---

 

			Page
		PRESENTATION OF FINANCIAL AND OTHER INFORMATION	1
		MARKET, INDUSTRY AND OTHER DATA	1
		CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS	1

PART I

Item 1		Identity of Directors, Senior Management and Advisers	2
Item 2		Offer Statistics and Expected Timetable	2
Item 3		Key Information	2
	A.	[Reserved]	2
	B.	Capitalization and Indebtedness	2
	C.	Reasons for the Offer and Use of Proceeds	2
	D.	Risk Factors	3
Item 4		Information on the Company	30
	A.	History and Development of the Company	30
	B.	Business Overview	30
	C.	Organizational Structure	46
	D.	Property, Plants and Equipment	46
Item 4 A.		Unresolved Staff Comments	47
Item 5		Operating and Financial Review and Prospects	48
	A.	Operating Results	48
	B.	Liquidity and Capital Resources	59
	C.	Research and Development, Patents and Licenses,etc.	61
	D.	Trend Information	61
	E.	Critical Accounting Estimates	62
Item 6		Directors, Senior Management and Employees	67
	A.	Directors and Senior Management	67
	B.	Compensation	69
	C.	Board Practices	69
	D.	Employees	71
	E.	Share Ownership	71
Item 7		Major Shareholders and Related Party Transactions	74
	A.	Major Shareholders	74
	B.	Related Party Transactions	75
	C.	Interests of Experts and Counsel	76
Item 8		Financial Information	76
	A.	Consolidated Statements and Other Financial Information	76
	B.	Significant Changes	76
Item 9		The Offer and Listing	76
	A.	Offer and Listing Details	76
	B.	Plan of Distribution	76
	C.	Markets	76
	D.	Selling Shareholders	76
	E.	Dilution	77
	F.	Expense of the Issue	77
Item 10		Additional Information	77
	A.	Share Capital	77
	B.	Memorandum and Articles of Association	77
	C.	Material Contracts	78
	D.	Exchange Controls	79
	E.	Taxation	80
	F.	Dividends and Paying Agents	85
	G.	Statement by Experts	85
	H.	Documents on Display	86
	I.	Subsidiary Information	86
Item 11		Quantitative and Qualitative Disclosures about Market Risks	86
Item 12		Description of Securities Other than Equity Securities	87

PART II
Item 13	Defaults, Dividend Arrearages and Delinquencies	89
Item 14	Material Modification to the Rights of Security Holders and Use of Proceeds	89
Item 15	Controls and Procedures	89
Item 16	Reserved	90
Item 16A	Audit Committee Financial Expert	90
Item 16B	Code of Ethics	90
Item 16C	Principal Accountant Fees and Services	90
Item 16D	Exemptions from the Listing Standards for Audit Committees	90
Item 16E	Purchases of Equity Securities by the Issuer and Affiliated Purchasers	90
Item 16F	Changes in Registrant’s Certifying Accountant	91
Item 16G	Corporate Governance	91
Item 16H	Mine Safety Disclosure	91
Item 16I	Disclosures Regarding Foreign Jurisdictions That Prevent Inspections	91
PART III
Item 17	Financial Statements	92
Item 18	Financial Statements	92
Item 19	Exhibits	174

•

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.

Item 1.

Identity of Directors, Senior Management and Advisers

Item 2.

Offer Statistics and Expected Timetable

Item 3.

Key Information

A.

Reserved

B.	Capitalization and Indebtedness

C.	Reasons for the Offer and Use of Proceeds

•

Competition and trading conditions - our ability to sell products could be adversely affected by competition from new and existing diagnostic products, changing conditions in the diagnostic market, including, inter alia, reductions in government funding and sector consolidation.

•

Borrowings - we have incurred substantial debt, which could impair our flexibility and access to capital and adversely affect our financial position. To the extent we are unable to repay our debt as it becomes due with cash on hand or from other sources, we will need to refinance our debt, sell assets or repay the debt with the proceeds from equity offerings in order to continue in business. Our ability to obtain additional funding may determine our ability to continue as a going concern.  Failure to comply with the terms of the credit agreement for our term loan could result in a default under its terms and, if uncured, could result in action against our pledged assets. We are exposed to interest rate risk on some of our borrowings, which could cause our debt service obligations to increase significantly.

•

Capital structure - we expect we will require future additional capital.

•

New product development - our long-term success depends upon the successful development and commercialization of new products.

•

Supply chains - significant interruptions in production at our principal manufacturing facilities and/or third-party manufacturing facilities would adversely affect our business and operating results. We are dependent on third-party suppliers for certain critical components and the primary raw materials required for our test kits. Our inability to manufacture products in accordance with applicable specifications, performance standards or quality requirements could adversely affect our business.

•

Product recalls and claims - our products may in the future be subject to product recalls that could harm our reputation, business and financial results. If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or regulatory agency enforcement actions. We may be subject to liability resulting from our products or services.

•

Financial impairment - the large amount of intangible assets and goodwill recorded on our balance sheet may lead to significant impairment charges in the future.

•

Corporate strategy - failure to achieve our financial and strategic objectives could have a material adverse impact on our business prospects.

•

Global economic conditions – changes in global economic conditions may have a material adverse impact on our results.

•

People - we are highly dependent on our senior management team and other key employees, and the loss of one or more of these employees or the inability to attract and retain qualified personnel as necessary could adversely affect our operations.

•

Distributor network - our revenues are highly dependent on a network of distributors worldwide. Our success depends on our ability to service and support our products directly or in collaboration with our strategic partners.

•

Cyber security - our ability to protect our information systems and electronic transmissions of sensitive data from data corruption, cyber-based attacks, security breaches or privacy violations is critical to the success of our business.

•

Foreign exchange - our sales and operations are subject to the risks of fluctuations in currency exchange rates.

•

Taxation - tax matters, including disagreements with taxing authorities, the changes in corporate tax rates and imposition of new taxes could impact our results of operations and financial condition.

•

Acquisitions - future acquisitions may be less successful than expected, not generate the expected benefits, disrupt our ongoing business, distract our management, increase our expenses and adversely affect our business, and therefore, growth may be limited.

•

Pandemic impact - the Covid-19 outbreak could significantly disrupt our operations and adversely affect our results of operations.

•

Environmental, Social and Governance - increasing scrutiny and changing expectations from investors, lenders, customers and other market participants with respect to our Environmental, Social and Governance, or ESG, policies may impose additional costs on us or expose us to additional risks.

•

Clinical trials - clinical trials necessary to support future premarket submissions will be expensive and will require enrolment of suitable patients who may be difficult to identify and recruit. Delays or failures in our clinical trials will prevent us from commercializing any modified or new products and will adversely affect our business, operating results and prospects. If the third parties on whom we rely to conduct our pre-clinical studies and clinical trials and to assist in pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory approval or commercialize our products. The results of our clinical trials may not support our product candidate claims.

•

Regulatory compliance - we may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or “off-label” uses. If the FDA were to modify its policy of enforcement discretion with respect to our laboratory developed tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance or other approvals.

•

Product approvals - if we fail to maintain regulatory approvals and clearances our ability to commercially distribute and market these products could suffer. Failure to comply with FDA or other regulatory requirements may require us to suspend production of our products or institute a recall which could result in higher costs and a loss of revenues. Modifications to our products may require new 510(k) clearances or pre-market approvals, or may require us to cease marketing or recall the modified products until clearances or approvals are obtained. Our laboratory business could be harmed from the loss or suspension of a licence or imposition of a fine or penalties under, or future changes in, the law or regulations of the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), or those of other state or local agencies.

•

International regulations - we face risks relating to our international sales and business operations, including regulatory risks, which could impact our current business operations and growth strategy.

•

Healthcare industry laws and public company regulations - we are subject to various laws targeting fraud and abuse in the healthcare industry. Changes in healthcare regulation could affect our revenues, costs and financial condition. Compliance with regulations governing public company corporate governance and reporting is complex and expensive.

•

Proprietary rights - we may be unable to protect or obtain proprietary rights that we utilise or intend to utilise.

•

Patent protection – our patent protection may not be sufficiently broad to compete effectively, the existing patents could be challenged; and trade secrets and confidential know-how could be obtained by competitors.  Our patent protection could be reduced or eliminated for non-compliance with various procedural requirements or due to changes in patent law. We may be involved in lawsuits to enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful. Product infringement claims by other companies could result in costly disputes and could limit our ability to sell our products.

•

Significant shareholder - MiCo IVD Holdings, LLC (“MiCo”) currently owns approximately 29.3% of the voting share capital of our Company, which may give MiCo significant influence over our management and affairs and may deter a change in control or other transaction that may be favorable to our shareholders.

•

Information - as a foreign private issuer we are exempt from a number of reporting requirements under the Exchange Act and are permitted to file less information with the SEC than a domestic U.S. reporting company.

•

Passive foreign investment company - we may be classified as a passive foreign investment company, or PFIC, which would subject our U.S. investors to adverse tax rules.

•

Volatility - the market price of our ADSs has been, and may continue to be, highly volatile.  Future sales of our ADSs could reduce the market price of the ADSs.

•

Capital - we expect we will need additional capital in the future.

•

Dilution - the conversion of our outstanding employee share options, any new employee share options and existing warrants would dilute the ownership interest of existing shareholders.

•

Governed by Irish law - it could be difficult for U.S. holders of ADSs to enforce any securities laws claims against Trinity Biotech, its officers or directors in Irish Courts.

•

Dividends - we have no plans to pay dividends on our ADSs, and you may not receive funds without selling the ADSs.

•

Voting rights of holders of ADSs – the terms of the deposit agreement limit the voting rights of holders of ADSs.

•

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;

•

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; or

•

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 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 success of our research and product development efforts;

•

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

•

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;

•

Competing technological and market developments; and

•

The scope and timing of strategic acquisitions.

•

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.

•

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.

•

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (2008);

•

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;

•

ISO 14155:2011: 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.

•

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

•

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 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

•

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 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 is not for a debt or a definite sum of money;

•

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;

•

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;

•

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

•

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

Item 4.

Information on the Company

A.	History and Development of the Company

•

Trinity Biotech Manufacturing Limited, based in Bray, Ireland;

•

Clark Laboratories Inc, based in Jamestown, New York;

•

Primus Corporation, based in Kansas City;

•

Biopool US Inc (trading as Trinity Biotech USA), based in Jamestown, New York;

•

Immco Diagnostics Inc, based in Amherst and Buffalo, New York;

•

Nova Century Scientific Inc, based in Burlington, Canada; and

•

Trinity Biotech Brazil based in Sao Paulo, Brazil.

Point-Of-Care		Clinical Laboratory
Infectious Diseases		Infectious Diseases		Haemoglobin		Autoimmune		Clinical Chemistry		Blood Bank Screening
UniGold		MarDx		Premier		ImmuBlot		EZ		Captia
Recombigen		FlexTrans		Ultra		ImmuGlo
Trinscreen						ImmuLisa
						OTOblot

•

Infectious diseases;

•

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

•

Autoimmune diseases.

•

Sexually transmitted diseases, including Syphilis and Herpes;

•

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

•

Lyme disease; and

•

SARS-CoV-2.

•

Immunofluorescence Assay (“IFA”);

•

Enzyme-linked immunosorbent (“ELISA”);

•

Western Blot (“WB”); and

•

Line immunoassay (“LIA”).

•

Its Clinical Chemistry product range directly to hospitals and laboratories in Germany and France;

•

Infectious Diseases and Clinical Chemistry product ranges directly to hospitals and laboratories in the UK; and

•

All product lines through independent distributors and strategic partners in a further approximately 100 countries.

		2022				2021				Total project costs to December 31, 2022¹
Product Name		US$’000				US$’000				US$’000
Premier Instruments for A1c and haemoglobinopathies testing			1,904				2,538				37,828
HIV screening rapid test			379				1,488				12,619
COVID-19 tests²			1,378				1,320				3,165
Mid-tier haemoglobins instrument			484				303				1,093

•

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

•

unanticipated expenditures to address or defend such actions

•

customer notifications for repair, replacement, 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 or PMA approvals that have already been granted;

•

refusal to grant export approval for our products; or

•

criminal prosecution.

•

product design, development and manufacture;

•

product safety, testing, labelling and storage;

•

record keeping procedures;

•

product marketing, sales and distribution; and

•

post-marketing surveillance, complaint handling, medical device reporting, reporting of deaths, serious injuries or device malfunctions and repair or recall of products.

•

Are non-invasive;

•

product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;

•

Quality System Regulation, (“QSR”), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;

•

labelling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;

•

clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices;

•

approval of product modifications that affect the safety or effectiveness of one of our approved devices;

•

medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur;

•

post-approval restrictions or conditions, including post-approval study commitments;

•

post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device;

•

the FDA's recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations;

•

regulations pertaining to voluntary recalls; and

•

notices of corrections or removals.

•

includes a reduction in the annual update factor used to adjust payments under the CLFS for inflation. This update factor reflects the consumer price index for all urban consumers, or CPI-U, and the ACA reduces the CPI-U by 1.75% for the years 2011 through 2015.  The Affordable Care Act also imposes a multifactor productivity adjustment in addition to the CPI-U, which may further reduce payment rates;

•	requires certain medical device manufacturers to pay an excise tax in an amount equal to 2.3% of the price for which such manufacturer sells its medical devices that are listed with the FDA; and

•

requires the coordination and promotion of research on comparative clinical effectiveness of different technologies and procedures, initiatives to revise Medicare payment methodologies, such as bundling of payments across the continuum of care by providers and clinicians and initiatives to promote quality indicators in payment methodologies.

•

day-to-day operation of a clinical laboratory, including training and skill levels required of laboratory personnel;

•

physical requirements of a facility;

•

equipment; and

•

validation and quality control.

Item 4A.

Unresolved Staff Comments

A.

Operating Results

		Year ended December 31,
		2022 US$’000				2021 US$’000				% Change
Revenues
Clinical laboratory goods			58,294				74,700				(22.0%	)
Clinical laboratory services			7,272				7,928				(8.3%	)
Point-of-Care			9,213				10,337				(10.9%	)
			74,779				92,965				(19.6%	)

		Year ended December 31,
		2022 US$‘000				2021 US$‘000				% Change
Revenues
Americas			40,176				57,799				(30.5%	)
Asia/Africa			25,022				25,504				(1.9%	)
Europe			9,581				9,662				(0.8%	)
Total			74,779				92,965				(19.6%	)

i.

VTM inventory write down (US$3.5 million) – as disclosed previously, we have not seen any evidence during the winter season of 2022-23 of significant peaks in demand for VTM products. This has led management to revisit our strategy of maintaining significant levels of raw materials inventory to meet demand peaks.  Consequently, the value of inventory was written down in Q3, 2022 to our estimate of its net realisable value.

ii.

Other inventory write down (US$0.9 million) - the value of certain excess raw materials and work in progress was written down in Q3, 2022 following a review and an update to our relevant quality assurance policy.

iii.

Tri-stat inventory write down (US$0.3 million) - as disclosed previously, we undertook a strategic review of our Tri-stat instrument line as part of a broader review of our haemoglobins product portfolio. Management decided to limit sales of Tri-stat to certain targeted partnerships and as a consequence the value of this inventory was written down to reflect the revised outlook.

o

The share-based payments expense was US$0.7m higher in 2022 compared to 2021, mainly due to share options granted during 2022. The majority of the options granted in 2022 are performance share options and are structured such that they are exercisable only if the market price for Company’s ADSs exceeds certain levels ($3.00, $4.00 and $5.00 per ADS) during the life of the option.  These performance share options align the goals of our team and our shareholders in the creation of shareholder value.

o

With the lifting of COVID-related travel restrictions, we have tasked our sales and marketing teams to increase travel to customers and trade shows as we continue to revitalise our sales activities. Similarly, some key functional leaders based in Ireland have resumed visits to our overseas facilities as we seek to drive operational efficiencies. All of this has led to an approximately US$1.1 million increase in travel and promotional costs in 2022.

o

Due diligence and other legal and professional fees increased by approximately US$0.8 million in 2022 as we took an active, but disciplined, approach to pursuing a pipeline of attractive M&A opportunities.

o

Non-recurring professional fees, primarily associated with the debt refinancing, of US$0.6 million were expensed in 2022.

o

Increased expected credit loss on trade receivables, with the majority of the increase due to one distributor.

o

Higher recruitment fees in 2022 due to the hiring of more employees in senior management roles.

o

Autoimmune smart reader (impairment charge US$1.3 million) - there is significant uncertainty whether the Company will complete the project to develop its own in-house autoimmune smart reader. While we may re-visit this decision in the future, in the interests of prudence we impaired the project’s carrying value.

o

Tri-stat instrument (impairment charge US$1.0 million) - following a strategic review of the Tri-stat instrument, it was decided that Tri-stat sales would be restricted to only certain targeted partnerships, and this led to an impairment in the carrying value of the Tri-stat intangible asset.

o

COVID-19 antigen test on a rapid lateral flow format (impairment charge US$2.2 million) - this test is approved for professional use in the EU. However, the demand for our COVID-19 portfolio of products is highly uncertain and very difficult to predict and in our experience the market has moved to over the counter (“OTC”) rapid COVID-19 tests, for which this product is not yet approved. As such the Company’s efforts to commercialise this test have been unsuccessful. In addition, pricing for rapid COVID-19 tests in the EU is relatively weak, with stronger pricing available in, for example, the US market, for which this product is not yet approved. Given the market outlook for rapid COVID-19 testing products and continued uncertainty regarding regulatory approval pathways in key markets, including the US, management chose not to immediately pursue further regulatory approvals but does intend to monitor these markets and regulatory pathways with a view to potentially seeking additional regulatory approvals. As the Company has no imminent plans to pursue these regulatory approvals, under IFRS accounting rules these intangible assets were written down to zero.

o

COVID-19 test on an ELISA format (impairment charge US$0.1 million) – this development project was written off because the market changed and there was no demand for a test on this format.

	2022 US$’000	2021 US$’000
Loss on disposal of exchangeable notes	9.7	-
Penalty for early settlement of term loan	3.5	-
Term loan interest	9.8	-
Convertible note interest	0.7	-
Notional interest on lease liabilities for Right-of-use assets	0.7	0.8
Exchangeable note interest	0.4	4.6
Loan origination costs - term loan	-	1.6
Fair value movement for derivative asset	0.1	-
Total	24.7	7.1

		Year ended December 31,
		2021 US$’000				2020 US$’000				% Change
Revenues
Clinical laboratory goods			74,700				84,280				(11.4%	)
Clinical laboratory services			7,928				8,485				(6.6%	)
Point-of-Care			10,337				9,215				12.2%
			92,965				101,980				(8.8%	)

		Year ended December 31,
		2021 US$‘000				2020 US$‘000				% Change
Revenues
Americas			57,799				70,408				(17.9%	)
Asia/Africa			25,504				22,567				13.0%
Europe			9,662				9,005				7.3%
Total			92,965				101,980				(8.8%	)

B.	Liquidity and Capital Resources

•

The ability of the Group to generate revenue growth from its existing product lines and from new products following the successful completion of its development projects;

•

The extent to which capital expenditure is incurred on additional property plant and equipment;

•

The level of investment required to undertake both new and existing development projects; and

		Year ended December 31,
		2022 US$‘000				2021 US$‘000
Net cash (used in) / generated by operating activities			(921	)			13,238
Net cash outflow from investing activities			(5,977	)			(8,691	)
Net cash outflow from financing activities			(12,322	)			(6,019	)
Net decrease in cash and cash equivalents and short-term investments			(19,220	)			(1,472	)

•

Payments to acquire intangible assets of US$4.9 million (2021: US$6.9 million), which principally related to development expenditure capitalised as part of the Group’s on-going product development activities; and

•

Acquisition of property, plant and equipment of US$1.1 million (2021: US$1.8 million) incurred as part of the Group’s investment programme for its manufacturing and distributing activities.

•

Significant underperformance relative to expected, historical or projected future operating results;

•

Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;

•

Obsolescence of products;

•

Significant decline in our stock price for a sustained period; and

•

Our market capitalisation relative to net book value.

•

In the event that there was a reduction of 10% in the assumed level of future growth in revenue growth rate, which would represent a reasonably likely range of outcomes, there would be no additional impairment loss recorded at December 31, 2022.

•

In the event there was a 10% increase in the discount rate used to calculate the potential impairment of the carrying values, which would represent a reasonably likely range of outcomes, there would be no additional impairment loss recorded at December 31, 2022.

(i)

VTM inventory – there was no evidence during the winter season of 2022-23 of significant peaks in demand for VTM products. This has led management to revisit the strategy of maintaining significant levels of raw materials inventory to meet demand peaks.  Consequently, the provision for this inventory was increased by US$3.5 million in 2022 reflecting our estimate of its net realisable value.

(ii)

Tri-stat inventory – the Company undertook a strategic review of our Tri-stat instrument line as part of a broader review of our haemoglobins product portfolio. Management decided to limit sales of Tri-stat to certain targeted partnerships and as a consequence the value of this inventory was written down by US$0.3 million to reflect the revised outlook.

(iii)

Raw materials and work in progress failing to meet our revised quality policy - the value of certain excess raw materials and work in progress was written down by US$0.9 million in 2022 following a review and an update to our relevant quality assurance policy.

		Year Ended December 31, 2022
		2022				2021				2020
Numbers of employees by geographic location
United States			217				237				310
Ireland			146				211				199
United Kingdom			1				2				3
Brazil			34				27				31
Total workforce			398				477				543
Numbers of employees by category of activity
Research scientists & technicians			30				41				52
Manufacturing/Operations			188				239				280
Quality Assurance			61				63				63
Finance/Administration			75				68				65
Sales & Marketing			44				66				83
Total workforce			398				477				543

Name		Number of ‘A’ Ordinary Shares Beneficially Owned (1)				Percentage of Ownership (2)
Ronan O’Caoimh (3)			18,761,496				11.6	%
Aris Kekedjian (4)			4,000,000				2.6	%
Jim Walsh (5)			2,743,612				1.8	%
John Gillard (6)			1,900,000				1.2	%
Tom Lindsay			-				-
Simon Dunne (7)			240,000				*
Ian Wells			-				-
Eibhlín Kelly			-				-
Gary Keating			-				-
Colm Molloy			-				-
John Mee			-				-
Nick O’Hare			-				-
Mícheál Roche			-				-
Executive officers and directors as a group (13 persons)			27,645,108				16.3	%

*	Less than 1%

(1)

Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. Ordinary Shares relating to options currently exercisable or exercisable within 60 days of the date of this table are deemed outstanding for computing the percentage of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Share options that have a performance condition related to the share price of the equity of the Company are deemed to be exercisable irrespective of whether the performance condition has been, or is expected to be, satisfied within 60 days of the date of this table. Except as indicated by footnote, and subject to community property laws where applicable, the persons named in the table above have sole voting and investment power with respect to all shares shown as beneficially owned by them.

(2)	The percentages shown are based on ‘A’ Ordinary Shares issued and outstanding as of April 15, 2023.

(3)	Represents (a) 9,724,160 ‘A’ ordinary shares and (b) 9,037,336 ‘A’ ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2023. Includes options issued to Darnick Company which in the past provided Trinity Biotech with the services of Mr. O’Caoimh as Chief Executive Officer.
(4)	Represents 4,000,000 ‘A’ ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2023.

(5)

Represents (a) 1,393,612 ‘A’ ordinary shares and (b) 1,350,000 ‘A’ ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2023. Note that 1,393,612 ‘A’ ordinary shares of Dr Walsh’s shares are held in trust for the benefit of Dr Walsh’s immediate family.

(6)	Represents 1,900,000 ‘A’ ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2023.

(7)	Represents 240,000 ‘A’ ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2023.

Director/Company Secretary		Number of Options ‘A’ Shares				Number of Options ADS Equivalent				Exercise Price (Per ‘A’ Share)				Exercise Price (Per ADS)				Hurdle Price 2 (Per ADS)			Expiration Date of Options
Aris Kekedjian			8,000,000				2,000,000				0.27				1.07			None			03/10/2029
			4,000,000				1,000,000				0.27				1.07			$	3.00		03/10/2029
			4,000,000				1,000,000				0.27				1.07			$	4.00		03/10/2029
			4,000,000				1,000,000				0.27				1.07			$	5.00		03/10/2029
John Gillard			600,000				150,000				0.67				2.69			None			23/10/2027
			1,400,000				350,000				0.27				1.09			None			25/03/2029
			3,200,000				800,000				0.29				1.14			None			19/12/2029
			1,600,000				400,000				0.29				1.14			$	3.00		19/12/2029
			1,600,000				400,000				0.29				1.14			$	4.00		19/12/2029
			1,600,000				400,000				0.29				1.14			$	5.00		19/12/2029
Ronan O’Caoimh 1			2,244,000				561,000				1.34				5.35			None			07/09/2024
			4,060,000				1,015,000				0.69				2.74			None			14/06/2026
			333,336				83,334				0.19				0.77			None			20/03/2027
			2,400,000				600,000				0.73				2.90			None			17/11/2027
Jim Walsh			750,000				187,500				1.34				5.35			None			07/09/2024
			600,000				150,000				0.19				0.77			None			20/03/2027

Number of ‘A’ Ordinary Shares Subject to Option

Range of Exercise Price per Ordinary Share

Range of Exercise Price per ADS

Total options outstanding

46,794,672

$

US0.19-US$1.34

$

US0.77-US$5.35

A.	Major Shareholders

Name		Number of ‘A’ Ordinary Shares Beneficially Owned				Number of ADSs Beneficially Owned (1)				Percentage ownership (2)
MiCo IVD Holdings, LLC			44,759,388	(3)			11,189,847				29.3	%
All directors and officers as a group			27,645,108				6,911,277				16.3	%
Perceptive Credit Holdings III, LP			10,000,000	(4)			2,500,000				6.1	%

(1)	Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. Ordinary Shares relating to options currently exercisable or exercisable within 60 days of the date of this table are deemed outstanding for computing the percentage of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Share options that have a performance condition related to the share price of the equity of the Company are deemed to be exercisable irrespective of whether the performance condition has been, or is expected to be, satisfied within 60 days of the date of this table. Except as indicated by footnote, and subject to community property laws where applicable, the persons named in the table above have sole voting and investment power with respect to all shares shown as beneficially owned by them.
(2)	The percentages shown are based on ‘A’ Ordinary Shares outstanding (excluding treasury shares).
(3)	Based upon a Schedule 13D filed on December 8, 2022, by MiCo IVD Holdings, LLC with the SEC. The principal business address of MiCo IVD Holdings, LLC is 85 Orchard Road. Skillman, New Jersey 08558 United States.
(4)	Based upon warrant agreement issued to Perceptive Credit Holdings III, LP in January 2022 in respect of 10,000,000 ‘A’ Ordinary Shares (2,500,000 ADSs).

		Number of ‘A’ Ordinary Shares Beneficially Owned				Number of ADSs Beneficially Owned (1)				Percentage ‘A’ Ordinary Shares (2)				Percentage Total Voting Power			Date of Filing
Whitefort Capital Master Fund, LP			2,342,280				585,570				1.5	%			1.5	%	February 16, 2021
Highbridge Capital Management, LLC			675,064				168,766				0.4	%			0.4	%	April 14, 2022
Renaissance Technologies LLC			5,573,752				1,393,438				3.6	%			3.6	%	February 13, 2023
Stonehill Capital Management LLC			6,690,592				1,672,648				4.4	%			4.4	%	February 13, 2023
Paradice Investment Management, LLC			6,172,460				1,543,115				4.0	%			4.0	%	February 7, 2020

•

an individual resident in the U.S. (or certain other countries with which Ireland has a double taxation treaty) and who is neither resident nor ordinarily resident in Ireland; or

•

a U.S. tax resident corporation (or a corporation resident in certain other countries with which Ireland has a double taxation treaty) not under the control of Irish residents; or

•

a corporation that is not resident in Ireland and which is ultimately controlled by persons resident in the U.S. (or certain other countries with which Ireland has a double taxation treaty), with such person or persons not under the control of persons who are not so resident; or

•

a corporation that is not resident in Ireland and the principal class of whose shares (or its 75% parent’s principal class of shares) is substantially or regularly traded on a recognised stock exchange; or

•

is otherwise entitled to an exemption from DWT.

•

the recipient is the direct beneficial owner of the shares and is beneficially entitled to the dividend, and

•

the depository bank’s ADS register shows that the direct beneficial owner of the dividends has a U.S. address on the register, and

•

there is an intermediary between the depository bank and the beneficial shareholder and the depository bank receives confirmation from the intermediary that the beneficial shareholder’s address in the intermediary’s records is in the U.S.

Service	Rate	By whom paid
(1) Issuance of ADSs upon deposit of ordinary shares.	Up to $10.00 per 100 ADSs (or portion thereof) issued.	Persons depositing ordinary shares or person receiving ADSs.
(2) Delivery of deposited securities against surrender of ADSs.	Up to $10.00 per 100 ADSs (or portion thereof) issued.	Persons surrendering ADSs for the purpose of withdrawal of deposited securities or persons to whom deposited securities are delivered.
(3) Issuance of ADSs in connection with a distribution of shares.	Up to $10.00 per 100 ADSs (or portion thereof) issued.	Person to whom distribution is made.
(4) Distribution of cash dividends or other cash distributions, including distribution of cash proceeds following the sale of rights, shares or other property in accordance with the deposit agreement	Up to $0.02 per 1 ADS	Person to whom distribution is made.
(5) Transfer of ADSs	Up to $1.50 per certificate for ADRs or ADRs transferred	Person to whom Receipt is transferred.

•

transfer and registration fees of securities on Trinity Biotech’s securities register to or from the name of the depositary or its agent when ADS holders deposit or withdrawal securities;

•

expenses for cable, telex and fax transmissions and for delivery of securities;

•

expenses incurred for converting foreign currency into U.S. dollars; and

•

taxes and duties upon the transfer of securities (i.e., when ordinary shares are deposited or withdrawn from deposit, other than taxes for which Trinity Biotech is liable).

Item 13.

Defaults, Dividend Arrearages and Delinquencies

Item  14.

Material Modifications to the Rights of Security Holders and Use of Proceeds

Item  15.

Controls and Procedures

		Year ended December 31, 2022								Year ended December 31, 2021
		US$’000				%				US$’000				%
Audit			1,064				92	%			571				86	%
Tax			89				8	%			89				14	%
Total			1,153								660

•

Rule 5605(b)(1) - The Rule requiring maintaining a majority of independent directors. Instead, under Irish law and practice, we are not required to appoint a majority of independent directors.

•

Rule 5605(b)(2) -The Rule requiring that our independent directors have regularly scheduled meetings at which only independent directors are present. Instead, we follow Irish law according to which independent directors are not required to hold executive sessions.

•

Rule 5605(e) - The Rule regarding independent director oversight of director nominations process for directors. Instead, we follow Irish law and practice according to which our board of directors recommends directors for election/re-election by our shareholders.

•

Rule 5635(c) - The requirement to obtain shareholder approval for the establishment or amendment of certain equity based compensation plans, an issuance that will result in a change of control of the company (Rule 5635(b)), certain transactions other than a public offering involving issuances of a 20% or more interest in the company (Rule 5635(d)) and certain acquisitions of the stock or assets of another company (Rule 5635(a)). Instead, we follow Irish law and practice in approving such procedures, according to which Board approval may suffice in certain circumstances, depending on the extent existing general authorities to issue shares are in place.

•

Rule 5605(c)(2) - The Rule requiring maintaining an audit committee consisting of at least three independent directors.  Instead, we follow Irish law that requires that an audit committee have at least one independent director.

•

Rule 5605(d)(2) - The Rule requiring a compensation committee consisting of at least two independent directors. We have had a compensation committee, which we referred to as the remuneration committee.  We have engaged an international consultancy to advise the Board on Board and executive compensation.

•

Rule 5620(c) - The Rule requiring a quorum of 33 1/3% at any meeting of shareholders (Rule 5620(c)). Instead, we follow the provisions of our Articles which require a quorum of 40%. If a quorum is not present within 30 minutes (or such longer time not exceeding one hour as the chairperson of the meeting may decide to wait) after the time appointed for the holding of the meeting a quorum is not present, or if during the meeting a quorum ceases to be present, the meeting, if convened on the requisition of shareholders, shall be dissolved and in any other case, shall stand adjourned to the same day in the next week or to such other day and at such other time and place as the chairperson (or, in default, the board of directors) may, subject to the provisions of the Companies Act 2014, determine. If at such adjourned meeting a quorum is not present within 15 minutes after the time appointed for holding it, the members present in person or by proxy shall be a quorum, but so that not less than two individuals shall constitute a quorum.

16 I. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections