Washington, D.C.  20549

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REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of September 2024

(Name of Registrant)

IDA Business Park

Bray, County Wicklow, Ireland

 (Address of Principal Executive Office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒    Form 40-F ☐    

 EXPLANATORY NOTE

A copy of the Trinity Biotech plc Annual Report 2023 is furnished herewith as Exhibit 99.1.

EXHIBIT INDEX

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date:  September 5, 2024

Exhibit 99.1

TABLE OF CONTENTS
	Page
Corporate Information	2
Market, Industry and Other Data	3
Cautionary Statement Regarding Forward-Looking Statements	3
Board of Directors & Executive Officers	4
Business Overview	5
Directors’ Report	9
Statement of Directors’ Responsibilities in respect of the annual report and the   financial statements	21
Risk Factors	22
Performance Review	49
Independent Auditor’s Report to the members of Trinity Biotech plc	53
Financial Statements
Consolidated Statement of Operations	59
Consolidated Statement of Comprehensive Income	60
Consolidated Statement of Financial Position	61
Consolidated Statement of Changes in Equity	62
Consolidated Statements of Cash Flows	63
Notes to the Consolidated Financial Statements	64
Company Statement of Comprehensive Income	142
Company Statement of Financial Position	143
Company Statement of Changes in Equity	144
Company Statement of Cash Flows	145
Notes to the Company Financial Statements	146

Mr Ronan O’Caoimh
Dr Jim Walsh
Mr John Gillard
Mr Aris Kekedjian	US	Resigned 17 December 2023
Mr Tom Lindsay	UK	Appointed 29 September 2023
Dr Andrew Omidvar	US	Appointed 29 September 2023

•

the development of our products;

•

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

•

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

•

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

•

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

•

potential strategic relationships; and

•

the duration of our patent portfolio.

•

Infectious diseases;

•

Glycated haemoglobin (for diabetes monitoring and diagnosis) and haemoglobin variants for the detection of haemoglobinopathies (haemoglobin abnormalities); and

•

Autoimmune diseases.

•

Sexually transmitted diseases, including Syphilis and Herpes;

•

Markers for Epstein Barr, Measles, Mumps, Toxoplasmosis, Cytomegalovirus, Rubella, Varicella and other viral pathogens, and

•

SARS-CoV-2.

•

Immunofluorescence Assay (“IFA”);

•

Enzyme-linked immunosorbent (“ELISA”);

•

Western Blot (“WB”); and

•

Line immunoassay (“LIA”).

		2023				2022
		US$’000				US$’000
Revenue			56,832				62,521
Operating loss			(27,045	)			(19,349	)
Loss for the year			(24,018	)			(41,009	)

		US$’000
ASSETS ACQUIRED
Non-current assets
Property, plant and equipment			1,569
Goodwill			12,071
Other intangible assets			9,360
Financial assets			9
Total non-current assets			23,009
Current assets
Inventory			1,296
Other receivables			135
Total current assets			1,431
Total assets acquired			24,440
LIABILITIES ASSUMED
Current liabilities
Trade and other payables			50
Total current liabilities			50
Non-current liabilities
Deferred tax liability			1,170
Total non-current liabilities			1,170
Total liabilities assumed			1,220
NET ASSETS ACQUIRED			23,220

i.

Consolidation of our main manufacturing operations into a considerably smaller number of sites and move to an outsourced model for a significant amount of our less complex manufacturing activities. As part of this initiative, we intend to cease manufacturing at our main Kansas City manufacturing plant which currently serves our Haemoglobin business. We expect to have fully executed this change by the end of 2024 and expect this will deliver significant annualised savings.

ii.

Product cost reduction from changing suppliers and negotiating new deals with existing suppliers. This is an area we have already successfully executed on a number of cost saving initiatives, which we expect will deliver multi-million-dollar annualised savings.

iii.

Transfer of significant aspects of our business support functions to a lower cost and centralised location. We plan to complete this activity by the end of 2024 and it is expected to deliver significant reductions to our existing indirect overheads, plus provide an efficient scalable business support platform to facilitate efficient growth in our wearable biosensor business.

		Number of A Ordinary Shares December 31, 2023				Number of A Ordinary Shares December 31, 2022				Number of options* December 31, 2023				Number of options* December 31, 2022				Weighted average exercise price of options outstanding at December 31, 2023				Weighted average exercise price of options outstanding at December 31, 2022
Directors
John Gillard			-				-				20,000,000				10,000,000			US$3.60				US$6.20
Ronan O’Caoimh**			9,724,165				9,724,165				9,037,336				9,037,336			US$16.80				US$16.80
Jim Walsh			1,393,612				1,393,612				1,350,000				1,510,000			US$16.60				US$20.00
Tom Lindsay			-				-				-				-				-				-
Andrew Omidvar			-				-				-				-				-				-

		Number of options held at January 1, 2023				Options granted during the year				Options exercised during the year				Options forfeited during the year				Number of options held at December 31, 2023
Aris Kekedjian			20,000,000	1			-				-				12,000,000				8,000,000
John Gillard			10,000,000	1			14,000,000				-				4,000,000				20,000,000
Ronan O’Caoimh			9,037,336				-				-				-				9,037,336
Jim Walsh			1,510,000				-				-				160,000				1,350,000
Tom Lindsay			-				-				-				-				-
Andrew Omidvar			-				-				-				-				-

Director		Title		Salary/Other payments/ Benefits US$’000				Performance related bonus US$’000				Transaction related bonus US$’000				Defined contribution pension US$’000				Total 2022 US$’000
Aris Kekedjian1		Former Chairman and Former Chief Executive Officer			1,171				—				—				—				1,171
John Gillard 2		President and Chief Executive Officer			473				—				211				26				710
Ronan O’Caoimh		Director, Founder & Executive Advisor			80				—				—				—				80
Jim Walsh		Director of Business Development			50				—				—				—				50
Tom Lindsay		Independent Director			63				—				—				—				63
Andrew Omidvar 3		Independent Director			10				—				—				—				10
					1,847				-				211				26				2,084

•

select suitable accounting policies and then apply them consistently;

•

make judgments and accounting estimates that are reasonable and prudent;

•

state whether the financial statements have been prepared in accordance with applicable accounting standards, identify those standards, and note the effect and the reasons for any material departure from those standards; and

•

prepare the financial statements on the going concern basis unless it is inappropriate to presume that the company will continue in business.

•

require us to use a substantial portion of our cash flow from operations to make debt service payments;

•

limit our ability to use our cash flow or obtain additional financing for working capital, capital expenditures, acquisitions or other general business purposes;

•

limit our flexibility to plan for, or react to, changes in our business and industry;

•

result in dilution to our existing shareholders in the event we issue equity to fund our debt obligations;

•

place us at a competitive disadvantage compared to our less leveraged competitors; and

•

increase our vulnerability to the impact of adverse economic and industry conditions.

•

incur, assume or guarantee additional indebtedness;

•

repurchase capital stock;

•

make other restricted payments, including paying dividends and making investments;

•

create liens;

•

sell or otherwise dispose of assets, including capital stock of subsidiaries;

•

enter into agreements that restrict dividends from subsidiaries;

•

acquire another company or business or enter into mergers or consolidations;

•

The success of our research and product development efforts, in particular the significant development effort required to develop and commercialise the biosensor technology, including the glucose monitoring technology acquired in January 2024;

•

The time, cost and degree of success of conducting clinical trials and obtaining regulatory approvals;

•

The costs and timing of expansion of sales and marketing activities;

•

The timing and size of any repayment requirements for existing debt obligations;

•

The timing and success of the commercial launch of new products;

•

The extent to which we gain or expand market acceptance for existing, new or enhanced products;

•

The costs and timing of the expansion of our manufacturing capacity;

•

The magnitude of capital expenditures;

•

Changes in existing and potential relationships with distributors and other business partners;

•

The costs involved in obtaining and enforcing patents, proprietary rights and necessary licences;

•

The costs and liability associated with patent infringement or other types of litigation;

•

The costs related to, and the success of, our operational efficiency focused activities;

•

Competing technological and market developments; and

•

The scope and timing of strategic acquisitions.

•

The acquisition of the CGM assets and the related integration activities may require greater capital and other resources than originally anticipated at the time of acquisition;

•

The benefits expected to be derived from the acquisition of the CGM assets may not materialize and could be affected by numerous factors, such as the failure to complete planned research and development objectives, regulatory developments, general economic conditions and increased competition;

•

We may be unable to successfully integrate the CGM assets, products and technology into our business;

•

Worse than expected performance of the acquired assets may result in the impairment of intangible assets;

•

The acquisition will require substantial expense and management time and this could disrupt our business;

•

The biosensor industry, including the CGM industry, is a highly innovative area with several industry participants developing intellectual property portfolios over many years. As such there can be no assurance that the technology acquired from Waveform or further developed by us, will not infringe on other parties’ existing IP portfolios. We could incur significant costs and management time in defending against IP infringement claims.

•

We may not be able to accurately forecast the performance or ultimate impact of an acquired CGM business; and

•

The acquisition may result in the incurrence of unexpected expenses, the dilution of our earnings or our existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an indemnification from the seller(s) of the acquired business;

•

Suitable acquisitions or investments may not be found or consummated on terms or schedules that are satisfactory to us or consistent with our objectives;

•

The benefits expected to be derived from an acquisition may not materialize and could be affected by numerous factors, such as regulatory developments, insurance reimbursement, general economic conditions and increased competition;

•

We may be unable to successfully integrate an acquired company’s personnel, assets, management systems, products and/or technology into our business;

•

Worse than expected performance of an acquired business may result in the impairment of intangible assets;

•

Acquisitions may require substantial expense and management time and could disrupt our business;

•

We may not be able to accurately forecast the performance or ultimate impact of an acquired business;

•

An acquisition and subsequent integration activities may require greater capital and other resources than originally anticipated at the time of acquisition;

•

An acquisition may result in the incurrence of unexpected expenses, the dilution of our earnings or our existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an indemnification from the seller(s) of the acquired business;

•

An acquisition may result in the loss of our or the acquired company’s key personnel, customers, distributors or suppliers;

•

An acquisition of a foreign business may involve additional risks, including, but not limited to, foreign currency exposure, liability or restrictions under foreign laws or regulations, and our inability to successfully assimilate differences in foreign business practices or overcome language or cultural barriers; and

•

Our ability to integrate future acquisitions may be adversely affected by inexperience in dealing with new technologies.

•

Decreased demand for our products;

•

Lost revenues;

•

Damage to our image or reputation;

•

Costs related to litigation; and

•

Diversion of management time and attention;

•

contract manufacturers or suppliers may fail to comply with regulatory requirements or make errors in manufacturing that could negatively affect the efficacy or safety of our products or cause delays in shipments of our products;

•

we or our contract manufacturers and suppliers may not be able to respond to unanticipated changes in customer orders, and if orders do not match forecasts, we or our suppliers may have excess or inadequate inventory of materials and components;

•

we or our contract manufacturers and suppliers may be subject to price fluctuations due to a lack of long-term supply arrangements for key components;

•

we or our contract manufacturers and suppliers may lose access to critical services and components, resulting in an interruption in the manufacture, assembly and shipment of our systems;

•

we may experience delays in delivery by our contract manufacturers and suppliers due to changes in demand from us or their other customers;

•

fluctuations in demand for products that our contract manufacturers and suppliers manufacture for others may affect their ability or willingness to deliver components to us in a timely manner;

•

our suppliers or those of our contract manufacturer may wish to discontinue supplying components or services to us for risk management reasons;

•

we may not be able to find new or alternative components or reconfigure our system and manufacturing processes in a timely manner if the necessary components become unavailable; and

•

our contract manufacturers and suppliers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfil our orders and meet our requirements.

•

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (2013);

•

ICH Harmonised Guidelines - Integrated Addendum to ICH E6 (R2) Guideline for Good Clinical Practice (Nov 2016);

•

ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice; and

•

ISO 14155:2020: Clinical investigation of medical devices for human subjects – Good clinical practice.

•

our inability to demonstrate to the FDA’s satisfaction that our products are safe and effective for their intended users;

•

insufficient data from our pre-clinical studies and clinical trials to support clearance or approval, where required; and

•

the failure of the manufacturing process or facilities we use to meet applicable requirements.

•

unanticipated expenditures to address or defend such actions;

•

customer notifications for repair, replacement and refunds;

•

recall, detention or seizure of our products;

•

operating restrictions or partial suspension or total shutdown of production;

•

refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;

•

operating restrictions;

•

withdrawing 510(k) clearances on PMA approvals that have already been granted;

•

refusal to grant export approval for our products; or

•

criminal prosecution.

•

the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and wilfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

•

the Physician Self-Referral Law, also known as the “Stark Law”, which provides for strict liability for referrals by physicians to entities with which they or their immediate family members have a financial arrangement for certain designated health services, including clinical laboratory services provided by our CLIA-certified laboratory owned and operated by our subsidiary Immco Diagnostics Inc., that are reimbursable by federal healthcare programs, unless an exception applies. Penalties for violating the Stark Law include denial of payment, civil monetary penalties of up to fifteen thousand dollars per claim submitted, and exclusion from federal health care programs, as well as a penalty of up to one-hundred thousand dollars for attempts to circumvent the law;

•

federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal third-party payers that are false or fraudulent. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “whistleblowers”, may share in any amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. Often, to avoid the threat of treble damages and penalties under the False Claims Act, which in 2020 were $11,665 to $23,331 per false claim, companies will resolve allegations in a settlement without admitting liability to avoid the potential treble damages. Any such settlement could materially affect our business, financial operations, and reputation;

•

the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

•

federal criminal laws that prohibit executing a scheme to defraud any federal healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

•

the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

•

the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS, information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other “transfers of value” to such physician owners. Manufacturers are required to submit reports to CMS by the 90th day of each calendar year. We cannot assure you that we have and will successfully report all transfers of value by us, and any failure to comply could result in significant fines and penalties. Failure to submit the required information may result in civil monetary penalties up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for “knowing failures”) for all payments, transfers of value or ownership or investment interests not reported in an annual submission, and may result in liability under other federal laws or regulations;

•

federal and state laws governing the certification and licensing of clinical laboratories, including operational, personnel and quality requirements designed to ensure that testing services are accurate and timely, and federal and state laws governing the health and safety of clinical laboratory employees;

•

the U.S. Foreign Corrupt Practices Act, or the FCPA, which prohibits corporations and individuals from paying, offering to pay or authorising the payment of anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity; the U.K. Bribery Act, which prohibits both domestic and international bribery, as well as bribery across both public and private sectors; and bribery provisions contained in the German Criminal Code, which makes the corruption and corruptibility of physicians in private practice and other healthcare professionals a criminal offense; and

•

analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any payor, including commercial insurers; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

•

announcements of new products by us or others;

•

announcements by us of significant acquisitions, disposals, strategic partnerships, in-licensing,

•

joint ventures or capital commitments;

•

the developments of the businesses and projects of our various subsidiaries;

•

expiration or terminations of licences, research contracts or other collaboration agreements;

•

public concern as to the safety of the products we sell;

•

the volatility of market prices for shares of companies with whom we compete;

•

developments concerning intellectual property rights or regulatory approvals;

•

variations in our and our competitors’ results of operations;

•

changes in revenues, gross profits and earnings announced by us;

•

changes in estimates or recommendations by securities analysts, if the ADSs are covered by analysts;

•

fluctuations in the share price of our publicly traded subsidiaries;

•

changes in government regulations or patent decisions; and

•

general market conditions and other factors, including factors unrelated to our operating performance.

•

the debt is for a liquidated or defined sum;

•

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

•

the judgment must be final and conclusive and the decree must be final and unalterable in the U.S. 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.

•

if the judgment was obtained or alleged to have been obtained by fraud;

•

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;

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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;

•

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; or

•

if the judgment is not consistent with a judgment of an Irish Court in respect of the same matter.

		Year ended December 31,
			2023 US$’000				2022 US$’000			% Change
Revenues
Clinical laboratory goods			42,288				46,036				(8.1	)%
Clinical laboratory services			5,453				7,272				(25.0	)%
Point-of-Care			9,091				9,213				(1.3	)%
			56,832				62,521				(9.1	)%

			Year ended December 31,
			2023 US$‘000				2022 US$‘000			% Change
Revenues
Americas			32,282				35,557				(9.2	)%
Asia/Africa			18,909				20,401				(7.3	)%
Europe			5,641				6,563				(14.0	)%
Total			56,832				62,521				(9.1	)%

i)

technical advisory, legal and professional fees were higher in 2023 compared to 2022 by US$1.6 million primarily due to costs associated with the acquisition of the biosensor assets of Waveform (which closed in January 2024) and other corporate development and corporate finance activities as we continue to assess strategic opportunities for inorganic growth and balance sheet optimization,

ii)

an increase of US$1.5 million in foreign exchange losses largely relating to the accounting requirement to mark to market euro-denominated lease liabilities for right-of-use assets, and

iii)

higher non-cash share-based payments expense of US$0.3 million mainly due to the full year effect of options granted in 2022.

		Year ended December 31, 2023				Year ended December 31, 2022
		US$m				US$m
Interest on senior secured term loan			8.4				9.8
Interest on convertible note			1.1				0.7
Penalty for early partial settlement of term loan			0.9				3.5
Lease interest			0.6				0.7
Loss on disposal of exchangeable notes			0.0				9.7
Interest on exchangeable notes			0.0				0.4
Other non-cash financial expense			0.0				0.1
Total			11.1				24.7

•

the consolidated financial statements give a true and fair view, in accordance with IFRS as adopted by the European Union, of the assets, liabilities and financial position of the group as at December 31, 2023 and of its financial performance and cash flows for the financial year then ended;

•

the parent company financial statements give a true and fair view, in accordance with IFRS as adopted by the European Union, of the assets, liabilities and financial position of the parent company as at December 31, 2023 and of its cash flows for the financial year then ended; and

•

the financial statements have been properly prepared in accordance with the requirements of the Companies Act 2014.

•

We examined the directors’ assessment on going concern and performed an independent assessment of the inputs and assumptions used by the directors in preparing their assessment on going concern by comparing the assumptions and estimates used elsewhere in the preparation of the financial statements;

•

We reviewed the increase in the existing loan facility and the acquisition of WaveForm assets in January 2024;

•

We evaluated the directors’ assessment of any liquidity issues with the group and parent company by reviewing if the group and parent company has sufficient liquidity sources from operating activities for at least 12 months from the date of approval of the financial statements;

•

We made enquiries with the Directors and reviewed board minutes available up to and including the date of authorisation of the financial statements in order to understand the future plans of the group and parent company;

•

We assessed the adequacy of the disclosures with respect to the going concern assumption; and

•

We obtained a signed letter of representation from the Directors that it is appropriate to prepare the financial statements on a going concern basis and that the Directors have considered various financing options to meet its repayment obligations regarding the exchangeable notes over the next 12 months.

•

We evaluated the design of relevant controls over management’s selection of the discount rates, short-term forecasts of future revenues and margins, and long-term growth rates used to determine the recoverable amount of each selected CGU.

•

We identified relevant CGUs with significant non-current assets.

•

We agreed the underlying cash flow forecasts to the Board approved projections and we evaluated management’s ability to accurately forecast future revenues and margins by:

•

performing a look-back analysis and comparing actual results to management’s historical forecasts; and

•

assessing the reasonableness of the impact of new products, new partnerships and other macroeconomic activity on short-term cash flows.

•

We assessed the reasonableness of the valuation model used by the group compared to generally accepted valuation practices and accounting standards.

•

We tested the source information underlying the determination of the discount rates through the use of observable inputs from independent external sources.

•

We compared the long-term growth rates, used by management to estimate cash flows in order to calculate a terminal value at that point, to independent external sources to assess the reasonableness of these rates.

•

We performed sensitivity analyses around significant management assumptions, such as discount rate and growth rate, to account for uncertainties around assumptions in the valuation model.

•

We have obtained all the information and explanations which we consider necessary for the purposes of our audit.

•

In our opinion the accounting records of the group and parent company were sufficient to permit the financial statements to be readily and properly audited.

•

The financial statements are in agreement with the accounting records.

•

In our opinion the information given in the Directors’ report is consistent with the financial statements.  Based solely on the work undertaken in the course of our audit, in our opinion, the Directors’ report has been prepared in accordance with the requirements of the Companies Act 2014.

•

enquiries of management, board and Audit Committee on the policies and procedures in place regarding compliance with laws and regulations, including consideration of known or suspected instances of non-compliance and whether they have knowledge of any actual, suspected or alleged fraud;

•

inspection of the group and parent company regulatory and legal correspondence and review of minutes of board meetings during the year to corroborate inquiries made;

•

gaining an understanding of the entity’s current activities, the scope of authorisation and the design effectiveness of its control environment to mitigate risks related to fraud;

•

discussion amongst the engagement team in relation to the identified laws and regulations and regarding the risk of fraud, and remaining alert to any indications of non-compliance or opportunities for fraudulent manipulation of financial statements throughout the audit;

•

identifying and testing journal entries to address the risk of inappropriate journals and management override of controls;

•

designing audit procedures to incorporate unpredictability around the nature, timing or extent of our testing

•

challenging assumptions and judgements made by management in their significant accounting estimates, including impairment assessment of intangible assets and property, plant and equipment, and capitalisation of internal development costs; and

•

review of the financial statement disclosures to underlying supporting documentation and inquiries of management.

						Year ended December 31
		Notes				2023 Total US$‘000				2022 Total US$‘000				2021 Total US$‘000
Revenues			2				56,832				62,521				81,149
Cost of sales							(37,382	)			(45,253	)			(47,695	)
Gross profit							19,450				17,268				33,454
Other operating income			4				141				343				4,428
Research and development expenses							(4,379	)			(4,138	)			(4,497	)
Selling, general and administrative expenses							(31,152	)			(26,983	)			(22,503	)
Impairment charges			5				(11,105	)			(5,839	)			(6,944	)
Operating (loss)/profit							(27,045	)			(19,349	)			3,938
Financial income			6				1,171				303				1,223
Financial expenses			6				(11,053	)			(24,734	)			(7,085	)
Net financing expense							(9,882	)			(24,431	)			(5,862	)
Loss before tax			9				(36,927	)			(43,780	)			(1,924	)
Total income tax credit			2, 7				59				194				74
Loss for the year on continuing operations			2				(36,868	)			(43,586	)			(1,850	)
Profit for the year on discontinued operations			8				12,850				2,577				2,725
(Loss)/profit for the year (all attributable to owners of the parent)			2				(24,018	)			(41,009	)			875
Basic (loss)/profit per ADS (US Dollars) – continuing operations			10				(4.81	)			(6.46	)			(0.44	)
Diluted (loss)/profit per ADS (US Dollars) – continuing operations			10				(4.81	)			(6.46	)			(0.44	)
Basic (loss)/profit per A Ordinary Share (US Dollars) –continuing operations			10				(0.24	)			(0.32	)			(0.02	)
Diluted (loss)/profit) per A Ordinary Share (US Dollars) – continuing operations			10				(0.24	)			(0.32	)			(0.02	)
Basic (loss)/profit per ADS (US Dollars) – group			10				(3.14	)			(6.08	)			0.21
Diluted (loss)/profit per ADS (US Dollars) – group			10				(3.14	)			(6.08	)			0.16
Basic (loss)/profit per A Ordinary Share (US Dollars) – group			10				(0.16	)			(0.30	)			0.01
Diluted (loss)/profit) per A Ordinary Share (US Dollars) – group			10				(0.16	)			(0.30	)			0.01

						Year ended December 31
		Notes				2023 US$‘000				2022 US$‘000				2021 US$‘000
(Loss)/profit for the year			2				(24,018	)			(41,009	)			875
Other comprehensive profit/(loss)
Items that will be reclassified subsequently to profit or loss
Foreign exchange translation differences							69				(396	)			(86	)
Other comprehensive profit/(loss)							69				(396	)			(86	)
Total Comprehensive (Loss)/profit (all attributable to owners of the parent)							(23,949	)			(41,405	)			789

						At December 31
		Notes				2023 US$‘000				2022 US$‘000
ASSETS
Non-current assets
Property, plant and equipment			11				1,892				5,682
Goodwill and intangible assets			12				16,270				35,269
Deferred tax assets			14				1,975				4,218
Derivative financial instruments			23				178				128
Other assets			15				79				139
Total non-current assets							20,394				45,436
Current assets
Inventories			16				19,933				22,503
Trade and other receivables			17				13,901				15,753
Income tax receivable							1,516				1,834
Cash and cash equivalents			18				3,691				6,578
Total current assets							39,041				46,668
TOTAL ASSETS			2				59,435				92,104
EQUITY AND LIABILITIES
Equity attributable to the equity holders of the parent
Share capital			19				1,972				1,963
Share premium							46,619				46,458
Treasury shares			19				(24,922	)			(24,922	)
Accumulated deficit							(48,644	)			(26,695	)
Translation reserve			19				(5,706	)			(5,775	)
Equity component of convertible note			19, 23				6,709				6,709
Other reserves			19				23				86
Total deficit							(23,949	)			(2,176	)
Current liabilities
Income tax payable							279				28
Trade and other payables			21				12,802				15,375
Provisions			22				50				50
Exchangeable notes and other borrowings			23				210				210
Lease liabilities			24				1,694				1,676
Total current liabilities							15,035				17,339
Non-current liabilities
Senior secured term loan			23				40,109				44,301
Derivative financial liability			23				526				1,569
Convertible Note			23				14,542				13,746
Lease liabilities			24				10,872				12,267
Deferred tax liabilities			14				2,300				5,058
Total non-current liabilities							68,349				76,941
TOTAL LIABILITIES			2				83,384				94,280
TOTAL EQUITY AND LIABILITIES							59,435				92,104

		Share capital A Ordinary Shares US$’000				Share premium US$’000				Treasury Shares US$’000				Translation reserve US$’000				Equity Component of Convertible Note US$’000				Other reserves US$’000				Accumulated (deficit)/surplus US$’000				Total US$’000
Balance at January 1, 2021			1,213				16,187				(24,922	)			(5,293	)			-				23				10,573				(2,219	)
Profit for the period			-				-				-				-				-				-				875				875
Other comprehensive income			-				-				-				(86	)			-				-				-				(86	)
Total comprehensive loss			-				-				-				(86	)			-				-				875				789
Share-based payments (Note 20)			-				-				-				-				-				-				1,111				1,111
Balance at December 31, 2021			1,213				16,187				(24,922	)			(5,379	)			-				23				12,559				(319	)
Balance at January 1, 2022			1,213				16,187				(24,922	)			(5,379	)			-				23				12,559				(319	)
Loss for the period			-				-				-				-				-				-				(41,009	)			(41,009	)
Other comprehensive loss			-				-				-				(396	)			-				-				-				(396	)
Total comprehensive loss			-				-				-				(396	)			-				-				(41,009	)			(41,405	)
Shares issued in the year (Note 19)			750				30,271				-				-				-				-				-				31,021
Shares to be issued			-				-				-				-				-				63				-				63
Equity component of convertible note (Note 19)			-				-				-				-				6,709				-				-				6,709
Share-based payments (Note 20)			-				-				-				-				-				-				1,755				1,755
Balance at December 31, 2022			1,963				46,458				(24,922	)			(5,775	)			6,709				86				(26,695	)			(2,176	)
Balance at January 1, 2023			1,963				46,458				(24,922	)			(5,775	)			6,709				86				(26,695	)			(2,176	)
Loss for the period			-				-				-				-				-				-				(24,018	)			(24,018	)
Other comprehensive income			-				-				-				69				-				-				-				69
Total comprehensive loss			-				-				-				69				-				-				(24,018	)			(23,949	)
Shares issued in the year (Note 19)			9				161				-				-				-				(63	)			-				107
Share-based payments (Note 20)			-				-				-				-				-				-				2,069				2,069
Balance at December 31, 2023			1,972				46,619				(24,922	)			(5,706	)			6,709				23				(48,644	)			(23,949	)

						Year ended December 31,
		Notes				2023 US$‘000				2022 US$‘000				2021 US$‘000
Cash flows from operating activities
(Loss)/profit for the year							(24,018	)			(41,009	)			875
Adjustments to reconcile net profit/(loss) to cash provided by operating activities:
Depreciation			9, 11				831				1,410				1,827
Amortisation			9,12				946				923				917
Income tax credit			7				(59	)			(192	)			(167	)
Financial income			6				(1,171	)			(303	)			(1,223	)
Financial expense			6				11,053				24,745				7,097
Share-based payments (net of capitalized amounts)			20				2,069				1,755				1,100
Foreign exchange gains on operating cash flows							238				(76	)			(251	)
Loss/(gain) on disposal or retirement of property, plant and equipment			9				-				2				(1	)
Movement in inventory provision			16				2,291				7,391				5,589
Impairment of prepayments			5, 17				-				482				583
Impairment of property, plant and equipment			5, 11				3,772				733				2,508
Impairment of intangible assets			5, 12				5,833				4,624				3,853
Impairment of financial assets			5, 13				1,500				-				-
Gain on sale of business			8				(12,718	)			-				-
Other non-cash items							257				269				(5,317	)
Operating cash flows before changes in working capital							(9,176	)			754				17,390
Decrease/(increase) in trade and other receivables							1,047				(966	)			6,236
Increase in inventories							(971	)			(877	)			(4,406	)
(Decrease)/increase in trade and other payables							(2,769	)			181				(7,591	)
Cash (used in)/generated from operations							(11,869	)			(908	)			11,629
Interest paid							-				-				(11	)
Interest received							-				2				1
Income taxes received/(paid)							312				(15	)			1,619
Net cash (used in)/generated by operating activities							(11,557	)			(921	)			13,238
Cash flows from investing activities
Payments to acquire intangible assets							(1,901	)			(4,876	)			(6,879	)
Acquisition of property, plant and equipment							(803	)			(1,101	)			(1,812	)
Payments to acquire financial asset			13				(700	)			-				-
Proceeds from sale of business (net of transaction costs)			8				28,160				-				-
Net cash generated by/(used in) investing activities							24,756				(5,977	)			(8,691	)
Cash flows from financing activities
Issue of ordinary share capital including share premium (net of issuance costs)			19				-				25,336				-
Proceeds from shares to be issued							-				63				-
Net proceeds from senior secured term loan			23				5,000				80,015				-
Proceeds from convertible note issued			23				-				20,000				-
Expenses paid in connection with debt financing			23				(147	)			(2,356	)			(848	)
Purchase of exchangeable notes			23				-				(86,730	)			-
Repayment of senior secured term loan			23				(10,050	)			(34,500	)			-
Penalty for early settlement of term loan			23				(905	)			(3,450	)			-
Repayment of other loan							-				(23	)			-
Interest paid on senior secured term loan							(7,314	)			(6,424	)			-
Interest paid on convertible note							(300	)			(199	)			-
Proceeds from Paycheck Protection loans							-				-				1,764
Interest paid on exchangeable notes			28				(8	)			(1,293	)			(3,996	)
Payment of lease liabilities			28				(2,318	)			(2,761	)			(2,939	)
Net cash used in financing activities							(16,042	)			(12,322	)			(6,019	)
Decrease in cash and cash equivalents and short-term investments							(2,843	)			(19,220	)			(1,472	)
Effects of exchange rate movements on cash held							(44	)			(112	)			55
Cash and cash equivalents and short-term investments at beginning of year							6,578				25,910				27,327
Cash and cash equivalents and short-term investments at end of year			18				3,691				6,578				25,910

1.	BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES

i)

General information Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood and the Company intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product.

iii)	Basis of preparation

1.	BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

iv)	Basis of consolidation

v)	Property, plant and equipment

•    Leasehold improvements		5-15 years
•    Buildings		50 years
•    Office equipment and fittings		10 years
•    Computer equipment		3-5 years
•    Plant and equipment		5-15 years

•

the contract contains an identified asset, which is either explicitly identified in the contract or implicitly specified by being identified at the time the asset is made available to the Group

•

the Group has the right to obtain substantially all of the economic benefits from use of the identified asset throughout the period of use, considering its rights within the defined scope of the contract

•

the Group has the right to direct the use of the identified asset throughout the period of use. The Group assess whether it has the right to direct ‘how and for what purpose’ the asset is used throughout the period of use.

vi)

Goodwill

vii)	Intangibles, including research and development (other than goodwill)

•    Capitalised development costs		15 years
•    Patents and licences		6-15 years
•    Other (including acquired customer and supplier lists)		6-15 years

(a)

once a diagnostic test becomes established, customers are reluctant to change to new technology until it is fully proven, thus resulting in relatively long product life cycles. There is also reluctance in customers to change to a new product as it can be costly both in terms of the initial changeover cost and as new technology is typically more expensive.

(b)

demand for the diagnostic tests is enduring and robust within a wide geographic base. The diseases that the products diagnose are widely prevalent (HIV, Diabetes and Chlamydia being just three examples) in many countries. There is a general consensus that these diseases will continue to be widely prevalent in the future. Demand for biosensors is showing high growth in recent years due to the ease of use and the appeal of real time information.

(c)

there are significant barriers to new entrants in this industry. Patents and/or licences are in place for several of our products, though this is not the only barrier to entry. There is a significant cost and time to develop new products, it is necessary to obtain regulatory approval and tests are protected by proprietary know-how, manufacturing techniques and trade secrets.

viii)

Impairment