Exhibit		Description
99.1		Trinity Biotech plc Annual Report 2020

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	Page
Corporate Information	1
Market, Industry and Other Data	2
Cautionary Statement Regarding Forward-Looking Statements	2
Board of Directors & Executive Officers	3
Chairman’s Statement	5
Business Overview	6
Directors’ Report	11
Statement of Directors’ Responsibilities in respect of the annual report and the   financial statements	21
Selected Consolidated Financial Data	22
Risk Factors	24
Performance Review	50
Independent Auditor’s Report to the members of Trinity Biotech plc	65
Financial Statements
Consolidated Statement of Operations	72
Consolidated Statement of Comprehensive Income	73
Consolidated Statement of Financial Position	74
Consolidated Statement of Changes in Equity	75
Consolidated Statements of Cash Flows	76
Notes to the Consolidated Financial Statements	77
Company Statement of Comprehensive Income	148
Company Statement of Financial Position	149
Company Statement of Changes in Equity	150
Company Statement of Cash Flows	151
Notes to the Company Financial Statements	152

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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);

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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;

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Lyme disease; 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”).

		2020				2019
		US$’000				US$’000
Revenue			101,980				90,435
Operating profit/(loss)			82				(24,112	)
Loss for the year			(6,388	)			(28,914	)

	Number of ‘A’ Ordinary Shares December 31, 2020		Number of ‘A’ Ordinary Shares December 31, 2019		Number of options* December 31, 2020		Number of options* December 31, 2019		Weighted average exercise price of options outstanding at December 31, 2020		Weighted average exercise price of options outstanding at December 31, 2019
Directors
Ronan O’Caoimh**	7,057,501		7,057,501		11,704,000		7,104,000		US$0.69		US$1.09
John Gillard	-		-		600,000		-		US$0.67		-
Jim Walsh	1,393,612		1,393,612		1,510,000		910,000		US$1.00		US$1.53
Kevin Tansley	150,000		150,000		1,664,000		1,364,000		US$0.79		US$1.74
James Merselis	188,600		188,600		630,000		270,000		US$0.79		US$1.58
Clint Severson	288,000		288,000		630,000		270,000		US$0.79		US$1.58

	Number of options held at January 1, 2020		Options granted during the year		Options lapsed /exercised/forfeited during the year		Number of options held at December 31, 2020
Directors
Ronan O’Caoimh	7,104,000		5,400,000		(800,000)		11,704,000
John Gillard	-		600,000		-		600,000
Jim Walsh	910,000		600,000		-		1,510,000
Kevin Tansley	1,364,000		800,000		(500,000)		1,664,000
Denis R. Burger*	496,000		360,000		(200,000)		656,000
James Merselis	270,000		360,000		-		630,000
Clint Severson	270,000		360,000		-		630,000

Executive Director		Salary/ Benefits US$’000				Performance related bonus US$’000				Defined contribution pension US$’000				Total 2020 US$’000				Total 2019 US$’000
Ronan O’Caoimh			697				355				—				1,052				425
John Gillard			52				—				—				52				—
Jim Walsh			38				—				—				38				—
Kevin Tansley			487				229				41				757				630
			1,274				584				41				1,899				1,055

Non-executive Director		Fees US$’000				Total 2020 US$’000				Total 2019 US$’000
Denis R. Burger1			48				48				75
James Merselis			57				57				75
Clint Severson			57				57				75
			162				162				225

Renaissance Technologies Holdings Corporation	9.1%
Paradice Investment Management, LLC	7.4%
Heartland Advisors, Inc.	5.6%
Lapides Asset Management, LLC	5.3%
Boston Partners	5.1%
Stonehill Capital Management, LLC	4.7%

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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.

Year Ended December 31,
			2020 US$‘000				2019 US$‘000				2018 US$‘000
Revenues			101,980				90,435				97,035
Cost of sales			(53,400	)			(52,315	)			(55,586	)
Gross profit			48,580				38,120				41,449
Other operating income			1,860				91				102
Research and development expenses			(5,080	)			(5,325	)			(5,369	)
Selling, general and administrative expenses			(26,390	)			(27,661	)			(29,477	)
Selling, general and administrative expenses – recognition of contingent asset			1,316				—				—
Selling, general and administrative expenses – closure costs			(2,425	)			—				—
Selling, general and administrative expenses - impairment charges and inventory write off/provision			(17,779	)			(24,295	)			(26,932	)
Selling, general and administrative expenses – tax audit settlement			—				(5,042	)			—
Operating profit/(loss)			82				(24,112	)			(20,227	)
Financial income			36				697				2,124
Financial expenses			(6,751	)			(6,582	)			(5,080	)
Net financing expense			(6,715	)			(5,885	)			(2,956	)
Loss before tax			(6,633	)			(29,997	)			(23,183	)
Income tax credit			620				1,006				525
Loss for the year			(6,013	)			(28,991	)			(22,658	)
(Loss)/profit for the year on discontinued operations			(375	)			77				568
Loss for the year (all attributable to owners of the parent)			(6,388	)			(28,914	)			(22,090	)
Basic loss per ADS (US Dollars)			(0.31	)			(1.38	)			(1.06	)
Diluted loss per ADS (US Dollars)			(0.31	)			(1.38	)			(1.06	)
Basic loss per ‘A’ ordinary share  (US Dollars)			(0.08	)			(0.35	)			(0.26	)
Diluted loss per ‘A’ ordinary share (US Dollars)			(0.08	)			(0.35	)			(0.26	)
Weighted average number of shares used in computing basic EPS per ADS			20,901,703				20,901,703				20,903,227
Weighted average number of shares used in computing diluted EPS per ADS			26,256,183				25,467,516				25,877,205
Weighted average number of shares used in computing basic EPS per ‘A’ ordinary share			83,606,810				83,606,810				83,612,908
Weighted average number of shares used in computing diluted EPS per ‘A’ ordinary share			105,024,732				101,870,064				103,508,820

		December 31, 2020 US$’000				December 31, 2019 US$’000
Net current assets (current assets less current liabilities)			56,242				51,941
Non-current liabilities			(105,558	)			(106,909	)
Total assets			130,397				131,071
Capital stock			1,213				1,213
Shareholders’ (deficit)/equity			(2,219	)			4,713

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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.

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

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Capital structure - we may require future additional capital.

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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.

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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.

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

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

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

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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.

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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.

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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.

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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.

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

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

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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.

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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.

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Brexit - the United Kingdom’s withdrawal from the European Union could potentially impact our supply chains and the market for our products in the United Kingdom.

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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.

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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.

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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.

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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.

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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.

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Healthcare industry laws - 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.

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Public company regulations - compliance with regulations governing public company corporate governance and reporting is complex and expensive.

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

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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.

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

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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.

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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.

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

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Dilution - the conversion of our outstanding employee share options would dilute the ownership interest of existing shareholders.

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

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

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Voting rights of holders of ADSs - the terms of the deposit agreement limits the voting rights of holders of ADSs.

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limit our ability to borrow additional funds for working capital, capital expenditures, acquisitions or other general business purposes;

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

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

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

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result in dilution to our existing shareholders in the event exchanges of the exchangeable notes are settled in our ordinary shares;

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

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

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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 success of our research and product development efforts;

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

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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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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;

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Diversion of management time and attention; and

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Incurrence of damages payable to plaintiffs.

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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 fulfill our orders and meet our requirements.

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

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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;

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

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

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

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

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

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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;

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

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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

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

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

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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;

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ISO 14155:2011: Clinical investigation of medical devices for human subjects – Good clinical practice.

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our ability 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, 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 willfully 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 Centers for Medicare & Medicaid Services (“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.

	●	announcements of new products by us or others;
	●	announcements by us of significant acquisitions, 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.

1.

Impact of Covid-19 Pandemic

2.

Overview

3.

Revenues

4.

Operating Profit

5.

Loss for the year

6.

Discontinued operations

		Year ended December 31,
			2020 US$’000				2019 US$’000			% Change
Revenues
Clinical laboratory goods			84,280				68,127				23.7	%
Clinical laboratory services			8,485				10,915				(22.3	)%
Point-of-Care			9,215				11,393				(19.1	)%
			101,980				90,435				12.8	%

		Year ended December 31,
			2020 US$‘000				2019 US$‘000			% Change
Revenues
Americas			70,408				52,183				34.9	%
Asia/Africa			22,567				27,686				(18.5	)%
Europe			9,005				10,566				(14.8	)%
Total			101,980				90,435				12.8	%

		Year ended December 31,
			2020 US$’000				2019 US$’000			% Change
Revenues			101,980				90,435				12.8	%
Cost of sales			(53,400	)			(52,315	)			2.1	%
Gross profit			48,580				38,120				27.4	%
Other operating income			1,860				91				1944.0	%
Research & development			(5,080	)			(5,325	)			(4.6	)%
SG&A expenses			(26,390	)			(27,661	)			(4.6	)%
Selling, general and administrative expenses – recognition of contingent asset			1,316				-				100.0	%
Selling, general and administrative expenses – tax audit settlement			-				(5,042	)			(100.0	)%
Selling, general and administrative expenses – closure costs			(2,425	)			-				100	%
Selling, general and administrative expenses - impairment charges			(17,779	)			(24,295	)			(26.8	)%
Operating profit/(loss) on continuing operations			82				(24,112	)			(100.3	)%

		Year ended December 31,
			2020 US$’000				2019 US$’000			% Change
SG&A (excl. share-based payments and amortisation)			24,207				24,561				(1.4	)%
Share-based payments			780				732				6.6	%
Amortisation			1,403				2,368				(40.8	)%
Total			26,390				27,661				(4.6	)%

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A range of cost saving measures implemented in response to the Covid-19 pandemic including the furloughing of employees in the second quarter of 2020, the receipt of government payroll subsidies, significantly reduced travel costs and the cancellation of trade shows and other marketing activities.

•

Partially offsetting these savings were increased foreign currency losses mainly due to the re-translation of Euro-denominated lease liabilities for right-of-use assets and increased performance-related pay due to higher revenues and profits.

		Year ended December 31,
			2020 US$‘000				2019 US$‘000			% Change
Operating profit/(loss)			82				(24,112	)			(100.3	)%
Net financing expense			(6,715	)			(5,885	)			14.1	%
Loss before tax			(6,633	)			(29,997	)			(77.9	)%
Income tax credit			620				1,006				(38.4	)%
Loss for the year from continuing operations			(6,013	)			(28,991	)			(79.3	)%

		Year ended December 31,
			2020 US$‘000				2019 US$‘000
(Loss)/Profit on discontinued operations			(375	)			77

1.

Overview

2.

Revenues

3.

Operating Loss

4.

Loss for the year

5.

Discontinued operations

i.

Lyme disease revenues decreased following the loss of certain large customers that migrated their Lyme testing away from Western Blot assays to alternative testing platforms,

ii.

HIV point-of-care sales decreased following our decision to discontinue sales of the Unigold HIV test in the USA and

iii.

Revenues for our Fitzgerald business, which sells antibodies to the life sciences and research industries, reduced following higher than average revenues in 2018.

		Year ended December 31,
			2019 US$’000				2018 US$’000			% Change
Revenues
Clinical Laboratory			68,127				71,618				(4.9	)%
Point-of-Care			11,393				14,836				(23.2	)%
Laboratory Services			10,915				10,581				3.2	%
Total			90,435				97,035				6.8	%

		Year ended December 31,
			2019 US$‘000				2018 US$‘000			% Change
Revenues
Americas			52,183				57,559				(9.3	)%
Asia/Africa			27,686				29,466				(6.0	)%
Europe			10,566				10,010				5.6	%
Total			90,435				97,035				(6.8	)%

		Year ended December 31,
			2019 US$’000				2018 US$’000			% Change
Revenues			90,435				97,035				(6.8	)%
Cost of sales			(52,315	)			(55,586	)			(5.9	)%
Gross profit			38,120				41,449				(8.0	)%
Other operating income			91				102				(10.8	)%
Research & development			(5,325	)			(5,369	)			(0.8	)%
SG&A expenses			(27,661	)			(29,477	)			(6.2	)%
Selling, general and administrative expenses – tax audit settlement			(5,042	)			—				—
Selling, general and administrative expenses - impairment charges			(24,295	)			(26,932	)			(9.8	)%
Operating loss on continuing operations			(24,112	)			(20,227	)			19.2	%

		Year ended December 31,
			2019 US$’000				2018 US$’000			% Change
SG&A (excl. share-based payments and amortisation)			24,561				25,317				(3.0	)%
Share-based payments			732				1,335				(45.2	)%
Amortisation			2,368				2,825				(16.2	)%
Total			27,661				29,477				(6.2	)%

•

full year effect of cost savings implemented in 2018 as part of a cost saving programme.  This resulted in lower costs under a wide range of headings including salaries, I.T. costs and discretionary sales and marketing costs and commission payments,

•

lower pay for employees as a consequence of lower revenues,

•

the foreign currency impact which resulted in Euro-denominated and Brazilian-denominated costs being lower by 5% and 7% respectively,

•

partly offset by a gain on the purchase of a portion of our exchangeable notes recorded in 2018 (US$463,000) and higher legal fees and tax professional fees mainly associated with the tax audit which was concluded in 2019 in one of the jurisdictions in which the Group operates.

		Year ended December 31,
			2019 US$‘000				2018 US$‘000			% Change
Operating loss			(24,112	)			(20,227	)			19.2	%
Net financing expense			(5,885	)			(2,956	)			99.1	%
Loss before tax			(29,997	)			(23,183	)			29.4	%
Income tax credit			1,006				525				91.6	%
Loss for the year from continuing operations			(28,991	)			(22,658	)			28.0	%

		Year ended December 31,
			2019 US$‘000				2018 US$‘000
Profit on discontinued operations			77				568

•

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, 2020 and of its loss 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 state of the parent company’s assets, liabilities and financial position of the company as at December 31, 2020 and of its loss and 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.

•

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

•

Discussing with management the options being considered in relation to repayment plan of the loan notes;

•

Discussion with professional advisors engaged by the company to discuss the various options being considered by management;

•

Evaluating management’s assessment of any liquidity issues with the Company by reviewing if the Company has enough liquidity sources from operating activities;

•

Making inquiries with the Directors and reviewing board minutes available up to and including the date of authorisation of the financial statements in order to understand the future plans of the Company;

•

Assessing the adequacy of the disclosures with respect to the going concern assertion; and

•

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

•	We examined the supporting documents of internally generated intangible asset additions in the financial year to ensure they constituted development phase costs allowable for capitalisation as stipulated by IAS 38.

•	We tested the key assumptions used by management in concluding that intangible projects capitalised at year-end demonstrate the required characteristics to permit capitalisation, particularly the commercial and technical feasibility of on-going development projects.

•	We conducted detailed discussions with senior intangible project personnel to understand their rationale for concluding on the appropriateness of capitalisation of the development phase costs under IAS 38 and, where necessary, challenged the underlying reasoning.

•	We obtained a detailed understanding of the role of the employees in the development of the intangibles whose salaries are capitalized.

•	We tested the design and effectiveness of management review controls (including specific controls for review of revenue recognition and year end cut-off analyses).

•	We selected a statistical sample of revenue transactions from the ship and bill revenue stream to vouch to underlying documents.

•	We examined contracts specific to the Company’s Covid-19 related portfolio of products; and

•	We examined post year-end sales activity, the assumptions made and the inputs used in the calculation of the return deferral.

•

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 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

•

Identify and assess the risks of material misstatement of the financial statements, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for their opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control.

•

Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the group and company’s internal control.

•

Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by management.

•

Conclude on the appropriateness of management’s use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the group and company’s ability to continue as a going concern. If they conclude that a material uncertainty exists, they are required to draw attention in the auditor’s report to the related disclosures in the financial statements or, if such disclosures are inadequate, to modify their opinion. Their conclusions are based on the audit evidence obtained up to the date of the auditor’s report. However, future events or conditions may cause the group or company to cease to continue as a going concern.

•

Evaluate the overall presentation, structure and content of the financial statements, including the disclosures, and whether the financial statements represent the underlying transactions and events in a matter that achieves a true and fair view.

					Year ended December 31
		Notes			2020 Total US$‘000				2019 Total US$‘000				2018 Total US$‘000
Revenues		2				101,980				90,435				97,035
Cost of sales						(53,400	)			(52,315	)			(55,586	)
Gross profit						48,580				38,120				41,449
Other operating income		4				1,860				91				102
Research and development expenses						(5,080	)			(5,325	)			(5,369	)
Selling, general and administrative expenses						(26,390	)			(27,661	)			(29,477	)
Selling, general and administrative expenses – recognition of contingent asset		27				1,316				-				-
Selling, general and administrative expenses – closure costs		5				(2,425	)			-				-
Selling, general and administrative expenses – tax audit settlement		6				-				(5,042	)			-
Impairment charges		7				(17,779	)			(24,295	)			(26,932	)
									·				·
Operating profit/(loss)						82				(24,112	)			(20,227	)
Financial income		2,8				36				697				2,124
Financial expenses		2, 8				(6,751	)			(6,582	)			(5,080	)
Net financing expense						(6,715	)			(5,885	)			(2,956	)
Loss before tax		11				(6,633	)			(29,997	)			(23,183	)
Total income tax credit		2, 9				620				1,006				525
Loss for the year on continuing operations		2				(6,013	)			(28,991	)			(22,658	)
(Loss)/Profit for the year on discontinued operations		10				(375	)			77				568
Loss for the year (all attributable to owners of the parent)		2				(6,388	)			(28,914	)			(22,090	)
Basic loss per ADS (US Dollars) – continuing operations		12				(0.29	)			(1.39	)			(1.08	)
Diluted loss per ADS (US Dollars) – continuing operations		12				(0.29	)			(1.39	)			(1.08	)
Basic loss per ‘A’ ordinary share (US Dollars) –continuing operations		12				(0.07	)			(0.35	)			(0.27	)
Diluted loss per ‘A’ ordinary share (US Dollars) – continuing operations		12				(0.07	)			(0.35	)			(0.27	)
Basic loss per ADS (US Dollars) – group		12				(0.31	)			(1.38	)			(1.06	)
Diluted loss per ADS (US Dollars) – group		12				(0.31	)			(1.38	)			(1.06	)
Basic loss per ‘A’ ordinary share (US Dollars) – group		12				(0.08	)			(0.35	)			(0.26	)
Diluted loss per ‘A’ ordinary share (US Dollars) – group		12				(0.08	)			(0.35	)			(0.26	)

					Year ended December 31
		Notes				2020 US$‘000				2019 US$‘000				2018 US$‘000
Loss for the year		2				(6,388	)			(28,914	)			(22,090	)
Other comprehensive loss
Items that will be reclassified subsequently to profit or loss
Foreign exchange translation differences						(1,360	)			(167	)			(520	)
					·				·				·
Other comprehensive loss						(1,360	)			(167	)			(520	)
					·				·				·
Total Comprehensive Loss (all attributable to owners of the parent)						(7,748	)			(29,081	)			(22,610	)

					At December 31
		Notes				2020 US$‘000				2019 US$‘000
ASSETS
Non-current assets
Property, plant and equipment		13				8,547				9,290
Goodwill and intangible assets		14				33,860				43,654
Deferred tax assets		15				4,185				6,252
Derivative financial instruments		25				150				-
Other assets		16				355				485
					·				·
Total non-current assets						47,097				59,681
					·				·
Current assets
Inventories		17				30,219				32,021
Trade and other receivables		18				22,668				20,987
Income tax receivable						3,086				1,982
Cash and cash equivalents		19				27,327				15,231
Short term investments		20				-				1,169
					·				·
Total current assets						83,300				71,390
					·				·
TOTAL ASSETS		2				130,397				131,071
EQUITY AND LIABILITIES
Equity attributable to the equity holders of the parent
Share capital		21				1,213				1,213
Share premium		21				16,187				16,187
Treasury shares		21				(24,922	)			(24,922	)
Accumulated surplus		21				10,573				16,145
Translation reserve		21				(5,293	)			(3,933	)
Other reserves		21				23				23
					·				·
Total (deficit)/equity						(2,219	)			4,713
					·				·
Current liabilities
Income tax payable						154				48
Trade and other payables		23				24,335				16,947
Provisions		24				416				50
Lease liabilities		26				2,153				2,404
					·				·
Total current liabilities						27,058				19,449
					·				·
Non-current liabilities
Exchangeable notes and other borrowings		25				82,695				82,021
Derivative financial instruments		25				1,370				4
Lease liabilities		26				16,588				17,745
Deferred tax liabilities		15				4,905				7,139
					·				·
Total non-current liabilities						105,558				106,909
					·				·
TOTAL LIABILITIES		2				132,616				126,358
					·				·
TOTAL EQUITY AND LIABILITIES						130,397				131,071

		Share capital ‘A’ ordinary shares US$’000				Share premium US$’000				Treasury Shares US$’000				Translation reserve US$’000				Hedging reserves US$’000				Accumulated surplus US$’000				Total US$’000
Balance at January 1, 2018			1,213				16,187				(24,783	)			(3,246	)			23				75,802				65,196
Loss for the period			-				-				-				-				-				(22,090	)			(22,090	)
Other comprehensive income			-				-				-				(520	)			-				-				(520	)
		·				·				·				·				·				·				·
Total comprehensive loss			-				-				-				(520	)			-				(22,090	)			(22,610	)
Share-based payments (Note 22)			-				-				-				-				-				1,607				1,607
Shares purchased (Note 21)			-				-				(139	)			-				-				-				(139	)
		·				·				·				·				·				·				·
Balance at December 31, 2018			1,213				16,187				(24,922	)			(3,766	)			23				55,319				44,054
		·				·				·				·				·				·				·
Balance at January 1, 2019			1,213				16,187				(24,922	)			(3,766	)			23				55,319				44,054
Loss for the period			-				-				-				-				-				(28,914	)			(28,914	)
Other comprehensive income			-				-				-				(167	)			-				-				(167	)
		·				·				·				·				·				·				·
Total comprehensive loss			-				-				-				(167	)			-				(28,914	)			(29,081	)
Share-based payments (Note 22)			-				-				-				-				-				839				839
Adjustment on transition to IFRS 16 (Note 13)			-				-				-				-				-				(11,099	)			(11,099	)
		·				·				·				·				·				·				·
Balance at December 31, 2019			1,213				16,187				(24,922	)			(3,933	)			23				16,145				4,713
		·				·				·				·				·				·				·
Balance at January 1, 2020			1,213				16,187				(24,922	)			(3,933	)			23				16,145				4,713
Loss for the period			-				-				-				-				-				(6,388	)			(6,388	)
Other comprehensive income			-				-				-				(1,360	)			-				-				(1,360	)
			•				•-				•-				•				•			·				·
Total comprehensive loss			-				-				-				(1,360	)			-				(6,388	)			(7,748	)
Share-based payments (Note 22)			-				-				-				-				-				816				816
			•				•-				•-				•				•			·				·
Balance at December 31, 2020			1,213				16,187				(24,922	)			(5,293	)			23				10,573				(2,219	)

					Year ended December 31,
		Notes				2020 US$‘000				2019 US$‘000				2018 US$‘000
Cash flows from operating activities
Loss for the year						(6,388	)			(28,914	)			(22,090	)
Adjustments to reconcile net loss to cash provided by operating activities:
Depreciation		11				1,674				2,526				1,296
Amortisation		11,14				1,403				2,368				2,825
Income tax credit		9				(182	)			(1,006	)			(1,115	)
Financial income		8				(36	)			(697	)			(2,124	)
Financial expense		8				6,751				6,582				5,080
Share-based payments (net of capitalized amounts)		22				792				758				1,369
Foreign exchange (gains)/losses on operating cash flows						(663	)			(93	)			311
Loss on disposal or retirement of property, plant and equipment		11				30				17				15
Movement in inventory provision		17				5,059				1,567				300
Impairment of prepayments		7, 18				562				1,376				1,608
Impairment of property, plant and equipment		7, 13				1,795				6,349				6,112
Impairment of intangible assets		7, 14				15,422				16,570				19,212
Other non-cash items						(634	)			835				570
					·				·				·
Operating cash flows before changes in working capital						25,585				8,238				13,369
(Increase) / decrease in trade and other receivables						(2,489	)			445				(5,960	)
(Increase) / decrease in inventories						(3,419	)			(2,959	)			1,988
Increase / (decrease) in trade and other payables						4,994				151				(3,419	)
					·				·				·
Cash generated from operations						24,671				5,875				5,978
Interest paid						(48	)			(1,000	)			(39	)
Interest received						104				560				874
Income taxes (paid) / received						(972	)			(18	)			416
					·				·				·
Net cash generated by operating activities						23,755				5,417				7,229
Cash flows from investing activities
Payments to acquire intangible assets						(6,990	)			(9,718	)			(9,863	)
Acquisition of property, plant and equipment						(3,178	)			(2,118	)			(7,528	)
Disposal of property, plant and equipment						(30	)			(17	)			-
						•				•			·
Net cash used in investing activities						(10,198	)			(11,853	)			(17,391	)
Cash flows from financing activities
Share buyback						-				-				(434	)
Proceeds from Paycheck Protection Loans						4,520				-				-
Interest payment on exchangeable notes		30				(3,996	)			(3,996	)			(4,503	)
Purchase of exchangeable notes		30				-				-				(12,042	)
Proceeds from sale & leaseback transactions						-				-				481
Payment of lease liabilities		30				(3,240	)			(3,533	)			(374	)
						•				•			·
Net cash used in financing activities						(2,716	)			(7,529	)			(16,872	)
Increase/(Decrease) in cash and cash equivalents and short term investments						10,841				(13,965	)			(27,034	)
Effects of exchange rate movements on cash held						86				88				(296	)
Cash and cash equivalents and short-term investments at beginning of year						16,400				30,277				57,607
						•				•			·
Cash and cash equivalents and short term investments at end of year		19,20				27,327				16,400				30,277