Title of each class | Trading Symbol | Name of each exchange on which registered |
American Depositary Shares (each representing 4 ‘A’ Ordinary Shares, par value US$0.0109) | TRIB | NASDAQ Global Market |
U.S. GAAP ☐ | International Financial Reporting Standards as issued by the International Accounting Standards Board ☒ | Other ☐ |
Page | |||
1 | |||
1 | |||
1 | |||
PART I |
2 | |||
2 | |||
2 | |||
A. | [Reserved] | 2 | |
B. | Capitalization and Indebtedness | 2 | |
C. | Reasons for the Offer and Use of Proceeds | 2 | |
D. | Risk Factors | 3 | |
30 | |||
A. | History and Development of the Company | 30 | |
B. | Business Overview | 30 | |
C. | Organizational Structure | 46 | |
D. | Property, Plants and Equipment | 46 | |
47 | |||
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 | |
67 | |||
A. | Directors and Senior Management | 67 | |
B. | Compensation | 69 | |
C. | Board Practices | 69 | |
D. | Employees | 71 | |
E. | Share Ownership | 71 | |
74 | |||
A. | Major Shareholders | 74 | |
B. | Related Party Transactions | 75 | |
C. | Interests of Experts and Counsel | 76 | |
76 | |||
A. | Consolidated Statements and Other Financial Information | 76 | |
B. | Significant Changes | 76 | |
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 | |
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 | |
86 | |||
87 |
PART II | ||
89 | ||
89 | ||
89 | ||
90 | ||
90 | ||
90 | ||
90 | ||
90 | ||
90 | ||
91 | ||
91 | ||
91 | ||
91 | ||
PART III | ||
92 | ||
92 | ||
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. |
• | NASDAQ listing standards - our securities could be delisted from Nasdaq if we do not comply with Nasdaq’s listing standards. |
• | require us to use a substantial portion of our cash flow from operations to make debt service payments; |
• | limit our ability to use our cash flow or obtain additional financing for working capital, capital expenditures, acquisitions or other general business purposes; |
• | limit our flexibility to plan for, or react to, changes in our business and industry; |
• | result in dilution to our existing shareholders in the event we issue equity to fund our debt obligations; |
• | place us at a competitive disadvantage compared to our less leveraged competitors; and |
• | increase our vulnerability to the impact of adverse economic and industry conditions. |
• | incur, assume or guarantee additional indebtedness; 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; |
• | enter into certain inbound and outbound licenses of intellectual property, subject to certain exceptions; and |
• | enter into transactions with affiliates. |
• | 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 |
¹ Cumulative costs to December 31, 2022 are shown before deduction of amortization and impairment losses.
• | 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; |
• | Do not require an invasive sampling procedure that poses a significant risk; |
• | Do not introduce energy into a subject by design or intention; |
• | Are not to be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure; and |
• | Comply with the labelling requirements for IUO devices, as outlined in 21 C.F.R. § 812.2(c)(3). |
• | 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 |
Item 5. | Operating and Financial Review and Prospects |
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$‘000 | % Change | ||||||||||
Revenues | ||||||||||||
Americas | 57,799 | 70,408 | (17.9% | ) | ||||||||
Asia/Africa | 25,504 | 22,567 | 13.0% | |||||||||
Europe | 9,662 | 9,005 | 7.3% | |||||||||
Total | 92,965 | 101,980 | (8.8% | ) |
B. | Liquidity and Capital Resources |
• | The ability of the Group to generate revenue growth from its existing product lines and from new products following the successful completion of its development projects; |
• | The extent to which capital expenditure is incurred on additional property plant and equipment; |
• | The level of investment required to undertake both new and existing development projects; and |
• | Successful working capital management in the context of a growing business. |
Year ended December 31, | ||||||||
2022 US$‘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$0.9 million in 2022 following a review and an update to our relevant quality assurance policy. |
Name | Age | Title |
Directors | ||
Aris Kekedjian | 57 | Chairman and Chief Executive Officer |
Ronan O’Caoimh | 67 | Founder & Director |
Jim Walsh, PhD | 64 | Executive Director of Business Development |
John Gillard | 42 | Chief Financial Officer, Company Secretary, Director |
Tom Lindsay | 65 | Director |
Senior Management | ||
Ian Wells, PhD | 54 | Vice President of Quality and Regulatory Affairs |
Simon Dunne | 49 | Chief Accounting Officer |
Gary Keating, PhD | 50 | Chief Technology Officer |
Eibhlín Kelly | 39 | Chief Information Officer |
Colm Molloy | 52 | Group Director of Human Resources and Culture |
John Mee | 59 | Global Supply Chain Director |
Nick O’Hare | 50 | Vice President of Global Commercial Operations and International Sales |
Mícheál Roche | 63 | Vice President of Global Health |
Director | Title | Salary/Other payments/ Benefits US$’000 | Performance related bonus US$’000 | Transaction related bonus US$’000 | Defined contribution pension US$’000 | Total 2022 US$’000 | Total 2021 US$’000 | |||||||||||||||||||
Aris Kekedjian1, 2 | Chairman and Chief Executive officer | 262 | 125 | — | — | 387 | — | |||||||||||||||||||
Ronan O’Caoimh1 | Executive Director | 340 | — | — | — | 340 | 643 | |||||||||||||||||||
Jim Walsh | Executive Director | 20 | — | — | — | 20 | 20 | |||||||||||||||||||
John Gillard 3 | Executive Director | 452 | 183 | 204 | 24 | 863 | 593 | |||||||||||||||||||
Tom Lindsay4 | Director | — | — | — | — | — | — | |||||||||||||||||||
Kevin Tansley5 | Former Director | 19 | — | — | — | 19 | 60 | |||||||||||||||||||
Clint Severson6 | Former Director | 17 | — | — | — | 17 | 49 | |||||||||||||||||||
James Merselis7 | Former Director | 17 | — | — | — | 17 | 49 | |||||||||||||||||||
1,127 | 308 | 204 | 24 | 1,663 | 1,414 |
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 |
- | Options to purchase 2 million ADS at an exercise price of US$1.071 (the closing price on 30 September 2022). The options will vest on a quarterly basis over 24 months from the date of commencement of employment. |
- | Options to purchase 3 million ADS which become exercisable in the event the closing price of the ADS reach certain levels for ten (10) trading days out of the thirty (30) previous trading days, of which: (i) options to purchase 1 million ADSs become exercisable if and when the closing price of the ADSs is equal to or greater than $3.00, (ii) options to purchase 1 million ADSs become exercisable if and when the closing price of the ADSs is equal to or greater than $4.00, and (iii) options to purchase 1 million ADSs become exercisable if and when the closing price of the ADSs is equal to or greater than $5.00, in each case adjusted for any stock splits, reverse splits or equivalent reorganisations. These options have an exercise price of US$1.071 and vest rateably over 3 years from the date of commencement of employment. |
- | Accelerated vesting of the share options in certain circumstances. |
• | 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 $1.50 per certificate for ADRs or ADRs transferred | Person to whom Receipt is transferred. |
• | transfer and registration fees of securities on Trinity Biotech’s securities register to or from the name of the depositary or its agent when ADS holders deposit or withdrawal securities; |
• | expenses for cable, telex and fax transmissions and for delivery of securities; |
• | expenses incurred for converting foreign currency into U.S. dollars; and |
• | taxes and duties upon the transfer of securities (i.e., when ordinary shares are deposited or withdrawn from deposit, other than taxes for which Trinity Biotech is liable). |
Item 13. | Defaults, Dividend Arrearages and Delinquencies |
Item 14. | Material Modifications to the Rights of Security Holders and Use of Proceeds |
Item 15. | Controls and Procedures |
Item 16. | Reserved |
Year ended December 31, 2022 | Year ended December 31, 2021 | |||||||||||||||
US$’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 |
The audited consolidated financial statements as required under Item 18 are attached hereto starting on page 93 of this Annual Report. The audit report of Grant Thornton (PCAOB ID 1402), independent registered public accounting firm, is included herein preceding the audited consolidated financial statements.
• | We evaluated the design effectiveness of controls over management’s selection of the discount rates, short-term forecasts of future revenues and margins, and long-term growth rates used to determine the recoverable amount of each selected CGU. |
• | We compared the underlying cash flow forecasts against budgets and we evaluated management’s ability to accurately forecast future revenues and margins by: |
• | performing a look-back analysis and comparing actual results to management’s historical forecasts; and |
• | assessing the reasonableness of the impact of new products, new partnerships and other macroeconomic activity on short-term cash flows. |
• | We assessed the reasonableness of the valuation model used by the Company compared to generally accepted valuation practices and accounting standards. |
• | We tested the source information underlying the determination of the discount rates through use of observable inputs from independent external sources and we developed independent estimates and compared those to the discount rates selected by management. |
• | We developed independent estimates and compared those to the discount rates selected by management. |
• | We compared the long-term growth rates, used by management to grow cash flows in order to calculate a terminal value, to independent external sources to assess the reasonableness of these rates. |
• | We examined the supporting documents of internally generated development costs additions in the financial year to ensure they constituted development phase costs allowable for capitalization as stipulated by accounting standards. |
• | We tested the key assumptions used by management in concluding that development projects capitalized during the financial year demonstrate the required characteristics to permit capitalization, particularly the commercial and technical feasibility of on-going development projects. |
• | We conducted detailed discussions with senior project personnel in charge of the developments to understand their rationale for concluding on the appropriateness of capitalization of the development phase costs and, where necessary, challenged the underlying reasoning. |
• | We obtained a detailed understanding of the role of the employees in the development of the relevant projects whose salaries are capitalized. |
• | We evaluated the design effectiveness of management’s control on costs capitalization and progress and likely outcome of on-going projects. |
Year ended December 31 | ||||||||||||||||
Notes | 2022 Total US$‘000 | 2021 Total US$‘000 | 2020 Total US$‘000 | |||||||||||||
Revenues | 2 | 74,779 | 92,965 | 101,980 | ||||||||||||
Cost of sales | (52,731 | ) | (54,888 | ) | (53,400 | ) | ||||||||||
Gross profit | 22,048 | 38,077 | 48,580 | |||||||||||||
Other operating income | 4 | 343 | 4,672 | 1,860 | ||||||||||||
Research and development expenses | (4,138 | ) | (4,497 | ) | (5,080 | ) | ||||||||||
Selling, general and administrative expenses | (29,166 | ) | (24,683 | ) | (26,390 | ) | ||||||||||
Selling, general and administrative expenses – closure costs | 9 | - | - | (2,425 | ) | |||||||||||
Selling, general and administrative expenses – recognition of contingent asset | 24 | - | - | 1,316 | ||||||||||||
Impairment charges | 5 | (5,839 | ) | (6,944 | ) | (17,779 | ) | |||||||||
Operating (loss)/profit | (16,752 | ) | 6,625 | 82 | ||||||||||||
Financial income | 6 | 303 | 1,223 | 36 | ||||||||||||
Financial expenses | 6 | (24,745 | ) | (7,097 | ) | (6,751 | ) | |||||||||
Net financing expense | (24,442 | ) | (5,874 | ) | (6,715 | ) | ||||||||||
(Loss)/profit before tax | 9 | (41,194 | ) | 751 | (6,633 | ) | ||||||||||
Total income tax credit | 2, 7 | 192 | 178 | 620 | ||||||||||||
(Loss)/profit for the year on continuing operations | 2 | (41,002 | ) | 929 | (6,013 | ) | ||||||||||
Loss for the year on discontinued operations | 8 | (7 | ) | (54 | ) | (375 | ) | |||||||||
(Loss)/profit for the year (all attributable to owners of the parent) | 2 | (41,009 | ) | 875 | (6,388 | ) | ||||||||||
Basic (loss)/profit per ADS (US Dollars) – continuing operations | 10 | (1.22 | ) | 0.04 | (0.29 | ) | ||||||||||
Diluted (loss)/profit per ADS (US Dollars) – continuing operations | 10 | (1.22 | ) | 0.04 | (0.29 | ) | ||||||||||
Basic (loss)/profit per ‘A’ ordinary share (US Dollars) –continuing operations | 10 | (0.30 | ) | 0.01 | (0.07 | ) | ||||||||||
Diluted (loss)/profit) per ‘A’ ordinary share (US Dollars) – continuing operations | 10 | (0.30 | ) | 0.01 | (0.07 | ) | ||||||||||
Basic (loss)/profit per ADS (US Dollars) – group | 10 | (1.22 | ) | 0.04 | (0.31 | ) | ||||||||||
Diluted (loss)/profit per ADS (US Dollars) – group | 10 | (1.22 | ) | 0.04 | (0.31 | ) | ||||||||||
Basic (loss)/profit per ‘A’ ordinary share (US Dollars) – group | 10 | (0.30 | ) | 0.01 | (0.08 | ) | ||||||||||
Diluted (loss)/profit) per ‘A’ ordinary share (US Dollars) – group | 10 | (0.30 | ) | 0.01 | (0.08 | ) |
Year ended December 31 | |||||||||||||||
Notes | 2022 US$‘000 | 2021 US$‘000 | 2020 US$‘000 | ||||||||||||
(Loss)/profit for the year | 2 | (41,009 | ) | 875 | (6,388 | ) | |||||||||
Other comprehensive loss | |||||||||||||||
Items that will be reclassified subsequently to profit or loss | |||||||||||||||
Foreign exchange translation differences | (396 | ) | (86 | ) | (1,360 | ) | |||||||||
Other comprehensive loss | (396 | ) | (86 | ) | (1,360 | ) | |||||||||
Total Comprehensive (Loss)/profit (all attributable to owners of the parent) | (41,405 | ) | 789 | (7,748 | ) |
At December 31 | |||||||||||
Notes | 2022 US$‘000 | 2021 US$‘000 | |||||||||
ASSETS | |||||||||||
Non-current assets | |||||||||||
Property, plant and equipment | 11 | 5,682 | 5,918 | ||||||||
Goodwill and intangible assets | 12 | 35,269 | 35,981 | ||||||||
Deferred tax assets | 13 | 4,218 | 4,101 | ||||||||
Derivative financial instruments | 22 | 128 | - | ||||||||
Other assets | 14 | 139 | 207 | ||||||||
Total non-current assets | 45,436 | 46,207 | |||||||||
Current assets | |||||||||||
Inventories | 15 | 22,503 | 29,123 | ||||||||
Trade and other receivables | 16 | 15,753 | 16,116 | ||||||||
Income tax receivable | 1,834 | 1,539 | |||||||||
Cash and cash equivalents | 17 | 6,578 | 25,910 | ||||||||
Total current assets | 46,668 | 72,688 | |||||||||
TOTAL ASSETS | 2 | 92,104 | 118,895 | ||||||||
EQUITY AND LIABILITIES | |||||||||||
Equity attributable to the equity holders of the parent | |||||||||||
Share capital | 18 | 1,963 | 1,213 | ||||||||
Share premium | 18 | 46,458 | 16,187 | ||||||||
Treasury shares | 18 | (24,922 | ) | (24,922 | ) | ||||||
Accumulated (deficit)/surplus | 18 | (26,695 | ) | 12,559 | |||||||
Translation reserve | 18 | (5,775 | ) | (5,379 | ) | ||||||
Equity component of convertible note | 18, 22 | 6,709 | - | ||||||||
Other reserves | 18 | 86 | 23 | ||||||||
Total deficit | (2,176 | ) | (319 | ) | |||||||
Current liabilities | |||||||||||
Income tax payable | 28 | 22 | |||||||||
Trade and other payables | 20 | 15,375 | 15,127 | ||||||||
Provisions | 21 | 50 | 50 | ||||||||
Exchangeable notes and other borrowings | 22 | 210 | 83,312 | ||||||||
Lease liabilities | 23 | 1,676 | 1,980 | ||||||||
Total current liabilities | 17,339 | 100,491 | |||||||||
Non-current liabilities | |||||||||||
Senior secured term loan | 22 | 44,301 | - | ||||||||
Derivative financial liability | 22 | 1,569 | - | ||||||||
Convertible Note | 22 | 13,746 | - | ||||||||
Lease liabilities | 23 | 12,267 | 13,865 | ||||||||
Deferred tax liabilities | 13 | 5,058 | 4,858 | ||||||||
Total non-current liabilities | 76,941 | 18,723 | |||||||||
TOTAL LIABILITIES | 2 | 94,280 | 119,214 | ||||||||
TOTAL EQUITY AND LIABILITIES | 92,104 | 118,895 |
Share capital ‘A’ ordinary shares US$’000 | Share premium US$’000 | Treasury Shares US$’000 | Translation reserve US$’000 | Equity Component of Convertible Note US$’000 | Other reserves US$’000 | Accumulated | Total US$’000 | |||||||||||||||||||||||||
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 19) | - | - | - | - | - | - | 816 | 816 | ||||||||||||||||||||||||
Balance at December 31, 2020 | 1,213 | 16,187 | (24,922 | ) | (5,293 | ) | - | 23 | 10,573 | (2,219 | ) | |||||||||||||||||||||
Balance at January 1, 2021 | 1,213 | 16,187 | (24,922 | ) | (5,293 | ) | - | 23 | 10,573 | (2,219 | ) | |||||||||||||||||||||
Profit for the period | - | - | - | - | - | - | 875 | 875 | ||||||||||||||||||||||||
Other comprehensive loss | - | - | - | (86 | ) | - | - | - | (86 | ) | ||||||||||||||||||||||
Total comprehensive profit/(loss) | - | - | - | (86 | ) | - | - | 875 | 789 | |||||||||||||||||||||||
Share-based payments (Note 19) | - | - | - | - | - | - | 1,111 | 1,111 | ||||||||||||||||||||||||
Balance at December 31, 2021 | 1,213 | 16,187 | (24,922 | ) | (5,379 | ) | - | 23 | 12,559 | (319 | ) | |||||||||||||||||||||
Balance at January 1, 2022 | 1,213 | 16,187 | (24,922 | ) | (5,379 | ) | - | 23 | 12,559 | (319 | ) | |||||||||||||||||||||
Loss for the period | - | - | - | - | - | - | (41,009 | ) | (41,009 | ) | ||||||||||||||||||||||
Other comprehensive loss | - | - | - | (396 | ) | - | - | - | (396 | ) | ||||||||||||||||||||||
Total comprehensive loss | - | - | - | (396 | ) | - | - | (41,009 | ) | (41,405 | ) | |||||||||||||||||||||
Shares issued in the year (Note 18) | 750 | 30,271 | - | - | - | - | - | 31,021 | ||||||||||||||||||||||||
Shares to be issued | - | - | - | - | - | 63 | - | 63 | ||||||||||||||||||||||||
Equity component of convertible note (Note 18) | - | - | - | - | 6,709 | - | - | 6,709 | ||||||||||||||||||||||||
Share-based payments (Note 19) | - | - | - | - | - | 1,755 | 1,755 | |||||||||||||||||||||||||
Balance at December 31, 2022 | 1,963 | 46,458 | (24,922 | ) | (5,775 | ) | 6,709 | 86 | (26,695 | ) | (2,176 | ) |
Year ended December 31, | ||||||||||||||||
Notes | 2022 US$‘000 | 2021 US$‘000 | 2020 US$‘000 | |||||||||||||
Cash flows from operating activities | ||||||||||||||||
(Loss)/profit for the year | (41,009 | ) | 875 | (6,388 | ) | |||||||||||
Adjustments to reconcile net profit/(loss) to cash provided by operating activities: | ||||||||||||||||
Depreciation | 9,11 | 1,410 | 1,827 | 1,674 | ||||||||||||
Amortisation | 9,12 | 923 | 917 | 1,403 | ||||||||||||
Income tax credit | 7 | (192 | ) | (167 | ) | (182 | ) | |||||||||
Financial income | 6 | (303 | ) | (1,223 | ) | (36 | ) | |||||||||
Financial expense | 6 | 24,745 | 7,097 | 6,751 | ||||||||||||
Share-based payments (net of capitalized amounts) | 19 | 1,755 | 1,100 | 792 | ||||||||||||
Foreign exchange gains on operating cash flows | (76 | ) | (251 | ) | (663 | ) | ||||||||||
Loss/(gain) on disposal or retirement of property, plant and equipment | 9 | 2 | (1 | ) | 30 | |||||||||||
Movement in inventory provision | 15 | 7,391 | 5,589 | 5,059 | ||||||||||||
Impairment of prepayments | 5, 16 | 482 | 583 | 562 | ||||||||||||
Impairment of property, plant and equipment | 5, 11 | 733 | 2,508 | 1,795 | ||||||||||||
Impairment of intangible assets | 5, 12 | 4,624 | 3,853 | 15,422 | ||||||||||||
Other non-cash items | 269 | (5,317 | ) | (634 | ) | |||||||||||
Operating cash flows before changes in working capital | 754 | 17,390 | 25,585 | |||||||||||||
(Increase)/decrease in trade and other receivables | (966 | ) | 6,236 | (2,489 | ) | |||||||||||
(Increase) in inventories | (877 | ) | (4,406 | ) | (3,419 | ) | ||||||||||
Increase/(decrease) in trade and other payables | 181 | (7,591 | ) | 4,994 | ||||||||||||
Cash (used in)/generated from operations | (908 | ) | 11,629 | 24,671 | ||||||||||||
Interest paid | - | (11 | ) | (48 | ) | |||||||||||
Interest received | 2 | 1 | 104 | |||||||||||||
Income taxes (paid)/received | (15 | ) | 1,619 | (972 | ) | |||||||||||
Net cash (used in)/generated by operating activities | (921 | ) | 13,238 | 23,755 | ||||||||||||
Cash flows from investing activities | ||||||||||||||||
Payments to acquire intangible assets | (4,876 | ) | (6,879 | ) | (6,990 | ) | ||||||||||
Acquisition of property, plant and equipment | (1,101 | ) | (1,812 | ) | (3,178 | ) | ||||||||||
Disposal of property, plant and equipment | - | - | (30 | ) | ||||||||||||
Net cash used in investing activities | (5,977 | ) | (8,691 | ) | (10,198 | ) | ||||||||||
Cash flows from financing activities | ||||||||||||||||
Issue of ordinary share capital including share premium (net of issuance costs) | 18 | 25,336 | - | - | ||||||||||||
Proceeds from shares to be issued | 63 | - | - | |||||||||||||
Net proceeds from senior secured term loan | 22 | 80,015 | - | - | ||||||||||||
Proceeds from convertible note issued | 22 | 20,000 | - | - | ||||||||||||
Expenses paid in connection with debt financing | 22 | (2,356 | ) | (848 | ) | - | ||||||||||
Purchase of exchangeable notes | 22 | (86,730 | ) | - | - | |||||||||||
Repayment of senior secured term loan | 22 | (34,500 | ) | - | - | |||||||||||
Penalty for early settlement of term loan | 22 | (3,450 | ) | - | - | |||||||||||
Repayment of other loan | (23 | ) | - | - | ||||||||||||
Interest paid on senior secured term loan | (6,424 | ) | - | - | ||||||||||||
Interest paid on convertible note | (199 | ) | - | - | ||||||||||||
Proceeds from Paycheck Protection loans | - | 1,764 | 4,520 | |||||||||||||
Interest paid on exchangeable notes | 27 | (1,293 | ) | (3,996 | ) | (3,996 | ) | |||||||||
Payment of lease liabilities | 27 | (2,761 | ) | (2,939 | ) | (3,240 | ) | |||||||||
Net cash used in financing activities | (12,322 | ) | (6,019 | ) | (2,716 | ) | ||||||||||
(Decrease)/increase in cash and cash equivalents and short-term investments | (19,220 | ) | (1,472 | ) | 10,841 | |||||||||||
Effects of exchange rate movements on cash held | (112 | ) | 55 | 86 | ||||||||||||
Cash and cash equivalents and short-term investments at beginning of year | 25,910 | 27,327 | 16,400 | |||||||||||||
Cash and cash equivalents and short-term investments at end of year | 17 | 6,578 | 25,910 | 27,327 |
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES |
i) | General information |
ii) | Statement of compliance |
iii) | Basis of preparation |
100
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
iv) | Basis of consolidation |
v) | Property, plant and equipment |
• Leasehold improvements | 5-15 years | |||
• Buildings | 50 years | |||
• Office equipment and fittings | 10 years | |||
• Computer equipment | 3-5 years | |||
• Plant and equipment | 5-15 years |
101
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
• | the contract contains an identified asset, which is either explicitly identified in the contract or implicitly specified by being identified at the time the asset is made available to the Group |
• | the Group has the right to obtain substantially all of the economic benefits from use of the identified asset throughout the period of use, considering its rights within the defined scope of the contract |
• | the Group has the right to direct the use of the identified asset throughout the period of use. The Group assess whether it has the right to direct ‘how and for what purpose’ the asset is used throughout the period of use. |
vi) | Goodwill |
102
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
vii) | Intangibles, including research and development (other than goodwill) |
• Capitalised development costs | 15 years | ||
• Patents and licences | 6-15 years | ||
• Other (including acquired customer and supplier lists) | 6-15 years |
103
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
(a) | once a diagnostic test becomes established, customers are reluctant to change to new technology until it is fully proven, thus resulting in relatively long product life cycles. There is also reluctance in customers to change to a new product as it can be costly both in terms of the initial changeover cost and as new technology is typically more expensive. |
(b) | demand for the diagnostic tests is enduring and robust within a wide geographic base. The diseases that the products diagnose are widely prevalent (HIV, Diabetes and Chlamydia being just three examples) in many countries. There is a general consensus that these diseases will continue to be widely prevalent in the future. |
(c) | there are significant barriers to new entrants in this industry. Patents and/or licences are in place for several of our products, though this is not the only barrier to entry. There is a significant cost and time to develop new products, it is necessary to obtain regulatory approval and tests are protected by proprietary know-how, manufacturing techniques and trade secrets. |
viii) | Impairment |
104
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
ix) | Inventories |
x) | Trade and other receivables |
xi) | Trade and other payables |
xii) | Cash and cash equivalents |
xiii) | Short-term investments |
105
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
xiv) | Share-based payments |
xv) | Government grants and financial support |
xvi) | Revenue recognition |
106
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
xvii) | Employee benefits |
107
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
xviii) | Foreign currency |
xix) | Hedging |
108
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
xx) | Exchangeable notes and derivative financial instruments |
xxi) | Senior secured term loan The senior secured term loan is initially recorded at the fair value of the consideration received net of: a) directly attributable transaction costs, b) the fair value at the date of issue of the warrants issued to the lender (see Note 1xxii) and c) the fair value of the option to prepay the loan at the date of issue (see Note 1xxii). Subsequent to initial recognition, the term loan is measured at amortised cost employing the effective interest methodology. Borrowing costs, including any penalties for early settlement of the loan, are recognised as an expense in the period in which they are incurred. |
xxii) | Warrants and loan prepayment option |
xxiii) | Convertible Note |
xxiv) | Segment reporting |
109
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
xxv) | Tax (current and deferred) |
i. | Where the deferred tax liability arises from goodwill not deductible for tax purposes or the initial recognition of an asset or a liability in a transaction that is not a business combination and affects neither the accounting profit nor the taxable profit or loss at the time of the transaction; and |
ii. | Where, in respect of temporary differences associated with investments in subsidiary undertakings, the timing of the reversal of the temporary difference is subject to control and it is probable that the temporary difference will not reverse in the foreseeable future. |
xxvi) | Provisions |
xxvii) | Cost of sales |
xxviii) | Finance income and costs |
110
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. | BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) |
xxvix) | Treasury shares |
xxx) | Equity |
xxxi) | Profit or loss from discontinued operations |
xxxii) | Fair values |
xxxiii) | New IFRS Standards adopted as of January 1, 2022 |
• | Amendments to IFRS 3 Business Combinations – Reference to the Conceptual Framework |
• | Amendments to IAS 16 Property, Plant and Equipment – Proceeds before Intended Use |
• | Amendments to IAS 37 Provisions, Contingent Liabilities and Contingent Assets – Onerous Contracts – Costs of Fulfilling a Contract |
xxxiv) | Standards, amendments and interpretations to existing IFRS Standards that are not yet effective |
At the date of authorisation of these financial statements, several new, but not yet effective, Standards and amendments to existing Standards, and interpretations have been published by the IASB or IFRIC. None of these Standards or amendments to existing Standards have been adopted early by the Group and no interpretations have been issued that are applicable and need to be taken into consideration by the Group at either reporting date. Management anticipates that all relevant pronouncements will be adopted for the first period beginning on or after the effective date of the pronouncement. New Standards, amendments and Interpretations not adopted in the current year have not been disclosed as they are not expected to have a material impact on the Group’s consolidated financial statements.
111
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. | SEGMENT INFORMATION |
i) | The distribution of revenue by geographical area based on location of assets was as follows: |
Revenue | Americas | Rest of World Ireland | Eliminations | Total | ||||||||||||
Year ended December 31, 2022 | US$‘000 | US$‘000 | US$’000 | US$‘000 | ||||||||||||
Revenue from external customers | 50,508 | 24,271 | - | 74,779 | ||||||||||||
Inter-segment revenue | 26,110 | 828 | (26,938 | ) | - | |||||||||||
Total revenue | 76,618 | 25,099 | (26,938 | ) | 74,779 |
Revenue | Americas | Rest of World Ireland | Eliminations | Total | ||||||||||||
Year ended December 31, 2021 | US$‘000 | US$‘000 | US$’000 | US$‘000 | ||||||||||||
Revenue from external customers | 67,249 | 25,716 | - | 92,965 | ||||||||||||
Inter-segment revenue | 49,059 | 2,517 | (51,576 | ) | - | |||||||||||
Total revenue | 116,308 | 28,233 | (51,576 | ) | 92,965 |
112
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. | SEGMENT INFORMATION (CONTINUED) |
Revenue | Americas | Rest of World Ireland | Eliminations | Total | ||||||||||||
Year ended December 31, 2020 | US$‘000 | US$‘000 | US$’000 | US$‘000 | ||||||||||||
Revenue from external customers | 77,688 | 24,292 | - | 101,980 | ||||||||||||
Inter-segment revenue | 59,304 | 1,095 | (60,399 | ) | - | |||||||||||
Total revenue | 136,992 | 25,387 | (60,399 | ) | 101,980 |
ii) | The distribution of revenue by customers’ geographical area was as follows: |
Revenue | December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | |||||||||
Americas | 40,176 | 57,799 | 70,408 | |||||||||
Asia / Africa | 25,022 | 25,504 | 22,567 | |||||||||
Europe (including Ireland) * | 9,581 | 9,662 | 9,005 | |||||||||
74,779 | 92,965 | 101,980 |
* | Revenue from customers in Ireland is not disclosed separately due to the immateriality of these revenues. |
iii) | The distribution of revenue by major product group was as follows: |
Revenue | December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | |||||||||
Clinical laboratory goods | 58,294 | 74,700 | 84,280 | |||||||||
Clinical laboratory services | 7,272 | 7,928 | 8,485 | |||||||||
Point-of-Care | 9,213 | 10,337 | 9,215 | |||||||||
74,779 | 92,965 | 101,980 |
iv) | The group has recognised the following amounts relating to revenue in the consolidated statement of operations: |
Revenue | December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | |||||||||
Revenue from contracts with customers (a) | 74,779 | 92,965 | 101,980 | |||||||||
74,779 | 92,965 | 101,980 |
113
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. | SEGMENT INFORMATION (CONTINUED) |
(v) | Disaggregation of revenue from contracts with customers: The Group derives revenue from the transfer of goods and services over time and at a point in time in the following geographical areas: |
Timing of revenue recognition | Americas | Rest of World Ireland | Rest of World Other | Total | ||||||||||||
Year ended December 31, 2022 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
At a point in time | 50,174 | 24,271 | - | 74,445 | ||||||||||||
Over time | 334 | - | - | 334 | ||||||||||||
Total | 50,508 | 24,271 | - | 74,779 |
Timing of revenue recognition | Americas | Rest of World Ireland | Rest of World Other | Total | ||||||||||||
Year ended December 31, 2021 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
At a point in time | 66,806 | 25,716 | - | 92,522 | ||||||||||||
Over time | 443 | - | - | 443 | ||||||||||||
Total | 67,249 | 25,716 | - | 92,965 |
Timing of revenue recognition | Americas | Rest of World Ireland | Rest of World Other | Total | ||||||||||||
Year ended December 31, 2020 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
At a point in time | 77,060 | 24,292 | - | 101,352 | ||||||||||||
Over time | 628 | - | - | 628 | ||||||||||||
Total | 77,688 | 24,292 | - | 101,980 |
(vi) | The Group derives revenue from the transfer of goods and services over time and at a point in time based on customers’ geographical area as follows: |
Timing of revenue recognition | Americas | Asia / Africa | Europe | Total | ||||||||||||
Year ended December 31, 2022 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
At a point in time | 39,842 | 25,022 | 9,581 | 74,445 | ||||||||||||
Over time | 334 | - | - | 334 | ||||||||||||
Total | 40,176 | 25,022 | 9,581 | 74,779 |
Timing of revenue recognition | Americas | Asia / Africa | Europe | Total | ||||||||||||
Year ended December 31, 2021 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
At a point in time | 57,356 | 25,504 | 9,662 | 92,522 | ||||||||||||
Over time | 443 | - | - | 443 | ||||||||||||
Total | 57,799 | 25,504 | 9,662 | 92,965 |
114
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. | SEGMENT INFORMATION (CONTINUED) |
Timing of revenue recognition | Americas | Asia / Africa | Europe | Total | ||||||||||||
Year ended December 31, 2020 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
At a point in time | 69,780 | 22,567 | 9,005 | 101,352 | ||||||||||||
Over time | 628 | - | - | 628 | ||||||||||||
Total | 70,408 | 22,567 | 9,005 | 101,980 |
vii) | The distribution of segment results by geographical area was as follows: |
Rest of World | ||||||||||||||||
Americas | Ireland | Other | Total | |||||||||||||
Year ended December 31, 2022 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
Result before impairment and unallocated expenses | (5,891 | ) | (2,516 | ) | (33 | ) | (8,440 | ) | ||||||||
Impairment charges | (2,331 | ) | (3,508 | ) | - | (5,839 | ) | |||||||||
Result after impairment | (8,222 | ) | (6,024 | ) | (33 | ) | (14,279 | ) | ||||||||
Unallocated expenses * | (2,473 | ) | ||||||||||||||
Operating loss | (16,752 | ) | ||||||||||||||
Net financing expense (Note 6) | (24,442 | ) | ||||||||||||||
Loss before tax | (41,194 | ) | ||||||||||||||
Income tax credit (Note 7) | 192 | |||||||||||||||
Loss for the year on continuing operations | (41,002 | ) | ||||||||||||||
Loss for the year on discontinued operations (Note 8) | (7 | ) | ||||||||||||||
Loss for the year | (41,009 | ) |
Rest of World | ||||||||||||||||
Americas | Ireland | Other | Total | |||||||||||||
Year ended December 31, 2021 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
Result before impairment and unallocated expenses | 9,276 | 5,084 | (12 | ) | 14,348 | |||||||||||
Impairment charges | (6,088 | ) | (856 | ) | - | (6,944 | ) | |||||||||
Result after impairment | 3,188 | 4,228 | (12 | ) | 7,404 | |||||||||||
Unallocated expenses * | (779 | ) | ||||||||||||||
Operating profit | 6,625 | |||||||||||||||
Net financing expense (Note 6) | (5,874 | ) | ||||||||||||||
Profit before tax | 751 | |||||||||||||||
Income tax credit (Note 7) | 178 | |||||||||||||||
Profit for the year on continuing operations | 929 | |||||||||||||||
Loss for the year on discontinued operations (Note 8) | (54 | ) | ||||||||||||||
Profit for the year | 875 |
115
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. | SEGMENT INFORMATION (CONTINUED) |
Rest of World | ||||||||||||||||
Americas | Ireland | Other | Total | |||||||||||||
Year ended December 31, 2020 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
Result before impairment and unallocated expenses | 14,495 | 4,264 | (71 | ) | 18,688 | |||||||||||
Impairment | (17,779 | ) | - | - | (17,779 | ) | ||||||||||
Result after impairment | (3,284 | ) | 4,264 | (71 | ) | 909 | ||||||||||
Unallocated expenses * | (827 | ) | ||||||||||||||
Operating profit | 82 | |||||||||||||||
Net financing expense (Note 6) | (6,715 | ) | ||||||||||||||
Loss before tax | (6,633 | ) | ||||||||||||||
Income tax credit (Note 7) | 620 | |||||||||||||||
Loss for the year on continuing operations | (6,013 | ) | ||||||||||||||
Loss for the year on discontinued operations (Note 8) | (375 | ) | ||||||||||||||
Loss for the year | (6,388 | ) |
* | Unallocated expenses represent head office general and administration costs of the Group, which cannot be allocated to the results of any specific geographical area. |
viii) | The distribution of segment assets and segment liabilities by geographical area was as follows: |
Rest of World | ||||||||||||||||
Americas | Ireland | Other | Total | |||||||||||||
As at December 31, 2022 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
Assets and liabilities | ||||||||||||||||
Segment assets | 41,779 | 37,695 | - | 79,474 | ||||||||||||
Unallocated assets: | ||||||||||||||||
Income tax assets (current and deferred) | 6,052 | |||||||||||||||
Cash and cash equivalents and short-term investments | 6,578 | |||||||||||||||
Total assets as reported in the Group balance sheet | 92,104 | |||||||||||||||
Segment liabilities | 58,307 | 30,845 | 42 | 89,194 | ||||||||||||
Unallocated liabilities: | ||||||||||||||||
Income tax liabilities (current and deferred) | 5,086 | |||||||||||||||
Total liabilities as reported in the Group balance sheet | 94,280 |
Rest of World | ||||||||||||||||
Americas | Ireland | Other | Total | |||||||||||||
As at December 31, 2021 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||
Assets and liabilities | ||||||||||||||||
Segment assets | 45,891 | 41,453 | 1 | 87,345 | ||||||||||||
Unallocated assets: | ||||||||||||||||
Income tax assets (current and deferred) | 5,640 | |||||||||||||||
Cash and cash equivalents and short-term investments | 25,910 | |||||||||||||||
Total assets as reported in the Group balance sheet | 118,895 | |||||||||||||||
Segment liabilities | 12,382 | 101,927 | 25 | 114,334 | ||||||||||||
Unallocated liabilities: | ||||||||||||||||
Income tax liabilities (current and deferred) | 4,880 | |||||||||||||||
Total liabilities as reported in the Group balance sheet | 119,214 |
ix) | The distribution of long-lived assets, which are property, plant and equipment, goodwill and intangible assets and other non-current assets (excluding deferred tax assets and derivative financial instruments), by geographical area was as follows: |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | |||||||
Rest of World – Ireland | 21,180 | 22,617 | ||||||
Americas | 19,910 | 19,489 | ||||||
41,090 | 42,106 |
116
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. | SEGMENT INFORMATION (CONTINUED) |
x) | The distribution of depreciation and amortisation by geographical area was as follows: |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Depreciation: | ||||||||||||
Rest of World – Ireland | 128 | 204 | 127 | |||||||||
Americas | 1,282 | 1,662 | 1,587 | |||||||||
1,410 | 1,866 | 1,714 | ||||||||||
Amortisation: | ||||||||||||
Rest of World – Ireland | 123 | 69 | 32 | |||||||||
Americas | 800 | 848 | 1,371 | |||||||||
923 | 917 | 1,403 |
xi) | The distribution of share-based payment expense by geographical area was as follows: |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Rest of World – Ireland | 632 | 1,072 | 722 | |||||||||
Americas | 1,123 | 28 | 70 | |||||||||
1,755 | 1,100 | 792 |
xii) | The distribution of taxation (expense)/credit by geographical area was as follows: |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Rest of World – Ireland | 284 | 540 | 293 | |||||||||
Rest of World – Other | (4 | ) | (2 | ) | (8 | ) | ||||||
Americas | (88 | ) | (360 | ) | 335 | |||||||
192 | 178 | 620 |
xiii) | During 2022 and 2020 there were no customers generating 10% or more of total revenues. In 2021, one customer accounted for more than 10% of total revenues. |
xiv) | The distribution of capital expenditure by geographical area was as follows: |
December 31 2022 US$‘000 | December 31, 2021 US$‘000 | |||||||
Rest of World – Ireland | 2,443 | 3,826 | ||||||
Rest of World – Other | - | - | ||||||
Americas | 4,370 | 4,776 | ||||||
6,813 | 8,602 |
117
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
3. | EMPLOYMENT |
December 31, 2022 | December 31, 2021 | December 31, 2020 | ||||||||||
Research and development | 30 | 41 | 52 | |||||||||
Administration and sales | 119 | 134 | 148 | |||||||||
Manufacturing and quality | 249 | 302 | 343 | |||||||||
398 | 477 | 543 |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Wages and salaries | 23,608 | 26,561 | 26,187 | |||||||||
Social welfare costs | 2,036 | 2,403 | 2,195 | |||||||||
Pension costs | 352 | 352 | 447 | |||||||||
Share-based payments | 1,755 | 1,100 | 792 | |||||||||
Restructuring Cost | 274 | 270 | 388 | |||||||||
Recognition of contingent asset (Note 24) | - | - | (1,316 | ) | ||||||||
28,025 | 30,686 | 28,693 |
4. | OTHER OPERATING INCOME |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Government supports - COVID-19 | 7 | 4,668 | 1,840 | |||||||||
Government grants | 333 | - | - | |||||||||
Other income | - | - | 17 | |||||||||
Rental income from premises | 3 | 4 | 3 | |||||||||
343 | 4,672 | 1,860 |
118
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
4. | OTHER OPERATING INCOME (CONTINUED) |
5. | IMPAIRMENT CHARGES |
December 31, | December 31, | December 31, | ||||||||||
2022 | 2021 | 2020 | ||||||||||
US$’000 | US$’000 | US$’000 | ||||||||||
Selling, general & administration expenses | ||||||||||||
Impairment of PP&E (Note 11) | 733 | 2,508 | 1,795 | |||||||||
Impairment of goodwill and other intangible assets (Note 12) | 4,624 | 3,853 | 15,422 | |||||||||
Impairment of prepayments (Note 16) | 482 | 583 | 562 | |||||||||
Total impairment loss | 5,839 | 6,944 | 17,779 |
119
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
6. | FINANCIAL INCOME AND EXPENSES |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Financial income: | ||||||||||||
Non-cash financial income | 303 | 1,220 | - | |||||||||
Interest income | - | 3 | 36 | |||||||||
303 | 1,223 | 36 | ||||||||||
Financial expense: | ||||||||||||
Interest on leases (Note 27) | (657 | ) | (815 | ) | (896 | ) | ||||||
Loss on disposal of exchangeable notes (Note 22, 27) | (9,678 | ) | - | - | ||||||||
Penalty for early partial settlement of senior secured term loan (Note 22) | (3,450 | ) | - | - | ||||||||
Cash interest payable on senior secure term loan | (7,039 | ) | - | - | ||||||||
Cash interest payable on convertible note | (199 | ) | - | - | ||||||||
Cash interest on exchangeable notes | (296 | ) | (3,996 | ) | (3,996 | ) | ||||||
Loan origination costs | - | (1,638 | ) | - | ||||||||
Non-cash interest on exchangeable notes | (84 | ) | (648 | ) | (643 | ) | ||||||
Non-cash interest on senior secured term loan | (2,772 | ) | - | - | ||||||||
Non-cash interest on convertible note | (495 | ) | - | - | ||||||||
Non-cash financial expense | (74 | ) | - | (1,216 | ) | |||||||
Other | (1 | ) | - | - | ||||||||
(24,745 | ) | (7,097 | ) | (6,751 | ) | |||||||
Net Financing Expense | (24,442 | ) | (5,874 | ) | (6,715 | ) |
120
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
7. | INCOME TAX CREDIT |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Current tax (credit)/expense | ||||||||||||
Irish Corporation tax | (331 | ) | (511 | ) | (480 | ) | ||||||
Foreign taxes (a) | (5 | ) | 296 | 179 | ||||||||
Adjustment in respect of prior years | 61 | - | (152 | ) | ||||||||
Total current tax credit | (275 | ) | (215 | ) | (453 | ) | ||||||
Deferred tax credit (b) | ||||||||||||
Origination and reversal of temporary differences (see Note 13) | 321 | 620 | 48 | |||||||||
Origination and reversal of net operating losses (see Note 13) | (238 | ) | (583 | ) | (215 | ) | ||||||
Total deferred tax charge/(credit) | 83 | 37 | (167 | ) | ||||||||
Total income tax credit on continuing operations in statement of operations | (192 | ) | (178 | ) | (620 | ) | ||||||
Tax charge on discontinued operations (see Note 8) | - | 12 | 438 | |||||||||
Total tax credit | (192 | ) | (166 | ) | (182 | ) |
(a) | In 2022, the foreign taxes relate primarily to USA and Canada. |
(b) | In 2022, there was a deferred tax charge of US$109,000 (2021: charge of US$118,000) (2020: credit of US$444,000) recognised in respect of Ireland and a deferred tax credit of US$26,000 (2021: credit of US$81,000) (2020: credit of US$397,000) recognised in respect of overseas tax jurisdictions. |
Effective tax rate | December 31, 2022 | December 31, 2021 | December 31, 2020 | |||||||||
(Loss)/profit before taxation – continuing operations (US$‘000) | (41,194 | ) | 751 | (6,633 | ) | |||||||
As a percentage of (loss)/profit before tax: | ||||||||||||
Current tax % | (0.67 | )% | (28.63 | )% | (6.83 | )% | ||||||
Total (current and deferred) % | (0.47 | )% | (23.70 | )% | (9.35 | )% |
121
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
7. | INCOME TAX CREDIT (CONTINUED) |
December 31, 2022 | December 31, 2021 | December 31, 2020 | ||||||||||
Irish corporation tax | (12.5 | )% | 12.5 | % | (12.5 | )% | ||||||
Effect of current year net operating losses and temporary differences for which no deferred tax asset was recognised (a) | 11.66 | % | 49.63 | % | 24.13 | % | ||||||
Effect of tax rates on overseas earnings | (7.76 | )% | (0.22 | )% | (9.92 | )% | ||||||
Effect of Irish income taxable at higher tax rate | 4.17 | % | 98.68 | % | 5.92 | % | ||||||
Adjustments in respect of prior years | 0.15 | % | (0.01 | )% | (10.66 | )% | ||||||
R&D tax credits | (0.81 | )% | (79.22 | )% | (11.00 | )% | ||||||
Other items (b) | 4.62 | % | (105.06 | )% | 4.68 | % | ||||||
Effective tax rate | (0.47 | )% | (23.70 | )% | (9.35 | )% |
(a) | No deferred tax asset was recognised because there was no reversing deferred tax liability in the same jurisdiction reversing in the same period and insufficient future projected taxable income in the same jurisdiction. |
(b) | Other items comprise items not chargeable to tax and expenses not deductible for tax purposes. This was a significant number in 2021 because the US$4.7 million income from the Paycheck Protection Program loans was not chargeable for tax purposes. There is no Paycheck Protection Program income in 2022. In 2022, other items mainly relate to the loss on disposal of the exchangeable notes. |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Rest of World – Ireland | (19,768 | ) | 1,862 | 296 | ||||||||
Rest of World – Other | (33 | ) | 3,939 | 3,304 | ||||||||
Americas | (21,393 | ) | (5,050 | ) | (10,233 | ) | ||||||
(41,194 | ) | 751 | (6,633 | ) |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Rest of World – Ireland | 62,731 | 68,132 | 78,700 | |||||||||
Rest of World – Other | 448 | 1,000 | 2,185 | |||||||||
Americas | 12,778 | 4,761 | 4,313 | |||||||||
75,957 | 73,893 | 85,198 |
122
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
7. | INCOME TAX CREDIT (CONTINUED) |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Rest of World – Ireland – unused tax losses | 7,489 | 9,272 | 12,514 | |||||||||
Rest of World – Other – unused tax losses | 124 | 279 | 546 | |||||||||
Americas – unused tax losses | 3,163 | 5,891 | 1,466 | |||||||||
Americas – unused tax credits | 4,658 | 3,368 | 2,862 | |||||||||
Unrecognised deferred tax asset | 15,434 | 18,810 | 17,388 |
8. | LOSS FOR THE YEAR ON DISCONTINUED OPERATION |
123
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
8. | LOSS FOR THE YEAR ON DISCONTINUED OPERATION (CONTINUED) |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Administrative expenses | (7 | ) | - | - | ||||||||
Closure provision | - | (42 | ) | 127 | ||||||||
Foreign currency translation reserve | - | - | (64 | ) | ||||||||
Tax expense | - | (12 | ) | (438 | ) | |||||||
Total loss | (7 | ) | (54 | ) | (375 | ) | ||||||
Loss for the year from discontinued operations | (7 | ) | (54 | ) | (375 | ) |
December 31, 2022 | December 31, 2021 | December 31, 2020 | ||||||||||
Basic loss per ADS (US Dollars) – discontinued operations | 0.00 | 0.00 | (0.02 | ) | ||||||||
Diluted loss per ADS (US Dollars) – discontinued operations | 0.00 | 0.00 | (0.02 | ) | ||||||||
Basic loss per ‘A’ share (US Dollars) – discontinued operations | 0.00 | 0.00 | 0.00 | |||||||||
Diluted loss per ‘A’ share (US Dollars) – discontinued operations | 0.00 | 0.00 | 0.00 |
124
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
8. | LOSS FOR THE YEAR ON DISCONTINUED OPERATION (CONTINUED) |
December 31, 2022 | December 31, 2021 | December 31, 2020 | ||||||||||
US$000 | US$000 | US$000 | ||||||||||
Cash flows from operating activities | (10 | ) | (40 | ) | (22 | ) |
9. | (LOSS)/PROFIT BEFORE TAX |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Directors’ emoluments (including non- executive directors): | ||||||||||||
Remuneration | 1,639 | 1,391 | 2,020 | |||||||||
Pension | 24 | 24 | 41 | |||||||||
Share based payments | 1,707 | 986 | 678 | |||||||||
Auditor’s remuneration | ||||||||||||
Audit fees | 888 | 580 | 558 | |||||||||
Tax fees | 89 | 77 | 146 | |||||||||
Depreciation (Note 11)1 | 1,410 | 1,827 | 1,674 | |||||||||
Amortisation (Note 12) | 923 | 917 | 1,403 | |||||||||
Loss/(profit) on the disposal of property, plant and equipment | 2 | (1 | ) | 30 | ||||||||
Selling, General and Administrative Expenses – Closure Costs | - | - | 2,425 | |||||||||
Net foreign exchange differences | (1,210 | ) | (789 | ) | 583 |
1 In 2022, no depreciation was capitalised to research and development projects (2021: US$38,000) (2020: US$40,000).
Selling, General and Administrative Expenses – Closure Costs - in early 2020, management decided to close a production facility in Carlsbad, California facility which specialized in Western Blot manufacturing. The preceding number of years had seen a steady migration of customers away from using the Western Blot testing format for diagnosing Lyme in favour of alternative testing platforms. Production volumes declined steadily at the plant to the extent that it no longer made economic sense to continue. The plant was closed on June 30, 2020. Production of remaining products was transferred to other locations in the Group. The charge for closing the facility was US$2,425,000 which comprised redundancy costs, the write-off of inventory, the cost of exiting lease obligations and other costs associated with the closure of the facility.
125
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
10. | (LOSS)/EARNINGS PER SHARE |
December 31, 2022 | December 31, 2021 | December 31, 2020 | ||||||||||
‘A’ ordinary shares | 134,939,327 | 83,606,810 | 83,606,810 | |||||||||
Basic (loss)/earnings per share denominator | 134,939,327 | 83,606,810 | 83,606,810 | |||||||||
Reconciliation to weighted average (loss)/earnings per share denominator: | ||||||||||||
Number of ‘A’ ordinary shares at January 1 (Note 18) | 96,162,410 | 96,162,410 | 96,162,410 | |||||||||
Weighted average number of ‘A’ ordinary shares issued during the year | 51,332,517 | - | - | |||||||||
Weighted average number of treasury shares | (12,555,600 | ) | (12,555,600 | ) | (12,555,600 | ) | ||||||
Basic (loss)/earnings per share denominator | 134,939,327 | 83,606,810 | 83,606,810 |
December 31, 2022 | December 31, 2021 | December 31, 2020 | ||||||||||
Potentially Dilutive Instruments: | ||||||||||||
Issuable on exercise of options (Note 19) | 44,814,672 | 18,727,990 | 19,485,990 | |||||||||
Issuable on exercise of warrants to Perceptive (Note 22) | 10,000,000 | - | - | |||||||||
Issuable on conversion of Exchangeable notes (Note 22) | 38,391 | 18,263,254 | 18,263,254 | |||||||||
Issuable on conversion of Convertible notes (Note 22) | 24,691,358 | - | - | |||||||||
Total number of potentially dilutive instruments excluded from the weighted average number of ‘A’ ordinary shares in calculating dilutive (loss)/earnings per ‘A’ ordinary share | 79,544,421 | 36,991,244 | 37,749,244 |
126
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
10. | (LOSS)/EARNINGS PER SHARE (CONTINUED) |
o | Options over 3,000,000 ‘A’ ordinary shares were granted, of which 1,400,000 are contingently issuable as their issue is contingent upon satisfaction of specified performance conditions in addition to the passage of time. |
o | Options over 280,000 ‘A’ ordinary shares lapsed unexercised. |
o | 400,000 ‘A’ ordinary shares were issued on the exercise of options. |
o | Warrants over 10,000,000 ‘A’ ordinary shares held by Perceptive were repriced from an exercise price of $0.325 per ‘A’ ordinary share to $0.268 per ‘A’ ordinary share. |
December 31, 2022 | December 31, 2021 | December 31, 2020 | ||||||||||
ADS | 33,734,832 | 20,901,703 | 20,901,703 | |||||||||
Basic (loss)/earnings per ADS denominator | 33,734,832 | 20,901,703 | 20,901,703 | |||||||||
Reconciliation to weighted average (loss)/earnings per ADS denominator: | ||||||||||||
Number of ADS at January 1 (Note 18) | 24,040,602 | 24,040,602 | 24,040,602 | |||||||||
Weighted average number of shares issued during the year* | 12,833,129 | - | - | |||||||||
Weighted average number of treasury shares | (3,138,899 | ) | (3,138,899 | ) | (3,138,899 | ) | ||||||
Basic (loss)/earnings per ADS denominator | 33,734,832 | 20,901,703 | 20,901,703 |
December 31, 2022 | December 31, 2021 | December 31, 2020 | ||||||||||
Potentially Dilutive Instruments: | ||||||||||||
Issuable on exercise of options (Note 19) | 11,203,668 | 4,681,998 | 4,871,498 | |||||||||
Issuable on exercise of warrants to Perceptive (Note 22) | 2,500,000 | - | - | |||||||||
Issuable on conversion of Exchangeable notes (Note 22) | 9,598 | 4,565,814 | 4,565,814 | |||||||||
Issuable on conversion of Convertible notes (Note 22) | 6,172,840 | - | - | |||||||||
Total number of potentially dilutive instruments excluded from the weighted average number of ADS in calculating dilutive (loss)/earnings per ADS | 19,886,106 | 9,247,812 | 9,437,312 |
127
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
10. | (LOSS)/EARNINGS PER SHARE (CONTINUED) |
o | Options over 750,000 ADS were granted, of which 350,000 are contingently issuable as their issue is contingent upon satisfaction of specified performance conditions in addition to the passage of time. |
o | Options over 70,000 ADS lapsed unexercised. |
o | 100,000 ADS were issued on the exercise of options. |
o | Warrants over 2,500,000 ADS held by Perceptive were repriced from an exercise price of $1.30 per ADS to $1.071 per ADS. |
128
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
11. | PROPERTY, PLANT AND EQUIPMENT |
Land & Buildings US$‘000 | Leasehold Improvements US$‘000 | Computer & Office Equipment US$‘000 | Plant & Equipment US$‘000 | Total US$‘000 | ||||||||||||||||
Cost | ||||||||||||||||||||
At January 1, 2021 | 24,287 | 2,670 | 4,309 | 33,839 | 65,105 | |||||||||||||||
Additions | 46 | 126 | 144 | 1,392 | 1,708 | |||||||||||||||
Disposals or retirements | - | (186 | ) | (255 | ) | (2,410 | ) | (2,851 | ) | |||||||||||
Exchange adjustments | 1 | (18 | ) | 2 | (484 | ) | (499 | ) | ||||||||||||
At December 31, 2021 | 24,334 | 2,592 | 4,200 | 32,337 | 63,463 | |||||||||||||||
At January 1, 2022 | 24,334 | 2,592 | 4,200 | 32,337 | 63,463 | |||||||||||||||
Additions | 379 | 93 | 362 | 1,100 | 1,934 | |||||||||||||||
Disposals or retirements | - | - | (25 | ) | (42 | ) | (67 | ) | ||||||||||||
Reallocations/ reclassifications | - | - | (2 | ) | 2 | - | ||||||||||||||
Exchange adjustments | (31 | ) | 16 | 5 | 286 | 276 | ||||||||||||||
At December 31, 2022 | 24,682 | 2,701 | 4,540 | 33,683 | 65,606 | |||||||||||||||
Accumulated amortisation and Impairment losses | ||||||||||||||||||||
At January 1, 2021 | (19,629 | ) | (1,884 | ) | (3,946 | ) | (31,099 | ) | (56,558 | ) | ||||||||||
Charge for the year | (628 | ) | (149 | ) | (115 | ) | (974 | ) | (1,866 | ) | ||||||||||
Disposals or retirements | - | 186 | 255 | 2,410 | 2,851 | |||||||||||||||
Impairment losses | (1,196 | ) | (279 | ) | (98 | ) | (935 | ) | (2,508 | ) | ||||||||||
Exchange adjustments | 21 | (5 | ) | (46 | ) | 566 | 536 | |||||||||||||
At December 31, 2021 | (21,432 | ) | (2,131 | ) | (3,950 | ) | (30,032 | ) | (57,545 | ) | ||||||||||
At January 1, 2022 | (21,432 | ) | (2,131 | ) | (3,950 | ) | (30,032 | ) | �� | (57,545 | ) | |||||||||
Charge for the year | (414 | ) | (133 | ) | (214 | ) | (649 | ) | (1,410 | ) | ||||||||||
Disposals or retirements | - | - | 22 | 43 | 65 | |||||||||||||||
Impairment losses | (48 | ) | (4 | ) | (31 | ) | (650 | ) | (733 | ) | ||||||||||
Exchange adjustments | 9 | (16 | ) | (5 | ) | (289 | ) | (301 | ) | |||||||||||
At December 31, 2022 | (21,885 | ) | (2,284 | ) | (4,178 | ) | (31,577 | ) | (59,924 | ) | ||||||||||
Carrying amounts | ||||||||||||||||||||
At December 31, 2022 | 2,797 | 417 | 362 | 2,106 | 5,682 | |||||||||||||||
At December 31, 2021 | 2,902 | 461 | 250 | 2,305 | 5,918 |
129
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
11. | PROPERTY, PLANT AND EQUIPMENT (CONTINUED) |
Carrying amount | Depreciation Charge | Impairment Charge | ||||||||||
At December 31, 2022 | Year ended December 31, 2022 | Year ended December 31, 2022 | ||||||||||
US$000 | US$000 | US$000 | ||||||||||
Buildings | 2,482 | (398 | ) | (48 | ) | |||||||
Computer equipment | 217 | (40 | ) | - | ||||||||
Plant and Equipment, vehicles | - | (17 | ) | (200 | ) | |||||||
2,699 | (455 | ) | (248 | ) |
Carrying amount | Depreciation Charge | Impairment Charge | ||||||||||
At December 31, 2021 | Year ended December 31, 2021 | Year ended December 31, 2021 | ||||||||||
US$000 | US$000 | US$000 | ||||||||||
Buildings | 2,549 | (609 | ) | (1,089 | ) | |||||||
Computer equipment | 23 | (5 | ) | - | ||||||||
Plant and Equipment, vehicles | - | - | - | |||||||||
2,572 | (614 | ) | (1,089 | ) |
Right-of-Use assets at 31 December 2022 | No. of Right-of-Use leased assets | Range of remaining term in years | Average remaining lease term (years) | No. of Leases with extension options | No. of Leases with options to purchase | No. of leases with variable payments linked to index | No. of leases with termination options | |||||||||||||||||||||
Building | 9 | 1 to 11 | 5 | 2 | - | - | - | |||||||||||||||||||||
Vehicle | 20 | 0.4 to 3 | 2 | - | 20 | - | 20 | |||||||||||||||||||||
I.T. and office equipment | 5 | 4 | 4 | - | - | - | - |
Right-of-Use assets at 31 December 2021 | No. of Right-of-Use leased assets | Range of remaining term in years | Average remaining lease term (years) | No. of Leases with extension options | No. of Leases with options to purchase | No. of leases with variable payments linked to index | No. of leases with termination options | ||||||||||||||||||
Building | 11 | 1 to 12 | 3 | 1 | - | 2 | - | ||||||||||||||||||
Vehicle | 16 | 1 to 3 | 2 | - | 16 | - | 16 | ||||||||||||||||||
I.T. and office equipment | 2 | 1 to 5 | 4 | - | - | - | - |
130
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
11. | PROPERTY, PLANT AND EQUIPMENT (CONTINUED) |
131
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
12. | GOODWILL AND INTANGIBLE ASSETS |
Goodwill US$‘000 | Development costs US$‘000 | Patents and licenses US$‘000 | Other US$‘000 | Total US$‘000 | ||||||||||||||||
Cost | ||||||||||||||||||||
At January 1, 2021 | 79,182 | 128,977 | 8,947 | 33,311 | 250,417 | |||||||||||||||
Additions | - | 6,771 | 102 | 21 | 6,894 | |||||||||||||||
Disposals or retirements | - | (14,576 | ) | (342 | ) | (134 | ) | (15,052 | ) | |||||||||||
Exchange adjustments | - | 1 | - | - | 1 | |||||||||||||||
At December 31, 2021 | 79,182 | 121,173 | 8,707 | 33,198 | 242,260 | |||||||||||||||
At January 1, 2022 | 79,182 | 121,173 | 8,707 | 33,198 | 242,260 | |||||||||||||||
Additions | - | 4,475 | 22 | 382 | 4,879 | |||||||||||||||
Exchange adjustments | - | (64 | ) | - | - | (64 | ) | |||||||||||||
At December 31, 2022 | 79,182 | 125,584 | 8,729 | 33,580 | 247,075 | |||||||||||||||
Accumulated amortisation and Impairment losses | ||||||||||||||||||||
At January 1, 2021 | (66,591 | ) | (115,533 | ) | (8,790 | ) | (25,643 | ) | (216,557 | ) | ||||||||||
Charge for the year | - | (482 | ) | (7 | ) | (428 | ) | (917 | ) | |||||||||||
Disposals or retirements | - | 14,573 | 342 | 132 | 15,047 | |||||||||||||||
Impairment losses | (54 | ) | (2,053 | ) | (106 | ) | (1,640 | ) | (3,853 | ) | ||||||||||
Exchange adjustments | - | 1 | - | - | 1 | |||||||||||||||
At December 31, 2021 | (66,645 | ) | (103,494 | ) | (8,561 | ) | (27,579 | ) | (206,279 | ) | ||||||||||
At January 1, 2022 | (66,645 | ) | (103,494 | ) | (8,561 | ) | (27,579 | ) | (206,279 | ) | ||||||||||
Charge for the year | (479 | ) | (9 | ) | (435 | ) | (923 | ) | ||||||||||||
Impairment losses | - | (4,623 | ) | - | (1 | ) | (4,624 | ) | ||||||||||||
Exchange adjustments | - | 20 | - | - | 20 | |||||||||||||||
At December 31, 2022 | (66,645 | ) | (108,576 | ) | (8,570 | ) | (28,015 | ) | (211,806 | ) | ||||||||||
Carrying amounts | ||||||||||||||||||||
At December 31, 2022 | 12,537 | 17,008 | 159 | 5,565 | 35,269 | |||||||||||||||
At December 31, 2021 | 12,537 | 17,679 | 146 | 5,619 | 35,981 |
132
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
12. | GOODWILL AND INTANGIBLE ASSETS (CONTINUED) |
Product Name | 2022 US$’000 | 2021 US$’000 | ||||||
Premier Instruments for A1c and haemoglobinopathies testing | 1,904 | 2,538 | ||||||
COVID-19 tests | 1,378 | 1,320 | ||||||
Mid-tier haemoglobins instrument | 484 | 303 | ||||||
HIV screening rapid test | 379 | 1,488 | ||||||
Tri-stat point-of-care instrument | 163 | 245 | ||||||
Uni-gold raw material stabilisation | 42 | 144 | ||||||
Autoimmune Smart Reader | 82 | 550 | ||||||
Other projects | 43 | 183 | ||||||
Total capitalised development costs | 4,475 | 6,771 |
133
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
12. | GOODWILL AND INTANGIBLE ASSETS (CONTINUED) |
Asset name | Entity | 2022 US$’000 | |||
Rapid COVID-19 antigen test | Trinity Biotech Manufacturing Ltd | 2,214 | |||
Autoimmune smart reader | Trinity Biotech Manufacturing Ltd | 1,265 | |||
Tri-stat instrument | Primus Corp. | 1,024 | |||
COVID-19 ELISA test | Trinity Biotech Manufacturing Ltd | 120 | |||
Total | 4,623 |
134
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
12. | GOODWILL AND INTANGIBLE ASSETS (CONTINUED) |
December 31, 2022 | December 31, 2021 | |||||||
US$’000 | US$’000 | |||||||
Trinity Biotech Manufacturing Limited | 3,599 | 856 | ||||||
Primus Corp | 1,024 | - | ||||||
Trinity Biotech Do Brasil | 454 | 956 | ||||||
Clark Laboratories Inc. | 407 | - | ||||||
Biopool US Inc. | 355 | 153 | ||||||
Immco Diagnostics Inc | - | 4,979 | ||||||
Total impairment loss | 5,839 | 6,944 |
December 31, 2022 | December 31, 2021 | |||||||
US$’000 | US$’000 | |||||||
Goodwill and other intangible assets | 4,624 | 3,853 | ||||||
Property, plant and equipment (see Note 11) | 733 | 2,508 | ||||||
Prepayments (see Note 16) | 482 | 583 | ||||||
Total impairment loss | 5,839 | 6,944 |
• | In the event that there was a reduction of 10% in the assumed level of future growth in revenue growth rate, which would represent a reasonably likely range of outcomes, there would be no additional impairment loss recorded at December 31, 2022. |
• | In the event there was a 10% increase in the discount rate used to calculate the potential impairment of the carrying values, which would represent a reasonably likely range of outcomes, there would be no additional impairment loss recorded at December 31, 2022. |
135
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
12. | GOODWILL AND INTANGIBLE ASSETS (CONTINUED) |
Fitzgerald Industries | December 31, 2022 | December 31, 2021 | ||||||
Carrying amount of goodwill (US$’000) | 12,591 | 12,591 | ||||||
Discount rate applied (real pre-tax) | 15.77 | % | 19.66 | % | ||||
Excess value-in-use over carrying amount (US$’000) | 7,432 | 3,496 | ||||||
% EBITDA would need to decrease for an impairment to arise | 31.28 | % | 18.15 | % | ||||
Long-term growth rate | 2.0 | % | 2.0 | % |
Intangible Assets with Indefinite Useful lives (included in other intangibles) | December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | ||||||
Fitzgerald Industries International CGU | ||||||||
Fitzgerald trade name | 970 | 970 | ||||||
RDI trade name | 560 | 560 | ||||||
Primus Corporation CGU | ||||||||
Primus trade name | 365 | 365 | ||||||
Immco Diagnostic CGU | ||||||||
Immco Diagnostic trade name | 2,069 | 2,069 | ||||||
Total | 3,964 | 3,964 |
136
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
13. | DEFERRED TAX ASSETS AND LIABILITIES |
Assets | Liabilities | Net | ||||||||||||||||||||||
2022 US$’000 | 2021 US$’000 | 2022 US$’000 | 2021 US$’000 | 2022 US$’000 | 2021 US$’000 | |||||||||||||||||||
Property, plant and equipment | 229 | 477 | (5 | ) | (11 | ) | 224 | 466 | ||||||||||||||||
Intangible assets | - | - | (3,950 | ) | (3,969 | ) | (3,950 | ) | (3,969 | ) | ||||||||||||||
Inventories | 423 | 620 | - | - | 423 | 620 | ||||||||||||||||||
Provisions | 2,194 | 1,871 | - | - | 2,194 | 1,871 | ||||||||||||||||||
Tax value of loss carry-forwards | 1,254 | 1,016 | - | - | 1,254 | 1,016 | ||||||||||||||||||
Other items | 118 | 117 | (1,103 | ) | (878 | ) | (985 | ) | (761 | ) | ||||||||||||||
Deferred tax assets/(liabilities) | 4,218 | 4,101 | (5,058 | ) | (4,858 | ) | (840 | ) | (757 | ) |
Balance January, 1 2022 | Recognised in income | Balance December 31, 2022 | ||||||||||
US$’000 | US$’000 | US$’000 | ||||||||||
Property, plant and equipment | 466 | (242 | ) | 224 | ||||||||
Intangible assets | (3,969 | ) | 19 | (3,950 | ) | |||||||
Inventories | 620 | (197 | ) | 423 | ||||||||
Provisions | 1,871 | 323 | 2,194 | |||||||||
Tax value of loss carry-forwards | 1,016 | 238 | 1,254 | |||||||||
Other items | (761 | ) | (224 | ) | (985 | ) | ||||||
(757 | ) | (83 | ) | (840 | ) |
137
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
13. | DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED) |
Balance January, 1 2021 | Recognised in income | Balance December 31, 2021 | ||||||||||
US$’000 | US$’000 | US$’000 | ||||||||||
Property, plant and equipment | 724 | (258 | ) | 466 | ||||||||
Intangible assets | (4,072 | ) | 103 | (3,969 | ) | |||||||
Inventories | 750 | (130 | ) | 620 | ||||||||
Provisions | 2,159 | (288 | ) | 1,871 | ||||||||
Tax value of loss carry-forwards | 433 | 583 | 1,016 | |||||||||
Other items | (714 | ) | (47 | ) | (761 | ) | ||||||
(720 | ) | (37 | ) | (757 | ) |
December 31, 2022 | December 31, 2021 | |||||||
US$’000 | US$’000 | |||||||
Capital losses | 8,293 | 8,293 | ||||||
Net operating losses | 75,957 | 73,893 | ||||||
US alternative minimum tax credits | 1,906 | 1,704 | ||||||
Other temporary timing differences | 38,960 | 21,301 | ||||||
US state credit carryforwards | 2,753 | 1,664 | ||||||
127,869 | 106,855 |
14. | OTHER NON-CURRENT ASSETS |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | |||||||
Finance lease receivables (see Note 16) | 84 | 151 | ||||||
Other assets | 55 | 56 | ||||||
139 | 207 |
138
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
15. | INVENTORIES |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | |||||||
Raw materials and consumables | 12,094 | 13,650 | ||||||
Work-in-progress | 3,948 | 5,546 | ||||||
Finished goods | 6,461 | 9,927 | ||||||
22,503 | 29,123 |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Opening provision at January 1 | 12,063 | 9,781 | 6,716 | |||||||||
Charged during the year | 7,391 | 5,589 | 5,179 | |||||||||
Utilised during the year | (3,180 | ) | (3,307 | ) | (1,994 | ) | ||||||
Released during the year | - | - | (120 | ) | ||||||||
Closing provision at December 31 | 16,274 | 12,063 | 9,781 |
16. | TRADE AND OTHER RECEIVABLES |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | |||||||
Trade receivables, net of impairment losses | 12,620 | 13,290 | ||||||
Prepayments | 1,932 | 1,945 | ||||||
Contract assets | 739 | 739 | ||||||
Value added tax | 43 | - | ||||||
Finance lease receivables | 86 | 142 | ||||||
Grant receivable | 333 | - | ||||||
15,753 | 16,116 |
139
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
16. | TRADE AND OTHER RECEIVABLES (CONTINUED) |
December 31, 2022 US$‘000 | ||||||||||||
Gross investment | Unearned income | Minimum payments receivable | ||||||||||
Less than one year | 180 | 6 | 86 | |||||||||
Between one and five years (Note 14) | 173 | 6 | 84 | |||||||||
353 | 12 | 170 |
December 31, 2021 US$‘000 | ||||||||||||
Gross investment | Unearned income | Minimum payments receivable | ||||||||||
Less than one year | 292 | 11 | 142 | |||||||||
Between one and five years (Note 14) | 310 | 11 | 151 | |||||||||
602 | 22 | 293 |
December 31, 2022 US$‘000 | ||||||||
Instruments | Total | |||||||
Less than one year | 1,589 | 1,589 | ||||||
1,589 | 1,589 |
140
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
16. | TRADE AND OTHER RECEIVABLES (CONTINUED) |
(ii) Operating lease commitments – Group as lessor
December 31, 2021 US$‘000 | ||||||||
Instruments | Total | |||||||
Less than one year | 3,953 | 3,953 | ||||||
Between one and five years | 171 | 171 | ||||||
4,124 | 4,124 |
17. | CASH AND CASH EQUIVALENTS |
December 31, 2022 US$’000 | December 31, 2021 US$’000 | |||||||
Cash at bank and in hand | 6,578 | 22,790 | ||||||
Short-term deposits | - | 3,120 | ||||||
Cash and cash equivalents | 6,578 | 25,910 |
18. | CAPITAL AND RESERVES |
December 31, 2022 | December 31, 2021 | |||||||
Class ‘A’ Ordinary shares ‘000s | Class ‘A’ Ordinary shares ‘000s | |||||||
In thousands of shares | ||||||||
In issue at January 1 | 96,162 | 96,162 | ||||||
Issued for cash (a) | 47,492 | - | ||||||
Issued as consideration for Exchangeable Notes purchase (b) | 21,332 | - | ||||||
At period end | 164,986 | 96,162 |
December 31, 2022 | December 31, 2021 | |||||||
ADS | ADS | |||||||
In thousands of ADSs | ||||||||
Balance at January 1 | 24,041 | 24,041 | ||||||
Issued for cash | 11,873 | - | ||||||
Issued as consideration for Exchangeable Notes purchase | 5,333 | - | ||||||
At period end | 41,247 | 24,041 |
141
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
18. | CAPITAL AND RESERVES (CONTINUED) |
December 31, 2022 | December 31, 2021 | |||||||
Class ‘A’ Treasury shares ‘000s | Class ‘A’ Treasury shares ‘000s | |||||||
In thousands of shares | ||||||||
Balance at January 1 | 12,556 | 12,556 | ||||||
Purchased during period | - | - | ||||||
At period end | 12,556 | 12,556 |
December 31, 2022 | December 31, 2021 | |||||||
Class ‘A’ Treasury shares ‘000s | Class ‘A’ Treasury shares ‘000s | |||||||
In thousands of ADSs | ||||||||
Balance at January 1 | 3,139 | 3,139 | ||||||
Purchased during period | - | - | ||||||
At period end | 3,139 | 3,139 |
(a) | During the year ended December 31, 2022, the Company issued 47,492,000 ‘A’ Ordinary shares for a consideration of US$25,707,000 settled in cash. The Company incurred US$606,000 in connection with the issues of shares. The total shares issued for cash comprises 44,759,000 ‘A’ Ordinary shares issued to MiCo and 2,733,328 ‘A’ Ordinary from the exercise of employee share options. For more information on the investment by MiCo, refer to Note 22. |
(b) | During the year ended December 31, 2022, the Company issued 21,332,000 ‘A’ Ordinary shares, with a market value of US$6,133,000, as partial consideration for the purchase of Exchangeable Notes. The Company incurred US$213,000 in connection with this issue of shares. For more information on the purchase of Exchangeable Notes, refer to Note 22. |
142
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
18. | CAPITAL AND RESERVES (CONTINUED) |
19. | SHARE OPTIONS |
143
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
19. | SHARE OPTIONS (CONTINUED) |
Share | Weighted- average exercise price US$ | Range US$ | ||||||||||
Options ‘A’ Ordinary Shares | Per ‘A’ Ordinary Share | Per ‘A’ Ordinary Share | ||||||||||
Outstanding January 1, 2020 | 12,303,990 | 1.31 | 0.46 –4.36 | |||||||||
Granted | 9,100,000 | 0.38 | 0.19 –1.10 | |||||||||
Exercised | - | - | - | |||||||||
Expired / Forfeited | (1,918,000 | ) | 2.14 | 0.19-4.21 | ||||||||
Outstanding at end of year | 19,485,990 | 0.79 | 0.19-4.36 | |||||||||
Exercisable at end of year | 7,959,323 | 1.27 | 0.66-4.36 | |||||||||
Outstanding January 1, 2021 | 19,485,990 | 0.79 | 0.19-4.36 | |||||||||
Granted | - | - | - | |||||||||
Exercised | - | - | - | |||||||||
Expired / Forfeited | (758,000 | ) | 1.07 | 0.19-4.21 | ||||||||
Outstanding at end of year | 18,727,990 | 0.78 | 0.19-4.36 | |||||||||
Exercisable at end of year | 13,401,322 | 0.93 | 0.19-4.36 | |||||||||
Outstanding January 1, 2022 | 18,727,990 | 0.78 | 0.19-4.36 | |||||||||
Granted | 29,400,000 | 0.27 | 0.27-0.29 | |||||||||
Exercised | (2,733,328 | ) | 0.19 | 0.19-0.19 | ||||||||
Expired / Forfeited | (579,990 | ) | 1.87 | 0.69-4.36 | ||||||||
Outstanding at end of year | 44,814,672 | 0.47 | 0.19-2.43 | |||||||||
Exercisable at end of year | 14,138,004 | 0.89 | 0.19-2.43 |
144
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
19. | SHARE OPTIONS (CONTINUED) |
Share Options ‘ADS’ | Weighted- average exercise price US$ | Range US$ | ||||||||||
Equivalent | Per ‘ADS’ | Per ‘ADS’ | ||||||||||
Outstanding January 1, 2020 | 3,075,998 | 5.24 | 1.83 - 17.45 | |||||||||
Granted | 2,275,000 | 1.52 | 0.77 - 4.41 | |||||||||
Exercised | - | - | - | |||||||||
Expired / Forfeited | (479,500 | ) | 8.56 | 0.77 - 16.84 | ||||||||
Outstanding at end of year | 4,871,498 | 3.15 | 0.77-17.45 | |||||||||
Exercisable at end of year | 1,989,831 | 5.08 | 2.64 -17.45 | |||||||||
Outstanding January 1, 2021 | 4,871,498 | 3.15 | 0.77-17.45 | |||||||||
Granted | - | - | - | |||||||||
Exercised | - | - | - | |||||||||
Expired / Forfeited | (189,500 | ) | 4.28 | 0.76 - 16.84 | ||||||||
Outstanding at end of year | 4,681,998 | 3.12 | 0.76 - 17.44 | |||||||||
Exercisable at end of year | 3,350,331 | 3.72 | 0.76 –17.44 | |||||||||
Outstanding January 1, 2022 | 4,681,998 | 3.12 | 0.76 - 17.44 | |||||||||
Granted | 7,350,000 | 1.09 | 1.07-1.14 | |||||||||
Exercised | (683,332 | ) | 0.77 | 0.77-0.77 | ||||||||
Expired / Forfeited | (144,998 | ) | 7.48 | 2.76 - 17.44 | ||||||||
Outstanding at end of year | 11,203,668 | 1.88 | 0.77-9.73 | |||||||||
Exercisable at end of year | 3,534,501 | 3.56 | 0.77-9.73 |
Outstanding | Exercisable | |||||||||||||||||||||||
Exercise price range | No. of options ‘A’ ordinary shares | Weighted– average exercise price | Weighted- average contractual life remaining (years) | No. of options ‘A’ ordinary shares | Weighted– average exercise price | Weighted- average contractual life remaining (years) | ||||||||||||||||||
US$0.19-US$0.99 | 39,546,672 | 0.35 | 6.10 | 8,930,004 | 0.59 | 4.05 | ||||||||||||||||||
US$1.00-US$1.74 | 4,988,000 | 1.34 | 1.78 | 4,928,000 | 1.34 | 1.74 | ||||||||||||||||||
US$1.75- US$2.43 | 280,000 | 2.43 | 0.15 | 280,000 | 2.43 | 0.15 | ||||||||||||||||||
44,814,672 | 14,138,004 |
145
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
19. | SHARE OPTIONS (CONTINUED) |
Outstanding | Exercisable | |||||||||||||||||||||||
Exercise price range | No. of options ‘ADS equivalent’ | Weighted– average exercise price | Weighted- average contractual life remaining (years) | No. of options ‘ADS equivalent’ | Weighted– average exercise price | Weighted- average contractual life remaining (years) | ||||||||||||||||||
US$0.77-US$3.96 | 9,886,668 | 1.39 | 6.10 | 2,232,501 | 2.37 | 4.05 | ||||||||||||||||||
US$4.00-US$6.94 | 1,247,000 | 5.37 | 1.78 | 1,232,000 | 5.38 | 1.74 | ||||||||||||||||||
US$6.95- US$9.73 | 70,000 | 9.73 | 0.15 | 70,000 | 9.73 | 0.15 | ||||||||||||||||||
11,203,668 | 3,534,501 |
Outstanding | Exercisable | |||||||||||||||||||||||
Exercise price range | No. of options ‘A’ ordinary shares | Weighted– average exercise price | Weighted- average contractual life remaining (years) | No. of options ‘A’ ordinary shares | Weighted– average exercise price | Weighted- average contractual life remaining (years) | ||||||||||||||||||
US$0.19-US$0.99 | 13,000,006 | 0.48 | 3.54 | 7,960,004 | 0.55 | 2.92 | ||||||||||||||||||
US$1.00-US$2.05 | 5,228,000 | 1.34 | 0.79 | 4,941,334 | 1.35 | 0.99 | ||||||||||||||||||
US$2.06- US$2.99 | 439,984 | 2.53 | 0.03 | 439,984 | 2.53 | 0.04 | ||||||||||||||||||
US$3.00 -US$4.36 | 60,000 | 4.17 | 0.00 | 60,000 | 4.17 | 0.00 | ||||||||||||||||||
18,727,990 | 13,401,322 |
Outstanding | Exercisable | |||||||||||||||||||||||
Exercise price range | No. of options ‘ADS equivalent’ | Weighted– average exercise price | Weighted- average contractual life remaining (years) | No. of options ‘ADS equivalent’ | Weighted– average exercise price | Weighted- average contractual life remaining (years) | ||||||||||||||||||
US$0.77-US$3.96 | 3,250,002 | 1.94 | 3.54 | 1,990,001 | 2.19 | 2.92 | ||||||||||||||||||
US$4.00-US$8.20 | 1,307,000 | 5.36 | 0.79 | 1,235,334 | 5.40 | 0.99 | ||||||||||||||||||
US$8.24- US$11.96 | 109,996 | 10.13 | 0.03 | 109,996 | 10.13 | 0.04 | ||||||||||||||||||
US$12.00 -US$17.45 | 15,000 | 16.67 | 0.00 | 15,000 | 16.67 | 0.00 | ||||||||||||||||||
4,681,998 | 3,350,331 |
146
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
19. | SHARE OPTIONS (CONTINUED) |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | December 31, 2020 US$‘000 | ||||||||||
Share-based payments – cost of sales | - | 5 | 12 | |||||||||
Share-based payments – selling, general and administrative | 1,755 | 1,095 | 780 | |||||||||
Total – continuing operations | 1,755 | 1,100 | 792 | |||||||||
Share-based payments – discontinued operations | - | - | - | |||||||||
Total | 1,755 | 1,100 | 792 |
No share-based payments expense was capitalised in intangible development project assets during the year. In 2021, US$11,000, (2020: US$24,000) of share-based payments was capitalised in intangible development project assets. The total share-based payments charge gross of any capitalisations for 2021 was US$1,111,000 (2020: US$816,000).
The fair value of services received in return for share options granted are measured by reference to the fair value of share options granted. The estimate of the fair value of services received is measured based on a Black-Scholes model. The following are the input assumptions used in determining the fair value of share options granted in 2022, 2021 and 2020:
Key management personnel | Other employees | Key management personnel | Other employees | Key management personnel | Other employees | |||||||||||||||||||
2022 | 2022 | 2021 | 2021 | 2020 | 2020 | |||||||||||||||||||
Weighted average fair value at measurement date per ‘A’ share / (per ADS) | US$0.19 / (US$0.77 | ) | - / - | - / - | - / - | US$0.20 / (US$0.80 | ) | US$0.27 / (US$1.08 | ) | |||||||||||||||
Total ‘A’ share options granted / (ADS’s equivalent) | 29,400,000 / (7,350,000 | ) | - / - | - / - | - / - | 8,480,000 / (2,120,000 | ) | 620,000 / (155,000 | ) | |||||||||||||||
Weighted average share price per ‘A’ share / (per ADS) | US$0.27 / (US$1.09 | ) | - / - | - / - | - / - | US$0.38 / (US$1.52 | ) | US$0.48 / (US$1.96 | ) | |||||||||||||||
Weighted average exercise price per ‘A’ share / (per ADS) | US$0.27 / (US$1.09 | ) | - / - | - / - | - / - | US$0.38 / (US$1.52 | ) | US$0.48 / (US$1.96 | ) | |||||||||||||||
Weighted average expected volatility | 76.79 | % | - | % | - | % | - | % | 66.98 | % | 65.89 | % | ||||||||||||
Weighted average expected life | 6.82 | - | - | - | 4.34 | 4.35 | ||||||||||||||||||
Weighted average risk-free interest rate | 3.59 | % | - | % | - | % | - | % | 0.44 | % | 0.42 | % |
147
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
19. | SHARE OPTIONS (CONTINUED) |
20. | TRADE AND OTHER PAYABLES |
December 31, 2022 US$’000 | December 31, 2021 US$’000 | |||||||
Trade payables | 6,205 | 6,763 | ||||||
Accruals and other liabilities | 8,585 | 7,595 | ||||||
Payroll taxes | 368 | 398 | ||||||
Employee related social insurance | 103 | 130 | ||||||
Deferred income | 114 | 141 | ||||||
Deferred government grants | - | 69 | ||||||
Other payables | - | 31 | ||||||
15,375 | 15,127 |
21. | PROVISIONS |
December 31, 2022 US$’000 | December 31, 2021 US$’000 | |||||||
Product warranty provision | 50 | 50 | ||||||
50 | 50 |
148
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
22. | INTEREST-BEARING LOANS AND BORROWINGS |
December 31, 2022 US$’000 | December 31, 2021 US$’000 | |||||||
Current liabilities | ||||||||
Exchangeable senior notes | 210 | 83,312 | ||||||
Total | 210 | 83,312 |
December 31, 2022 US$’000 | December 31, 2021 US$’000 | |||||||
Non-Current liabilities | ||||||||
Senior secured term loan | 44,301 | - | ||||||
Derivative financial liability | 1,569 | - | ||||||
Convertible Note | 13,746 | - | ||||||
Total non-current liabilities | 59,616 | - |
December 31, 2022 US$’000 | December 31, 2021 US$’000 | |||||||
Non-Current assets | ||||||||
Derivative financial asset | 128 | - | ||||||
Total non-current assets | 128 | - |
149
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
22. | INTEREST-BEARING LOANS AND BORROWINGS (CONTINUED) |
December 31, 2022 US$000 | December 31, 2021 US$000 | |||||||
Balance at January 1 | (83,312 | ) | (82,664 | ) | ||||
Accretion interest | (83 | ) | (648 | ) | ||||
Repaid to Note holders | 86,730 | 0 | ||||||
Shares issued to Note holders as consideration | 6,133 | 0 | ||||||
Loss on disposal | (9,678 | ) | 0 | |||||
Liability | (210 | ) | (83,312 | ) |
(i) | Senior secured term loan |
150
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
22. | INTEREST-BEARING LOANS AND BORROWINGS (CONTINUED) |
(ii) | 7-year convertible note |
Senior secured term loan US$000 | 7-year Convertible Note US$000 | |||||||
Balance at January 1, 2022 | - | - | ||||||
Principal amount loaned | (81,250 | ) | (20,000 | ) | ||||
Loan origination costs | 3,551 | 40 | ||||||
Derivative financial liability at date of issue | 1,872 | - | ||||||
Derivative financial asset at date of issue | (202 | ) | - | |||||
Equity component at date of issue | - | 6,709 | ||||||
Accretion interest | (2,772 | ) | (495 | ) | ||||
Cash repayment of principal | 34,500 | - | ||||||
Non-current liability at December 31, 2022 | (44,301 | ) | (13,746 | ) |
The movement in the derivative financial liability in the year ended December 31, 2022 was as follows:
US$000 | ||||
Balance at January 1, 2022 | - | |||
Derivative financial liability at date of issue of Term Loan | (1,872 | ) | ||
Fair value adjustments in the period | 303 | |||
Non-current liability at December 31, 2022 | (1,569 | ) |
The movement in the derivative financial asset in the year ended December 31, 2022 was as follows:
US$000 | ||||
Balance at January 1, 2022 | - | |||
Derivative financial asset at date of issue of Term Loan | 202 | |||
Fair value adjustments in the period | (74 | ) | ||
Non-current asset at December 31, 2022 | 128 |
151
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
23. | LEASE LIABILITIES |
December 31, 2022 US$’000 | December 31, 2021 US$’000 | |||||||
Current liabilities | ||||||||
Lease liabilities related to Right of Use assets | 1,631 | 1,878 | ||||||
Sale and leaseback liabilities | 45 | 102 | ||||||
1,676 | 1,980 | |||||||
Non-Current liabilities | ||||||||
Lease liabilities related to Right of Use assets | 12,267 | 13,790 | ||||||
Sale and leaseback liabilities | - | 75 | ||||||
12,267 | 13,865 |
December 31, 2022 | December 31, 2022 | |||||||||||||||||||||
Lease liabilities related to Right of Use assets | Sale and leaseback Liabilities | |||||||||||||||||||||
Minimum lease payments | Interest | Principal | Minimum lease payments | Interest | Principal | |||||||||||||||||
Less than one year | 2,249 | 618 | 1,631 | 46 | 1 | 45 | ||||||||||||||||
In more than one year, but not more than two | 2,240 | 561 | 1,679 | - | - | - | ||||||||||||||||
In more than two years but not more than five | 5,739 | 1,217 | 4,522 | - | - | - | ||||||||||||||||
more than five years | 6,968 | 902 | 6,066 | - | - | - | ||||||||||||||||
17,196 | 3,298 | 13,898 | 46 | 1 | 45 |
152
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
23. | LEASE LIABILITIES (CONTINUED) |
December 31, 2021 US$’000 | December 31, 2021 US$’000 | |||||||||||||||||||||||
Lease liabilities related to Right of Use assets | Sale and leaseback Liabilities | |||||||||||||||||||||||
Minimum lease payments | Interest | Principal | Minimum lease payments | Interest | Principal | |||||||||||||||||||
Less than one year | 2,575 | 697 | 1,878 | 109 | 7 | 102 | ||||||||||||||||||
In more than one year, but not more than two | 2,175 | 621 | 1,554 | 77 | 2 | 75 | ||||||||||||||||||
In more than two years but not more than five | 5,985 | 1,469 | 4,516 | - | - | - | ||||||||||||||||||
more than five years | 8,992 | 1,272 | 7,720 | - | - | - | ||||||||||||||||||
19,727 | 4,059 | 15,668 | 186 | 9 | 177 |
Facility | Currency | Nominal interest rate | Year of maturity | Fair Value | Carrying Value | ||||||||||||
Sale and leaseback liabilities | USD | 5.51 | % | 2023 | 45 | 45 |
Facility | Currency | Nominal interest rate | Year of maturity | Fair Value | Carrying Value | ||||||||||||
Sale and leaseback liabilities | Euro | 4.53 | % | 2023 | 65 | 65 | |||||||||||
Sale and leaseback liabilities | USD | 5.51 | % | 2023 | 111 | 111 | |||||||||||
Total | 176 | 176 |
24. | COMMITMENTS AND CONTINGENCIES |
(a) | Capital Commitments |
(b) | Leasing Commitments |
153
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
24. | COMMITMENTS AND CONTINGENCIES (CONTINUED) |
(c) | Bank Security |
(d) | Group Company Guarantees |
(e) | Contingent Asset |
(f) | Government Grant Contingencies |
(g) | Other Contingencies |
154
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
25. | RELATED PARTY TRANSACTIONS |
Trinity Biotech and its directors (excepting Mr O’Caoimh and Dr Walsh who express no opinion on this point) believe at the time that the arrangements were entered into represented a fair and reasonable basis on which the Group could meet its ongoing requirements for premises. Dr Walsh has no ownership interest in the additional space adjoining the warehouse owned by Mr O’Caoimh and was therefore entitled to express an opinion on this arrangement.
December 31, 2022 | December 31, 2021 | |||||||
US$’000 | US$’000 | |||||||
Short-term employee benefits | 1,074 | 1,065 | ||||||
Performance related bonus | 512 | 227 | ||||||
Post-employment benefits | 24 | 24 | ||||||
Share-based compensation benefits as calculated under IFRS 2 | 1,690 | 965 | ||||||
3,300 | 2,281 |
155
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
25. | RELATED PARTY TRANSACTIONS (CONTINUED) |
‘A’ Ordinary Shares | Share options | |||||||
At January 1, 2022 | 9,077,713 | 16,738,000 | ||||||
Shares of retired director | (626,600 | ) | - | |||||
Options of retired director | - | (2,924,000 | ) | |||||
Shares purchased during the year | 2,666,664 | (2,666,664 | ) | |||||
Shares sold during the year | - | - | ||||||
Granted | - | 29,400,000 | ||||||
Expired / forfeited | - | - | ||||||
At December 31, 2022 | 11,117,777 | 40,547,336 |
‘A’ Ordinary Shares | Share options | |||||||
At January 1, 2021 | 9,077,713 | 17,394,000 | ||||||
Shares of retired director | - | - | ||||||
Options of retired director | - | (656,000 | ) | |||||
Shares purchased during the year | - | - | ||||||
Shares sold during the year | - | - | ||||||
Granted | - | - | ||||||
Expired / forfeited | - | - | ||||||
At December 31, 2021 | 9,077,713 | 16,738,000 |
26. | CAPITAL AND FINANCIAL RISK MANAGEMENT |
156
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
26. | CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED) |
Level 1 | Level 2 | Total carrying amount | Fair Value | |||||||||||||||||
Note | US$’000 | US$’000 | US$’000 | US$’000 | ||||||||||||||||
December 31, 2022 | ||||||||||||||||||||
Loans and receivables at amortised cost | ||||||||||||||||||||
Trade receivables | 16 | 12,620 | - | 12,620 | 12,620 | |||||||||||||||
Cash and cash equivalents | 17 | 6,578 | - | 6,578 | 6,578 | |||||||||||||||
Finance lease receivable | 14, 16 | 170 | - | 170 | 170 | |||||||||||||||
19,368 | - | 19,368 | 19,368 | |||||||||||||||||
Liabilities at amortised cost | ||||||||||||||||||||
Senior secured term loan | 22 | - | (44,301 | ) | (44,301 | ) | (44,301 | ) | ||||||||||||
Convertible note | 22 | - | (13,746 | ) | (13,746 | ) | (13,746 | ) | ||||||||||||
Exchangeable note | 22 | (210 | ) | - | (210 | ) | (210 | ) | ||||||||||||
Lease liabilities | 23 | (13,943 | ) | - | (13,943 | ) | (13,943 | ) | ||||||||||||
Trade and other payables (excluding deferred income) | 20 | (15,261 | ) | - | (15,261 | ) | (15,261 | ) | ||||||||||||
Provisions | 21 | (50 | ) | - | (50 | ) | (50 | ) | ||||||||||||
(29,464 | ) | (58,047 | ) | (87,511 | ) | (87,511 | ) | |||||||||||||
Fair value through profit and loss (FVPL) | ||||||||||||||||||||
Derivative liability - warrants | 22 | - | (1,569 | ) | (1,569 | ) | (1,569 | ) | ||||||||||||
Derivative asset – prepayment option | 22 | - | 128 | 128 | 128 | |||||||||||||||
- | (1,441 | ) | (1,441 | ) | (1,441 | ) | ||||||||||||||
(10,096 | ) | (59,488 | ) | (69,584 | ) | (69,584 | ) |
For financial reporting purposes, fair value measurements are categorized into Level 1, 2 or 3 based on the degree to which inputs to the fair value measurements are observable and the significance of the inputs to the fair value measurement in its entirety, which are described as follows:
157
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
26. | CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED) |
Level 1 | Level 2 | Total carrying amount | Fair Value | |||||||||||||||||
Note | US$’000 | US$’000 | US$’000 | US$’000 | ||||||||||||||||
December 31, 2021 | ||||||||||||||||||||
Loans and receivables at amortised cost | ||||||||||||||||||||
Trade receivables | 16 | 13,290 | - | 13,290 | 13,290 | |||||||||||||||
Cash and cash equivalents | 17 | 25,910 | - | 25,910 | 25,910 | |||||||||||||||
Finance lease receivable | 14, 16 | 293 | - | 293 | 293 | |||||||||||||||
39,493 | - | 39,493 | 39,493 | |||||||||||||||||
Liabilities at amortised cost | ||||||||||||||||||||
Exchangeable note¹ | 22 | - | (83,312 | ) | (83,312 | ) | (83,312 | ) | ||||||||||||
Lease liabilities | 23 | (15,845 | ) | - | (15,845 | ) | (15,845 | ) | ||||||||||||
Trade and other payables (excluding deferred income) | 20 | (14,986 | ) | - | (14,986 | ) | (14,986 | ) | ||||||||||||
Provisions | 21 | (50 | ) | - | (50 | ) | (50 | ) | ||||||||||||
(30,881 | ) | (83,312 | ) | (114,193 | ) | (114,193 | ) | |||||||||||||
Fair value through profit and loss (FVPL) | ||||||||||||||||||||
Exchangeable note bond call option | 22 | - | - | - | - | |||||||||||||||
Exchangeable note equity conversion option | 22 | - | - | - | - | |||||||||||||||
- | - | - | - | |||||||||||||||||
8,612 | (83,312 | ) | (74,700 | ) | (74,700 | ) |
The valuation techniques used for instruments categorised as level 2 are described below:
158
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
26. | CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED) |
As at December 31, 2022 | Note | Effective interest rate | Total US$’000 | 6 mths or less US$’000 | 6 –12 mths US$’000 | 1-2 years US$’000 | 2-5 years US$’000 | > 5 years US$’000 | ||||||||||||||||||||||||
Cash and cash equivalents | 17 | 0.00 | % | 6,578 | 6,578 | - | - | - | - | |||||||||||||||||||||||
Lease receivable | 14,16 | 4.0 | % | 170 | 46 | 41 | 49 | 34 | - | |||||||||||||||||||||||
Exchangeable note | 22 | 4.8 | % | (210 | ) | - | - | - | - | (210 | ) | |||||||||||||||||||||
Senior secured term loan1 | 22 | 15.4 | % | (44,301 | ) | - | - | - | (44,301 | ) | - | |||||||||||||||||||||
Convertible note2 | 22 | 1.5 | % | (13,746 | ) | - | - | - | - | (13,746 | ) | |||||||||||||||||||||
Lease payable on Right of Use assets | 23 | 5.0 | % | (13,898 | ) | (812 | ) | (819 | ) | (1,679 | ) | (4,522 | ) | (6,066 | ) | |||||||||||||||||
Lease payable on sale & leaseback transactions | 23 | 5.0 | % | (45 | ) | (35 | ) | (10 | ) | - | - | - | ||||||||||||||||||||
Total | (65,452 | ) | 5,777 | (788 | ) | (1,630 | ) | (48,789 | ) | (20,022 | ) |
As at December 31, 2021 | Note | Effective interest rate | Total US$’000 | 6 mths or less US$’000 | 6 -12 mths US$’000 | 1-2 years US$’000 | 2-5 years US$’000 | > 5 years US$’000 | ||||||||||||||||||||||||
Cash and cash equivalents | 17 | 0.01 | % | 25,910 | 25,910 | - | - | - | - | |||||||||||||||||||||||
Lease receivable | 14,16 | 4.0 | % | 293 | 81 | 61 | 89 | 62 | - | |||||||||||||||||||||||
Exchangeable note¹ | 22 | 4.8 | % | (83,312 | ) | - | - | - | - | (83,312 | ) | |||||||||||||||||||||
Other borrowings | 0 | % | (31 | ) | - | (31 | ) | - | - | - | ||||||||||||||||||||||
Lease payable on Right of Use assets | 23 | 5.0 | % | (15,668 | ) | (973 | ) | (905 | ) | (1,554 | ) | (4,516 | ) | (7,720 | ) | |||||||||||||||||
Lease payable on sale & leaseback transactions | 23 | 5.0 | % | (177 | ) | (51 | ) | (51 | ) | (75 | ) | - | - | |||||||||||||||||||
Total | (72,985 | ) | 24,967 | (926 | ) | (1,540 | ) | (4,454 | ) | (91,032 | ) |
159
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
26. | CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED) |
December 31, 2022 US$‘000 | December 31, 2021 US$‘000 | |||||||
Variable rate instruments | ||||||||
Cash at bank and in hand | 6,578 | 22,790 | ||||||
Short-term deposits | - | 3,120 | ||||||
Variable rate financial liabilities (senior secured term loan) | (44,301 | ) | - | |||||
(37,723 | ) | 25,910 | ||||||
Fixed rate instruments | ||||||||
Fixed rate financial liabilities (exchangeable note) | (210 | ) | (83,312 | ) | ||||
Fixed rate financial liabilities (convertible note) | (13,746 | ) | - | |||||
Fixed rate financial liabilities (borrowings) | - | (31 | ) | |||||
Fixed rate financial liabilities (lease payables) | (13,943 | ) | (15,844 | ) | ||||
Financial assets (short-term deposits and short-term investments) | - | 3,121 | ||||||
Financial assets (lease receivables) | 170 | 293 | ||||||
(27,729 | ) | (95,773 | ) |
As at December 31, 2022 US$’000 | Carrying amount US$’000 | Contractual cash flows US$’000 | 6 mths or less US$’000 | 6 mths – 12 mths US$’000 | 1-2 years US$’000 | 2-5 years US$’000 | >5 years US$’000 | |||||||||||||||||||||
Financial liabilities | ||||||||||||||||||||||||||||
Trade & other payables | 15,261 | 15,261 | 15,261 | - | - | - | - | |||||||||||||||||||||
Lease payable on Right of Use assets | 13,898 | 17,196 | 1,120 | 1,130 | 2,240 | 5,739 | 6,967 | |||||||||||||||||||||
Lease payable on sale & leaseback transactions | 45 | 46 | 36 | 10 | - | - | - | |||||||||||||||||||||
Senior secured term loan | 44,301 | 69,519 | 4,194 | 3,595 | 7,190 | 54,540 | - | |||||||||||||||||||||
Convertible note | 13,746 | 21,900 | 150 | 150 | 300 | 900 | 20,400 | |||||||||||||||||||||
Exchangeable notes | 210 | 397 | 4 | 4 | 8 | 24 | 357 | |||||||||||||||||||||
87,461 | 124,319 | 20,765 | 4,889 | 9,738 | 61,203 | 27,724 |
¹ The contractual cash flows of interest on the senior secured term loan is estimated based on the prevailing interest rate at December 31, 2022
160
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
26. | CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED) |
As at December 31, 2021 US$’000 | Carrying amount US$’000 | Contractual cash flows US$’000 | 6 mths or less US$’000 | 6 mths – 12 mths US$’000 | 1-2 years US$’000 | 2-5 years US$’000 | >5 years US$’000 | |||||||||||||||||||||
Financial liabilities | ||||||||||||||||||||||||||||
Trade & other payables | 15,127 | 15,127 | 15,127 | - | - | - | - | |||||||||||||||||||||
Lease payable on Right of Use assets | 15,668 | 15,668 | 973 | 905 | 1,554 | 4,516 | 7,720 | |||||||||||||||||||||
Lease payable on sale & leaseback transactions | 177 | 177 | 51 | 51 | 75 | - | - | |||||||||||||||||||||
Other borrowings | 31 | 31 | - | 31 | - | - | - | |||||||||||||||||||||
Exchangeable notes ¹ | 83,312 | 99,900 | - | - | - | - | 99,900 | |||||||||||||||||||||
Exchangeable note interest | 999 | 93,906 | 1,998 | 1,998 | 3,996 | 11,988 | 73,926 | |||||||||||||||||||||
115,314 | 224,809 | 18,149 | 2,985 | 5,625 | 16,504 | 181,546 |
EUR | GBP | SEK | CAD | BRL | Other | |||||||||||||||||||
As at December 31, 2022 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||||||||
Cash | 700 | 199 | 5 | 2,061 | 756 | - | ||||||||||||||||||
Trade and other receivable | 1,001 | 27 | - | 950 | 1,443 | - | ||||||||||||||||||
Trade and other payables | (3,481 | ) | (5 | ) | (6 | ) | (473 | ) | (662 | ) | - | |||||||||||||
Lease liabilities | (9,024 | ) | - | - | - | (277 | ) | - | ||||||||||||||||
Total exposure | (10,804 | ) | 221 | (1 | ) | 2,538 | 1,260 | - |
EUR | GBP | SEK | CAD | BRL | Other | |||||||||||||||||||
As at December 31, 2021 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | US$‘000 | ||||||||||||||||||
Cash | 327 | 115 | 5 | 4,617 | 1,370 | - | ||||||||||||||||||
Trade and other receivable | 464 | 58 | - | 488 | 1,538 | - | ||||||||||||||||||
Trade and other payables | (2,456 | ) | (28 | ) | (11 | ) | (166 | ) | (629 | ) | - | |||||||||||||
Lease liabilities | (10,629 | ) | - | - | - | (139 | ) | - | ||||||||||||||||
Total exposure | (12,294 | ) | 145 | (6 | ) | 4,939 | 2,140 | - |
161
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
26. | CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED) |
Profit or Loss US$’000 | ||||
December 31, 2022 | ||||
Euro | 982 | |||
December 31, 2021 | ||||
Euro | 780 |
Profit or Loss US$000 | ||||
December 31, 2022 | ||||
Euro | (1,200 | ) | ||
December 31, 2021 | ||||
Euro | (953 | ) |
162
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
26. | CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED) |
Carrying Value December 31, 2022 US$’000 | Carrying Value December 31, 2021 US$’000 | |||||||
Third party trade receivables (Note 16) | 12,620 | 13,290 | ||||||
Finance lease income receivable (Note 16) | 170 | 293 | ||||||
Cash and cash equivalents (Note 17) | 6,578 | 25,910 | ||||||
19,368 | 39,493 |
Carrying Value December 31, 2022 US$’000 | Carrying Value December 31, 2021 US$’000 | |||||||
United States | 6,061 | 5,822 | ||||||
Euro-zone countries | 1,183 | 1,072 | ||||||
United Kingdom | 67 | 118 | ||||||
Other regions | 5,479 | 6,571 | ||||||
12,790 | 13,583 |
Carrying Value December 31, 2022 US$’000 | Carrying Value December 31, 2021 US$’000 | |||||||
End-user customers | 7,365 | 6,923 | ||||||
Distributors | 4,630 | 6,220 | ||||||
Non-governmental organisations | 795 | 440 | ||||||
12,790 | 13,583 |
163
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
26. | CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED) |
Gross | Impairment | Expected Credit Loss Rate | Gross | Impairment | Expected Credit Loss Rate | |||||||||||||||||||
2022 | 2022 | 2022 | 2021 | 2021 | 2021 | |||||||||||||||||||
US$’000 | US$’000 | % | US$’000 | US$’000 | % | |||||||||||||||||||
Not past due | 8,341 | - | - | % | 8,461 | - | - | % | ||||||||||||||||
Past due 0-30 days | 1,622 | - | - | % | 2,423 | 1 | 0.1 | % | ||||||||||||||||
Past due 31-120 days | 1,564 | 23 | 1.5 | % | 1,981 | 97 | 4.9 | % | ||||||||||||||||
Greater than 120 days | 3,783 | 2,668 | 70.5 | % | 3,011 | 2,888 | 73.0 | % | ||||||||||||||||
15,310 | 2,691 | - | 15,876 | 2,986 | - |
2022 | 2021 | |||||||
US$’000 | US$’000 | |||||||
Balance at January 1 | 2,986 | 3,922 | ||||||
Charged to costs and expenses | 1,240 | 76 | ||||||
Amounts written off during the year | (1,535 | ) | (1,012 | ) | ||||
Balance at December 31 | 2,691 | 2,986 |
164
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
27. | RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES |
Note | Borrowings & derivative financial instruments US$’000 | Lease liabilities US$’000 | ||||||||||
Balance at January 1, 2022 | 20,22,23 | 83,343 | 15,845 | |||||||||
Cash-flows: | ||||||||||||
Principal amount loaned – term loan | 81,250 | |||||||||||
Principal amount loaned – convertible note | 20,000 | - | ||||||||||
Loan origination costs paid | (3,591 | ) | - | |||||||||
Interest paid for term loan | (6,424 | ) | - | |||||||||
Interest paid for convertible note | (199 | ) | ||||||||||
Interest paid for exchangeable notes | (1,293 | ) | ||||||||||
Repayment of exchangeable notes | (86,730 | ) | ||||||||||
Repayment of term loan | (34,500 | ) | ||||||||||
Repayment of CEBA loan | (23 | ) | (2,761 | ) | ||||||||
Penalty paid for early settlement of term loan | (3,450 | ) | - | |||||||||
Non-cash: | ||||||||||||
Interest charged | 7,914 | - | ||||||||||
Penalty for early settlement charged | 3,450 | - | ||||||||||
Shares issued as consideration for purchase of Exchangeable Notes | (6,133 | ) | - | |||||||||
Equity component of convertible note at date of issue | (6,709 | ) | - | |||||||||
Derivative financial asset at date of issue | 202 | - | ||||||||||
Loss on disposal of Exchangeable Notes | 9,678 | - | ||||||||||
Additions (related to Right of Use assets) | - | 830 | ||||||||||
Exchange adjustment | - | (628 | ) | |||||||||
Loan forgiven | (7 | ) | - | |||||||||
Accretion interest | 3,351 | 657 | ||||||||||
Fair value of derivative liability - warrants | (303 | ) | - | |||||||||
Balance at December 31, 2022 | 22,23 | 59,826 | 13,943 |
165
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
27. | RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES (CONTINUED) |
Note | Borrowings & derivative financial instruments | Lease liabilities | ||||||||||
Balance at January 1, 2021 | 20, 22,23 | 84,065 | 18,741 | |||||||||
Cash-flows: | ||||||||||||
Interest paid | (3,996 | ) | (11 | ) | ||||||||
Repayment | - | (2,939 | ) | |||||||||
Non-cash: | - | |||||||||||
Interest charged | 3,996 | - | ||||||||||
Additions (related to Right of Use assets) | - | 71 | ||||||||||
Exchange adjustment | - | (820 | ) | |||||||||
Accretion interest | 648 | 803 | ||||||||||
Fair value | 6 | (1,370 | ) | - | ||||||||
Balance at December 31, 2021 | 22,23 | 83,343 | 15,845 |
28. | POST BALANCE SHEET EVENTS |
166
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
28. | POST BALANCE SHEET EVENTS (CONTINUED) |
29. | ACCOUNTING ESTIMATES AND JUDGEMENTS |
167
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
29. | ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED) |
• | 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. | |
168
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
29. | ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED) |
(i) | VTM inventory – there has been 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 US0.3 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. |
169
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
29. | ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED) |
170
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
30. | GROUP UNDERTAKINGS |
Name and registered office | Principal activity | Principal Country of incorporation and operation | Group % holding | |||
Trinity Biotech Manufacturing Limited IDA Business Park, Bray County Wicklow, Ireland | Manufacture and sale of diagnostic test kits | Ireland | 100% | |||
Trinity Research Limited IDA Business Park, Bray County Wicklow, Ireland | Research and development | Ireland | 100% | |||
Benen Trading Limited IDA Business Park, Bray County Wicklow, Ireland | Trading | Ireland | 100% | |||
Trinity Biotech Manufacturing Services Limited IDA Business Park, Bray County Wicklow, Ireland | Dormant | Ireland | 100% | |||
Trinity Biotech Luxembourg Sarl 1, rue Bender, L-1229 Luxembourg | Investment and provision of financial services | Luxembourg | 100% | |||
Trinity Biotech Inc Girts Road, Jamestown, NY 14702, USA | Holding Company | U.S.A. | 100% | |||
Clark Laboratories Inc Trading as Trinity Biotech (USA) Girts Road, Jamestown NY14702, USA | Manufacture and sale of diagnostic test kits | U.S.A. | 100% | |||
Mardx Diagnostics Inc 5919 Farnsworth Court Carlsbad CA 92008, USA | Dormant | U.S.A. | 100% | |||
Fitzgerald Industries International, Inc 2711 Centerville Road, Suite 400 Wilmington, New Castle Delaware, 19808, USA | Management services company | U.S.A. | 100% | |||
Biopool US Inc (trading as Trinity Biotech Distribution) Girts Road, Jamestown NY14702, USA | Sale of diagnostic test kits | U.S.A. | 100% | |||
Primus Corporation 4231 E 75th Terrace Kansas City, MO 64132, USA | Manufacture and sale of diagnostic test kits and instrumentation | U.S.A. | 100% |
171
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
30. | GROUP UNDERTAKINGS (CONTINUED) |
Name and registered office | Principal activity | Principal Country of incorporation and operation | Group % holding | |||
Phoenix Bio-tech Corp. 1166 South Service Road West Oakville, ON L6L 5T7 Canada. | Dormant | Canada | 100% | |||
Fiomi Diagnostics Holding AB Dag Hammarskjöldsv 52A SE-752 37 Uppsala Sweden | Holding Company | Sweden | 100% | |||
Fiomi Diagnostics AB Dag Hammarskjöldsv 52A SE-752 37 Uppsala Sweden | Discontinued operation | Sweden | 100% | |||
Trinity Biotech Do Brasil Comercio e Importacao Ltda Rua Silva Bueno 1.660 – Cj. 101/102 Ipiranga Sao Paulo Brazil | Sale of diagnostic test kits | Brazil | 100% | |||
Trinity Biotech (UK) Ltd Mills and Reeve LLP Botanic House 100 Hills Road Cambridge, CB2 1PH United Kingdom | Sales & marketing activities | UK | 100% | |||
Immco Diagnostics Inc 60 Pineview Drive Buffalo NY 14228, USA | Manufacture and sale of autoimmune products and laboratory services | U.S.A. | 100% | |||
Nova Century Scientific Inc 5022 South Service Road Burlington Ontario Canada | Manufacture and sale of autoimmune products and infectious diseases | Canada | 100% | |||
Trinity Biotech Investment Ltd PO Box 309 Ugland House Grand Cayman KY1-1104 Cayman Islands | Investment and provision of financial services | Cayman Islands | 100% |
31. | AUTHORISATION FOR ISSUE |
TRINITY BIOTECH PLC | |||
By | /s/ Mr Aris Kekedjian | ||
Mr Aris Kekedjian | |||
Director/ | |||
Chief Executive Officer | |||
Date: May 16, 2023 | |||
By: | /s/ Mr John Gillard | ||
Mr John Gillard | |||
Company secretary/ | |||
Chief Financial Officer | |||
Date: May 16, 2023 |
Item 19 | Exhibits |
Exhibit No. | Description of Exhibit |
4.17 | |
4.18 | |
4.19 | |
101.INS | XBRL Instance Document (The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document). |
101.SCH | Inline XBRL Taxonomy Extension Schema Document. |
101.PRE | Inline XBRL Taxonomy Presentation Linkbase Document. |
101.CAL | Inline XBRL Taxonomy Calculation Linkbase Document. |
101.LAB | Inline XBRL Taxonomy Label Linkbase Document. |
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |