Form F-3 - Registration statement by foreign private issuers

Registration No. 333-

As filed with the Securities and Exchange Commission on November 15, 2024

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

                                                                

FORM F-3

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

                                                                

TRINITY BIOTECH PLC

 (Exact name of registrant as specified in its charter)

Republic of Ireland (State or other jurisdiction of incorporation or organization)

Not Applicable (I.R.S. Employer Identification No.)

IDA Business Park

Bray, County Wicklow

Ireland

[phone]

(Address and telephone number of registrant's principal executive offices)

 

Puglisi & Associates

850 Library Avenue, Suite 204

Newark, Delaware 19711

Tel. [phone]

 (Name, address and telephone number of agent for service)

                                                                

Copies of all communications, including communications sent to agent for service, should be sent to:

Steven J. Glusband, Esq. Mary Brown, Esq. Carter Ledyard & Milburn LLP  28 Liberty Street New York, New York 10005  [phone]

David Fitzgibbon, Esq. David Jones, Esq. Matheson LLP 70 Sir John Rogerson's Quay Dublin 2 Ireland [phone]

                                                                

Approximate date of commencement of proposed sale to the public: From time to time after the effective date of this Registration Statement.

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If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box.  ☐

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a registration statement pursuant to General Instruction I.C. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box.  ☐

If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.C. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box.  ☐

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

                Emerging growth company  ☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 7(a)(2)(B) of the Securities Act.  ☐

 † The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

                                                                                               

The registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine. Pursuant to the provisions of Rule 429 under the Securities Act, the prospectus contained in this Registration Statement also relates to the Existing F-3 Registration Statement (as defined in the Explanatory Note herein). Upon effectiveness, this Registration Statement will also act as a post-effective amendment to the Existing F-3 Registration Statement.

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The information contained in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED NOVEMBER 15, 2024

TRINITY BIOTECH PLC

 

 

650,000 American Depositary Shares

representing

13,000,000 A Ordinary Shares

 This prospectus relates to the resale, from time to time, by the selling shareholder named in this prospectus or its permitted assigns, of up to 650,000 American Depositary Shares (“ADSs”) (each ADS represents 20 A Ordinary Shares of Trinity Biotech plc (the “Company’), par value $0.0109 per share) that Craig-Hallum Capital Group LLC (“Craig-Hallum” or the “Selling Shareholder”) acquired from us on October 10, 2024 pursuant to a financial advisory agreement between the Company and the Selling Shareholder (the “Advisory Agreement”). 

 

Our ADSs are listed on The NASDAQ Global Select Market (“Nasdaq”) under the symbol “TRIB.”  On November 14, 2024, the closing price of an ADS on The NASDAQ Global Select Market was $1.48. The Selling Shareholder may offer and sell any of the ADSs from time to time at fixed prices, at market prices or at negotiated prices, and may engage a broker, dealer or underwriter to sell the ADSs. For additional information on the possible methods of sale that may be used by the Selling Shareholder, you should refer to the section entitled “Plan of Distribution” elsewhere in this prospectus. We will not receive any proceeds from the sale of any ADSs by the Selling Shareholder. We do not know when or in what amount the Selling Shareholder may offer the ADSs for sale. The Selling Shareholder may sell any, all or none of the ADSs offered by this prospectus.

 

INVESTING IN THE ADSs INVOLVES A HIGH DEGREE OF RISK.  BEFORE BUYING ANY SECURITIES, YOU SHOULD CAREFULLY CONSIDER THE RISK FACTORS DESCRIBED IN “RISK FACTORS” BEGINNING ON PAGE 5 OF THIS PROSPECTUS AND UNDER SIMILAR HEADINGS IN THE OTHER DOCUMENTS THAT ARE INCORPORATED BY REFERENCE INTO THIS PROSPECTUS.

 

NEITHER THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS ARE TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

 

The date of this prospectus is               , 2024.

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TABLE OF CONTENTS

 

	Page
FORWARD‑LOOKING STATEMENTS	1
PROSPECTUS SUMMARY	3
THE OFFERING	4
RISK FACTORS	5
USE OF PROCEEDS	8
CAPITALIZATION	8
SELLING SHAREHOLDER	9
PLAN OF DISTRIBUTION	10
DESCRIPTION OF OUR ADSs	12
TAXATION	12
AUTHORIZED REPRESENTATIVE	12
OFFERING EXPENSES	12
MATERIAL CHANGES	12
LEGAL MATTERS	12
EXPERTS	12
WHERE YOU CAN FIND MORE INFORMATION	13
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE	13
ENFORCEABILITY OF CIVIL LIABILITIES	14

 

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Unless expressly stated otherwise, in this prospectus, references to “we”, “us”, “Trinity Biotech” or the “Group” shall mean Trinity Biotech plc and its world-wide subsidiaries, collectively.  References to the “Company” shall mean Trinity Biotech plc. All references to “dollars” or “$” in this prospectus are to U.S. dollars, and all references to “Euro” or “€” are to European Union Euro.

You should read this document together with the additional information described under the headings “Where You Can Find More Information” and “Incorporation of Certain Information by Reference” in this prospectus.  We have not authorized any dealer, salesperson or other person to give any information or to make any representation and you should not rely upon any information or representation not contained or incorporated by reference in this prospectus.  This prospectus does not constitute an offer to sell or the solicitation of an offer to buy ADSs, nor does this prospectus constitute an offer to sell or the solicitation of an offer to buy ADSs in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should not assume that the information contained in this prospectus is accurate on any date subsequent to the date set forth on the front of the document or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus is delivered or ADS is sold on a later date.

 

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 into 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.

 

This prospectus is not intended to be and is not a prospectus for purposes of: (i) Regulation (EU) 2017/1129 of the European Parliament and of the Council or the European Union (Prospectus) Regulations of Ireland 2019; or (ii) Regulation (EU) 2017/1129 as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 of the United Kingdom, as amended by the Prospectus (Amendment etc.) (EU Exit) Regulations 2019 of the United Kingdom, or the UK Prospectus Regulation. No offer of shares to the public is made, or will be made, that requires the publication of a prospectus pursuant to European prospectus law or the UK Prospectus Regulation. This document has been prepared on the basis that any offer of shares in any relevant European Economic Area member state or the United Kingdom will be made pursuant to an exemption under European prospectus law and the UK Prospectus Regulation from the requirement to publish a prospectus for offers of shares and does not constitute an offer or solicitation to anyone to purchase shares in any jurisdiction in which such an offer or solicitation is not authorized nor to any person to whom it is unlawful to make such an offer or solicitation. This document has not been reviewed or approved by the Central Bank of Ireland nor by any other competent or supervisory authority of any other member state of the European Economic Area or the United Kingdom for the purposes of the EU Prospectus Regulation, or the UK Prospectus Regulation, as applicable. Any representation to the contrary is a criminal offense.

 

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FORWARD‑LOOKING STATEMENTS

 

Some of the statements contained in this prospectus and the documents incorporated by reference are forward-looking statements. Forward-looking statements involve risks and uncertainties, such as statements about our plans, objectives, expectations, assumptions or future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “we believe,” “we intend,” “may,” “should,” “will,” “could” and similar expressions denoting uncertainty or an action that may, will or is expected to occur in the future. These statements involve estimates, assumptions, known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from any future results, performances or achievements expressed or implied by the forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements about:

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the development of future products;

 

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the potential attributes and benefit of our products and their competitive position;

 

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our ability to successfully commercialize, or enter into strategic relationships with third parties to commercialize, our products;

 

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our estimates regarding expenses, future revenues, capital requirements and our need for additional financing;

 

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statements of our plans and objectives;

 

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our ability to acquire or in-license new product candidates;

 

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potential strategic relationships;

 

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the duration of our patent portfolio; and

 

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statements regarding the capabilities of our business operations;

 

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statements of expected future economic performance;

 

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statements regarding competition in our market; and

 

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assumptions underlying statements regarding us or our business.

 

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following:

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our substantial indebtedness, which could impair our flexibility and access to capital and adversely affect our financial position;

 

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our ability to generate or raise sufficient funds to repay our debt as it becomes due and to continue as a going concern;

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our continued listing on the Nasdaq Global Select Market:

 

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pandemics or other public health emergencies, including ongoing effects of the COVID-19 pandemic;

 

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the occurrence of hostilities and political instability, including hostilities between Russia and Ukraine and between Hamas and Israel, and resulting volatility and other effects on global economic conditions;

 

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changes in customer demand;

 

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our ability to successfully develop and commercialize new products, including our new biosensor related products, including our continuous glucose monitoring (“CGM”) product;

 

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recalls of our products or liability claims in connection with our products and services and the cost and reputational harm associated with such recalls or claims and with any voluntary corrective actions or regulatory agency enforcement actions;

 

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delays or failures in our clinical trials and failure to maintain regulatory approvals and clearances to manufacture, market and distribute our products;

 

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interruptions in production at our principal manufacturing facilities, our third-party manufacturing facilities or our suppliers;

 

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the extent to which we are successful in gaining new long-term relationships with customers or retaining existing ones;

 

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developments and changes in laws and regulations, including increased regulation of our industry through legislative action and revised rules and standards;

 

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security breaches, cybersecurity attacks and other significant disruptions;

 

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natural events such as severe weather, fires, floods and earthquakes or man-made or other disruptions of our business and facilities;

 

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strategic actions, including acquisitions and dispositions and our success in integrating acquired businesses; and

 

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our ability to obtain and protect rights to the intellectual property necessary for the conduct of our business and the potential costs of enforcing or defending those rights.

The ultimate correctness of these forward-looking statements depends upon a number of known and unknown risks and events. We discuss our known material risks in the section entitled “Risk Factors” on page 5 of this prospectus and on page 3 in our annual report on Form 20-F for the year ended December 31, 2023 incorporated by reference herein. Many factors could cause our actual results to differ materially from the forward-looking statements. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

The forward-looking statements speak only as of the date on which they are made, and, except as required by law, we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.

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PROSPECTUS SUMMARY

 

This summary highlights selected information contained elsewhere or incorporated by reference in this prospectus. The summary does not contain all the information that you should consider before investing in our ADSs.  You should read the entire prospectus carefully, including “Risk Factors” contained in this prospectus and the documents incorporated by reference in this prospectus, before making an investment decision. Unless otherwise indicated herein, the terms “Trinity Biotech,” the “Company,” “we,” “us” or “our” refer to Trinity Biotech plc.

We and our subsidiaries develop, acquire, manufacture and market medical diagnostic products and services for the clinical laboratory and point-of-care segments of the diagnostic market. These products and services are used to detect and support the management of autoimmune, infectious and sexually transmitted diseases, diabetes and disorders of the liver and intestine.  We have recently entered into the biosensor industry, with the acquisition (the “Waveform Acquisition”) of the biosensor assets of Waveform Technologies Inc. (“Waveform”) and intend to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring (“CGM”) product.

For a full and comprehensive description of our business, markets and product lines, see our most recent Annual Report on Form 20-F and any updates in our Reports of Foreign Private Issuer on Form 6-K, to the extent that they are incorporated herein by reference.

Recent Developments

In July 2024, we entered into an At the Market Offering Agreement with Craig-Hallum pursuant to which the Company may sell its ADSs from time to time in an at the market offering through Craig-Hallum, acting as sales agent (the “ATM Program”). As of the date of the registration statement of which this prospectus forms a part, we have issued a total of 3,344,208 ADSs pursuant to the ATM Program.

On September 24, 2024, we acquired Metabolomics Diagnostics (the “Metabolomics Acquisition”), an Irish deep-tech company, specialized in the development of novel biomarker-based diagnostic solutions for complex diseases. The purchase price was approximately $498,000, with the consideration paid with approximately 270,000 ADSs. Metabolomics Limited had developed a test to accurately predict the risk of preeclampsia in pregnant women. We intend to manufacture the preeclampsia test in-house and commercialize the test in our New York State Department of Health-certified Immco diagnostic reference laboratory, with first revenues from preeclampsia testing expected in 2025.  Given the late stage of development of the test, and significant synergies with our existing capabilities and infrastructure, the additional investment for commercialization in 2025 is expected to be limited.

On October 10, 2024 we issued 650,000 of our ADSs to Craig-Hallum pursuant to the Advisory Agreement. We also issued 361,892 of our ADSs to Native Design Limited pursuant to a design services agreement dated October 10, 2024.

On October 17, 2024, we completed a strategic investment in Novus Diagnostics (the “Novus Investment”), a company pioneering a rapid sepsis testing platform.  We acquired a 12.5% equity interest in Novus Diagnostics, valued at approximately $2.5 million in exchange for approximately 1.4 million of our ADSs.

On October 22, 2024, we acquired EpiCapture Limited (the “EpiCapture Acquisition”) a company developing a non-invasive test for monitoring the risk of aggressive prostate cancer. The purchase price included initial consideration of approximately $3 million, with additional consideration of $0.5 million contingent on the achievement of future milestones. The initial consideration was paid through the issuance of approximately 1.7 million ADSs.

Corporate Information

 

We were incorporated as a private limited company registered in Ireland in January 1992 and subsequently re-registered as a public limited company (“plc”) in July 1992. The Company commenced operations in 1992 and, in October 1992, completed an initial public offering of our securities in the United States. Our principal offices are located at IDA Business Park, Bray, Co. Wicklow, Ireland and our telephone number is [phone]. Our North American headquarters is based at 2823 Girts Rd., Jamestown, NY 14701, USA.  The Company’s website is www.trinitybiotech.com. The information in our website is not incorporated by reference herein.

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THE OFFERING

 

ADSs offered by the selling shareholder	650,000 ADSs (each ADS represents 20 A Ordinary Shares, par value $0.0109 per share).  The offered ADSs are evidenced by ADRs.
A Ordinary Shares outstanding as of November 14, 2024	357,005,182 A Ordinary Shares (which excludes  48,696,672 A Ordinary Shares issuable upon the exercise of options at exercise prices that range from US$0.12-US$1.29 per share, 21,200,000 A Ordinary Shares represented by ADSs issuable upon the exercise of outstanding warrants, and 24,691,358 A Ordinary Shares  represented by ADSs issuable upon conversion of the $20 million convertible note (the “MiCo Convertible Note”) held by MiCo IDV Holdings, LLC (“MiCo”), with an ADS conversion price of $16.20 per ADS).
Use of proceeds	We will not receive any proceeds from the sale of the ‘ADSs offered hereby.
Nasdaq symbol	“TRIB”
Risk Factors	Prospective investors should carefully consider the Risk Factors beginning on Page 5 and under similar headings in the other documents that are incorporated by reference into this prospectus for a discussion of certain factors that should be considered before buying the ADSs offered hereby.

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RISK FACTORS

 

Investing in our securities involves significant risks. Please see the risk factors under the heading “Risk Factors” in our most recent Annual Report on Form 20-F on file with the Commission, as revised or supplemented by our reports subsequently filed after the date hereof with the Commission and incorporated by reference in this prospectus. Before making an investment decision, you should carefully consider these risks as well as other information we include or incorporate by reference in this prospectus. The risks and uncertainties we have described are not the only ones facing our company. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business operations. The occurrence of any of these risks might cause you to lose all or part of your investment in the offered securities. The discussion of risks includes or refers to forward-looking statements; you should read the explanation of the qualifications and limitations on such forward-looking statements discussed elsewhere in this.

 

Risks Related to Ownership of our ADSs

We may encounter difficulties in realizing the potential financial or strategic benefits of recent business acquisitions. We expect to make additional acquisitions in the future that could disrupt our operations and harm our operating results.

 

A significant part of our business strategy is to pursue acquisitions and other initiatives based on a strategy centered on adding complementary solutions to our portfolio—all while we seek to ensure our continued high quality of services and product delivery. In the past year we have made numerous acquisitions including the acquisition of the biosensor assets of Waveform Technologies Inc. and intend to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring (“CGM”) product.

 

Mergers and acquisitions of companies and assets are inherently risky and subject to many factors outside of our control and no assurance can be given that our future acquisitions will be successful and will not adversely affect our business, operating results, or financial condition. In the future, we may seek to acquire or make strategic investments in complementary businesses, technologies, services or products, or enter into strategic partnerships or alliances with third parties in order to expand our business. Failure to manage and successfully integrate such acquisitions could materially harm our business and operating results. Prior acquisitions have resulted in a wide range of outcomes, from successful introduction of new products technologies and professional services to a failure to do so. There can be no assurance that new product enhancements will be made in a timely manner or that pre-acquisition due diligence will have identified all possible issues that might arise with respect to such products. If we acquire other businesses, we may face difficulties, including:

 

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Difficulties in integrating the operations, systems, technologies, products, and personnel of the acquired businesses or enterprises;

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Diversion of management’s attention from normal daily operations of the business and the challenges of managing larger and more widespread operations resulting from acquisitions;

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Integrating financial forecasting and controls, procedures and reporting cycles;

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Potential difficulties in completing projects associated with in-process research and development;

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Difficulties in entering markets in which we have no or limited direct prior experience and where competitors in such markets have stronger market positions;

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Insufficient revenue to offset increased expenses associated with acquisitions; and

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The potential loss of key employees, customers, distributors, vendors and other business partners of the companies we acquire following and continuing after announcement of acquisition plans.

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We may not succeed in our efforts to implement a comprehensive transformation plan to improve the financial performance of our existing business.

In April 2024, we announced the adoption of a transformation plan to improve the financial performance of our existing business. The plan has several key components that we believe are achievable, in most cases by mid-2025, including:

 

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Reducing complexity and cost by consolidating our main manufacturing operations into a considerably smaller number of sites and also moving to an outsourced model for a significant amount of our less complex manufacturing activities;

 

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Reducing the cost of goods of many of our products by changing suppliers and negotiating new deals with existing suppliers:

 

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Continued market acceptance of our new TrinScreen™ HIV rapid point-of-care test;  and

 

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Simplifying our internal operations and optimizing our business support function locations.

          Although we have implemented or are in the midst of implementing a number of these cost-saving initiatives, including consolidating manufacturing, moving some manufacturing offshore to improve our operating margins, and moving significant aspects of our business support functions to a lower cost and centralized location, we cannot assure you that these efforts will be successful or that we can achieve our long-term profitability goals. A failure to achieve these goals will have a material adverse effect on our results of operations and financial condition.

In 2021, certain of our U.S. subsidiaries received loans which were subsequently forgiven under the Paycheck Protection Program under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) which they may not have been eligible to receive. If it is determined that the subsidiaries were ineligible to receive the loans, they may be required to return the proceeds, pay interest and may be subject to other penalties.

In January 2021, two of our U.S. based subsidiaries applied for and received loans totaling approximately $1.8 million under the Paycheck Protection Program (the “PPP”) of the CARES Act. In accordance with the requirements of the CARES Act, as amended by the Paycheck Protection Program Flexibility Act of 2020 (the “PPP Flexibility Act”), the PPP loans were to be forgiven under certain circumstances. In September 2021, the two subsidiaries applied for forgiveness of the loans and those loans were subsequently forgiven. While our subsidiaries believed at the time that they obtained the loans that they met all of the eligibility requirements under the CARES Act, they were notified by the Department of Justice in late October 2024 that the two subsidiaries may have not been eligible to receive those loans. We are currently conducting an internal review of their actions with the assistance of counsel and have not verified whether the U.S. subsidiaries met the eligibility criteria for those loans. If they were not eligible for those loans, we will likely be required to return the proceeds of those loans, pay interest, and may be subject to enforcement proceedings. This may result in adverse publicity and damage to our reputation and have a material adverse effect on our results of operations and financial condition.

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The Nasdaq Global Select Market imposes listing standards on our ADSs that we may not be able to fulfill in the future, thereby leading to a possible delisting of our ADSs.

 

As a listed Nasdaq Global Select Market company, we are subject to various listing standards.  There can be no assurance that we will be able to meet all of the criteria necessary for Nasdaq to allow our ADSs to remain listed.

On November 21, 2023, we received a deficiency letter from the Listing Qualifications Department of Nasdaq (the “Staff”) notifying us that our company was not in compliance with the minimum market value of publicly held shares (“MVPHS”) requirement of the Nasdaq Listing Rules applicable to companies listed on the Nasdaq Global Select Market. For continued listing, registrants are required to maintain a minimum MVPHS of $15 million. A failure to meet the minimum MVPHS requirement exists if the deficiency continues for a period of 30 consecutive business days. In accordance with the Nasdaq Listing Rules, we had 180 calendar days from the date of the deficiency notice, or until May 20, 2024, to regain compliance with the minimum MVPHS requirement.

On May 22, 2024, we received a determination letter (the “Determination Letter”) from the Staff notifying us that we had not regained compliance with the MVPHS Requirement by May 20, 2024 and that, unless we timely requested a hearing before a Hearings Panel (the “Panel”), trading of the ADSs would be suspended and the ADSs would be delisted. On July 16, 2024, the Company met with the Nasdaq Hearings Panel (the “Panel”) to discuss its plan to regain compliance with the MVPHS Requirement and requested an extension until October 31, 2024, to demonstrate compliance. On August 1, 2024, the Panel granted the Company an extension until October 31, 2024, to meet the MVPHS requirement. On November 6, 2024, the Staff notified us that they determined that we had regained compliance with the MVPHS Requirement.  However, there can be no assurance that the ADSs will continue to meet the MVPHS Requirement or other listing requirements.

We had also received a deficiency letter from the Staff, in April of 2023, that for the preceding 30 consecutive business days, the ADSs did not maintain a minimum closing bid price of $1.00 (the “Minimum Bid Price Requirement”) per ADS, as required by Nasdaq Listing Rule 5450(a)(1). To satisfy the Minimum Bid Price Requirement, we effected a change to the number of A Ordinary Shares represented by each ADS on February 23, 2024, pursuant to which the ADS to ordinary share ratio changed from one ADS representing four A Ordinary Shares to one ADS representing 20 A Ordinary Shares (the “ADS Ratio Change”). For existing ADS holders, the ADS Ratio Change had the same effect as a one-for-five reverse ADS split. On March 8, 2024, the Staff notified us that they determined that we regained compliance with Listing Rule 5450(a)(1). However, there can be no assurance that the ADSs will continue to meet the Minimum Bid Price Requirement.

If the ADSs are ultimately delisted from Nasdaq and we are unable to successfully transfer the listing of the ADSs to The Nasdaq Capital Market, the ADSs would likely then trade only in the over-the-counter market and the market liquidity of the ADSs could be adversely affected and their market price could decrease. If the ADSs were to trade on the over-the-counter market, selling the ADSs could be more difficult because smaller quantities of shares would likely be bought and sold, transactions could be delayed, and we could face significant material adverse consequences, including: a limited availability of market quotations for our securities; reduced liquidity with respect to our securities; a determination that our shares are a “penny stock,” which will require brokers trading in our securities to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our securities; a reduced amount of news and analyst coverage for our company; and a decreased ability to issue additional securities or obtain additional financing in the future. These factors could result in lower prices and larger spreads in the bid and ask prices for the ADSs and would substantially impair our ability to raise additional funds and could result in a loss of institutional investor interest and fewer development opportunities for us.

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USE OF PROCEEDS

 

We will not receive the proceeds from the resale of the ADSs by the Selling Shareholder.

 

CAPITALIZATION

 

The following table sets forth our capitalization and indebtedness as of September 30, 2024 as derived from our unaudited balance sheet as of September 30, 2024, which was prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board. The information in this table should be read in conjunction with the audited condensed consolidated interim financial statements for the year ended December 31, 2023 and other financial information incorporated by reference into this prospectus and any prospectus supplement.

The table below presents our capitalization on an actual basis and on an as-adjusted basis to give effect to (a) the issuance of 1,730,603 ADSs in connection with the EpiCapture Acquisition, (b) the issuance of 1,399,985 ADSs in connection with the Novus Investment, (c) the issuance of 361,892 ADSs to Native Design Limited pursuant to a design services agreement, and (d) the issuance of 650,000 ADSs to the Selling Shareholder pursuant to the Advisory Agreement.

 

		As of September 30, 2024
		Actual				As Adjusted
Equity (1):
A Ordinary Shares, par value $0.0109 per share		$	2,377.00			$	2,422.55
Share Premium		$	57,519.00			$	64,371.87
Treasury shares		$	(24,922.00	)		$	24,922.00	)
Reserves		$	984.00			$	984.00
Accumulated deficit		$	(62,300.00	)		$	(63,197.91	)
Total shareholders’ equity		$	(26,342.00	)		$	(20,342.08	)

(1)

The number of A Ordinary Shares issued and outstanding excludes: 48,696,672 A Ordinary Shares issuable upon exercise of stock options outstanding as of September 30, 2024 at exercise prices that range from US$0.12-US$1.29 per share; 21,200,000 A Ordinary Shares represented by ADSs issuable upon the exercise of outstanding warrants; 24,691,358 A Ordinary Shares represented by ADSs issuable upon conversion of the MiCo Convertible Note.

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SELLING SHAREHOLDER

 

We are registering the resale of 650,000 ADSs (representing 13 million A Ordinary Shares) pursuant to the registration rights provisions of the Advisory Agreement.  Craig-Hallum is an investment banking firm based in Minneapolis, MN.  The term “Selling Shareholder” includes the entities identified in the table below (as such table may be amended from time to time by means of an amendment to the registration statement of which this prospectus forms a part or by a supplement to this prospectus) and any permitted assignees of the ADSs from the Selling Shareholder. Craig-Hallam has acted as manager in connection with the Company’s at the market offering pursuant to an at the market offering agreement between the Company and Craig-Hallum, dated July 12, 2024. Except as described herein or in the documents incorporated by reference herein, we did not have any material relationship with the Selling Shareholder prior to the Advisory Agreement.

 

Our registration of the resale of the ADSs covered by this prospectus does not necessarily mean that the Selling Shareholder will sell any or all of the ADSs.

 

The information in the table below is based upon information provided by the Selling Shareholder.

 

Selling Shareholder		Ordinary Shares Beneficially Owned Prior to Offering/ Percentage of Class				Ordinary Shares Being Offered				Ordinary Shares Beneficially Owned Upon Completion of Offering / Percentage of Class
Craig-Hallum(1)			3.6% (2)				13,000,000 A Ordinary Shares (represented by 650,000 million ADSs)			-- %(3)

(1)	Craig-Hallum’s address is 222 South Ninth Street, Suite 350, Minneapolis, Minnesota 55420.

(2)	The A Ordinary Shares represented by the 650,000 ADSs offered hereby.

(3)	Assuming all ADSs representing A Ordinary Shares being registered for resale hereunder are sold.

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PLAN OF DISTRIBUTION

The selling shareholder, may, from time to time, sell, transfer or otherwise dispose of any or all of its ADSs or interests therein on any stock exchange, market or trading facility on which the ADSs are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.

 

The selling shareholder may use any one or more of the following methods when disposing of shares or interests therein:

 

•

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

•

block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction;

 

•

purchases by a broker-dealer as principal and resale by the broker-dealer for its own account;

 

•

an exchange distribution in accordance with the rules of the applicable exchange;

 

•

privately negotiated transactions;

 

•

short sales effected after the date the registration statement of which this prospectus is a part is declared effective by the Commission;

 

•

through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

 

•

through agreements between broker-dealers and the selling shareholder to sell a specified number of such shares at a stipulated price per share;

 

•

a combination of any such methods of sale; and

 

•

any other method permitted by applicable law.

 

In connection with the sale of our ADSs or interests therein, the selling shareholder may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the ADSs or interests therein in the course of hedging the positions they assume. The selling shareholder may also sell ADSs or interests therein short and deliver these securities to close out their short positions, or loan or pledge the ADSs or interests therein to broker-dealers that in turn may sell these securities. The selling shareholder may also enter into options or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to each such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

 

The aggregate proceeds to the selling shareholder from the sale of the ADSs or interests therein offered by the selling shareholder will be the purchase price of such securities less discounts or commissions, if any. The selling shareholder reserves the right to accept and, together with its agents from time to time, to reject, in whole or in part, any proposed purchase of ‘ADSs or interests therein to be made directly or through agents. We will not receive any of the proceeds from this offering.

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The selling shareholder also may resell all or a portion of the ADS or interests therein in open market transactions in reliance upon Rule 144 under the Securities Act of 1933, provided that they meet the criteria and conform to the requirements of that rule.

 

The selling shareholder and any underwriters, broker-dealers or agents that participate in the sale of the ADSs or interests therein may be “underwriters” within the meaning of Section 2(a)(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. If the selling shareholder is an “underwriter” within the meaning of Section 2(a)(11) of the Securities Act, it will be subject to the prospectus delivery requirements of the Securities Act.

 

To the extent required, the ADSs or interest therein to be sold, the name of the selling shareholder, the respective purchase prices and public offering prices, the names of any agents, dealer or underwriter, and any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.

 

In order to comply with the securities laws of some states, if applicable, the ADSs or interests therein may be sold in those jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the ADSs or interests therein may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.

 

We have advised the selling shareholder that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to the activities of the selling shareholder and its affiliates. In addition, to the extent applicable we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the selling shareholder for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling shareholder may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.

 

We have agreed with the selling shareholder to keep the registration statement of which this prospectus constitutes a part effective until the earlier of (1) such time as all of the shares covered by this prospectus have been disposed of pursuant to and in accordance with the registration statement or have been withdrawn.

 

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DESCRIPTION OF OUR ADSs

 

The primary trading market for our ADSs is the NASDAQ Global Select Market, where our ADSs are listed and traded under the symbol “TRIB”. The ratio of ADSs to underlying A Ordinary Shares is 1 ADS : 20 A Ordinary Shares. The Bank of New York Mellon is the depositary for the ADSs pursuant to the deposit agreement filed with the Commission on January 15, 2004 as an exhibit to our Form F-6, registration no. 333-111946.

 

Descriptions of our A Ordinary Shares and ADSs can be found in our Annual Report on Form 20-F for the year ended December 31, 2023, which descriptions are incorporated herein by reference

 

TAXATION

 

A description of taxation affecting our ADSs can be found in our Annual Report on Form 20-F for the year ended December 31, 2023, which description is incorporated herein by reference.

 

AUTHORIZED REPRESENTATIVE

 

Our authorized representative in the United States for this offering as required pursuant to Section 6(a) of the Securities Act is Puglisi & Associates; 850 Library Avenue, Suite 204; Newark, Delaware 19711. We have agreed to indemnify the authorized representative against liabilities under the Securities Act of 1933.

 

OFFERING EXPENSES

 

The following is a statement of expenses in connection with the distribution of the securities registered. All amounts shown are estimates except the Commission registration fee.  The estimates do not include expenses related to offerings of particular securities. Each prospectus supplement describing an offering of securities will reflect the estimated expenses related to the offering of securities under that prospectus supplement.

 

Commission registration fee		$	157.73
EDGAR and printing fees		$	1,000
Legal fees and expenses		$	10,000
Accounting fees and expenses		$	5,500
Miscellaneous		$	2,000
Total		$	18,657.73

 

MATERIAL CHANGES

 

Except as otherwise described in our Annual Report on Form 20-F for the fiscal year ended December 31, 2023, and in our Reports of Foreign Private Issuer on Form 6-K filed under the Exchange Act and incorporated by reference or disclosed herein, no reportable material changes have occurred since December 31, 2023.

 

LEGAL MATTERS

 

Carter Ledyard & Milburn LLP, New York, New York, will be passing upon matters of United States law for us with respect to securities offered by this prospectus.  The validity of the A Ordinary Shares represented by ADSs offered hereby will be passed upon for us by Matheson LLP, Dublin, Ireland.

 

EXPERTS

 

The consolidated financial statements incorporated in this prospectus by reference to the Annual Report on Form 20-F for the year ended December 31, 2023 and the Statement of Assets Acquired and Liabilities Assumed with respect to the asset acquisition from Waveform Technologies, Inc. incorporated in this prospectus by reference to the Report on Form 6-K filed with the Commission on April 30, 2024 have been so incorporated in reliance on the reports of Grant Thornton, an independent registered public accounting firm, upon the authority of said firm as experts in auditing and accounting.

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WHERE YOU CAN FIND MORE INFORMATION

 

This prospectus is a part of a registration statement on Form F-3 that we filed with the Commission under the Securities Act.  We refer you to this registration statement for further plea information about us and the securities offered hereby.

 

 We file annual and special reports and other information with the Commission (Commission File Number 000-22320). These filings contain important information that does not appear in this prospectus. Our SEC filings are also available on the Commission Internet site at www.sec.gov, which contains periodic reports and other information regarding issuers that file electronically.

 

INCORPORATION OF CERTAIN INFORMATION BY REFERENCE

 

We file annual and special reports and other information with the Commission (File Number 000-22320).  These filings contain important information which does not appear in this prospectus. The Commission allows us to “incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to other documents which we have filed or will file with the Commission.  We are incorporating by reference in this prospectus the documents listed below and all amendments or supplements we may file to such documents, as well as any future filings we may make with the Commission on Form 20-F under the Exchange Act before the time that all of the securities offered by this prospectus have been sold or de-registered.  

 

	●	Our Annual Report on Form 20-F for the fiscal year ended December 31, 2023, as filed with the Commission on April 30, 2024, and Amendment No. 1 thereto on Form 20-F/A, as filed with the Commission on July 12, 2024;
	●	Our Reports on Form 6-K furnished to the Commission on April 30, 2024, May 16, 2024, May 28, 2024, July 11, 2024, July 12, 2024, August 7, 2024, August 7, 2024, August 20, 2024, August 21, 2024, August 29, 2024, September 5, 2024 (with materials relating to the Company’s annual general meeting), September 23, 2024, September 25, 2024, September 30, 2024, October 2, 2024, October 25, 2024 (with respect to each of the EpiCapture Acquisition and the Novus Investment), November 7, 2024 and November 15, 2024; and
	●	The description of our ADSs contained in our Form 20-F for the fiscal year ended December 31, 2023 filed with the Commission April 30, 2024.

 

In addition, we may incorporate by reference into this prospectus our reports on Form 6-K filed after the date of this prospectus (and before the time that all of the securities offered by this prospectus have been sold or de-registered) if we identify in the report that it is being incorporated by reference in this prospectus.

 

Certain statements in and portions of this prospectus update and replace information in the above listed documents incorporated by reference.  Likewise, statements in or portions of a future document incorporated by reference in this prospectus may update and replace statements in and portions of this prospectus or the above listed documents.

 

We will provide you without charge, upon your written or oral request, a copy of any of the documents incorporated by reference in this prospectus, other than exhibits to such documents which are not specifically incorporated by reference into such documents. Please direct your written or telephone requests to Trinity Biotech plc, IDA Business Park, Bray, Co. Wicklow, Ireland, Attn: Corporate Secretary, telephone number +(353) 1 276 9800. You may also obtain information about us by visiting our website at www.trinitybiotech.com. Information contained in our website is not part of this prospectus.

You should rely only on the information contained or incorporated in this prospectus. We have not authorized anyone else to provide you with different information. You should not rely on any other representations. Our affairs may change after this prospectus is distributed. You should not assume that the information in this prospectus is accurate as of any date other than the date on the front of those documents. You should read all information supplementing this prospectus.

We are an Irish company and are a “foreign private issuer” as defined in Rule 3b-4 under the Exchange Act.  As a result, (i) our proxy solicitations are not subject to the disclosure and procedural requirements of Regulation 14A under the Exchange Act, (ii) transactions in our equity securities by our officers, directors and principal shareholders are exempt from Section 16 of the Exchange Act; and (iii) we are 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.

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ENFORCEABILITY OF CIVIL LIABILITIES

Service of process upon us and upon our directors and officers and the Irish experts named in this prospectus, most of whom reside outside the United States, may be difficult to obtain within the United States.  Furthermore, because substantially all of our assets and substantially all of our directors and officers are located outside the United States, any judgment obtained in the United States against us or any of our directors and officers may not be collectible within the United States.

 

We have been advised by counsel that the United States currently does not have a treaty with Ireland providing for the reciprocal recognition and enforcement of judgments in civil and commercial matters. Therefore, a final judgment for the payment of money rendered by any U.S. federal or state court based on civil liability, whether or not based solely on U.S. federal or state securities laws, would not automatically be recognized or enforceable in Ireland.

 

A judgment of the U.S. courts will be enforced by the Irish courts, by way of separate action in Ireland,  if the following general requirements are met: (i) the debt is for a liquidated or defined sum; (ii) the procedural rules of the U.S. court must have been observed and the U.S. court must have had jurisdiction in relation to the particular defendant according to Irish conflict of law rules (the submission to jurisdiction by the defendant would satisfy this rule); and (iii) the judgment must be final and conclusive and the decree must be final and unalterable in the court which pronounces it. A judgment can be final and conclusive even if it is subject to appeal or even if an appeal is pending. If the effect of lodging an appeal under the applicable law is to stay execution of the judgment, it is possible that, in the meantime, the judgment should not be actionable in Ireland. It remains to be determined whether final judgment given in default of appearance is final and conclusive. However, the Irish courts may refuse to enforce a judgment of the U.S. courts which meets the above requirements for one of the following reasons: (a) if the judgment is not for a debt or a definite sum of money; (b) if the judgment was obtained or alleged to have been obtained by fraud; (c) if the process and decision of the U.S. Courts were contrary to natural or constitutional justice under the laws of Ireland and if the enforcement of the judgment in Ireland would be contrary to natural or constitutional justice; (d) if the judgment is contrary to Irish public policy or involves certain United States laws which will not be enforced in Ireland or constitute the enforcement of a judgment of a penal or taxation nature; (e) if jurisdiction cannot be obtained by the Irish courts over the judgment debtors in the enforcement proceedings by personal service in Ireland or outside Ireland under Order 11 of the Irish Superior Courts Rules; (f) there is no practical benefit to the party in whose favor the foreign judgment is made in seeking to have that judgment enforced in Ireland, or (g) if the judgment is not consistent with a judgment of an Irish court in respect of the same matter.

 

We have irrevocably appointed Puglisi & Associates as our agent to receive service of process in any action against us in the state and federal courts sitting in the City of New York, Borough of Manhattan arising out of this offering or any purchase or sale of securities in connection therewith. We have not given consent for this agent to accept service of process in connection with any other claim.

 

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TRINITY BIOTECH PLC

650,000 American Depositary Shares

representing

13,000,000 A Ordinary Shares

PROSPECTUS

                                    , 2024

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PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 8. Indemnification of Directors and Officers.

 

The registrant’s constitution provides that every director and other officer of the registrant (other than an auditor) shall be indemnified out of the assets of the registrant against any liability incurred by him in defending any proceedings, whether civil or criminal, in relation to his acts while acting in such office in which judgment is given in his favor or in which he is acquitted or in connection with any application in which relief is granted to him by the court under the Irish Companies Act 2014.

 

Item 9.  Exhibits.

 

The index to exhibits appears below on the page immediately following the signature pages of this Registration Statement.

 

Item 10.  Undertakings.

 

(a)          The undersigned registrant hereby undertakes:

 

(1)

to file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:

 

(i)

to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933 (the “Securities Act”);

 

(ii)

to reflect in the prospectus any facts or events arising after the effective date of this Registration Statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in this Registration Statement.  Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the ‘‘Calculation of Registration Fee’’ table in the effective registration statement; and

 

(iii)

to include any material information with respect to the plan of distribution not previously disclosed in the Registration Statement or any material change to such information in this Registration Statement;

 

provided, however, that paragraphs (i), (ii) and (iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 (the “Exchange Act”) that are incorporated by reference in this Registration Statement or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the Registration Statement.

 

(2)

that, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

(3)

to remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

 

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(4)

to file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A. of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Securities Act of 1933 need not be furnished, provided, that the registrant includes in the prospectus, by means of a post-effective amendment, financial statements required pursuant to this paragraph (4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements. Notwithstanding the foregoing, a post-effective amendment need not be filed to include financial statements and information required by Section 10(a)(3) of the Securities Act of 1933 or Rule 3-19 of Regulation S-X if such financial statements and information are contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in this Form F-3.

 

(5)

that, for the purpose of determining any liability under the Securities Act to any purchaser:

 

(i)

each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be a part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

 

(ii)

each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which the prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof; provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

 

(6)

that, for the purpose of determining liability of a registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 

(i)

any preliminary prospectus or prospectus of the undersigned registrant to the offering required to be filed pursuant to Rule 424;

 

(ii)

any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by an undersigned registrant;

 

(iii)

the portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

 

(iv)

any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

 

(b)

The registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in this Registration Statement shall be deemed to be a new registration statement relating to the securities offered herein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

(c)

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions referred to in Item 8, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Act, the registrant certifies that it has reasonable grounds to believe that it complies with all of the requirements for filing on Form F-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Dublin, Ireland, on November 15, 2024.

 

	TRINITY BIOTECH PLC
	By:	/s/ John Gillard
		John Gillard Chief Executive Officer

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POWER OF ATTORNEY

 

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints John Gillard as his true and lawful attorney-in-fact and agent, with full powers of substitution and re-substitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Registration Statement and any and all additional registration statements pursuant to Rule 462(b) of the Securities Act of 1933, as amended, and to file the same, with all exhibits thereto, and all other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite and necessary to be done, as fully for all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or either of them or their or his substitute or substitutes, may lawfully do or cause to be done by virtue thereof.

 

Pursuant to the requirements of the Securities Act, this Registration Statement has been signed below on November 15, 2024 by or on behalf of the following persons in the capacities indicated.

Signature		Title
/s/ John Gillard		Chief Executive Officer (Principal Executive Officer), Company Secretary and Director
John Gillard
/s/ Louise Tallon		Chief Financial Officer (Principal Accounting Officer)
Louise Tallon
/s/ James Walsh		Director
James Walsh
/s/ Ronan O’Caoimh		Director
Ronan O’Caoimh
/s/ Thomas Lindsay		Director
Thomas Lindsay
/s/ Andrew Omidvar		Director
Andrew Omidvar

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SIGNATURE OF AUTHORIZED REPRESENTATIVE IN THE UNITED STATES

Pursuant to the requirements of the Securities Act of 1933, as amended, the undersigned, the duly authorized representative in the United States of the Registrant, has signed this registration statement on November 15, 2024.

Puglisi & Associates

By:	/s/ Donald J. Puglisi
Name:	Donald J. Puglisi
Title:	Managing Director

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Exhibit No.	Description of Exhibit
4.1	Constitution of Trinity Biotech plc (included as Exhibit 1.1 to our Annual Report on Form 20-F (File No. 000-22320 as amended by Form 20-F/A filed with the Commission on May 25, 2022).
4.2	Form of Deposit Agreement dated as of October 21, 1992, as amended and restated, among Trinity Biotech plc, The Bank of New York as Depositary, and all Owners and holders from time to time of American Depositary Receipts issued thereunder (included as Exhibit 1 to our Form F-6 (File No. 333-111946), filed with the Commission on January 15, 2004).
5.1	Opinion of Matheson LLP
23.1	Consent of Grant Thornton
23.2	Consent of Matheson LLP (contained in Exhibit 5.1)
24.1	Power of Attorney (included in the signature page to the Registration Statement)
107.1	Filing Fee Table

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EXHIBIT 5.1

Trinity Biotech plc   IDA Business Park Bray Co. Wicklow Ireland Private and Confidential

Our Ref		15 November 2024
DJ/TB/LC 4031/2

Dear Trinity Biotech plc

 

Registration Statement on Form F-3

We have acted as Irish counsel to Trinity Biotech plc, a public limited company incorporated under the laws of Ireland (company number 183476) (the “Company”) in connection with the registration statement on Form F-3 (the “Registration Statement”) to be filed by the Company  with the U.S. Securities and Exchange Commission (the “Commission”) under the U.S. Securities Act of 1933, as amended (the “Securities Act”) on or around the date hereof.  The Registration Statement relates to the resale, from time to time, by the Selling Shareholder named in the Registration Statement, or its permitted assigns, of up to 650,000 (“ADSs”) (each ADS represents 20 A Ordinary Shares, par value $0.0109 per share (an “Ordinary Share”)) (the Ordinary Shares represented by the ADSs, the “Shares”).

In connection with this Opinion, we have reviewed and relied upon the corporate resolutions, records and other documents and searches listed in Schedule 1 to this Opinion (the “Documents”) and such corporate resolutions, records and other documents as referred to in any of the Documents.

Based on the foregoing, and subject to the assumptions, qualification and limitations set out in Schedule 2, Schedule 3 and elsewhere in this Opinion, we are of the opinion that:

1.	the Company is a public limited company, duly incorporated and validly existing under the laws of Ireland;

2.

the Shares, subject to their issuance having been made in accordance with all necessary corporate action of the Company (including a valid resolution of the board of directors of the Company or a duly appointed committee thereof) and the provisions of the Company’s constitution, and subject to the full consideration payable therefor having been received by the Company, are validly issued, fully-paid and non-assessable (“non-assessable” is a phrase which has no defined meaning under Irish law, but, for the purposes of this Opinion, shall mean that the registered holders of shares are not subject to calls for additional payments on such shares);

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This Opinion is based upon, and limited to, the laws of Ireland in effect on the date hereof and is based on legislation published and cases fully reported before that date and our knowledge of the facts relevant to the opinions contained herein. We have assumed, without enquiry, that there is nothing in the laws of any jurisdiction other than Ireland which would, or might, affect our opinions as stated herein. We have made no investigations of, and we express no opinion on, the laws of any jurisdiction other than Ireland, or the effect thereof. This Opinion is expressed as of the date hereof and we assume no obligation to update this Opinion.

This Opinion is furnished to you and the persons entitled to rely upon it pursuant to the applicable provisions of the Securities Act strictly for use in connection with the Registration Statement and may not be relied upon by any other person without our prior written consent. This Opinion is confined strictly to the matters expressly stated herein and is not to be read as extending, by implication or otherwise, to any other matter.

We hereby consent to the filing of this Opinion as Exhibit 5.1 to the Registration Statement and to the reference to Matheson LLP in the prospectus constituting a part of the Registration Statement. In giving such consent, we do not admit that we are included in the category of persons whose consent is required under section 7 of the Securities Act, or the rules and regulations of the Commission promulgated thereunder.

This Opinion and the opinions given in it are governed by, and construed in accordance with, the laws of Ireland.

Yours faithfully

/s/ Matheson LLP

MATHESON LLP

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Schedule 1

Documents

1.	A certificate executed by Mr. John Gillard, the Chief Executive Officer of the Company, dated the same date as this Opinion Letter as to certain matters to be relied on by us (the "Corporate Certificate").

 

2.	A copy of the constitution of the Company, which is currently in force as appended at appendix A to the Corporate Certificate.

 

3.	The Registration Statement, as filed with the U.S. Securities and Exchange Commission on the date hereof.

 

4.

Searches carried out by independent law researchers on our behalf against Trinity Biotech plc on 15 November 2024 in (i) the Index of Petitions and Winding-up Notices maintained at the Central Office of the High Court of Ireland, (ii) the Judgments’ Office of the Central Office of the High Court of Ireland and (iii) the Companies Registration Office.

 

5.	A copy of minutes of the meeting the board of directors of the Company dated 8 October 2024.

 

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Schedule 2

 

Assumptions

 

For the purposes of this Opinion, we have assumed:

 

1.	The truth and accuracy of the contents of the Documents as to factual matters, but have made no independent investigation regarding such factual matters.

 

2.	All signatures (including, for the avoidance of doubt, electronic signatures), initials, seals and stamps contained in, or on, the Documents submitted to us are genuine.

 

3.

Any electronic signature inserted on a Document was inserted by the signatory in question and not by another person and, where attested by a witness, was inserted in the physical presence of the witness, and each other party to any Document which has been executed using an electronic signature has consented to the execution by the Company of that Document by way of electronic signature.

 

4.

All Documents submitted to us as originals are authentic and complete and all Documents submitted to us as copies (including without limitation any document submitted to us as a .pdf, or any other format, attachment to an email) are complete and conform to the originals of such Documents, and the originals of such Documents are authentic and complete.

 

5.	Any Document furnished to us in unsigned or unexecuted form will be duly signed or executed (as the case may be) in substantially the same form as that reviewed by us for the purposes of this Opinion.

 

6.

The copy produced to us of the minutes of the meeting of the board of directors of the Company dated 8 October 2024 is a true copy of the minutes and accurately record the resolutions duly passed and approved, by the directors acting bona fide in the interests of the Company and in accordance with the provisions contained in the Companies Act 2014 (the “Companies Act”) and / or the Company's constitution.

 

7.	The filing of the Registration Statement with the Commission has been authorised by all necessary actions under all applicable laws other than Irish law.

 

8.	There are no contractual or similar restrictions or other arrangements binding on the Company which could affect the conclusions in this Opinion.

 

9.

Any power of attorney granted by the Company in respect of the allotment and issue of the Shares shall have been duly granted, approved and executed in accordance with the Company's constitution, the Companies Act, the Powers of Attorney Act,1996 and all other applicable laws, rules and regulations.

 

10.	The Corporate Certificate is accurate in all respects (other than in relation to any matter of Irish law on which we expressly opine).

 

11.

Each party to the Documents (other than the Company) had (when it entered into), and continues to have, the due and requisite capacity, power and authority to enter into, execute and perform its obligations under the Documents, and the Documents are, and will not become, subject to avoidance by any person under all applicable laws in any applicable jurisdictions (other than, in the case of the Company, the laws of Ireland and the jurisdiction of Ireland).

 

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12.	All Documents dated on or prior to the date hereof and on which we have expressed reliance have not been revoked or amended and remain accurate.

 

13.

The resolutions of the shareholders of the Company and of the board of directors of the Company on which we have placed reliance (including as referred to in the Corporate Certificate) were duly passed at a properly constituted, convened and quorate meeting of the shareholders and the board of directors of the Company respectively, and such resolutions have not been amended or rescinded and are in full force and effect.

 

14.

When filed with the Commission, the Registration Statement will not differ in any material respect from the drafts that we have examined and that the Registration Statement and amendments to the Registration Statement (including post-effective amendments) will have become effective under the Securities Act.

 

15.	A complete prospectus supplement will have been prepared and filed with the Commission describing the Shares offered thereby.

 

16.

All securities issued and sold under the Registration Statement have been issued and will be sold in compliance with all applicable laws (other than Irish law), including applicable federal and state securities laws, in the manner stated in the Registration Statement and the appropriate prospectus supplement.

 

17.	A definitive purchase, underwriting or similar agreement with respect to the Shares offered will have been duly authorised and validly executed and delivered by the Company and the other parties thereto.

18.

The Company will derive a commercial benefit from entering into any document referred to in, or contemplated by, the Registration Statement (including the prospectus contained therein and any prospectus supplement) in connection with the issue the Shares (a "Relevant Document") and derived a commercial benefit from issuing Shares.

 

19.	In approving the entry into any Relevant Document, the directors of the Company have acted in a manner they consider, in good faith, to be in the interests of the Company for its legitimate business purposes and which would be likely to promote the success of the Company for its members as a whole.

 

20.

At the time of the allotment of any Shares (including upon the grant or issuance of any rights, or securities conferring rights, to be allotted or which are convertible into Shares (“Convertible Rights”), the Company had a sufficient number of authorised but unissued Ordinary Shares in its share capital (being at least equal to the number of Ordinary Shares the subject of the relevant allotment). For the avoidance of doubt, an “allotment” includes an agreement to allot Shares.

 

21.

At the time of the allotment of the Shares (including upon the grant or issuance of any Convertible Right, to the extent required: (a) the directors of the Company, in accordance with section 1021 of the Companies Act, had been generally and unconditionally authorised by the shareholders of the Company to allot a sufficient number of “relevant securities” (within the meaning of that section), being at least equal to the number of Ordinary Shares the subject of such allotment (including upon the grant or issuance of a Convertible Right) and (b) the directors of the Company, in accordance with section 1023 of the Companies Act, had been empowered by the shareholders of the Company to allot such Ordinary Shares or to grant or issue such Convertible Rights as if section 1022(1) of the Companies Act did not apply to such allotment.

 

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22.	Where treasury shares are being re-issued, the maximum and minimum prices of re-issue shall have been determined in advance at a general meeting of the Company in accordance with the requirements of section 1078 of the Companies Act.

 

23.	No Share was allotted and issued for less than its nominal value, and no Share was allotted and issued for consideration other than cash save in accordance with the provisions of sections 1027, 1028 and 1029 of the Companies Act.

 

24.

No Share was allotted and issued: (a) for consideration of an undertaking from any person that he, she or another will do work or perform services for the Company or for any other person, (b) for consideration otherwise than in cash that includes an undertaking which is to be or may be performed more than five years after the date of allotment or (c) for other consideration which, from time to time, is not considered good or adequate consideration.

 

25.	The Shares were issued by the entry of the name of the registered holder thereof in the register of members of the Company confirming that such Share has been issued fully paid-up.

 

26.

The Company has not, by virtue of or in connection with any Shares allotted or issued, given any financial assistance, as contemplated by sections 82 and 1043 of the Companies Act for the purpose of any acquisition of shares in the capital of the Company or any company which, from time to time, is the holding company of the Company, save as permitted by, or pursuant to an exemption to, the said sections 82 and 1043.

 

27.	The Companies Act will continue in full force and have effect without amendment, revision, repeal or replacement as and from the date of this Opinion.

 

28.	From the date of this Opinion, no corporate, shareholder or other action will be taken to amend, alter or repeal the Company's constitution.

 

29.	From the date of this Opinion, no corporate, shareholder or other action will be taken to redesignate or reclassify the Shares or create any other classes of share in the capital of the Company.

 

30.	The Company will continue to renew its authority to issue the Shares in accordance with the terms and conditions set out in the Company’s constitution and the Companies Act and that, where such authority has not been renewed, the Company will not issue the Shares after such authority has expired.

 

31.

In approving the allotment, issue, and / or sale of the Shares, there was no intent by the directors and / or any duly authorised officer of the Company acting under delegated authority to give a creditor a preference which could be deemed to be an unfair preference in accordance with section 604 of the Companies Act.

 

32.

The obligations expressed to be assumed by each party to any Relevant Document are legal, valid, binding and enforceable obligations under all applicable laws and in all applicable jurisdictions, other than, in the case of the Company, the laws of Ireland and the jurisdiction of Ireland and any obligations expressed to be assumed by each party to any Relevant Document(s) will be legal, valid, binding and enforceable obligations under all applicable laws and in all applicable jurisdictions, including the laws of Ireland and the jurisdiction of Ireland.

 

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33.

If any obligation of any of the parties under any Relevant Document or any supplemental Relevant Document(s) is to be performed in any jurisdiction other than Ireland, its performance will not be illegal or ineffective by virtue of the laws of that jurisdiction and there are no provisions of the laws or public policy of any jurisdiction outside Ireland which would be contravened by the execution or performance of any Relevant Document or any supplemental Relevant Document(s) or which would render their performance ineffective by virtue of the laws of that jurisdiction.

 

34.

Any Relevant Document(s) and the transactions contemplated thereby and the payments made or to be made thereunder were not, are not and will not be affected by any financial restrictions or sanctions arising from orders made by the Irish Minister for Finance under the Financial Transfers Act 1992 of Ireland and / or section 42 of the Criminal Justice (Terrorist Offences) Act 2005 of Ireland or the Criminal Justice (Money Laundering and Terrorist Financing) Act 2010 of Ireland.

 

35.

All authorisations, approvals, licences, exemptions or consents of governmental or regulatory authorities with respect to the agreements or arrangements referred to in the Registration Statement (including the prospectus contained therein and any prospectus supplement) or with respect to the issue, offer or sale of the Shares (other than, in the case of the Company, the governmental or regulatory authorities of Ireland) have been, or will be, obtained and are, or will be, in full force and effect, all Shares will conform with the descriptions contained in the Registration Statement (including the prospectus contained therein and any prospectus supplement) and, subject to such changes as may be required in order to comply with any requirement of Irish law, the selling restrictions contained in the Registration Statement (including the prospectus and any supplemental prospectus) have been and will, at all times, be observed and the Company will otherwise comply with the terms of any other lawful agreements relating to the issue, sale and / or offer of any Shares.

 

36.

The creation, issuance, offer or sale, including the marketing, of any Shares was be made, effected and conducted in accordance with and will not otherwise violate any applicable laws and regulations of any jurisdiction, including Ireland, or supra-national authority, including, without limitation: (a) the securities laws and regulations of any jurisdiction or supra-national authority which impose any restrictions, or mandatory requirements, in relation to the offering or sale of the Shares to the public in any jurisdiction, including the obligation to prepare a prospectus or registration document relating to any Shares and (b) any requirement or restriction imposed by any court, governmental body or supra-national authority having jurisdiction over the Company or the members of its group.

 

37.

That: (a) the Company was, and continued to be fully solvent at the time of and immediately following the issue of the Shares, (b) no resolution or petition for the appointment of a liquidator or examiner was passed or presented prior to the issue of the Shares, (c) no receiver had been appointed in relation to any of the assets or undertaking of the Company prior to the issue of the Shares and (d) no composition in satisfaction of debts, scheme of arrangement, or compromise or arrangement with creditors or members (or any class of creditors or members) was proposed, sanctioned or approved in relation to the Company prior to the issue of the Shares.

 

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38.

The information disclosed by the Searches was accurate and complete as of the date the Searches were made and has not been altered, and the Searches did not fail to disclose any information which had been delivered for registration but which did not appear from the information available at the time the Searches were made or which ought to have been delivered for registration at that time but had not been so delivered. No additional matters would have been disclosed by searches being carried out since that time.

 

39.

No proceedings had been or will be instituted or injunction granted against the Company to restrain it from issuing the Shares and the issue or giving of same would not be contrary to any state, government, court, state or quasi-governmental agency, licencing authority, local or municipal government body or regulatory authority’s order, direction, guideline, recommendation, decision, licence or requirement.

 

40.	The absence of fraud and the presence of good faith on the part of all parties to the Documents and any other relevant documents and their respective officers, employees, agents and advisors.

 

41.	No Shares will be listed or traded on a stock exchange or other market in the European Economic Area.

 

42.	The issue of the Shares was in compliance with the Companies Act, the Takeover Panel Act, 1997, Takeover Rules, 2022, and all other applicable Irish company, takeover, securities, market abuse, insider dealing laws and other rules and regulations.

 

43.

The Registration Statement does not constitute (and is not intended / required to constitute) a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council (the "EU Prospectus Regulation"), that no offer of Shares to the public was or is made, or will be made, that required or requires the publication of a prospectus pursuant to European or Irish prospectus law in general, or, in particular, pursuant to the EU Prospectus Regulation and that the Shares are not and will not be admitted to trading on a regulated market as such term is defined in Article 4(1) of Directive 2014/65/EU of the European Parliament and of the Council.

 

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Schedule 3

Qualifications

The opinions in this Opinion are subject to the following qualifications:

 

1.

A search at the Companies Registration Office is not conclusively capable of revealing whether or not a winding-up petition or a petition for the appointment of an examiner, receiver or liquidator has been presented or a resolution passed for the winding-up of the Company. A search on the Index of Petitions and Winding-up Notices maintained at the Central Office of the High Court of Ireland is not capable of revealing whether or not a receiver has been appointed in respect of the Company.

 

2.

Whilst each of the making of a winding-up order, the making of an order for the appointment of an examiner or the appointment of a receiver may be revealed by a search at the Companies Registration Office it may not be filed at the Companies Registration Office immediately and, therefore, our searches at the Companies Registration Office may not have revealed such matters. Similarly whilst a petition to wind-up the Company may be revealed by a search on Index of Petitions and Winding-up Notices maintained at the Central Office of the High Court of Ireland, the making of a winding-up order may not be filed on the Index immediately and therefore our searches may not have revealed such matters.

 

3.	The position reflected in the Searches may not be fully up to date.

 

4.

The expressions “validly” and “valid and binding” when used in this Opinion mean that the obligations expressed to be assumed are of a type which the courts of Ireland will treat as valid and binding. It does not mean that these obligations will necessarily be enforced in all circumstances in accordance with their terms. In particular, enforcement of obligations may be:

 

(a)

limited by general principles of equity, in particular, equitable remedies (such as an order for specific performance or an injunction) which are discretionary and are not available where damages are considered to be an adequate remedy;

 

(b)

subject to any limitations arising from examinership, administration, bankruptcy, insolvency, moratoria, receivership, liquidation, reorganisation, court scheme of arrangement, arrangement and similar laws affecting the rights of creditors;

 

(c)

limited by the provisions of the laws of Ireland applicable to contracts held to have been frustrated by events happening after their execution;

 

(d)

invalidated if and to the extent that performance or observance arising in a jurisdiction outside Ireland would be unlawful, unenforceable, or contrary to public policy or to the exchange control regulations under the laws of such jurisdiction;

 

(e)

invalidated by reason of fraud; and

 

(f)

barred under the Statutes of Limitations of 1957 of Ireland (as amended).

 

5.

The Companies Act prohibits certain steps being taken except with the leave of the court against a company after the presentation of a petition for the appointment of an examiner. This prohibition continues if an examiner is appointed for so long as the examiner remains appointed (maximum period of one hundred days or such period as the court in question may determine). Prohibited steps include steps taken to enforce any security over the company’s property, the commencement or continuation of proceedings or execution or other legal process or the levying of distress against the company or its property and the appointment of a receiver.

 

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6.

Under the provisions of the Companies Act, an examiner can be appointed on a petition to the Circuit Court, if certain criteria are met. It is not possible for anyone other than a party to the relevant proceedings or the solicitors on record for such parties to inspect the Circuit Court files to ascertain whether a petition for the appointment of an examiner has been made in the Circuit Court, and we have made no searches or enquiries in this regard in respect of the Company.

 

7.

A contractual provision conferring or imposing a remedy or an obligation consequent upon default may not be enforceable if it were construed by an Irish court as being a penalty, particularly if it involved enforcing an additional pecuniary remedy (such as a default or overdue interest) referable to such default and which does not constitute a genuine and reasonable pre-estimate of the damage likely to be suffered as a result of the default in payment of the amount in question or the termination in question; further, recovery may be limited by laws requiring mitigation of loss suffered.

 

8.	An Irish court may not give effect to an indemnity given by any party to the extent it is in respect of legal costs incurred by an unsuccessful litigator or to the extent that it is in respect of litigation costs which are not awarded by the court.

 

9.

In the event of any proceedings being brought in an Irish court in respect of a monetary obligation expressed to be payable in a currency other than euro, an Irish court would have the power to give a judgment to pay a currency other than euro but may decline to do so in its discretion and an Irish court might not enforce the benefit of currency conversion or indemnity clauses and, with respect to a bankruptcy, liquidation, insolvency, reorganisation or similar proceeding, the laws of Ireland may require that all claims or debts be converted into euro at an exchange rate determined by the court as at a date related thereto, such as the date of commencement of a winding-up.

 

10.	This Opinion does not deal with the tax (including stamp duty) treatment of the issuance, transfer and/or assignment of the Shares or any payments in respect of the Shares or any other tax matter.

 

11.	Where a party is vested with a discretion or may determine a matter in his or its opinion, the laws of Ireland may require that such discretion is exercised reasonably or that such opinion is based upon reasonable grounds.

 

12.	An Irish court may not give effect to any provision of a contract which (a) provides for a matter to be determined by future agreement or negotiation or (b) it considers to be devoid of any meaning, vague or uncertain.

 

13.	A right of set-off provided for in a contract or another document may not be enforceable in all circumstances.

 

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EXHIBIT 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We have issued our reports dated April 30, 2024 with respect to (i) the consolidated financial statements of Trinity Biotech plc included in the Annual Report on Form 20-F for the year ended December 31, 2023, and (ii) the Waveform Technologies, Inc. Statement of Assets Acquired and Liabilities Assumed as of January 30, 2024, which are included in Form 6-K filed on April 30, 2024, which are incorporated by reference in this Registration Statement. We consent to the incorporation by reference of the aforementioned reports in this Registration Statement and to the use of our name as it appears under the caption “Experts.”

 

/s/ GRANT THORNTON

 

Dublin, Ireland

November 15, 2024

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EXHIBIT 107.1

 

CALCULATION OF FILING FEE TABLE

 

Form F-3

(Form Type)

 

TRINITY BIOTECH PLC

(Exact Name of Registrant as Specified in its Charter)

 

Newly Registered Securities

Security Type	Security Class Title	Fee Calculation Rule	Amount to be Registered (2)	Proposed maximum offering price per share (3)	Proposed maximum aggregate offering price (3)	Fee Rate	Amount of registration fee
Equity	A Ordinary Shares, par value $0.0109 per share(1)	457(c)	13,000,000	$0.0793	$1,030,900.00	$153.10 per $1,000,000	$157.73
Total Offering Amount:					$1,030,900.00		$157.73
Net Fees Due:							$157.73

(1)

The A Ordinary Shares registered hereby are evidenced by American Depositary Shares (“ADSs”). ADSs (each representing 20 A Ordinary Shares, par value $0.0109 per share), have been registered on separate registration statements on Form F-6 filed on July 20, 1992 and January 15, 2004 (File No. 333-111946).

 

(2)

The 13 million A Ordinary Shares are represented by 650,000 ADSs held by the selling shareholder. The registration statement also includes an indeterminate number of A Ordinary Shares underlying the ADSs that may become issuable to prevent dilution resulting from stock splits, stock dividends and similar transactions, which are included pursuant to Rule 416 under the Securities Act of 1933, as amended.

 

(3)

Estimated solely for the purpose of calculating the amount of the registration fee pursuant to Rule 457(c) under the Securities Act of 1933, as amended, and based on the average high and low prices of the registrant’s ADSs on the NASDAQ Select Market on November 13, 2024 of $1.585 per ADS (to give effect to the 20:1 ratio of A Ordinary Shares to ADSs).

 

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