TABLE OF CONTENTS
	Page
Corporate Information	1
Market, Industry and Other Data	2
Cautionary Statement Regarding Forward-Looking Statements	2
Board of Directors & Executive Officers	3
Business Overview	4
Directors’ Report	8
Statement of Directors’ Responsibilities in respect of the annual report and the   financial statements	17
Risk Factors	18
Performance Review	51
Independent Auditor’s Report to the members of Trinity Biotech plc	56
Financial Statements
Consolidated Statement of Operations	64
Consolidated Statement of Comprehensive Income	65
Consolidated Statement of Financial Position	66
Consolidated Statement of Changes in Equity	67
Consolidated Statements of Cash Flows	68
Notes to the Consolidated Financial Statements	69
Company Statement of Comprehensive Income	155
Company Statement of Financial Position	156
Company Statement of Changes in Equity	157
Company Statement of Cash Flows	158
Notes to the Company Financial Statements	159

Mr Ronan O’Caoimh
Dr Jim Walsh
Mr John Gillard
Mr Tom Lindsay	UK
Dr Andrew Omidvar	US
Mr John Paul Tivnan	(appointed August 6, 2025)

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the development of our 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-licence new product candidates;

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potential strategic relationships;

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the duration of our patent portfolio,

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the capabilities of our business operations;

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expected future economic performance;

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competition in our market; and

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assumptions underlying statements regarding us or our business.

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Infectious diseases;

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

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Autoimmune diseases.

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Sexually transmitted diseases, including Syphilis and Herpes;

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

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SARS-CoV-2.

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Immunofluorescence Assay (“IFA”);

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Enzyme-linked immunosorbent (“ELISA”);

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Western Blot (“WB”); and

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Line immunoassay (“LIA”).

		2024				2023
		US$’000				US$’000
Revenue			61,555				56,832
Operating loss			(21,165	)			(27,045	)
Loss for the year			(31,789	)			(24,018	)

		Number of A Ordinary Shares December 31, 2024				Number of A Ordinary Shares December 31, 2023				Number of options* December 31, 2024				Number of options* December 31, 2023			Weighted average exercise price of options outstanding at December 31, 2024		Weighted average exercise price of options outstanding at December 31, 2023
Directors
John Gillard			200,000				-				20,000,000				20,000,000		US$0.18		US$0.18
Ronan O’Caoimh**			9,724,165				9,724,165				8,193,336				9,037,336		US$0.58		US$0.84
Jim Walsh			3,095,620				1,393,612				2,000,000				1,350,000		US$0.15		US$0.84
Tom Lindsay			-				-				1,400,000				-		US$0.14			-
Andrew Omidvar			-				-				1,400,000				-		US$0.14			-

		Number of options held at January 1, 2024				Options granted during the year				Options exercised during the year				Options forfeited during the year				Number of options held at December 31, 2024
John Gillard			20,000,000	1			-				-				-				20,000,000
Ronan O’Caoimh			9,037,336				1,400,000				-				(2,244,000	)			8,193,336
Jim Walsh			1,350,000				1,400,000				-				(750,000	)			2,000,000
Tom Lindsay			-				1,400,000				-				-				1,400,000
Andrew Omidvar			-				1,400,000				-				-				1,400,000

Director		Title		Salary/Other payments/ Benefits US$’000				Performance related bonus US$’000				Transaction related bonus US$’000				Defined contribution pension US$’000				Total 2024 US$’000
John Gillard		President and Chief Executive Officer			676				260	*			—				39				975
Ronan O’Caoimh		Director, Founder & Executive Advisor			84				—				—				—				84
Jim Walsh		Director of Business Development			83				—				—				—				83
Tom Lindsay		Independent Director			57				—				—				—				57
Andrew Omidvar		Independent Director			57				—				—				—				57
					957				260				—				39				1,256

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select suitable accounting policies and then apply them consistently;

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make judgments and accounting estimates that are reasonable and prudent;

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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

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

In May 2022, we received a US$45.2 million investment from MiCo. The investment consisted of an equity investment of US$25.2 million and a seven-year, unsecured junior convertible note of US$20.0 million, The convertible note has an interest rate of 1.5% and interest is payable quarterly. The convertible note mandatorily converts into ADSs if the volume weighted average price of  our ADSs is at or above US$16.20 for any five consecutive NASDAQ trading days. Based on public filings, we understand that on December 17, 2024, MiCo was acquired by Dayli Trinity Holdings Limited as a result of a share purchase agreement with Mainstream Holdings Limited.

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incur, assume or guarantee additional indebtedness;

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repurchase capital stock;

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

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create liens;

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

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enter into agreements that restrict dividends from subsidiaries;

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

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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;

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Simplifying our internal operations and optimizing and outsourcing some of our business support function locations; and

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Realigning our existing business portfolio to support our planned growth in the CGM space.

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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 continuous glucose monitoring technology acquired in January 2024;

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

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

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

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

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

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

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The magnitude of capital expenditures;

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

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

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

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

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Competing technological and market developments; and

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The scope and timing of strategic acquisitions.

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Decreased demand for our products;

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Lost revenues;

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Damage to our image or reputation;

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Costs related to litigation; and

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Diversion of management time and attention;

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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;

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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;

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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;

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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;

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

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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;

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

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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

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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.

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

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

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

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

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

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

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

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untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties

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unanticipated expenditures to address or defend such actions;

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customer notifications for repair, replacement and refunds;

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recall, detention or seizure of our products;

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operating restrictions or partial suspension or total shutdown of production;

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

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operating restrictions;

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

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refusal to grant export approval for our products; or

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criminal prosecution.

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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;

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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;

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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;

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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;

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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;

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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;

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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;

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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;

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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 UK 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

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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.

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announcements of new products by us or others;

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announcements by us of significant acquisitions, disposals, strategic partnerships, in-licensing, joint ventures or capital commitments;

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

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

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

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

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developments concerning intellectual property rights or regulatory approvals;

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variations in our and our competitors’ results of operations;

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

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

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fluctuations in the share price of our publicly traded subsidiaries;

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changes in government regulations or patent decisions; and

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

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the debt is for a liquidated or defined sum;

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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

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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.

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if the judgment is not for a debt or a definite sum of money;

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

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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;

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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;

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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

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