424B5
Filed Pursuant to Rule 424(b)(5)
Registration No. 333-124385
PROSPECTUS SUPPLEMENT
(to Prospectus Dated May 16, 2005)
7,260,816 Class A Ordinary Shares
and
Warrants to Purchase 2,178,244 Class A Ordinary Shares
Class A Ordinary Shares Represented by American Depositary Shares
TRINITY BIOTECH PLC
We
are offering up to 1,815,204 American Depositary Shares, or ADSs, each ADS representing four
of our Class A Ordinary Shares, together with warrants to
purchase 544,561 ADSs at an exercise
price of $5.54 per ADS, which warrants have a term of five years and are exercisable beginning on
the date of issue. The negotiated price for the offering of the ADSs and the warrants is $3.92 per
unit. The ADSs and warrants comprising the units are immediately separable and will be issued
separately.
Our ADSs are listed on the Nasdaq Global Select Market and traded under the symbol TRIB.
On April 7, 2008, the last reported sale price of our ADSs on the Nasdaq Global Select Market was
$4.61 per ADS.
Investing in our securities involves risks. See Risk Factors beginning on page S-4 of this
prospectus supplement and Summary of Risks beginning on page 10 of the accompanying prospectus.
We have retained Roth Capital Partners, LLC to act as our exclusive placement agent in connection
with this offering. We have agreed to pay the placement agent the placement agent fees set forth
in the table below. The placement agent is not required to arrange for the sale of any specific
number or dollar amount of securities but will use best efforts to arrange for the sale of all of
the securities offered hereby.
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Proceeds to Trinity Biotech |
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Before Expenses and After |
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Price to |
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Placement |
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Placement |
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Investors |
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Agency Fees |
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Agency Fees |
Per unit |
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$ |
3.9200 |
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$ |
0.1568 |
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$ |
3.7632 |
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Total |
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$ |
7,115,599.00 |
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$ |
284,624.00 |
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$ |
6,830,975.00 |
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We expect the total offering expenses, excluding placement agency fees, to be approximately
$100,000 for all sales pursuant to this prospectus supplement and accompanying prospectus.
Because there is no minimum offering amount required as a condition to the closing of this
offering, the actual public offering amount, placement agency fees and proceeds to us are not
presently determinable and may be substantially less than the maximum amounts set forth above.
The above summary of offering proceeds to us does not give effect to any exercise of the warrants
being issued in this offering. Delivery of the ADSs and warrants will be made on or about April
11, 2008. Investor funds will be deposited into an escrow account and held until jointly released
by us and the placement agent on the date the ADSs and warrants are to be delivered to the
investors. All funds received will be held in a non-interest bearing account.
Neither the Securities Exchange Commission nor any state securities commission has approved or
disapproved of these securities or passed upon the accuracy or adequacy of this prospectus
supplement or the accompanying prospectus. Any representation to the contrary is a criminal
offense.
Roth Capital Partners
Prospectus Supplement dated April 7, 2008.
TABLE OF CONTENTS
Prospectus Supplement
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S-3 |
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S-4 |
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S-10 |
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S-11 |
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S-11 |
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Accompanying Prospectus
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i
ABOUT THIS PROSPECTUS SUPPLEMENT AND THE
ACCOMPANYING PROSPECTUS
This document is in two parts. The first part is the prospectus supplement, which describes
the specific terms of the ADSs and warrants we are offering and also adds to, and updates
information contained in, the accompanying prospectus and the documents incorporated by reference
into the accompanying prospectus. The second part, the accompanying prospectus, provides more
general information. Generally, when we refer to this prospectus, we are referring to both parts
of this document combined. To the extent there is a conflict between the information contained in
this prospectus supplement, on the one hand, and the information contained in the accompanying
prospectus or any document incorporated by reference therein, on the other hand, you should rely on
the information in this prospectus supplement; provided that if any statement in one of these
documents is inconsistent with a statement in another document having a later date for example, a
document incorporated by reference in the accompanying prospectus the statement in the document
having the later date modifies or supersedes the earlier statement.
We further note that the representations, warranties and covenants made by us in any agreement
that is filed as an exhibit to any document that is incorporated by reference in the accompanying
prospectus were made solely for the benefit of the parties to such agreement, including, in some
cases, for the purpose of allocating risk among the parties to such agreements, and should not be
deemed to be a representation, warranty or covenant to you. Moreover, such representations,
warranties or covenants were accurate only as of the date when made. Accordingly, such
representations, warranties and covenants should not be relied on as accurately representing the
current state of our affairs.
Whenever we refer to Trinity Biotech or to us, or use the terms we or our in this
prospectus, we are referring to Trinity Biotech plc an Irish public limited company, and its
consolidated subsidiaries. However, for purposes of the sections entitled Description of Class A
Ordinary Shares and Description of Equity Warrants in the accompanying prospectus whenever we
refer to Trinity Biotech or to us, or use the terms we or our, we are referring only to
Trinity Biotech plc.
You should rely only on the information contained in this prospectus supplement and contained,
or incorporated by reference, in the accompanying prospectus. We have not authorized, and the
placement agent has not authorized, anyone to provide you with information that is different. The
information contained in this prospectus supplement and contained, or incorporated by reference, in
the accompanying prospectus is accurate only as to the respective dates thereof, regardless of the
time of delivery of this prospectus supplement and the accompanying prospectus or of any sale of
our ADSs or warrants. It is important for you to read and consider all information contained in
this
S-1
prospectus supplement and the accompanying prospectus, including the documents incorporated by
reference therein, in making your investment decision. You should also read and consider the
information in the documents we have referred you to in the section entitled Where You Can Find
More Information in the accompanying prospectus.
We are offering to sell, and seeking offers to buy, our ADSs and warrants only in
jurisdictions where offers and sales are permitted. The distribution of this prospectus supplement
and the accompanying prospectus and the offering of the ADSs and warrants in certain jurisdictions
may be restricted by law. Persons outside the United States who come into possession of this
prospectus supplement and the accompanying prospectus must inform themselves about, and observe any
restrictions relating to, the offering of the ADSs and warrants and the distribution of this
prospectus supplement and the accompanying prospectus outside the United States. This prospectus
supplement and the accompanying prospectus do not constitute, and may not be used in connection
with, an offer to sell, or a solicitation of an offer to buy, any securities offered by this
prospectus supplement and the accompanying prospectus by any person in any jurisdiction in which it
is unlawful for such person to make such an offer or solicitation.
S-2
THE OFFERING
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ADSs offered (each ADS representing four
Class A Ordinary Shares) |
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Up to 1,815,204 ADSs, plus
544,561 ADSs underlying the
warrants offered hereby
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Class A Ordinary Shares to be outstanding
after this offering |
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Up to 82,017,581 Class A Ordinary
Shares, or 84,195,825 Class A Ordinary Shares if the warrants
sold in this offering are
exercised in full |
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Use of Proceeds
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For general corporate
purposes, including research
and development expenses,
manufacturing expenses,
clinical trial costs, general
and administrative expenses,
repayment of indebtedness and
potential acquisitions of
companies, products and
technologies that complement
our business. See Use of
Proceeds. |
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Risk Factors
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You should read the Risk
Factors section of this
prospectus supplement for a
discussion of factors to
consider before deciding to
purchase ADSs and warrants. |
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Nasdaq Global Select Market Symbol
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TRIB |
The number of Class A Ordinary Shares to be outstanding after this offering is based
on 74,756,765 shares outstanding as of April 4, 2008.
The number of Class A Ordinary Shares to be outstanding after this offering excludes, as of
April 4, 2008:
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An aggregate of 1,258,824 additional Class A Ordinary Shares reserved for issuance
under our Common Stock Purchase Warrant dated January 6, 2004 and our Class A Ordinary
Share Warrant dated November 27, 2002 at a weighted average
conversion price of $5.25 per Class A Ordinary Share. |
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An aggregate of 3,839,824 additional Class A Ordinary Shares reserved for future
issuance under our 2003 Stock Option Plan and 2006 Stock Option Plan. |
S-3
RISK FACTORS
Investing in our securities involves risks. The most significant factors that make an
investment in our securities risky or speculative are discussed under the caption Item 3. Selected
Consolidated Financial Data Risk Factors and elsewhere in our most recent Annual Report on Form
20-F and in any later reports and other documents that are incorporated by reference in this
prospectus supplement. These factors, and others that are not presently known to us, may cause our
operating results to vary from anticipated results or may materially and adversely affect our
business and financial condition. If any of the unfavorable events or circumstances described in
the risk factors actually occur, our business may suffer, the trading price of our ADSs and other
securities could decline, and you could lose all or part of your investment.
FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus and the documents incorporated in it
by reference contain forward-looking statements which involve known and unknown risks and
uncertainties. We include this notice for the express purpose of permitting Trinity Biotech to
avail itself of the protections of the safe harbor provided by the Private Securities Litigation
Reform Act of 1995 for all such forward looking statements. Examples of forward-looking statements
include: (1) projections of capital expenditures, revenues, growth, prospects, financial resources
and other financial matters; (2) statements of our plans or objectives; and (3) statements using
the words anticipate, believe, estimate, expect, may, intent, plan, project,
understand, and other verbs suggesting uncertainty.
Our ability to predict results of Trinity Biotechs operations or the effects of certain
events on Trinity Biotechs operating results is inherently uncertain. Therefore, we caution you
to consider carefully the matters described under the caption Risk Factors and certain other
matters discussed in this prospectus supplement, the accompanying prospectus, the documents
incorporated by reference in this prospectus, and other publicly available sources. Such risks and
many other factors beyond the control of Trinity Biotechs management could cause the actual
results, performance or achievements of Trinity Biotech to be materially different from any future
results, performance or achievements that may be expressed or implied by the forward-looking
statements.
USE OF PROCEEDS
We estimate that the net proceeds from the sale of the ADSs and warrants that we are offering
at a price of $3.92 per unit will be approximately $6.7 million after deducting the estimated
placement agency fees and offering expenses payable by us. We intend to use the net proceeds of
this offering for general corporate purposes, including research and development expenses,
manufacturing expenses, clinical trial costs, general and administrative expenses, repayment of
indebtedness and potential acquisitions of companies, products and technologies that complement our
business.
S-4
DILUTION
Our net
tangible book value as of December 31, 2007 was approximately
$31.9 million, or
$0.43 per Class A Ordinary Share. Net tangible book value per Class A Ordinary Share is calculated
by subtracting our total liabilities from our total tangible assets, which is total assets less
intangible assets, and dividing this amount by the number of Class A Ordinary Shares outstanding.
After giving effect to the sale by us of the ADSs and warrants offered in this offering at a price
of $3.92 per unit and after deducting the estimated placement agency fees and offering expenses
payable by us, our net tangible book value as of December 31, 2007 would have been approximately
$38.6 million, or $0.47 per Class A Ordinary Share. This represents an immediate increase in the
net tangible book value of $0.04 per Class A Ordinary Share to the existing stockholders and an
immediate dilution of $0.51 per Class A Ordinary Share to new investors. The following table
illustrates this per share dilution:
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Price per Class A Ordinary Share to investors |
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0.98 |
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Net tangible book value per Class A Ordinary Share
as of December 31, 2007 |
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0.43 |
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Increase per Class A Ordinary Share attributable to new investors |
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0.04 |
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Net tangible book value per Class A Ordinary Share
after this offering |
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0.47 |
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Dilution per Class A Ordinary Share to new investors |
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0.51 |
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In the
discussion and table above, we assume no exercise of outstanding warrants. As of
December 31, 2007, there were 1,258,824 Class A Ordinary Shares reserved for issuance upon exercise
of outstanding warrants with a weighted average exercise price of
$5.25 per Class A Ordinary
Share. To the extent that any of these warrants are exercised, there will be further dilution to
new investors.
The foregoing dilution information does not give effect to the exercise of the warrants that
are being offered with the ADSs pursuant to this prospectus supplement and the accompanying
prospectus.
S-5
PLAN OF DISTRIBUTION
We
are directly selling to one or more purchasers 1,815,204 ADSs and warrants to purchase
544,561 ADSs under this prospectus supplement at a price of $3.92 per unit. The warrants have a
five year term at an exercise price of $5.54 per ADS.
We estimate the gross proceeds from the financing will be approximately $7.1 million, and we
estimate the net proceeds from the financing to be approximately $6.7 million after deducting
placement agency fees and the estimated costs payable by us associated with the offering. We have
negotiated with the purchasers regarding the sale of the ADSs and warrants being offered hereunder,
and have entered into subscription agreements with the purchasers which set forth the specific
terms of the transaction. We anticipate that we will effect the sale
of the aggregate of 1,815,204 ADSs and warrants to purchase 544,561 ADSs in one or more closings.
Pursuant to a placement agency agreement dated April 7, 2008, we have engaged Roth Capital
Partners, LLC, or Roth Capital, to act as our exclusive placement agent in connection with an
offering of our ADSs and warrants under the registration statement on Form F-3, of which this
prospectus supplement is a part. Under the terms of the placement agency agreement, Roth Capital
agreed to be our exclusive placement agent, on a best efforts basis, in connection with the
issuance and sale by us of our ADSs and warrants in a proposed takedown from our registration
statement. The terms of any such offering will be subject to market conditions and negotiations
between us, the placement agent and prospective purchasers. The placement agency agreement does
not give rise to any commitment by Roth Capital to purchase any of the ADSs or warrants, and Roth
Capital will have no authority to bind us by virtue of the placement agency agreement. Further,
Roth Capital does not guarantee that they will be able to raise new capital in any prospective
offering.
With respect to the offering, we have agreed to pay compensation as follows:
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an aggregate placement agency fee to the placement agent equal to 4.0% of the gross
proceeds received from the sale of ADSs and warrants in the offering; and |
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the placement agents out-of- pocket expenses, including the fees and expenses of
the placement agents legal counsel, incurred in connection with the offering. |
For a period of 135 days after the closing of this offering, Roth Capital will have a right of
first refusal to act as our placement agent in connection with an offering of equity or
equity-linked securities.
We will not pay any other compensation in connection with the sale of our ADSs and warrants
pursuant to the placement agency agreement.
S-6
In order to facilitate the closing, all purchaser funds will be deposited into a non-interest
bearing escrow account and held by the escrow agent until jointly released by us and the placement
agent in a written instruction to the escrow agent on the date the ADSs and warrants are delivered
to the purchasers. The escrow agent will not accept any purchaser funds until the date of this
prospectus supplement.
We have agreed to indemnify Roth Capital against certain liabilities arising in connection
with the engagement, including liabilities under federal securities laws.
This is a brief summary of the material provisions of the placement agency agreement and does
not purport to be a complete statement of its terms and conditions.
In compliance with the guidelines of the Financial Industry Regulatory Authority maximum
consideration or discount to be received by any FINRA member may not exceed 8% of the aggregate
amount of the securities offered pursuant to this prospectus supplement.
We and each of our directors and executive officers have agreed to certain restrictions on the
ability to sell our Class A Ordinary Shares, ADSs and other securities that they beneficially own,
including securities convertible into or exercisable or exchangeable for Class A Ordinary Shares,
for a period of 90 days following the date of this prospectus supplement. This means that, subject
to certain exceptions, for a period of 90 days following the date of this prospectus supplement, we
and such persons may not, directly or indirectly, offer, pledge, announce the intention to sell,
sell, contract to sell, sell any option or contract to purchase (with respect to us, to the extent
such option or contract to purchase is exercisable within one year from the Closing Date), purchase
any option or contract to sell, grant any option, right or warrant to purchase, or otherwise
transfer or dispose of any Class A Ordinary Shares, without the prior written consent of Roth
Capital. Notwithstanding the foregoing, if (x) during the last 17 days of such 90 day period, we
announce that we will release earnings results or publicly announce other material news or a
material event relating to us occurs or (y) prior to the expiration of the 90 day period, we
announce that we will release earnings results during the 16 day period beginning on the last day
of the 90 day period, then in each case the 90 day period will be extended until the expiration of
the 18 day period beginning on the date of release of the earnings results or the public
announcement regarding the material news or the occurrence of the material event, as applicable,
unless Roth Capital waives, in writing, such extension. At any time and without public notice, Roth
Capital may in its sole discretion release all or some of the securities from these lock-up
agreements.
The transfer agent and depositary for our Class A Ordinary Shares and ADSs is The Bank of New
York.
Our ADSs are traded on the Nasdaq Global Select Market under the symbol TRIB.
S-7
Selling Restrictions
European Economic Area
In relation to each Member State of the European Economic Area which has implemented the
Prospectus Directive (each a Relevant Member State) an offer to the public of any ADSs or
warrants which are the subject of the offering contemplated by this prospectus supplement may not
be made in that Relevant Member State except that an offer to the public in that Relevant Member
State of any ADSs or warrants may be made at any time under the following exemptions under the
Prospectus Directive, if they have been implemented in that Relevant Member State:
(a) to legal entities which are authorized or regulated to operate in the financial markets
or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;
(b) to any legal entity which two or more of (1) an average of at least 250 employees
during the last financial year; (2) a total balance sheet of more than 43,000,000 and (3) an
annual net turnover of more than 50,000,000, as shown in its last annual or consolidated
accounts;
(c) by the placement agent to fewer than 100 natural or legal persons (other than
qualified investors as defined in the Prospectus Directive); or
(d) in any other circumstances falling within Article 3(2) of the Prospectus
Directive,
provided that no such offer of ADSs or warrants shall result in a requirement for the publication
by Trinity Biotech or the placement agent of a prospectus pursuant to Article 3 of the Prospectus
Directive.
For the purposes of this provision, the expression an offer to the public in relation to any
ADSs or warrants in any Relevant Member State means the communication in any form and by any means
of sufficient information on the terms of the offer and any ADSs or warrants to be offered so as to
enable an investor to decide to purchase any ADSs or warrants, as the same may be varied in that
Member State by any measure implementing the Prospectus Directive in that Member State and the
expression Prospectus Directive means Directive 2003/71/EC and includes any relevant implementing
measure in each Relevant Member State.
France
No prospectus (including any amendment, supplement or replacement thereto) has been prepared
in connection with the offering of our ADSs and warrants that has been approved by the Autorité des
marchés financiers or by the competent authority of another
S-8
State that is a contracting party to the Agreement on the European Economic Area and notified
to the Autorité des marchés financiers; no ADSs or warrants have been offered or sold and will be
offered or sold, directly or indirectly, to the public in France except to permitted investors,
consisting of persons licensed to provide the investment service of portfolio management for the
account of third parties, qualified investors (investisseurs qualifiés) acting for their own
account and/or corporate investors meeting one of the four criteria provided in Article 1 of Decree
N° 2004-1019 of September 28, 2004 and belonging to a limited circle of investors (cercle restreint
dinvestisseurs) acting for their own account, with qualified investors and limited circle of
investors having the meaning ascribed to them in Article L. 411-2 of the French Code Monétaire et
Financier and applicable regulations thereunder; none of this prospectus supplement or any other
materials related to the offer or information contained therein relating to our ADSs and warrants
has been released, issued or distributed to the public in France except to Permitted Investors; and
the direct or indirect resale to the public in France of any ADSs or warrants acquired by any
Permitted Investors may be made only as provided by articles L. 412-1 and L. 621-8 of the French
Code Monétaire et Financier and applicable regulations thereunder.
Switzerland
The ADSs may not and will not be publicly offered, distributed or re-distributed on a
professional basis in or from Switzerland and neither this prospectus supplement nor any other
solicitation for investments in our ADSs and warrants may be communicated or distributed in
Switzerland in any way that could constitute a public offering within the meaning of Articles 1156
or 652a of the Swiss Code of Obligations or of Article 2 of the Federal Act on Investment Funds of
March 18, 1994. This prospectus supplement may not be copied, reproduced, distributed or passed on
to others without the placement agents prior written consent. This prospectus supplement is not a
prospectus within the meaning of Articles 1156 and 652a of the Swiss Code of Obligations or a
listing prospectus according to article 32 of the Listing Rules of the Swiss Exchange and may not
comply with the information standards required thereunder. We will not apply for a listing of our
ADSs or warrants on any Swiss stock exchange or other Swiss regulated market and this prospectus
supplement may not comply with the information required under the relevant listing rules. The ADSs
and warrants offered hereby have not and will not be registered with the Swiss Federal Banking
Commission and have not and will not be authorized under the Federal Act on Investment Funds of
March 18, 1994. The investor protection afforded to acquirers of investment fund certificates by
the Federal Act on Investment Funds of March 18, 1994 does not extend to acquirers of our ADSs and
warrants.
United Kingdom
Our ADSs and warrants may not be offered or sold and will not be offered or sold to any
persons in the United Kingdom other than to persons whose ordinary activities involve them in
acquiring, holding, managing or disposing of investments (as principal or as agent) for the
purposes of their businesses and in compliance with all applicable provisions of the Financial
Services and Markets Act 2000, or the FSMA, with respect to
S-9
anything done in relation to our ADSs and warrants in, from or otherwise involving the United
Kingdom. In addition, the placement agent has only communicated or caused to be communicated and
will only communicate or cause to be communicated any invitation or inducement to engage in
investment activity (within the meaning of Section 21 of the FSMA) received by it in connection
with the issue or sale of our ADSs and warrants in circumstances in which Section 21(1) of the FSMA
does not apply to us. Without limitation to the other restrictions referred to herein, this
prospectus supplement is directed only at (1) persons outside the United Kingdom, (2) persons
having professional experience in matters relating to investments who fall within the definition of
investment professionals in Article 19(5) of the Financial Services and Markets Act 2000
(Financial Promotion) Order 2005; or (3) high net worth bodies corporate, unincorporated
associations and partnerships and trustees of high value trusts as described in Article 49(2) of
the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005. Without limitation to
the other restrictions referred to herein, any investment or investment activity to which this
prospectus supplement relates is available only to, and will be engaged in only with, such persons,
and persons within the United Kingdom who receive this communication (other than persons who fall
within (2) or (3) above) should not rely or act upon this communication.
Ireland
The placement agent has represented and agreed that (a) otherwise than in circumstances which
are not deemed to be an offer to the public by virtue of the provisions of the Irish Companies
Acts, 1963 to 2003, it has not offered or sold, and will not offer or sell, in Ireland, by means of
any document, any ADSs, warrants or ordinary shares, unless such offer or sale has been or is made
to persons whose ordinary business it is to buy or sell shares or debentures, whether as principal
or agent, and it has not issued, and will not issue, in Ireland any form of application for ADSs,
warrants or ordinary shares; and (b) it has not made and will not make any offer of ADSs, warrants
or ordinary shares to the public in Ireland to which the European Communities (Transferable
Securities and Stock Exchange) Regulations, 1992 of Ireland would apply, except in accordance with
the provisions of those regulations; and (c) it has complied, and will comply, with all applicable
provisions of the Investment Intermediaries Act 1995 of Ireland, as amended, with respect to
anything done by it in relation to the offer, sale or delivery of the ADSs, warrants or ordinary
shares in or involving Ireland.
DESCRIPTION OF WARRANTS
The material terms and provisions of the warrants being offered pursuant to this prospectus
supplement and the accompanying prospectuses are summarized below. This summary is subject to, and
qualified in its entirety by, the form of warrant, which will be provided to each purchaser in this offering.
The warrants will be exercisable at any time and from time to time for a period of five years
from issuance. The warrants will be exercisable, at the option of each holder, upon the surrender
of the warrants to us and at an exercise price equal to $5.54 per ADS,
S-10
which, except as described below, must be paid in cash at the time of exercise. The exercise
price is subject to appropriate adjustment in the event of stock dividends, stock splits,
reorganizations or similar events affecting our outstanding Class A ordinary shares. The warrant
holders must surrender payment in cash of the exercise price of the ADSs being acquired upon
exercise of the warrants; provided, however, that if we are unable to offer and sell the shares
underlying these warrants pursuant to this prospectus supplement due to the ineffectiveness of the
registration statement of which this prospectus supplement is a part, then the warrants may only be
exercised on a net or cashless basis. In no event is the warrant holder entitled to a cash
settlement from us upon exercise.
In the event that the trading price of our ADSs close above 200% of the exercise price of the
warrant for 20 consecutive trading days during the warrant term, we can then send a redemption
notice to the warrant holders. This redemption notice will provide the warrant holders with at
least 30 days to exercise outstanding warrants, after which time we may redeem and cancel any
unexercised warrants for nominal consideration.
The warrants contain a limitation on exercise, pursuant to which a warrant holder will not be
entitled to exercise any portion of the warrant if, after giving effect to the exercise, the
holder, together with its affiliates, would beneficially own more than 9.99% of the shares of our
outstanding Class A ordinary shares after giving effect to the exercise. Upon the written request
of any investor in this offering, we will set this exercise limit at a lower percentage.
LEGAL MATTERS
The validity of any offered securities will be passed upon for Trinity Biotech by William Fry,
Dublin, Ireland, our Irish counsel. Carter Ledyard & Milburn LLP, New York, New York, has acted as
our U.S. securities counsel. Lowenstein Sandler PC, New York, New York is counsel for the
placement agent in connection with this offering.
EXPERTS
The consolidated financial statements of Trinity Biotech plc as of December 31, 2007 and 2006, and
for each of the years in the three-year period ended December 31, 2007, and managements assessment
of the effectiveness of internal control over financial reporting as of December 31, 2007 have been
incorporated by reference herein in reliance upon the reports of KPMG, independent registered
public accounting firm, incorporated by reference herein, and upon the authority of said firm as
experts in accounting and auditing.
S-11
PROSPECTUS
TRINITY BIOTECH PLC
Class A Ordinary Shares
and Equity Warrants
Trinity Biotech plc may offer from time to time, in one or more series or issuances and at
prices and on terms that will determine at the time of offering, up to $75,000,000 in gross
proceeds to Trinity Biotech of
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Class A Ordinary Shares; or |
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warrants to purchase Class A Ordinary Shares. |
The American Depositary Receipts of Trinity Biotech trade in the United States on the Nasdaq
SmallCap Market under the symbol TRIB.
We will provide specific terms of these securities in supplements to this prospectus at the
time when we offer them. You should read this prospectus and the applicable supplement carefully
before you invest in any of these securities.
Neither the Securities and Exchange Commission nor any other regulatory body has approved or
disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any
representation to the contrary is a criminal offense.
The date of this prospectus is May 16, 2005.
We have not authorized any dealer, salesman or other person to give any information or to make
any representation other than those contained or incorporated by reference in this prospectus and
any accompanying prospectus supplement. You must not rely upon any information or representation
not contained or incorporated by reference in this prospectus or a prospectus supplement. This
prospectus and any accompanying prospectus supplement do not contain an offer to sell or the
solicitation of an offer to buy any securities other than the registered securities to which they
relate, or an offer to sell or the solicitation of an offer to buy securities in any jurisdiction
where the offer or sale is not permitted. The information contained in this prospectus and any
accompanying prospectus supplement is accurate as of the dates on their covers. When we deliver
this prospectus or a supplement or make a sale pursuant to this prospectus, we are not implying
that the information is current as of the date of the delivery or sale.
Table of Contents
Prospectus
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About This Prospectus |
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About Trinity Biotech |
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Where You Can Find More Information |
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Enforceability of Civil Liabilities Against Foreign Persons |
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Currency Translation |
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Description of Class A Ordinary Shares |
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Description of Equity Warrants |
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Summary of Risks |
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Market Price Data |
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Notice Regarding Forward-Looking Statements |
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Use of Proceeds |
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Plan of Distribution |
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Expenses Associated with the Registration |
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Legal Matters |
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Experts |
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1
Whenever we refer to Trinity Biotech or to us, or use the terms we or our in this
prospectus, we are referring to Trinity Biotech plc an Irish public limited company, and its
consolidated subsidiaries. However, for purposes of the sections entitled Description of Class A
Ordinary Shares and Description of Equity Warrants, whenever we refer to Trinity Biotech plc
or to us, or use the terms we or our, we are referring only to Trinity Biotech plc.
About This Prospectus
This prospectus is part of a registration statement that we filed with the Securities and
Exchange Commission utilizing a shelf registration process. Under this shelf registration
process, we may sell any combination of the securities described in this prospectus in one or more
offerings resulting in gross proceeds to us of up to $75,000,000. This prospectus provides you
with a general description of the securities we may offer. Each time we sell securities, we will
provide a prospectus supplement that will contain specific information about the terms of that
offering. The prospectus supplement may also add, update or change information contained in this
prospectus. To the extent that any statement that we make in a prospectus supplement is
inconsistent with statements made in this prospectus, you should assume that the statements made in
the prospectus supplement modify or supersede those made in this prospectus. You should read both
this prospectus and any prospectus supplement together with additional information described under
the heading Where You Can Find More Information.
About Trinity Biotech
Trinity Biotech plc, an Irish public limited company, was formed in January 1992 to acquire,
develop, manufacture and market rapid and laboratory based diagnostic tests for the detection of
various infectious diseases, blood coagulation disorders and other medical conditions. In
addition, we manufacture, acquire and market diagnostic tests and antibodies through our UK, German
and Swedish subsidiaries as well as our U.S. subsidiaries, Clark Laboratories Inc. (trading as
Trinity Biotech (USA) Corp.), MarDx Diagnostics Inc., Biopool U.S., Inc. and Fitzgerald Industries
International, Inc. Our address is IDA Business Park, Bray, Co. Wicklow, Ireland, telephone number
011 353 1 276 9800.
Where You Can Find More Information
We file annual and special reports and other information with the SEC. You may obtain these
filings over the internet at the SECs Web site at http://www.sec.gov. You may also read and copy
these filings at the SECs public reference room at 450 Fifth Street, N.W., Washington, D.C. 20549.
You may obtain information on the operation of the public reference room by calling the SEC at
1-800-SEC-0330, and may obtain copies of Trinity Biotechs filings from the public reference room
by calling (202) 942-8090. Our internet address is http://www.trinitybiotech.com.
The SEC allows us to incorporate by reference the information we file with them, which means
that we can disclose important information to you by referring you to
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those documents. The information incorporated by reference is considered to be part of this
prospectus, and later information that we file with the SEC will automatically update and supersede
this information. We incorporate by reference the documents listed below and any future filings
made with the SEC under Sections 13(a), 13(c), 14, or 15(d) of the Securities Exchange Act of 1934
until the termination of this offering of Trinity Biotechs securities. This prospectus is part of
a registration statement we filed with the SEC (Registration No 333-124385).
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Annual Report on Form 20-F for the year ended December 31, 2004, filed on April 1,
2005. |
You may request a copy of these filings as well as any agreements relating to Trinity
Biotechs securities offered hereby, at no cost, by writing or telephoning us at the following
address:
Corporate Secretary
Trinity Biotech plc
IDA Business Park
Bray, Co. Wicklow, Ireland
Tel: 011 353 1 276 9800
You should rely only on the information incorporated by reference or provided in this
prospectus or any supplement. We have not authorized anyone else to provide you with different
information. You should not assume that the information in this prospectus or any supplement is
accurate as of any date other than the date on the front of those documents.
Trinity Biotech is a foreign private issuer as defined in Rule 3b-4 under the Securities
Exchange Act of 1934. As a result, our proxy solicitations are not subject to the disclosure and
procedural requirements of Regulation 14A under the Exchange Act and transactions in Trinity
Biotechs equity securities by its officers and directors are exempt from Section 16 of the
Exchange Act. In addition, Trinity Biotech is not required under the Exchange Act to file periodic
reports and financial statements as frequently or as promptly as U.S. companies whose securities
are registered under the Exchange Act.
Our ADRs are listed for quotation on The Nasdaq SmallCap Market, and reports and other
information filed by us can be inspected at the offices of Nasdaq. Each ADR represents one Class A
Ordinary Share of Trinity Biotech.
Enforceability of Civil Liabilities Against Foreign Persons
We are a public limited company organized under the laws of the Republic of Ireland. Several
of our directors and officers and certain experts named in the registration statement are residents
of Ireland or other non-U.S. jurisdictions. Substantial portions of the assets of these persons
and of Trinity Biotech are located in Ireland or other non-U.S. jurisdictions.
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We have appointed Alan Bernstein of Carter Ledyard & Milburn LLP as our agent to receive
service of process in any legal action against us. However, it may not be possible for investors
to effect service of process upon Trinity Biotech or its non-U.S. directors, officers or experts
named in the registration statement or to enforce any judgment obtained against these persons in
U.S. courts. Also, it may not be possible to enforce U.S. securities laws or judgments obtained in
U.S. courts against these persons in a non-U.S. jurisdiction.
Currency Translation
Trinity Biotech publishes its financial statements in United States dollars. Unless otherwise
specified, all references to U.S. dollars, dollars, $ or U.S. $ are to United States
dollars and references to Euro, or are to the European Euro. No representation is made that
the Euro or U.S. dollar amounts shown in this prospectus could have been or could be converted into
U.S. dollars or Euros, as the case may be, at any particular rate or at all.
Description of Class A Ordinary Shares
Trinity Biotech is authorized to issue 75,000,000 Class A Ordinary Shares, par value $0.0109
per share. At the close of business on February 28, 2005, it had 55,588,050 Class A Ordinary
Shares outstanding. Our Class A Ordinary Shares are represented by American Depository Receipts or
ADRs. An ADR is a receipt for the shares of a foreign corporation held in the vault of a U.S. bank
and entitling the holder to all dividends and capital gains. Instead of buying shares of
foreign-based companies in overseas markets, U.S. persons can buy shares in the United States in
the form of an ADR. An American Depositary Share or ADS is the share issued under a depositary
agreement representing the underlying ordinary share that trades in the issuers home market.
Technically, ADS is the instrument that actually is traded, whereas the ADR is the certificate that
represents a number of ADSs.
The Bank of New York acts as the depositary for Trinitys ADSs pursuant to an amended and
restated deposit agreement which is an exhibit to the Form F-6 registration statement filed by
Trinity on January 15, 2004, registration no. 333-111946. The depositarys offices are located at
101 Barclay Street, New York, NY 10286.
Trinity Biotech ADSs are listed on the NASDAQ Small Cap Market under the symbol TRIB. The
number of record holders of Trinity Biotechs ADSs as at February 28, 2005 amounted to 1,681,
inclusive of those brokerage firms and/or clearing houses holding Trinity Biotechs securities for
their clientele (with each such brokerage house and/or clearing house being considered as one
holder).
Our Class A Ordinary Shares and our Class B Ordinary Shares rank pari passu in all respects
save that the Class B Ordinary Shares have two votes per share and the right to receive dividends
and participate in the distribution of the assets of Trinity Biotech upon liquidation or winding up
at a rate of twice that of the Class A Ordinary Shares.
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Where a shareholder or person who appears to be interested in shares fails to comply with a
request for information from Trinity Biotech in relation to the capacity in which such shares or
interest are held, who is interested in them or whether there are any voting arrangements, that
shareholder or person may be disenfranchised and thereby restricted from transferring the shares
and voting or receiving any sums in respect thereof (except in the case of a liquidation). In
addition, if cheques in respect of the last three dividends paid to a shareholder remain uncashed,
we are, subject to compliance with the procedure set out in our Articles of Association, entitled
to sell the shares of that shareholder.
At a general meeting, on a show of hands, every Class A Shareholder who is present in person
or by proxy and entitled to vote shall have one vote (so, however, that no individual shall have
more than one vote) and upon a poll, every Class A Shareholder present in person or by proxy shall
have one vote for every share. In the case of joint holders, the vote of the senior (being the
first person named in the register of members in respect of the joint holding) who tendered a vote,
whether in person or by proxy, shall be accepted to the exclusion of votes of the other joint
holders.
One third of the directors other than an executive director or, if their number is not three
or a multiple of three, then the number nearest to but not exceeding one third, shall retire from
office at each annual general meeting. If, however, the number of directors subject to retirement
by rotation is two, one of such directors shall retire. If the number is one, that director shall
retire. The directors to retire at each annual general meeting shall be the ones who have been
longest in office since their last appointment. Where directors are of equal seniority, the
directors to retire shall, in the absence of agreement, be selected by lot. A retiring director
shall be eligible for re-appointment and shall act as director throughout the meeting at which he
retires. A separate motion must be put to a meeting in respect of each director to be appointed
unless the meeting itself has first agreed that a single resolution is acceptable without any vote
being given against it.
We may, subject to the provisions of the Companies Acts, 1963 to 2003 of Ireland, issue any
share on the terms that it is to be redeemed on such terms and in such manner as we may determine
by special resolution. Before recommending a dividend, the directors may reserve out of our
profits such sums as they think proper which shall be applicable for any purpose to which our
profits may properly be applied and, pending such application, may be either employed in our
business or be invested in such investments (other than shares of the Company or of its holding
company (if any)) as the directors may from time to time think fit.
Subject to any conditions of allotment, the directors may from time to time make calls on
members in respect of monies unpaid on their shares. At least 14 days notice must be given of each
call. A call shall be deemed to have been made at the time when the directors resolve to authorize
such call.
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The Articles do not contain any provisions discriminating against any existing or prospective
holder of securities as a result of such shareholder owning a substantial number of shares.
In order to change the rights attaching to any class of shares, including Class A Ordinary
Shares, a special resolution passed at a class meeting of the holders of such shares is required.
The provisions in relation to general meetings apply to such meetings except the quorum shall be
two persons holding or representing by proxy at least one third in nominal amount of the issued
shares of that class. In addition, in order to amend any provisions of the Articles of Association
in relation to rights attaching to shares, including Class A Ordinary Shares, a special resolution
of the shareholders as a whole is required.
We must hold a general meeting each year. Not more than 15 months can elapse between annual
general meetings. The annual general meetings are held at such time and place as the directors
determine and all other general meetings are called extraordinary general meetings. Every general
meeting shall be held in Ireland unless all of the members entitled to attend and vote at it
consent in writing to it being held elsewhere or a resolution providing that it be held elsewhere
was passed at the preceding annual general meeting. The directors may at any time call an
extraordinary general meeting and such meetings may also be convened on such requisition, or in
default may be convened by such requisitions, as is provided by the Companies Acts, 1963 to 2003 of
Ireland. In the case of an annual general meeting or a meeting at which a special resolution is
proposed, 21 clear days notice of the meeting is required and in any other case it is 7 clear days
notice. Notice must be given in writing to all members and to the auditors and must state the
details specified in the Articles of Association. A general meeting (other than one at which a
special resolution is to be proposed) may be called on shorter notice subject to the agreement of
the auditors and all members entitled to attend and vote at it. In certain circumstances provided
in the Companies Acts, 1963 to 2003 of Ireland, extended notice is required. These include removal
of a director. No business may be transacted at a general meeting unless a quorum is present.
Five members present in person or by proxy (not being less than five individuals) representing not
less than 40% of the ordinary shares shall be a quorum. Trinity Biotech is not obliged to serve
notices upon members who have addresses outside of Ireland and the USA but otherwise there are no
limitations in the Articles of Association or under Irish law restricting the rights of
non-resident or foreign shareholders to hold or exercise voting rights on the shares in Trinity
Biotech.
However, the Financial Transfers Act, 1992 and regulations made thereunder prevent transfers
of capital or payments between Ireland and certain countries. These restrictions on financial
transfers are more comprehensively described in Exchange Controls below. In addition, Irish
competition law may restrict the acquisition by a party of shares in Trinity Biotech but this does
not apply on the basis of nationality or residence.
The Memorandum and Articles of Association do not contain any provisions:
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which would have an effect of delaying, deferring or preventing a change in control
of Trinity Biotech and which would operate only with respect to a merger, acquisition
or corporate restructuring involving Trinity Biotech (or any of its subsidiaries); or |
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governing the ownership threshold above which a shareholder ownership must be
disclosed; or |
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imposing conditions governing changes in the capital which are more stringent than
is required by Irish law. |
Trinity Biotech incorporates by reference all other information concerning its Memorandum and
Articles of Association from the Registration Statement on Form F-1 on June 12, 1992.
Pursuant to Irish law, Trinity Biotech must maintain a register of its shareholders. This
register is open to inspection by shareholders free of charge and to any member of the public on
payment of a small fee. The books containing the minutes of proceedings of any general meeting of
Trinity Biotech are required to be kept at the registered office of Trinity Biotech and are open to
the inspection of any member without charge. Minutes of meetings of the Board of Directors are not
open to scrutiny by shareholders. Trinity Biotech is obliged to keep Proper Books of Account. The
shareholders have no statutory right to inspect the books of account. The only financial records,
which are open to the shareholders, are the financial statements, which are sent to shareholders
with the annual report. Irish law also obliges Trinity Biotech to file information relating to
certain events within Trinity Biotech (new share capital issues, changes to share rights, changes
to the Board of Directors). This information is filed with the Companies Registration Office (the
CRO) in Dublin and is open to public inspection. The Articles of Association of Trinity Biotech
permit ordinary shareholders to approve corporate matters in writing provided that a written
consent is signed by all the members for the time being entitled to vote and attend at general
meeting. Ordinary shareholders are entitled to call a meeting by way of a requisition. The
requisition must be signed by ordinary shareholders holding not less than one-tenth of the paid up
capital of Trinity Biotech carrying the right of voting at general meetings of Trinity Biotech.
Trinity Biotech is generally permitted, subject to company law, to issue shares with preferential
rights, including preferential rights as to voting, dividends or rights to a return of capital on a
winding up of Trinity Biotech. Any shareholder who complains that the affairs of Trinity Biotech
are being conducted or that the powers of the directors of Trinity Biotech are being exercised in
a manner oppressive to him or any of the shareholders (including himself), or in disregard of his
or their interests as shareholders, may apply to the Irish courts for relief. Shareholders have no
right to maintain proceedings in respect of wrongs done to Trinity Biotech.
Ordinarily, our directors owe their duties only to Trinity Biotech and not its shareholders.
The duties of directors are twofold, fiduciary duties and duties of care and skill. Fiduciary
duties are owed by the directors individually and owed to Trinity Biotech. Those duties include
duties to act in good faith towards Trinity Biotech in any
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transaction, not to make use of any money or other property of Trinity Biotech, not to gain
directly or indirectly any improper advantage for himself at the expense of Trinity Biotech, to act
bona fide in the interests of Trinity Biotech and exercise powers for the proper purpose. A
director need not exhibit in the performance of his duties a greater degree of skill than may
reasonably be expected from a person of his knowledge and experience. When directors, as agents in
transactions, make contracts on behalf of Trinity Biotech, they generally incur no personal
liability under these contracts. It is Trinity Biotech, as principal, which will be liable under
them, as long as the directors have acted within Trinity Biotechs objects and within their own
authority. A director who commits a breach of his fiduciary duties shall be liable to Trinity
Biotech for any profit made by him or for any damage suffered by Trinity Biotech as a result of the
breach. In addition to the above, a breach by a director of his duties may lead to a sanction from
a Court including damages of compensation, summary dismissal of the director, a requirement to
account to Trinity Biotech for profit made and restriction of the director from acting as a
director in the future.
Description of Equity Warrants
Trinity Biotech may issue warrants to purchase ADRs, or equity warrants. Equity warrants
may be issued independently or together with any securities and may be attached to or separate from
those securities. We will issue equity warrants under warrant agreements to be entered into either
between us and the warrant holders directly or between us and a bank or trust company, as warrant
agent.
A prospectus supplement will describe the terms of equity warrants offered thereby, the
warrant agreement relating to the equity warrants and the equity warrant certificates representing
the equity warrants, including the following:
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the title of the equity warrants; |
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the price or prices at which the equity warrants will be issued; |
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if applicable, the number of equity warrants issued with Trinity Biotech ADRs; |
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any date on and after which the equity warrants and such ADRs will be separately
transferable; |
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the date on which the right to exercise the equity warrants will commence, and the
date on which those rights will expire; |
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the maximum or minimum number of equity warrants which may be exercised at any
time; |
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information with respect to any book-entry procedures for the registration and
transfer of equity warrants; |
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a discussion of any material federal income tax considerations applicable to
holding, transferring or exercising equity warrants; and |
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any other terms of the equity warrants, including terms, procedures and limitations
relating to the exercise of the equity warrants. |
Unless we specify otherwise in a prospectus supplement, holders of equity warrants will not be
entitled, by virtue of being such holders, to vote, consent, receive dividends, receive notice as
shareholders with respect to any meeting of Trinity Biotech shareholders, or to exercise any rights
whatsoever as Trinity Biotech shareholders.
As described in a prospectus supplement, the exercise price payable and the number of ADRs
purchasable upon the exercise of each equity warrant will be adjusted in certain events, including
the issuance of a stock dividend to holders of common stock or a stock split, reverse stock split,
combination, subdivision or reclassification of common stock. Instead of adjusting the number of
ADRs purchasable upon exercise of each equity warrant, Trinity Biotech may elect to adjust the
number of equity warrants. Unless otherwise provided in a prospectus supplement, no adjustments in
the number of ADRs purchasable upon exercise of the equity warrants will be required until
cumulative adjustments require an adjustment of at least 1% thereof. Trinity Biotech may, at its
option, reduce the exercise price at any time. No fractional ADRs will be issued upon exercise of
equity warrants, but we will pay the cash value of any fractional ADRs otherwise issuable. Unless
we specify otherwise in a prospectus supplement, in case of any consolidation, merger, or sale or
conveyance of Trinity Biotechs property as an entirety or substantially as an entirety, the holder
of each outstanding equity warrant shall have the right to the kind and amount of shares of stock
and other securities and property (including cash) receivable by a holder of the number of ADRs
into which the equity warrant was exercisable immediately prior to the particular triggering event.
Each equity warrant will entitle the holder to purchase the principal amount or number of
securities at the exercise price as shall in each case be set forth in, or be determinable as set
forth in, the applicable prospectus supplement. Equity warrants may be exercised at any time up to
the close of business on the expiration date set forth in the prospectus supplement relating to the
warrants offered thereby. After the close of business on the expiration date, unexercised warrants
will become void.
We will describe the procedures for exercising warrants in a prospectus supplement. Upon
receipt of payment and the warrant certificate properly completed and duly executed at the
corporate trust office of the warrant agent or any other office indicated in the applicable
prospectus supplement, Trinity Biotech will, as soon as practicable, forward the securities
purchasable upon that exercise. If less than all of the warrants represented by a particular
warrant certificate are exercised, a new warrant certificate will be issued for the remaining
warrants.
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Summary of Risks
Before you invest in our securities, you should be aware that there are various risks, which
are described below. You should consider carefully these risks together with all of the other
information included in this prospectus before you decide to purchase our securities.
Trinity Biotechs operating results may be subject to fluctuations.
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Trinity Biotechs operating results may fluctuate as a result of many factors
related to our business, including the competitive conditions in the industry, loss of
significant customers, delays in the development of new products and currency
fluctuations, as described in more detail below, and general factors such as size and
timing of orders and general economic conditions. |
Trinity Biotechs revenues are dependent to a high degree on its relationship with Wampole
Laboratories, a former affiliate of Carter Wallace, Inc.
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During the financial years ended December 31, 2004, December 31, 2003 and December
31, 2002, approximately 7%, 12% and 20% respectively of Trinity Biotechs revenues
were derived from a distribution agreement by and among our subsidiary, Trinity
Biotech (USA) Corp. (trading name of Clark Laboratories, Inc.) and Carter-Wallace,
Inc. and its affiliate Wampole Laboratories. In 2001, Wampole was acquired by
Medpointe, Inc. and was subsequently acquired by Inverness Medical Innovations, Inc.
in 2002. In 2002, Trinity Biotech negotiated an amendment to the distribution
agreement whereby the exclusivity of Inverness Medicals right to sell our products in
the U.S. would be removed in stages throughout 2004. During 2003, we experienced
declining sales revenues under the distribution agreement which we believe was due to
Inverness Medical attempting to convert customers from the Trinity Biotech product to
an alternative product. Accordingly, in December 2003, we filed legal action against
Inverness and Wampole for declaratory judgment and breach of contract. In January
2004, Inverness and Wampole countersued and sought a preliminary injunction to prevent
Trinity Biotech from selling direct in the U.S. any of its products which are
competitive with products sold by Inverness Medical and sourced by other suppliers.
The Superior Court of Middlesex County, Massachusetts, denied the motion for
preliminary injunction on January 28, 2004. In April 2004, Trinity Biotech amended its
complaint to add additional claims alleging breaches of the distribution agreement by
Inverness Medical. In May of 2004, Inverness Medical amended their counterclaims to
add claims alleging, among other things, that Trinity Biotech was selling certain
products without a license. Following the expiration of Inverness Medicals exclusive
distribution rights under the distribution agreement on October 1, 2004, Trinity
Biotech moved to amend its complaint to eliminate the |
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declaratory judgment claims and add additional claims for breach of the
distribution agreement and tortuous interference with advantageous business
relations that had arisen after December 2003. Inverness Medical filed a
cross-motion to amend their complaint. There has been no ruling by the court on
either partys motion. The case is currently in the discovery phase. For further
information relating to this matter, please refer to Item 8 Legal Proceedings in
our Annual Report on Form 20-F. We have decided to sell our products directly in
the U.S. and have increased our direct sales force. Any inability to recapture
lost sales from Inverness Medical may have a material adverse effect on our
business. |
A need for capital might arise in the future if Trinity Biotechs capital requirements increase or
revenues decrease.
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Up to now Trinity Biotech has funded its operations through the sale of its ADRs
and securities convertible into ADRs, revenues from operations and bank borrowings.
Trinity Biotech expects that the proceeds of recent equity financings, bank
borrowings, current working capital and sales revenues will fund its existing
operations and payment obligations for the future. However, if our capital
requirements are greater than expected, or if our revenues are not sufficient to fund
our operations, we may need to find additional financing which may not be available on
attractive terms or at all. Any future financing could have an adverse effect on our
current shareholders or the price of our ADRs in general. |
The diagnostics industry is highly competitive, and Trinity Biotechs research and development
could be rendered obsolete by technological advances of competitors.
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The diagnostics industry is extremely competitive. Trinity Biotech is competing
directly with companies which have greater capital resources and larger marketing and
business organizations than Trinity Biotech. Trinity Biotechs ability to grow
revenue and earnings may be adversely impacted by competitive product and pricing
pressures and by its inability to gain or retain market share as a result of the
action of competitors. We have significantly invested in research and development
(R&D) but there can be no guarantees that our R&D programmes will not be rendered
technologically obsolete or financially non-viable by the technological advances of
our competitors, which would also adversely affect our existing product lines and
inventory. The main competitors of Trinity Biotech (and their principal products with
which Trinity Biotech competes) are Dade Behring (Sysmex® CA, D-Dimer plus,
Enzygnost®), bioMerieux (MDA®, VIDAS), Zeus Scientific Inc. (Zeus EIA, IFA), Diasorin
Inc. (ETI), Abbott Diagnostics (AxSYM, IMx), Diagnostic Products Corp. DPC
(Immulite), Bio-Rad (ELISA & WB), Roche Diagnostics (COBAS AMPLICOR, Ampliscreen,
Accutrend) and OraSure Technologies, Inc. (OraQuick®). |
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Trinity Biotech is highly dependent on suitable distributors worldwide.
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Revenue and earnings stability and growth are directly dependent on the
effectiveness of advertising, marketing and promotional programmes. Trinity Biotech
currently distributes its product portfolio through distributors in over 80 countries
worldwide. Our continuing economic success and financial security is dependent on our
ability to secure effective channels of distribution on favourable trading terms with
suitable distributors. |
Trinity Biotechs business could be adversely affected by changing market conditions resulting in
the reduction of the number of institutional customers.
|
|
|
The healthcare industry is in transition with a number of changes that affect the
market for diagnostic test products. Changes in the healthcare industry delivery
system have resulted in major consolidation among reference laboratories and in the
formation of multi-hospital alliances, reducing the number of institutional customers
for diagnostic test products. There can be no assurance that we will be able to enter
into and/or sustain contractual or other marketing or distribution arrangements on a
satisfactory commercial basis with these institutional customers. |
Trinity Biotechs acquisition strategy may be less successful than expected, and therefore, growth
may be limited.
|
|
|
Trinity Biotech has historically grown organically and through the acquisition of,
and investment in, other companies, product lines and technologies. There can be no
guarantees that recent or future acquisitions can be successfully assimilated or that
projected growth in revenues or synergies in operating costs can be achieved. Our
ability to integrate future acquisitions may also be adversely affected by
inexperience in dealing with new technologies, and changes in regulatory or
competitive environments. Additionally, even during a successful integration, the
investment of managements time and resources in the new enterprise may be detrimental
to the consolidation and growth of our existing business. |
Trinity Biotechs long-term success depends on its ability to develop new products subject to
stringent regulatory control. Even if new products are successfully developed, Trinity Biotechs
patents have a limited life time and are thereafter subject to competition with generic products.
Also, competitors might claim an exclusive patent for products Trinity Biotech plans to develop.
|
|
|
We are committed to significant expenditure on research and development. However,
there is no certainty that this investment in research and development will yield
technically feasible or commercially viable products. Our organic growth and
long-term success is dependent |
12
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|
|
on our ability to develop and market new products but this work is subject to very
stringent regulatory control and very significant costs in research, development
and marketing. Failure to introduce new products could significantly slow our
growth and adversely affect our market share. |
|
|
|
Even when products are successfully developed and marketed, Trinity Biotechs
ownership of the technology behind these products has a finite life. In general,
generic competition, which can arise after the expiration of a patent, can have a
detrimental effect on a products revenue, profitability and market share. There can
be no guarantee that the net income and financial position of Trinity Biotech will not
be adversely affected by competition from generic products. Conversely, on occasion,
certain companies have claimed exclusive patent, copyright and other intellectual
property rights to technologies in the diagnostics industry. If these technologies
relate to Trinity Biotechs planned products, Trinity Biotech would be obliged to seek
licenses to use this technology and, in the event of being unable to obtain such
licenses or it being obtainable on grounds that would be materially disadvantageous to
Trinity Biotech, we would be precluded from marketing such products, which could
adversely impact our revenues, sales and financial position. |
Trinity Biotechs patent applications could be rejected or the existing patents could be
challenged; our technologies could be subject to patent infringement claims; and trade secrets and
confidential know-how could be obtained by competitors.
The following table sets forth the US patents Trinity Biotech currently owns. The table
provides the relevant patent number, a brief description and the remaining life time for each
patent:
|
|
|
|
|
|
|
|
|
Patent life remaining from |
Patent Number |
|
Description |
|
April 30, 2005 |
5,006,474
|
|
Bi-Directional Lateral
Chromatography Test Device
|
|
3 years |
|
|
|
|
|
5,114,845
|
|
Improved Assays for
Plasminogen Activator
Inhibitor and Soluble
Fibrin
|
|
2 years 3 months |
|
|
|
|
|
5,175,087
|
|
Method of Performing
Tissue Plasminogen
Activator Assay
|
|
2 years 3 months |
|
|
|
|
|
5,985,582
|
|
Thrombin-Based Assay for
Antithrombin III
|
|
12 years 8 months |
13
|
|
|
|
|
|
|
|
|
Patent life remaining from |
Patent Number |
|
Description |
|
April 30, 2005 |
6,194,394
|
|
Coagulation controls for
Prothrombin Time (PT) and
Activated Partial
Thromboplastin Time (APTT)
Assays
|
|
13 years 3 months |
|
|
|
|
|
6,528,273
|
|
Methods for quality
control of Prothrombin
Time (PT) and Activated
Partial Thromboplastin
Time (APTT) Assays Using
Coagulation Controls
|
|
13 years 7 months |
|
|
|
|
|
6,391,609
|
|
Thromboplastin Reagents
and Methods for Preparing
and Using Such Reagents
|
|
14 years 6 months |
|
|
|
|
|
6,653,066
|
|
Device and method for
detecting polyvalent
substances
|
|
18 years and 7 months |
In addition to these US patents, Trinity Biotech owns a total of 24 non-US patents.
|
|
|
We can provide no assurance that the patents Trinity Biotech may apply for will be
obtained or that existing patents will not be challenged. The patents owned by
Trinity Biotech and its subsidiaries may be challenged by third parties through
litigation and could adversely affect the value of our patents. We can provide no
assurance that our patents will continue to be commercially valuable. |
|
|
|
|
Also, our technologies could be subject to claims of infringement of patents or
proprietary technology owned by others. The cost of enforcing our patent and
technology rights against infringers or defending our patents and technologies against
infringement charges by others may be high and could adversely affect our business. |
|
|
|
|
Trade secrets and confidential know-how are important to our scientific and
commercial success. Although we seek to protect our proprietary information through
confidentiality agreements and other contracts, we can provide no assurance that
others will not independently develop the same or similar information or gain access
to our proprietary information. |
14
Trinity Biotechs business is heavily regulated, and compliance with applicable regulations could
reduce revenues and profitability.
|
|
|
Our manufacturing and marketing diagnostic test kits are subject to government
regulation in the United States of America by the Food and Drug Administration
(FDA), and by comparable regulatory authorities in other jurisdictions. The
approval process for our products, while variable across countries, is generally
lengthy, time consuming, detailed and expensive. Our continued success is dependent
on our ability to develop and market new products, some of which are currently
awaiting approval from these regulatory authorities. There is no certainty that such
approval will be granted or, even once granted, will not be revoked during the
continuing review and monitoring process. |
We are required to comply with extensive post market regulatory requirements.
Non-compliance with applicable regulatory requirements of the FDA or comparable foreign
regulatory bodies can result in enforcement action which may include recalling products,
ceasing product marketing, paying significant fines and penalties, and similar actions that
could limit product sales, delay product shipment, and adversely affect profitability.
Trinity Biotechs success is dependent on certain key management personnel and qualified staff.
|
|
|
Trinity Biotechs success is dependent on certain key management personnel. Our
key employees are Ronan OCaoimh, our CEO and Chairman, Brendan Farrell, our
President, Dr. Jim Walsh, our COO, and Rory Nealon, our CFO and Secretary, with all of
which we have entered into employment contracts. We carry a life insurance policy for
Mr. OCaoimh in the amount of 533,000. Competition for qualified employees among
biotechnology companies is intense, and the loss of such personnel or the inability to
attract and retain the additional highly skilled employees required for the expansion
of our activities, could adversely affect its business. In the US, Germany and Sweden
we were able to attract and retain qualified staff. In Ireland, we have experienced
some difficulties in attracting and retaining staff due to competition from other
employers in our industry and due to the strength of the Irish economy. |
Trinity Biotech is dependent on its suppliers for the primary raw materials required for its test
kits.
|
|
|
The primary raw materials required for Trinity Biotechs test kits consist of
antibodies, antigens or other reagents, glass fibre and packaging materials which are
acquired from third parties. Although Trinity Biotech does not expect to be dependent
upon any one source for these raw materials and although we have recently acquired a
significant source for |
15
|
|
|
antibodies and antigens, other sources of antibodies with the specificity and
sensitivity desired by Trinity Biotech may not be available. Such unavailability
could affect the quality of our products and our ability to meet orders for
specific products. |
Trinity Biotech may be subject to liability resulting from its products or services.
|
|
|
Trinity Biotech may be subject to claims for personal injuries or other damages
resulting from its products or services. Trinity Biotech has product liability
insurance in place for its US manufacturing subsidiaries up to a maximum of $4,000,000
for any one accident, limited to a maximum of $4,000,000 in any one year period of
insurance. A separate policy is in place for non-US subsidiaries, which are also
covered up to a maximum of 4,000,000 (approximately $5,456,000) for any one
accident, limited to a maximum of 4,000,000 (approximately $5,456,000) in any one
year period of insurance. A deductible of $25,000 is applicable to each insurance
event. There can be no assurance that our product liability insurance is sufficient
to protect us against liability that could have a material adverse effect on our
business. |
Currency fluctuations may adversely affect our earnings and assets.
|
|
|
Trinity Biotech records its transactions in Euro, U.S. dollars and Swedish Kroner
and prepares its financial statements in U.S. dollars. A substantial portion of our
expenses is denominated in Euro. However, Trinity Biotechs revenues are primarily
denominated in U.S. dollars. As a result, we are affected by fluctuations in currency
exchange rates, especially the exchange rate between the U.S. dollar and the Euro.
Fluctuations between these and other exchange rates may adversely affect our earnings
and assets. The percentage of 2004 consolidated revenue denominated in US$ was
approximately 67%. Of the remaining 33% revenue, the breakdown was as follows: Euro
(27%), Sterling (5%), and Swedish Kroner and Yen (1%). Thus, a 10% decrease in the
value of each of the Euro, Sterling, Swedish Kroner and Yen would have approximately a
3% adverse impact on consolidated revenues. As part of the process of mitigating
foreign exchange risk, the principal exchange risk identified by Trinity Biotech was
with respect to fluctuations in the Euro. This is attributable to the level of Euro
denominated expenses exceeding the level of Euro denominated revenues thus creating a
Euro deficit. As part of a managed hedging policy, Trinity Biotech has identified the
extent of this Euro mismatch and implemented a forward currency hedging policy which
aims to cover a portion of this mismatch through the use of forward contracts.
Trinity Biotech entered into a series of forward contracts to sell US$ forward for
Euro. These contracts remain in place until late 2005. Trinity Biotech continues to
monitor its exposure to foreign currency movements. In the medium term, our objective
is to increase the level of non-US$ |
16
|
|
|
denominated revenue, thus creating a natural hedge of the non-US$ expenditure. |
Penny Stock Regulations impose sales practice limitations on broker-dealers who sell our ADRs.
|
|
|
SEC regulations concerning penny stock apply to Trinity Biotechs ADRs. These
regulations impose sales practice requirements on broker-dealers who sell our shares
to persons other than established customers and accredited investors as defined in
SEC regulations. For transactions covered by the regulations, broker-dealers must
make a suitability determination and receive a written agreement from the purchaser
prior to the sale. These regulations may affect the ability of broker-dealers to sell
our ADRs in the secondary market and thus adversely affect our share price. |
The conversion of our outstanding convertible notes and warrants would dilute the ownership
interest of existing shareholders.
|
|
|
The Convertible Notes issued in July 2003 and March 2004, described in the
Financial Statements contained in our Annual Report on Form 20-F, Item 18, Note 9 (e),
and the warrants described in Item 18, Note 10, are convertible into ADRs representing
our Class A Ordinary Shares. Conversion of the remainder of the notes and exercise
of the warrants will likely occur only when the conversion price is below the trading
price of our ADRs and will dilute the ownership interests of existing shareholders.
For instance, should the holders of the Convertible Notes issued in July 2003 decide
to convert the balance of the US$20,000,000 total principal amount of US$11,896,000
and the holders of the Convertible Notes issued in March 2004 decide to convert the
balance of the US$5,000,000 total principal amount of US$4,500,000 into ADRs at
conversion prices of US$3.55 and US$4, respectively, and should the 1,317,324 warrants
be exercised, Trinity Biotech would have to issue 5,793,239 additional ADRs. On the
basis of 55,588,050 outstanding shares at February 28, 2005, this would effectively
dilute the ownership interest of the existing shareholders by approximately 9.4%.
Management also has the option of repaying the Convertible Notes in ordinary shares.
Any such repayment would effectively dilute the ownership interest of the existing
shareholders. In addition, any sales in the public market of the ADRs issuable upon
conversion of the Convertible Notes could adversely affect prevailing market prices of
our ADRs. |
It could be difficult for US holders of ADRs to enforce any securities laws claims against Trinity
Biotech, its officers or directors in Irish Courts.
|
|
|
At present, no treaty exists between the United States and Ireland for the
reciprocal enforcement of foreign judgments. The laws of Ireland do |
17
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|
|
however, as a general rule, provide that the judgments of the courts of the United
States have in Ireland the same validity as if rendered by Irish Courts. Certain
important requirements must be satisfied before the Irish Court will recognize the
United States judgment. The originating court must have been a court of competent
jurisdiction, the judgment may not be recognized if it is based on public policy,
was obtained by fraud or its recognition would be contrary to Irish public policy.
Any judgment obtained in contravention of the rules of natural justice will not be
enforced in Ireland. |
Trinity Biotech is exposed to potential risks and increased costs from the requirements of Section
404 of the Sarbanes Oxley Act of 2002 to evaluate internal controls over financial reporting.
|
|
|
Section 404 of the Sarbanes Oxley Act of 2002 requires that Trinity Biotech
evaluates and reports on the internal controls over financial reporting and have an
auditor attest to such evaluation. We have prepared an internal plan for compliance
and are in the process of documenting and testing the system of internal controls to
provide the basis for this report for the year ended December 31, 2006. Due to ongoing
evaluation and testing of our internal controls and the uncertainties of the
interpretation of these new requirements, we cannot assure that there may not be
significant deficiencies or material weaknesses (in addition to the material
weaknesses disclosed in Item 15 of our Annual Report on Form 20-F) that would be
required to be reported. In the event that significant deficiencies or additional
material weaknesses are reported, investor perceptions may be adversely affected and
could cause a decline in the market price of our stock. |
|
|
|
|
We are spending increased costs and an increased amount of management time and
external resources in order to comply with the above legislation by the end of 2006.
The process of documenting and testing the internal control systems and procedures and
considering improvements has required us to hire additional personnel and outside
advisory services, resulting in additional accounting and consultancy expenses. |
Market Price Data
The Nasdaq SmallCap Market
Our ADRs are traded on the Nasdaq SmallCap Market.
Quarterly Stock Information
The following table sets forth, for the periods indicated, the high and low sale prices for
our ADRs, as reported by Nasdaq.
18
|
|
|
|
|
|
|
|
|
|
|
Per Ordinary Share (US$) |
|
|
High |
|
Low |
Fiscal Year Ended 2003: |
|
|
|
|
|
|
|
|
First Quarter |
|
|
2.44 |
|
|
|
1.25 |
|
Second Quarter |
|
|
3.50 |
|
|
|
2.09 |
|
Third Quarter |
|
|
4.01 |
|
|
|
2.26 |
|
Fourth Quarter |
|
|
6.72 |
|
|
|
2.61 |
|
Fiscal Year Ended 2004: |
|
|
|
|
|
|
|
|
First Quarter |
|
|
5.99 |
|
|
|
3.52 |
|
Second Quarter |
|
|
3.81 |
|
|
|
2.70 |
|
Third Quarter |
|
|
3.42 |
|
|
|
2.36 |
|
Fourth Quarter |
|
|
3.18 |
|
|
|
2.60 |
|
Monthly Stock Information
The following table sets forth, for each of the most recent last six months, the high and low sale
prices for our ADRs, as reported by Nasdaq.
|
|
|
|
|
|
|
|
|
|
|
Per Ordinary Share (US$) |
|
|
High |
|
Low |
Month |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 2004 |
|
|
3.15 |
|
|
|
2.66 |
|
December 2004 |
|
|
2.99 |
|
|
|
2.61 |
|
January 2005 |
|
|
3.02 |
|
|
|
2.65 |
|
February 2005 |
|
|
2.83 |
|
|
|
2.50 |
|
March 2005 |
|
|
2.82 |
|
|
|
2.40 |
|
April |
|
|
2.53 |
|
|
|
1.82 |
|
Notice Regarding Forward-Looking Statements
This prospectus and the documents incorporated in it by reference contain forward-looking
statements which involve known and unknown risks and uncertainties. We include this notice for the
express purpose of permitting Trinity Biotech to avail itself of the protections of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995 for all such forward looking
statements. Examples of forward-looking statements include: (1) projections of capital
expenditures, revenues, growth, prospects, financial resources and other financial matters; (2)
statements of our plans or objectives; and (3) statements using the words anticipate, believe,
estimate, expect, may, intend, plan, project, understand and other verbs suggesting
uncertainty.
19
Our ability to predict results of Trinity Biotechs operations or the effects of certain events on
Trinity Biotechs operating results is inherently uncertain. Therefore, we
caution you to consider carefully the matters described under the caption Summary of Risks and
certain other matters discussed in this prospectus, the documents incorporated by reference in this
prospectus, and other publicly available sources. Such risks and many other factors beyond the
control of Trinity Biotechs management could cause the actual results, performance or achievements
of Trinity Biotech to be materially different from any future results, performance or achievements
that may be expressed or implied by the forward-looking statements.
Use of Proceeds
Unless we identify other uses of proceeds in a prospectus supplement, we intend to use the net
proceeds form the sale of the securities for our general corporate purposes, which may include
repayment of debt, capital expenditures, acquisitions, and working capital. Pending uses, the net
proceeds may also be temporarily invested in short-term securities.
Depending on market conditions and our financial needs, we may, from time to time, undertake
additional financings. We cannot at this time estimate the amount and timing of such financings,
if any.
Plan of Distribution
We may sell the offered securities:
|
|
|
through underwriters or dealers; |
|
|
|
|
directly to a limited number of purchasers or to a single purchaser; or |
|
|
|
|
through agents. |
Any underwriters or agents will be identified and their compensation described in the
applicable prospectus supplement.
We directly or through agents, may sell, and the underwriters may resell, the offered
securities in one or more transactions, including negotiated transactions, at a fixed public
offering price or prices, which may be changed, or at market prices prevailing at the time of sale,
at prices related to prevailing market prices or at negotiated prices.
In connection with the sale of offered securities, the underwriters or agents may receive
compensation from us or from purchasers of the offered securities for whom they may act as agents.
The underwriters may sell offered securities to or through dealers, who may also receive
compensation from purchasers of the offered securities for whom they may act as agents.
Compensation may be in the form of discounts, concessions, commissions or warrants. Any
underwriters, dealers and agents that participate in the distribution of the offered securities may
be underwriters as defined in the Securities Act, and any discounts, concessions, commissions or
warrants received by them from us and
20
any profit on the resale of the offered securities by them
may be treated as underwriting discounts and commissions under the Securities Act.
We will indemnify the underwriters and agents against certain civil liabilities, including
liabilities under the Securities Act.
Underwriters, dealers and agents may engage in transactions with, or perform services for, us
or our affiliates in the ordinary course of their businesses.
If so indicated in the prospectus supplement relating to an issue of offered securities, we
will authorize underwriters, dealers or agents or solicit offers by certain institutions to
purchase the offered securities from us under delayed delivery contracts providing for payment and
delivery at a future date. These contracts will be subject only to those conditions set forth in
the prospectus supplement, and the prospectus supplement will set forth the commission payable for
solicitation of these contracts.
Expenses Associated with the Registration
The expenses relating to the registration of the securities registered pursuant to the
registration statement of which this prospectus is a part are estimated to be approximately
US$35,000, which include the following categories of expenses:
|
|
|
|
|
SEC registration fee |
|
US$ |
8,827.50 |
|
Printing and photocopying |
|
|
5,000 |
|
Legal fees and expenses |
|
|
10,000 |
|
Accounting fees and expenses |
|
|
10,000 |
|
Miscellaneous expenses |
|
|
1,172.50 |
|
|
|
|
|
Total Expenses |
|
US$ |
35,000 |
|
Legal Matters
The validity of any offered securities will be passed upon for Trinity Biotech by ODonnell
Sweeney, Dublin, Ireland, our Irish counsel. Carter Ledyard & Milburn LLP has acted as our U.S.
securities counsel. Certain legal matters with respect to offered securities will be passed upon
for the underwriters, dealers or agents, if any, by their counsel.
Experts
Ernst & Young, Independent Registered Public Accounting Firm, has audited our consolidated
financial statements and schedule included in our Annual Report on Form 20-F for the year ended
December 31, 2004, as set forth in their report, which is incorporated by reference in this
prospectus and elsewhere in the registration statement. Our financial statements are incorporated
by reference in reliance on Ernst & Youngs report, given on their authority as experts in
accounting and auditing.
21
7,260,816 Class A Ordinary Shares
and
Warrants to Purchase 2,178,244 Class A Ordinary Shares
Class A Ordinary Shares Represented by American Depositary Shares
TRINITY BIOTECH PLC
Prospectus Supplement
Roth Capital Partners
April 7, 2008