuations in the exchange rate between the Euro and the US dollar may impact
on the Company's Euro monetary assets and liabilities and on Euro expenses and
consequently the Company's earnings.
Off-Balance Sheet Arrangements
Not applicable
30
Research and Products under Development
History
Trinity Biotech has invested considerable funds in research and development over
the past number of years. It has developed a platform technology for its rapid
UniGold(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
A research project is presently underway to develop a rapid test for influenza A
and B using the UniGold(TM) technology.
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:
Microtitre Plate Development Group
Development of microtitre plate assay for the detection of HSV-1 and HSV-2
The Company has developed HSV-1 and HSV-2 specific tests to complement its
HSV-1/2 tests. HSV-2 causes more serious complications to pregnant women and
HSV-2 positive patients are more susceptible to contracting HIV. These type
specific tests utilize recombinant proteins rather than the less specific viral
lysates in the older generations of these products. This work was completed in
the latter half of 2003 and the Company is now seeking approval for these tests
from the FDA.
Development of microtitre plate assay for the detection of Lyme IgG and IgM
Prompted by the company's successful Western Blots, development has commenced on
two new elisas to specifically detect Lyme IgG and IgM.
Adaptation of assays to Microtrak XL units
During 1998, Trinity Biotech acquired the Microtrak Chlamydia business from Dade
Behring Inc. As a result of the acquisition, Trinity Biotech acquired
instruments to run Microtitre plate tests. These instruments only ran Chlamydia
EIA tests and Trinity Biotech 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
Biotech's ability to sell these tests.
Redevelopment of the Captia Products
The re-development of the Captia Syphilis IgM product commenced in 2002. This
re-optimization includes the provision of a stable freeze-dried conjugate and
the introduction of a stable one component, ready-to-use substrate.
Rapid Development Group
Development of UniGold(TM) Recombigen HIV (2000-2003)
This represents a modification of Trinity Biotech's original UniGold HIV Test
using recombinant protein antigens rather than peptides in the test. It is a
single use rapid test for the detection of antibodies to HIV-1 in plasma, serum
and whole blood. The test is intended for use as an aid in diagnosis, in
settings where the rapid diagnosis of HIV infection can ensure early initiation
of antiretroviral therapy. The test can be performed in 10 minutes, enabling
health care providers to supply preliminary results to patients at the time of
testing, potentially increasing the overall effectiveness of counselling and
testing programs.
The recombinant proteins are manufactured by Trinity Biotech and allow the
UniGold(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 with a sensitivity of 100% and a specificity of 99.7%. On
December 29, 2003 the company announced that it had received approval from the
U.S. Food and Drug Administration (FDA) to market its Uni-Gold Recombigen(tm)
HIV test in the United States.
Development of UniGold(TM) Influenza A and B test. A project to develop a rapid
test for Influenza A and B using UniGold(TM) technology commenced in 2002. This
test will allow for the rapid qualitative detection of influenza A and B
directly from nasal swab, nasal wash and/or nasal aspirate specimens. It is an
immunochromatographic test using UniGold(TM) lateral flow technology and is
intended for use as an aid in the rapid diagnosis of acute influenza virus
infection. The UniGold(TM) Influenza A and B test employs highly sensitive
monoclonal antibodies that are specific for influenza antigens.
31
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 were launched in
the first quarter of 2003.
HIV Western Blot
Trinity Biotech has developed a western blot test for detecting antibodies to
HIV. This product is expected to be ready for commencement of trials in the USA
in 2004 which will run for approximately 6 months. This product is available for
evaluation use outside of the USA.
Immunofluorescent Assay Development Group
The development department in Trinity Biotech 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.
Influenza A/B DFA kit.
This is a test for the detection of Influenza A and B in both patient specimens
and culture samples. It employs a one step method with a total test time of 15
minutes, allowing the differentiation of Influenza A from Influenza B.
Influenza/RSV DFA kit.
This is combined screening test for Influenza A, Influenza B and RSV
(Respiratory syncytial virus) in both direct patient specimens and cultured
samples. The test employs a one step method with a total test time of 15
minutes. Such a product will complement the Influenza A/B DFA kit and the
existing RSV DFA kit.
For the 12 months ended December 31, 2003, the Company spent US$5,210,039 on
research and development. This expenditure is broken down into salary costs,
reagents, consultancy fees and other related costs. The comparable net
expenditure in 2002 and 2001 was US$4,470,745 and US$2,779,729 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.
Item 6
Directors and Senior Management
Directors and Executive Officers
Name Age Title
Ronan O'Caoimh 48 Chairman of the Board of Directors
Chief Executive Officer
Brendan K. Farrell 56 Director, President
Jim Walsh Ph.D. 45 Director, Chief Operating Officer
Rory Nealon 36 Director, Chief Financial Officer,
Company Secretary
Denis R. Burger, Ph.D. 60 Non Executive Director
Peter Coyne 44 Non Executive Director
Board of Directors
Ronan O'Caoimh, Chairman and Chief Executive Officer, co-founded Trinity Biotech
in June 1992 and acted as Chief Financial Officer until March 1994 when he
became Chief Executive Officer. He has been Chairman since May 1995. Prior to
joining Trinity Biotech, Mr. O'Caoimh was Managing Director of Noctech Limited,
an Irish diagnostics company. Mr. O'Caoimh was Finance Director of Noctech
Limited from 1988 until January 1991 when he became Managing Director. Mr.
O'Caoimh holds a Bachelor of Commerce degree from University College, Dublin and
is a Fellow of the Institute of Chartered Accountants in Ireland.
32
Brendan Farrell, President, joined Trinity Biotech in July 1994. He was
previously Marketing Director of B.M. Browne Limited, a company involved in the
marketing and distribution of medical and diagnostic products. Prior to that he
was Chief Executive of Noctech Limited, an Irish based diagnostics company,
following six years with Baxter Healthcare where he was Director of European
Business Development. Mr. Farrell has a Masters degree in Biochemistry from
University College, Cork.
Rory Nealon, Chief Financial Officer, joined Trinity Biotech as Chief Financial
Officer and Company Secretary in January 2003. Prior to joining Trinity Biotech,
he was Chief Financial Officer of Conduit plc, an Irish directory services
provider with operations in Ireland, the UK, Austria and Switzerland. Prior to
joining Conduit he was an Associate Director in AIB Capital Markets, a
subsidiary of AIB Group plc, the Irish banking group. Mr. Nealon holds a
Bachelor of Commerce degree from University College Dublin, is a Fellow of the
Institute of Chartered Accountants in Ireland, a member of the Institute of
Taxation in Ireland and a member of the Institute of Corporate Treasurers in the
UK.
Jim Walsh, Ph.D., Chief Operating Officer, joined Trinity Biotech in October
1995. Prior to joining the Company, Dr. Walsh was Managing Director of Cambridge
Diagnostics Ireland Limited (CDIL). He was employed with CDIL since 1987. Before
joining CDIL he worked with Fleming GmbH as Research & Development Manager. Dr.
Walsh has a degree in Chemistry and a Ph.D. in Microbiology from University
College, Galway.
Denis R. Burger, Ph.D., non-executive director, was Chairman of Trinity Biotech
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 Biotech in
November 2001 as a non-executive director. Mr. Coyne is a director of AIB
Corporate Finance, a subsidiary of AIB Group plc, the Irish banking group. He
has extensive experience in advising public and private groups on all aspects of
corporate strategy. Prior to joining AIB, Mr Coyne trained as a chartered
accountant and was a senior manager in Arthur Andersen's Corporate Financial
Services practice. Mr Coyne holds a Bachelor of Engineering degree from
University College, Dublin and is a Fellow of the Institute of Chartered
Accountants in Ireland.
Compensation of Directors and Officers
The remuneration committee is responsible for determining the remuneration of
the executive directors. The basis for the executive directors' remuneration and
level of annual bonuses is determined by the remuneration committee of the
board. In all cases, performance bonuses and the granting of share options are
subject to stringent performance criteria. The remuneration committee consists
of Dr. Denis Burger (committee chairman and senior independent director), Mr.
Peter Coyne and Mr. Ronan O'Caoimh. Directors' remuneration shown below
comprises salaries, pension contributions and other benefits and emoluments in
respect of executive directors. Non-executive directors are remunerated by fees
and the granting of share options. Non-executive directors who perform
additional services outside the normal duties of a director receive additional
fees. The fees payable to non-executive directors are determined by the Board.
Each director is reimbursed for expenses incurred in attending meetings of the
board of directors.
33
Performance Defined
Director Salary/ related contribution Total Total
US$ Benefits bonus pension 2003 2002
-------- ----- ------- ---- ----
Ronan O'Caoimh 314,667 60,190 48,092 422,949 421,942
Brendan Farrell 232,122 40,127 21,327 293,576 297,892
Rory Nealon 131,541 - 13,350 144,891 -
Jim Walsh 232,695 40,127 21,327 294,149 284,408
------- ------ ------ ------- -------
911,025 140,444 104,096 1,155,565 1,004,242
------- ------- ------- --------- ---------
Total Total
Non-executive director Fees 2003 2002
---- ---- ----
US$
Denis R. Burger 20,000 20,000 10,000
Peter Coyne 20,000 20,000 10,000
------ ------ ------
40,000 40,000 20,000
------ ------ ------
Board Practices
The Articles of Association of Trinity Biotech provide that one third of the
directors in office (other than the Managing Director or a director holding an
executive office with Trinity Biotech) or, if their number is not three or a
multiple of three, then the number nearest to but not exceeding one third, shall
retire from office at every annual general meeting. If at any annual general
meeting the number of directors who are subject to retirement by rotation is
two, one of such directors shall retire and if the number of such directors is
one that director shall retire. Retiring directors may offer themselves for
re-election. The directors to retire at each annual general meeting shall be the
directors who have been longest in office since their last appointment. As
between directors of equal seniority the directors to retire shall, in the
absence of agreement, be selected from among them by lot.
In accordance with the Articles of Association of the Company, Mr. Denis Burger
will retire by rotation and, being eligible, offer himself for re-election at
the Annual General Meeting of the Company, which will be held on May 17, 2004.
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.
Employees
As of December 31, 2003, Trinity Biotech had 624 employees (2002: 580)
consisting of a research director and 40 research scientists and technicians,
430 manufacturing and quality assurance employees, and 153 finance,
administration and marketing staff (2002: a research director and 40 research
scientists and technicians, 389 manufacturing and quality assurance employees,
and 150 finance, administration and marketing staff). Trinity Biotech's future
hiring levels will depend on the growth of revenues.
The geographic spread of the Company's employees was as follows: 318 in Bray,
Co. Wicklow, Ireland, 93 in Germany, 9 in Sweden, 3 in the United Kingdom and
201 in its US operations.
Stock Option Plan
The board of directors has adopted the Employee Share Option Plan 2003 (the
"Plan"), the purpose of which is to provide Trinity Biotech's employees,
consultants, officers and directors with additional incentives to improve
Trinity Biotech's ability to attract, retain and motivate individuals upon whom
Trinity Biotech's sustained growth and financial success depends. The Plan is
administered by a compensation committee designated by the board of directors.
The aggregate maximum number of `A' Ordinary shares of Trinity Biotech available
for awards under the Plan is 3,000,000 subject to adjustments to reflect changes
in Trinity Biotech's capitalization. Options under the Plan may be awarded only
to employees, officers, directors and consultants of Trinity Biotech.
34
The exercise price of options is determined by the compensation committee. The
term of an option will be determined by the compensation committee, provided
that the term may not exceed seven years from the date of grant. All options
will terminate 90 days after termination of the option holder's employment,
service or consultancy with Trinity Biotech (or one year after such termination
because of death or disability). Under certain circumstances involving a change
in control of Trinity Biotech, the committee may accelerate the exercisability
and termination of the options. As of February 29, 2004, 4,838,541 of the
options outstanding were held by directors and officers of Trinity Biotech.
As of February 29, 2004 the following options were outstanding:
Number of 'A' Ordinary Shares Range of
Subject to Option Exercise Price
per Share
Total Options Outstanding 7,409,241 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. Since the year end, the
Company has completed a private placement, as part of this the investors were
granted five year warrants to purchase an aggregate of 1,058,824 Class 'A'
Ordinary Shares of the Company at an exercise price of US$5.25 per share and the
agent received 200,000 warrants to purchase 200,000 Class 'A' Ordinary Shares of
the Company at an exercise price of US$5.25. As of February 29, 2004 there were
warrants to purchase 1,417,324 Class 'A' Ordinary Shares in the Company
outstanding.
Item 7
Major Shareholders and
Related Party Transactions
As of February 29, 2004 Trinity Biotech has outstanding 51,766,449 'A' Ordinary
shares and 700,000 'B' Ordinary shares. Such totals exclude 8,826,565 shares
issuable upon the exercise of outstanding options and warrants.
The following table sets forth, as of February 29, 2004, the Trinity Biotech 'A'
Ordinary Shares and 'B' Ordinary Shares beneficially held by (i) each person
known by Trinity Biotech to beneficially hold 5% or more of such shares, (ii)
each director and officer of Trinity Biotech, and (iii) all officers and
directors as a group. Except as otherwise noted, all of the persons and groups
shown below have sole voting and investment power with respect to the shares
indicated. The Company is not controlled by another corporation or government.
Number of Number of
'A' Ordinary Percentage 'B' Ordinary Percentage Percentage
Shares Outstanding Shares Outstanding Total
Beneficially 'A' Ordinary Beneficially 'B' Ordinary Voting
Owned Shares Owned Shares Power
----- ------ ----- ------ -----
Ronan O'Caoimh 1,785,321 (1) 3.4% 0 0 3.3%
Brendan Farrell 1,064,135 (2) 2.0% 0 0 2.0%
Rory Nealon 100,000 (3) 0.2% 0 0 0.2%
Jim Walsh 1,099,615 (4) 2.1% 0 0 2.0%
Denis R. Burger 391,000 (5) 0.8% 0 0 0.7%
Peter Coyne 13,333 (6) 0.03% 0 0 0.03%
Potenza Investments, Inc 0 0 500,000 (7) 71.4% 1.9%
("Potenza")
Statenhof Building, Reaal 2A
23 50AA Leiderdorp, Netherlands
Smithfield Fiduciary LLC 3,381,316 (8) 6.24% 0 0 6.24%
Officers and Directors
as a group (6 persons) 4,453,404(1)(2)(3)(4)(5)(6) 8.2% 0 0 8.0%
35
(1) Includes 914,666 shares issuable upon exercise of options.
(2) Includes 1,011,875 shares issuable upon exercise of options.
(3) Includes 100,000 shares issuable upon exercise of options.
(4) Includes 680,000 shares issuable upon exercise of options.
(5) Includes 50,000 of 100,000 owned by Sovereign Ventures, a general
partnership owned 50% by Dr. Denis Burger which are included in the
shares deemed owned by Dr. Denis Burger.
(6) Includes 13,333 shares issuable upon exercise of options.
(7) Includes shares beneficially owned by SRL (350,000 'B') and
Brindisi Investments Inc. (150,000 'B'). SRL has advised Trinity
Biotech 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 Smithfield Fiduciary LLC on March 8,
2004. The filing discloses voting and dispositive power over 941,176
"A" Ordinary Shares and US$9 million of 3% convertible notes
convertible into 2,440,140 "A" Ordinary Shares. The filing excludes
dispositive power over 188,235 warrants; the percentage total voting
power including these warrants would be 6.56%.
Related Party Transactions
The Company has entered into various arrangements with JRJ Investments ("JRJ"),
a partnership owned by Mr. O'Caoimh and Dr. Walsh, directors of the Company, to
provide for current and potential future needs to extend its premises at IDA
Business Park, Bray, Co. Wicklow, Ireland. It has entered into an agreement with
JRJ pursuant to which the Company has taken a lease of premises adjacent to the
existing facility for a term of 20 years at a rent of (euro)7.62 per square foot
("the Current Extension"). The lease commenced on the newly completed 25,000
square foot building in July 2000. The Company also envisages that a further
premises may potentially be required by it and, for that purpose, has entered
into a four years eleven month lease at (euro)12,860 per annum over adjacent
lands with JRJ. On November 20, 2002, the Company entered into an agreement for
lease with JRJ for offices that have been constructed on part of these lands.
The annual rent of (euro)365,760 (US$459,054) is payable from January 1, 2004.
Independent valuers have advised the Company that the rent fixed in respect of
the Current Extension, the agreement for lease and the lease of adjacent lands
represents a fair market rent. The rent for any future property constructed will
be set at the then open market value. The Company and its directors (excepting
Mr. O'Caoimh and Dr. Walsh who express no opinion on this point) believe that
the arrangements entered into represent a fair and reasonable basis on which the
Company can meet its ongoing requirements for premises.
Item 8
Financial Statements
Legal Proceedings
Dispute Regarding the Acquisition from Xtrana Inc.
In December 2002, the Company filed an action against Xtrana Inc relating to the
purchase of the Biopool business from Xtrana in 2001. The Company was seeking
US$1,200,000 in damages and US$3,000,000 in punitive damages alleging breach of
contract and other damages regarding the sale of an individual product line. On
January 17, 2003 Xtrana countersued seeking US$57,000,000 in damages.
On June 16, 2003 Trinity Biotech and Xtrana settled this litigation. Pursuant to
the terms of the Settlement Agreement entered into between the parties, Trinity
Biotech agreed to pay Xtrana the amounts due on two promissory notes of
US$1,166,200 and US$570,100, together with interest thereon as provided in the
notes, less US$225,000, and less US$24,148, which represented the amount due and
owing by Xtrana to Trinity Biotech as of May 31, 2003 pursuant to a Letter
Agreement, dated December 20, 2001, between Trinity Biotech and Xtrana, relating
to a third party. The total amount of the settlement payment made by Trinity
Biotech to Xtrana was US$1,505,942.
36
The parties also agreed that, following Xtrana's receipt of the settlement
payment, they would cause the litigation to be dismissed with prejudice and
without costs to any party. The parties also released each other from any claims
arising from or in connection with the notes due from Trinity Biotech to Xtrana,
the litigation, the security agreements entered into between the parties, the
Asset Purchase Agreement made as of November 9, 2001 and any other matter
whatsoever, except for the parties executory obligations as set forth in the
settlement agreement.
Dispute Regarding the Distribution Agreement with Inverness Medical Innovations
Inc.
In December 2003, the Company filed an action against Inverness Medical for
declaratory judgment and breach of contract. Inverness Medical, through its
affiliate, Wampole Laboratories, has acted as exclusive distributor for certain
of Trinity Biotech's infectious disease products in the US. This exclusivity is
due to end on September 30, 2004, at which time it had been agreed that both
Trinity Biotech and Inverness Medical would sell the products under their
respective labels. The suit alleges that Inverness Medical is attempting to
convert customers from the Trinity Biotech product to a product manufactured by
a competitor by claiming that the Trinity Biotech product is unavailable and
being discontinued. The suit alleges that, under the terms of the contract, the
Company is entitled to sell direct in the US any of its products which are
competitive with products sold by Inverness Medical and sourced by other
suppliers. With immediate effect, the Company has exercised this right.
In January 2004, Inverness Medical countersued and sought a preliminary
injunction to prevent the Company from selling direct in the US of its products
which are competitive with products sold by Inverness Medical and sourced by
other suppliers. The Superior Court of Middlesex County, Massachusetts, denied
the motion for preliminary injunction on January 28, 2004. Please see also Item
4, Distribution Agreement between Trinity Biotech USA and Carter Wallace.
Item 9 The Offer and Listing
Trinity Biotech's American Depository Shares ("ADS's") are listed on the NASDAQ
Small Cap Market under the symbol "TRIB". The Company's Class B Warrant (symbol
"TRIZF"), expired on February 28, 1999. Each ADS represents one 'A' Ordinary
Share of the Company. The Company's 'A' Ordinary Shares are also listed and
trade on the Irish Stock Exchange. The Company's depository bank for the ADS's
is The Bank of New York. On February 27, 2004, the reported closing sale price
of the ADS's was US$4.03 per ADS. The following tables set forth the range of
quoted high and low sale prices of Trinity Biotech's ADS, and Class B Warrants
for (a) the years ended December 31, 1999, 2000, 2001, 2002 and 2003; (b) the
quarters ended March 31, June 30, September 30 and December 31, 2002; March 31,
June 30, September 30 and December 31, 2003; and (c) the months of March, April,
May, June, July, August, September, October, November and December 2003 and
January and February 2004 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
1999 $2.47 $1.16 $0.12 $0.03
2000 $7.59 $1.69
2001 $3.22 $0.97
2002 $1.86 $0.89
2003 $6.72 $1.25
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
Quarter ended June 30 $3.50 $2.09
Quarter ended September 30 $4.01 $2.26
37
Quarter ended December 31 $6.72 $2.61
Month Ended
March 31, 2003 $2.44 $1.77
April 30, 2003 $2.83 $2.09
May 31, 2003 $2.73 $2.20
June 30, 2003 $3.50 $2.36
July 31, 2003 $3.45 $2.31
August 31, 2003 $3.65 $2.26
September 30, 2003 $4.01 $3.11
October 31, 2003 $4.41 $3.55
November 30,2003 $3.79 $3.10
December 31, 2003 $6.72 $2.61
January 31, 2004 $5.99 $4.25
February 29, 2004 $4.75 $3.75
The number of record holders of Trinity Biotech's ADS's as at February 29, 2004
amounts to 1,690, inclusive of those brokerage firms and/or clearing houses
holding Trinity Biotech's securities for their clientele (with each such
brokerage house and/or clearing house being considered as one holder).
Item 10
Memorandum and
Articles of Association
Objects
The Company's objects, detailed in Clause 3 of its Memorandum of Association,
are varied and wide ranging and include principally researching, manufacturing,
buying, selling and distributing all kinds of patents, pharmaceutical, medicinal
and diagnostic preparations, equipment, drugs and accessories. They also include
the power to acquire shares or other interests or securities in other companies
or businesses and to exercise all rights in relation thereto. The Company's
registered number in Ireland is 183476.
Powers and Duties of Directors
A director may enter into a contract and be interested in any contract or
proposed contract with the Company either as vendor, purchaser or otherwise and
shall not be liable to account for any profit made by him resulting therefrom
provided that he has first disclosed the nature of his interest in such a
contract at a meeting of the board as required by Section 194 of the Irish
Companies Act 1963. Generally, a director must not vote in respect of any
contract or arrangement or any proposal in which he has a material interest
(otherwise than by virtue of his holding of shares or debentures or other
securities in or through the Company). In addition, a director shall not be
counted in the quorum at a meeting in relation to any resolution from which he
is barred from voting.
A director is entitled to vote and be counted in the quorum in respect of
certain arrangements in which he is interested (in the absence of some other
material interest). These include the giving of a security or indemnity to him
in respect of money lent or obligations incurred by him for the Company, the
giving of any security or indemnity to a third party in respect of a debt or
obligation of the Company for which he has assumed responsibility, any proposal
concerning an offer of shares or other securities in which he may be interested
as a participant in the underwriting or sub-underwriting and any proposal
concerning any other company in which he is interested provided he is not the
holder of or beneficially interested in 1% or more of the issued shares of any
class of share capital of such company or of voting rights.
The Board may exercise all the powers of the Company to borrow money but it is
obliged to restrict these borrowings to ensure that the aggregate amount
outstanding of all monies borrowed by the Company does not, without the previous
sanction of an ordinary resolution of the Company, exceed an amount equal to 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.
38
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.
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
39
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.
Irish Law
Pursuant to Irish law, Trinity Biotech must maintain a register
of its shareholders. This register is open to inspection by shareholders free of
charge and to any member of the public on payment of a small fee. The books
containing the minutes of proceedings of any general meeting of Trinity Biotech
are required to be kept at the registered office of the company and are open to
the inspection of any member without charge. Minutes of meetings of the Board of
Directors are not open to scrutiny by shareholders. Trinity Biotech is obliged
to keep Proper Books of Account. The shareholders have no statutory right to
inspect the books of account. The only financial records, which are open to the
shareholders, are the financial statements, which are sent to shareholders with
the annual report. Irish law also obliges Trinity Biotech to file information
relating to certain events within the company (new share capital issues, changes
to share rights, changes to the Board of Directors). This information is filed
with the Companies Registration Office (the "CRO") in Dublin and is open to
public inspection. The Articles of Association of Trinity Biotech permit
ordinary shareholders to approve corporate matters in writing provided that it
is signed by all the members for the time being entitled to vote and attend at
general meeting. Ordinary shareholders are entitled to call a meeting by way of
a requisition. The requisition must be signed by ordinary shareholders holding
not less than one-tenth of the paid up capital of the company carrying the right
of voting at general meetings of the company. Trinity Biotech is generally
permitted, subject to company law, to issue shares with preferential rights,
including preferential rights as to voting, dividends or rights to a return of
capital on a winding up of the company. Any shareholder who complains that the
affairs of the company are being conducted or that the powers of the directors
of the company are being exercised in a manner oppressive to him or any of the
shareholders (including himself), or in disregard of his or their interests as
shareholders, may apply to the Irish courts for relief. Shareholders have no
right to maintain proceedings in respect of wrongs done to the company.
Ordinarily, our directors owe their duties only to Trinity
Biotech and not its shareholders. The duties of directors are twofold, fiduciary
duties and duties of care and skill. Fiduciary duties are owed by the directors
individually and owed to Trinity Biotech. Those duties include duties to act in
good faith towards Trinity Biotech in any transaction, not to make use of any
money or other property of Trinity Biotech, not to gain directly or indirectly
any improper advantage for himself at the expense of Trinity Biotech, to act
bona fide in the interests of Trinity Biotech and exercise powers for the proper
purpose. A director need not exhibit in the performance of his duties a greater
degree of skill than may reasonably be expected from a person of his knowledge
and experience. When directors, as agents in transactions, make contracts on
behalf of the company, they generally incur no personal liability under these
contracts. It is Trinity Biotech, as principal, which will be liable under them,
as long as the directors have acted within Trinity Biotech's objects and within
their own authority. A director who commits a breach of his fiduciary duties
shall be liable to Trinity Biotech for any profit made by him or for any damage
suffered by Trinity Biotech as a result of the breach. In addition to the above,
a breach by a director of his duties may lead to a sanction from a Court
including damages of compensation, summary dismissal of the director, a
requirement to account to Trinity Biotech for profit made and restriction of the
director from acting as a director in the future.
40
Material Contracts
See Item 4 "History and Development of the Company" regarding acquisitions made
by the Company.
Exchange Controls and Other Limitations
Affecting Security Holders
Irish exchange control regulations ceased to apply from and after December 31,
1992. Except as indicated below, there are no restrictions on non-residents of
the Republic of Ireland dealing in domestic securities which includes shares or
depository receipts of Irish companies such as Trinity Biotech, and dividends
and redemption proceeds, subject to the withholding where appropriate of
withholding tax as described under Item 10, are freely transferable to
non-resident holders of such securities.
The Financial Transfers Act, 1992 was enacted in December 1992. This Act gives
power to the Minister of Finance of the Republic of Ireland to make provision
for the restriction of financial transfers between the Republic of Ireland and
other countries. Financial transfers are broadly defined and include all
transfers, which would be movements of funds within the meaning of the treaties
governing the European Communities. The acquisition or disposal of ADS's
representing shares issued by an Irish incorporated company and associated
payments may fall within this definition. In addition, dividends or payments on
redemption or purchase of shares, interest payments, debentures or other
securities in an Irish incorporated company and payments on a liquidation of an
Irish incorporated company would fall within this definition. Currently, orders
under this Act prohibit any financial transfer to or by the order of or on
behalf of residents of the Federal Republic of Yugoslavia, Federal Republic of
Serbia, Angola and Iraq, any financial transfer in respect of funds and
financial resources belonging to the Taliban of Afghanistan (or related
terrorist organisations), financial transfers to the senior members of the
Zimbabwean government and financial transfers to any persons, groups or entities
listed in EU Council Decision 2002/400/EC of June 17, 2002 unless permission for
the transfer has been given by the Central Bank of Ireland.
Trinity Biotech does not anticipate that Irish exchange controls or orders under
the Financial Transfers Act, 1992 will have a material effect on its business.
For the purposes of the orders relating to Iraq and the Federal Republic of
Yugoslavia, reconstituted in 1991 as Serbia and Montenegro, a resident of those
countries is a person living in these countries, a body corporate or entity
operating in these countries and any person acting on behalf of any of these
persons.
Any transfer of, or payment for, an ordinary share or ADS involving the
government of any country which is currently the subject of United Nations
sanctions, any person or body controlled by any government or country under
United Nations sanctions or any persons or body controlled acting on behalf of
these governments of countries, may be subject to restrictions required under
these sanctions as implemented into Irish law. 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 all as of the date of
this annual report. Taxation laws are subject to change, from time to time, and
no representation is or can be made as to whether such laws will change, or what
impact, if any, such changes will have on the statements contained in this
summary. No assurance can be given that proposed amendments will be enacted as
proposed, or that legislative or judicial changes, or changes in administrative
practice, will not modify or change the statements expressed herein.
This summary is of a general nature only. It does not constitute legal or tax
advice nor does it discuss all aspects of Irish taxation that may be relevant to
any particular Irish Holder or U.S. Holder of ordinary shares or ADRs.
This summary does not discuss all aspects of Irish and US federal income
taxation that may be relevant to a particular holder of Trinity Biotech ADRs in
light of the holder's own circumstances or to certain types of investors subject
to special treatment under applicable tax laws (for example, financial
institutions, life insurance companies, tax-exempt organizations, and non-US
taxpayers) and it does not discuss any tax consequences arising under the laws
of taxing jurisdictions other than the Republic of Ireland and the US federal
government. The tax treatment of holders of Trinity Biotech ADRs may vary
depending upon each holder's own particular situation.
Prospective purchasers of Trinity Biotech ADRs are advised to consult their own
tax advisors as to the U.S., Irish or other tax consequences of the purchase,
ownership and disposition of such ADRs.
41
US Federal Income Tax Consequences to US Holders
The following is a summary of the material US federal income tax consequences
that generally would apply with respect to the ownership and disposition of
Trinity Biotech ADRs, in the case of a purchaser of such ADRs who is a US Holder
(as defined below) and who holds the ADRs as capital assets. This summary is
based on the US Internal Revenue Code of 1986, as amended (the "Code"), Treasury
Regulations promulgated thereunder, and judicial and administrative
interpretations thereof, all as in effect on the date hereof and all of which
are subject to change either prospectively or retroactively. For purposes of
this summary, a US Holder is: an individual who is a citizen or a resident of
the United States; a corporation created or organized in or under the laws of
the United States or any political subdivision thereof; an estate whose income
is subject to US federal income tax regardless of its source; or a trust that
(a) is subject to the primary supervision of a court within the United States
and the control of one or more US persons or (b) has a valid election in effect
under applicable US Treasury regulations to be treated as a US person.
For US federal income tax purposes, US Holders of Trinity Biotech ADRs will be
treated as owning the underlying Class `A' Ordinary Shares, or ADSs, represented
by the ADRs held by them. The gross amount of any distribution made by Trinity
Biotech to US Holders with respect to the underlying shares represented by the
ADRs held by them, including the amount of any Irish taxes withheld from such
distribution, will be treated for US federal income tax purposes as a dividend,
to the extent of Trinity Biotech's current and accumulated earnings and profits
as determined for US federal income tax purposes. The amount of any such
distribution that exceeds Trinity Biotech's current and accumulated earnings and
profits will be applied against and reduce a US Holder's tax basis in the
holder's ADRs, and any amount of the distribution remaining after the holder's
tax basis has been reduced to zero will constitute capital gain. The capital
gain will be treated as a long-term, or short-term, capital gain depending on
whether or not the holder's ADRs have been held for more than one year as of the
date of the distribution.
Dividends paid by Trinity Biotech generally will not qualify for the dividends
received deduction otherwise available to US corporate shareholders.
Irish withholding tax imposed on any dividends paid by Trinity Biotech will
constitute a foreign income tax eligible for credit against a US Holder's US
federal income tax liability, subject to certain limitations set out in the
Code. Alternatively, the Irish withholding tax may be claimed by the US Holder
as a deduction against income in determining such tax liability. The rules
relating to the determination of the allowable foreign tax credit are complex,
and US Holders should consult with their own tax advisors to determine whether
and to what extent they may be entitled to this credit.
Upon a sale or exchange of ADRs, a US Holder will recognize a gain or loss for
US federal income tax purposes in an amount equal to the difference between the
amount realized on the sale or exchange and the holder's adjusted tax basis in
the ADRs sold or exchanged. Such gain or loss generally will be capital gain or
loss and will be long-term or short-term capital gain or loss depending on
whether the US Holder has held the ADRs sold or exchanged for more than one year
at the time of the sale or exchange.
Under recently enacted amendments to the Code, dividends received by individuals
from domestic and certain foreign corporations, and long-term capital gains
realized by individuals, generally are subject to US federal income tax at a
reduced maximum tax rate of 15%. Dividends received by a US Holder with respect
to the underlying shares represented by the holder's ADRs should qualify for the
15% rate. The reduced tax rate on capital gains applies to sales and exchanges
occurring on or after May 6, 2003 and before January 1, 2009. The reduced tax
rate on dividend income applies to dividends received after December 31, 2002
and before January 1, 2009. The reduced tax rate will not apply to dividends
received in respect of certain short-term or hedged positions in common stock or
in certain other situations. The legislation enacting the reduced tax rate
contains special rules for computing the foreign tax credit limitation of a
taxpayer who receives dividends subject to the reduced tax rate. US Holders of
Trinity Biotech ADRs should consult their own tax advisors regarding the effect
of these rules in their particular circumstances.
For US federal income tax purposes, a foreign corporation is treated as a
"passive foreign investment company" (or PFIC) in any taxable year in which,
after taking into account the income and assets of the corporation and certain
of its subsidiaries pursuant to the applicable "look through" rules, either (1)
at least 75% of the corporation's gross income is passive income or (2) at least
50% of the average value of the corporation's assets is attributable to assets
that produce passive income or are held for the production of passive income.
Based on the nature of its present business operations, assets and income,
Trinity Biotech believes that it is not currently subject to treatment as a
PFIC. However, no assurance can be given that there will not occur changes in
Trinity Biotech's business operations, assets and income that might cause it to
be treated as a PFIC at some future time.
42
If Trinity Biotech were to become a PFIC, a US Holder of Trinity Biotech ADRs
would be required to allocate to each day in the holding period for such
holder's ADRs a pro rata portion of any distribution received (or deemed to be
received) by the holder from Trinity Biotech, to the extent the distribution so
received constitutes an "excess distribution," as defined under US federal
income tax law. Generally, a distribution received during a taxable year by a US
Holder with respect to the underlying shares represented by any of the holder's
ADRs would be treated as an "excess distribution" to the extent that the
distribution so received, plus all other distributions received (or deemed to be
received) by the holder during the taxable year with respect to such underlying
shares, is greater than 125% of the average annual distributions received by the
holder with respect to such underlying shares during the three preceding years
(or during such shorter period as the US Holder may have held the ADRs). Any
portion of an excess distribution that is treated as allocable to one or more
taxable years prior to the year of distribution would be subject to US federal
income tax in the year in which the excess distribution is made, but it would be
subject to tax at the highest tax rate applicable to the holder in the prior tax
year or years. The holder also would be subject to an interest charge, in the
year in which the excess distribution is made, on the amount of taxes deemed to
have been deferred with respect to the excess distribution. In addition, any
gain recognized on a sale or other disposition of a US Holder's ADRs, including
any gain recognized on a liquidation of Trinity Biotech, would be treated in the
same manner as an excess distribution. Any such gain would be treated as
ordinary income rather than as capital gain. Finally, the 15% reduced US federal
income tax rate otherwise applicable to dividend income as discussed above, will
not apply to any distribution made by Trinity Biotech in any taxable year in
which it is a PFIC (or made in the taxable year following any such year),
whether or not the distribution is an "excess distribution".
For US federal income tax purposes, a foreign corporation is treated as a
"foreign personal holding company" (or FPHC) in any taxable year in which (i)
five or fewer individuals who are citizens or residents of the United States own
directly or by attribution more than 50%, by vote or value, of the shares of the
corporation and (ii) at least 60% of the corporation's gross income consists of
foreign personal holding company income. Based on the composition of its share
ownership and the nature of its business operations and gross income at the
present time, Trinity Biotech believes that it is not currently subject to
treatment as an FPHC. However, no assurance can be given that there will not
occur changes in the composition of its share ownership and in the nature of its
business operations and gross income that might cause Trinity Biotech to be
treated as a FPHC at some future time.
If Trinity Biotech were to become a FPHC, each U.S. Holder of Trinity Biotech
ADRs on the last day of any taxable year in which Trinity Biotech is a FPHC
would have to include in the holder's gross income for that year the holder's
pro rata share of Trinity Biotech's "undistributed foreign personal holding
company income." The amount so included would not qualify for taxation at the
15% reduced tax rate applicable to dividend income, and thus would be subject to
US federal income tax at regular ordinary income rates. If Trinity Biotech were
to distribute in a subsequent tax year any undistributed foreign person holding
company income so taxed, the amount so distributed would not be counted as part
of an "excess distribution" under the PFIC rules discussed above.
For US federal income tax purposes, a foreign corporation is treated as a
"controlled foreign corporation" (or CFC) in any taxable year in which one or
more US Shareholders, each of whom owns (directly or by attribution) at least
10% of the voting power of all classes of the corporation's stock (a "US
Ten-Percent Shareholder"), own, in the aggregate, more than 50% of the
corporation's stock, by vote or value.
If Trinity Biotech were to become a CFC, each US Holder treated as a US
Ten-percent Shareholder would be required to include in income each year such US
Ten-percent Shareholder's pro rata share of Trinity Biotech's undistributed
"Subpart F income." For this purpose, Subpart F income generally would include
interest, original issue discount, dividends, net gains from the disposition of
stocks or securities, net gains on forward and option contracts, receipts with
respect to securities loans and net payments received with respect to equity
swaps and similar derivatives.
Any undistributed Subpart F income included in a US Holder's income for any year
would be added to the tax basis of the US Holder's ADR's. Amounts distributed by
Trinity Biotech to the US Holder in any subsequent year would not be subject to
further US federal income tax in the year of distribution, to the extent
attributable to amounts so included in the US Holder's income in prior years
under the CFC rules but would be treated, instead, as a reduction in the tax
basis of the US Holder's ADRs, the FPHC rules and PFIC rules discussed above
would not apply to any undistributed Subpart F income required to be included in
a US Holder's income under the CFC rules, or to the amount of any distributions
received from Trinity Biotech that were attributable to amounts so included.
Distributions made with respect to underlying shares represented by ADRs may be
subject to information reporting to the US Internal Revenue Service and to US
backup withholding tax at a rate equal to the fourth lowest income tax rate
applicable to individuals (which, under current law, is 28%). Backup withholding
will not apply, however, if the holder (i) is a corporation or comes within
certain exempt categories, and demonstrates its eligibility for exemption when
so required, or (ii) furnishes a correct taxpayer identification number and
makes any other required certification.
Backup withholding is not an additional tax. Amounts withheld under the backup
withholding rules may be credited against a US Holder's US tax liability, and a
US Holder may obtain a refund of any excess amounts withheld under the backup
withholding rules by filing the appropriate claim for refund with the Internal
Revenue Service.
43
Any holder who holds 10% or more in vote or value of Trinity Biotech will be
subject to certain additional United States information reporting requirements.
US Holders may be subject to state or local income and other taxes with respect
to their ownership and disposition of ADRs . US Holders of ADRs should consult
their own tax advisers as to the applicability and effect of any such taxes.
Republic of Ireland Taxation
For the purposes of this summary, an "Irish Holder" means a holder of ordinary
shares or ADSs evidenced by ADRs that (i) beneficially owns the ordinary shares
or ADSs registered in their name; (ii) in the case of individual holders, are
resident, ordinarily resident and domiciled in Ireland under Irish taxation
laws; (iii) in the case of holders that are companies, are resident in Ireland
under Irish taxation laws; and (iv) are not also resident in any other country
under any double taxation agreement entered into by Ireland.
For Irish taxation purposes, Irish Holders of ADSs will be treated as the owners
of the underlying ordinary shares represented by such ADSs.
Solely for the purposes of this summary of Irish Tax Considerations, a "U.S.
Holder" means a holder of ordinary shares or ADSs evidenced by ADRs that (i)
beneficially owns the ordinary shares or ADSs registered in their name; (ii) is
resident in the United States for the purposes of the Republic of Ireland/United
States Double Taxation Convention (the Treaty); (iii) in the case of an
individual holder, is not also resident or ordinarily resident in Ireland for
Irish tax purposes; (iv) in the case of a corporate holder, is not a resident in
Ireland for Irish tax purposes and is not ultimately controlled by persons
resident in Ireland; and (v) is not engaged in any trade or business and does
not perform independent personal services through a permanent establishment or
fixed base in Ireland.
The board of directors does not expect to pay dividends for the foreseeable
future. Should Trinity Biotech begin paying dividends, such dividends will
generally be subject to a 20% withholding tax (DWT). Under current legislation,
where DWT applies Trinity Biotech will be responsible for withholding it at
source. DWT will not apply where an exemption applies and where Trinity Biotech
has received all necessary documentation from the recipient prior to payment of
the dividend.
Corporate Irish Holders will generally be entitled to claim an exemption from
DWT by delivering a declaration to us in the form prescribed by the Irish
Revenue Commissioners. Such corporate Irish Holders will generally not otherwise
be subject to Irish tax in respect of dividends received.
Individual Irish Holders will be subject to income tax on the gross amount of
any dividend (that is the amount of the dividend received plus any DWT
withheld), at their marginal rate of tax (currently either 20% or 42% depending
on the individual's circumstances). Individual Irish Holders will be able to
claim a credit against their resulting income tax liability in respect of DWT
withheld.
Individual Irish Holders may, depending on their circumstances, also be subject
to the Irish health levy of 2% and pay related social insurance contribution of
up to 3% in respect of their dividend income.
Shareholders who are individuals resident in the US (and certain other
countries) and who are not resident or ordinarily resident in Ireland may
receive dividends free of DWT where the shareholder has provided the Company
with the relevant declaration and residency certificate required by legislation.
Corporate shareholders that are not resident in Ireland and who are ultimately
controlled by persons resident in the 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 resident in a member state of the European Union other than Ireland
which are not controlled by Irish residents or whose principal class of shares
or its 75% parent's principal class of shares are substantially or regularly
traded on a recognized stock exchange in a country with which Ireland has a tax
treaty, may receive dividends free of DWT where they provide Trinity Biotech
with the relevant declaration, auditors' certificate and Irish Revenue
Commissioners' certificate as required by Irish law.
44
US resident holders of ordinary shares (as opposed to ADRs) should note that
these documentation requirements may be burdensome. As described below, these
documentation requirements do not apply in the case of holders of ADRs. US
resident holders who do not comply with the documentation requirements or
otherwise do not qualify for an exemption may be able to claim treaty benefits
under the Treaty. US resident holders who are entitled to benefits under the
Treaty will be able to claim a partial refund of DWT from the Irish Revenue
Commissioners.
Special DWT arrangements are available in the case of shares held by US resident
holders in Irish companies through American depository banks using ADRs who
enter into intermediary agreements with the Irish Revenue Commissioners. Under
such agreements, American depository banks who receive dividends from Irish
companies and pay the dividends on to the US resident ADR holders are allowed to
receive and pass on a dividend from the Irish company on a gross basis (without
any withholding) if:
o the depository bank's ADR register shows that the direct
beneficial owner has a US address on the register, or
o there is an intermediary between the depository bank and the
beneficial shareholder and the depository bank receives
confirmation from the intermediary that the beneficial
shareholder's address in the intermediary's records is in the
US.
Where the above procedures have not been complied with and DWT is withheld from
dividend payments to U.S. Holders of ordinary shares or ADSs evidenced by ADRs,
such U.S. Holders can apply to the Irish Revenue Commissioners claiming a full
refund of DWT paid by filing a declaration, a certificate of residency and, in
the case of U.S. Holders that are corporations, an auditor's certificate, each
in the form prescribed by the Irish Revenue Commissioners.
The DWT rate applicable to U.S. Holders is reduced to 5% under the terms of the
Treaty for corporate U.S. Holders holding 10% or more of our voting shares, and
to 15% for other U.S. Holders. While this will, subject to the application of
Article 23 of the Treaty, generally entitle U.S. Holders to claim a partial
refund of DWT from the Irish Revenue Commissioners, U.S. Holders will, in most
circumstances, likely prefer to seek a full refund of DWT under Irish domestic
legislation.
Under the Irish Taxes Consolidation Act 1997, non-Irish shareholders may, unless
exempted, be liable to Irish income tax on dividends received from Trinity
Biotech. Such a shareholder will not have an Irish income tax liability on
dividends if the shareholder is:
o an individual resident in the US (or certain other countries
with which Ireland has a double taxation treaty) and who is
neither resident nor ordinarily resident in Ireland; or
o a corporation that is not resident in Ireland and which is
ultimately controlled by persons resident in the US (or
certain other countries); or
o a corporation that is not resident in Ireland and whose
principal class of shares (or its 75% parent's principal class
of shares) are substantially or regularly traded on a
recognized stock exchange; or
o is otherwise entitled to an exemption from DWT.
Disposals of Ordinary Shares or ADRs
Irish Holders that acquire ordinary shares or ADRs will generally be considered,
for Irish tax purposes, to have acquired their ordinary shares or ADRs at a base
cost equal to the amount paid for the ordinary shares or ADRs. On subsequent
dispositions, ordinary shares or ADRs acquired at an earlier time will generally
be deemed, for Irish tax purposes, to be disposed of on a "first in first out"
basis before ordinary shares or ADRs acquired at a later time.
Irish Holders that dispose of their ordinary shares or ADRs will be subject to
Irish capital gains tax (CGT) to the extent that the proceeds realized from such
disposition exceed the indexed base cost of the ordinary shares or ADRs disposed
of and any incidental expenses. The current rate of CGT is 20%. Indexation of
the base cost of the ordinary shares or ADRs will only be available up to
December 31, 2002, and only in respect of ordinary shares or ADRs held for more
than 12 months prior to their disposal.
Irish Holders that have unutilised capital losses from other sources in the
current, or any previous tax year, can generally apply such losses to reduce
gains realized on the disposal of the ordinary shares or ADRs.
45
An annual exemption allows individuals to realize chargeable gains of up to
(euro)1,270 in each tax year without giving rise to CGT. This exemption is
specific to the individual and cannot be transferred between spouses. Irish
Holders are required, under Ireland's self-assessment system, to file a tax
return reporting any chargeable gains arising to them in a particular tax year.
Where disposal proceeds are received in a currency other than euro they must be
translated into euro amounts to calculate the amount of any chargeable gain or
loss. Similarly, acquisition costs denominated in a currency other than euro
must be translated at the date of acquisition in euro amounts.
Irish Holders that realize a loss on the disposition of ordinary shares or ADRs
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
U.S. Holders will not be subject to Irish capital gains tax (CGT) on the
disposal of ordinary shares or ADRs provided that such ordinary shares or ADRs
are quoted on a stock exchange at the time of disposition. A stock exchange for
this purpose includes, among others, the Irish Stock Exchange (the ISE) or the
Nasdaq National Market (NASDAQ). While it is our intention to continue the
quotation of our ordinary shares on the ISE and the quotation of ADRs on NASDAQ,
no assurances can be given in this regard.
If, for any reason, our ADRs cease to be quoted on NASDAQ and our ordinary
shares cease to be quoted on the ISE, U.S. Holders will not be subject to CGT on
the disposal of their ordinary shares or ADRs provided that the ordinary shares
or ADRs do not, at the time of the disposal, derive the greater part of their
value from land, buildings, minerals, or mineral rights or exploration rights in
Ireland.
A gift or inheritance of ordinary shares or ADRs will be within the charge to
capital acquisitions tax, regardless of where the disponer or the
donee/successor in relation to the gift/inheritance is domiciled, resident or
ordinarily resident. The capital acquisitions tax is charged at a rate of 20% on
the taxable value of the gift or inheritance above a tax-free threshold. This
tax-free threshold is determined by the amount of the current benefit and of
previous benefits, received within the group threshold since December 5, 1991,
which are within the charge to the capital acquisitions tax and the relationship
between the former holder and the successor. Gifts and inheritances between
spouses are not subject to the capital acquisitions tax. Gifts of up to
(euro)3,000 can be received each year from any given individual without
triggering a charge to capital acquisitions tax. Where a charge to Irish 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 inheritance of ordinary shares or ADRs is subject to both
Irish capital acquisitions tax and US federal estate tax. The Estate Tax
Convention does not apply to Irish capital acquisitions tax paid on gifts.
Irish stamp duty, which is a tax imposed on certain documents, is payable on all
transfers of ordinary shares (other than transfers made between spouses,
transfers made between 90% associated companies, or certain other exempt
transfers) regardless of where the document of transfer is executed. Irish stamp
duty is also payable on electronic transfers of ordinary shares.
A transfer of ordinary shares made as part of a sale or gift will generally be
stampable at the ad valorem rate of 1% of the value of the consideration
received for the transfer, or, if higher, the market value of the shares
transferred. A minimum stamp duty of (euro)1.00 will apply to a transfer of
ordinary shares. Where the consideration for a sale is expressed in a currency
other than euro, the duty will be charged on the euro equivalent calculated at
the rate of exchange prevailing at the date of the transfer.
Transfers of ordinary shares where no beneficial interest passes (e.g. a
transfer of shares from a beneficial owner to a nominee), will generally be
exempt from stamp duty if the transfer form contains an appropriate
certification, otherwise a nominal stamp duty rate of (euro)12.50 will apply.
46
Transfers of ADRs are exempt from Irish stamp duty as long as the ADRs are
quoted on any recognized stock exchange in the US or Canada.
Transfers of ordinary shares from the Depositary or the Depositary's custodian
upon surrender of ADRs for the purposes of withdrawing the underlying ordinary
shares from the ADS/ADR system, and transfers of ordinary shares to the
Depositary or the Depositary's custodian for the purposes of transferring
ordinary shares onto the ADS/ADR system, will be stampable at the ad valorem
rate of 1% of the value of the shares transferred if the transfer relates to a
sale or contemplated sale or any other change in the beneficial ownership of
ordinary shares. Such transfers will be exempt from Irish stamp duty if the
transfer does not relate to or involve any change in the beneficial ownership in
the underlying ordinary shares and the transfer form contains the appropriate
certification. In the absence of an appropriate certification, stamp duty will
be applied at the nominal rate of (euro)12.50.
The person accountable for the payment of stamp duty is the transferee or, in
the case of a transfer by way of gift or for consideration less than the market
value, both parties to the transfer. Stamp duty is normally payable within 30
days after the date of execution of the transfer. Late or inadequate payment of
stamp duty will result in liability for interest, penalties and fines.
Dividend Policy
Since its inception Trinity Biotech has not declared or paid dividends on its
'A' Ordinary Shares. Trinity Biotech anticipates, for the foreseeable future,
that it will retain any future earnings in order to fund the business operations
of the Company. The Company does not, therefore, anticipate paying any cash or
share dividends on its 'A' Ordinary Shares in the foreseeable future.
Any cash dividends or other distributions, if made, are expected to be made in
US Dollars, as provided for by the Articles of Association.
Item 11
Qualitative and Quantitative Disclosures About Market Risk
Qualitative information about Market Risk
The Company's treasury policy is to manage financial risks arising in relation
to or as a result of underlying business needs. The activities of the treasury
function, which does not operate as a profit centre, are carried out in
accordance with board approved policies and are subject to regular internal
review. These activities include the Company making use of spot and forward
foreign exchange markets.
Trinity Biotech uses a range of financial instruments (including cash, bank
borrowings, convertible debentures and finance leases) to fund its operations.
These instruments are used to manage the liquidity of the Company in a cost
effective, low-risk manner. Working capital management is a key additional
element in the effective management of overall liquidity. The Company does not
trade in financial instruments or derivatives.
The main risks arising from the utilization of these financial instruments are
interest rate risk, liquidity risk and foreign exchange risk.
The Company's reported net income, net assets and gearing (net debt expressed as
a percentage of shareholders' equity) are all affected by movements in foreign
exchange rates.
The Group borrows in appropriate currencies at fixed and floating rates of
interest. Year-end borrowings, net of cash, totalled US$5,707,384 (2002:
US$8,644,320) at interest rates ranging from 2.15% to 7.42% and including
US$14,134,621 of fixed rate debt at interest rates ranging from 3% to 5.50%
(2002: US$3,964,683 at interest rates ranging from 5% to 7.50%). In broad terms,
a one-percentage point increase in interest rates would decrease the net
interest charge by US$82,544 (2002: increase by US$46,796).
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, 34% of gross debt fell due for repayment within one
year.
47
A significant portion of the Company's activities are conducted in US Dollars.
The primary foreign exchange risk arises from the fluctuating value of the
Company's Euro expenses as a result of the movement in the exchange rate between
the US Dollar and the Euro. Arising from this, the Company pursues a treasury
policy which aims to sell US Dollars forward to match a portion of the uncovered
Euro expenses at exchange rates lower than budgeted exchange rates. The
Company's current hedging policy is to cover forward a portion of its exposure
for a minimum of three months. Under US GAAP, US$67,682 was recognised in the
income statement in respect of gains on the fair value of derivative instruments
(2002: US$161,975). 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$585,758 at December 31, 2003.
Quantitative information about Market Risk
Interest rate sensitivity
The Company monitors its exposure to changes in interest and exchange rates by
estimating the impact of possible changes on reported profit before tax and net
worth. The Company accepts interest rate and currency risk as part of the
overall risks of operating in different economies and seeks to manage these
risks by following the policies set above.
The Company estimates that the maximum effect of a rise of one percentage point
in one of the principal interest rates to which the Company is exposed, without
making any allowance for the potential impact of such a rise on exchange rates,
would be an increase in profit before tax for 2003 of less than two per cent.
The table below provides information about the Company's long term debt
obligations that are sensitive to changes in interest rates. The table presents
principal cash flows and related weighted average interest rates by expected
maturity dates. Weighted average variable rates are based on rates set at the
balance sheet date. The information is presented in US Dollars, which is the
Company's reporting currency. The actual currencies of the instruments are as
indicated.
Maturity After Fair
before December 31 2005 2006 2007 2008 2008 Total Value*
-------------------------------------------------------------------------------------------------------------
US$000 (except percentages)
Long-term debt
Variable rate - US$000 4,666 4,666 4,666
Average interest rate 2.41% 2.41%
Fixed rate - US$000 5,493 5,474 1,542 184 - 12,693 12,693
Average interest rate 3.08% 3.08% 3.21% 4.78% - 3.12%
*Represents the net present value of the expected cash flows discounted at
current market rates of interest which approximate the total average interest
rates.
Exchange rate sensitivity
At year-end 2003, less than 6% of the Company's US$80,261,927 net worth
(shareholders' equity) was denominated in currencies other than the US Dollar,
principally the Euro.
A strengthening or weakening of the US Dollar by 10% against all the other
currencies in which the Company operates would not materially reduce the
Company's 2003 year-end net worth.
Item 12
Description of Securities Other than Equity Securities
Not applicable.
Part II
Item 13
Defaults, Dividend Arrearages and Delinquencies
Not applicable.
Item 14
Material Modifications to the Rights of Security Holders and Use of Proceeds
Not applicable.
48
Item 15
Control Procedures
In the fourth quarter of this annual report period, we carried out an
evaluation, under the supervision and with the participation of our senior
management, including Chief Executive Officer, Ronan O'Caoimh, and Chief
Financial Officer, Rory Nealon, of the effectiveness of the design and operation
of our disclosure controls and procedures pursuant to Rule 13(a)-14(c) of the
Securities Exchange Act of 1934. Disclosure controls and procedures are designed
to ensure that the material financial and non-financial information required to
be disclosed in this Form 20-F filed with the SEC is recorded, processed,
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
Audit Committee Financial Expert
Our board of directors has determined that Mr Peter Coyne meets the definition
of an audit committee financial expert, as defined in Item 401 of
Regulation S-K.
Code of Ethics
We have adopted a Code of Ethics for Executive and Financial Officers, a code of
ethics that applies to our chief executive officer, chief financial officer,
corporate controller and other finance organization employees. Written copies of
the Code of Ethics are available free of charge upon request. If we make any
substantive amendments to the Code of Ethics or grant any waivers, including any
implicit waiver, from a provision of these codes to our chief executive officer,
chief financial officer or corporate controller, we will disclose the nature of
such amendment or waiver on our website.
Principal Accounting fees and services
Fees Paid to Independent Public Accountants
The following table sets forth, for each of the years indicated, the fees paid
to our independent public accountants and the percentage of each of the fees out
of the total amount paid to the accountants.
Year Ended December 31,
------------------------------------------------------
2002 2003
------------------------- --------------------------
Services Rendered Fees (US$) Percentages Fees (US$) Percentages
----------------- ---------- ----------- ---------- -----------
Audit 190,000 90% 421,207 66%
Audit-related - - *208,557 33%
Tax - - 4,986 1%
Other 20,000 10% -
------- -------
Total 210,000 634,750
------- -------
* includes capitalized costs of acquisition and costs of finance relating to
fundraising activities.
Pre-Approval Policies and Procedures
Our Audit Committee has adopted a policy and procedures for the pre-approval of
audit and non-audit services rendered by our independent public accountants,
Ernst & Young. The policy generally pre-approves certain specific services in
the categories of audit services, audit-related services, and tax services up to
specified amounts, and sets requirements for specific case-by-case pre-approval
of discrete projects, those which may have a material effect on our operations
or services over certain amounts. Pre-approval may be given as part of the Audit
Committee's approval of the scope of the engagement of our independent auditor
or on an individual basis. The pre-approval of services may be delegated to one
or more of the Audit Committee's members, but the decision must be presented to
the full Audit Committee at its next scheduled meeting. The policy prohibits
retention of the independent public accountants to perform the prohibited
non-audit functions defined in Section 201 of the Sarbanes-Oxley Act or the
rules of the SEC, and also considers whether proposed services are compatible
with the independence of the public accountants.
49
Exemptions from the Listing Requirements and Standards for Audit Committee
Not applicable.
Purchase of equity securities by the issuer and affiliates and purchasers
The following table sets forth, for each of the months indicated, the total
number of shares purchased by us or on our behalf or any affiliated purchaser,
the average price paid per share, the number of shares purchased as part of a
publicly announced repurchase plan or program, the maximum number of shares or
approximate dollar value that may yet be purchased under the plans or programs.
Total Number of Maximum Number
Shares Purchased of Shares that May
as Part of Publicly Yet Be Purchased
Total Number of Average Price Paid Announced Plans Under the Plans or
Period in 2003 shares Purchased per Share or Programs Programs
-------------- ---------------- ------------------ ------------------- ------------------
January - - - 3,925,322
February - - - 3,925,322
March - - - 3,925,322
April - - - 3,925,322
May - - - 3,925,322
June - - - 4,183,462
July - - - 4,183,462
August - - - 4,183,462
September - - - 4,183,462
October - - - 4,183,462
November - - - 4,183,462
December - - - 4,183,462
Part III
Item 17
Financial Statements
The registrant has responded to Item 18 in lieu of responding to this item.
Item 18
Financial Statements
50
REPORT OF INDEPENDENT AUDITORS
To: The Board of Directors of Trinity Biotech plc
We have audited the accompanying consolidated balance sheets of Trinity Biotech
plc as of December 31, 2003 and 2002, and the related consolidated statements of
income, total recognised gains and losses, movement in shareholders' equity and
cash flows for each of the three years in the period ended December 31, 2003.
Our audits also included the financial statement schedule included at Item 18.
These financial statements and schedule are the responsibility of the Company's
management. Our responsibility is to express an opinion on these financial
statements and schedule based on our audits.
We conducted our audits in accordance with Irish Auditing Standards issued by
the Auditing Practices Board and auditing standards generally accepted in the
United States of America. Those standards require that we plan and perform the
audit to obtain reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements. An
audit also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the consolidated financial position of Trinity Biotech
plc at December 31, 2003 and 2002, and the consolidated results of its
operations and its cash flows for each of the three years in the period ended
December 31, 2003, in conformity with accounting principles generally accepted
in the Republic of Ireland, which differ in certain respects from accounting
principles generally accepted in the United States of America (see note 28 of
Notes to the Consolidated Financial Statements). Also, in our opinion, the
related financial statement schedule, when considered in relation to the basic
financial statements taken as a whole, presents fairly in all material respects
the information set forth therein.
Dublin, Ireland Ernst & Young
March 31, 2004 Registered Auditors
51
CONSOLIDATED BALANCE SHEETS
As at As at
December 31 December 31
2003 2002
Notes US$ US$
ASSETS
Inventories 2 30,554,618 20,851,459
Accounts receivable, net and prepayments 3 13,912,889 12,676,756
Cash and cash equivalents 20,563,418 5,807,514
------------ ------------
65,030,925 39,335,729
Intangible assets, net 4 38,850,780 39,511,786
Property, plant and equipment, net 5 13,659,680 9,883,681
Financial assets 6 -- 1,067,262
Other assets 3 550,104 --
------------ ------------
TOTAL ASSETS 118,091,489 89,798,458
------------ ------------
LIABILITIES & SHAREHOLDERS' EQUITY
Accounts payable and accrued expenses 7 19,400,947 18,912,207
Provisions for liabilities and charges (deferred tax) 9 910,902 293,579
Long-term liabilities 8 17,517,713 7,745,442
SHAREHOLDERS' EQUITY
Called up share capital
Class 'A' Ordinary shares 10 658,133 597,840
Class 'B' Ordinary shares 10 12,255 12,255
Share premium account 87,596,132 75,987,779
Currency adjustment (4,091,568) (4,266,173)
Profit and loss reserve 12(a) (4,168,943) (9,966,417)
Other reserves 255,918 172,000
------------ ------------
Shareholders' equity - (all equity interests) 80,261,927 62,537,284
Minority interest - (all equity interests) 12(b) -- 309,946
------------ ------------
80,261,927 62,847,230
------------ ------------
Total Liabilities and Shareholders' Equity 118,091,489 89,798,458
------------ ------------
See Notes to the Consolidated Financial Statements
52
Consolidated STATEMENTS OF INCOME
Year ended December 31
2003 2002 2001
Notes US$ US$ US$
Revenues
- Continuing operations 65,675,398 47,447,422 36,627,278
- Acquisitions 15 -- 4,531,000 448,295
----------- ----------- -----------
13 65,675,398 51,978,422 37,075,573
Cost of sales (32,876,951) (25,689,879) (18,049,765)
----------- ----------- -----------
Gross profit 32,798,447 26,288,543 19,025,808
Research and development expenses (5,210,039) (4,470,745) (2,779,729)
Administrative expenses - normal (17,919,806) (15,234,937) (9,563,019)
Administrative expenses - exceptional 16 -- -- (3,635,000)
----------- ----------- -----------
Operating profit
- Continuing operations 9,668,602 6,523,834 5,816,912
- Acquisitions -- 59,027 (2,768,852)
----------- ----------- -----------
13 9,668,602 6,582,861 3,048,060
Interest receivable and similar income 174,117 103,133 142,364
Interest payable and similar charges 13 (792,353) (704,460) (538,401)
----------- ----------- -----------
Profit on ordinary activities before taxation
and share of operating loss in associate
company and impairment 9,050,366 5,981,534 2,652,023
Share of operating loss in associate
company and impairment (1,067,262) (317,113) (268,870)
----------- ----------- -----------
Profit on ordinary activities before taxation 14 7,983,104 5,664,421 2,383,153
Tax on profit on ordinary activities 17 (2,185,630) (767,510) (15,876)
----------- ----------- -----------
Retained profit for the financial period 5,797,474 4,896,911 2,367,277
----------- ----------- -----------
Basic earnings per ordinary share (US dollars) 18 0.13 0.12 0.06
Diluted earnings per ordinary share (US dollars) 18 0.12 0.12 0.06
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
2003 2002 2001
US$ US$ US$
Profit for the financial period attributable to group shareholders
excluding share of operating loss in associate
company and impairment 6,864,736 5,214,024 2,636,147
Share of operating loss in associate company
and impairment (1,067,262) (317,113) (268,870)
Currency adjustment 174,605 355,782 48,951
---------- ---------- ----------
Total recognised gains and losses for the period 5,972,079 5,252,693 2,416,228
---------- ---------- ----------
See Notes to the Consolidated Financial Statements
53
CONSOLIDATED STATEMENTS OF MOVEMENT IN SHAREHOLDERS' EQUITY
Class 'A' Ordinary Shares Class 'B' Ordinary Shares
Share Share
capital capital
Number of US$0.0109 Number of US$0.0109 Share
shares each shares each premium
US$ US$ US$
Authorised 75,000,000 817,500 700,000 12,255
------- ------- ------- -------
Issued:
Balance as at December 31, 2000 38,973,496 590,552 700,000 12,255 75,183,433
------- ------- ------- ------- --------
Options exercised 43,250 613 - - 73,531
Share issue expenses - - - - (15,476)
Currency adjustment - - - - -
Retained profit - - - - -
Stock compensation - - - - -
------- ------- ------- ------- --------
Balance as at December 31, 2001 39,016,746 591,165 700,000 12,255 75,241,488
------- ------- ------- ------- --------
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
Share issue expenses - - - - (7,606)
Currency adjustment - - - - -
Retained profit - - - - -
Stock compensation - - - - -
------- ------- ------- ------- --------
Balance as at December 31, 2002 39,629,169 597,840 700,000 12,255 75,987,779
------- ------- ------- ------- --------
Shares issued for cash 10,279 112 - - 44,389
Options and warrants exercised 1,397,717 15,235 - - 2,228,984
Class 'A' shares issued on conversion of debenture 4,123,475 44,946 - - 9,810,053
Share issue expenses - - - - (475,073)
Currency adjustment - - - - -
Retained profit - - - - -
Stock compensation - - - - -
------- ------- ------- ------- --------
Balance as at December 31, 2003 45,160,640 658,133 700,000 12,255 87,596,132
------- ------- ------- ------- --------
Retained Currency Goodwill Other
profit adjustment reserve reserve Total
US$ US$ US$ US$ US$
Authorised
Issued:
Balance as at December 31, 2000 4,546,078 (4,670,906)(21,776,683) 7,000 53,891,729
------- ------- ------- ------- -------
Options exercised - - - - 74,144
Share issue expenses - - - - (15,476)
Currency adjustment - 48,951 - - 48,951
Retained profit 2,367,277 - - - 2,367,277
Stock compensation - - - 45,000 45,000
------- ------- ------- ------- -------
Balance as at December 31, 2001 6,913,355 (4,621,955)(21,776,683) 52,000 56,411,625
------- ------- ------- ------- -------
Shares issued for cash - - - - 544,823
Options exercised - - - - 13,875
Class 'A' shares issued for financial asset - - - - 201,874
Share issue expenses - - - - (7,606)
Currency adjustment - 355,782 - - 355,782
Retained profit 4,896,911 - - - 4,896,911
Stock compensation - - - 120,000 120,000
------- ------- ------- ------- -------
Balance as at December 31, 2002 11,810,266 (4,266,173)(21,776,683) 172,000 62,537,284
------- ------- ------- ------- -------
Shares issued for cash - - - - 44,501
Options and warrants exercised - - - - 2,244,219
Class 'A' shares issued on conversion of debenture - - - - 9,854,999
Share issue expenses - - - - (475,073)
Currency adjustment - 174,605 - - 174,605
Retained profit 5,797,474 - - - 5,797,474
Stock compensation - - - 83,918 83,918
------- ------- ------- ------- -------
Balance as at December 31, 2003 17,607,740 (4,091,568)(21,776,683) 255,918 80,261,927
------- ------- ------- ------- -------
See Notes to Consolidated Financial Statements
54
Consolidated Statements of Cash Flows
Year ended December 31
2003 2002 2001
Notes US$ US$ US$
Net cash inflow from operating activities 20 4,176,227 3,580,752 5,722,748
----------- ----------- -----------
Returns on investments and servicing of finance
Interest received 174,117 57,133 142,364
Interest paid (566,077) (695,489) (369,312)
Finance interest paid (23,120) (9,037) (23,424)
----------- ----------- -----------
Net cash outflow from returns on investments and servicing of finance (415,080) (647,393) (250,372)
----------- ----------- -----------
Taxation
Taxation (paid) (156,625) (403,935) (319,510)
----------- ----------- -----------
Capital expenditure and financial investment
Purchase of tangible fixed assets 19 (3,856,069) (2,516,982) (1,343,370)
Purchase of intangible fixed assets (1,846,109) (468,941) (986,502)
----------- ----------- -----------
Net cash outflow from investing activities (5,702,178) (2,985,923) (2,329,872)
----------- ----------- -----------
Acquisitions and disposals
Acquisition of subsidiary undertakings -- -- (4,777,388)
Payments to acquire trades or businesses (762,518) (4,408,692) --
Purchase of associate undertaking -- -- (309,399)
Deferred consideration paid (4,374,053) -- --
----------- ----------- -----------
Net cash outflow for acquisitions and disposals (5,136,571) (4,408,692) (5,086,787)
----------- ----------- -----------
Net cash outflow before use of liquid resources and financing (7,234,227) (4,865,191) (2,263,793)
----------- ----------- -----------
Management of liquid resources 19 (15,296,181) 553,310 (2,373,316)
----------- ----------- -----------
Financing
Repayment of loan from unconnected third party (57,198) (163,213) (73,336)
Repayment of minority interest (309,946) -- --
Issue of shares 2,251,844 558,698 74,144
Expenses paid in respect of share issues and debt financing (1,123,058) -- (183,521)
Movement in finance leases (129,889) 3,955 (310,076)
Increase /(decrease) in long term debt 2,449,653 (1,803,466) 4,829,963
(Decrease) in promissory note -- -- (350,000)
(Decrease) /increase in other financial liabilities (1,092,516) 4,107,755 --
Issue /(settlement) of convertible debentures 20,000,000 2,500,000 (625,000)
----------- ----------- -----------
Net cash inflow from financing 21,988,890 5,203,729 3,362,174
----------- ----------- -----------
(Decrease)/increase in cash (541,518) 891,848 (1,274,935)
----------- ----------- -----------
Reconciliation of net cash flow to movement in net debt
(Decrease)/increase in cash in the year (541,518) 891,848 (1,274,935)
(Increase)/ decrease in long term debt (2,449,653) 1,803,466 (4,829,963)
Decrease / (increase) in other financial liabilities 1,149,714 (4,041,506) --
(Issue) / settlement of convertible debentures (20,000,000) (2,500,000) 625,000
Increase/ (decrease) in liquid resources 15,296,181 (553,310) 2,373,316
Decrease in finance leases 129,889 17,350 310,076
Expenses paid in respect of debt financing 650,287 -- --
----------- ----------- -----------
Change in net debt resulting from cash flows (5,765,100) (4,382,152) (2,796,506)
----------- ----------- -----------
New finance leases (670,620) -- --
Finance leases acquired (201,926) -- --
Conversion of debentures 9,834,321 -- --
Promissory notes paid -- -- 350,000
Exchange movements on net debt (391,936) (87,554) --
Non cash exchange movement 1,241 95,000 --
Debt issue costs 130,956 20,679 --
----------- ----------- -----------
8,702,036 28,125 350,000
Movement in net debt in the year 2,936,936 (4,354,027) (2,446,506)
Net debt at January 1 (8,644,320) (4,290,293) (1,843,787)
----------- ----------- -----------
Net debt at December 31 21 (5,707,384) (8,644,320) (4,290,293)
----------- ----------- -----------
55
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
1. BASIS OF PREPARATION AND ACCOUNTING POLICIES
The financial statements have been prepared in United States Dollars
under the historical cost convention and are in accordance with
accounting principles generally accepted in Ireland.
The principal accounting policies adopted by Trinity Biotech plc and its
subsidiaries ("the Group") are as follows:
(a) Basis of Consolidation
The consolidated financial statements include the financial statements
of Trinity Biotech plc ("Trinity Biotech" and/or "the Company") and its
subsidiary 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 10 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 included in intangible assets and is
to be released over the period of release of the related non-monetary
assets. This is also subject to an annual impairment review by the
directors and any diminution in value is immediately taken to the
profit and loss account.
(e) Inventories
Inventories are stated at the lower of cost or net realisable value on
a first-in, first-out basis. Cost includes all expenditure which has
been incurred in bringing the products to their present location and
condition, and includes an appropriate allocation of manufacturing
overhead based on the normal level of activity. Net realisable value is
the estimated selling price of inventory on hand less all further costs
to completion and costs expected to be incurred in marketing,
distribution and selling.
(f) Taxation
Taxation, which is based on the results for the year, is reduced where
appropriate by manufacturing companies' relief. Deferred taxation, the
estimated future tax consequences of transactions and events recognised
in the financial statements of the current and previous years, is
provided on all material timing differences using the tax rates
substantively enacted at the balance sheet date which are expected to
apply in the periods in which the 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.
56
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
1. ACCOUNTING POLICIES (Continued)
(g) Sales and Revenue Recognition
Sales of products are recorded as of the date of shipment. Sales
represent the value of goods supplied to external customers and exclude
sales taxes and discounts.
(h) Pension Costs
The Group operates a defined contribution pension scheme. Contributions
to the scheme are expensed as incurred.
(i) Leases
Where tangible assets are financed by leasing agreements which give
rights approximating to ownership ("finance leases"), they are treated
as if they had been purchased outright at the present values of the
minimum lease payments; the corresponding obligations are shown in the
balance sheet as obligations under finance leases. The present value of
the minimum payments under a lease is derived by discounting those
payments at the interest rate implicit in the lease, and is normally
the price at which the asset could be acquired in an arm's length
transaction.
Amortisation is calculated in order to write-off the amounts
capitalised over the estimated useful lives of the assets by equal
annual instalments. The excess of the total rentals under a lease over
the amount capitalised is treated as interest, which is charged to the
income statement in proportion to the amount outstanding under the
lease.
Leases other than finance leases are classified as "operating leases",
and the rentals thereunder are charged to the income statement on a
straight line basis over the periods of the leases.
(j) Government Grants
Research and development, employment and training grants are credited
to the income statement against related expenditure in the period in
which the expenditure is incurred.
(k) Foreign Currency
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.
(l) 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.
(m) Use of Estimates
The preparation of financial statements in conformity with accounting
principles generally accepted in the Republic of Ireland requires
management to make estimates and assumptions that affect the amounts
reported in the financial statements and accompanying notes. Actual
results could differ from these estimates.
(n) Companies Acts, 1963 to 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. Copies of statutory financial statements of Trinity Biotech
plc are annexed to the Company's annual returns.
(o) Cost of Sales
Cost of sales comprises the product cost including shipping, handling
and packaging costs.
(p) Provision for Bad Debts
The Group sells its products to companies in various markets throughout
the world. The Group maintains reserves for potential credit losses. To
date such losses have been within management's expectations. The Group
had an allowance for doubtful accounts of approximately US$478,062,
US$496,412 and US$30,000 as at December 31, 2003, 2002 and 2001,
respectively.
57
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
1. ACCOUNTING POLICIES (Continued)
(q) Financial Instruments
Financial instruments include (i) borrowings; (ii) cash deposits and
liquid resources; and, (iii) interest and forward contracts.
Derivatives, principally forward foreign exchange contracts, are used
to manage the working capital requirements of the Group in a cost
effective, low-risk manner. Working capital management is a key element
in the effective management of overall liquidity. Where derivatives are
used to hedge cross-currency cash flows arising from trading
activities, the underlying transaction is ultimately recorded at the
contract rate upon settlement.
(r) Employee Stock Compensation
Options may be issued to employees to purchase ordinary shares with
exercise prices which are less than the market value of the ordinary
shares at the date of grant. In such cases the excess of the market
value over the exercise price for the total number of options so issued
is treated as compensation expense and recorded in the profit and loss
account over the vesting period, with an appropriate credit to other
reserves.
2. INVENTORIES
December 31 December 31
2003 2002
US$ US$
Raw materials 11,712,402 5,995,894
Work-in-progress 9,206,838 6,499,224
Finished goods 9,635,378 8,356,341
---------- ----------
30,554,618 20,851,459
---------- ----------
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
2003 2002
US$ US$
Accounts receivable, net 11,602,955 9,798,967
Prepayments 825,030 1,015,795
Value added tax 73,914 159,736
Called up share capital not paid 252,580 260,203
Grants receivable 181,687 532,665
Other receivables 282,597 490,482
Deferred costs 138,897 --
Deferred tax asset (see note 9) 555,229 418,908
---------- ----------
13,912,889 12,676,756
---------- ----------
Other assets, falling due after
more than one year 550,104 --
---------- ----------
4. INTANGIBLE ASSETS December 31 December 31
2003 2002
US$ US$
Cost
Patents and licenses 7,068,390 4,889,791
Goodwill (see note 22) 39,643,377 41,580,827
---------- ----------
46,711,767 46,470,618
Less accumulated amortisation (7,860,987) (6,958,832)
---------- ----------
38,850,780 39,511,786
---------- ----------
58
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
5. PROPERTY, PLANT AND EQUIPMENT December 31 December 31
2003 2002
US$ US$
Cost
Land and buildings 5,133,246 4,229,485
Leasehold improvements 2,444,469 1,213,153
Computer and office equipment 3,838,985 2,758,023
Plant and equipment 9,163,810 8,194,774
---------- ----------
20,580,510 16,395,435
Less accumulated depreciation
and amortisation (6,920,830) (6,511,754)
---------- ----------
13,659,680 9,883,681
---------- ----------
Included in the net book value of tangible fixed assets is an amount
for capitalised leased assets of US$1,538,042 (2002: US$944,352). The
amortisation charge in respect of capitalised leased assets for the
year ended December 31, 2003 was US$117,506 (2002: US$110,345, 2001:
US$111,512).
6. FINANCIAL ASSETS December 31 December 31
2003 2002
US$ US$
Investment in associate (see below) -- 1,067,262
----------- ----------
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
(euro)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$201,874
was satisfied by the issue of 156,189 'A' Ordinary Shares in Trinity
Biotech plc. During 2003 HiberGen Limited was unsuccessful in raising
additional funds and on November 14, 2003, the Board of HiberGen
Limited decided to cease trading.
The carrying amount of the investment in the associate is split as
follows:
December 31 December 31
2003 2002
US$ US$
Share of net assets of associate on acquisition 118,220 118,220
Goodwill arising on acquisition 1,764,695 1,764,695
Accumulated amortisation (270,455) (199,670)
Share of operating loss in associate (869,625) (615,983)
Write-off of investment (742,835) --
-------- ---------
-- 1,067,262
-------- ---------
59
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
7. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
(Amounts falling due within one year) December 31 December 31
2003 2002
US$ US$
Accounts payable 3,518,470 3,080,455
Income tax deducted under PAYE 137,442 90,953
Employee related social insurance 140,172 81,960
Corporate income taxes 1,573,913 184,394
Accrued liabilities 4,895,142 3,854,477
Accrued royalties 224,235 532,621
Obligations under finance leases 264,442 218,163
Financial liabilities from unconnected third party 3,309,027 4,107,755
Long-term debt - current portion (see note 8) 4,176,403 1,978,155
Deferred consideration - current portion -- 3,803,953
3% convertible debenture (see note 8) 1,161,701 --
6.0/7.5% convertible debenture (see note 8) -- 979,321
---------- ----------
19,400,947 18,912,207
---------- ----------
In December 2001, the Company acquired the assets of the Biopool
haemostasis business. Under the terms of the purchase agreement
US$2,591,500 of the total consideration of US$6,409,329 had been
deferred. The deferred consideration was payable in three instalments,
commencing on December 21, 2002. At December 31, 2002, US$2,021,400 of
the deferred consideration for the Biopool haemostasis business was
included in current liabilities under deferred consideration. In
December 2002, the Company filed an action against Xtrana Inc relating
to the purchase of the Biopool business from Xtrana in 2001. On June
16, 2003 Trinity Biotech and Xtrana settled this litigation. Pursuant
to the terms of the Settlement Agreement entered into between the
parties, Trinity Biotech agreed to pay Xtrana the remaining amounts due
on the deferred consideration.
In November 2002, the Company acquired the speciality clinical
chemistry product line from Sigma Diagnostics. Under the terms of the
purchase agreement US$1,810,000 of the total consideration of
US$4,412,372 was deferred and payable in two instalments commencing on
May 27, 2003. Included in the line "Deferred consideration - current
portion" at December 31, 2002 is an amount of US$1,782,553,
representing the present value of the deferred consideration. This debt
was settled in full during 2003.
As at December 31, 2003, the undrawn portion of existing banking
facilities amounted to US$1,000,000.
8. LONG-TERM LIABILITIES
(Amounts falling due after more than one year) December 31 December 31
2003 2002
US$ US$
5.25% convertible debenture -- 2,500,000
3% convertible debenture 11,874,903 --
Bank loans (secured, see note 23(h)) 4,734,343 4,655,785
Deferred consideration -- 570,100
Lease creditors 749,983 12,655
Corporate income taxes 158,484 6,902
---------- ---------
17,517,713 7,745,442
---------- ---------
The age profile of the Group's long-term debt, excluding obligations
under finance leases, is as follows:
December 31 December 31
2003 2002
US$ US$
In more than one year, but not more than two 6,461,675 2,065,750
In more than two years, but not more than three 6,480,394 1,466,965
In more than three years, but not more than four 2,562,538 1,055,071
In more than four years, but not more than five 1,255,077 3,073,491
In more than five years 8,046 71,510
---------- ---------
16,767,730 7,732,787
---------- ---------
60
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
8. LONG-TERM LIABILITIES (continued)
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 of 6% and a
conversion price of US$1.50. During 2003 the remaining US$1,000,000
principal amount of the debenture was converted into 666,667 Class 'A'
Ordinary Shares of the Company.
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 bore interest at a rate of 5.25% per annum and were
convertible into Class 'A' Ordinary Shares of the Company at a price of
US$1.50. During 2003 these debentures were converted into 1,666,667
Class 'A' Ordinary Shares of the Company.
In June 2003, Trinity Biotech completed a new US$10,000,000 club
banking facility with Allied Irish Bank plc and Bank of Scotland
(Ireland) Ltd. The new facility consists of a five year term loan of
US$6,000,000 and a one year revolver of US$4,000,000. This facility is
secured by the assets of the Group; the term loan is repayable in ten
equal instalments commencing on January 2, 2004. The debt is stated
net of unamortised issue costs of US$172,846.
In July 2003, the Company completed a private placement of
US$20,000,000 principal amount of 3% convertible debentures. The
debentures bear interest at a rate of 3% per annum and are convertible
into Class 'A' Ordinary Shares of the Company at a price of US$3.55.
The debentures are unsecured, and are repayable in ten equal
instalments commencing on October 1, 2004. In December 2003,
US$6,355,000 of the US$20,000,000 principal amount of the debenture and
US$44,500 of the related accrued interest was converted into 1,802,676
Class 'A' Ordinary Shares of the Company. Since the year end, a further
US$427,500 of the principal amount of the debenture has been converted
into 120,423 Class 'A' Ordinary Shares of the Company. As part of the
July placement, convertible notes in the aggregate principal amount of
up to US$5,000,000 could be issued at the option of the investors by
the later of January 9, 2004 and the three month anniversary of the
effective date of the registration statement. In March 2004, the
investors exercised this option in full and the Company completed a
further placement of US$5,000,000 principal amount of 3% convertible
debentures. The debentures bear interest at a rate of 3% per annum and
are convertible into Class 'A' Ordinary Shares of the Company at a
price of US$4. The debt is stated net of unamortised issue costs of
US$608,397.
As at December 31, 2003 payments falling due under finance leases of
less than one year's duration amounted to US$264,442 (2002:
US$218,163). As at December 31, 2003 obligations under finance leases
of between two and five years' duration amounted to US$749,983 (2002:
US$12,655). There were no payments falling due extending beyond five
years.
9. DEFERRED TAXATION
December 31 December 31
2003 2002
US$ US$
Movement in Deferred Tax Asset
At beginning of year 418,908 608,800
Charge to profit and loss account (see note 17) (306,585) (189,892)
Credit to profit and loss account (see note 17) 442,906 --
-------- --------
At end of year 555,229 418,908
-------- --------
Movement in Deferred Tax Liability
At beginning of year 293,579 143,000
Charge to profit and loss account (see note 17) 632,587 150,579
Credit to profit and loss account (see note 17) (15,264) --
-------- --------
At end of year 910,902 293,579
-------- --------
61
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
9. DEFERRED TAXATION (Continued)
The deferred tax asset is due to timing differences created by net
operating losses and state credit carryforwards, the tax written-down
value of fixed assets being greater than the related net book value and
the elimination of unrealised intercompany profit. The deferred tax
asset increased in 2003 as the tax effect of the excess of the tax
written-down value of fixed assets over the net book value and the
elimination of unrealised intercompany profit exceeded the tax
consequences of the utilisation of net operating loss carryforwards. In
2002 the deferred tax asset decreased as the Company utilised some of
its loss carryforwards.
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Net operating loss carryforwards 41,511 488,513 707,659
Other timing differences 692,583 61,812 174,800
--------- --------- ---------
Total deferred tax assets 734,094 550,325 882,459
--------- --------- ---------
Valuation allowance (178,865) (131,417) (273,659)
--------- --------- ---------
Net deferred tax assets 555,229 418,908 608,800
--------- --------- ---------
At December 31, 2003, the Company had Irish net operating loss
carryforwards of US$332,087. The utilisation of these net operating
loss carryforwards is limited to the future profitable operations of
the parent company in Ireland. These losses carry forward indefinitely.
Valuation allowances have been provided against state credit
carryforwards for uncertainties regarding future full utilisation of
these credits in the related tax jurisdiction in future periods.
The deferred tax liability is caused by the net book value of fixed
assets being greater than the tax written down value of fixed assets
and timing differences due to the acceleration of the recognition of
certain charges in calculating taxable income permitted in Ireland. The
deferred tax liability increased in 2003 as the excess of the net book
value of fixed assets over the tax written down value increased and the
Company was able to recognise an upfront charge in the calculation of
its taxable income in Ireland.
During 2002 the excess of the book value of fixed assets over the tax
value increased thereby resulting in an increase in the deferred tax
liability.
10. CALLED UP SHARE CAPITAL
(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. During 2003 the remaining US$1,000,000
principal amount of the debenture was converted into 666,667 Class 'A'
Ordinary Shares of the Company.
(b) On April 3, 2002, the Company acquired a further 165,000 Ordinary
Shares in its then associate HiberGen Limited. The consideration of
US$201,874 was satisfied by the issue of 156,189 'A' Ordinary Shares in
Trinity Biotech plc.
(c) In November 2002, the Company completed a private placement of
US$2,500,000 principal amount of 5.25% convertible debentures. The
debentures bore interest at a rate of 5.25% per annum and were
convertible into Class 'A' Ordinary Shares of the Company at a price of
US$1.50. During 2003 these debentures were converted into 1,666,667
Class 'A' Ordinary Shares of the Company.
(d) In December 2002, Enterprise Ireland subscribed for 443,900 'A'
Ordinary Shares in the Company (see note 23(d)).
(e) In July 2003, the Company completed a private placement of
US$20,000,000 principal amount of 3% convertible debentures. The
debentures bear interest at a rate of 3% per annum and are convertible
into Class 'A' Ordinary Shares of the Company at a price of US$3.55. In
December 2003, US$6,355,000 of the US$20,000,000 principal amount of
the debenture was converted into 1,790,141 Class 'A' Ordinary Shares of
the Company, a further US$44,500 of accrued interest was settled by the
issue of 12,535 Class 'A' ordinary shares of the Company at US$3.55
per share. Since the year end, a further US$427,500 of the principal
amount of the debenture has been converted into 120,423 Class 'A'
Ordinary Shares of the Company. As part of the July placement,
convertible notes in the aggregate principal amount of up to
US$5,000,000
62
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
10. CALLED UP SHARE CAPITAL (Continued)
could be issued at the option of the investors by the later of January
9, 2004 and the three month anniversary of the effective date of the
registration statement. In March 2004, the investors exercised this
option in full and the Company completed a further placement of
US$5,000,000 principal amount of 3% convertible debentures. The
debentures bear interest at a rate of 3% per annum and are convertible
into Class 'A' Ordinary Shares of the Company at a price of US$4.
(f) Since the year end, the Company has completed a US$22.5 million private
placement of 5,294,118 of Class 'A' Ordinary Shares of the Company at a
price of US$4.25 per share. The investors were granted five year
warrants to purchase an aggregate of 1,058,824 Class 'A' Ordinary
Shares of the Company at an exercise price of US$5.25 per share. Under
the terms of the placement, investors were also granted the right to
purchase an additional 2,647,059 Class 'A' Ordinary Shares of the
Company at a price of US$4.25 per share for a period of up to 30 days
after the closing of the transaction. An additional 431,617 Class 'A'
Ordinary Shares of the Company, amounting to US$1,834,372, were issued
within the 30 day period following the closing of the transaction to
investors who exercised this option.
(g) 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.
(h) The AGM held on May 28, 2001, approved a resolution for the
renominalisation of the Company's share capital from IR(pound)0.01 each
to US$0.0109 each.
(i) Since its incorporation the Company has not declared or paid dividends
on its 'A' Ordinary Shares. The Company anticipates, for the
foreseeable future, that it will retain any future earnings in order to
fund its business operations. The Company does not, therefore,
anticipate paying any cash or share dividends on its 'A' Ordinary
Shares in the foreseeable future.
As provided in the Articles of Association of the Company, dividends or
other distributions will be declared and paid in US Dollars.
11. SHARE OPTIONS AND WARRANTS
Under the terms of the Company's Employee Share Option Plan options to
purchase 8,068,894 Class 'A' Ordinary Shares were outstanding at
December 31, 2003. Under the plan, options are granted to officers,
employees and consultants of the Group at the discretion of the board.
In addition, the Company granted warrants to purchase 940,405 Class 'A'
Ordinary Shares in the Company to agents of the Company who were
involved in the Company's private placements in 1994 and 1995 and the
debenture issues in 1997, 1999 and 2002. A further warrant to purchase
100,000 Class 'A' Ordinary Shares was also granted to a consultant of
the Company. At December 31, 2003 there were warrants to purchase
258,500 Class 'A' Ordinary Shares in the Company outstanding. Since the
year end, the Company has completed a private placement of 5,294,118 of
Class 'A' Ordinary Shares of the Company at a price of US$4.25 per
share. The investors were granted five year warrants to purchase an
aggregate of 1,058,824 Class 'A' Ordinary Shares of the Company at an
exercise price of US$5.25 per share. The Company further granted
warrants to purchase 200,000 Class 'A' Ordinary Shares in the Company
to agents of the Company who were involved in this private placement.
63
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
11. SHARE OPTIONS AND WARRANTS (Continued)
The share options and warrants outstanding at December 31, 2003 were as
follows:
Options & Warrants
Shares Range
Outstanding US$
January 1, 2001 5,939,453* 0.81-5.00
Granted 665,000* 1.20 -1.75
Granted under value 1,414,500* 0.98
Exercised (43,250) 1.00-2.00
---------- ----------
December 31, 2001 7,975,703 0.81-5.00
Granted 2,243,500* 0.98-1.50
Exercised (12,334) 1.13
Cancelled (741,420) 0.98-2.78
---------- ----------
December 31, 2002 9,465,449 0.81-5.00
Granted 1,340,500 0.98- 3.11
Granted over value 155,000 1.80
Exercised (1,397,717) 0.81- 2.75
Cancelled (1,235,838) 0.98- 2.60
---------- ----------
December 31, 2003 8,327,394 0.81-5.00
---------- ----------
* Amounts adjusted for previously issued stock options
12. PROFIT AND LOSS RESERVE/MINORITY INTEREST
(a) Profit and loss reserve December 31 December 31
2003 2002
US$ US$
Accumulated surplus 17,607,740 11,810,266
Goodwill reserve (21,776,683) (21,776,683)
----------- -----------
(4,168,943) (9,966,417)
----------- -----------
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.
(b) Minority interest December 31 December 31
2003 2002
US$ US$
Minority interest -- 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. On April 4, 2003 this option was
exercised and the shares of Benen were purchased by Trinity Biotech
Plc.
In 2001 it was considered that the injection of these funds was in the
nature of quasi equity. The Group had obligations to transfer economic
benefits at the end of the investment period. This obligation was
limited to a maximum of (euro)330,200 being (euro)1.32 per share.
Accordingly, the Group had consolidated Benen as a 100% subsidiary
undertaking and the proceeds (after deducting share issue costs and
expenses) of the investment had been credited to minority interest.
64
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
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 two
reportable segments, the United States and the Rest of World, which are
based on a geographical split. Information on assets is maintained by
location analysed between the United States and the Rest of World. The
information presented below relates to these operating segments and is
presented in a manner consistent with information presented to the
Group's chief operating decision maker. The basis of accounting for
each segment is the same basis as used in the preparation of the
consolidated financial statements.
b) The distribution of revenue by geographical area was as follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Rest of World 46,526,957 23,968,227 13,548,075
United States 19,148,441 28,010,195 23,527,498
---------- ---------- ----------
65,675,398 51,978,422 37,075,573
---------- ---------- ----------
Revenue is attributed to geographical area based on where customer
orders are satisfied from.
c) The distribution of revenue by customers' geographical area was as
follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
United States 36,299,136 33,511,564 25,057,609
Europe 19,982,761 11,899,290 6,879,597
Middle East/Africa 6,248,603 4,396,270 3,900,154
Other overseas 3,144,898 2,171,298 1,238,213
---------- ---------- ----------
65,675,398 51,978,422 37,075,573
---------- ---------- ----------
d) The distribution of revenue by major product group was as follows
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Infectious diseases 35,127,128 37,829,479 37,075,573
Haemostasis 24,435,581 13,779,611 --
Clinical chemistry 6,112,689 369,332 --
---------- ---------- ----------
65,675,398 51,978,422 37,075,573
---------- ---------- ----------
This analysis of revenue is provided for information purposes but does
not form the basis of information provided to or used by the group's
chief operating decision maker in making strategic or operational
decisions.
65
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
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
2003 2002 2001
US$ US$ US$
Rest of World 25,480,477 21,448,012 12,208,904
Rest of World - intersegmental sales 15,964,429 18,365,780 13,732,096
United States 37,120,136 28,010,195 23,527,498
Less intercompany sales (12,889,644) (15,845,565) (12,392,925)
----------- ----------- -----------
65,675,398 51,978,422 37,075,573
----------- ----------- -----------
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
2003 2002 2001
US$ US$ US$
Rest of World 7,947,134 3,754,912 679,891
United States 1,721,468 2,827,949 2,368,169
----------- ---------- ----------
Total operating income 9,668,602 6,582,861 3,048,060
----------- ---------- ----------
g) The distribution of consolidated total assets by geographical area was
as follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Rest of World 85,178,683 62,073,836 54,743,563
United States 32,912,806 27,724,622 22,328,480
----------- ----------- -----------
Total assets 118,091,489 89,798,458 77,072,043
----------- ----------- -----------
h) The distribution of consolidated long-lived assets by geographical area
was as follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Rest of World 42,893,866 38,741,894 35,954,907
United States 10,166,698 11,720,835 11,597,729
---------- ---------- -- -------
Total long-lived assets 53,060,564 50,462,729 47,552,636
---------- ---------- ----------
66
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
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
2003 2002 2001
Customer A 12% 20% 27%
j) The distribution of depreciation and amortisation by geographical area
was as follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Rest of World 1,268,222 2,405,981 2,111,876
United States 955,445 1,098,034 763,445
--------- --------- ---------
Total depreciation and amortisation 2,223,667 3,504,015 2,875,321
--------- --------- ---------
k) The distribution of unusual items by geographical area was as follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
United States -- -- (3,635,000)
-------- -------- ----------
Total unusual items -- -- (3,635,000)
-------- -------- ----------
l) The analysis of interest expense by geographical area was as follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Rest of World (728,220) (607,750) (310,877)
United States (64,133) (96,710) (227,524)
-------- -------- --------
Total interest (792,353) (704,460) (538,401)
-------- -------- --------
m) The analysis of taxation charge by geographical area was as follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Rest of World 1,408,407 230,557 6,876
United States 777,223 536,953 9,000
--------- ------- ------
2,185,630 767,510 15,876
--------- ------- ------
67
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
14. PROFIT ON ORDINARY ACTIVITIES BEFORE TAXATION
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
The profit on ordinary activities before
taxation is stated after charging/(crediting):
Directors' emoluments:
Remuneration 1,091,469 1,165,171 953,841
Pension 104,096 94,706 59,157
Auditors' remuneration:
Audit fees 455,335 190,000 170,000
Non audit fees 18,255 20,000 25,377
Depreciation 1,367,312 1,118,494 873,186
Amortisation 856,355 2,385,521 2,002,135
Operating lease rentals:
Plant and machinery -- 26,048 --
Other 1,686,713 1,444,623 942,495
Employment grants (306,799) (214,091) --
Settlement of litigation (see note below) (225,000) -- (1,360,971)
Other non-recurring charges -- -- 357,447
--------- --------- ----------
Trinity Biotech and Selfcare entered into a settlement in 2001 whereby
Selfcare paid Trinity Biotech US$1,500,000 and Trinity Biotech (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.
On June 16, 2003 Trinity Biotech and Xtrana entered into a settlement
agreement. Pursuant to the terms of the Settlement Agreement entered
into between the parties, Trinity Biotech agreed to pay Xtrana the
amounts due on two promissory notes of US$1,166,200 and US$570,100,
together with interest thereon as provided in the notes, less
US$225,000, and less US$24,148, which represented the amount due and
owing by Xtrana to Trinity Biotech.
15. ACQUISITIONS
On August 27, 2002 Trinity Biotech purchased the Haemostasis 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 of the Biopool Haemostasis 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.
68
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
16. ADMINISTRATIVE EXPENSES - EXCEPTIONAL ITEMS
An exceptional charge of US$2,835,000 was incurred during 2001 relating
to the acquisition of the assets of the Biopool haemostasis business on
December 21, 2001. The principal components of this charge were
commitments on the acquisition of the assets of the Biopool haemostasis
business to make payments to employees.
An exceptional charge of US$800,000 was also incurred during 2001
relating to the acquisition of Bartels Inc. on December 8, 2000. This
charge comprised payments to employees. There were no exceptional
charges recognised in 2002 or 2003.
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Administrative expenses
-Exceptional -- -- 3,635,000
---------- --------- ---------
17. INCOME TAXES
(a) The charge for taxation based on the profit on ordinary activities,
comprises:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Current tax
Corporation tax at 12.5% (2002: 16%, 2001: 20%) 1,531,692 9,299 107,876
Manufacturing relief (194,890) -- (64,000)
---------- ---------- ----------
1,336,802 9,299 43,876
Overseas tax 367,826 481,862 47,000
Relief in respect of prior year -- (64,122) --
---------- ---------- ----------
Total current tax 1,704,628 427,039 90,876
Deferred tax charge/(credit)
Movement in deferred tax asset (see note 9) (136,321) 189,892 (218,000)
Movement in deferred tax liability (see note 9) 617,323 150,579 143,000
---------- ---------- ----------
Total taxation on profit on ordinary activities 2,185,630 767,510 15,876
---------- ---------- ----------
Effective tax rate
Profit on ordinary activities before taxation 7,983,104 5,664,421 2,383,153
As a percentage of profit before tax
Current tax 21.4% 7.5% 3.8%
Total tax (current and deferred) 27.4% 13.5% 0.7%
The following table relates the applicable Republic of Ireland
statutory tax rate to the effective current tax rate of the Group:
2003 2002 2001
% of profit % of profit % of profit
before taxation before taxation before taxation
Irish corporation tax 12.5 16.0 20.0
Manufacturing relief (2.4) (0.0) (2.7)
Tax rates on overseas earnings 1.2 4.0 0.7
Relief in respect of prior year -- (1.1) --
Effect of non-taxable costs in PBT 6.2 -- --
Other including benefit of loss carryforwards 3.9 (11.4) (14.2)
------ ------ ------
Current tax 21.4 7.5 3.8
Deferred tax 6.0 6.0 (3.1)
------ ------ ------
Total tax (current and deferred) 27.4 13.5 0.7
------ ====== ======
69
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
17. INCOME TAXES (Continued)
(b) The distribution of profit on ordinary activities before taxes by
geographical area was as follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Ireland 5,771,847 2,933,528 389,193
Overseas 2,211,257 2,730,893 1,993,960
--------- --------- ---------
Total profits before taxation 7,983,104 5,664,421 2,383,153
--------- --------- ---------
(c) The tax effects of temporary differences that give rise to significant
portions of deferred tax assets relate principally to the elimination
of unrealised intercompany profit and net operating losses and state
credit carryforwards. The valuation allowance for deferred tax assets
at December 31, 2003, 2002 and 2001 was US$178,865, US$131,417 and
US$273,659 respectively.
(d) At December 31, 2003, the Group had Irish net operating losses of
approximately US$332,087 (2002: approximately US$399,013). The
utilisation of these net operating loss carryforwards is limited to
offset against the future profits earned by the Group arising from the
same trade and in the company in which they arose.
At December 31, 2003, the Group had fully utilised its U.S. net
operating loss carryforwards.
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$5,797,474 (December 31, 2002, US$4,896,911 and December 31, 2001,
US$2,367,277) for the financial year by the weighted average number of
ordinary shares in issue of 43,093,146 (December 31, 2002 - 40,550,367
and December 31, 2001 - 40,408,978).
(b) Diluted earnings per ordinary share Diluted earnings per ordinary share
is computed by dividing the profit on ordinary activities after
taxation of US$5,797,474 (December 31, 2002, US$4,896,911 and December
31, 2001, US$2,367,277) for the financial year, adjusted for debenture
interest saving of US$343,910 (December 31, 2002, US$85,829 and
December 31, 2001 US$nil) by the diluted weighted average number of
ordinary shares in issue of 50,583,247 (December 31, 2002, 42,486,227
and December 31, 2001, 41,120,060). 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
2003 2002 2001
Basic earnings per share denominator 43,093,146 40,550,367 40,408,978
Issuable on exercise of options 4,106,791 1,214,703 711,082
Issuable on conversion of debentures 3,383,310 721,157 --
---------- ---------- ----------
Diluted earnings per share denominator 50,583,247 42,486,227 41,120,060
---------- ---------- ----------
No adjustment is included for debenture conversion for 2001 as the
impact would have been anti-dilutive.
If the 5,294,118 and the 431,617 of Class 'A' Ordinary Shares issued in
the private placement completed since the year end (see note 10 (f))
had been included in the calculation of the weighted average number of
shares; the basic earnings per share denominator would have been
43,108,833 and the diluted earnings per share denominator would have
been 50,598,934.
70
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
19. SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
(a) Purchase of tangible fixed assets
Additions to tangible fixed assets 4,526,689 2,516,982 1,343,370
Less new finance leases (670,620) -- --
--------- --------- ---------
3,856,069 2,516,982 1,343,370
--------- --------- ---------
(b) Management of liquid resources
Cash flows of US$15,296,181 from the use of liquid resources in 2003
arose from the movement of cash to fixed deposit accounts. Cash flows
of US$553,310 from the use of liquid resources in 2002 arose from the
movement of cash from fixed deposit accounts. Cash flows of
US$2,373,316 from the use of liquid resources in 2001 arose from the
movement of cash to fixed deposit accounts.
(c) Impact of acquisitions on cash flow headings
There were no acquisitions in 2003. Additional costs incurred and
obligations assumed from the acquisitions completed in 2002 resulted in
cash outflows to the Group of US$762,518 during 2003. Deferred
consideration of US$1,810,000 relating to the purchase of the
speciality clinical chemistry product line from Sigma Diagnostics was
paid during 2003.
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). As the working
capital of the acquired businesses was fully integrated within the
Group by December 31, 2002 post acquisition operating cash flows were
not readily obtainable. The operating results of the haemostasis
division and the speciality clinical chemistry product line of Sigma
Diagnostics acquired on August 27 and November 27, 2002 respectively
contributed US$59,027 to the operating profit of the Group.
The operating results of the Amerlex hormone business of Ortho Clinical
Diagnostics acquired on October 19, 2001 contributed US$41,148 to the
net cash inflow from operating activities of the Group.
20. RECONCILIATION OF OPERATING PROFIT TO NET CASH INFLOW FROM OPERATING
ACTIVITIES
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Operating profit 9,668,602 6,582,861 3,048,060
Depreciation and amortisation 2,223,667 3,504,015 2,875,321
Exceptional administrative expenses - (2,835,000) 2,835,000
(Increase)/decrease in receivables and prepayments (64,500) (4,250,982) 990,800
(Decrease) / increase in accounts payable (2,560,673) 2,874,740 (2,044,110)
Increase in inventory (6,005,103) (2,414,882) (2,027,323)
Non cash compensation expense 83,918 120,000 45,000
Foreign exchange losses on non-operating cashflows 484,822 -- --
Loss on retirement of fixed assets 185,987 -- --
Other non-cash items 159,507 -- --
---------- ---------- ----------
Net cash inflow from operating activities 4,176,227 3,580,752 5,722,748
---------- ---------- ----------
71
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
21. ANALYSIS OF NET DEBT
December 31 Cash flow Acquisitions/ Non-cash Exchange December 31
2002 disposals changes movements 2003
US$ US$ US$ US$ US$ US$
Cash 3,093,692 (541,518) -- -- 1,241 2,553,415
Liquid resources 2,713,822 15,296,181 -- -- -- 18,010,003
---------- ----------- -------- ---------- -------- -----------
5,807,514 14,754,663 -- -- 1,241 20,563,418
Long-term debt
- current portion (1,978,155) (2,198,248) -- -- -- (4,176,403)
Long-term debt (4,655,785) (78,558) -- -- -- (4,734,343)
Other financial liabilities (4,107,755) 1,149,714 -- -- (350,986) (3,309,027)
Finance leases (230,818) 129,889 (201,926) (670,620) (40,950) (1,014,425)
Convertible debentures (3,479,321) (19,522,560) -- 9,965,277 -- (13,036,604)
---------- ----------- -------- ---------- -------- -----------
Net debt (8,644,320) (5,765,100) (201,926) 9,294,657 (390,695) (5,707,384)
---------- ----------- -------- ---------- -------- -----------
December 31 Cash flow Acquisitions/ Non-cash Exchange December 31
2001 disposals changes movements 2002
US$ US$ US$ US$ US$ US$
Cash 2,106,844 891,848 -- -- 95,000 3,093,692
Liquid resources 3,267,132 (553,310) -- -- -- 2,713,822
---------- ----------- -------- --------- -------- -----------
5,373,976 338,538 -- -- 95,000 5,807,514
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 - (4,041,506) -- -- (66,249) (4,107,755)
Finance leases (226,863) 17,350 -- -- (21,305) (230,818)
Convertible debentures (1,000,000) (2,500,000) -- 20,679 -- (3,479,321)
---------- ---------- ------- ------- ------- ----------
Net debt (4,290,293) (4,382,152) -- 20,679 7,446 (8,644,320)
---------- ---------- ------- ------- ------- ----------
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 (1,274,935) -- -- -- 2,106,844
Liquid resources 893,816 2,373,316 -- -- -- 3,267,132
---------- ----------- -------- --------- -------- -----------
4,275,595 1,098,381 -- -- -- 5,373,976
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) (2,446,506) -- -- -- (4,290,293)
---------- ---------- ------- ------- ------- ----------
72
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
22. ACQUISITION OF BUSINESSES
On August 27, 2002 Trinity Biotech purchased the haemostasis division
of Sigma Diagnostics for a total consideration of US$1,428,001. The
consideration was satisfied in cash. Acquisition expenses amounted to
US$78,698. The division comprises a portfolio of reagents manufactured
in St. Louis, Missouri and the Amelung range of instruments
manufactured in Lemgo, Germany. The Company recently completed training
its workforce in the manufacture of the reagent product line in the
Sigma St Louis operations and has recently transferred the production
of these reagents to Bray, Ireland. This acquisition together with the
acquisition of Biopool in 2001 position the Company with a significant
market position in the haemostasis diagnostic market.
On November 27, 2002 the Company also acquired the speciality clinical
chemistry product line from Sigma Diagnostics for a total consideration
of US$4,443,852 satisfied in cash and deferred consideration with a
fair value of US$4,412,372. 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 fair value of deferred consideration at November 27,
2002 was US$1,778,520. The deferred consideration is not conditional on
any future event. During 2003 the deferred consideration was paid in
full. Total acquisition expenses amounted to US$93,852. The Company
recently completed training its workforce in the manufacture of this
product line in the Sigma St Louis operations and has recently
transferred production of the product line from St. Louis, Missouri to
Bray, Ireland. Goodwill arising on acquisition of US$4 million after
fair value adjustments represents the value of the expected synergies
created by combining production within Trinity Biotech's existing
manufacturing operations.
The Company does not allocate any value to trademarks of acquired
entities as part of the purchase price allocation as the Company
re-brands any products acquired, under a Trinity Biotech label. The
Company does not allocate any value to customer relationships or
customer lists obtained as part of these acquisitions as these are not
considered proprietary to the acquired entities and the Company is
already in possession of such customer lists and has existing
relationships with customers of acquired entities given its existing
position in the diagnostics industry.
Sigma Sigma Total
Haemostasis Clinical
Chemistry
US$ 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 (1,278,461) 3,787,103 2,508,642
---------- --------- ---------
Consideration 1,428,001 4,412,372 5,840,373
---------- --------- ---------
Satisfied by:
Cash payments including costs 1,428,001 2,633,852 4,061,853
---------- --------- ---------
Net cashflow 1,428,001 2,633,852 4,061,853
Deferred consideration -- 1,778,520 1,778,520
---------- --------- ---------
Consideration 1,428,001 4,412,372 5,840,373
---------- --------- ---------
73
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
22. ACQUISITION OF BUSINESSES (Continued) Goodwill capitalised during 2002
in respect of acquired businesses amounted to US$2,508,642 and
comprises:
Fair
Book Value Fair
Values Adjustment Value Consideration Goodwill
US$ US$ US$ US$ US$
Sigma Haemostasis
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 (1,428,001) 1,278,461
---------- ---------- --------- ---------- ----------
Sigma Clinical Chemistry
Working capital 1,490,593 (865,324)* 625,269
---------- ---------- --------- ---------- ----------
1,490,593 (865,324) 625,269 (4,412,372) (3,787,103)
---------- ---------- --------- ---------- ----------
Total 11,270,128 (7,938,397) 3,331,731 (5,840,373) (2,508,642)
---------- ---------- --------- ---------- ----------
The book values of the assets shown above have been taken from
management accounts and other information of the acquired businesses at
the dates of acquisitions.
The fair value adjustments above principally arise for the following
reasons:
* Revaluation of fixed assets and inventories following an assessment
of the continuing economic contribution of fixed assets and the
realisable value of inventories.
Following the completion of the fair value exercises in 2003 in respect
of the acquisitions made during 2002, amendments have been made to the
fair values reported in the 2002 financial statements. The amendments
relate to the identification of additional obligations assumed on the
acquisition of the Sigma Haemostasis business, the fair valuation of
inventory acquired and the recognition of additional costs in both the
Sigma Haemostasis and Clinical Chemistry acquisitions. The difference
has been taken as an adjustment to goodwill on acquisition. Provisional
and final values of net assets acquired and consideration paid are as
follows:
Provisional Adjustments Adjustments Final
fair value to net assets to costs fair value
2002 2003 2003 2003
US$ US$ US$ US$
Sigma Haemostasis
Tangible fixed assets 2,500,000 -- -- 2,500,000
Working capital 206,462 2,239,693 -- 2,446,155
---------- --------- ------- ----------
Net Assets 2,706,462 2,239,693 -- 4,946,155
---------- --------- ------- ----------
Consideration and costs (1,428,001) -- (67,595) (1,495,596)
---------- --------- ------- ----------
Sigma Clinical Chemistry
Working capital 625,269 (137,154) -- 488,115
---------- --------- ------- ----------
Consideration and costs (4,412,372) -- (97,479) (4,509,851)
---------- --------- ------- ----------
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. This business added a range of tests which diagnose hormone
disorders to the Company's portfolio of products. The manufacture of
these products was transferred to the Bray, Ireland manufacturing
facility. Goodwill arising on acquisition of US$877,797 represents the
value of expected synergies created by combining production within the
Company's existing manufacturing operations.
74
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
22. ACQUISITION OF BUSINESSES (Continued)
On December 21, 2001 the Group acquired the assets of the Biopool
haemostasis business for a total consideration of US$6,409,329
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. All amounts due have been paid. Total acquisition
expenses amounted to US$159,329. This business comprises a range of
test kits which assess and diagnose disorders of blood coagulation,
thrombotic risk factors, fibrinolysis, platelet function and the
vascular system. As part of the acquisition the Company assumed the
workforce in Ventura, California and Umea, Sweden. In the ten months
after acquisition the Company learnt the production techniques
associated with this product range and transferred the Ventura
production facility together with a number of key employees to the
Bray, Ireland facility. The Company has maintained the Umea operation
and will continue to benefit from the expertise associated with this
assumed workforce. Goodwill arising on acquisition of US$5.1 million
after fair value adjustments represents the value of the expected
synergies created by combining production within the Company's existing
manufacturing operations in Ireland together with the specialist
product knowledge acquired with the assumed workforce in Ventura and
Umea.
The Company does not allocate any value to any trademarks of acquired
entities as part of the purchase price allocation as the Company
re-brands any products acquired, under a Trinity Biotech label. The
Company does not allocate any value to customer relationships or
customer lists obtained as part of these acquisitions as these are not
considered proprietary to the acquired entities and the Company is
already in possession of such customer lists and has existing
relationships with customers of acquired entities given its existing
position in the diagnostics industry.
Ortho Biopool Total
US$ US$ US$
Working capital -- (136,000) (136,000)
------- --------- ---------
Net 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
------- --------- ---------
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.
75
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
22. ACQUISITION OF BUSINESSES (Continued)
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.
Following the completion of the fair value exercises in 2002 in respect
of the acquisitions made during 2001, amendments have been made to the
fair values reported in the 2001 financial statements. The difference
has been taken as an adjustment to goodwill on acquisition. Provisional
and final values of net assets acquired and consideration paid are as
follows:
Provisional Adjustments Adjustments Final
fair value to net assets to costs fair value
2001 2002 2002 2002
US$ US$ US$ US$
Ortho
Consideration and costs 877,797 -- -- 877,797
---------- --------- ------- ----------
Biopool
Working capital (136,000) 1,551,132 -- 1,415,132
---------- --------- ------- ----------
Consideration and costs (6,409,329) -- (68,164) (6,477,493)
---------- --------- ------- ----------
23. COMMITMENTS AND CONTINGENCIES
(a) Capital Commitments
The capital commitments of the Group were as follows:
31 December 31 December 31 December
2003 2002 2001
US$ US$ US$
Contracted for -- -- --
Authorised, not contracted for -- -- --
------- ------- -------
-- -- --
------- ------- -------
(b) Operating lease commitments payable during the next twelve months
amount to US$2,182,494 (2002: US$1,529,849) payable on leases of
buildings at Dublin and Bray, Ireland, Darmstadt, Germany, Umea,
Sweden, St. Louis, Missouri, upstate New York and Carlsbad, California
and cars and equipment in the UK and Lemgo, Germany. US$53,458 of the
operating lease commitments total relates to leases whose remaining
term will expire within one year, US$169,094 relates to leases whose
remaining term expires between one and two years, US$654,496 between
two and five years and the balance of US$1,305,446 relates to leases
which expire after more than five years.
76
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
23. COMMITMENTS AND CONTINGENCIES (Continued)
Future minimum operating and finance lease commitments with
non-cancellable terms in excess of one year are as follows:
Operating Leases Finance Leases
US$ US$
2004 2,182,494 307,408
2005 2,072,879 252,774
2006 1,725,041 223,791
2007 1,380,804 173,144
2008 1,306,562 168,786
Later years 18,238,295 -
---------- ---------
Total minimum payments 26,906,075 1,125,903
Less amounts representing interest - (111,478)
---------- ---------
Total lease obligations 26,906,075 1,014,425
---------- ---------
(c) Under agreements between the Group and Enterprise Ireland, grants
amounting to US$181,687 (2002: US$532,665) are receivable which may be
revoked, cancelled or abated in certain circumstances.
(d) 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 (euro)1,097,054 at a share price 10%
below the market price of the Company's shares. In December 2000
Enterprise Ireland subscribed (euro)548,527 of this amount for 239,198
'A' Ordinary Shares of the Company. In December 2002 Enterprise Ireland
subscribed the remaining (euro)548,527 for 443,900 'A' Ordinary Shares
of the Company.
(e) At December 31, 2002 the Company had guaranteed the borrowings of
subsidiary undertakings to the amount of US$2,776,343. These borrowings
were paid in full during 2003.
(f) In June 2003, Trinity Biotech completed a new US$10,000,000 club
banking facility with Allied Irish Banks plc and Bank of Scotland
(Ireland) Ltd, this facility is guaranteed by the subsidiaries of the
company.
(g) Pursuant to the provisions of Section 17, Companies (Amendment) Act,
1986, the Company has guaranteed the liabilities of Trinity Biotech
Manufacturing Limited and Trinity Research Limited, subsidiary
undertakings in the Republic of Ireland, for the financial year to
December 31, 2003 and, as a result, these subsidiary undertakings have
been exempted from the filing provisions of Section 7, Companies
(Amendment) Act, 1986.
(h) The Company's bank borrowings are secured by a fixed and floating
charge over the assets of the Company.
(i) In December 2003, the Company filed an action against Inverness Medical
for declaratory judgment and breach of contract. The suit alleges that
Inverness Medical is attempting to convert customers from the Trinity
Biotech product to a product manufactured by a competitor by claiming
that the Trinity Biotech product is unavailable and being discontinued.
In January 2004, Inverness Medical countersued and sought a preliminary
injunction to prevent the Company from selling direct in the US any of
its products which are competitive with products sold by Inverness
Medical and sourced by other suppliers. The Superior Court of Middlesex
County, Massachusetts, denied the motion for preliminary injunction on
January 28, 2004.
77
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
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$400,411 (December 31, 2002, US$522,797 and December 31, 2001,
US$583,065). 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 (euro)7.62 per square foot ("the Current
Extension"). The lease commenced on the newly completed 25,000 square
foot building in July 2000. The Company also envisages that further
premises may potentially be required by it and, for that purpose, has
entered into a four years eleven month lease at (euro)12,860 per annum
over adjacent lands with JRJ. On November 20, 2002, the Company entered
into an agreement for lease with JRJ for offices that have been
constructed on part of these lands. The annual rent of (euro)365,760
(US$459,094) is payable from January 1, 2004 Independent Valuers have
advised the Company that the rent fixed in respect of the Current
Extension, the agreement for lease and the adjacent lands represents a
fair market rent. The rent for any future property constructed will be
set at the then open market value. The Company and its directors
(excepting Mr. O'Caoimh and Dr. Walsh who express no opinion on this
point) believe that the arrangements entered into represent a fair and
reasonable basis on which the Company can meet its ongoing requirements
for premises.
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$5,707,384
(2002: US$8,644,320) at interest rates ranging from 2.15% to 7.42% and
including US$14,134,621 of fixed rate debt at interest rates ranging
from 3% to 5.50% (2002: US$3,985,988 at interest rates ranging from 5%
to 7.50%). In broad terms, a one-percentage point increase in interest
rates would reduce the net interest charge by US$82,544 (2002: increase
by US$46,796).
Liquidity Risk
The Group's operations are cash generating. Short-term flexibility is
achieved with overdraft facilities.
78
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
27. DERIVATIVES AND FINANCIAL INSTRUMENTS (Continued)
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 treasury policy which aims to sell US Dollars forward to
match a portion of its uncovered Euro expenses at exchange rates lower
than budgeted exchange rates. With an increasing level of Euro
denominated sales, the Group anticipates that, over the next three
years, a higher proportion of its non-US Dollar expenses will be
matched by non-US Dollar revenues. The Group had foreign currency
denominated cash balances equivalent to US$585,758 at December 31,
2003.
The disclosures below exclude short term accounts receivable
and payable
Interest Rate Profile of Financial Liabilities
The interest rate profile of financial liabilities of the Group was as
follows:
December 31 December 31
2003 2002
US$ US$
Financial liabilities on which no interest is paid -- 57,198
Floating rate financial liabilities 12,136,181 10,429,953
Fixed rate financial liabilities 14,134,621 3,964,683
---------- ----------
26,270,802 14,451,834
---------- ----------
Financial liabilities at December 31, 2002, on which no interest is
paid, comprise loans from unconnected third parties.
Floating rate financial liabilities comprise overdrafts and other
borrowings that bear interest at rates of between 2.15% and 7.42%.
These overdrafts and borrowings are provided by financial institutions
at margins ranging from 1% to 3.25% over interbank rates.
December 31 December 31
Fixed rate financial liabilities 2003 2002
- weighted-average interest rate 3.28% 5.50%
- weighted-average period for which rate is fixed 3.24 years 3.78 years
Maturity of Financial Liabilities
The maturity profile of the Group's financial liabilities was as
follows:
December 31 December 31
2003 2002
US$ US$
In one year or less, or on demand 8,911,573 7,296,049
In more than one year, but not more than two 6,654,177 1,488,748
In more than two years, but not more than five 10,705,052 5,595,527
In more than five years -- 71,510
---------- ----------
26,270,802 14,451,834
---------- ----------
Fair Values of Financial Assets and Liabilities
There is no significant difference between the fair value and the
carrying value of the Group's financial assets and liabilities as at
December 31, 2003. At December 31, 2003 forward contracts with a
carrying value of US$Nil had a fair value of US$3,120,691 (asset) and
US$2,775,000 (liability) respectively (2002: US$1,068,738 (asset) and
US$271,515 (liability) respectively).
79
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
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 Statement of Income on a systematic basis
over its useful economic life. From 1998, goodwill must be
capitalised and amortised over the period of its expected useful
life, however, historic goodwill continues to remain an offset
against shareholders' equity. Under US GAAP, accounting for
goodwill as an offset against shareholders' equity is not
permitted. Prior to January 1, 2002 goodwill was amortised,
except for goodwill arising on acquisitions after June 30, 2001,
over the period of its expected useful life, subject to a maximum
write off period of 40 years, through the income statement. A
useful life of 10 years was adopted for the purposes of the
reconciliation.
In June 2001, the 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 is no longer amortised under US GAAP, but is
subject to annual impairment tests in accordance with SFAS 142
and when conditions of impairment are present. On January 1, 2002
the Group performed the required impairment review of goodwill
and indefinite-lived intangible assets upon the adoption of SFAS
142 and determined that there was no impairment. On December 31,
2002 and December 31, 2003, the Group performed further
impairment tests of goodwill and indefinite-lived intangible
assets, and concluded that there was no impairment in the
carrying value of these assets at those dates.
There has not been a disposal of all or a portion of a reporting
unit in the three years to December 31, 2003. The aggregate
amount of goodwill relating to acquisitions during the period for
the Group and for each reportable segment for each of the periods
presented including goodwill arising on acquisition of interest
in associate, net of fair value adjustments, is as follows:
2003 2002 2001
US$ US$ US$
Rest of World (1,937,465) 1,181,211 7,553,576
United States - - -
------- -------- --------
Total (1,937,465) 1,181,211 7,553,576
----------- --------- ---------
In 2003 the Group's investment in its associate, including
unamortized goodwill of US$1,659,171, was written off.
Negative goodwill arises when the net amounts assigned to assets
acquired and liabilities assumed exceed the cost of an acquired
entity. Under Irish GAAP, negative goodwill arising on
acquisitions is recognised as a negative asset, within intangible
fixed assets, and recognised in the profit and loss account in
the periods in which the non-monetary assets acquired are
depreciated or sold. Any negative goodwill in excess of the fair
values of the non-monetary assets acquired is recognised in the
profit and loss account in the periods expected to benefit. Under
US GAAP, negative goodwill would be allocated to reduce
proportionately the values assigned to the acquired non-current
assets. Any excess remaining negative goodwill is recognised in
US GAAP income as an extraordinary gain for the periods beginning
after December 15, 2001. At December 31, 2003, gross negative
goodwill of US$2,500,000 within intangible fixed assets under
Irish GAAP would be disclosed as a reduction from property, plant
and equipment under US GAAP and the balance of US$950,559 would
be recognised as an extraordinary gain in 2003. At December 31,
2002, gross negative goodwill of US$1,278,461 within intangible
fixed assets under Irish GAAP would be disclosed as a reduction
from property, plant and equipment under US GAAP.
Depreciation of US$76,634 in 2003, under Irish GAAP, on property,
plant and equipment acquired would not be recognised under
US GAAP as the value of the acquired building has been fully
offset by the negative goodwill arising on the acquisition.
Following the completion of the fair value exercises in 2003
in respect of the Sigma Haemostasis and Sigma Clinical
Chemistry acquisitions made during 2002, amendments have been
made to the fair values reported in the 2002 financial
statements. The amendments relate to the identification of
additional obligations of US$928,881 assumed on the
acquisition of the Sigma Haemostasis business, the completion
of the fair value exercise on inventory acquired in both
acquisitions resulting in the recognition of additional value
of US$3,031,420 and the recognition of additional costs of
US$67,595 relating to the Sigma Hemostasis acquisition and
US$97,479 relating to the Clinical Chemistry acquisition. The
difference has been taken as an adjustment to goodwill on
acquisition.
80
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
Net income and earnings per share for the years ended December
31, 2003, 2002 and 2001, adjusted to exclude amortization of goodwill, is as
follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Reported net income under US GAAP 5,145,594 5,042,943 710,151
Excluded goodwill amortisation under Irish GAAP - - 1,825,960
Excluded additional goodwill amortisation under
US GAAP - - 2,166,700
------- -------- --------
Adjusted net income 5,145,594 5,042,943 4,702,811
Reported basic earnings per share (US dollars) 0.12 0.12 0.02
Excluded goodwill amortisation - - 0.10
------- -------- --------
Adjusted basic earnings per share (US dollars) 0.12 0.12 0.12
Reported diluted earnings per share (US dollars) 0.11 0.12 0.02
Excluded goodwill amortisation - - 0.10
------- -------- --------
Adjusted diluted earnings per share (US dollars) 0.11 0.12 0.12
Identifiable intangible assets comprise goodwill, which is not
amortizable and certain other non-current intangible assets,
which are amortizable. Other non-current asset amortization
under US GAAP for the years ended December 31, 2003, 2002 and
2001 was US$154,052, US$138,886 and US$115,175 respectively.
Other non-current amortization of identifiable intangible
assets under US GAAP is estimated to be approximately
US$184,363 in 2004, US$182,804 in 2005, US$180,940 in 2006,
US$180,941 in 2007, US$180,944 in 2008 and US$806,529
thereafter.
The net book value of goodwill at December 31, 2003 was
US$48,397,474.
(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.
81
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
(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, 2003, is US$252,580
(2002: US$260,203).
(d) Statement of Comprehensive Income:
The Company prepares a "Statement of Total Recognised Gains and
Losses" which is essentially the same as the "Statement of
Comprehensive Income" required under US GAAP, except for the
recognition of unrealised gains and losses on derivative hedging
transactions which are recognised in US GAAP Comprehensive
Income. SFAS 130 requires disclosure of the cumulative amounts of
other comprehensive income.
(e) Sale and Leaseback:
Under Irish GAAP, the Company's sale and leaseback transaction
which took place in December 1999 was treated as a disposal of
assets with the gain on the disposal of US$1,014,080 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) Sales on Extended Credit Terms:
In 2003 the Company made certain sales on extended credit terms.
Under US GAAP, SAB 104 "Revenue Recognition in Financial
Statements", such sales on extended credit terms would not be
recognisable as revenue until 2004, when the cash is actually
received. No similar provisions exist under Irish GAAP to
preclude revenue recognition. Sales were not made on extended
credit terms in 2002 or 2001. Revenue of US$35,000 was recognized
in 2001, relating to sales made on extended credit terms in 2000.
(g) Restructuring Costs:
Under Irish GAAP, certain provisions made for restructuring costs
incurred upon and related to acquisitions of acquired companies
(principally payments to employees and certain facilities costs)
and expensed immediately would not be recognisable under US GAAP,
because EITF 95-3, "Recognition of Liabilities in Connection with
a Purchase Business Combination", requires costs that meet
certain criteria be treated as part of the purchase price
allocation. Certain termination costs not determined on the basis
of length of service or other exit costs which are not
incremental to the acquired company, even if they provide a
reduced economic benefit, are considered period costs which are
expensed when incurred. Certain facilities costs amounting to
US$270,000 representing post-closure lease commitments for a
facility acquired in 2001 were originally capitalised. These
costs were subsequently excluded as a fair value adjustment in
2002 as the facility was not closed within a year of the
acquisition. A decision to maintain the facility for certain
operations was subsequently taken in 2003.
(h) Research and Development:
US GAAP, as set forth in SFAS 2, "Accounting for Research and
Development Costs", requires development costs to be written-off
in the year of expenditure. Under Irish GAAP, development
expenditure on projects whose outcome can be assessed with
reasonable certainty as to technical feasibility, commercial
viability and recovery of costs through future revenues, are
capitalised at cost within intangible assets.
(i) Derivatives and Financial Instruments:
In June 1998, the FASB issued SFAS 133, "Accounting for
Derivative Instruments and Hedging Activities". SFAS 133 requires
that all derivatives be recognised on the balance sheet at fair
value. Derivatives which are not hedges or where hedge
correlation cannot be demonstrated must be adjusted to fair value
through income. Under Irish GAAP derivatives are not recognised
until settled. Realised gains and losses on transactions where
derivatives are used to hedge cross-currency cashflows are
ultimately recorded in the income statement on settlement.
82
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
As part of a managed hedging policy Trinity Biotech has entered
into a series of forward contracts to sell US$ forward for Euro.
These contracts were entered into by the Company to mitigate its
foreign exchange risk. The principal exchange risk identified by
Trinity Biotech was with respect to fluctuations in the Euro as a
substantial portion of its expenses is denominated in Euro but
its revenues are primarily denominated in U.S. dollars. These
forward contracts are cashflow hedging instruments whose
objective is to cover a portion of this Euro mismatch. In the
medium term, the Company's objective is to increase the level of
non-US$ denominated revenue, thus creating a natural hedge of its
non-US$ expenditure.
During 2001 Trinity Biotech began documenting its hedging
transactions in accordance with the requirements of SFAS 133. In
2003 an unrealized loss of US$790,729 (2002: gain of
US$1,178,278) was taken to comprehensive income in respect of
such contracts in accordance with the standard.
During the year ended December 31, 2003 US$2,374,055 of foreign
exchange gains were recognised in the Income Statement. This
included realised foreign exchange gains of US$67,682 (2002:
US$161,975) on the exercise of forward contracts under US GAAP,
relating to contracts entered into in 2003 which had not been
designated as hedging instruments as the level of cover provided
was not deemed significant. At December 31, 2003 contracts with a
fair value of US$101,449 are recorded in other comprehensive
income which the Company anticipates will be reclassified into
earnings on the exercise of forward contracts in the year ending
December 31, 2004. The last of the Company's forward contracts
expires in December 2005.
(j) Deferred Tax:
Deferred tax differences arise between Irish GAAP and US GAAP due
to the impact of the nature and timing of the reconciling items
arising.
CUMULATIVE EFFECT ON December 31 December 31 December 31
SHAREHOLDERS' EQUITY 2003 2002 2001
US$ US$ US$
Total shareholders' equity before
minority interests under Irish GAAP 80,261,927 62,537,284 56,411,625
US GAAP adjustments:
Goodwill
- Gross (a) 21,776,683 21,776,683 21,776,683
(b) - - 270,000
- Aggregate amortisation (9,853,550) (11,412,266) (13,677,901)
Property, plant and equipment 76,634 - -
Share capital not paid (252,580) (260,203) (291,211)
Adjustment for sale and leaseback (811,264) (861,968) (912,672)
Adjustment for sales on extended credit (144,345) - -
Adjustment for restructuring costs - - 2,565,000
Adjustment for research and development costs (4,667,646) (2,327,444) (1,910,083)
Adjustment for fair value of derivative instruments 345,691 1,068,738 (271,515)
Deferred tax 502,375 423,444 (496,635)
---------- -------- --------
Shareholders' equity under US GAAP
87,233,925 70,944,268 63,463,291
---------- ---------- ----------
(a) Pre-1998 goodwill written-off against shareholders' equity under Irish GAAP.
(b) Liabilities assumed on acquisition capitalised under EITF 95-3.
83
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
CUMULATIVE TOTAL OF OTHER COMPREHENSIVE INCOME
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
US GAAP Other Comprehensive Income at January 1 (3,373,995) (4,908,055) (4,670,906)
Translation adjustment 174,605 355,782 48,951
Fair value of derivative instruments (790,729) 1,178,278 (286,100)
--------- --------- ---------
US GAAP Other Comprehensive Income at
December 31 (3,990,119) (3,373,995) (4,908,055)
---------- ---------- ---------
At December 31, 2003 the cumulative total fair value of
derivative instruments in Other Comprehensive Income was
US$101,449, (2002: US$892,178, 2001: (US$286,100)). At
December 31, 2003 the total accumulated translation reserve in
Other Comprehensive Income was (US$4,091,568), (2002:
(US$4,266,173), 2001: (US$4,621,955)).
EFFECT ON NET PROFIT December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Profit on ordinary activities after taxation
under Irish GAAP 5,797,474 4,896,911 2,367,277
US GAAP adjustments:
Goodwill amortisation 1,558,716 2,265,635 (2,166,700)
Adjustment for property, plant and equipment 76,634 - -
Adjustment for sale and leaseback 50,704 50,704 50,704
Adjustment for sales on extended credit (144,345) - 35,000
Adjustment for restructuring costs - (2,835,000) 1,612,797
Adjustment for research and development costs (2,340,202) (417,361) (881,710)
Adjustment for fair value of derivative instruments 67,682 161,975 14,585
Deferred tax 78,931 920,079 (321,802)
-------- -------- --------
Profit under US GAAP 5,145,594 5,042,943 710,151
-------- -------- --------
Profit per ordinary share (US dollars) 0.12 0.12 0.02
Diluted profit per ordinary share (US dollars) 0.11 0.12 0.02
Weighted average number of ordinary shares used
in computing basic earnings per ordinary share 43,093,146 40,550,367 40,408,978
Diluted weighted average number of ordinary shares
used in computing diluted profit per ordinary share 50,583,247 42,486,227 41,120,060
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Profit under US GAAP 5,145,594 5,042,943 710,151
Translation adjustment 174,605 355,782 48,951
Fair value of derivative instruments (790,729) 1,178,278 (286,100)
-------- -------- --------
Total Comprehensive Income 4,529,470 6,577,003 473,002
-------- -------- --------
84
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
CHANGES IN US GAAP EQUITY FOR THE YEARS ENDED DECEMBER 31, 2003, DECEMBER 31,
2002 AND DECEMBER 31, 2001
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
US GAAP Shareholders' Equity at January 1 70,944,268 63,463,291 62,899,307
Net profit for the period 5,145,594 5,042,943 710,151
`A' shares issued for cash 44,500 544,823 -
`A' shares issued for conversion of debenture 9,855,000 - -
`A' shares issued on conversion of warrant 232,640 - -
Options exercised 2,011,579 13,875 74,144
Stock-based compensation - additional paid-in capital 83,918 120,000 45,000
`A' shares issued for financial asset - 201,874 -
Share issue expenses (475,073) (7,606) (15,476)
Share capital not paid in previous periods now paid 7,623 31,008 -
Share capital not paid - - (12,686)
Other comprehensive income:
Translation adjustment 174,605 355,782 48,951
Fair value of derivative instruments (790,729) 1,178,278 (286,100)
--------- --------- ---------
US GAAP Shareholders' Equity at December 31 87,233,925 70,944,268 63,463,291
---------- ---------- ----------
85
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
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
2003 2002 2001
US$ US$ US$
Operating Activities
Retained profit under Irish GAAP 5,797,474 4,896,911 2,367,277
Adjustments to reconcile net profit to cash
provided by operating activities:
Depreciation 1,367,312 1,118,494 873,186
Amortisation 856,355 2,385,521 2,002,135
Taxation (paid) (156,625) (403,935) (319,510)
Share of operating loss in associate 253,642 317,113 268,870
Write off of investment in associate 813,620 - -
Provision for corporation tax charge 2,185,630 767,510 15,876
Net interest payable accrual 158,656 (46,066) 145,665
Exceptional administrative expenses - (2,835,000) 2,835,000
(Increase)/decrease in accounts receivable and prepayments (64,500) (4,250,982) 990,800
(Decrease) /increase in accounts payable and accrued expenses (2,560,673) 2,874,740 (2,044,110)
Increase in inventory (6,005,103) (2,414,882) (2,027,323)
Non-cash compensation expense 83,918 120,000 45,000
Foreign exchange losses on non-operating cash flows 484,822 - -
Loss on retirement of fixed assets 185,987 - -
Non cash settlement of interest 44,500 - -
Other non-cash items 159,507 - -
--------- --------- ---------
Net cash inflow from operating activities 3,604,522 2,529,424 5,152,866
--------- --------- ---------
Investing activities
Acquisition of subsidiary undertakings - - (4,777,388)
Payments to acquire trades or businesses (762,518) (4,408,692) -
Purchase of associate undertaking - - (309,399)
Deferred consideration paid (4,374,053) - -
Payment for patents and deferred development costs (1,846,109) (468,941) (986,502)
Payment for tangible fixed assets (3,856,069) (2,516,982) (1,343,370)
----------- ----------- -----------
Net cash outflow from investing activities (10,838,749) (7,394,615) (7,416,659)
------------ ----------- -----------
Financing Activities
Repayment of loan from unconnected third party (57,198) (163,213) (73,336)
Repayment of minority interest (309,946) - -
Issue of ordinary share capital including premium 2,251,844 558,698 74,144
Expenses paid in connection with share issue and debt financing (1,123,058) - (183,521)
Increase / (decrease) in long-term debt 2,449,653 (1,803,466) 4,829,963
Movement in finance leases (129,889) 3,955 (310,076)
Issue /(redemption) of convertible debentures 20,000,000 2,500,000 (625,000)
Decrease in promissory note - - (350,000)
(Decrease) / increase in other financial liabilities (1,092,516) 4,107,755 -
-------- -------- --------
Net cash inflow from financing 21,988,890 5,203,729 3,362,174
-------- -------- ---------
Increase in cash and cash equivalents 14,754,663 338,538 1,098,381
Effects of exchange rate movements on cash 1,241 95,000 -
Cash and cash equivalents at beginning of year 5,807,514 5,373,976 4,275,595
--------- --------- ---------
Cash and cash equivalents at end of year 20,563,418 5,807,514 5,373,976
---------- --------- ---------
86
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
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 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 Rest of World reportable segment.
In December 2001, the Group acquired the assets of the Biopool
haemostasis 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 was not conditional on
any future event and has been fully settled. This transaction
relates to the Rest of World reportable segment.
In November 2002, the Company acquired the speciality clinical
chemistry product line from Sigma Diagnostics for a total
consideration of US$4,412,372 satisfied in cash and deferred
consideration. The cash consideration was partly financed by the
issue of US$2,500,000 of 5.25% convertible debentures. The
debentures bear interest at a rate of 5.25% per annum and are
convertible into Class `A' Ordinary Shares of the Company at a
price of US$1.50. The Company also issued 50,000 warrants (the
"Second Warrants") in November 2002. The deferred consideration
of US$1,810,000 was paid in full in 2003. This transaction
relates to the Rest of World reportable segment.
On April 3, 2002, the Company acquired a further 165,000 Ordinary
Shares in its associate HiberGen Limited. The consideration of
US$201,874 was satisfied by the issue of 156,189 `A' Ordinary
Shares in Trinity Biotech plc. During 2003 HiberGen Limited was
unsuccessful in raising additional funds and on November 14,
2003, the Board of HiberGen Limited decided to cease trading. The
Company wrote off its remaining investment in quarter four of the
2003 financial year. This transaction relates to the Rest of
World reportable segment.
In December 1999, the Company completed a private placement of
(i) US$3,500,000 principal amount of 7.5% Convertible Debentures
and (ii) 483,701 warrants to purchase `A' Ordinary shares of the
Company (the "First Warrants"), which resulted in aggregate gross
proceeds to the Company of US$3,500,000.
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 2003 the debenture has been fully converted into
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. The
balance of these 150,000 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. 133,701 of the remaining
First Warrants were exercised in 2003 and 100,000 were exercised
in the first quarter of 2004. The balance of the First Warrants
expires in December 2004.
In July 2003, the Company completed a private placement of
US$20,000,000 principal amount of 3% convertible debentures. The
debentures bear interest at a rate of 3% per annum and are
convertible into Class `A' Ordinary Shares of the Company at a
price of US$3.55. In December 2003, US$6,355,000 of the
US$20,000,000 principal amount of the debenture was converted
into 1,790,141 Class `A' Ordinary Shares of the Company. Since
the year end, a further US$427,500 of the principal amount of the
debenture has been converted into 120,423 Class `A' Ordinary
Shares of the Company. As part of the July placement, convertible
notes in the aggregate principal amount of up to US$5,000,000
could be issued at the option of the investors by the later of
January 9, 2004 and the three month anniversary of the effective
date of the registration statement. In March 2004, the investors
exercised this option in full and the Company completed a further
placement of US$5,000,000 principal amount of 3% convertible
debentures. The debentures bear interest at a rate of 3% per
annum and are convertible into Class `A' Ordinary Shares of the
Company at a price of US$4.
87
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
Since the year end, the Company has completed a private placement
of 5,294,118 of Class `A' Ordinary Shares of the Company at a
price of US$4.25 per share. The investors were granted five year
warrants to purchase an aggregate of 1,058,824 Class `A' Ordinary
Shares of the Company at an exercise price of US$5.25 per share.
The Company further granted warrants to purchase 200,000 Class 'A'
Ordinary Shares in the Company to agents of the Company who were
involved in this private placement. Under the terms of the
placement, investors were also granted the right to purchase an
additional 2,647,059 Class `A' Ordinary Shares of the Company at a
price of US$4.25 per share for a period of up to 30 days after the
closing of the transaction. An additional 431,617 Class `A'
Ordinary Shares of the Company were issued within the 30 day
period following the closing of the transaction to investors who
exercised this option.
Share Option Scheme - Additional information required by SFAS 123
The Company has elected to follow Accounting Principles Board
Opinion No. 25, "Accounting for Stock Issued to Employees" (APB
25) and related interpretations in accounting for its employee
stock options because, as discussed below, the alternative fair
value accounting provided for under SFAS. 123, "Accounting for
Stock-Based Compensation," requires use of option valuation models
that were not developed for use in valuing employee stock options.
Under APB 25, where the exercise price of the Company's employee
stock options is less than the market price of the underlying
stock on the grant date, compensation expense is recognised in the
Income Statement over the vesting period.
Proforma information regarding net income and earnings per share
is required by 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:
2003 2002 2001
Expected option life (years) 4.0 4.0 3.0
Risk-free weighted-average interest rate 4.25% 2.3% 4.5%
Stock price volatility 0.855 0.411 0.620
Dividend yield 0% 0% 0%
The Black-Scholes option valuation model was developed for use in
estimating the fair value of traded options which have no vesting
restrictions and are fully transferable. In addition, option
valuation models require the input of highly subjective
assumptions including the expected stock price volatility. Because
the Company's employee stock options have characteristics
significantly different from those of traded options, and because
changes in the subjective input assumptions can materially affect
the fair value estimate, in management's opinion, the existing
models do not necessarily provide a reliable single measure of the
fair value of its employee stock options.
The information required by SFAS 148, "Accounting for Stock-Based
Compensation" is as follows:
December 31 December 31 December 31
2003 2002 2001
US$ US$ US$
Net income as reported 5,145,594 5,042,943 710,151
Add: Stock-based employee compensation
expense included in reported net income,
net of related tax effects 83,918 120,000 45,000
Deduct: Total stock based employee compensation under fair
value based method for all awards,
net of related tax effects (1,807,763) (1,425,348) (1,249,719)
----------- ----------- -----------
Proforma net income / (loss) 3,421,749 3,737,595 (494,568)
Earnings per share:
Basic - as reported (US dollars) 0.12 0.12 0.02
Diluted - as reported (US dollars) 0.11 0.12 0.02
Basic - proforma (US dollars) 0.08 0.09 (0.01)
Diluted - proforma (US dollars) 0.07 0.09 (0.01)
88
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
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:
2003 Weighted-Average 2002 Weighted-Average 2001 Weighted-Average
Options Exercise Price Options Exercise Price Options Exercise Price
Outstanding-beginning of year 9,465,449 $1.44 7,975,703 $1.57 5,939,453* $1.70
Granted 1,495,500 $1.90 2,243,500* $1.10 2,079,500* $1.02
Exercised (1,397,717) $1.61 (12,334) $1.13 (43,250) $1.71
Forfeited (1,235,838) $1.82 (741,420) $1.80 - -
Outstanding at end of year 8,327,394 $1.44 9,465,449 $1.44 7,975,703 $1.57
Exercisable at end of year 3,995,076 $1.48 3,927,771 $1.56 2,899,339 $1.37
Weighted-average fair value
of options granted during the year $1.09 $0.58 $0.56
* Amounts adjusted for previously issued stock options
The weighted-average remaining contractual life of options outstanding at
December 31, 2003 is 3.98 years. The information above also includes outstanding
warrants.
A summary of the range of prices for the Company's stock options
for the year ended December 31 2003 follows:
Outstanding Exercisable
Option price range No. of Shares Weight.-Av. Weight.-Av. No. of Shares Weight.-Av. Weight.-Av.
exercise price contractual exercise price contractual
life remaining life remaining
$0.81 - $0.99 3,127,530 $0.95 1.6 years 1,043,197 $0.88 0.54 years
$1.00 - $1.99 3,892,674 $1.42 1.78 years 2,302,672 $1.39 1.62 years
$2.00 - $2.99 1,052,690 $2.45 0.45 years 559,207 $2.43 0.25 years
$3.00 - $5.00 254,500 $3.70 0.15 years 90,000 $4.78 0.01 years
Capital shares reserved for future issuance
The following table sets forth the shares of common stock reserved
for future issuance:
Year ended
December 31, 2003
Shares issuable on conversion of debentures 3,843,662
Shares underlying outstanding stock options 8,068,894
Shares available for grant under option plans 2,507,000
Shares issuable upon exercise of warrants 258,500
-------
14,678,056
----------
89
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
Investments
The Company had no trading securities as at December 31, 2003 or
December 31, 2002.
The gross realised gains on sales of trading securities during
2003 was US$Nil (2002: US$Nil, 2001: US$Nil).
The Company had no "available for sale" or "held to maturity
securities" as at December 31, 2003 or December 31, 2002.
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.
The carrying amounts and fair values of the Company's financial
instruments at December 31, 2003 and 2002 are as follows:
December 31, 2003 December 31, 2002
Carrying Fair Carrying Fair
Amount Value Amount Value
US$ US$ US$ US$
Cash and cash equivalents 20,563,418 20,563,418 5,807,514 5,807,514
Short-term debt 8,911,573 9,152,783 7,283,394 7,283,394
Long-term debt 17,359,229 17,899,262 7,168,440 7,168,440
Forward contracts - 345,691 - 1,068,738
Additional Unaudited Proforma Information for Acquisitions made in
2001 and 2002
The information below presents the proforma effect of the
acquisitions made in 2001 as if they had occurred on January 1,
2001, and the proforma effect of the acquisitions made in 2002, as
if they had occurred on January 1, 2001.
December 31 December 31
2002 2001
US$ US$
Proforma revenues 63,351,166 63,596,202
Proforma net income 6,445,995 2,347,447
Proforma earnings per share (US dollars) 0.16 0.06
Proforma diluted earnings per share (US dollars) 0.15 0.06
The proforma information was compiled using extrapolations of the
results for the haemostasis division and speciality clinical
chemistry product line acquired from Sigma Diagnostics during
2002. There were no acquisitions in 2003.
90
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
Restructuring Costs
In December 2000 the Company purchased Bartels and decided to
consolidate the Seattle operation into its existing facilities in
Bray, Ireland. Similarly in December 2001 the Company purchased
Biopool and decided to consolidate its operation into the Bray
facility.
Restructuring provisions were determined based on estimates
prepared at the time the restructuring actions were approved by
management. These exit plans were submitted to the Board on
December 22, 2000 in the case of Bartels and on December 7, 2001
in the case of Biopool. An analysis of the Company's
restructuring plan reserves is as follows:
Provision for Restructuring Costs
2000 2001
Bartels US$ US$
Opening Provision - 1,222,203
Current year provision
Employee severance 491,000 -
Other employee costs 554,953 -
Idle facilities 176,250 -
------- -
1,222,203 -
Incurred - (1,153,322)
Write back of provision - (68,881)
--------
Closing provision 1,222,203 -
--------- -
2001 2002 2003
Biopool US$ US$ US$
Opening Provision - 2,835,000 315,000
Current year provision
Employee severance 1,059,000 - -
Other employee costs 1,140,000 - -
Idle facilities 636,000 - -
------- ----------- --------
2,835,000 2,835,000 315,000
Incurred - (2,289,930) (315,000)
Write back of provision - (230,070) -
--------- --------
Closing provision 2,835,000 315,000 -
--------- ------- --------
The above costs are broken down as follows:
Idle facilities
In December 2001 the Company recorded restructuring provisions
relating to idle facilities and related costs of approximately
US$636,000 in connection with the consolidation of the Biopool
facilities at Ventura, CA and Umea, Sweden into the Company's
existing operations in Bray, Ireland and Jamestown, New York.
Idle facilities costs represented management's allocation of the
lease rental costs for the portion of the facilities not engaged
in productive activities from consummation to the expected date
of cessation of site operations and amounted to US$393,000. A
commensurate allocation of associated maintenance, utilities,
insurance and other site costs were also provided for and
amounted to US$243,000. In December 2000, a similar provision of
US$176,250 was made in relation to the Bartels facility.
91
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
Employee severance and termination benefits
The accruals for employee severance and termination benefits
comprised the expected future payments relating to the
termination of contracts including severance payments and payroll
taxes. Bartels and Biopool employees were notified of the
intention to terminate in December 2000 and December 2001,
respectively. Termination benefits not based on length of service
were subsequently communicated to employees. In fiscal year 2000
the Company recorded restructuring provisions relating to such
costs of US$491,000 associated with the Bartels acquisition and
the related consolidation of the Seattle facility to Bray,
Ireland. In fiscal year 2001 the Company also recorded
restructuring costs of US$1,059,000 relating to employee
severance and termination benefits associated with the Biopool
consolidation from Ventura and Umea to Bray.
Other employee costs
Employees not involved in the manufacturing, product support,
customer service, sales and marketing, distribution and
warehousing functions and certain key employees in quality
control, product development and finance and administration
functions were deemed excess to requirements in the period from
consummation of the acquisitions to the envisaged date of
closure. However these employees were not given an earlier date
for involuntary termination. Costs for such resources which were
providing no significant economic benefit were included in the
restructuring provisions at December 31, 2000 and December 31,
2001, respectively.
Date of completion
The anticipated date of completion of the transfer of operations
from Bartels to the Company's facilities in Bray, Ireland was
June 30, 2001 and the transfer was completed in June 2001. The
anticipated and actual date of closure of the Biopool facility at
Ventura, CA was September 30, 2002. The anticipated date of
completion of the transfer of operations from the Biopool
facility at Umea, Sweden was also September 30, 2002. However, in
2003 the Company made a decision to maintain the operations of
the Umea facility at a reduced level with a staff of
approximately eight employees and the transfer of certain other
operations did not occur until 2003. Fifteen employees were only
terminated in January 2003 and fifteen further employees in July,
2003. Sixty three employees were involuntarily terminated
consequent to the Bartels facility closure. Fifty four employees
were involuntarily terminated consequent to the Biopool Ventura
facility closure.
Accounting Pronouncements
Asset Retirement Obligations
The Company is responsible for certain costs of restoring leased
premises to their original condition. The terms of such
obligations vary. Generally, a maximum obligation is not
explicitly stated. Because the obligated amounts of these types
of agreements often are not explicitly stated, the overall
maximum amount of the obligations cannot be reasonably estimated.
Historically, the Company has not been obligated to make
significant payments for these obligations, and no liabilities
have been recorded for these obligations on its balance sheet as
of December 31, 2003 and 2002.
Impairment or disposal of long-lived assets
In August 2001, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards 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.
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.
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, 2003, the Company has elected not to
change to the fair value based method of accounting for
stock-based employee compensation.
92
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
Costs Associated with Exit or Disposal Activities
The Financial Accounting Standards Board issued Statement No.
146, "Accounting for Costs Associated with Exit or Disposal
Activities" ("SFAS 146") in June 2002. SFAS 146 provides guidance
on the recognition and measurement of liabilities associated with
exit or disposal activities and requires that such liabilities be
recognized when incurred. In many cases, those costs will be
recognized as liabilities in periods following a commitment to a
plan, not at the date of commitment. SFAS 146 also changes the
recognition of one-time termination benefits, such as severance
pay or other termination indemnities, whenever the benefit
arrangement requires employees to render future service beyond a
`minimum retention period.' SFAS 146 also addresses the
accounting for other costs associated with an exit or disposal
activity, such as costs to consolidate or close facilities and
relocate employees. A liability for such costs has to be
recognized and measured at its fair value in the period in which
it is incurred. SFAS 146 is effective for exit or disposal
activities that are initiated after December 31, 2002.
Application of SFAS 146 had no material impact on the
consolidated financial statements of the Company as it had no
exit costs in 2003.
Guarantor's Accounting and Disclosure Requirements for
Guarantees, Including Indirect Guarantees of Indebtedness of
Others
The Financial Accounting Standards Board issued FASB
Interpretation No. 45 "Guarantor's Accounting and Disclosure
Requirements for Guarantees, Including Indirect Guarantees of
Indebtedness of Others", ("FIN 45") in November 2002. FIN 45
requires a guarantor to recognize, at the inception of a
guarantee, a liability for the fair value of the obligation
undertaken by it in issuing the guarantee. It also expands the
disclosure requirements in the financial statements of the
guarantor with respect to its obligations under certain
guarantees that it has issued. The Company is required to adopt
the initial recognition and initial measurement accounting
provisions of this interpretation on a prospective basis to
guarantees issued or modified after December 31, 2002. The
disclosure requirements are required to and have been adopted by
the Company as of December 31, 2002. Application of FIN 45 had no
material impact on the consolidated financial statements of the
Company. In the normal course of business, the Company does not
issue guarantees to third parties and the Company had no
guarantees in 2003.
Consolidation of Variable Interest Entities
The Financial Accounting Standards Board issued FASB
Interpretations No. 46, "Consolidation of Variable Interest
Entities", ("FIN 46") in January 2003. This interpretation
clarifies the application of Accounting Research Bulletin No. 51,
"Consolidated Financial Statements," to certain entities in which
equity investors do not have the characteristics of a controlling
financial interest or do not have sufficient equity at risk for
the entity to finance its activities without additional
subordinated financial support from other parties. The provisions
of FIN 46 were revised in December 2003 to be effective for
financial statement periods ended after March 15, 2004. The
adoption of FIN 46 is not expected to have a material impact on
the consolidated financial statements of the Company as the
company has a controlling interest in all of its subsidiaries.
Derivative Instruments and Hedging Activities
The Financial Accounting Standards Board issued Statement No.
149, " Amendment of Statement 133 on Derivative Instruments and
Hedging Activities", ("SFAS 149") in April 2003. SFAS 149 amends
and clarifies financial accounting and reporting for derivative
instruments, including certain derivative instruments embedded in
other contracts (collectively referred to as "derivatives") and
for hedging activities under SFAS No. 133, "Accounting for
Derivative Instruments and Hedging Activities". This statement
requires contracts with comparable characteristics be accounted
for similarly. In particular, this Statement (a) clarifies under
what circumstances a contract with an initial net investment
meets the characteristic of a derivative as discussed in SFAS No.
133, (b) clarifies when a derivative contains a financing
component and (c) amends the definition of an "underlying" to
conform it to language used in FASB Interpretation No. 45,
"Guarantor's Accounting and Disclosure Requirements for
Guarantees, Including Indirect Guarantees of Indebtedness of
Others". This Statement is effective for contracts entered into
or modified after June 30, 2003 and for hedging relationships
designated after June 30, 2003. The adoption of the new rules had
no material impact on the consolidated financial statements of
the Company.
Accounting for Certain Financial Instruments with Characteristics
of both Liabilities and Equity
The Financial Accounting Standards Board issued SFAS No. 150,
"Accounting for Certain Financial Instruments with
Characteristics of both Liabilities and Equity", ("SFAS 150") in
May 2003. SFAS 150 establishes standards for how an issuer
classifies and measures certain financial instruments with
characteristics of both liabilities and equity. It requires that
an issuer classify a financial instrument that is within its
scope as a liability (or an asset in some circumstances).
93
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
28. DIFFERENCES BETWEEN ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN
IRELAND AND IN THE UNITED STATES (Continued)
Many of those instruments were previously classified as equity.
SFAS 150 is effective for financial instruments entered into or
modified after May 31, 2003. Application of SFAS 150 had no
material impact on the consolidated financial statements of the
Company as it had no financial instruments as defined in
SFAS 150 in 2003.
29. GROUP UNDERTAKINGS
Name and Principal Country
registered office of incorporation Group
Holding Company Principal activity and operation % holding
Trinity Biotech plc Investment
IDA Business Park and holding
Bray, Co. Wicklow, Ireland company Ireland
Trinity Biotech Inc. Holding Company U.S.A. 100%
(Formerly Disease Detection
International Inc.)
Girts Road
Jamestown
NY 14702, USA
Clark Laboratories Inc. Manufacture and sale U.S.A. 100%
Trading as Trinity Biotech (USA) of diagnostic test kits
Girts Road
Jamestown
NY 14702, USA
FHC Corporation Non-trading U.S.A. 100%
Girts Road
Jamestown
NY 14702, USA
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
94
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
29. GROUP UNDERTAKINGS (Continued)
Name and Principal Country
registered office of incorporation Group
Holding Company Principal activity and operation % holding
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
Benen Trading Ltd Non-trading Ireland 100%
IDA Business Park, Bray
Co. Wicklow, Ireland
Reddinview Ltd Dormant company Ireland 100%
IDA Business Park, Bray
Co. Wicklow, Ireland
Trinity Biotech 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 THE BALANCE SHEET DATE
In July 2003, the Company completed a private placement of
US$20,000,000 principal amount of 3% convertible debentures. As
part of this placement convertible notes in the aggregate
principal amount of up to US$5,000,000 could be issued at the
option of the investors by the later of January 9, 2004 and the
three month anniversary of the effective date of the registration
statement. In March 2004, the investors exercised this option in
full and the Company completed a further placement of
US$5,000,000 principal amount of 3% convertible debentures. The
debentures bear interest at a rate of 3% per annum and are
convertible into Class `A' Ordinary Shares of the Company at a
price of US$4.
In January 2004, the Company completed a private placement of
5,294,118 of Class `A' Ordinary Shares of the Company at a price
of US$4.25 per share. The investors were granted five year
warrants to purchase an aggregate of 1,058,824 Class `A' Ordinary
Shares of the Company at an exercise price of US$5.25 per share.
Under the terms of the placement, investors were also granted the
right to purchase an additional 2,647,059 Class `A' Ordinary
Shares of the Company at a price of US$4.25 per share for a
period of up to 30 days after the closing of the transaction. An
additional 431,617 Class `A' Ordinary Shares of the Company were
issued within the 30 day period following the closing of the
transaction to investors who exercised this option.
In December 2003, the Company filed an action against Inverness
Medical for declaratory judgment and breach of contract.
Inverness Medical, through its affiliate, Wampole Laboratories,
has acted as exclusive distributor for certain of Trinity
Biotech's infectious disease products in the US. This exclusivity
is due to end on September 30, 2004, at which time it had been
agreed that both Trinity Biotech and Inverness Medical would sell
the products under their respective labels. The suit alleges that
Inverness Medical is attempting to convert customers from the
Trinity Biotech product to a product manufactured by a competitor
by claiming that the Trinity Biotech product is unavailable and
being discontinued. The lawsuit alleges that, under the terms of
the contract, the Company is entitled to sell direct in the US
any of its products which are competitive with products sold by
Inverness Medical and sourced by other suppliers. With immediate
effect, the Company has exercised this right.
95
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2003
30. EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE (Continued)
In January 2004, Inverness Medical countersued and sought a
preliminary injunction to prevent the Company from selling direct
in the US any of its products which are competitive with products
sold by Inverness Medical and sourced by other suppliers. The
Superior Court of Middlesex County, Massachusetts, denied the
motion for preliminary injunction on January 28, 2004.
96
Schedule II
TRINITY BIOTECH PLC.
VALUATION AND QUALIFYING ACCOUNTS
Doubtful Debts Balance at Charged to Charged to Balance
beginning costs and other at end
of period expenses accounts Deductions of period
US$ US$ US$ US$ US$
(a) (b)
2003 496,412 261,562 (38,273) (241,639) 478,062
2002 30,000 466,412 - - 496,412
2001 31,850 30,000 - (31,850) 30,000
(a) Amounts recovered during the year
(b) Amounts written off during the year
Valuation Allowance for Balance at Provided Reductions Balance
Income Taxes beginning at end
of period of period
US$ US$ US$ US$
(a) (b)
2003 131,417 178,865 (131,417) 178,865
2002 273,659 - (142,242) 131,417
2001 937,690 - (664,031) 273,659
(a) Increase in valuation allowance associated with deferred tax asset.
(b) Reduction in valuation allowance associated with deferred tax asset.
97
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: RONAN O'CAOIMH
--------------
Mr. Ronan O'Caoimh
Director/
Chief Executive Officer
Date: March 31, 2004
By: RORY NEALON
-----------
Mr. Rory Nealon
Director/
Chief Financial Officer
Date: March 31, 2004
98
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.
99