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FORM 20-F
(MARK ONE)
REGISTRATION STATEMENT PURSUANT TO SECTION 12(B) OR (G)
OF THE SECURITIES EXCHANGE ACT OF 1934
OR
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED: DECEMBER 31, 1997
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 1 IRISH PENNY)
..................................................................
(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: 22,191,771 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...............
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ITEM 1
BUSINESS
Trinity Biotech plc ("Trinity" or the "Company") develops, manufactures and
markets rapid diagnostic test kits used for the clinical laboratory,
point-of-care ("POC"), and self-testing ("OTC") segments of the diagnostic
market. The Company's rapid tests provide fast and accurate results designed
for home (OTC) and doctor's office (POC) use. In addition, the Company
manufactures and markets a range of diagnostic test kits used in clinical
laboratories to detect infectious diseases and autoimmune disorders. The
Company markets over 90 different diagnostic tests in 65 countries.
Trinity was incorporated as a public limited company (plc) registered in
Ireland in 1992. The Company commenced operations in 1992 and in October 1992,
completed an initial public offering of its securities in the United States.
The Company has expanded its product base through internal development and
acquisitions in the areas of pregnancy, infectious disease and autoimmune
products. Trinity now markets these products in the United States and in 65
countries worldwide through a network of national and international
distributors. In the 4th quarter of 1997, the Company purchased a new
manufacturing facility in Bray, Ireland and has transferred its Irish
operations to this new facility. In addition, since the acquisition of Clark
Laboratories Inc. in the 1st quarter of 1997 (see "Acquisition of Clark
Laboratories"), Trinity now has a manufacturing site in the U.S. Trinity
acquired Centocor UK Holdings Limited ("Centocor"), in June 1997 and during the
1st quarter of 1998, Trinity transferred the operations of Centocor to the
Company's new facility in Ireland.
ACQUISITION OF CENTOCOR UK HOLDINGS LIMITED
In June 1997, Trinity purchased all the outstanding share capital of Centocor
UK Holdings Limited, a company based in Guildford in the U.K. Centocor was a
100% subsidiary of Centocor, Inc., a U.S. biotechnology company. Centocor
develops, manufactures and markets infectious disease and auto-immune
diagnostic tests in micro titre enzyme linked immunoassay ("EIA") plate format.
The company operated out of a 17,000 square foot FDA and ISO 9001 approved
facility in Guildford, however, in quarter 1 of 1998, the entire operation was
transferred to Trinity's new manufacturing facility in Bray, Ireland. As a
result of this integration, the Company has closed the facility in the U.K.
Certain of the Centocor's tests are FDA approved including tests for
Toxoplasmosis, Rubella, Syphillis and Herpes Simplex Virus 2. The tests are
marketed in the United States, Europe, and Central and South America. Trinity
paid $5.5 million for the business in the form of cash and loan notes.
ACQUISITION OF CLARK LABORATORIES
In February 1997 Trinity acquired all the outstanding share capital of Clark
Laboratories Inc., ("Clark"), based in Jamestown, New York. After the
acquisition the name of the Company was changed to Trinity Biotech (USA),
("Trinity USA"). Trinity USA manufactures and markets a range of enzyme linked
immunoassays (EIAs), microtitre plates for the detection of infectious diseases
and autoimmune disorders. Trinity USA sells most of its products to Wampole
Laboratories, a division of Carter Wallace, Inc. ("Carter Wallace") for which
it has a 5 year exclusive supply agreement entered into in December 1994, for
all Trinity USA's FDA approved test kits (approximately 45 kits). Since the
acquisition Trinity has consolidated its existing U.S. pregnancy marketing
activities into Trinity USA's facilities in Jamestown, New York.
ACQUISITION OF DDI
In October 1994 completed a merger with Disease Detection Intl, Inc ("DDI").
DDI was renamed Trinity Biotech, Inc ("TBI"). As a result of the merger,
Trinity obtained marketing and manufacturing rights held by DDI for Trinity's
products in the United States, Canada and South America.
ACQUISITION OF FHC
As a result of the DDI merger, Trinity obtained a 50% interest in FHC
Corporation ("FHC"). FHC supplies Warner-Lambert Company ("Warner Lambert")
with its ept(TM) over-the-counter home pregnancy test, which is reportedly the
market leader in the United States. On December 30, 1994 Trinity Biotech Inc.
acquired the remaining 50% of the share capital of FHC.
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PRINCIPAL MARKETS
The primary market for Trinity's tests is the U.S. During fiscal 1997 the
Company sold 71% (IRL.8,453,697) (1996 IRL.3,566,194 or 84%) of product in the
U.S. Sales to non U.S. (principally European and Asian) countries represented
29% (IRL.3,382,736) during fiscal 1997 and 16% (IRL.661,003) during fiscal 1996.
PRINCIPAL PRODUCTS
General
Trinity's main focus is the development, manufacture and marketing of
easy-to-use, rapid, disposable diagnostic tests for worldwide markets in
addition to the development of laboratory based tests. The Company has
acquired and developed proprietary procedures, which extend the technology
developed for the detection of infectious diseases in blood samples for use
with saliva samples.
The Company's products are based on three diagnostic technologies. Two of
these technologies are rapid test technologies, the Uni-Gold
immuno-chromatographic assay and the SeroCard/SalivaCard enzyme-linked
immunoabsorbant assay. The third technology is a laboratory based
enzyme-linked immunoabsorbant assay ("EIA"). During 1997, Trinity developed 12
tests using the above technologies. In addition , through the acquisiton of
Trinity USA and Centocor, the Company has added a further 68 EIA tests to the
product range.
All of Trinity's products are immunoassays. Immunoassays are medical
diagnostic procedures based upon the interaction of "antigens" and
"antibodies". In general, antigens are foreign substances (including certain
drug complexes, infectious bacteria, or viruses) which stimulate production of
antibodies by the immune system for the purpose of protecting the body from the
foreign substance. Each type of antibody has a unique molecular structure
which enables it to bind with a specific antigen to form an antigen-antibody
complex. Immunodiagnostic testing makes use of the known characteristics of
antigen-antibody binding to determine the concentration of a particular
substance in the body by means of testing blood samples, urine or other body
fluids.
Uni-Gold
Trinity's Uni-Gold one step assays detect antibodies to various infectious
diseases and conditions in serum and plasma or whole blood based on the
principle of an immuno-chromatographic assay. In an immuno-chromatographic
assay, the sample travels up a membrane strip activating reagents in the
process and, where the sample is positive, allowing a colour forming reaction
visible by eye. Each test device (card) contains a plastic backed membrane
strip and absorber pads in a disposable plastic housing. The housing has two
openings: the smaller forms the sample application well and the larger contains
the test and control region. Trinity currently markets four products based on
this technology, Uni-Gold HIV, Uni-Gold Hepatitis B, Uni-Gold hCG (pregnancy)
and Uni-Gold H. pylori. In addition, Trinity sells a modified form of the ,
Uni-Gold hCG test to Warner-Lambert for distribution of to retail
over-the-counter markets in the United States intended for home use and to
health care professionals who advise consumers. In December 1996, Trinity
filed a pre-market application ("PMA") with the U.S. Food and Drug
Administration ("FDA") for approval to sell its Uni-Gold HIV test in the United
States for use in the POC segment of the market. The FDA has acknowledged
receipt of the application and has made initial comments which are currently
being addressed by the Company. Trinity's Uni-Gold hCG has already received a
510(k) approval from the FDA and is currently being marketed in the U.S. in
clinics and doctors offices under the Uni-Gold(TM) brand and in pharmacies
under Warner-Lambert's ept(TM) brand. The Company is currently compiling an
FDA submission for its Uni-Gold H. pylori test which it expects to file in the
3rd quarter of 1998. There are no assurances that the Company will get
approval from the FDA to market this test in the United States. The Company
has decided not to file for approval to sell its Uni-Gold Hepatitis B test in
the United States at this time, however the test is approved for sale in 5
other countries outside of the United States.
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EIA Tests
Enzyme-linked Immunoassay (EIA) tests are sold to the traditional clinical
laboratory market. During 1997, Trinity developed 11 tests on this format.
The tests are based on a plate of 96 test wells and are used for high volume
testing. Each well is an individual patient test and the tests are generally
run in a laboratory as a batch. Each well is coated with an antibody or
antigen depending on the analyte being tested for. When the test is run, the
first step is to add the sample and a reaction binds the antibody and antigen
to the well wall. After the removal of interfering substances through washing,
a colour forming reagent is added and the result read on an instrument with the
amount of colour corresponding to the concentration of analyte in the original
sample. Trinity is currently selling 84 different EIA tests. Of the total of
84 different tests, 52 were added on the acquisition of Trinity USA and 16 were
added on the acquisiton of Centocor UK. The tests which were purchased as part
of the Trinity USA acquisition covered the infectious disease and autoimmune
areas of the market. Of these two areas, the infectious disease area is the
largest, accounting for 90% of Trinity USA's sales in 1997. Of the products
currently being manufactured by Trinity USA, 51 are FDA approved. The
acquisition of Centocor UK added 16 products to Trinity's portfolio, the main
product being a test for Syphilis. All of Centocor's tests are FDA approved.
SeroCard/SalivaCard HIV
These products are blood and saliva based card tests using blood, serum or
saliva obtained by pricking a finger with a needle, or collecting saliva by
means of a patented saliva collection device. The cards can detect HIV-1 or
HIV-2 antibodies utilizing synthetic peptides. They are easy-to-use, seven
minute (rapid) tests and are packaged in the form of test kits consisting of
the card and vials containing reagents which are applied to the card.
Successful clinical trials were completed during 1994 and 1995 and distributors
have been appointed in over 40 countries for SeroCard and 25 countries for
SalivaCard. Approvals to sell this product have been received to date in
Ireland, the United Kingdom, Greece, Estonia, Ukraine, Portugal, Russia,
Finland, Thailand, China, The United Arab Emirates, Pakistan, Nepal, India,
Guatemala, Venezuela, Mexico, South Africa, Ivory Coast, Uganda, Kenya and
Nigeria. In 1997 Trinity received revenues of approximately $1.2 million on
these tests from sales made in Thailand, Mexico, Paraguay, Pakistan, U.A.E.,
Guatemala, Venezuela, Nigeria and Germany. Evaluation results on the Company's
SeroCard HIV test indicates that the test has a sensitivity of 99.9% and a
specificity of 99.6% when compared to conventional laboratory tests and on
SalivaCard indicate that the test has a sensitivity of 99.6% and a specificity
of 98.3% when compared to conventional laboratory tests.
MAJOR AGREEMENTS
Supply Agreement for Over-the-Counter Pregnancy Tests
In February 1993 FHC and ABI, the manufacturer of its one step pregnancy tests,
entered into a Supply and Development Agreement dated February 26, 1993 (the
"Supply Agreement") with Warner-Lambert. The Supply Agreement grants exclusive
rights to Warner-Lambert for distribution of a modified form of the in-stream
one-step pregnancy test to retail over-the-counter markets in the United States
intended for home use and to health care professionals who advise consumers.
Warner-Lambert has advised Trinity the one-step pregnancy test product is being
marketed under Warner-Lambert's e.p.t. trademark, which is reportedly the
largest selling home pregnancy test in the United States. Under the Supply
Agreement, Warner-Lambert is committed to source its United States requirement
for this product from Trinity for the term of the agreement. The initial term
of the Supply Agreement was two years following first shipment of product in
September 1993. In September 1995 the contract was renewed for a further three
years and, in September 1997, the Company negotiated a further three year
extension through to September 2001. In the event Trinity and ABI are unable
to supply products to Warner-Lambert, Warner-Lambert has retained the right to
access ABI's proprietary manufacturing know-how and to seek an alternative
manufacturer or manufacture those products itself until such time as Trinity or
ABI is able to resume the supply of products.
A portion of sales to Warner-Lambert under the Supply Agreement, ranging from
$.26 to $.28 per test (depending on annual unit volumes) was required to be
deposited into an escrow account until the escrow account totalled $2.5
million, exclusive of interest income, which occurred in May 1995. Negotiated
terms of the Supply Agreement require interest on escrowed funds for the first
three years to be paid to Warner-Lambert and thereafter interest is to be
shared in equal thirds by Warner-Lambert, Trinity and ABI. Escrowed funds may
be applied to reimburse Warner-Lambert as to any losses for which Trinity or
ABI are responsible under the Supply Agreement. If there are no claims for a
period of three years, escrowed funds are to be released at the rate of $1
million after the end of such period and $500,000 per year thereafter, of which
50% will be paid to Trinity and 50% to ABI. This three year period ended in
September 1996. If there is a claim and funds are dispersed from the escrow
account, it is to be reimbursed at a rate of $0.20 per test. Trinity has
received no claims against the escrow account. Trinity recognised $711,000 as
revenue in 1997.
ABI and Trinity have each represented in the Supply Agreement, among other
things, that products supplied to Warner-Lambert are produced in accordance
with applicable laws and regulations, are merchantable and fit for their
intended purpose, meet written specifications of Warner Lambert, and do not
infringe upon the proprietary rights of third parties. Trinity and ABI have
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also agreed to indemnify Warner-Lambert against any claims asserted by
regulatory authorities or other third parties arising from the manufacture and
sale of products supplied to Warner-Lambert under the Supply Agreement. The
obligation to reimburse Warner-Lambert for any such indemnification obligation
or for any other losses of Warner-Lambert arising from breach of
representations, warranties and agreements of ABI and Trinity under the Supply
Agreement are reimbursable to Warner-Lambert from the escrow deposits described
above.
Currently, ABI manufactures and ships its one-step pregnancy tests covered by
the Supply Agreement directly to Warner-Lambert. ABI invoices Trinity for
those tests at an agreed price, and Trinity concurrently invoices
Warner-Lambert at a price per test stipulated by the Supply Agreement.
Supply Agreement between Trinity USA and Carter Wallace
Trinity USA entered into a five year supply agreement with the Wampole division
of Carter Wallace on December 18th, 1995. Under the terms of the agreement,
Carter Wallace has exclusive rights to Trinity USA's products in the United
States and Puerto Rico. Trinity USA and Trinity may market certain Trinity USA
products in the U.S. and Puerto Rico which Carter Wallace has chosen not to
market in those territories. In addition, Trinity and Trinity USA may market
all of Trinity USA's products in all territories outside of the U.S. and Puerto
Rico. As part of the agreement, Carter Wallace undertook to pay Trinity USA an
amount of $2,000,000 for the rights to the Trinity USA products in the
territories of the U.S. and Puerto Rico. Of the total amount, $1,000,000 was
paid 2 days after the signing of the agreement and the remaining $1,000,000 was
to be paid $500,000 12 months after the initial payment and $500,000 24 months
after the initial payment. At the date of the acquisition of Trinity USA by
Trinity $1,500,000 of the $2,000,000 had been paid. The remaining $500,000 was
paid on December 18th, 1997.
SALES AND MARKETING
Trinity's primary goal is to acquire, develop, manufacture and market novel
tests which feature simplified procedures, immediate answers, reduced total
cost, unequivocal interpretation and non-hazardous waste. The Company also
develops tests for use in the clinical laboratory.
Trinity's primary markets are the infectious disease, autoimmune and fertility
test market.
Trinity has a large portfolio of laboratory based EIA tests which it markets
through private label agreements and national distributors. The tests are used
primarily in laboratories on open automated diagnostic systems.
The need for rapid testing in the well equipped routine laboratory is small,
being largely confined to emergency situations or to a low volume need for the
particular test. However, an important virtue of most rapid tests is the
limited need for laboratory equipment, thus shifting the market emphasis to
non-laboratory sites (doctor's office, dentist's office, emergency rooms,
correctional institutions, immigration authorities) or poorly equipped
laboratories (developing countries and field clinics).
Trinity's marketing strategy is to a) further develop its existing distributor
network; and b) private label market its products under the label of a
multinational partner that has the requisite distribution network and financial
resources.
Uni-Gold Product Line
The primary marketing focus for Trinity's Uni-Gold range has been to seek
private label opportunities for the individual tests within the range. Trinity
currently sells a modified form of the Uni-Gold hCG test to Warner Lambert
under an exclusive supply agreement, (see "Supply Agreement for
Over-the-Counter Pregnancy Tests"), in the United States. At present, a
substantial proportion of Trinity's revenues are derived from sales of
pregnancy tests to Warner Lambert. For the year ended December 31, 1997 37%
(1996 73%) of total sales were pregnancy tests to Warner Lambert. The Company
is seeking other partners to distribute the Uni-Gold hCG test in territories
outside of the U.S. and to distribute its range of Uni-Gold tests for
infectious diseases including HIV, Hepatitis B and H. pylori. A number of
potential distribution partners have been identified however no significant
contract has yet been finalised.
EIA Product Line
During 1996 and 1997, Trinity developed a number of EIA tests for use in the
clinical laboratory. In addition through the acquisition of Trinity USA and
Centocor in 1997, Trinity acquired an additional 68 tests for both the
infectious disease and auto-immune markets. The Company's marketing strategy
is concentrated on private label contracts with a lesser emphasis on
distribution through national distributors. Trinity USA sells 46 of their
tests, on an OEM basis, to the Wampole division of Carter Wallace under an
exclusive supply agreement (see "Carter Wallace Supply Agreement"). In
addition Trinity USA sells its products to 14 distributors in 9 countries
outside the U.S. Trinity has signed a supply agreement with Merlin Diagnostics
GmbH in Germany to supply five of its gastroenteric EIA plates on an OEM basis.
The tests initially covered in the agreement are Adenovirus, Rotavirus and C.
Difficile with tests for Cryptosporidium and Giardia Lamblia added in 1997.
Shipments under the Merlin agreement commenced in the 1st quarter of 1997.
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SeroCard/SalivaCard HIV
Trinity markets these tests primarily through national distributors. The
Company has also entered into a number of private label OEM agreements with
multi-national strategic partners to sell these products in different
territories worldwide. Shipments under one of the agreements commenced in 1995
and two other agreements commenced shipments in early 1996. In the year to
December 31, 1997, product amounting to IRL.107,000 ($181,000) had been shipped
under these agreements.
RESEARCH AND PRODUCTS UNDER DEVELOPMENT
Trinity is focusing a substantial effort on developing a next generation range
of diagnostic products based on technologies which facilitate the development
of a reagentless test. In order to meet this goal, the Company's research has
focused on developing tests which reduce the number of testing steps and
reagents required to be used. Trinity has developed a the Uni-Gold(TM) test
format, an enabling format which can be adapted to detect the antibodies to
various infectious diseases and medical conditions using serum or whole blood
as the sample.
Trinity's scientists finalised the development of this simple, one-step,
reagentless rapid test format in 1996 and filed a patent application in the
United States for this one-step rapid test for HIV using serum as a sample.
Trinity has been concentrating on using this format to develop a range of
single-step tests using blood or serum for the detection of other infectious
diseases and conditions. Trinity completed the development of its Uni-Gold H.
pylori test during 1997 and is currently finalising the development of Uni-Gold
tests for Strep A, Chlamydia and Prostate Specific Antigen ("PSA").
During 1997, Trinity's scientists completed the development of 11 laboratory
based EIA tests and received FDA approval for 8 of these.
During 1997 Trinity licensed five cancer markers from Centocor Inc. Cancer
markers are analytes, which detect levels of cancer indicative pathogens in the
blood stream. The Company intends to use these markers to develop diagnostic
tests for the monitoring of prostate, breast, ovarian and gastric cancers. The
research projects are ongoing and are expected to continue through 1998 and
into 1999.
As of December 1997, Trinity employed 36 full-time research and development
professionals at its facilities in Bray, Ireland and Jamestown, New York.
For the 12 months ended December 31, 1997 the Company spent IRL.1,433,000
($2,038,000) on research and development. This was offset to some extent by a
grant receivable of IRL.187,000 ($267,000), resulting in a net charge to the
profit and loss account of IRL.1,246,000 ($1,771,000). This expenditure was
spent on salary costs, reagents, consultancy fees and other related costs.
MANUFACTURING AND RAW MATERIALS
The primary raw materials required for Trinity's test kits consist of
antibodies, antigens or other reagents, glass fibre and packaging materials.
The reagents used as raw materials have been acquired for the most part from
third parties. Although Trinity is not dependent upon any one source for such
raw materials, alternative sources of antibodies with the specificity and
sensitivity desired by Trinity may not be available. Such unavailability could
affect the quality of its products and its ability to meet orders for specific
products, if such orders are obtained. Trinity's growth may be limited by its
ability to obtain or develop the necessary quantity of antibodies or antigens
required for specific products. Thus, Trinity's strategy is, whenever
possible, to establish alternative sources of supply of antibodies.
COMPETITION
The diagnostic industry is very competitive. There are many companies, both
public and private, engaged in diagnostics-related research and development,
including a number of well-known pharmaceutical and chemical companies.
Competition is based primarily on product reliability, customer service and
price. Some of these companies have substantially greater capital resources
and have marketing and business organisations of substantially greater size
than Trinity. Many companies have been working on immunodiagnostic reagents
and products, including some products believed to be similar to those currently
marketed or under development by the Company, for a longer period of time than
has the Company. The Company believes that its primary competitors in the
diagnostics market include Abbott laboratories, Boehringer Mannheim, Sanofi
Diagnostics Pasteur, Inc, Ortho Diagnostics, Inc, Selfcare, Inc, Incstar, Inc,
Meridian, Inc, Murex Diagnostics, Inc. and Gull Laboratories Inc. The Company
expects competition within the industry to intensify.
Trinity supplies Warner-Lambert with its ept(TM) test. Warner-Lambert has
approximately 24% of the OTC market in the United States. The main competitors
in the market are Unipath, Johnson & Johnson and Carter Wallace.
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PATENTS AND LICENCES
Trinity's SeroCard and SalivaCard blood and saliva-based diagnostic tests are
based on DDI's patent for its "Bi-Directional Lateral Chromatography Test
Device". On April 9, 1991, a patent was issued to DDI by the U.S. Patent and
Trademark Office covering this device. The patent expires in 2008. This
patented technology allows Trinity to concentrate and detect antibodies or
antigens using a whole blood specimen in addition to serum, urine, or other
fluid samples. Trinity had combined revenues for these products of
IRL.1,193,000 ($1,696,000) in the year ending December 31, 1997.
In February 1993, Trinity filed a patent application with the Irish Patent
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 filed for a second patent covering the
mechanics of its Saliva Collection Device in October, 1993. Management
believes that these two patents, which expire in 2010, will help protect
Trinity's Saliva Card test from being copied by a competitor.
In June 1994, Trinity filed a patent application with the Patent and Trademark
Office of the United States for a one-step test, which uses blood serum as the
test medium.
Many of the Company's tests are not protected by specific patents however, the
development of the test kits by Trinity, Centocor and Trinity USA was done
using 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 which are important to
the industry in which Trinity intends to operate. In the event that any of
such claims relate to its planned products, Trinity intends to evaluate such
claims, and if appropriate, seek a licence to use the protected technology.
There can be no assurance that Trinity would be able to obtain licences to use
such technology or obtain such licences on terms which would not have a
material adverse effect on Trinity. If Trinity or its suppliers are unable to
licence any such protected technology that might be used in Trinity's products,
Trinity could be prohibited from marketing such products. It could also incur
substantial costs to redesign its products or to defend any legal action taken
against it. If Trinity's products should be found to infringe protected
technology, Trinity also could be required to pay damages to the infringed
party.
Licence Agreement with Becton Dickinson Trinity has taken a licence to two
patents held by Becton Dickinson. The terms of the agreement provided for
Trinity and ABI to pay royalties on previous sales of pregnancy tests to Warner
Lambert, which resulted in a charge to the profit and loss account of
IRL.179,000 in 1995, and for ongoing royalties on sales at an effective rate of
2% on Warner Lambert sales. In the year to December 31, 1997 IRL.89,000 was
charged to the profit and loss account in respect of these royalties.
GOVERNMENT REGULATION
The Company's manufacturing and marketing of diagnostic test kits is subject to
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 involves lengthy and detailed laboratory and clinical
testing, and other costly and time consuming procedures. This regulatory
process may delay marketing of new products for lengthy periods and impose
costly procedures, thereby furnishing an advantage to competitors with greater
resources. Through the acquisition of Trinity USA and Centocor, Trinity has
added 67 other tests, which have been cleared by the FDA for sale in the U.S.
after completing successful 510(k) reviews. Two of the Company's products have
been submitted to the FDA for approval. Trinity's Uni-Gold(TM) HIV test has
been submitted under a pre-market approval application ("PMA") and the
Company's Captia EBV test has been submitted under the 510(k) review process
both of which are described below. Trinity plans to submit a number of other
tests under the 510(k) review process during 1998 including Uni-Gold H. pylori
and EIA tests for Cryptosporidium Giardia Lamblia and Entomoeba Histolytica.
There can be no assurance that regulatory clearance will be granted on a timely
basis in the future, if at all. The extent of government regulation which may
arise from future legislative or administrative action cannot be predicted.
In vitro monitoring products, such as those employing antibodies for the
detection of autoimmune diseases in humans, are generally classified as medical
devices by the FDA. For some in vitro products, the United States Food, Drug,
and Cosmetic Act provides a process known as a "510(k) review" to enable the
manufacturer to demonstrate that the proposed product is "substantially
equivalent" to another product in commercial distribution in the United States
before May 28, 1976 or which has subsequently been classified as a Class I or
Class II medical device. When a 510(k) review is used, a sponsor is required to
submit a Pre-Market Notification to the FDA. In the absence of a response from
the FDA, the Company would not be able to proceed with sales of its in vitro
product for diagnostic use unless and until it received notification from the
FDA. In the event that the FDA requests additional information for the
Pre-market Notification, there could be multiple cycles of submissions until
clearance is obtained. The FDA has statutory authority to also require clinical
studies data to support a PreMarket Notification 510(k) application.
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In cases where there are no existing FDA approved products "substantially
equivalent" to the new product, an approved PMA, which involves a lengthier and
more burdensome process, would be required before the FDA would allow
commercial distribution. No assurance can be given that any in vitro blood test
the Company develops in the future will be found to have an intended use that
would qualify the new test for 510(k) clearance. Accordingly, a PMA may be
required for any new application of the Company's proposed in vitro blood
tests.
The FDA invariably requires clinical data for a PMA and, although the FDA may
grant 510(k) clearance without supporting clinical data, such data may be
required if the FDA determines that technical differences from existing
products suggest the need for additional evidence of safety or effectiveness of
the new product. If clinical studies are necessary, the FDA may require the
Company to obtain an investigational device exemption ("IDE") . An IDE normally
restricts the distribution of an investigational device to a limited number of
institutions, and use by a limited number of investigators, for the purpose of
performing studies to be submitted to the FDA in a 510(k) Pre-Market
Notification or a PMA.
The amount that can be charged for use of an investigational device in a
clinical study is generally limited to recovery of costs until a 510(k)
notification is cleared or PMA approval is granted by the FDA. Accordingly, no
significant return can be expected during the study of investigational devices.
Although certain diagnostic products are exempt from IDE requirements, the
exemption applies only to tests which do not require an invasive sampling
procedure that presents significant risk, do not introduce energy (such as
X-rays) into a subject, and are not used as diagnostics without a confirmatory
diagnosis by a medically established diagnostic product or procedure. The
Company's products would not be used as diagnostics without such a confirmatory
diagnosis while an investigational device.
Medical devices may be exported before receiving IDE, 510(k) or PMA clearance
under certain conditions, providing FDA approval of the proposed exportation is
obtained. The receiving country must certify that the device is not in conflict
with the laws of that country and that the foreign government is aware of the
device's import. In addition, the FDA may require safety data similar to that
required for approval of an IDE before approving the exportation of a new
device. In foreign countries, the Company's distributors are generally
responsible for obtaining any required government consents.
The Company is also required to register with the FDA as a device manufacturer
and list its devices. As such, the Company is subject to inspection on a
routine basis for compliance with the FDA's Good Manufacturing Practice ("GMP")
regulations. These regulations require that the Company manufacture its
products and maintain its documents in a prescribed manner with respect to
manufacturing, testing and control activities. Failure to comply with
applicable GMP or other regulatory requirements can result in, among other
things, sanctions, fines, delays or suspensions of approvals, injunctions
against further distribution, seizures or recalls of products, operating
restrictions and criminal prosecutions. In addition, the Company is required
to comply with various FDA requirements for labelling. Pursuant to the Medical
Device Reporting Act regulations, the Company is also required to notify the
FDA of any deaths or serious injuries alleged to have been associated with the
use of its diagnostic test kits as well as product malfunctions that would
likely cause or contribute to death or serious injury if the malfunction were
to recur. Finally, the FDA prohibits an approved device from being marketed
for unapproved applications. Failure to comply with regulatory requirements
could have a material adverse effect on the Company's business, financial
condition and results of operations.
EMPLOYEES
As of December 31, 1997 Trinity had 181 employees consisting of a research
director and 35 research scientists and technicians, 123 manufacturing and
quality assurance, 15 finance and administration and 7 marketing staff.
Trinity's future hiring levels will depend on the growth of sales revenues.
8
<PAGE> 9
ITEM 2
FACILITIES
Trinity's executive offices and manufacturing and research and development
facilities consisting of approximately 42,000 square feet are located at IDA
Business Park, Bray, Co. Wicklow, the Republic of Ireland. This facility is
ISO 9001 approved and was purchased in December 1997 and has been fitted out to
Trinity's exact requirements. The facilities include offices, research and
development laboratories, three production laboratories, cold storage and
drying rooms and warehouse space. Trinity paid IRL.1,660,000 for the facility
and is currently spending a further IRL.1,200,000 fitting the facility out. The
Company has taken out a mortgage to cover the cost of the facility, the
term of which is 15 years. Trinity expects that the new facility will be
adequate for its foreseeable future manufacturing and operational needs.
Trinity USA operates out of a 24,000 square foot FDA and ISO 9001 approved
facility in Jamestown, New York. The facility was purchased by Trinity USA in
1994 and is the subject of a 5-year mortgage. The mortgage is repayable in
monthly instalments of $2,292 plus interest at 8 1/2 % through January 1, 1999,
when the entire principal balance remaining is due.
Trinity expects that the new facility in Ireland and Trinity USA's facility in
New York will be adequate for its foreseeable future manufacturing and
operational needs.
Centocor UK Holdings Limited operated out of a 17,000 sq ft FDA and ISO 9001
approved facility in Guildford, United Kingdom. The operations of Centocor UK
Holdings have been transferred to Trinity's new facility in Ireland and the
Guildford facility has been vacated.
ITEM 3
LEGAL PROCEEDINGS
Dispute Regarding Ownership of Stock of Selfcare, Inc.
Trinity acquired 778,622 shares of Selfcare, Inc. ("Selfcare"), a manufacturer
of diagnostic tests, (the "Selfcare Shares"), in a series of purchase
transactions involving subsidiaries of Trinity from Enviromed plc ("Enviromed")
in August and November 1996. Selfcare had been involved in a dispute with
Enviromed with respect to a joint venture agreement entered into between
Selfcare and Enviromed in March 1994. In connection with this dispute,
Selfcare informed Enviromed that, due to the failure of Enviromed to perform
its obligations under the Joint Venture Agreement, it disputed Enviromed's
ownership of the Selfcare Common Stock previously purchased for cash in a
private placement and held of record by Enviromed. On July 5, 1996, Enviromed
filed suit against Selfcare and the representatives of the underwriters ("IPO
Representatives") of Selfcare's initial public offering (the "Initial Public
Offering") alleging breach of a registration rights agreement relating to the
Selfcare Common Stock held of record by Enviromed. Enviromed claimed that its
rights under a registration rights agreement were breached in connection with
the Initial Public Offering and requested damages, injunctive relief and a
declaratory judgement that Enviromed is the lawful owner of the shares.
Selfcare filed counterclaims against Enviromed to perform their obligations
under the Joint Venture Agreement. On November 15, 1996, Enviromed filed a
dismissal without prejudice of its claims against the IPO Representatives.
On February 12, 1997, following the purchase of the Selfcare Shares from
Enviromed, Trinity commenced a lawsuit against Selfcare in the United States
District Court for the District of Massachusetts, seeking a declaratory
judgement that Trinity owns the Common Stock held of record by Enviromed and
damages for alleged breach of a registration rights agreement. On March 6,
1997, Selfcare filed an answer to the complaint.
As of March 6, 1998 the Company entered into a settlement agreement with
Selfcare whereby the parties agreed that Trinity shall have title to 80% of the
shares of Selfcare stock in dispute, amounting to 622,898 shares of Selfcare
Common Stock. Replacement share certificates have been issued and the lawsuit
has been dismissed with prejudice.
9
<PAGE> 10
ITEM 4
PRINCIPAL SHAREHOLDERS
As of June 15, 1998, Trinity has outstanding 23,191,956 'A' Ordinary shares and
700,000 'B' Ordinary shares. Such totals exclude shares issuable upon the
exercise of outstanding options and warrants.
The following table sets forth, as of June 15, 1998, the Trinity "A" Ordinary
Shares and B Ordinary Shares beneficially held by (i) each person known by
Trinity to beneficially hold 10% or more or such shares, (ii) each director and
officer of Trinity, and (iii) all officers and directors as a group. Except as
otherwise noted, all of the persons and groups shown below have sole voting and
investment power with respect to the shares indicated. The Company is not
controlled by another corporation or government.
<TABLE>
<CAPTION>
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
--------------- ----------- -------------- ------------- -------------
<S> <C> <C> <C> <C> <C>
Ronan O'Caoimh 1,063,333 (1) 4.6% 0 0 4.3%
Brendan Farrell 537,499 (2) 2.3% 0 0 2.2%
Jonathan O'Connell 543,666 (3) 2.3% 0 0 2.2%
Jim Walsh 607,499 (4) 2.6% 0 0 2.5%
Denis R. Burger 479,166 (5) 2.0% 0 0 1.9%
Potenza Investments, Inc 0 0 500,000 (6) 71.4% 4.3%
("Potenza")
Statenhof Building, Reaal 2A
23 50AA Leiderdorp, Netherlands
Officers and Directors
as a group (5 persons) 3,231,163(1)(2)(3)(4)(5) 14.0% 0 0 13.1%
</TABLE>
*less than 1%
(1) Includes 158,333 shares issuable upon exercise of options.
(2) Includes 107,499 shares issuable upon exercise of options.
(3) Includes 83,666 shares issuable upon exercise of options.
(4) Includes 107,499 shares issuable upon exercise of options..
(5) Includes 50,000 of 100,000 owned by Sovereign Ventures, a general
partnership owned 50% by Denis Burger which are included in the shares
deemed owned by Dr. Burger and 88,166 shares issuable upon exercise of
options.
(6) Includes shares beneficially owned by SRL (350,000 'B'), Brindisi
Investments Inc. (150,000 'B'). SRL has advised Trinity that Potenza
owns a majority of SRL's common stock. These 'B' shares have two votes
per share.
DIVIDEND POLICY
Since its organisation Trinity has not declared or paid dividends on its 'A'
Ordinary Shares. Trinity anticipates, for the foreseeable future, that it will
retain any future earnings in order to fund the business operations of the
Company. The Company does not, therefore, anticipate paying any cash or share
dividends on its 'A' Ordinary Shares in the foreseeable future.
Any cash dividends or other distributions, if made, are expected to be made in
Irish pounds, although the Articles of Association provide that dividends may
be declared and paid in U.S. Dollars.
10
<PAGE> 11
ITEM 5
MARKET INFORMATION
Trinity's Class B Warrants and American Depository Receipts ("ADRs") are
listed on the Nasdaq Stock Market Small Cap Market under the symbols "TRIZF"
and "TRIBY", respectively. The Company's Class A Warrant (symbol "TRIWF"),
expired on October 21, 1997. Each ADR represents one 'A' Ordinary Share of
the Company. The Company's shares ADRs and Warrant do not trade on any other
stock exchange or trading market. The Company's depository bank for the ADRs
is The Bank of New York. On June 15, 1998, the reported closing sale price of
the ADRs was $2 9/16 per ADR. The following tables sets forth the range of
quoted high and low sale prices of Trinity's ADRs, Class A Warrants and Class
B Warrants for the quarters ended March 31, June 30, September 30 and December
31, 1996. March 31, June 30, September 30 and December 31, 1997, the quarter
ended March 31, and the period April 1 through June 15, 1998 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.
<TABLE>
<CAPTION>
CLASS A CLASS B
ADRs Warrants Warrants
Period High Low High Low High Low
------- ------ ------- ------- ------ ------
<S> <C> <C> <C> <C> <C> <C>
1996
Quarter ended March 31 $4 1/8 $2 5/8 $2 1/4 $1 1/4 $1 9/16 $1 3/16
Quarter ended June 30 $6 15/16 $3 3/ 8 $6 1/2 $1 1/4 $3 1/8 $ 3/4
Quarter ended September 30 $4 7/8 $3 1/8 $4 $1 3/4 $2 5/8 $1 1/4
Quarter ended December 31 $3 3/4 $2 3/16 $2 3/4 $1 1/16 $1 7/16 $1 3/16
1997
Quarter ended March 31 $3 5/16 $2 7/16 $1 7/8 $1 1/16 $1 1/4 $ 7/8
Quarter Ended June 30 $3 1/32 $1 1/4 $ 7/8 $ 1/8 $ 3/4 $ 1/2
Quarter ended September 30 $3 $2 1/4 $ 5/16 $ 1/8 $1 $ 1/2
Quarter ended December 31 $2 29/32 $1 5/8 *$ 5/16 *$ 1/16 $ 9/8 $ 5/16
1998
Quarter ended March 31 $2 9/16 $1 3/16 $ 5/8 $ 9/32
Quarter commencing
April 1 through June 15, 1998 $2 9/16 $2 1/32 $ 1/2 $ 9/32
</TABLE>
* Includes trades through October 21, 1997.
The approximate number of record holders of Trinity's ADRs and Class B Warrants
amounts to 1,445 and 15, respectively, inclusive of those brokerage firms
and/or clearing houses holding Trinity's securities for their clientele (with
each such brokerage house and/or clearing house being considered as one
holder). Of the total ADR record holders of 1,445, 1442 are located in the US.
99.9% of the ADRs record holders are held by US record holders. Of the
23,191,956 'A' Ordinary Shares outstanding, 20,439,959 are held by US persons.
11
<PAGE> 12
ITEM 6
EXCHANGE CONTROLS AND OTHER LIMITATIONS
AFFECTING SECURITY HOLDERS
Irish exchange control regulations ceased to apply from and after December 31,
1992. Except as indicated below, there are no restrictions on non-residents
of the Republic of Ireland dealing in domestic securities which includes
shares or depository receipts of Irish companies such as Trinity and dividends
and redemption proceeds 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 ADRs 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 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
(Serbia and Montenegro), Iraq and Libya unless permission for the transfer has
been given by the Central Bank of Ireland.
Trinity does not anticipate that Irish exchange controls or orders under the
Financial Transfers Act, 1992 will have a material effect on its business.
There are no limitations under the laws of Ireland or under the Memorandum and
Articles of Association of the Company restricting the right of persons not
resident in Ireland to hold or vote Ordinary Shares.
ITEM 7
TAXATION
The following discussion is based on United States and Republic of Ireland tax
law, statutes, treaties, regulations, rulings and decisions now in effect, all
of which are subject to change. This summary does not discuss all aspects of
Irish and United States federal income taxation that may be relevant to a
particular stockholder in light of the stockholder's circumstances or to
certain types of investors subject to special treatment under the tax laws (for
example, financial institutions, life insurance companies, tax-exempt
organisations, and non-U.S. taxpayers) and it does not discuss any tax
consequences arising under the laws of taxing jurisdictions other than the
Republic of Ireland and the United States federal government. This description
is for general information only and is based on the Internal Revenue Code of
1986, as amended. The tax treatment of a holder of Trinity Stock may vary
depending upon his particular situation. As used herein, references to the
Trinity Stock include ADRs representing such Trinity Stock.
UNITED STATES FEDERAL INCOME TAXATION
Under the Income Tax Treaty currently in effect between the United States and
Ireland (the "Treaty"), Trinity will not be subject to United States federal
income tax (other than withholding tax imposed on U.S. source dividends and
certain interest) unless it engages in a trade or business in the United States
through a permanent establishment in the United States. Trinity's ownership of
its U.S. subsidiaries does not, in itself, constitute a permanent
establishment.
Trinity expects to be able to conduct its activities in a manner that will not
result in its being considered to be engaged in a trade or business or to have
a permanent establishment in the United States for U.S. federal income tax
purposes. The law is unclear, however, as to what constitutes being engaged in
a trade or business or a United States permanent establishment, so there can be
no assurance that Trinity will not be held to be in a trade or business or to
have a United States permanent establishment (in which case Trinity would
generally be subject to United States federal income tax on such of its net
income as is effectively connected to the permanent establishment). Trinity's
U.S. subsidiaries, as United States corporations, are subject to United States
taxation.
12
<PAGE> 13
FEDERAL INCOME TAX CONSEQUENCES OF U.S. INVESTORS
Holders of ADRs will be treated as the owners of the underlying Trinity stock
for United States federal income tax purposes. Distributions to ADR holders
from Trinity will be treated for U.S. tax purposes as dividends to the extent
of Trinity's current and accumulated earnings and profits. Distributions in
excess of current and accumulated earnings and profits will be applied against
and reduce a holder's basis in its ADRs. The excess, if any, of the
distribution remaining after the basis has been reduced to zero will constitute
capital gain.
Dividends paid by Trinity generally will not qualify for the dividends received
deduction otherwise available to United States corporate shareholders.
STATE AND LOCAL TAX CONSEQUENCES TO U.S. SHAREHOLDERS
The ownership of the ADRs may result in state or local taxes to United States
investors.
REPUBLIC OF IRELAND TAXATION
Trinity is a company incorporated, and resident for tax purposes, in Ireland.
A company is resident for tax purposes in Ireland if it is managed and
controlled in Ireland, and as this is a question of fact, there can be no
certainty that Trinity will continue to be regarded as resident in Ireland. A
company which is resident in Ireland for tax purposes is taxable in Ireland on
its worldwide income and gains. The Finance Act, 1973, provides that a
resident in Ireland shall be entitled to have any qualifying income from a
qualifying patent arising to it disregarded for income taxation purposes. It
should be noted that there are restrictions on the exemption where patent
income is received from a connected party. A qualifying patent means a patent
in relation to which the research, planning, processing, experimenting,
testing, devising, designing, developing or similar activities leading to the
invention which is the subject of the patent, was carried out in Ireland.
Accordingly, Trinity or its subsidiaries qualifying income from such qualifying
patents is disregarded for corporation taxation purposes in Ireland. Any Irish
manufacturing income of Trinity and its subsidiaries will be taxable at the
rate of 10% in Ireland until December 31, 2010. Although Trinity has no reason
to believe that the Republic of Ireland intends to change its method of
taxation as it relates to licensing, royalty or manufacturing income, there can
be no assurance that such changes will not actually occur.
The Finance Act, 1992, provides that non-residents of Ireland shall be exempt
from Irish taxation on dividends paid by companies resident in Ireland. There
is no Irish withholding tax on dividends paid by an Irish resident company.
Dividends paid by Trinity will carry an imputed tax credit ("tax credit")
unless the dividends are entirely paid out of disregarded patent income. The
tax credit with respect to a dividend is in practice represented as the
weighted average of the imputed tax credits applying to the component portions
of the dividend: it may be as high as 25/75% of the dividends or may be as low
as nil depending on the nature of the component portions of the profits out of
which the dividend is paid. Under the Treaty and US law, a US resident
shareholder may elect to credit the tax appropriate to a dividend, subject to
certain limitations, against the shareholder's United States tax liability if
the shareholder also includes the amount of the tax in gross income. Special
rules apply for the purposes of determining the foreign tax credit available to
a US corporation which controls 10% or more of the voting shares of Trinity.
The Capital Acquisitions Tax Act, 1976, provides for the imposition of both a
gift and an inheritance tax. Although ADRs may be held by non-residents, the
underlying Trinity shares are deemed to be situated in the Republic of Ireland
because Trinity is required to maintain its original share registers in the
Republic of Ireland. Accordingly, ADRs may be subject to gift or inheritance
tax payable by the donors of gifts and the successors in the case of
inheritances, notwithstanding that all or some of the parties involved are
domiciled and resident outside the Republic of Ireland. However, gifts and
inheritances taken from one's spouse are exempt from tax and there is a
cumulative tax-free threshold of IRL.185,550 on gifts and inheritances from
one's parents, a cumulative threshold of IRL.24,740 where the gift or
inheritance is from a lineal ancestor or descendant, brother, sister or child of
a brother or sister, and a cumulative threshold of IRL.12,370 on gifts and
inheritances between non-affiliated persons. The maximum tax-free threshold for
gifts and inheritances received by any one recipient is IRL.185,550 excluding
gifts and inheritances received from the recipient's spouse. Due to the
complexities of calculating the thresholds, tax may become payable on amounts
lower than the thresholds mentioned above. Irish gift taxes are not creditable
against United States gift taxes, if any, on a gift of Trinity shares. Irish
inheritance taxes should be creditable, in whole or in part, against United
States federal estate taxes. It is not anticipated that Trinity, itself, will
ever be liable for this tax.
In addition to the above, a probate tax of 2% on the entire value of Irish
assets comprised in the estate of decedent is payable where the value of those
assets exceeds IRL.10,820. This sum is indexed annually.
13
<PAGE> 14
A person holding Trinity shares who is not resident or ordinarily resident in
the Republic of Ireland for Irish tax purposes will not be subject to Irish
capital gains tax unless such shares derive the greater part of their value
from land, buildings or mineral rights in Ireland.
The Finance Act, 1992 makes any transfers or agreements to transfer American
Depository Receipts exempt from stamp duty. American Depository Receipts are
defined as instruments which:
a) acknowledge that a depository or his nominee holds stocks or marketable
securities which are dealt in and quoted on a recognised stock exchange,
and that the holder of the instrument has rights in or in relation to such
stocks or marketable securities including the right to receive them from
the depository or his nominee, and which
b) are dealt in and quoted on a recognised stock exchange which is situated
in the United States, or represent stocks or marketable securities which
are so dealt in and quoted.
As the Company's ADRs come within this definition, any transfer of ADRs will
not be chargeable with stamp duty in Ireland so long as the ADRs remain listed
on a recognised stock exchange.
Any transfer of the underlying Trinity Stock (which may include a transfer from
the Depository to an ADR holder unless the beneficial interest does not pass
and the transfer is not a sale or arising under a contract for sale or in
contemplation of a sale) would require the person acquiring such Common Stock
to pay stamp duty.
In the case of a transfer or sale, stamp duty is charged at the rate of L1.00
for every L100.00 (or part thereof) of the amount or value of the consideration.
Where the consideration for the sale is expressed in a currency other than Irish
Pounds, the duty is charged on the Irish Pound equivalent calculated at the rate
of exchange prevailing on the date of the transfer. In the case of a transfer
by way of gift (subject to certain exceptions) or for a consideration less than
the market value, stamp duty is charged at the above rate on such market value.
The person primarily accountable for payment of stamp duty is the transferee or,
in the case of a transfer by way of gift or for a consideration less than the
market value, both parties to the transfer. Stamp duty is payable within thirty
days after the date of execution of the transfer. Late or inadequate payment of
stamp duty will result in liability to interest, penalties and fines.
14
<PAGE> 15
Item 8
SELECTED CONSOLIDATED FINANCIAL DATA
The following selected financial data for the years ended December 31, 1997,
December 31, 1996 and December 31, 1995, the 10 months ended December 31, 1994
and the year ended February 28, 1994, are derived from the audited financial
statements of Trinity. The data should be read in conjunction with the
financial statements, related notes, and other financial information included
herein.
<TABLE>
<CAPTION>
Statement of
Operations Data Year Ended 10 Months Ended Year Ended Year Ended Year Ended Year Ended
Feb 28,1994 Dec 31,1994 Dec 31,1995 Dec 31, 1996 Dec 31,1997 Dec 31,1997
----------- --------------- ----------- ------------ ----------- ------------
<S> <C> <C> <C> <C> <C> <C>
IRL. IRL. IRL. IRL. IRL. US$
Revenues 1,667,456 3,342,992 6,191,502 4,227,197 11,836,433 16,831,408
Cost of goods sold (1,696,827) (3,034,553) (4,959,853) (3,084,740) (8,004,371) (11,382,216)
Administrative expenses (2,862,926) (1,486,027) (1,409,803) (1,315,764) (2,256,756) (3,209,108)
R.& D. expenses (88,084) (655,467) (936,277) (854,990) (1,245,860) (1,771,613)
Other Operating Income - 470,672 528,042 344,195 541,423 769,904
---------- ---------- ---------- ---------- ---------- ----------
Operating profit/(loss) (2,980,381) (1,362,383) (586,389) (684,112) 870,869 1,238,375
Interest expense (13,921) (19,897) (15,741) (10,580) (123,296) (175,327)
Write down of assets (168,015) (1,095,593) - - -
Interest income 46,876 35,369 83,001 226,488 102,124 145,221
Minority interests 701,466 318,708 - - - -
Net profit/(loss) (2,413,975) (2,123,796) (519,129) (468,204) 849,697 1,208,269
---------- ---------- ---------- ---------- ---------- ----------
Basic earnings
per ordinary share (0.49) (0.33) (0.05) (0.03) 0.04 0.06
Diluted earnings
per ordinary share (0.49) (0.33) (0.05) (0.03) 0.04 0.06
Weighted average
number of shares 4,891,277 6,471,315 1,135,753 16,119,559 19,108,363 19,108,363
</TABLE>
<TABLE>
<CAPTION>
Year Ended 10 Months Ended Year Ended Year Ended Year Ended Year Ended
Balance Sheet Data Feb 28,1994 Dec 31,1994 Dec 31,1995 Dec 31,1996 Dec 31, 1997 Dec 31, 1997
- ------------------ ----------- --------------- ----------- ----------- ------------ ------------
IRL. IRL. IRL. IRL. IRL. US$
<S> <C> <C> <C> <C> <C> <C>
Working Capital 401,172 145,079 4,084,026 3,952,878 4,971,610 7,069,628
Long-term Liabilities 74,727 37,770 - (45,106) (6,137,491) (8,727,511)
Total Assets 3,454,464 2,037,598 5,732,420 8,052,492 17,299,368 24,599,701
Shareholders' Equity 1,685,462 826,554 4,687,057 6,248,547 4,996,280 7,104,711
</TABLE>
Amounts Adjusted for US GAAP
<TABLE>
<CAPTION>
Year Ended 10 Months Ended Year Ended Year Ended Year Ended Year Ended
Balance Sheet Data Feb 28,1994 Dec 31,1994 Dec 31,1995 Dec 31,1996 Dec 31, 1997 Dec 31, 1997
- ------------------ ----------- --------------- ----------- ----------- ------------ ------------
<S> <C> <C> <C> <C> <C> <C>
IRL. IRL. IRL. IRL. IRL. US$
Net loss (2,609,354) (2,342,944) (1,465,414) (1,640,831) (1,306,174) (1,857,380)
Basic and diluted
earnings per
ordinary share (0.53) (0.36) (0.13) (0.10) (0.07) (0.10)
Total Assets 5,092,365 9,719,168 11,752,707 13,033,253 28,688,005 40,794,540
</TABLE>
No dividends were declared in any of the periods from February 28, 1994 to
December 31, 1997.
(1) The Company's financial statements are prepared in Irish Pounds. A
translation into US dollars using the closing exchange rate on December 31,
1997 of US$1.4220 per Irish Pound has been presented solely for the convenience
of the reader and is not intended to be a representation that the Irish Pound
amounts have been, could have been or could be converted into US dollars at
that rate or any other rate.
15
<PAGE> 16
ITEM 9 MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
GENERAL
Trinity was incorporated in Ireland in January 1992. The Company was organised
to acquire, develop and market technologies for rapid in vitro blood and saliva
diagnostics for HIV and other infectious diseases. In October 1992 Trinity
completed an initial public offering in the United States in which it raised net
proceeds in excess of IRL.2.8 million. In October 1993, Trinity took a
controlling interest in DDI and in October 1994 merged Trinity's wholly-owned
subsidiary into DDI so that DDI became a wholly-owned subsidiary of Trinity.
DDI was the surviving entity in the merger and was subsequently renamed Trinity
Biotech Inc ("TBI"). In December 1994 Trinity acquired the remaining 50% of FHC
which its subsidiary TBI did not own. During 1995 Trinity raised net proceeds
of in excess of $6 million as a result of a private placements of the Company's
shares. In February 1997, the Company purchased the entire share capital of
Trinity Biotech (USA), ("Trinity USA") and in June 1997 the company purchased
the entire share capital of Centocor UK Holdings Ltd ("Centocor"). The group
financial statements include the attributable results of Trinity USA, Centocor,
TBI and Trinity Biotech Manufacturing Limited, which are engaged in manufacture
and sale of diagnostic test kits. This discussion covers the years ended
December 31, 1997, December 31, 1996 and December 31, 1995.
The following discussion 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 generally
accepted accounting principals which conform in all material respects to US
GAAP except as indicated in Note 25 to the Consolidated Financial Statements.
RESULTS OF OPERATIONS
Year Ended December 31, 1997 Compared to Year Ended December 31, 1996.
- ----------------------------------------------------------------------
Trinity's consolidated revenues for the year ended December 31, 1997 were
IRL.11,836,000, an increase of IRL.7,609,000 compared to consolidated revenues
of IRL.4,227,000 for the year ended December 31, 1996. The growth in revenues
is due to an increase of IRL.2,954,000 relating to the growth in the level of
sales of Trinity's existing product lines and the effect of new product
introductions. The rest of the increase amounting to IRL.4,655,000 relates to
revenues from the Company's newly acquired subsidiaries, Trinity USA and
Centocor. Included in product sales for the year ended December 31, 1997 are
sales of pregnancy tests in the amount of IRL.4,762,000 compared to sales of
IRL.3,294,000 for these tests in the previous year. Of the pregnancy tests sold
by Trinity, approximately 91.5% was attributable to revenues of FHC to
Warner-Lambert and 8.5% were pregnancy tests sold by Trinity to the professional
markets.
Revenues for the year ended December 31, 1997, from the sale of the Company's
other tests were IRL.7,074,000 compared to IRL.621,000 for the year ended
December 31, 1996, an increase of IRL.6,543,000. Of the total increase,
IRL.4,655,000 was due to the inclusion of sales from the Company's newly
acquired subsidiaries, Centocor and Trinity USA. The remaining increase of
IRL.1,798,000 was due to increasing sales from the Company's existing product
lines and the impact from sales of newly launched products. Management expects
that revenues of Trinity's products will continue to increase due to further
regulatory approvals and increased sales from our existing distribution network.
Interest and other income decreased to IRL.102,000 for the year ended December
31, 1997 compared to IRL.226,000 in the year ended December 31, 1996. This
decrease reflects the lower cash reserves of the group during the period.
The gross margin from product sales for the year ended December 31, 1997 was
32% compared to 27% for the year ended December 31, 1996. This is mainly due
to the fact that the Company's lower margin pregnancy sales now make up a
smaller proportion of overall sales than the higher margin products. The gross
margin on the sale of pregnancy tests was 15% and the margin on the sale of the
Company's other tests was 41%.
As part of the agreement between Trinity, Warner Lambert and Applied Biotech
Inc. (ABI), certain amounts were required to be deposited in an escrow account.
Escrowed funds may be applied to reimburse Warner-Lambert as to any losses for
which FHC and ABI are responsible under the Supply Agreement. If there are no
claims for a period of three years, escrowed funds are to be released at a rate
of $1 million after the end of such period and $500,000 per year thereafter, of
which 50% will be paid to FHC and 50% to ABI. Trinity has recognised $711,000
as revenue during 1997.
Administrative expenses for the year ended December 31, 1997 amounted to
IRL.2,257,000 compared to IRL.1,316,000 for the year ended December 31, 1996.
This significant increase of IRL.941,000 is mainly attributable to addition of
the administration costs of Trinity USA and Centocor UK. Research and
development expenditure increased to IRL.1,246,000 from IRL.855,000 during the
period reflecting the addition of additional scientists and the allocation of
increased resources. The resources were utilised to develop the Company's
Uni-Gold one step range of tests and to add further products to the Company's
increasing laboratory test
16
<PAGE> 17
product lines. During the year the Company realised a gain of IRL.541,000 on
the movement of the current portion of its investment in Selfcare Inc. This
compares to a gain of IRL.344,000 in 1996 relating to the disposal of shares in
Athena Medical Corp and Quantech Inc.
The net profit for the year ended December 31, 1997 was IRL.850,000 compared to
a loss of IRL.468,000 for the year ended December 31, 1996. This improvement in
results was brought about by increased revenues, the addition of the results of
Trinity USA and Centocor UK and the non recurrence of two exceptional items
which occurred in 1996
Year Ended December 31, 1996 Compared to the Year Ended December 31, 1995
- -------------------------------------------------------------------------
Trinity's consolidated revenues for the year ended December 31, 1996 were
IRL.4,227,000 a decrease of IRL.1,965,000 (IRL.1,897,000 before the impact of
currency fluctuations), compared to consolidated revenues of IRL.6,192,000 for
the year ended December 31, 1995. Included in product sales for the year ended
December 31, 1996 are sales of pregnancy tests in the amount of IRL.3,294,000
compared to sales of IRL.5,575,000 for these tests in the previous period. The
decrease was brought about by a fall in revenues from sales to Warner-Lambert
brought about by two factors. First, Warner-Lambert relaunched the product in
the second quarter of 1996. They had built up significant stocks of the product
in the final quarter of 1995 and as a result orders in the first two quarters
were lower than normal levels. Trinity estimates that this increased revenue by
approximately $1,030,000 in 1995 and consequently reduced revenue by
approximately the same amount during 1996. Second, due to the renegotiation of
the contract with Warner-Lambert, the transfer prices from ABI to Trinity and
from Trinity to Warner-Lambert were reduced by 26%. This had the effect of
lowering revenues while keeping the margin level of approximately 16%. This
reduced revenues by approximately $900,000 during 1996. Trinity's current
contract with Warner Lambert has been extended to September 2001 and the Company
is currently negotiating a further extension to this contract at current price
levels. Of the pregnancy tests sold by Trinity, approximately 93% was
attributable to revenues to Warner-Lambert and 7% were pregnancy tests sold by
Trinity to the professional markets.
Revenues for the year ended December 31, 1996 derived from the sale of the
Company's other diagnostic tests were IRL.621,000 compared to IRL.616,000 for
the year ended December 31, 1995. This increase in test revenues is mainly due
to the commencement of sales of Trinity's new rapid and laboratory based
products which commenced production during 1996 and to increased orders from
Trinity's regular distributors. A tender for approximately $500,000 which the
company was awarded in 1995 was not repeated in 1996.
Interest and other income increased to IRL.226,000 for the year ended December
31, 1996 compared to IRL.83,000 in the year ended December 31, 1995 due to
increased cash reserves during the year.
The gross margin from product sales for the year ended December 31, 1996 was
27% compared to 20% for the year ended December 31, 1995. This is mainly due
to reduced manufacturing overhead following the consolidation of manufacturing
capability to Dublin in addition to the increase in product mix towards higher
margin products.
The gross margin on the sale of pregnancy tests was 16.9% and the margin on the
sale of other diagnostic tests was 43%. The margin on pregnancy tests
increased to 16.9% in June, 1995 because up to May, 1995 a portion of sales
revenues to Warner-Lambert were reserved for an escrow account which was not
credited to sales until the escrow account is completed.
Escrowed funds may be applied to reimburse Warner-Lambert as to any losses for
which TBI and Applied Biotech Inc. (ABI) are responsible under the Supply
Agreement. If there are no claims for a period of three years, escrowed funds
are to be released at a rate of $1 million after the end of such period and
$500,000 per year thereafter, of which 50% will be paid to TBI and 50% to ABI.
Trinity has recognised $500,000 as revenue during 1996.
Administrative expenses for the year ended December 31, 1996 amounted to
IRL.1,316,000 compared to IRL.1,410,000 for year ended December 31, 1995. This
decrease of IRL.94,000 (IRL.82,000 before the impact of exchange rate
fluctuations), is mainly attributable to the scale down of the operations of
Trinity Biotech Inc. (formerly DDI).
Research and development expenditure decreased to IRL.855,000 from IRL.936,000
during the period. This decrease is due to the netting off of a grant receivable
of IRL.318,600 against gross R&D expenditure of IRL.1,173,000. The resources
were utilised to develop the Company's Uni-Gold one step tests along with other
rapid and laboratory based tests. This grant aid may be revoked, cancelled or
abated if the Company conducts any of the R&D outside Ireland and the resulting
products are not manufactured in Ireland or if the Company changed or ceased its
projects without the consent of Forbairt or if the Company ceases to operate its
business. To date, Trinity has not engaged in or incurred any expenditure in
respect of collaborative research agreements.
During the year the Company realised a gain of IRL.165,000 on the disposals of
its shares in Athena Medical Corporation, compared to a gain of IRL.586,000 in
1995 and a gain of IRL.179,000 on the disposal of its shares in Quantech Inc.
17
<PAGE> 18
The net loss for the year ended December 31, 1996 was IRL.468,000 compared to
IRL.519,000 for the year ended December 31, 1995. The loss included two
exceptional charges. Firstly a charge of IRL.209,000 was made to cover a
pending law suit and its related legal costs and secondly, due to adverse
exchange rate fluctuations at the year end the Company reported an unrealised
exchange loss of IRL.230,000.
LIQUIDITY AND CAPITAL RESOURCES
As of December 31, 1997 Trinity's consolidated cash and cash equivalents were
IRL.1,988,000 ($2,827,000). This compares to cash and cash equivalents of
IRL.2,905,000 at December 31, 1996. The decrease is due to the acquisition of
Trinity USA and Centocor UK, the purchase of non-strategic investments and the
purchase of fixed assets. This resulted in net cash outflows of IRL.959,000
($1,365,000) during the year.
In addition, the Company holds current investments which stand at IRL.1,018,000
($1,448,000) at December 31, 1997 and a fixed asset investments in Selfcare Inc
and CLI Oncology which stand at IRL.1,819,000 ($2,587,000) at December 31, 1997.
Due to the acquisition of a new 42,000 sq. ft. manufacturing facility in
December 1997 the Company anticipates capital expenditures in excess of
IRL.1,250,000 ($1,778,000) over the next twelve months. Much of this
expenditure will relate to the fitting out of the new facility and the addition
of new equipment required to manufacture the Company's increasing portfolio of
tests.
As a result of the supply agreement between Trinity USA and Carter Wallace,
Trinity USA received $2,000,000 in return for Carter Wallace having exclusive
rights to its products in the U.S. The final $500,000 was paid in December
1997. If sales of products to Carter Wallace exceed certain levels, Trinity
is entitled to a 40% share in the gross profit received by Carter Wallace on
sales in excess of the stated levels.
In connection with the acquisition of Centocor, on June 25, 1997, the Company
completed a private placement of (i) $3,000,000 principal amount of 4%
Convertible Debentures (the "Debentures") and (ii) 50,000 warrants to purchase
'A' Ordinary Shares of the Company (the "Warrants"), which resulted in
aggregate gross proceeds to the Company of $3,000,000.
The Debentures bear interest at the rate of 4% per annum, payable quarterly,
and mature on December 24, 1999. The Debentures are convertible into 'A'
Ordinary Shares of the Company at a price equal to the lower of (i) the
average closing bid price of the Company's ADRs on the five trading days prior
to conversion, subject to a discount which ranges from 10% for conversions
made within the first 120 days after issuance to 22.5% for conversions made on
or after 181 days after issuance, or (ii) $3.78. As of June 15, 1998,
1,500,000 principal amount of the debentures have been converted resulting in
the issue of 987,359 shares.
The Warrants are each exercisable to purchase one 'A' Ordinary Share of the
Company at $3.78 per share until June 25, 2000.
Trinity has paid $1.5 million and $2.8 million in respect of its acquisitions
of Trinity USA and Centocor during 1997 respectively. The net effect of both
acquisitions has had a positive impact on Trinity's gross margins, operating
results and cash flows in 1997. The products acquired in the acquisition are
sold at margins in line with those of Trinity's higher margin, non-pregnancy
rapid products and as such provide a positive overall impact on margins within
the company. In quarter 1 of 1998 Trinity closed the Centocor UK facility in
the UK and transferred its operations to the Company's new facility in
Ireland. Management believes that this will improve the overall operating
efficiency and cost base of the company.
Trinity has three additional annual payments of $837,000 in December 1998,
1999 and 2000 to complete its acquisition of Centocor. However with the
placement above, the cash balance already on hand and further funds generated
from operations, Trinity believes it has sufficient funds to meet these
commitments and continue operations for the foreseeable future. If operating
margins of sales were to decline substantially or the Company was to make a
large and unanticipated cash outlay, the Company would have further funding
requirements. If this were the case, there can be no assurance that financing
will be available at attractive terms, or at all. The Company believes that
success in raising additional capital or obtaining profitability will be
dependent on the viability of its products and their success in the market
place.
In October 1997, the Company's 'A' Warrant expired. This resulted in the
cancellation of 805,849 unexercised 'A' Warrants. Trinity currently has
883,086 'B' Warrants outstanding. Each 'B' Warrant gives the holder an
Ordinary Share and is exercisable at $4.00. They expire in October, 1998.
Given the current share price, it is possible that Warrants will be
exercisable during 1998. Trinity cannot anticipate how much funds, if any,
could be raised in this manner.
18
<PAGE> 19
Reconciliation to US GAAP
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"). Those items
affecting Net Loss are as follows:
Goodwill; Under Irish GAAP, goodwill may be either written off immediately on
completion of the acquisition against shareholders' equity, or capitalised in
the balance sheet and amortised through the income statement on a systematic
basis over its useful economic life. Under US GAAP, accounting for goodwill
as an offset against shareholders' equity is not permitted; rather, goodwill
must be amortised over the period of its expected useful life, subject to a
maximum write off period of 40 years, through the income statement. For the
purposes of the reconciliation a useful life of 10 years has been adopted for
goodwill. In the year to December 31, 1997 the amount that would have been
amortised to the profit and loss was IRL.1,186,106 (US$1,686,643), December
31, 1996 IRL.693,491 and December 31, 1995 IRL.693,327.
Stock Compensation; In contrast to Irish GAAP, US GAAP requires that the grant
of share options exercisable at prices per share less than the fair market
value of the shares at the time of grant of the options be accounted for as
compensation expense to be recognised over the related vesting period. In the
year to December 31, 1997 the amount that would have been charged to the
profit and loss was IRL.469,765 (US$668,006), December 31, 1996 IRL.167,511
and December 31, 1995 IRL.252,958.
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.
Recognition of Escrow Income; Under Irish GAAP, the Company has recognised as
revenue amounts due to be released from an Escrow account in 1997. Under US
GAAP such amounts are not recognisable until received.
IMPACT OF INFLATION
Although Trinity's operations are influenced by general economic trends,
Trinity does not believe that inflation has a material effect on its
operations for the periods presented.
IMPACT OF CURRENCY FLUCTUATION
Trinity's revenue and expenses are affected by fluctuations in currency
exchange rates especially the exchange rate between the US Dollar and the
Irish Pound. Trinity's revenues are primarily denominated in US Dollars, its
expenses are incurred principally in Irish Pounds and US Dollars. The
revenues and costs incurred by US subsidiaries are denominated in US Dollars.
Trinity holds most of its cash assets in U.S. dollars. As Trinity reports in
Irish Pounds any fluctuation in exchange rates can lead to an unrealised
exchange gain or loss on its cash assets. These unrealised gains and losses
have little impact in the operations of the Company. Realised exchange gains or
losses are generally not significant in overall terms. In 1997 realised
exchange losses amounted to IRL.15,000 and net unrealised gains amounted to
IRL.83,000.
EXCHANGE RATES
Fluctuations in the exchange rate between the Irish pound (as part of the
European Monetary System) and the U.S. dollar may affect the Company's
earnings, the book value of its assets and shareholders' equity as expressed in
Irish pounds and U.S. dollars and consequently may affect the market price for
the ADSs.
The following table sets forth certain information with respect to the Noon
Buying Rate of Irish pounds in terms of U.S. dollars as reported by the Federal
Reserve Bank of New York during the periods indicated.
<TABLE>
<CAPTION>
PERIOD AVERAGE(1) HIGH LOW END
<S> <C> <C> <C> <C>
Fiscal period ended
February 28,
1991 1.6917 1.8390 1.5493 1.7460
1992 1.5884 1.7580 1.4585 1.6295
1993 1.6881 1.9028 1.4407 1.4785
1994 1.4486 1.5553 1.3550 1.4310
December 31,
1994 1.5200 1.6150 1.4075 1.5440
1995 1.6030 1.6575 1.5320 1.6002
1996 1.6063 1.6920 1.5515 1.6920
1997 1.5037 1.6927 1.4220 1.4220
</TABLE>
(1) The average represents the average of the Noon Buying Rates on the last
business day of each month during the period. On December 31, 1996 and
December 31, 1997 the Noon Buying Rates were $1.6920 = IRL.1 and US$1.4220
= IRL.1 respectively. For further information regarding the currency
translation policies of the Company, see Note 1 of the Notes to the
Consolidated Financial Statements.
19
<PAGE> 20
ITEM 10
MANAGEMENT OF TRINITY
DIRECTORS AND EXECUTIVE OFFICERS
<TABLE>
<CAPTION>
Name Age Title
<S> <C> <C>
Ronan O'Caoimh 42 Chairman of the Board of Directors
Chief Executive Officer
Brendan K. Farrell 50 Director, President, CEO Trinity USA
James Walsh Ph.D. 39 Director, Chief Operating Officer
Jonathan O'Connell 32 Director, Chief Financial Officer,
Company Secretary
Denis R. Burger, Ph.D. 54 Non Executive Director
Allan Pronovost, Ph.D. 45 Non Executive Director
</TABLE>
BOARD OF DIRECTORS
RONAN O'CAOIMH
Mr. O'Caoimh joined Trinity in June, 1992 as Chief Financial Officer and has
been Chief Executive Officer since March, 1994 and Chairman since May, 1995.
Prior to joining Trinity, Mr. O'Caoimh was Managing Director of Noctech
Limited, an Irish diagnostics company. Mr. O'Caoimh was Finance Director of
Noctech Limited from 1988 until January 1991 when he became Managing Director
following the acquisition of Noctech by Cambridge Biotech Corporation.
Between 1984 and 1988 Mr. O'Caoimh was Finance Director and subsequently
Managing Director of Laird Food Products, an Irish food manufacturer. Mr.
O'Caoimh, from 1980 to 1984 practised as a Chartered Accountant with Arthur
Andersen in Dublin. He holds a Bachelor of Commerce Degree from University
College Dublin and is a member of the Institute of Chartered Accountants in
Ireland.
BRENDAN K. FARRELL
Mr. Farrell joined Trinity in July 1994. He was previously Marketing Director
of B.M. Browne Limited, a company involved in the marketing and distribution
of medical and diagnostic products. Previously he was Chief Executive of
Noctech Limited, an Irish based diagnostics company, and prior to that he
worked for 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.
JONATHAN O'CONNELL
Mr. O'Connell joined Trinity in January 1993 as Group Financial Controller and
was appointed Chief Financial Officer in January, 1995. He also assumed the
position of Company Secretary in June 1994. Prior to joining Trinity Mr.
O'Connell practised as a chartered accountant with Arthur Andersen, Dublin.
Mr. O'Connell has a degree in Business Studies from Trinity College, Dublin.
DENIS R. BURGER, PH.D.
Dr. Burger was Chairman of Trinity from June, 1992 to May, 1995 and is
currently a Non Executive Director. Dr. Burger is President, Chief Operating
Officer and a director of Antivirals Inc., an Oregon biotechnology company
specialising in antisense technology. Dr. Burger is also a 50% partner in
Sovereign Ventures, a health care consulting and funding firm based in
Portland, Oregon (see "Consulting Agreement with Sovereign Ventures" below).
He was a co-founder and, from 1981 to 1990, Chairman of the Board 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 ("OHSU"). Dr. Burger received his A.B.
degree in Bacteriology and Immunology from the University of California in
Berkeley in 1965 and his M.S. and Ph.D. degrees in 1969 in Microbiology and
Immunology from the University of Arizona.
JIM WALSH
Dr. Walsh joined Trinity in October 1995. Prior to joining Trinity, Dr. Walsh
was Managing Director of Cambridge Diagnostics Limited (formerly Cambridge
Biotech Limited prior to its acquisition by Selfcare Inc.). He was employed
with Cambridge Biotech Limited since 1987. Before joining Cambridge he worked
with Fleming GmbH as Research & Development Manager.
20
<PAGE> 21
ALLAN PRONOVOST
Dr. Provonost joined the Board of Trinity on December 5, 1997 as a
Non-Executive Director. Since June 1997, Dr. Provonost has been a self-employed
consultant in the diagnostics industry. From March 1987 to June 1997 Dr.
Provonost was Vice-President - Research and Development at Quidel Corporation.
Previously he had various key research and development positions at Eastman
Kodak from 1986 to March 1987, Ortho Diagnostic systems, Inc. from 1983 to
1986, and E.I. duPont Corporation from 1980 to 1983. Dr. Provonost received
his post-doctoral clinical training at Yale University School of Medicine and
received his Ph. D. degree in virology from the University of Rhode Island. He
has a number of patents and has published numerous papers in immunology and
diagnostic assay methods.
The Articles of Association of Trinity provide that one third of the directors
in office (other than the Managing Director or a director holding an executive
office with Trinity) or, if their number is not three or a multiple of three,
then the number nearest to but not exceeding one third, shall retire from
office at every annual general meeting. If at any annual general meeting the
number of directors who are subject to retirement by rotation is two, one of
such directors shall retire and if the number of such directors is one that
director shall retire. Retiring directors may offer themselves for
re-election. The directors to retire at each annual general meeting shall be
the directors who have been longest in office since their last appointment.
As between directors of equal seniority the directors to retire shall, in the
absence of agreement, be selected from among them by lot.
ITEM 11
COMPENSATION OF DIRECTORS AND OFFICERS
The Board has appointed a compensation committee that is responsible for
determining executive remuneration and grant of options. The members of the
compensation committee are Denis Burger and Ronan O'Caoimh. The aggregate
compensation paid to the directors and executive officers of the company for
the period ended December 31, 1997 totalled of IRL.453,340 ($644,649). This
included an amount of IRL.38,000 ($54,000) paid on behalf of the Directors
into the Company pension plan.
No director of the Company is compensated in his capacity as a director, but
members of the Board received compensation for serving as officers or
consultants of the Company. Each director is reimbursed for expenses incurred
in attending meetings of the Board of Directors.
ITEM 12
STOCK OPTION PLAN
The Board of Directors has adopted the Employee Share Option Plan (the
"Plan"), the purpose of which is to provide Trinity's employees, consultants,
officers and directors with additional incentives to improve Trinity's ability
to attract, retain and motivate individuals upon whom Trinity's sustained
growth and financial success depends. The Plan is administered by a
compensation committee designated by the Board of Directors. The aggregate
maximum number of 'A' Ordinary shares of Trinity available for awards under
the Plan is 11,500,000 subject to adjustments to reflect changes in Trinity's
capitalisation. Options under the Plan may be awarded only to employees,
officers, directors and consultants of Trinity.
The exercise price of options is determined by the compensation committee.
The term of an option will be determined by the compensation committee,
provided that the term may not exceed ten years from the date of grant. All
options will terminate 90 days after termination of the option holders
employment, service or consultancy with Trinity (or one year after such
termination because of death or disability). Under certain circumstances
involving a change in control of Trinity, the committee may accelerate the
exercise ability and termination of the options. As of June 15, 1998 of the
options outstanding, 1,811,875 were held as a group by directors and officers
of Trinity.
As of June 15, 1998 the following options were outstanding:
<TABLE>
Name Number of 'A' Ordinary Shares Range of
Subject to Option Exercise Price
per Share
<S> <C> <C>
Total Options Outstanding 3,127,208 $0.50-$5.00
</TABLE>
21
<PAGE> 22
In addition to options granted under the Plan, Trinity granted options for
170,000 shares of Trinity to certain founders (the "Founder Plan"). Options
outstanding at December 31, 1997 which were granted to directors and officers
of Trinity under the Founder Plan amounted to 16,667 at an exercise price of
$0.50.
In addition, the Company granted warrants to purchase 381,704 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 and 1995 and the debenture
issue in 1997. At December 31, 1997 234,549 warrants were still outstanding.
A further warrant to purchase 100,000 Class 'A' Ordinary Shares price of $2.00
was granted in 1995 to a consultant of the Company.
ITEM 13
CERTAIN TRANSACTIONS
Not applicable.
PART II
ITEM 14
DESCRIPTION OF SECURITIES TO BE REGISTERED
Not applicable.
PART III
ITEM 15
DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 16
CHANGES IN SECURITIES AND CHANGES IN SECURITY FOR REGISTERED
SECURITIES
Not applicable.
PART IV
ITEM 17
FINANCIAL STATEMENTS
The registrant has responded to Item 18 in lieu of responding to the item.
ITEM 18
FINANCIAL STATEMENTS
22
<PAGE> 23
REPORT OF INDEPENDENT AUDITORS
To: The Board of Directors of Trinity Biotech plc
We have audited the consolidated balance sheets of Trinity Biotech plc as of
December 31, 1996 and December 31, 1997 and the related consolidated statements
of operations, movement in shareholders' equity and cash flows for each of the
three years ended December 31, 1997. These financial statements are the
responsibility of the Company's management. Our responsibility is to express
an opinion on these financial statements based on our audits.
We conducted our audits in accordance with Irish Auditing Standards, which do
not differ in any significant respect from United States generally accepted
auditing standards. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the financial statements are free
from material misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements.
An audit also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the consolidated financial position of Trinity Biotech
plc at December 31, 1996 and December 31, 1997, and the consolidated results of
its operations and its cash flows for each of the three years December 31,
1997, in conformity with accounting principles generally accepted in the
Republic of Ireland, which differ in certain respects from those followed in
the United States (see note 25 of Notes to Consolidated Financial Statements).
<TABLE>
<S> <C>
Dublin, Ireland Ernst & Young
March 5, 1998 Chartered Accountants
</TABLE>
23
<PAGE> 24
CONSOLIDATED BALANCE SHEET AT DECEMBER 31, 1997
<TABLE>
<CAPTION>
31 December 31 December 31 December
1996 1997 1997
Notes IRL. IRL. US$
<S> <C> <C> <C> <C>
ASSETS
Current investments 2 402,591 1,018,033 1,447,643
Inventories 3 310,354 2,575,975 3,663,036
Accounts receivable and prepayments 4 2,093,925 5,554,977 7,899,177
Cash and cash equivalents 2,904,847 1,988,222 2,827,251
_________ __________ __________
5,711,717 11,137,207 15,837,107
Intangible assets, net 5 24,645 263,831 375,168
Property, plant & equipment, net 6 750,902 4,078,881 5,800,169
Financial assets 7 1,565,228 1,819,449 2,587,257
_________ __________ __________
TOTAL ASSETS 8,052,492 17,299,368 24,599,701
_________ __________ __________
LIABILITIES & SHAREHOLDER'S EQUITY
Accounts payable and accrued expenses 8 1,758,839 6,165,597 8,767,479
Long term liabilities 9 45,106 6,137,491 8,727,511
SHAREHOLDERS' EQUITY
Called up share capital
Class 'A' Ordinary shares 10 155,988 221,918 315,567
Class 'B' Ordinary shares 10 7,000 7,000 9,954
Share premium account 18,302,300 24,652,136 35,055,338
Currency adjustment (138,910) (44,392) (63,125)
Retained deficit (5,024,878) (4,175,181) (5,937,107)
Goodwill reserve (7,052,953) (15,665,201) (22,275,916)
__________ ___________ ___________
6,248,547 4,996,280 7,104,711
__________ ___________ ___________
Total Liabilities and Shareholders' Equity 8,052,492 17,299,368 24,599,701
__________ ___________ ___________
</TABLE>
See Notes to Consolidated Financial Statements
Approved by the Board on 5th March, 1998
Ronan O'Caoimh
Jonathan O'Connell
Directors
24
<PAGE> 25
CONSOLIDATED STATEMENT OF OPERATIONS
FOR THE YEAR ENDED DECEMBER 31, 1997
<TABLE>
<CAPTION>
31 December 31 December 31 December 31 December
1995 1996 1997 1997
Revenues Notes IRL. IRL. IRL. US$
<S> <C> <C> <C> <C> <C>
- - Continuing operations 12 6,191,502 4,227,197 7,181,130 10,211,567
- - Acquisitions 12 - - 4,655,303 6,619,841
_________ _________ __________ __________
6,191,502 4,227,197 11,836,433 16,831,408
Cost of sales
- - Continuing operations (4,959,853) (3,084,740) (5,208,575) (7,406,594)
- - Acquisitions - - (2,795,796) (3,975,622)
_________ _________ __________ __________
(4,959,853) (3,084,740) (8,004,371) (11,382,216)
Gross profit 1,231,649 1,142,457 3,832,062 5,449,192
Research & development expenses (936,277) (854,990) (1,245,860) (1,771,613)
Administrative expenses - normal
- - Continuing operations (1,230,581) (876,692) (1,350,719) (1,920,722)
- - Acquisitions - - (973,929) (1,384,928)
_________ _________ __________ __________
(1,230,581) (876,692) (2,324,648) (3,305,650)
Administrative expenses - exceptional 14 (179,222) (439,072) 67,892 96,542
Other operating income 14 528,042 344,185 541,423 769,904
_________ _________ __________ __________
Operating profit (loss)
- - Continuing operations (586,389) (684,112) (14,709) (20,917)
- - Acquisitions - - 885,578 1,259,292
_________ _________ __________ __________
(586,389) (684,112) 870,869 1,238,375
Interest receivable and similar income 83,001 226,488 102,124 145,221
Interest payable and similar charges (15,741) (10,580) (123,296) (175,327)
_________ _________ __________ __________
Profit (loss) on ordinary activities
before taxation 13 (519,129) (468,204) 849,697 1,208,269
Tax on profit (loss) on ordinary
activities 15 - - - -
_________ _________ __________ __________
Retained profit (loss) for the financial
period (519,129) (468,204) 849,697 1,208,269
_________ _________ __________ __________
Basic earnings per ordinary
share 16 (0.05) (0.03) 0.04 0.06
Diluted earnings per ordinary
share 16 (0.05) (0.03) 0.04 0.06
</TABLE>
Movements on reserves are shown in the "Consolidated Statement of Movement in
Shareholders' Funds" on page 28.
<TABLE>
<CAPTION>
STATEMENT OF RECOGNISED GAINS AND LOSSES 31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Loss for the financial period attributable to group shareholders (468,204) 849,697 1,208,269
Currency adjustment (21,601) 94,518 134,405
Realised gain on disposal of treasury shares 877,994 - -
________ ________ _________
Total recognised losses for the period 388,189 944,215 1,342,674
________ ________ _________
</TABLE>
Approved by the Board on 5th March, 1998
Ronan O'Caoimh
Jonathan O'Connell
Directors
25
<PAGE> 26
CONSOLIDATED STATEMENT OF MOVEMENT IN SHAREHOLDERS' EQUITY
FOR THE YEAR ENDED DECEMBER 31, 1997
<TABLE>
<CAPTION>
Class 'A' Ordinary Shares Class 'B' Ordinary Shares
------------------------- ------------------------------------
Share Share
capital capital Premium
Number of IRL.0.01 Number of IRL.0.01 in excess
shares each shares each of par
IRL. IRL. IRL.
<S> <C> <C> <C> <C> <C>
Authorised 50,000,000 500,000 700,000 7,000
Issued:
Balance as
at December
31, 1994 9,317,151 93,171 700,000 7,000 13,119,775
Stock issued
for cash 96,953 970 - - 89,030
Private
placement of
Class 'A' shares
for cash
(note 10(c)) 4,284,713 42,847 - - 4,225,601
Options exercised 882,000 8,820 - - 313,370
Issue of shares for
services 35,000 350 - - 24,479
Fair value
adjustment to Goodwill
arising on acquisition
of FHC - - - - -
Share issue expenses - - - - (506,884)
Currency adjustment - - - - -
Profit and loss account - - - - -
Disposal of Treasury
Share - - - - -
Balance as at
December 31, 1995 14,615,817 146,158 700,000 7,000 17,265,371
Stock Issued
for cash 205,735 2,057 - - 209,145
Options exercised 589,211 5,892 - - 527,737
Class 'A' Warrants
exercised 188,086 1,881 - - 351,024
Goodwill arising on
acquisition of
product line - - - - -
Share issue expenses - - - - (50,977)
Currency adjustment - - - - -
Profit and loss
account - - - - -
Disposal of Treasury
Shares - - - - -
Balance as at
December 31, 1996 15,598,849 155,988 700,000 7,000 18,302,300
Class 'A' shares
issued for cash 175,548 1,755 - - 218,245
Class 'A' shares
issued for the
purchaseof Clark
Laboratories 1,427,142 14,272 - - 2,366,183
Class 'A' shares
issued for the
purchase of
financial asset 153,202 1,532 - - 254,006
Class 'A' Warrants
exercised 396,065 3,961 - - 814,659
Options
exercised 4,440,965 44,410 - - 3,017,856
Goodwill arising on
acquisition of Clark - - - - -
Goodwill arising on
acquisition of Centocor - - - - -
Share issue expenses - - - - (321,113)
Currency adjustment - - - - -
Profit and loss account - - - - -
Balance as
at December 31, 1997 22,191,771 221,918 700,000 7,000 24,652,136
</TABLE>
<PAGE> 27
<TABLE>
<CAPTION>
Retained Currency Goodwill Treasury
deficit Adjustment Reserve Shares Total Total
IRL. IRL. IRL. IRL. IRL. US$
<S> <C> <C> <C> <C> <C>
Authorised
Issued:
Balance as
at December
31, 1994 (4,975,852) (69,911) (6,928,342) (419,287) 826,554
Stock issued
for cash - - - - 90,000
Private
placement of
Class 'A' shares
for cash
(note 10(c)) - - - - 4,268,448
Options exercised - - - - 322,190
Issue of shares for
services - - - - 24,829
Fair value
adjustment to Goodwill
arising on acquisition
of FHC - - (6,569) - (6,569)
Share issue expenses - - - - (506,884)
Currency adjustment - (47,398) - - (47,398)
Profit and loss
account (519,129) - - - (519,129)
Disposal of Treasury
Share 60,313 - - 174,703 235,016
Balance as at
December 31, 1995 (5,434,668) (117,309) (6,934,911) (244,584) 4,687,057
Stock Issued
for cash - - - - 211,202
Options exercised - - - - 533,629
Class 'A' Warrants
exercised - - - - 352,905
Goodwill arising on
acquisition of
product line - - (118,042) - (118,042)
Share issue expenses - - - - (50,977)
Currency adjustment - (21,601) - - (21,601)
Profit and loss
account (468,204) - - - (468,204)
Disposal of Treasury
Shares 877,994 - - 244,584 1,122,578
Balance as at
December 31, 1996 (5,024,878) (138,910) (7,052,953) - 6,248,547 8,885,434
Class 'A' shares
issued for cash - - - - 220,000 312,841
Class 'A' shares
issued for the
purchaseof Clark
Laboratories - - - - 2,380,455 3,385,007
Class 'A' shares
issued for the
purchase of
financial asset - - - - 255,538 363,375
Class 'A' Warrants
exercised - - - - 818,620 1,164,078
Options
exercised - - - - 3,062,266 4,354,542
Goodwill arising on
acquisition of Clark - - (4,394,639) - (4,394,639) (6,249,177)
Goodwill arising on
acquisition of Centocor - - (4,217,609) - (4,217,609) (5,997,440)
Share issue expenses - - - - (321,113) (456,623)
Currency adjustment - 94,518 - - 94,518 134,405
Profit and loss account 849,697 - - - 849,697 1,208,711
Balance as
at December 31, 1997 (4,175,181) (44,392) (15,665,201) - 4,996,280 7,104,711
</TABLE>
See Notes to Consolidated Financial Statements
26
<PAGE> 28
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED DECEMBER 31, 1997
<TABLE>
<CAPTION>
31 December 31 December 31 December 31 December
1995 1996 1997 1997
Notes IRL. IRL. IRL. US$
<S> <C> <C> <C> <C> <C>
Net cash outflow from operating activities 18 (498,548) (2,122,964) (989,779) (1,407,466)
________ __________ __________ __________
Returns on investments and servicing of finance
Interest received 83,001 226,488 102,124 145,221
Interest paid (15,741) (10,580) (123,296) (175,327)
_________ __________ __________ __________
Net cash inflow and returns on investments
and servicing of finance 67,260 215,908 (21,172) (30,106)
_________ __________ _________ __________
Capital expenditure and financial investment
Purchase of tangible fixed assets (87,612) (275,179) (2,450,386) (3,484,449)
Purchase of intangible fixed assets (237) (7,068) (212,777) (302,569)
Purchase of financial fixed assets - (1,182,532) (419,173) (596,064)
Purchase of goodwill for product line
net of deferred consideration - (43,192) (75,758) (107,728)
Loan to unconnected party - (262,121) 135,422 192,570
_________ __________ __________ __________
Net cash inflow (outflow) from investing activities (87,849) (1,770,092) (3,022,672) (4,298,240)
_________ __________ __________ __________
Acquisitions
Acquisition of subsidiary undertaking - - (3,216,318) (4,573,604)
_________ __________ __________ __________
Cash outflow before use of liquid resources
And financing (519,137) (3,677,148) (7,249,941) (10,309,416)
_________ __________ ___________ ___________
Management of liquid resources 805,632 (20,436) 37,713 53,628
Financing
Loan from unconnected third party - - 131,782 187,394
Sale of treasury shares - 1,158,684 - -
Issue of shares 4,680,638 1,069,281 3,015,585 4,288,162
Expenses paid in respect of share issues (427,027) (50,977) (321,113) (456,623)
Capital element of finance lease payments (22,451) (8,741) (10,977) (15,609)
Increase (decrease) in long term debt (53,841) (28,238) 1,416,393 2,014,111
Issue of 4% convertible debenture - - 2,020,638 2,873,347
_________ __________ __________ __________
Net cash inflow from financing 4,177,319 2,140,009 6,252,308 8,890,782
_________ __________ __________ __________
(Decrease) increase in cash 4,463,814 (1,557,575) (959,920) (1,365,006)
_________ __________ __________ __________
Reconciliation of net cash flow to movement in net funds
(Decrease) increase in cash 4,463,814 (1,557,575) (959,920) (1,365,006)
Decrease (increase) increase in long term debt 53,841 28,238 (1,416,393) (2,014,111)
(Decrease) increase in liquid resources (805,632) 20,436 (37,713) (53,628)
Capital element of finance leases repaid 22,451 8,741 10,977 15,609
_________ __________ __________ __________
Change in net funds resulting from cash flows 3,734,474 (1,500,160) (2,403,049) (3,417,136)
_________ __________ ___________ ___________
New finance leases - - (53,830) (76,546)
Loans acquired with subsidiary undertakings - - (1,136,497) (1,616,099)
Other non cash movements 742,391 344,185 688,763 979,421
Translation difference (16,562) (198,000) (128,143) (182,219)
_________ __________ ___________ ___________
Movement in net funds in the year 4,460,303 (1,353,975) (3,032,756) (4,312,579)
Funds at January 1 201,110 4,661,413 3,307,438 4,703,177
_________ __________ ___________ ___________
Net funds at December 31 4,661,413 3,307,438 274,682 390,598
_________ __________ ___________ ___________
</TABLE>
Comparative amounts have been restated to reflect the requirements of FRS1
revised.
27
<PAGE> 29
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997
1. ACCOUNTING POLICIES
The financial statements have been prepared in Irish Pounds under the
historical cost convention and are in accordance with generally accepted
accounting principles in Ireland. The principal accounting policies
adopted by the Group are as follows:
(a) Basis of Consolidation
The consolidated financial statements include the financial statements
of the Company and its subsidiary undertakings 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
Goodwill arising on consolidation (representing the excess of the fair
value of consideration for an acquisition over the fair value of the
separable net assets acquired) is charged against reserves on
acquisition.
(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:
<TABLE>
<S> <C> <C> <C>
Leasehold improvements 5 - 10 years Computer equipment 5 years
Office equipment and fittings 10 years Plant and equipment 5 - 10 years
Buildings 50 years
</TABLE>
(d) Intangible Assets
Patents, licences and purchased intangibles are stated at cost and are
amortised over the lesser of their expected useful lives or their
statutory lives which range between 3 and 20 years.
Research and development expenditure is written off as incurred.
(e) Inventories
Inventories are stated at the lower of cost and net realisable value on
a first-in first-out basis. Cost includes all expenditure which has
been incurred in bringing the products to their present location and
condition, and includes an appropriate allocation of manufacturing
overhead based on the normal level of activity. Net realisable value
is the estimated selling price of inventory on hand less all further
costs to completion and costs expected to be incurred in marketing,
distribution and selling.
(f) Investments
The company adopted Statement of Financial Accounting Standard (SFAS)
No. 115 "Accounting for Certain Investments in Debt and Equity
Securities" at December 31, 1996. The company has classified long and
short term marketable investment securities and certain investments as
either held to maturity, trading or available for sale in accordance
with the terms of SFAS No. 115. Realised gains and losses are
determined using specific identification. Debt securities which the
company has the positive intent and ability to hold to maturity are
classified as held to maturity securities and reported at amortised
cost.
Debt and equity securities which are bought and held principally for the
purpose of selling them in the near term are classified as trading
securities and reported at fair value, with realised and unrealised
gains and losses included in income for the period.
Debt and equity securities not classified as either held to maturity or
trading securities are classified as available for sale securities and
reported at fair value, with unrealised gains or losses reported in a
separate component of shareholders' equity.
(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.
28
<PAGE> 30
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
1. ACCOUNTING POLICIES (Continued)
(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.
Depreciation is calculated in order to write off the amounts capitalised
over the estimated useful lives of the assets by equal annual
instalments.
The excess of the total rentals under a lease over the amount
capitalised is treated as interest, which is charged to the profit and
loss account in proportion to the amount outstanding under the lease.
Leases other than finance leases are "operating leases" and the rentals
thereunder are charged to the profit and loss account on a straight line
basis over the periods of the leases.
(j) Government Grants
Research and development and training grants are credited to the profit
and loss account against related expenditure in the period in which the
expenditure is incurred.
(k) Foreign Currency
The functional currency of the Company is the Irish pound.
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 profit and loss account.
The functional currency of the principal subsidiary undertakings is the
U.S. Dollar. On consolidation the assets and liabilities of overseas
subsidiary undertakings are translated into Irish Pounds using period
end exchange rates and revenues and expenses are translated at average
rates. All translation differences arising on consolidation are dealt
with in reserves.
(l) Expression of Financial Statements in US Dollars
The translation of the financial statements into US dollars is solely
for the convenience of the reader. The exchange rate used for
translation was IRL.1.00 = US$1.4221, the closing rate on December 31,
1997. No representation is made that the Irish pound amounts have been,
could have been, or could be converted into dollars at that rate or any
other rate.
(m) Advertising
Advertising expense is charged to the profit and loss account in the
period in which the expense is incurred.
(n) Use of Estimates
The preparation of financial statements in conformity with generally
accepted accounting principals requires management to make estimates and
assumptions that affect the amounts reported in the financial statements
and accompanying notes. Actual results could differ from those
estimates.
29
<PAGE> 31
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
<TABLE>
<CAPTION>
2. CURRENT INVESTMENTS 31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Listed abroad 402,591 1,018,033 1,447,643
_______ _________ _________
402,591 1,018,033 1,447,643
_______ _________ _________
</TABLE>
At December 31, 1996, the Company adopted SFAS No. 115 'Accounting for
Certain Investments in Debt and Equity Securities'. As a result current
investments have been classified as trading securities and reported at
fair value. As discussed in the accounting policy for investments on page
30, SFAS 115 requires trading investments to be marked to market with the
resulting gain/loss taken through the statement of operations. This
treatment is a departure from Irish accounting rules where current
investments are normally carried at the lower of cost and net realisable
value. Some companies, however, carry current investments at market value
in which case any unrealised gains and losses should be accounted for in a
revaluation reserve which would form part of shareholders' equity. In the
opinion of the board the adoption of SFAS 115 is necessary to present a
true and fair view so that readily marketable investments held by the
company as short term current investments would be correctly classified at
market value. The impact of adopting SFAS 115 is an increase of
IRL.541,423 (US$769,904), (1996:IRL.87,435) to current year 'other
operating income'.
<TABLE>
<CAPTION>
3. INVENTORIES 31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Raw materials 104,183 1,622,158 2,306,709
Work in progress 97,470 421,962 600,029
Finished goods 108,701 531,855 756,298
_______ _______ _______
310,354 2,575,975 3,663,036
_______ _______ _______
</TABLE>
The replacement cost of inventory is not materially different from that
stated.
4. ACCOUNTS RECEIVABLE AND PREPAYMENTS
<TABLE>
<CAPTION>
(Amounts falling due within one year) 31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Debtors 735,992 2,886,203 4,104,181
Prepayments 360,415 776,972 1,104,854
Value Added Tax 41,038 142,101 202,068
Called up share capital not paid 65,234 517,624 736,061
Loan to unconnected party 262,121 126,699 180,166
Grants receivable 317,500 129,043 183,499
Amounts due from escrow arrangement 311,625 877,501 1,247,806
Other debtors - 98,834 140,542
_________ _________ _________
2,093,925 5,554,977 7,899,177
_________ _________ _________
</TABLE>
30
<PAGE> 32
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
<TABLE>
<CAPTION>
31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
5. INTANGIBLE ASSETS
<S> <C> <C> <C> <C>
Cost
Patents and Licenses 323,870 618,119 878,965
_______ _______ _______
323,870 618,119 878,965
Less Accumulated Amortisation (299,225) (354,288) (503,797)
_______ _______ _______
24,645 263,831 375,168
_______ _______ _______
</TABLE>
<TABLE>
<CAPTION>
6. PROPERTY PLANT AND EQUIPMENT 31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Cost
Land & Buildings - 2,496,230 3,549,639
Leasehold Improvements 235,024 235,838 335,362
Computer & Office Equipment 115,683 369,435 525,337
Plant and Equipment 993,414 2,772,852 3,942,995
_______ _______ _______
1,344,121 5,874,355 8,353,333
Less Accumulated Depreciation (593,219) (1,795,474) (2,553,164)
_______ _______ _______
750,902 4,078,881 5,800,169
_______ _______ _______
</TABLE>
Certain of the company's assets were acquired under finance lease
arrangements. The balance outstanding on these leases at December 31,
1997 was IRL.42,853. The depreciation charge in respect of these assets
is included in the overall depreciation charge for the year.
Mortgages amounting to IRL.1,452,848 (US$2,065,950) are secured by a
charge over the Company's new plant in Bray, Ireland and a charge over the
Company's existing plant in Jamestown, New York.
7. FINANCIAL ASSETS
<TABLE>
<CAPTION>
31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Investment in Selfcare Inc. (at cost) 1,565,228 1,391,403 1,978,575
Unlisted investment in CLI Oncology - 428,046 608,682
________ ________ ________
1,565,228 1,819,449 2,587,257
________ ________ ________
</TABLE>
In 1996, Trinity acquired 778,622 of the shares of Common Stock of Selfcare,
Inc. ("Selfcare"), in a series of purchase transactions involving subsidiaries
of Trinity, from Enviromed plc in August and November 1996. Title to these
shares was being disputed by Selfcare Inc. however as of March 6, 1998, Trinity
entered into an agreement with Selfcare whereby the parties agreed that Trinity
shall have title to 80% of the shares of Selfcare stock in dispute, amounting
to 622,898 shares of Selfcare Common Stock. The lawsuit has been dismissed
with prejudice. Of the total, 120,000 shares are classified under current
investments whilst the remaining 502,898 are classified under financial assets.
The market value of the Selfcare listed investment on the basis of overseas
stock exchange quotation was IRL.4,367,001 (US$6,209,875).
The percentage of the Common Stock of Selfcare Inc current held by Trinity is
6%.
31
<PAGE> 33
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
8. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
<TABLE>
<CAPTION>
(Amounts falling due within one year) 31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Trade creditors 908,787 2,628,715 3,738,032
Income tax deducted under PAYE 7,462 21,471 30,532
Employee related social insurance 4,017 18,421 26,195
Accrued liabilities 276,433 1,789,924 2,545,273
Provision for litigation 149,700 - -
Obligations under finance leases - 14,612 20,778
Long term debt - current portion - 157,520 223,993
Deferred consideration - current portion 412,440 692,533 984,782
Deferred income - 842,401 1,197,894
________ ________ ________
1,758,839 6,165,597 8,767,479
________ ________ ________
</TABLE>
Included in the line "Deferred Consideration - current portion" at
December 31, 1997 is an amount of IRL.Nil (1996: IRL.382,696) was due in
respect of the purchase of the shares in Selfcare Inc.
In December 1996, the company purchased a product line from another
diagnostic company. Under the terms of the purchase agreement $125,000 of
the total consideration of $250,000 is being paid by a two year loan note
with an interest rate of 8%. Repayments under the loan note are made on a
monthly basis. All of the balance due of IRL.41,990 is due within one
year from the balance sheet date and is included in the line "Deferred
Consideration - current portion".
In June 1997, the Company purchased the entire share capital of Centocor
UK Holdings Ltd ("Centocor"). Under the terms of the purchase agreement
IRL.2,076,173 of the total consideration of IRL.4,129,403 is being paid by
a three year loan note with an interest rate of 7.5%. Repayments under
the loan will be made in three equal annual instalments commencing on
December 31, 1998. Included in the line "Deferred Consideration - current
portion" is an amount of IRL.650,543, which is deferred consideration
arising on the acquisiton of Centocor. The remaining balance of
IRL.1,425,630 has been classified under long term liabilities.
<TABLE>
<CAPTION>
9. LONG TERM LIABILITIES 31 December 31 December 31 December
(Amounts falling due after more than one year) 1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
4% convertible debenture - 2,020,638 2,873,347
Bank loans - 2,531,200 3,599,365
Loan from unconnected party - 131,782 187,394
Lease creditors - 28,241 40,159
Deferred consideration (see note 9) 45,106 1,425,630 2,027,246
______ ______ _______
45,106 6,137,491 8,727,511
______ ______ _______
</TABLE>
In connection with the acquisition of Centocor UK Holdings Ltd. On June
25, 1997, the Company completed a private placement of US$3,000,000
principal amount of convertible debentures. The Debentures bear interest
at the rate of 4% per annum, payable quarterly, and mature on December 24,
1999. The Debentures are convertible into 'A' Ordinary Shares of the
Company at a price equal to the lower of (i) the average closing bid price
of the Company's ADRs on the five trading days prior to conversion,
subject to a discount which ranges from 10% for conversions made within
the first 120 days after issuance to 22.5% for conversions made on or
after 181 days after issuance, or (ii) $3.78. Under Irish GAAP the
conversion of the debentures will be accounted for under FRS 4 "Capital
Instruments". When the debentures are converted, the amount recognised in
shareholders' funds in respect of the shares issued should be the amount
at which the liability for the debt is stated as at the date of
conversion. No gain or loss should be recognised on conversion.
32
<PAGE> 34
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
10. CALLED UP SHARE CAPITAL
(a) Class 'B' Ordinary Shares initially have two votes per share and have
rights to participate in dividends and in any liquidation or sale of
Trinity Biotech plc as if each Class 'B' Ordinary Share were two Class
'A' Ordinary Shares.
(b) In October 1994, the Company completed the acquisition of DDI which
involved an exchange of shares in which holders of DDI Common Stock
received American Depository Receipts representing one Class 'A'
Ordinary Share of Trinity for each share of DDI Common Stock. Holders
of DDI Series B Preferred Stock received American Depository Receipts
representing 2.78 Class 'A' Ordinary Shares of Trinity for each share of
DDI Series B Preferred Stock. Holders of DDI 10% Exchangeable
Convertible Preferred Stock received American Depository Receipts
representing 2.33 Class 'A' Ordinary Shares of Trinity for each share of
DDI 10% Preferred Stock. A total of 2,596,888 Trinity shares have been
issued to the DDI shareholders as at December 31, 1997, December 31,
1996 - 2,593,167. A further 72,892 will be issued upon the
presentation of DDI share certificates for exchange into Trinity shares.
(c) In June, 1995, the Company completed the first part of a private
placement, issuing 2,038,000 'A' Ordinary Shares for cash. In October
and December, 1995, the Company completed subsequent parts of the
private placement, issuing 1,669,284 and 577,429 'A' Ordinary Shares for
cash respectively.
(d) In February 1997, the Company completed the acquisition of Clark
Laboratories Inc. ("Clark") which involved an exchange of shares in
which holders of Clark Common Stock received 'A' Ordinary Shares
representing 334 Class 'A' Ordinary Shares for each share of Clark
Common Stock. A total of 1,427,142 Trinity Shares were issued as a
result of the acquisition. In addition as part of the acquisition,
153,202 Class 'A' Ordinary Shares were issued to purchase 85 shares in
CLI Oncology.
(e) Since its organisation Trinity has not declared or paid dividends on
its 'A' Ordinary Shares. Trinity anticipates, for the foreseeable
future, that it will retain any future earnings in order to fund the
business operations of the Company. The Company does not, therefore,
anticipate paying any cash or share dividends on its 'A' Ordinary Shares
in the foreseeable future.
Any cash dividends or other distributions, if made, are expected to be
made in Irish pounds, although the Articles of Association provide that
dividends may be declared and paid in U.S. Dollars.
11. SHARE OPTIONS AND WARRANTS
Under the terms of Trinity's Founder Plan and Employee Share Option Plan
options to purchase 3,127,208 Class 'A' Ordinary Shares were outstanding
at December 31, 1997. Under the plans, options over a further 8,372,792
Class 'A' Ordinary Shares are available for grant. Under the plans
options are granted to officers, employees and consultants of the
Company at the discretion of the compensation committee of the Board of
Directors. In addition the Company granted warrants over 481,704 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 issue in 1997. A further warrant over 100,000 Class 'A'
Ordinary Shares was granted to agents of the Company. At December 31,
1997 234,549 warrants were still outstanding.
The Company has Class 'A' and Class 'B' Warrants, which were issued as
part of its Initial Public Offering in 1992. On October 21, 1997 the
Company's Class 'A' Warrants expired. This resulted in the cancellation
of 805,849 unexercised Warrants. At December 31, 1996 1,201,914 Class
'A' Share Warrants were outstanding. At December 31, 1997 Share
Warrants are outstanding on 1,279,151Class 'B' Warrants, December 31,
1996 - 883,086, that the company issued in connection with its initial
public offering in October 1992.
During the year 396,065 Class 'A' Warrants were exercised resulting in
the issue of 396,065 Class 'A' Ordinary Shares and 396,065 Class 'B'
Warrants.
33
<PAGE> 35
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
11. SHARE OPTIONS AND WARRANTS (Continued)
In 1995 the terms of the warrants were amended as follows: Each Class
'A' Warrant entitled the holder, until the date which is five years
after the Effective Date (October 21, 1992), to purchase from the
Depository, for a price of $3.00, one ADS representing one Class 'A'
Ordinary Share and one Class 'B' Warrant. Each Class 'B' Warrant
entitles the holder beginning on the Effective Date until the date which
is six years after the Effective Date to purchase one ADS representing
one Class 'A' Ordinary Share of the Company at an exercise price of
$4.00. The Warrants are redeemable during the exercise period upon
notice from the Company, at a price of $.10 per Warrant during the
exercise period, upon 30 days written notice, provided that the average
closing bid price of the ADSs equalled or exceeded $6.50 in the case of
the Class 'A' Warrants or exceeds $9.00 in the case of the Class 'B'
Warrants for 30 consecutive trading days.
As of December 31, 1997 1,282,722 Options were exercisable. The share
options and warrants outstanding at December 31, 1997 were as follows:
<TABLE>
<CAPTION>
Options & Warrants 'A' Warrants 'B' Warrants
Shares Range Shares Range Shares Range
Outstanding US$ US$ US$
<S> <C> <C> <C> <C> <C> <C>
January 1, 1995 3,004,753 1.00-3.75 1,390,000 3.00 695,000 4.00
Granted 2,456,702 0.50-2.00 - - - -
Exercised (882,000) 0.50-2.25 - - - -
Cancelled (842,284) 0.90-3.63 - - - -
________ ________ ________ ____ ________ ____
December 31, 1995 3,737,171 0.50-3.75 1,390,000 3.00 695,000 4.00
Granted 1,743,700 0.50-5.00 - - 188,086 4.00
Exercised (794,946) 0.50-3.38 (188,086) 3.00 - -
Cancelled (168,000) 0.90-4.56 - - - -
________ ________ ________ ____ ________ ____
December 31, 1996 4,517,925 0.50-5.00 1,201,914 3.00 883,086 4.00
Granted 3,284,797 0.50-2.10 - - 396,065 4.00
Exercised (4,440,965) 0.50-2.10 (396,065) 3.00 - -
Cancelled - -- (805,849) 3.00 - -
________ ________ ________ ____ ________ ____
December 31, 1997 3,361,757 0.50-5.00 - - 1,279,151 4.00
________ ________ ________ ____ ________ ____
</TABLE>
12. ANALYSIS OF REVENUE, OPERATING INCOME, MAJOR CUSTOMERS AND ASSETS
b) The distribution of revenue by geographical area was as follows:
<TABLE>
<CAPTION>
31 December 31 December 31 December 31 December
1995 1996 1997 1997
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Ireland 616,311 661,005 2,050,055 2,915,178
United States 5,575,191 3,566,192 8,584,811 12,207,601
United Kingdom - - 1,201,567 1,708,629
________ ________ ________ ________
Total operating income (loss) 6,191,502 4,227,197 11,836,433 16,831,408
________ ________ ________ ________
</TABLE>
34
<PAGE> 36
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
12. ANALYSIS OF REVENUE, OPERATING INCOME, MAJOR CUSTOMERS AND ASSETS
(Continued)
b) The distribution of revenue by customers' geographical area was as
follows:
<TABLE>
<CAPTION>
31 December 31 December 31 December 31 December
1995 1996 1997 1997
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
U.S.A. 5,575,191 3,566,194 8,510,754 12,102,292
Central and South America 351,124 152,784 514,042 730,968
Asia 154,114 240,980 1,046,096 1,487,548
Europe 85,310 133,218 1,291,830 1,836,983
Africa 25,763 108,591 405,834 577,096
Ireland - 25,430 67,877 96,521
________ ________ ________ ________
6,191,502 4,227,197 11,836,433 16,831,408
________ ________ ________ ________
</TABLE>
c) The distribution of operating income (loss) by geographical area
was as follows:
<TABLE>
<CAPTION>
31 December 31 December 31 December 31 December
1995 1996 1997 1997
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Ireland (1,124,499) (1,071,338) (1,491,643) (2,121,115)
United States 538,110 387,226 1,810,921 2,575,130
United Kingdom - - 551,591 784,362
________ ________ ________ ________
Total operating income (loss) (586,389) (684,112) 870,869 1,238,375
________ ________ ________ ________
</TABLE>
d) The distribution of consolidated total assets by geographical area
was as follows:
<TABLE>
<CAPTION>
31 December 31 December 31 December 31 December
1995 1996 1997 1997
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Ireland 4,952,874 5,153,519 9,599,911 13,651,074
United States 779,546 2,898,974 6,201,904 8,819,107
United Kingdom - - 1,497,553 2,129,520
_________ _________ __________ __________
Total assets 5,732,420 8,052,493 17,299,368 24,599,701
_________ _________ __________ __________
</TABLE>
e) Trinity operates in one business segment, the market for rapid
diagnostic tests for infectious diseases and other medical conditions
(pregnancy).
In the year ended December 31, 1997 37% (December 31, 1996 73%, December
31, 1995 85%) of the Company's revenue was from a major pharmaceutical
company and the balance was from the sale of the groups diagnostic kits
to various local and national distributors.
13. PROFIT (LOSS) ON ORDINARY ACTIVITIES
BEFORE TAXATION
<TABLE>
<CAPTION>
31 December 31 December 31 December 31 December
1995 1996 1997 1997
Directors' emoluments IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Fees - - - -
Remuneration 450,742 369,127 453,340 644,649
Auditors' remuneration 25,000 25,000 40,000 56,880
Depreciation 96,968 101,323 308,440 438,602
Amortisation 58,063 7,937 5,790 8,233
Operating lease rentals in respect of premises 92,406 94,500 167,690 238,455
Research and development grants - (317,500) (187,500) (266,625)
_______ _________ _________ _________
723,179 280,387 787,760 1,120,191
======= ========= ========= =========
</TABLE>
35
<PAGE> 37
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
<TABLE>
<CAPTION>
14. EXCEPTIONAL ITEMS
31 December 31 December 31 December 31 December
1995 1996 1997 1997
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Administrative expenses
Licence fee payable (179,222) - - -
Provision for litigation - (208,800) - -
Exchange gain (loss) - (230,272) 67,892 96,542
_______ _______ _______ _______
(179,222) (439,072) 67,892 96,542
_______ _______ _______ _______
Other operating income
Gain on investments 528,042 344,185 541,523 769,904
_______ _______ _______ _______
</TABLE>
Due to adverse movements in the exchange rate between the IRL. and the US$
at December 31, 1996, the Company incurred a significant unrealised
exchange loss on the translation of US$ into IRL. for reporting purposes.
In accordance with FRS 3 the exchange loss was disclosed as an exceptional
item. In the current year there was a favourable movement in the exchange
rate between the IRL. and the US$ and to be consistent this exchange gain
has been disclosed as an exceptional item.
At December 31, 1996, the Company made a provision to cover pending
litigation at that time. In accordance with FRS 3 the charge for
litigation and related costs was disclosed as an exceptional item.
Included in "Other operating income - Gain on investments" is an amount of
IRL.539,358 (US$766,967) which is an unrealised gain in investments
resulting from the application of SFAS 115 in the year ended December 31,
1997, December 31, 1996 - IRL.87,435.
15. INCOME TAXES
(a) There was no income tax charge due to losses incurred.
(b) The distribution of profits (losses) before taxes by geographical area
was as follows:
<TABLE>
<CAPTION>
31 December 31 December 31 December 31 December
1995 1996 1997 1997
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Ireland (1,082,175) (968,287) (1,457,737) (2,072,902)
United States 563,046 500,084 1,785,148 2,538,480
United Kingdom - - 522,286 742,691
________ ________ _______ _________
Total profits (losses) before taxation (519,129) (468,204) 849,697 1,208,269
________ ________ _______ _________
</TABLE>
(c) The tax effects of temporary differences that give rise to significant
portions of deferred tax assets relate principally to net operating losses
in the amount of IRL.1,782,370 (December 31, 1996 IRL.4,502,150). There
are no significant deferred tax liabilities as of December 31, 1997. The
valuation allowance for deferred tax liabilities at December 31, 1997 was
IRL.1,782,370 (December 31, 1996 IRL.4,502,150).
At December 31, 1997, the Company had Irish net operating losses of
IRL.7,401,000. The utilisation of these net operating loss carryforwards
is limited to the future operations of the Company in the tax jurisdiction
in which they arose. These losses carry forward indefinitely.
At December 31, 1997, the Company had U.S. net operating loss
carryforwards of approximately $10million for U.S. federal income tax
purposes, which will expire in 2008 if not previously utilised.
Utilisation of the U.S. net operating loss carryforward may be subject to
an annual limitation due to the change in ownership rules provided by the
Internal Revenue Code of 1986. This limitation and other restrictions
provided by the Internal Revenue Code of 1986 may reduce the net operating
loss carryforward such that it would not be available to offset future
taxable income of the U.S. subsidiaries.
36
<PAGE> 38
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
16. NET PROFIT (LOSS) PER SHARE
(a) Basic earnings per share
Net profit (loss) per share is computed by dividing the profit (loss) on
ordinary activities after taxation of IRL.849,697 (US$1,208,269), December
31, 1996 loss IRL.468,204 and December 31, 1995 loss IRL.519,129, for the
financial period by the weighted average number of ordinary shares in issue
of 19,108,363, December 31, 1996 - 16,119,559 and December 31, 1995 -
11,135,753.
(b) Diluted earnings per share
Diluted earnings per share is computed by dividing the adjusted profit on
ordinary activities after taxation of IRL.1,088,664 (US$1,548,080) by the
fully diluted weighted average number of ordinary shares in issue of
24,405,603.
The diluted earnings per share presented for prior years is the same as the
basic earnings per share for those periods as outstanding options and
warrants have not been included as they would be anti-dilutive.
17. SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
<TABLE>
<CAPTION>
31 December 31 December 31 December 31 December
1995 1996 1997 1997
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
(a) Cash paid for:
Interest - - - -
Income taxes _ _ _ _
______ ______ _________ _________
- - - -
______ ______ _________ _________
(b) Purchase of tangible fixed assets
Additions to tangible fixed assets 87,612 275,179 2,504,216 3,560,995
Less new finance leases - - (53,830) (76,546)
_______ _______ _________ _________
87,612 275,179 450,386 3,484,449
_______ _______ _________ _________
</TABLE>
(c) Management of liquid resources
Cash flows from the use of liquid resources have primarily arisen from the
sale of equity investments.
<TABLE>
<CAPTION>
18. RECONCILIATION OF OPERATING 31 December 31 December 31 December 31 December
PROFIT (LOSS) TO NET CASH OUTFLOW 1995 1996 1997 1997
FROM OPERATING ACTIVITIES IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Operating profit (loss) (586,389) (684,112) 870,869 1,238,375
Depreciation and amortisation 155,031 109,260 314,230 446,835
Unrealised exchange loss - 198,000 - -
Loss on disposal of tangible fixed assets 42,431 - - -
Provision for legal costs - 149,700 - -
Profit on investments (528,042) (344,185) (435,563) (619,371)
Licence fee payable 179,222 - - -
(Increase) decrease in debtors and prepayments 263,696 (1,540,602) (1,402,711) (1,994,655)
Increase (decrease) in creditors (32,284) 188,315 (19,830) (28,198)
(Increase) decrease in inventory (839) (142,104) (317,597) (451,623)
Translation adjustments 8,626 (57,236) 823 1,171
________ __________ ________ __________
Net cash outflow from operating activities (498,548) (2,122,964) (989,779) (1,407,466)
________ __________ ________ __________
</TABLE>
37
<PAGE> 39
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
19. ANALYSIS OF NET FUNDS
<TABLE>
<CAPTION>
31 December Cashflow Acquisitions Non-cash Exchange 31 December 31 December
1996 changes movements 1997 1997
IRL. IRL. IRL. IRL. IRL. IRL. US$
<S> <C> <C> <C> <C> <C> <C> <C>
Cash
2,904,847 (959,920) - - 43,295 1,988,222 2,827,251
Liquid resources 402,491 (37,713) - 688,763 (35,608) 1,018,033 1,447,643
Long term debt
- current portion - (157,520) - - - (157,520) (223,993)
Long term debt - (1,258,873) (1,136,497) - (135,830) (2,531,200) (3,599,365)
Finance leases - 10,977 - (53,830) - (42,853) (60,937)
_________ __________ __________ _______ ________ __________ __________
Net funds 3,307,438 (2,403,049) (1,136,497) 634,933 (128,143) 272,682 390,599
_________ __________ __________ _______ ________ __________ __________
</TABLE>
<TABLE>
<CAPTION>
31 December Cashflow Acquisitions Non-cash Exchange 31 December 31 December
1995 changes movements 1996 1996
IRL. IRL. IRL. IRL. IRL. IRL. US$
<S> <C> <C> <C> <C> <C> <C> <C>
Cash 4,660,422 (1,557,575) - - (198,000) 2,904,847 4,130,692
Liquid resources 37,970 20,436 - 344,185 - 402,491 572,484
Long term debt
- current portion (28,238) 28,238 - - - - -
Long term debt - - - - - - -
Finance leases (8,741) 8,741 - - - - -
_________ __________ _______ _______ ________ _________ _________
Net funds 4,661,413 (1,500,160) - 344,185 (198,000) 3,307,438 4,703,176
_________ __________ _______ _______ ________ _________ _________
</TABLE>
<TABLE>
<CAPTION>
31 December Cashflow Acquisitions Non-cash Exchange 31 December 31 December
1994 changes movements 1995 1995
IRL. IRL. IRL. IRL. IRL. IRL. US$
<S> <C> <C> <C> <C> <C> <C> <C>
Cash 197,313 4,463,814 - - (705) 4,660,422 6,627,120
Liquid resources 117,068 (805,632) - 742,391 (15,857) 37,970 53,993
Long term debt
- current portion (54,407) 53,841 - (27,672) - (28,238) (40,154)
Long term debt (27,672) - - 27,672 - - -
Finance leases (31,192) 22,451 - - - (8,741) (12,430)
_______ _________ _______ _______ _______ _________ _________
Net funds 201,110 3,734,474 - 742,391 (16,562) 4,661,413 6,628,529
_______ _________ _______ _______ _______ _________ _________
</TABLE>
38
<PAGE> 40
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
19. ACQUISITION OF SUBSIDIARY UNDERTAKINGS
On 1 January 1997 the Company acquired the entire issued share capital
of Clark Laboratories, Inc. for a total consideration of IRL.5,312,951
(US$7,550,016). The consideration was satisfied by cash and the issue
of shares by the Company to the common stock holders of Clark
Laboratories, Inc. Acquisition expenses amounted to IRL.76,039
(US$108,127). On 1 July 1997 the Company acquired the entire issued
share capital of Centocor UK Holdings Limited for a total
consideration of IRL.4,129,403 (US$5,872,011). The consideration was
satisfied by cash and deferred consideration. Acquisition expenses
amounted to IRL.76,212 (US$108,373)
<TABLE>
<CAPTION>
Clark Centocor Total Total
Laboratories UK Holdings
Inc Ltd
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Investments 130,380 - 130,380 185,400
Tangible fixed assets 791,226 251,428 1,042,654 1,482,654
Intangible assets - 31,464 31,464 44,742
Stocks 1,064,578 771,004 1,835,582 2,610,197
Debtors 678,864 937,676 1,616,540 2,298,720
Creditors (1,746,736) (2,079,778) (3,826,514) (5,441,303)
__________ ____________ __________ ___________
Net assets (liabilities) 918,312 (88,206) 830,106 1,180,410
Goodwill 4,394,639 4,217,609 8,612,248 12,246,617
__________ ____________ __________ ___________
Consideration 5,312,951 4,129,403 9,442,354 13,427,027
__________ ____________ __________ ___________
SATISFIED BY:
Cash payment including costs 1,200,835 2,054,354 3,255,189 4,628,879
Cash acquired (37,747) (1,124) (38,871) (55,275)
__________ ____________ __________ ___________
Net cash outflow 1,163,088 2,053,230 3,216,318 4,573,604
Loans acquired 1,136,497 - 1,136,497 1,616,099
Shares issued 2,380,455 - 2,380,455 3,385,007
Option consideration 632,911 - 632,911 899,999
Deferred considerations - 2,076,173 2,076,173 2,952,318
__________ ____________ __________ ___________
Consideration 5,312,951 4,129,403 9,442,354 13,427,027
__________ ____________ __________ ___________
</TABLE>
The subsidiary undertakings acquired during the year contributed
IRL.374,491 (US$532,526) to the Companies net operating cash flows, paid
IRL.111,193 (US$158,116) in respect of returns on investments and
servicing of finance, utilised IRL.451,560 (US$642,118) for capital
expenditure and financial investment, and had inflows of IRL.179,117
(US$254,704) from increases in long term debt.
Goodwill written off during the year in respect of acquisitions of
subsidiary undertakings amounted to IRL.8,612,248 (US$12,246,617) and
comprises:
<TABLE>
<CAPTION>
Book Revaluations Accounting Other Other Fair Consideration Goodwill Goodwill
Values Policy Adjust. Adjust. Values
<S> <C> <C> <C> <C> <C> <C> <C> <C> <C>
CLARK LABORATORIES INC IRL. IRL. IRL. IRL. IRL. IRL. IRL. IRL. US$
Tangible fixed assets 874,666 (83,440)A - - - 791,226
Intangible fixed assets 553,880 (553,880)B - - - -
Investments 130,380 - - - - 130,380
Working capital 1,098,888 - (854,700)C (247,482)G - (3,294)
_________ _________ _________ _________ _______ _______ __________ __________ __________
2,657,814 (637,320) (854,700) (247,482) - 918,312 (5,312,951) (4,394,639) (6,249,177)
_________ _________ _________ _________ _______ _______ __________ __________ __________
</TABLE>
39
<PAGE> 41
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
20. ACQUISITION OF SUBSIDIARY UNDERTAKINGS
<TABLE>
<CAPTION>
Book Revaluations Accounting Other Other Fair Consideration Goodwill Goodwill
Values Policy Adjust. Adjust. Values
Alignment IRL. IRL. IRL. US$
IRL. IRL. IRL. IRL. IRL. <C> <C> <C> <C>
<S> <C> <C> <C> <C> <C>
CENTOCOR UK HOLDINGS
LIMITED
Tangible fixed assets 1,014,693 (763,265)D - - - 251,428
Intangible fixed assets 110,456 - - (78,992)B - 31,464
Working capital 1,621,458 - (781,938)E (71,951)F (1,138,667)G (371,098)
_________ __________ __________ ________ _________ ________ __________ __________ ___________
2,746,607 (763,265) (781,938) (150,943) (1,138,667) (88,206) (4,129,403) (4,217,609) (5,997,440)
_________ __________ __________ ________ __________ _______ __________ __________ ___________
Total 5,404,421 (1,400,585) (1,636,638) (398,425) (1,138,667) (830,106) (9,442,354) (8,612,248) (12,246,617)
_________ __________ __________ ________ __________ ________ __________ __________ ___________
</TABLE>
The book value of the assets and liabilities shown above have been taken
from the management accounts of the acquired businesses at the dates of
acquisition.
The fair value adjustments above principally arise for the following
reasons:
A. Revaluation representing the restatement of freehold property
acquired to estimated market value.
B. Write down of capitalised intangibles following assessment of
their realisable value.
C. Write down of stock following an assessment of the realisable
value of finished goods, work in progress and raw materials and
reflection of group policy in respect of recognition of sales income.
D. Write down of fixed assets following a physical verification
exercise and assessment of the realisable value of certain assets.
E. Write down of stock following an assessment of the realisable
value of finished goods, work in progress and raw materials.
F. Write down of debtors following an assessment of the estimated
recoverable value.
G. Recognition of unprovided amounts in respect of onerous
contracts and other liabilities.
19. PRE-ACQUISITION PROFIT AND LOSS DETAILS PERTAINING TO CERTAIN
ACQUISITIONS (Unaudited)
The unaudited US$ and StgL. profit and loss details have been translated
at the year end 1997 at the US Dollar and sterling rates of US$1.4245 to
IRL.1 and StgL.0.89 to IRL. respectively. The financial information has
been prepared in accordance with generally accepted accounting practices
and under the accounting policies of the companies prior to acquisition.
<TABLE>
<CAPTION>
Clark Laboratories Inc. Clark Laboratories Inc.
Acquisition date 1 January 1997 1 January 1997
Previous year end 30 June 1996 30 June 1996
IRL. US$
<S> <C> <C>
Profit after taxation
I July 1996 to 31 December 1996 171,371 243,690
Year ended 30 June 1996 166,718 237,073
ADDITIONAL DISCLOSURES - PRE-ACQUISITION PERIOD
SUMMARISED PROFIT AND LOSS STATEMENTS
Turnover 1,593,949 2,266,595
_______ _______
Operating loss (59,396) (84,461)
Interest and other income 353,855 503,182
Interest payable and similar charges (59,882) (85,152)
_______ _______
Profit on ordinary activities before taxation 234,577 333,569
Taxation (63,206) (89,879)
_______ _______
Profit on ordinary activities after taxation 171,371 243,690
_______ _______
</TABLE>
40
<PAGE> 42
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
20. PRE-ACQUISITION PROFIT AND LOSS DETAILS PERTAINING TO CERTAIN
ACQUISITIONS (Unaudited) (Continued)
The profit attributable to ordinary shareholders for the pre-acquisition
period is the same as the total recognised gains and losses for that period.
<TABLE>
<CAPTION>
Centocor UK Holdings Ltd. Centocor UK Holdings Ltd.
Acquisition date 1 July 1997 1 July 1997
Previous year end 31 December 1996 31 December 1996
IRL. US$
<S> <C> <C>
Profit after taxation
1 January 1997 to 30 June 1997 164,049 233,278
Year ended 31 December 1996 (53,932) (76,691)
ADDITIONAL DISCLOSURES - PRE-ACQUISITION PERIOD
SUMMARISED PROFIT AND LOSS STATEMENTS
Turnover 2,181,264 3,101,757
_______ _______
Operating profit 159,466 226,761
Interest and other income 6,708 9,539
Interest payable and similar charges (2,125) (3,022)
_______ _______
Profit on ordinary activities before taxation 164,049 233,278
Taxation - -
_______ _______
Profit on ordinary activities after taxation 164,049 233,278
_______ _______
</TABLE>
The profit attributable to ordinary shareholders for the pre-acquisition
period is the same as the total recognised gains and losses for that
period.
22. COMMITMENTS AND CONTINGENCIES
(a) Capital Commitments
The capital commitments of the Group were as follows:
<TABLE>
<CAPTION>
31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Contracted for - 1,050,000 1,493,100
Authorised, not contracted for - 150,000 213,300
_______ _______ _______
- 1,200,000 1,706,400
_______ _______ _______
</TABLE>
(b) Operating lease commitments payable during the next twelve months
amount to IRL.281,831 (US$400,764) payable on the lease of buildings
at Dublin, Ireland which expires after more than five years and at
Guildford, United Kingdom which expires in more than five years.
Future minimum operating and finance lease commitments with
non cancellable terms in excess of one year are as follows:
<TABLE>
<CAPTION>
Operating Leases Finance Leases
IRL. US$ IRL. US$
<S> <C> <C> <C> <C>
1998 281,831 400,764 19,215 27,324
1999 281,831 400,764 23,512 33,434
2000 281,831 400,764 126 179
2001 281,831 400,764 - -
Later years 3,945,634 5,610,696 - -
--------- --------- ------- -------
5,072,958 7,213,752 42,853 60,937
________ ________ ______ ______
</TABLE>
41
<PAGE> 43
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
22. COMMITMENTS AND CONTINGENCIES (Continued)
(c) During 1995 the Company entered into a licence agreement which provided
for the back payment of royalties on sales of the Company's pregnancy
test. The agreement also provided for the payment of royalties on future
sales of certain products of the Company.
(d) A portion of sales to Warner-Lambert under the Supply Agreement, ranging
from $.26 to $.28 per test (depending on annual unit volumes) was required
to be deposited into an escrow account until the escrow account totalled
$2.5 million, exclusive of interest income, which occurred in May 1995. If
there are no claims for a period of three years, escrowed funds are to be
released at the rate of $1 million after the end of such period and
$500,000 per year thereafter, of which 50% will be paid to Trinity Biotech
Inc and 50% to ABI. If there is a claim and funds are dispersed from the
escrow account, it is to be reimbursed at a rate of $0.20 per test.
During 1997 IRL.500,000 (US$711,000), (1996 IRL.311,625, 1995 IRL.Nil) of
escrow funds have been recognised as revenue.
(e) Under agreements between group companies and Forbairt, grants amounting
to IRL.505,500 (US$718,110) are receivable which may be revoked, cancelled
or abated in certain circumstances. At December 31, 1997 the company was
in compliance with the terms of the grant.
(f) Under agreements between group companies and The Irish Trade Board, a
loan amounting to IRL.131,782 (US$187,394) is payable which may be payable
in full in certain circumstances. At December 31, 1997 the company was in
compliance with the terms of the loan.
(g) The Company has guaranteed the bank borrowings of subsidiary undertakings
up to the amount of IRL.2,688,720 (US$3,823,360).
(h) Pursuant to the provisions of Section 17, Companies (Amendment) Act,
1986, the Company has guaranteed the liabilities of certain of its
subsidiary undertakings in the Republic of Ireland for the financial year
to 31 December, 1997 and as a result such subsidiary undertakings have
been exempted from the filing provisions of Section 7, Companies
(Amendment) Act, 1986.
23. SIGNIFICANT CONCENTRATIONS AND BUSINESS RISKS
(a) The Company 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 that are considered in the
Company's investment strategy.
The carrying amount reported in the balance sheet for cash and cash
equivalents approximates its fair value.
(b) The Company maintains current investments and financial assets 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 that are
considered in the Company's investment strategy.
The carrying amount reported in the balance sheet for current
investments and financial assets approximates its fair value.
(c) Trinity's pregnancy products are supplied by one supplier. Although
there are a limited number of manufacturers of similar pregnancy products,
management believes that other suppliers could adapt to provide similar
products on comparable terms. The time required to locate and qualify
other suppliers, however, could cause a delay in supply that may be
financially disruptive to the Company.
(d) At the present time a significant proportion of Trinity's revenues are
derived from sales to a single customer. These sales are governed by a
three year supply agreement which commenced in September 1995 and has been
extended to September 2001. Management believes that significant revenues
will be earned from this customer in the future, however, if the supply
agreement were to lapse it would result in financial disruption to the
Company. For the year ended December 31, 1997 37% (1996: 73%, 1995: 85%)
of total sales were sales made to this single customer.
42
<PAGE> 44
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
24. PENSION SCHEME
The Group operates a defined contribution pension scheme for its
full-time employees. The benefits under this scheme are financed by
Group and employee contributions. Total contributions made by the Group
in the financial period and charged against income amounted to
IRL.181,704 (US$258,383), December 31, 1996 IRL.38,187 and December 31,
1995 IRL.20,100.
25. DIFFERENCES BETWEEN IRISH AND US GENERALLY ACCEPTED
ACCOUNTING PRINCIPLES
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 material adjustments are shown in the table set out below;
(1) Stock Compensation:
For the purposes of the US GAAP reconciliation the Company has adopted
APB 25 in relation to the accounting for the issue of share options to
employees. The Company does not intend to change this accounting
treatment.
In contrast to Irish GAAP, US GAAP requires that the grant of share
options exercisable at prices per share less than the fair market value
of the shares at the time of grant of the options be accounted for as
compensation expense to be recognised over the related vesting period.
(2) Goodwill:
Under Irish GAAP, goodwill may be either written off immediately on
completion of the acquisition against shareholders' equity, or
capitalised in the balance sheet and amortised through the income
statement on a systematic basis over its useful economic life. Under US
GAAP, accounting for goodwill as an offset against shareholders' equity
is not permitted; rather, goodwill must be amortised over the period of
its expected useful life, subject to a maximum write off period of 40
years, through the income statement. For the purposes of the
reconciliation a useful life of 10 years has been adopted for goodwill.
The carrying value of goodwill arising on the acquisition of subsidiaries
is reviewed on each balance sheet date on the basis of estimated future
profits. If the review indicates a shortfall in the estimated future
profits then the goodwill is written down by the amount of the shortfall.
Management believe no adjustment to the carrying value is required in
the current period.
(3) Cash Flow Statements:
The cash flow statement prepared in conformity with the Irish Financial
Reporting Standard Number 1 is set out on page 29. A cash flow
statement prepared under FAS 95 is shown below. The company considers
all highly liquid investments with a maturity of three months or less
to be cash equivalents.
(4) 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.
(5) Recognition of Escrow Income
Under Irish GAAP, the Company has recognised as revenue amounts due to
be released from an Escrow account in 1997 and 1996. Under US GAAP such
amounts are not recognisable until received. See Note 22(d).
(6) Accounting for the Impairment of Long-Lived Assets
The Company reviews its long-term assets when changes in circumstances
indicate that the carrying amount of an asset may not be recoverable.
For the purposes of this US GAAP reconciliation, in 1996, the Company
adopted FASB Statement No. 121, "Accounting for the Impairment of
Long-Lived Assets and for Long-Lived Assets to be disposed of." SFAS
121 requires impairment losses to be recorded on long-lived assets used
in operations when indicators of impairment are present and the
undiscounted cash flows estimated to be generated by those assets are
less than the assets' carrying amount. The adoption of SFAS 121 did not
affect the Company's financial position or results of operations.
(7) Statement of Recognised Gains and Losses
The Statement of Recognised Gains and Losses on page 27 is a statement
required under Irish GAAP. This statement is not required by US GAAP.
43
<PAGE> 45
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
25. DIFFERENCES BETWEEN IRISH AND US GENERALLY ACCEPTED
ACCOUNTING PRINCIPLES (Continued)
(8) Earnings per share
In 1997, the Financial Accounting Standards Board issued Statement No.
128, Earnings per Share. Statement 128 replaced the calculation of
primary and fully diluted earnings per share, basic earnings per share
excludes the dilutive effects of options, warrants and convertible
securities. Diluted earnings per share is similar to the previously
reported fully diluted earnings per share. The US GAAP earnings per share
amounts for all periods conform to Statement 128 requirements.
<TABLE>
<CAPTION>
CUMULATIVE EFFECT ON 31 December 31 December 31 December
SHAREHOLDERS' EQUITY 1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Total shareholders' equity before
Minority Interests under Irish GAAP 6,248,547 4,996,280 7,104,711
US GAAP adjustments:
Goodwill 5,357,620 12,783,762 18,178,706
Share capital not paid (65,234) (517,624) (736,061)
Adjustment for amount due from escrow account (311,625) (877,501) (1,247,806)
________ _______ _________
Shareholders' equity under US GAAP 11,229,308 16,384,917 23,299,550
________ _______ _________
</TABLE>
<TABLE>
<CAPTION>
EFFECT ON NET PROFIT (LOSS) 31 December 31 December 31 December 31 December
1995 1996 1997 1997
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Profit (loss) on ordinary activities after taxation
under Irish GAAP (519,129) (468,204) 849,697 1,208,269
US GAAP adjustments:
Goodwill amortisation (693,327) (693,491) (1,186,106) (1,686,643)
Stock compensation (252,958) (167,511) (469,765) (668,006)
Adjustment for amount due from escrow account- (311,625) (500,000) (711,000)
________ ________ ________ ________
Loss under US GAAP (1,465,414) (1,640,831) (1,306,174) (1,857,380)
________ ________ ________ ________
Basic and diluted loss per ordinary share (0.13) (0.10) (0.07) (0.10)
Weighted average number of shares 11,135,753 16,119,559 19,108,363 19,108,363
</TABLE>
44
<PAGE> 46
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
25. DIFFERENCES BETWEEN IRISH AND US GENERALLY ACCEPTED
ACCOUNTING PRINCIPLES (Continued)
<TABLE>
CONSOLIDATED STATEMENT OF CASH FLOWS 31 December 31 December 31 December 31 December
FOR THE PERIOD ENDED DECEMBER 31, 1997 1995 1996 1997 1997
IRL. IRL. IRL. US$
<S> <C> <C> <C> <C>
Operating Activities
Net profit (loss) (519,129) (468,204) 849,697 1,208,269
Adjustments to reconcile net profit (loss) to cash
provided (required) by operating activities;
Depreciation and amortisation 155,031 109,260 314,230 446,835
Loss on disposal of tangible fixed assets 42,431 - - -
Unrealised exchange loss - 198,000 - -
Provision for legal costs - 149,700 - -
Purchases of trade investments - (315,155) - -
Disposals of trade investments - 294,719 37,713 53,628
Gain on investments (528,042) (344,185) (435,563) (619,371)
Licence fee payable 179,222 - - -
(Increase) decrease in accounts receivable and prepayments 263,696 (1,540,602) (1,402,711) (1,994,655)
Increase (decrease) in accounts payable & accrued expenses (32,284) 188,315 (19,830) (28,198)
(Increase) Decrease in inventory (839) (142,104) (317,597) (451,623)
Translation adjustments 8,626 (57,236) 823 1,171
_________ __________ __________ __________
Net cash inflow (outflow) from operating activities (431,288) (1,927,492) (973,238) (1,383,944)
_________ __________ __________ __________
Investing activities
Acquisition of subsidiary undertakings - - (3,216,318) (4,573,604)
Payment for patents and deferred development costs (237) (7,068) (212,777) (302,569)
Payment for tangible fixed assets (87,612) (275,179) (2,450,386) (3,484,449)
Payment for financial fixed assets - (1,182,532) (419,173) (596,064)
Disposals of trade investments 805,632 - - -
Purchase of product line
net of deferred consideration - (43,192) (75,758) (107,728)
Loan to unconnected party - (262,121) 135,422 192,570
_________ __________ __________ __________
Net cash inflow (outflow) from investing activities 717,783 (1,770,092) (6,238,990) (8,871,844)
Financing Activities _________ __________ __________ __________
Sale of treasury shares - 1,158,684 - -
Issue of ordinary share capital including premium 4,680,638 1,069,281 3,015,585 4,288,162
Expenses paid in connection with share issue (427,027) (50,977) (321,113) (456,623)
Repayment of long term debt (53,841) (28,238) (947,182) (1,346,893)
Increase in long term debt - - 2,363,575 3,361,004
Capital element of finance lease payments (22,451) (8,741) (10,977) (15,609)
Issue of 4% convertible debenture - - 2,020,638 2,873,347
Loan from unconnected third party - - 131,782 187,394
_________ _________ _________ _________
Net cash inflow from financing 4,177,319 2,140,009 6,252,308 8,890,782
_________ _________ _________ _________
Effect of exchange rate changes on cash (705) (198,000) 43,295 61,565
_________ __________ _________ __________
Increase/(decrease) in cash and cash equivalents 4,463,109 (1,755,575) (916,625) (1,303,441)
_________ __________ _________ __________
Cash and cash equivalents at beginning of year 197,313 4,660,422 2,904,847 4,130,692
Cash and cash equivalents at end of year 4,660,422 2,904,847 1,988,222 2,827,251
_________ __________ _________ __________
</TABLE>
45
<PAGE> 47
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
25. DIFFERENCES BETWEEN IRISH AND US GENERALLY ACCEPTED
ACCOUNTING PRINCIPLES (Continued)
NON CASH TRANSACTIONS
In December 1996, the Company purchased a product line from another
diagnostic company. Under the terms of the purchase agreement US$125,000
of the total consideration of US$250,000 is being paid by a two year loan
note with an interest rate of 8%. Repayments under the loan note are made
on a monthly basis. The total amount due at December 31, 1997 of
IRL.74,850 is classified under short term liabilities.
In June 1997, the Company purchased the entire share capital of Centocor
UK Holdings Limited. Under the terms of the purchase agreement
IRL.2,076,173 of the total consideration of IRL.4,129,403 is being paid by
a three year loan note with an interest rate of 7.5% (Deferred
Consideration). Repayments under the loan will be made in three equal
annual instalments commencing on December 31, 1998.
SHARE OPTION SCHEME - ADDITIONAL INFORMATION REQUIRED BY SFAS 123
The company has elected to follow Accounting Principles Board Opinion No.
25 "Accounting for Stock Issued to Employees" (APB 25) and related
Interpretations in accounting for its employee stock options because, as
discussed below, the alternative fair value accounting provided for under
FASB Statement No. 123, "Accounting for Stock-Based Compensation,"
requires use of option valuation models that were not developed for use in
valuing employee stock options. Under APB 25, where the exercise price of
the Company's employee stock options is less than the market price of the
underlying stock on the grant date, compensation expense in recognised in
the US GAAP reconciliation over the vesting period.
Pro forma 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 theses options was estimated at the
date of grant using a Black-Scholes option pricing model with the
following weighted average assumptions:
<TABLE>
<CAPTION>
1995 1996 1997
<S> <C> <C> <C>
Expected option life (years) 4.5 4.5 4.5
Risk-free weighted average interest rate 6.1% 6.9% 7.9%
Stock price volatility 0.831 0.831 0.631
Dividend yield 0% 0% 0%
</TABLE>
The Black-Scholes option valuation model was developed for use in
estimating the fair value of traded options which have no vesting
restrictions and are fully transferable. In addition, option valuation
models require the input of highly subjective assumptions including the
expected stock price volatility. Because the Company's employee stock
options have characteristics significantly different from those of traded
options, and because changes in the subjective input assumptions can
materially affect the fair value estimate, in management's opinion, the
existing models do not necessarily provide a reliable single measure of
the fair value of its employee stock options.
For purposes of pro forma disclosures, the estimated fair value of the
options is amortised to expense over the options' vesting period. The
Company's pro forma information follows:
<TABLE>
<CAPTION>
31 December 31 December 31 December
1996 1997 1997
IRL. IRL. US$
<S> <C> <C> <C>
Pro forma net profit (loss) (2,628,564) 429,998 611,458
Pro forma basic and diluted loss per share (0.14) 0.02 0.03
</TABLE>
46
<PAGE> 48
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
25. DIFFERENCES BETWEEN IRISH AND US GENERALLY ACCEPTED
ACCOUNTING PRINCIPLES (Continued)
SHARE OPTION SCHEME - ADDITIONAL INFORMATION REQUIRED BY SFAS 123 (CONTINUED)
A summary of the Company's stock option activity, and related information for
the years ended December 31 follows:
<TABLE>
<CAPTION>
1995 Weighted-Average 1996 Weighted-Average 1997 Weighted-Average
Options Exercise Price Options Exercise Price Options Exercise Price
<S> <C> <C> <C>
Outstanding-beginning of year 2,887,284 $1.06 3,305,467 $0.62 4,333,376 $1.67
Granted 2,142,467 $0.79 1,743,700 $2.94 3,234,797 $1.15
Exercised (882,000) $0.71 (547,791) $0.64 (4,440,965) $0.70
Forfeited (842,284) $2.45 (168,000) $3.24 -
Outstanding-end of year 3,305,467 $0.62 4,333,376 $1.67 3,127,208 $2.51
Exercisable at end of year 611,132 $1.05 1,033,289 $0.91 1,282,722 $2.19
Weighted average fair value
of options granted during the year 1.187 2.46 1.53
</TABLE>
The weighted average remaining contractual life of options outstanding at
December 31, 1997 is 8.1 years.
A summary of the range of prices for the Company's stock options for the
year ended December 31 1997 follows:
<TABLE>
<CAPTION>
Option price Outstanding Weight. Av. Weight. Av. Exercisable Weight. Av.
range No. of Shares exercise price contractual No. of Shares Weight. Av. contractual
life remaining exercise price life remaining
<S> <C> <C> <C> <C> <C> <C>
$0.50 - $0.75 1,095,539 $0.51 8.8 years 234,204 $0.55 8.9 years
$0.75 - $1.15 125,333 $0.90 6.9 years 107,066 $0.90 6.9 years
$1.13 - $1.69 500,000 $1.50 8 years 333,332 $1.50 8 years
$1.69 - $2.53 1,151,336 $1.94 9.2 years 493,954 $1.90 9.3 years
$2.53 - $3.80 30,000 $2.75 8.3 years 10,000 $2.75 8.3 years
$3.80 - $5.00 225,000 $4.66 8.3 years 104,166 $4.63 8.3 years
</TABLE>
INVESTMENTS
The following is a summary of trading securities:
<TABLE>
<CAPTION>
Gross Gross Estimated
Cost Unrealised Unrealised Fair
Gains Losses Value
<S> <C> <C> <C> <C>
December 31, 1997
U.S. Equity securities 409,579 544,770 35,866 918,483
Other Equity securities 148,319 - 48,769 99,550
______ ______ ______ ______
557,898 544,770 84,635 1,018,033
______ ______ ______ ______
December 31, 1996
U.S. Equity securities 153,940 79,106 10,455 222,591
Other Equity securities 161,216 18,784 - 180,000
______ ______ ______ ______
315,156 97,890 10,455 402,591
</TABLE>
The gross realised gains on sales of available-for-sale securities 1996
totalled IRL.344,185 (US$582,361).
The Company had no "available for sale" or "held to maturity securities"
as December 31, 1997 or December 31, 1996.
47
<PAGE> 49
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1996 (CONTINUED)
25. DIFFERENCES BETWEEN IRISH AND US GENERALLY ACCEPTED
ACCOUNTING PRINCIPLES (Continued)
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.
Investment securities: The values for marketable equity securities are
based on quoted market prices.
Long and short-term debt: The carrying amounts of the Companies
borrowings approximate their fair value.
The carrying amounts and fair values of the Company's financial
instruments at December 31, 1997 are as follows:
<TABLE>
<CAPTION>
Carrying Fair
Amount Value
IRL. IRL.
<S> <C> <C>
Cash and cash equivalents 1,988,222 1,988,222
Investment Securities
Marketable equities 1,018,033 1,018,033
Short term debt 692,533 692,533
Long term debt 6,137,491 6,137,491
</TABLE>
The market value of the Selfcare listed investment on the basis of
overseas stock exchange quotation was IRL.4,367,001 (US$6,209,825).
Selfcare Inc. was disputing title to these shares, however as of March 6,
1998, Trinity entered into an agreement with Selfcare and the lawsuit has
been dismissed with prejudice.
48
<PAGE> 50
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1997 (CONTINUED)
26. GROUP UNDERTAKINGS
<TABLE>
<CAPTION>
Principal Country
Name and of incorporation Group
registered office Principal activity and operation % holding
<S> <C> <C> <C>
Holding Company
Trinity Biotech plc Investment
Bray Business Park and holding
Bray company Ireland
Co. Wicklow, Ireland
Subsidiary Undertakings
Trinity Biotech Inc. Sale of pregnancy U.S.A. 100%
(Formerly Disease Detection and diagnostic tests
International Inc.)
Girts Road
Jamestown
New York, USA
Trinity Biotech (USA) Corp. Non-trading U.S.A. 100%
(Formerly Clark
Laboratories Inc.)
Girts Road
Jamestown
New York, USA
FHC Corporation Non-trading U.S.A. 100%
Girts Road
Jamestown
New York, USA
Trinity Biotech Manufacturing Limited Manufacture and sale Ireland 100%
Bray Business Park of diagnostic test kits
Bray
Co. Wicklow, Ireland
Trinity Research Limited Research and Ireland 100%
Bray Business Park development
Bray
Co. Wicklow, Ireland
Trinity Biotech Sales Limited Non - Trading Ireland 100%
Bray Business Park
Bray
Co. Wicklow, Ireland
Flambelle Limited Non-trading Ireland 100%
16 Fitzwilliam Place
Dublin, Ireland
Eastcourt Limited Non-trading UK 100%
Chichester House
278/282 High Holborn
London, UK
Trinity Biotech UK Holdings Ltd Holding Company UK 100%
(Formerly Centocor UK Holdings Ltd)
Captia House
Shalford
Guildford
Surrey, UK
Trinity Biotech UK Ltd Manufacture and UK 100%
(Formerly Centocor UK Ltd) sale of diagnostic
Captia House
Shalford
Guildford
Surrey, UK
</TABLE>
49
<PAGE> 51
SIGNATURES
Pursuant to the requirement of Section 12 of the Securities Exchange Act of
1934, the Registrant certifies that it meets all of the requirements for filing
on Form 20-F and has duly caused this annual report to be signed on its behalf
by the undersigned thereunto duly authorised.
TRINITY BIOTECH PLC
Dated: October 9, 1998 By: /s/ JONATHAN O'CONNELL
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MR. JONATHAN O'CONNELL
DIRECTOR/
CHIEF FINANCIAL OFFICER
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