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 |
29 | ||
A. |
History and Development of the Company |
29 |
B. |
Business Overview |
29 |
C. |
Organizational Structure |
45 |
D. |
Property, Plants and Equipment |
45 |
47 | ||
47 | ||
A. |
Operating Results |
47 |
B. |
Liquidity and Capital Resources |
57 |
C. |
Research and Development, Patents and Licenses,etc. |
59 |
D. |
Trend Information |
60 |
E. |
Critical Accounting Estimates |
60 |
65 | ||
A. |
Directors and Senior Management |
65 |
B. |
Compensation |
67 |
C. |
Board Practices |
67 |
D. |
Employees |
69 |
E. |
Share Ownership |
69 |
73 | ||
A. |
Major Shareholders |
73 |
B. |
Related Party Transactions |
74 |
C. |
Interests of Experts and Counsel |
75 |
75 | ||
A. |
Consolidated Statements and Other Financial Information |
75 |
B. |
Significant Changes |
75 |
75 | ||
A. |
Offer and Listing Details |
75 |
B. |
Plan of Distribution |
75 |
C. |
Markets |
76 |
D. |
Selling Shareholders |
76 |
E. |
Dilution |
76 |
F. |
Expense of the Issue |
76 |
76 | ||
A. |
Share Capital |
76 |
B. |
Memorandum and Articles of Association |
76 |
C. |
Material Contracts |
77 |
D. |
Exchange Controls |
78 |
E. |
Taxation |
78 |
F. |
Dividends and Paying Agents |
84 |
G. |
Statement by Experts |
84 |
H. |
Documents on Display |
84 |
I. |
Subsidiary Information |
84 |
85 | ||
86 |
|
PART II |
|
87 | ||
87 | ||
87 | ||
88 | ||
88 | ||
88 | ||
88 | ||
89 | ||
89 | ||
89 | ||
89 | ||
89 | ||
89 | ||
|
PART III |
|
90 | ||
90 | ||
171 |
• |
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. |
Selected Financial Data |
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. |
• |
New product development - our long-term
success depends upon the successful development and commercialization of new products. |
• |
Capital structure - we may require
future additional capital. |
• |
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. |
• |
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.
|
• |
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. |
• |
Pandemic impact - the Covid-19 outbreak
could significantly disrupt our operations and adversely affect our results of operations. |
• |
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. |
• |
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. |
• |
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. |
• |
Financial impairment - the large amount
of intangible assets and goodwill recorded on our balance sheet may lead to significant impairment charges in the future.
|
• |
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. |
• |
Brexit - the United Kingdom’s
withdrawal from the European Union could potentially impact our supply chains and the market for our products in the United Kingdom.
|
• |
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 - 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.
|
• |
Public company regulations - 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. |
• |
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 fulfill 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, 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. |
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 |
|
| |||||
|
|
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. |
|
2021
|
2020
|
Total project
costs to December 31, 2021¹ |
|||||||||
Product
Name |
US$’000
|
US$’000
|
US$’000
|
|||||||||
Premier Instrument for Haemoglobin A1c testing |
2,538 |
1,359 |
35,924 |
|||||||||
HIV screening rapid test |
1,488 |
2,278 |
12,240 |
|||||||||
Covid tests |
1,320 |
467 |
1,787 |
|||||||||
Autoimmune Smart Reader |
550 |
666 |
3,287 |
|||||||||
Mid-tier haemoglobins instrument |
303 |
243 |
609 |
|||||||||
Tri-stat Point-of-Care instrument |
245 |
203 |
9,477 |
|||||||||
Uni-Gold antigen improvement |
- |
556 |
2,918 |
|||||||||
Syphilis point-of-care test |
-
|
618 |
1,942 |
• |
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 |
|
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 |
)% |
|
Year ended December 31, |
|||||||||||
|
|
2020
US$’000 |
$ |
2019
US$’000 |
% Change |
|||||||
Revenues |
||||||||||||
Clinical laboratory goods |
84,280 |
68,127 |
23.7 |
% | ||||||||
Clinical laboratory services |
8,485 |
10,915 |
(22.3 |
)% | ||||||||
Point-of-Care |
9,215 |
11,393 |
(19.1 |
)% | ||||||||
101,980 |
90,435 |
12.8 |
% |
|
Year ended December 31, |
|||||||||||
|
|
2020
US$‘000 |
|
2019
US$‘000 |
% Change |
|||||||
Revenues |
||||||||||||
Americas |
70,408 |
52,183 |
34.9 |
% | ||||||||
Asia/Africa |
22,567 |
27,686 |
(18.5 |
)% | ||||||||
Europe |
9,005 |
10,566 |
(14.8 |
)% | ||||||||
Total |
101,980 |
90,435 |
12.8 |
% |
• |
A range of cost saving measures implemented in response to the Covid-19 pandemic including the furloughing of employees in the second
quarter of 2020, the receipt of government payroll subsidies, significantly reduced travel costs and the cancellation of trade shows and
other marketing activities. |
• |
Partially offsetting these savings were increased foreign currency losses mainly due to the re-translation of Euro-denominated lease
liabilities for right-of-use assets and increased performance-related pay due to higher revenues and profits. |
B. |
Liquidity and Capital Resources |
• |
The ability of the Group to continue to generate revenue growth from its existing product lines and from new products following the
successful completion of its development projects; |
• |
The ability of the Group to mitigate the negative impacts of the Covid-19 pandemic and maximize the opportunities to sell our Covid-19
related portfolio of products; |
• |
The extent to which capital expenditure is incurred on additional property plant and equipment; |
• |
The level of investment required to undertake both new and existing development projects; and |
Year ended December 31, |
||||||||
|
|
2021
US$‘000 |
|
2020
US$‘000 |
||||
Net cash inflow from operating activities |
13,238 |
23,755 |
||||||
Net cash outflow from investing activities |
(8,691 |
) |
(10,198 |
) | ||||
Net cash outflow from financing activities |
(6,019 |
) |
(2,716 |
) | ||||
Net (decrease)/increase in cash and cash equivalents and short-term investments |
(1,472 |
) |
10,841 |
• |
Payments to acquire intangible assets of US$6.9 million (2020: US$7.0 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$1.8 million (2020: US$3.2 million) incurred as part of the Group’s investment
programme for its manufacturing and distributing activities, and placement of instruments. |
• |
Significant underperformance relative to expected, historical or projected future operating results; |
• |
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business; |
• |
Obsolescence of products; |
• |
Significant decline in our stock price for a sustained period; and |
• |
Our market capitalisation relative to net book value. |
• |
In the event that there was a reduction of 10% in the assumed level of future growth in revenue growth rate, which would represent
a reasonably likely range of outcomes, there would be no additional impairment loss recorded at December 31, 2021. |
• |
In the event there was a 10% increase in the discount rate used to calculate the potential impairment of the carrying values, which
would represent a reasonably likely range of outcomes, there would be no additional impairment loss recorded at December 31, 2021.
|
Name |
Age
|
Title |
Directors |
||
Ronan O’Caoimh |
66 |
Chairman and Chief Executive Officer |
Jim Walsh, PhD |
63 |
Executive Director |
John Gillard |
41 |
Chief Financial Officer, Company Secretary and Executive Director |
Kevin Tansley |
51 |
Executive Director |
Clint Severson |
73 |
Non-Executive Director/Lead Director |
James D. Merselis |
68 |
Non-Executive Director |
Senior Management |
||
Simon Dunne |
48 |
Chief Accounting Officer |
Fernando Devia |
59 |
Executive Vice President Sales |
Sanjiv Suri |
63 |
Senior Vice President Global Sales and General Manager North America |
Terence Dunne, PhD |
41 |
Business Development Director |
Eibhlín Kelly |
38 |
Chief Information Officer |
Dan Goldsand |
66 |
Vice President of Autoimmunity |
Director |
Title |
Salary/
Benefits
US$’000 |
Performance
related bonus
US$’000 |
Defined
contribution
pension
US$’000 |
Total
2021
US$’000 |
Total
2020
US$’000 |
|||||||||||||||||
Ronan O’Caoimh |
Chairman and CEO |
643 |
— |
— |
643 |
1,052 |
|||||||||||||||||
Jim Walsh |
Executive Director |
20 |
— |
— |
20 |
38 |
|||||||||||||||||
John Gillard |
Chief Financial Officer |
346 |
227 |
20 |
593 |
52 |
|||||||||||||||||
Kevin Tansley |
Executive Director |
56 |
— |
4 |
60 |
757 |
|||||||||||||||||
Denis R. Burger |
Non-Executive director |
— |
— |
— |
— |
48 |
|||||||||||||||||
James Merselis |
Non-Executive director |
49 |
— |
— |
49 |
57 |
|||||||||||||||||
Clint Severson |
Non-Executive director |
49
|
—
|
—
|
49
|
57
|
|||||||||||||||||
|
|
1,163 |
227 |
24 |
1,414 |
2,061 |
- |
incurred by the person in his or her capacity as an officer of our company or a subsidiary of our company provided that the liability
does not arise out of a conduct involving a wilful breach of duty in relation to our company or a subsidiary of our company; or
|
- |
for costs and expenses incurred by that person defending proceedings, whatever their outcome. |
Year Ended December 31,
|
||||||||||||
2021 |
2020 |
2019 |
||||||||||
Numbers of employees by geographic location |
||||||||||||
United States |
237 |
310 |
334 |
|||||||||
Ireland |
211 |
199 |
215 |
|||||||||
United Kingdom |
2 |
3 |
2 |
|||||||||
Brazil |
27 |
31 |
28 |
|||||||||
Total workforce |
477 |
543 |
579 |
|||||||||
Numbers of employees by category of activity |
||||||||||||
Research scientists & technicians |
41 |
52 |
57 |
|||||||||
Manufacturing/Operations |
239 |
280 |
303 |
|||||||||
Quality Assurance |
63 |
63 |
60 |
|||||||||
Finance/Administration |
68 |
65 |
66 |
|||||||||
Sales & Marketing |
66 |
83 |
93 |
|||||||||
Total workforce |
477 |
543 |
579 |
Name |
Number of ‘A’
Ordinary Shares Beneficially
Owned (1)
|
Percentage of
Ownership (2)
|
||||||
Ronan O’Caoimh (3) |
17,228,160 |
15.0 |
% | |||||
Jim Walsh (4) |
2,863,612 |
2.6 |
% | |||||
John Gillard (5) |
150,000 |
* |
||||||
Kevin Tansley (6) |
1,547,336 |
1.4 |
% | |||||
Clint Severson (7) |
878,000 |
* |
||||||
James Merselis (8) |
778,600 |
* |
||||||
Simon Dunne (9) |
210,000 |
* |
||||||
Fernando Devia (10) |
330,000 |
* |
||||||
Sanjiv Suri (11) |
280,000 |
* |
||||||
Terence Dunne (12) |
283,336 |
* |
||||||
Dan Goldsand |
- |
* |
||||||
Eibhlín Kelly |
- |
* |
||||||
Executive officers and directors as a group (12 persons) |
24,549,044 |
20.4 |
% |
* |
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. 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, 2022. |
(3) |
Represents (a) 9,724,160 ‘A’ ordinary shares and (b) 7,504,000 ‘A’
ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2022. 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 (a) 1,393,612 ‘A’ ordinary shares and (b) 1,470,000 ‘A’ ordinary shares
underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2022. 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. |
(5) |
Represents 150,000 ‘A’ ordinary shares underlying options that are currently vested and exercisable
or that vest within sixty days of April 15, 2022. |
(6 |
Represents (a) 150,000 ‘A’ ordinary shares and (b) 1,397,336 ‘A’ ordinary shares
underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2022. |
(7) |
Represents (a) 288,000 ‘A’ ordinary shares and (b) 590,000 ‘A’
ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2022. |
(8) |
Represents (a) 188,600 ‘A’ ordinary shares and (b) 590,000 ‘A’
ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of April 15, 2022. |
(9) |
Represents 210,000 ‘A’ ordinary shares underlying options that are currently
vested and exercisable or that vest within sixty days of April 15, 2022. |
(10) |
Represents 330,000 ‘A’ ordinary shares underlying options that are
currently vested and exercisable or that vest within sixty days of April 15, 2022. |
(11) |
Represents 280,000 ‘A’ ordinary shares underlying options that are currently
vested and exercisable or that vest within sixty days of April 15, 2022. |
(12) |
Represents 283,336 ‘A’ ordinary shares underlying options that are currently
vested and exercisable or that vest within sixty days of April 15, 2022. |
Director/Company Secretary |
Number of
Options ‘A’ Shares |
Number of
Options ADS Equivalent |
Exercise
Price (Per ‘A’ Share) |
Exercise Price
(Per ADS) |
Expiration Date of Options | ||||||||||||
Ronan O’Caoimh* |
1,000,000 |
250,000 |
1.34 |
5.35 |
07/09/2024 | ||||||||||||
1,000,000 |
250,000 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
244,000 |
61,000 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
2,030,000 |
507,500 |
0.69 |
2.74 |
14/06/2026 | |||||||||||||
2,030,000 |
507,500 |
0.69 |
2.74 |
14/06/2026 | |||||||||||||
333,336 |
83,334 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
1,200,000 |
300,000 |
0.73 |
2.90 |
17/11/2027 | |||||||||||||
1,200,000 |
300,000 |
0.73 |
2.90 |
17/11/2027 | |||||||||||||
Jim Walsh |
53,333 |
13,333 |
2.43 |
9.73 |
24/02/2023 | ||||||||||||
53,333 |
13,333 |
2.43 |
9.73 |
24/02/2023 | |||||||||||||
53,334 |
13,334 |
2.43 |
9.73 |
24/02/2023 | |||||||||||||
360,000 |
90,000 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
360,000 |
90,000 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
30,000 |
7,500 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
280,000 |
70,000 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
280,000 |
70,000 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
40,000 |
10,000 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
Kevin Tansley |
340,000 |
85,000 |
1.34 |
5.35 |
07/09/2024 | ||||||||||||
340,000 |
85,000 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
184,000 |
46,000 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
266,668 |
66,667 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
266,668 |
66,667 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
266,664 |
66,666 |
0.19 |
0.77 |
20/03/2027 |
Director/Company Secretary |
Number of Options ‘A’ Shares |
Number of Options ADS Equivalent |
Exercise Price (Per ‘A’ Share) |
Exercise Price (Per ADS) |
Expiration Date of Options | ||||||||||||
|
|
|
|
Jim Merselis |
20,000 |
5,000 |
2.43 |
9.73 |
24/02/2023 | ||||||||||||
20,000 |
5,000 |
2.43 |
9.73 |
24/02/2023 | |||||||||||||
20,000 |
5,000 |
2.43 |
9.73 |
24/02/2023 | |||||||||||||
95,000 |
23,750 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
95,000 |
23,750 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
20,000 |
5,000 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
160,000 |
40,000 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
160,000 |
40,000 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
40,000 |
10,000 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
Clint Severson |
20,000 |
5,000 |
2.43 |
9.73 |
24/02/2023 | ||||||||||||
20,000 |
5,000 |
2.43 |
9.73 |
24/02/2023 | |||||||||||||
20,000 |
5,000 |
2.43 |
9.73 |
24/02/2023 | |||||||||||||
95,000 |
23,750 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
95,000 |
23,750 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
20,000 |
5,000 |
1.34 |
5.35 |
07/09/2024 | |||||||||||||
160,000 |
40,000 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
160,000 |
40,000 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
40,000 |
10,000 |
0.19 |
0.77 |
20/03/2027 | |||||||||||||
John Gillard |
150,000 |
37,500 |
0.67 |
2.69 |
23/10/2027 | ||||||||||||
150,000 |
37,500 |
0.67 |
2.69 |
23/10/2027 | |||||||||||||
150,000 |
37,500 |
0.67 |
2.69 |
23/10/2027 | |||||||||||||
150,000 |
37,500 |
0.67 |
2.69 |
23/10/2027 |
|
Number of ‘A’
Ordinary Shares
Subject to Option |
Range of
Exercise Price
per Ordinary Share |
Range of Exercise Price
per ADS |
|||||||||
Total options outstanding |
15,964,662 |
|
US$0.19-US$4.36 |
|
US$0.76-US$17.44 |
A. |
Major Shareholders |
|
Number of ‘A’
Ordinary Shares Beneficially Owned |
Number of ADSs Beneficially Owned (1) |
Percentage
‘A’ Ordinary Shares (2) |
Percentage
Total Voting Power |
||||||||||||
Renaissance Technologies LLC |
6,274,220 |
(3) |
1,568,555 |
5.8 |
% |
5.8 |
% | |||||||||
Paradice Investment Management, LLC |
6,172,460 |
(4) |
1,543,115 |
5.7 |
% |
5.7 |
% | |||||||||
Ronan O’Caoimh |
17,228,160 |
(5) |
4,307,040 |
15.0 |
% |
15.0 |
% | |||||||||
Stonehill Capital Management LLC |
9,272,872 |
(6) |
2,318,218 |
8.6 |
% |
8.6 |
% | |||||||||
Perceptive Credit Holdings III, LP |
10,000,000 |
(7) |
2,500,000 |
8.5 |
% |
8.5 |
% |
(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. 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 on a Schedule 13G/A filed on February 11, 2022, with the SEC by Renaissance
Technologies LLC and Renaissance Technologies Holdings Corporation. The principal business address of each of these entities is 800 Third
Avenue, New York, NY 10022 United States. | |
(4) |
Based on a Schedule 13G/A filed on February 7, 2020 by Paradice Investment Management,
LLC with the SEC. The principal business address of Paradice Investment Management, LLC is 257 Fillmore Street, Suite 200, Denver, Colorado
80206 United States. | |
(5) |
Based on information provided to the Company, the above total includes ‘A’
Ordinary shares issuable upon exercise of options issued to Darnick Company. The address of Mr. O’Caoimh is c/o Trinity Biotech
plc, Bray, Co. Wicklow, Ireland. | |
(6) |
Based on a Schedule 13G/A filed on February 4, 2022 by Stonehill Capital Management,
LLC with the SEC. The principal business address of Stonehill Capital Management, LLC is 320 Park Ave., 26th
Floor, New York, NY 10022 United States. | |
(7) |
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 |
2.2 |
% |
2.2 |
% |
February 16, 2021 | |||||||||
Highbridge Capital Management, LLC |
675,064 |
|
168,766 |
0.6 |
% |
0.6 |
% |
April 14, 2022 |
• |
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 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 |
• |
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. |
• |
transfer and registration fees of securities on Trinity Biotech’s securities register to or from the name of the depositary
or its agent when ADS holders deposit or withdrawal securities; |
• |
expenses for cable, telex and fax transmissions and for delivery of securities; |
• |
expenses incurred for converting foreign currency into U.S. dollars; and |
• |
taxes and duties upon the transfer of securities (i.e., when ordinary shares are deposited or withdrawn from deposit, other than
taxes for which Trinity Biotech is liable). |
Item 13. |
Defaults, Dividend Arrearages and Delinquencies |
Item 14. |
Material Modifications to the Rights of Security Holders and Use of Proceeds
|
Item 15. |
Controls and Procedures |
|
Year ended December 31,
2021 |
Year ended December 31,
2020 |
||||||||||||||
|
US$’000 |
% |
US$’000 |
% |
||||||||||||
Audit |
477 |
72 |
% |
495 |
80 |
% | ||||||||||
Audit-related |
94 |
14 |
% |
- |
- |
|||||||||||
Tax |
89 |
14 |
% |
124 |
20 |
% | ||||||||||
Total |
660 |
619 |
• |
The Rule requiring maintaining a majority of independent directors (Rule 5605(b)(1)).
Instead, under Irish law and practice, we are not required to appoint a majority of independent directors. |
• |
The Rule requiring that our independent directors have regularly scheduled meetings
at which only independent directors are present (Rule 5605(b)(2)). Instead, we follow Irish law according to which independent directors
are not required to hold executive sessions. |
• |
The Rule regarding independent director oversight of director nominations process
for directors (Rule 5605(e)). Instead, we follow Irish law and practice according to which our board of directors recommends directors
for election/re-election by our shareholders. |
• |
The requirement to obtain shareholder approval for the establishment or amendment
of certain equity based compensation plans (Rule 5635(c)), 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. |
• |
The Rule requiring maintaining an audit committee consisting of at least three independent
directors (Rule 5605(c)(2). Instead, we follow Irish law that requires that an audit committee have at least one independent director.
Our audit committee consists of two independent directors. | |
• |
The Rule requiring a compensation committee consisting of at least two independent
directors (Rule 5605(d)(2). We have a compensation committee, which we refer to as the remuneration committee, and although it consists
of two independent directors, we may follow Irish law in the future, which does not require us to have an independent compensation committee.
| |
• |
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 of Association which require a quorum of 40%> If a quorum is not present, unless
the meeting has been convened by shareholders in which case the meeting shall be dissolved, the meeting will be adjourned to another date.
If a quorum is not present within 15 minutes of the time set for the adjourned meeting, the meeting may commence so long as there are
two shareholders present. |
Item 17 |
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 agreed the underlying cash flow forecasts to
the Board-approved projections and we evaluated management’s ability to accurately forecast future revenues and margins by:
|
• |
performing a look-back analysis and comparing
actual results to management’s historical forecasts; and |
• |
assessing the reasonableness of the impact of
new products, the COVID-19 pandemic, 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. |
• |
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 tested the design and operating effectiveness
of operational controls (including specific controls for review of revenue recognition and year end cut-off analyses).
|
• |
We selected a statistical sample of revenue transactions
to vouch to underlying documents. |
• |
We examined contracts specific to samples selected
and assessed revenue recognition in accordance with the accounting standards. |
• |
We evaluated management assumptions in recognising
revenue related to the performance obligation of certain contracts with high subjectivity. |
|
Year
ended December 31 |
||||||||||||||
|
Notes
|
2021
Total
US$‘000
|
2020
Total
US$‘000
|
2019
Total
US$‘000
|
|||||||||||
Revenues
|
2
|
92,965 | 101,980 | 90,435 | |||||||||||
Cost
of sales |
(54,888 |
)
|
(53,400 |
)
|
(52,315 |
)
| |||||||||
|
|||||||||||||||
Gross
profit |
38,077 | 48,580 | 38,120 | ||||||||||||
Other
operating income |
4
|
4,672 | 1,860 | 91 | |||||||||||
Research
and development expenses |
(4,497 |
)
|
(5,080 |
)
|
(5,325 |
)
| |||||||||
Selling,
general and administrative expenses |
(24,683 |
)
|
(26,390 |
)
|
(27,661 |
)
| |||||||||
Selling,
general and administrative expenses – recognition of contingent asset |
26
|
- | 1,316 | - | |||||||||||
Selling,
general and administrative expenses – closure costs |
5 |
- | (2,425 |
)
|
- | ||||||||||
Selling,
general and administrative expenses – tax audit settlement |
6
|
- | - | (5,042 |
)
| ||||||||||
Impairment
charges |
7
|
(6,944 |
)
|
(17,779 |
)
|
(24,295 |
)
| ||||||||
|
|||||||||||||||
Operating
profit/(loss) |
6,625 | 82 | (24,112 |
)
| |||||||||||
Financial
income |
2,8
|
1,223 | 36 | 697 | |||||||||||
Financial
expenses |
2, 8
|
(7,097 |
)
|
(6,751 |
)
|
(6,582 |
)
| ||||||||
|
|||||||||||||||
Net
financing expense |
(5,874 |
)
|
(6,715 |
)
|
(5,885 |
)
| |||||||||
|
|||||||||||||||
Profit/(Loss)
before tax |
11
|
751
|
(6,633
|
)
|
(29,997
|
)
| |||||||||
Total
income tax credit |
2, 9
|
178 | 620 | 1,006 | |||||||||||
|
|||||||||||||||
Profit/(Loss)
for the year on continuing operations |
2
|
929
|
(6,013
|
)
|
(28,991
|
)
| |||||||||
|
|||||||||||||||
(Loss)/Profit
for the year on discontinued operations |
10
|
(54 |
)
|
(375 |
)
|
77 | |||||||||
|
|||||||||||||||
Profit(Loss)
for the year (all attributable to owners of the parent) |
2
|
875
|
(6,388
|
)
|
(28,914
|
)
| |||||||||
|
|||||||||||||||
Basic
profit/(loss) per ADS (US Dollars) – continuing operations |
12
|
0.04
|
(0.29
|
)
|
(1.39
|
)
| |||||||||
Diluted
profit/(loss) per ADS (US Dollars) – continuing operations |
12
|
0.04
|
(0.29
|
)
|
(1.39
|
)
| |||||||||
Basic
profit/(loss) per ‘A’ ordinary share (US Dollars) –continuing operations |
12
|
0.01
|
(0.07
|
)
|
(0.35
|
)
| |||||||||
Diluted
profit/(loss) per ‘A’ ordinary share (US Dollars) – continuing operations |
12
|
0.01
|
(0.07
|
)
|
(0.35
|
)
| |||||||||
Basic
profit/(loss) per ADS (US Dollars) – group |
12
|
0.04
|
(0.31
|
)
|
(1.38
|
)
| |||||||||
Diluted
profit/(loss) per ADS (US Dollars) – group |
12
|
0.04
|
(0.31
|
)
|
(1.38
|
)
| |||||||||
Basic
profit/(loss)
per ‘A’ ordinary share (US Dollars) – group |
12
|
0.01 | (0.08 |
)
|
(0.35 |
)
| |||||||||
Diluted
profit/(loss)
per ‘A’ ordinary share (US Dollars) – group |
12
|
0.01 | (0.08 |
)
|
(0.35 |
)
|
|
Year
ended December 31 |
||||||||||||||
|
Notes
|
2021
US$‘000
|
2020
US$‘000
|
2019
US$‘000
|
|||||||||||
Profit/(Loss) for the year |
2
|
875 | (6,388 |
)
|
(28,914 |
)
| |||||||||
Other
comprehensive loss |
|||||||||||||||
Items
that will be reclassified subsequently to profit or loss |
|||||||||||||||
Foreign
exchange translation differences |
(86 |
)
|
(1,360 |
)
|
(167 |
)
| |||||||||
|
|||||||||||||||
Other
comprehensive loss |
(86 |
)
|
(1,360 |
)
|
(167 |
)
| |||||||||
|
|||||||||||||||
Total Comprehensive Profit/(Loss) (all attributable to owners of the parent) |
789 | (7,748 |
)
|
(29,081 |
)
|
|
At
December 31 |
||||||||||
|
Notes
|
2021
US$‘000
|
2020
US$‘000
|
||||||||
ASSETS
|
|||||||||||
Non-current
assets |
|||||||||||
Property,
plant and equipment |
13
|
5,918 | 8,547 | ||||||||
Goodwill
and intangible assets |
14
|
35,981 | 33,860 | ||||||||
Deferred
tax assets |
15
|
4,101 | 4,185 | ||||||||
Derivative
financial instruments |
24
|
- | 150 | ||||||||
Other
assets |
16
|
207 | 355 | ||||||||
|
|||||||||||
Total
non-current assets |
46,207 | 47,097 | |||||||||
|
|||||||||||
Current
assets |
|||||||||||
Inventories
|
17
|
29,123 | 30,219 | ||||||||
Trade
and other receivables |
18
|
16,116 | 22,668 | ||||||||
Income
tax receivable |
1,539 | 3,086 | |||||||||
Cash
and cash equivalents |
19
|
25,910 | 27,327 | ||||||||
|
|||||||||||
Total
current assets |
72,688 | 83,300 | |||||||||
|
|||||||||||
TOTAL
ASSETS |
2
|
118,895 | 130,397 | ||||||||
|
|||||||||||
EQUITY
AND LIABILITIES |
|||||||||||
Equity
attributable to the equity holders of the parent |
|||||||||||
Share
capital |
20
|
1,213 | 1,213 | ||||||||
Share
premium |
20
|
16,187 | 16,187 | ||||||||
Treasury
shares |
20
|
(24,922 |
)
|
(24,922 |
)
| ||||||
Accumulated
surplus |
20
|
12,559 | 10,573 | ||||||||
Translation
reserve |
20
|
(5,379 |
)
|
(5,293 |
)
| ||||||
Other
reserves |
20
|
23 | 23 | ||||||||
|
|||||||||||
Total deficit |
(319 |
)
|
(2,219 |
)
| |||||||
|
|||||||||||
Current
liabilities |
|||||||||||
Income
tax payable |
22 | 154 | |||||||||
Trade
and other payables |
22
|
15,127 | 24,335 | ||||||||
Provisions
|
23
|
50 | 416 | ||||||||
Exchangeable
notes and other borrowings |
24
|
83,312 | - | ||||||||
Lease
liabilities |
25
|
1,980 | 2,153 | ||||||||
|
|||||||||||
Total
current liabilities |
100,491 | 27,058 | |||||||||
|
|||||||||||
Non-current
liabilities |
|||||||||||
Exchangeable
notes and other borrowings |
24
|
- | 82,695 | ||||||||
Derivative
financial instruments |
24
|
- | 1,370 | ||||||||
Lease liabilities
|
25
|
13,865 | 16,588 | ||||||||
Deferred
tax liabilities |
15
|
4,858 | 4,905 | ||||||||
|
|||||||||||
Total
non-current liabilities |
18,723 | 105,558 | |||||||||
|
|||||||||||
TOTAL
LIABILITIES |
2
|
119,214 | 132,616 | ||||||||
|
|||||||||||
TOTAL
EQUITY AND LIABILITIES |
118,895 | 130,397 |
|
Share
capital
‘A’ ordinary shares US$’000 |
Share
premium US$’000 |
Treasury
Shares US$’000 |
Translation
reserve US$’000 |
Hedging
reserves US$’000 |
Accumulated
surplus US$’000 |
Total
US$’000 |
|||||||||||||||||||||
Balance
at January 1, 2019 |
1,213 | 16,187 | (24,922 |
)
|
(3,766 |
)
|
23 | 55,319 | 44,054 | |||||||||||||||||||
Loss
for the period |
-
|
-
|
-
|
-
|
-
|
(28,914 |
)
|
(28,914 |
)
| |||||||||||||||||||
Other
comprehensive income |
-
|
-
|
-
|
(167 |
)
|
-
|
- | (167 |
)
| |||||||||||||||||||
|
||||||||||||||||||||||||||||
Total comprehensive loss |
-
|
-
|
-
|
(167 |
)
|
- | (28,914 |
)
|
(29,081 |
)
| ||||||||||||||||||
Share-based
payments |
-
|
-
|
-
|
-
|
-
|
839 | 839 | |||||||||||||||||||||
Adjustment on transition to IFRS 16 (Note 13) |
-
|
-
|
-
|
-
|
-
|
(11,099 |
)
|
(11,099 |
)
| |||||||||||||||||||
|
||||||||||||||||||||||||||||
Balance
at December 31, 2019 |
1,213 | 16,187 | (24,922 |
)
|
(3,933 |
)
|
23 | 16,145 | 4,713 | |||||||||||||||||||
|
||||||||||||||||||||||||||||
Balance
at January 1, 2020 |
1,213 | 16,187 | (24,922 |
)
|
(3,933 |
)
|
23 | 16,145 | 4,713 | |||||||||||||||||||
Loss for the period |
-
|
-
|
-
|
-
|
-
|
(6,388 |
)
|
(6,388 |
)
| |||||||||||||||||||
Other
comprehensive income |
-
|
-
|
-
|
(1,360 |
)
|
-
|
- | (1,360 |
)
| |||||||||||||||||||
|
|
|
||||||||||||||||||||||||||
Total
comprehensive loss |
-
|
-
|
-
|
(1,360 |
)
|
- | (6,388 |
)
|
(7,748 |
)
| ||||||||||||||||||
Share-based
payments (Note 21) |
- | - | - | - | - | 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 income |
-
|
-
|
-
|
(86 |
)
|
-
|
- | (86 |
)
| |||||||||||||||||||
|
|
|
||||||||||||||||||||||||||
Total
comprehensive profit/(loss) |
-
|
-
|
-
|
(86 |
)
|
- | 875 | 789 | ||||||||||||||||||||
Share-based
payments (Note 21) |
-
|
-
|
-
|
-
|
-
|
1,111 | 1,111 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
Balance
at December 31, 2021 |
1,213 | 16,187 | (24,922 |
)
|
(5,379 |
)
|
23 | 12,559 | (319 | ) |
|
Year
ended December 31, |
||||||||||||||
|
Notes
|
2021
US$‘000
|
2020
US$‘000
|
2019
US$‘000
|
|||||||||||
Cash
flows from operating activities |
|||||||||||||||
Profit/(Loss)
for the year |
875
|
(6,388
|
)
|
(28,914
|
)
| ||||||||||
Adjustments
to reconcile net profit/(loss) to cash provided by operating activities: |
|||||||||||||||
Depreciation
|
11
|
1,827
|
1,674
|
2,526
|
|||||||||||
Amortisation
|
11,14
|
917
|
1,403
|
2,368
|
|||||||||||
Income
tax credit |
9
|
(167
|
)
|
(182
|
)
|
(1,006
|
)
| ||||||||
Financial
income |
8
|
(1,223
|
)
|
(36
|
)
|
(697
|
)
| ||||||||
Financial
expense |
8
|
7,097
|
6,751
|
6,582
|
|||||||||||
Share-based
payments (net of capitalized amounts) |
21
|
1,100
|
792
|
758
|
|||||||||||
Foreign
exchange gains on operating cash flows |
(251
|
)
|
(663
|
)
|
(93
|
)
| |||||||||
(Gain)/Loss
on disposal or retirement of property, plant and equipment |
11
|
(1
|
)
|
30
|
17
|
||||||||||
Movement
in inventory provision |
17
|
5,589
|
5,059
|
1,567
|
|||||||||||
Impairment
of prepayments |
7,
18 |
583
|
562
|
1,376
|
|||||||||||
Impairment
of property, plant and equipment |
7,
13 |
2,508
|
1,795
|
6,349
|
|||||||||||
Impairment
of intangible assets |
7,
14 |
3,853
|
15,422
|
16,570
|
|||||||||||
Other
non-cash items |
(5,317
|
)
|
(634
|
)
|
835
|
||||||||||
|
|||||||||||||||
Operating
cash flows before changes in working capital |
17,390
|
25,585
|
8,238
|
||||||||||||
Decrease
/ (Increase) in trade and other receivables |
6,236
|
(2,489
|
)
|
445
|
|||||||||||
(Increase)
in inventories |
(4,406
|
)
|
(3,419
|
)
|
(2,959
|
)
| |||||||||
(Decrease)
/ Increase in trade and other payables |
(7,591
|
)
|
4,994
|
151
|
|||||||||||
|
|||||||||||||||
Cash
generated from operations |
11,629
|
24,671
|
5,875
|
||||||||||||
Interest
paid |
(11
|
)
|
(48
|
)
|
(1,000
|
)
| |||||||||
Interest
received |
1
|
104
|
560
|
||||||||||||
Income
taxes received / (paid) |
1,619
|
(972
|
)
|
(18
|
)
| ||||||||||
|
|||||||||||||||
Net
cash generated by operating activities |
13,238
|
23,755
|
5,417
|
||||||||||||
|
|||||||||||||||
Cash
flows from investing activities |
|||||||||||||||
Payments
to acquire intangible assets |
(6,879
|
)
|
(6,990
|
)
|
(9,718
|
)
| |||||||||
Acquisition
of property, plant and equipment |
(1,812
|
)
|
(3,178
|
)
|
(2,118
|
)
| |||||||||
Disposal
of property, plant and equipment |
-
|
(30
|
)
|
(17
|
)
| ||||||||||
|
|||||||||||||||
Net
cash used in investing activities |
(8,691
|
)
|
(10,198
|
)
|
(11,853
|
)
| |||||||||
|
|||||||||||||||
Cash
flows from financing activities |
|||||||||||||||
Proceeds
from Paycheck Protection loans |
1,764
|
4,520
|
-
|
||||||||||||
Interest
payment on exchangeable notes |
29
|
(3,996
|
)
|
(3,996
|
)
|
(3,996
|
)
| ||||||||
Loan
Origination Costs |
(848
|
)
|
-
|
-
|
|||||||||||
Payment
of lease liabilities |
29
|
(2,939
|
)
|
(3,240
|
)
|
(3,533
|
)
| ||||||||
|
|||||||||||||||
Net
cash used in financing activities |
(6,019
|
)
|
(2,716
|
)
|
(7,529
|
)
| |||||||||
|
|||||||||||||||
(Decrease)
/ Increase in cash and cash equivalents and short term investments |
(1,472
|
)
|
10,841
|
(13,965
|
)
| ||||||||||
Effects of exchange rate
movements on cash held |
55
|
86
|
88
|
||||||||||||
Cash
and cash equivalents and short-term investments at beginning of year |
27,327
|
16,400
|
30,277
|
||||||||||||
|
|||||||||||||||
Cash
and cash equivalents and short-term investments at end of year |
19
|
25,910
|
27,327
|
16,400
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT
ACCOUNTING POLICIES |
i) |
General
information |
ii) |
Statement
of compliance |
iii) |
Basis of
preparation |
At December 31, 2021, the Group had net currently liabilities. However, at the date of this report the Group’s financial position has substantially improved following the successful re-financing of the Group’s debt in early 2022. This has significantly improved the Group’s capital structure by reducing gross debt by approximately US$19 million and there are no material debt maturities until 2026. Furthermore, the investment by MiCo Group will facilitate an early repayment of a substantial portion of the debt due to Perceptive Advisors and will also facilitate the Group exploring lower cost debt funding options, in the short term, with the aim of further reducing the Group’s interest expense through refinancing the balance of the Group’s term loan at substantially lower interest rates.
99
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
The accounting policies set out below have been applied consistently to all periods presented in these consolidated financial statements. The accounting policies have been applied consistently by all Group entities. |
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 |
2-15
years |
100
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
• |
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. |
101
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
vi) |
Goodwill
|
vii) |
Intangibles, including
research and development (other than goodwill) |
102
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING
POLICIES (CONTINUED) |
•
Capitalised development costs |
15
years | |
•
Patents and licences |
6-15
years | |
•
Other (including acquired customer and supplier lists) |
6-15
years |
(a) |
once a diagnostic test becomes established, customers
are reluctant to change to new technology until it is fully proven, thus resulting in relatively long product life cycles. There is also
reluctance in customers to change to a new product as it can be costly both in terms of the initial changeover cost and as new technology
is typically more expensive. |
(b) |
demand for the diagnostic tests is enduring and
robust within a wide geographic base. The diseases that the products diagnose are widely prevalent (HIV, Diabetes and Chlamydia being
just three examples) in many countries. There is a general consensus that these diseases will continue to be widely prevalent in the future.
|
(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. |
103
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING
POLICIES (CONTINUED) |
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
|
xiv) |
Share-based payments
|
105
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING
POLICIES (CONTINUED) |
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
|
xviii) |
Foreign currency
|
107
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING
POLICIES (CONTINUED) |
xix)
|
Hedging
|
xx) |
Exchangeable notes and
derivative financial instruments |
xxi) |
Segment reporting
|
108
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING
POLICIES (CONTINUED) |
xxii) |
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. |
xxiii) |
Provisions
|
xxiv) |
Cost of sales
|
xxv) |
Finance income and costs
|
109
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING
POLICIES (CONTINUED) |
xxvi) |
Treasury shares
|
xxvii) |
Equity
|
xxviii) |
Profit or loss from
discontinued operations |
xxix) |
Fair values
|
xxx) |
New IFRS Standards and
Interpretations not applied |
• |
Amendments IFRS 9 Financial
Instruments, IAS 39 Financial Instruments: Recognition and measurement
|
• |
IFRS 7 Financial
Instruments: Disclosures |
• |
IFRS 4 Insurance
Contracts |
• |
IFRS 16 Leases
– Interest Rate Benchmark Reform – Phase 2 |
• |
Amendments to IFRS 16 – COVID-19-Related
Rent Concessions beyond 30 June 2021. The amendment was adopted effective 1 January 2021 and did not result in a material impact on the
Group’s results.
|
110
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: |
Rest
of World |
||||||||||||||||||||
Revenue
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
Year
ended December 31, 2021 |
US$‘000
|
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 |
|
Rest
of World |
|||||||||||||||||||
Revenue
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
Year
ended December 31, 2020 |
US$‘000
|
US$‘000
|
US$‘000
|
US$’000
|
US$‘000
|
|||||||||||||||
Revenue
from external customers |
77,688 | 24,292 | - | - | 101,980 | |||||||||||||||
Inter-segment
revenue |
59,304 | 1,095 | - | (60,399 |
)
|
- | ||||||||||||||
|
||||||||||||||||||||
Total
revenue |
136,992 | 25,387 | - | (60,399 |
)
|
101,980 |
111
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. |
SEGMENT
INFORMATION (CONTINUED) |
|
Rest
of World |
|||||||||||||||||||
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
Year
ended December 31, 2019 |
US$‘000
|
US$‘000
|
US$‘000
|
US$’000
|
US$‘000
|
|||||||||||||||
Revenue
from external customers |
64,045 | 26,390 | - | - | 90,435 | |||||||||||||||
Inter-segment
revenue |
39,563 | 1,629 | - | (41,192 |
)
|
- | ||||||||||||||
|
||||||||||||||||||||
Total
revenue |
103,608 | 28,019 | - | (41,192 |
)
|
90,435 |
ii) |
The
distribution of revenue by customers’ geographical area was as follows:
|
Revenue
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Americas
|
57,799 | 70,408 | 52,183 | |||||||||
Asia
/ Africa |
25,504 | 22,567 | 27,686 | |||||||||
Europe
(including Ireland) * |
9,662 | 9,005 | 10,566 | |||||||||
|
||||||||||||
|
92,965 | 101,980 | 90,435 |
* |
Revenue from customers in Ireland is not disclosed separately due to the immateriality of these
revenues. |
iii) |
The distribution of revenue by major
product group was as follows: |
Revenue
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Clinical
laboratory goods |
74,700 | 84,280 | 68,127 | |||||||||
Clinical
laboratory services |
7,928 | 8,485 | 10,915 | |||||||||
Point-of-Care
|
10,337 | 9,215 | 11,393 | |||||||||
|
||||||||||||
|
92,965 | 101,980 | 90,435 |
iv) |
The group has recognised the following
amounts relating to revenue in the consolidated statement of operations: |
Revenue
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Revenue
from contracts with customers (a) |
92,965 | 101,980 | 90,435 | |||||||||
Revenue
from other sources |
- | - | - | |||||||||
|
||||||||||||
|
92,965 | 101,980 | 90,435 |
112
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(a) |
Disaggregation of revenue from contracts
with customers: |
Timing
of revenue recognition |
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year
ended December 31, 2021 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At
a point in time |
66,806 | 25,716 | - | 92,522 | ||||||||||||
Over
time |
443 | - | - | 443 | ||||||||||||
|
||||||||||||||||
Total
|
67,249 | 25,716 | - | 92,965 |
Timing
of revenue recognition |
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year
ended December 31, 2020 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At
a point in time |
77,060 | 24,292 | - | 101,352 | ||||||||||||
Over
time |
628 | - | - | 628 | ||||||||||||
|
||||||||||||||||
Total
|
77,688 | 24,292 | - | 101,980 |
Timing
of revenue recognition |
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year
ended December 31, 2019 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At
a point in time |
63,300 | 26,390 | - | 89,690 | ||||||||||||
Over
time |
745 | - | - | 745 | ||||||||||||
|
||||||||||||||||
Total
|
64,045 | 26,390 | - | 90,435 |
(b) |
The Group derives revenue from the
transfer of goods and services over time and at a point in time based on customers’ geographical area as follows:
|
Timing
of revenue recognition |
Americas
|
Asia
/ Africa |
Europe
|
Total
|
||||||||||||
Year
ended December 31, 2021 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At
a point in time |
57,356 | 25,504 | 9,662 | 92,522 | ||||||||||||
Over
time |
443 | - | - | 443 | ||||||||||||
|
||||||||||||||||
Total
|
57,799 | 25,504 | 9,662 | 92,965 |
113
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. |
SEGMENT
INFORMATION (CONTINUED) |
Timing
of revenue recognition |
Americas
|
Asia
/ Africa |
Europe
|
Total
|
||||||||||||
Year
ended December 31, 2020 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At
a point in time |
69,780 | 22,567 | 9,005 | 101,352 | ||||||||||||
Over
time |
628 | - | - | 628 | ||||||||||||
|
||||||||||||||||
Total
|
70,408 | 22,567 | 9,005 | 101,980 |
Timing
of revenue recognition |
Americas
|
Asia
/ Africa |
Europe
|
Total
|
||||||||||||
Year
ended December 31, 2019 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At
a point in time |
51,438 | 27,686 | 10,566 | 89,690 | ||||||||||||
Over
time |
745 | - | - | 745 | ||||||||||||
|
||||||||||||||||
Total
|
52,183 | 27,686 | 10,566 | 90,435 |
|
|
Rest of World |
|||||||||||||||
|
Americas |
Ireland |
Other |
Total |
||||||||||||
Year ended December 31, 2021 |
US$‘000 |
US$‘000 |
US$‘000 |
US$‘000 |
||||||||||||
Result before impairment and unallocated expenses
|
9,276
|
5,084
|
(12
|
) |
14,348
|
|||||||||||
Impairment |
(6,088
|
) |
(856
|
) |
-
|
(6,944
|
) | |||||||||
|
||||||||||||||||
Result after impairment |
3,188
|
4,228
|
(12
|
) |
7,404
|
|||||||||||
Unallocated expenses * |
(779
|
) | ||||||||||||||
|
||||||||||||||||
Operating profit |
6,625
|
|||||||||||||||
Net financing expense (Note 8) |
(5,874
|
) | ||||||||||||||
|
||||||||||||||||
Profit before tax |
751
|
|||||||||||||||
Income tax credit (Note 9) |
178
|
|||||||||||||||
|
||||||||||||||||
Profit for the year on continuing operations |
929
|
|||||||||||||||
Loss for the year on discontinued operations (Note 10) |
(54
|
) | ||||||||||||||
|
||||||||||||||||
Profit for the year |
875
|
|
Rest
of World |
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year
ended December 31, 2020 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result
before impairment and unallocated expenses |
14,495 | 4,264 | (71 |
)
|
18,688 | |||||||||||
Impairment
|
(17,779 |
)
|
- | - | (17,779 |
)
| ||||||||||
|
||||||||||||||||
Result
after impairment |
(3,284 |
)
|
4,264 | (71 |
)
|
909 | ||||||||||
Unallocated
expenses * |
(827 |
)
| ||||||||||||||
|
||||||||||||||||
Operating
profit |
82 | |||||||||||||||
Net
financing expense (Note 8) |
(6,715 |
)
| ||||||||||||||
|
||||||||||||||||
Loss
before tax |
(6,633 |
)
| ||||||||||||||
Income
tax credit (Note 9) |
620 | |||||||||||||||
|
||||||||||||||||
Loss
for the year on continuing operations |
(6,013 |
)
| ||||||||||||||
Loss
for the year on discontinued operations (Note 10) |
(375 |
)
| ||||||||||||||
|
||||||||||||||||
Loss
for the year |
(6,388 |
)
|
114
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. |
SEGMENT
INFORMATION (CONTINUED) |
Rest
of World |
||||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year
ended December 31, 2019 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result
before impairment and unallocated expenses |
5,239 | (4,334 |
)
|
(108 |
)
|
797 | ||||||||||
Impairment
|
(14,562 |
)
|
(9,733 |
)
|
- | (24,295 |
)
| |||||||||
|
||||||||||||||||
Result
after impairment |
(9,323 |
)
|
(14,067 |
)
|
(108 |
)
|
(23,498 |
)
| ||||||||
Unallocated
expenses * |
(614 |
)
| ||||||||||||||
|
||||||||||||||||
Operating
loss |
(24,112 |
)
| ||||||||||||||
Net
financing expense (Note 8) |
(5,885 |
)
| ||||||||||||||
|
||||||||||||||||
Loss
before tax |
(29,997 |
)
| ||||||||||||||
Income
tax credit (Note 9) |
1,006 | |||||||||||||||
|
||||||||||||||||
Loss
for the year on continuing operations |
(28,991 |
)
| ||||||||||||||
Profit
for the year on discontinued operations (Note 10) |
77 | |||||||||||||||
|
||||||||||||||||
Loss
for the year |
(28,914 |
)
|
* |
Unallocated expenses represent head office general and administration costs of the Group, which
cannot be allocated to the results of any specific geographical area.
|
vi) |
The
distribution of segment assets and segment liabilities by geographical area was as follows:
|
|
Rest
of World |
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
As
at December 31, 2021 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Assets
and liabilities |
||||||||||||||||
Segment
assets |
45,891 | 41,453 | 1 | 87,345 | ||||||||||||
Unallocated
assets: |
||||||||||||||||
Income
tax assets (current and deferred) |
5,640 | |||||||||||||||
Cash
and cash equivalents and short-term investments |
25,910 | |||||||||||||||
Total
assets as reported in the Group balance sheet |
118,895 | |||||||||||||||
|
||||||||||||||||
Segment
liabilities |
12,382 | 101,927 | 25 | 114,334 | ||||||||||||
Unallocated
liabilities: |
||||||||||||||||
Income
tax liabilities (current and deferred) |
4,880 | |||||||||||||||
|
||||||||||||||||
Total
liabilities as reported in the Group balance sheet |
119,214 |
115
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. |
SEGMENT
INFORMATION (CONTINUED) |
|
Rest
of World |
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
As
at December 31, 2020 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Assets
and liabilities |
||||||||||||||||
Segment
assets |
58,164 | 37,632 | 3 | 95,799 | ||||||||||||
Unallocated
assets: |
||||||||||||||||
Income
tax assets (current and deferred) |
7,271 | |||||||||||||||
Cash
and cash equivalents and short-term investments |
27,327 | |||||||||||||||
Total assets
as reported in the Group balance sheet |
130,397 | |||||||||||||||
|
||||||||||||||||
Segment liabilities
|
20,431 | 107,080 | 46 | 127,557 | ||||||||||||
Unallocated
liabilities: |
||||||||||||||||
Income
tax liabilities (current and deferred) |
5,059 | |||||||||||||||
|
||||||||||||||||
Total liabilities
as reported in the Group balance sheet |
132,616 |
vii) |
The
distribution of long-lived assets, which are property, plant and equipment, goodwill and intangible assets and other non-current assets
(excluding deferred tax assets and derivative financial instruments), by geographical area was as follows:
|
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
||||||
Rest
of World – Ireland |
22,617 | 19,927 | ||||||
Americas
|
19,489 | 22,835 | ||||||
|
||||||||
|
42,106 | 42,762 |
viii) |
The
distribution of depreciation and amortisation by geographical area was as follows:
|
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Depreciation:
|
||||||||||||
Rest
of World – Ireland |
204 | 127 | 322 | |||||||||
Americas
|
1,662 | 1,587 | 2,208 | |||||||||
|
||||||||||||
|
1,866 | 1,714 | 2,530 | |||||||||
|
||||||||||||
Amortisation:
|
||||||||||||
Rest
of World – Ireland |
69 | 32 | 642 | |||||||||
Americas
|
848 | 1,371 | 1,726 | |||||||||
|
||||||||||||
|
917 | 1,403 | 2,368 |
ix) |
The
distribution of share-based payment expense by geographical area was as follows:
|
|
December
31, 2021 US$‘000 |
December
31, 2020 US$‘000 |
December
31, 2019 US$‘000 |
|||||||||
Rest
of World – Ireland |
1,072 | 722 | 659 | |||||||||
Americas
|
28 | 70 | 99 | |||||||||
|
||||||||||||
|
1,100 | 792 | 758 |
116
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
2. |
SEGMENT
INFORMATION (CONTINUED) |
x) |
The
distribution of taxation (expense)/credit by geographical area was as follows:
|
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Rest
of World – Ireland |
540 | 293 | 831 | |||||||||
Rest
of World – Other |
(2 |
)
|
(8 |
)
|
- | |||||||
Americas
|
(360 |
)
|
335 | 175 | ||||||||
|
||||||||||||
|
178 | 620 | 1,006 |
xi) |
During
2020 and 2019 there were no customers generating 10% or more of total revenues. In 2021, one customer accounted for more than 10% of total
revenues. |
xii) |
The
distribution of capital expenditure by geographical area was as follows:
|
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
||||||
Rest
of World – Ireland |
3,826 | 5,609 | ||||||
Rest
of World – Other |
- | - | ||||||
Americas
|
4,776 | 4,317 | ||||||
|
||||||||
|
8,602 | 9,926 |
3. |
EMPLOYMENT |
|
December
31, 2021 |
December
31, 2020 |
December
31, 2019 |
|||||||||
Research
and development |
41 | 52 | 57 | |||||||||
Administration
and sales |
134 | 148 | 159 | |||||||||
Manufacturing
and quality |
302 | 343 | 363 | |||||||||
|
||||||||||||
|
477 | 543 | 579 |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Wages
and salaries |
26,561 | 26,187 | 25,885 | |||||||||
Social
welfare costs |
2,403 | 2,195 | 2,538 | |||||||||
Pension
costs |
352 | 447 | 503 | |||||||||
Tax
settlement (Note 6) |
- | - | 5,094 | |||||||||
Share-based
payments |
1,100 | 792 | 758 | |||||||||
Restructuring
Cost |
270 | 388 | - | |||||||||
Recognition
of contingent asset (Note 26) |
- | (1,316 |
)
|
- | ||||||||
|
||||||||||||
|
30,686 | 28,693 | 34,778 |
117
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
3. |
EMPLOYMENT (CONTINUED) |
4. |
OTHER OPERATING INCOME |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Government
supports - COVID-19 |
4,668 | 1,840 | - | |||||||||
Other
income |
- | 17 | 88 | |||||||||
Rental
income from premises |
4 | 3 | 3 | |||||||||
|
||||||||||||
|
4,672 | 1,860 | 91 |
5. |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES –
CLOSURE COSTS |
6. |
SELLING, GENERAL AND ADMINISTRATIVE
EXPENSES – TAX AUDIT SETTLEMENT |
118
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
6. |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
– TAX AUDIT SETTLEMENT (CONTINUED) |
Darnick Company agreed to contribute US$1,231,000 to the above settlement and this amount was outstanding at December 31, 2019 and was treated as a contingent asset and not recognized in the 2019 financial statements. This balance was settled in the year ended December 31, 2020 and has been credited to the Statement of Operations within Selling, General and Administrative Expenses. The underlying amount was denominated in Euro. Due to a depreciation in the US Dollar since 2019, the US Dollar equivalent amount increased from US$1,231,000 to US$1,316,000. The settlement amount received by the Company was US$177,000 more than the balance owed and this overpayment is recorded as a related party current liability for the benefit of Ronan O’Caoimh as at December 31, 2020. The amount was settled by the Group in January 2021.
7.
|
IMPAIRMENT
CHARGES |
December
|
December
|
December
|
||||||||||
31,
2021 |
31,
2020 |
31,
2019 |
||||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Selling,
general & administration expenses |
||||||||||||
Impairment
of PP&E (Note 13) |
2,508 | 1,795 | 6,349 | |||||||||
Impairment
of goodwill and other intangible assets (Note 14) |
3,853 | 15,422 | 16,570 | |||||||||
Impairment
of prepayments (Note 18) |
583 | 562 | 1,376 | |||||||||
|
||||||||||||
Total
impairment loss |
6,944 | 17,779 | 24,295 | |||||||||
|
||||||||||||
Income
tax impact of impairment loss |
- | - | 148 | |||||||||
|
||||||||||||
Total
impairment loss after tax |
6,944 | 17,779 | 24,443 |
8.
|
FINANCIAL INCOME AND
EXPENSES |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Financial
income: |
||||||||||||
Non-cash
financial income |
1,220 | - | 233 | |||||||||
Interest
income |
3 | 36 | 464 | |||||||||
|
||||||||||||
|
1,223 | 36 | 697 | |||||||||
|
||||||||||||
Financial
expense: |
||||||||||||
Interest
on leases |
(815 |
)
|
(896 |
)
|
(947 |
)
| ||||||
Interest
on tax audit settlement (Note 6) |
- | - | (1,000 |
)
| ||||||||
Cash
interest on exchangeable notes |
(3,996 |
)
|
(3,996 |
)
|
(3,996 |
)
| ||||||
Loan origination costs |
(1,638 | ) | - | - | ||||||||
Non-cash
interest on exchangeable notes (Note 24) |
(648 |
)
|
(643 |
)
|
(639 |
)
| ||||||
Non-cash
financial expense |
- | (1,216 |
)
|
- | ||||||||
|
||||||||||||
|
(7,097 |
)
|
(6,751 |
)
|
(6,582 |
)
| ||||||
Net
Financing Expense |
(5,874 |
)
|
(6,715 |
)
|
(5,885 |
)
|
119
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
9.
|
INCOME
TAX CREDIT |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Current
tax (credit)/expense |
||||||||||||
Irish
Corporation tax |
(511 |
)
|
(480 |
)
|
(312 |
)
| ||||||
Foreign
taxes (a) |
296 | 179 | 197 | |||||||||
Adjustment
in respect of prior years |
- |
|
(152 |
)
|
(50 |
)
| ||||||
|
||||||||||||
Total current tax credit |
(215 |
)
|
(453 |
)
|
(165 |
)
| ||||||
|
||||||||||||
Deferred
tax credit (b) |
||||||||||||
Origination
and reversal of temporary differences (see Note 15) |
620 | 48 | (625 |
)
| ||||||||
Origination
and reversal of net operating losses (see Note 15) |
(583 |
)
|
(215 |
)
|
(216 |
)
| ||||||
|
||||||||||||
Total deferred tax credit |
37 |
|
(167 |
)
|
(841 |
)
| ||||||
|
||||||||||||
Total
income tax credit on continuing operations in statement of operations |
(178 |
)
|
(620 |
)
|
(1,006 |
)
| ||||||
|
||||||||||||
Tax
charge on discontinued operations (see Note 10) |
12 | 438 | - | |||||||||
|
|
|||||||||||
Total
tax credit |
(166 |
)
|
(182 |
)
|
(1,006 |
)
|
(a) |
In 2021, the foreign taxes relate primarily to USA and Canada. |
(b) |
In 2021, there
was a deferred tax charge of US$118,000
(2020: charge of US$53,000;
2019: credit of US$444,000)
recognised in respect of Ireland and a deferred tax credit of US$81,000
(2020: credit of US$220,000;2019:
credit of US$397,000)
recognised in respect of overseas tax jurisdictions. |
Effective
tax rate |
December
31, 2021 |
December
31, 2020 |
December
31, 2019 |
|||||||||
Profit/(Loss) before
taxation – continuing operations (US$‘000) |
751 |
|
(6,633 |
)
|
(29,997 |
)
| ||||||
As
a percentage of loss before tax: |
||||||||||||
Current
tax % |
28.63 |
%
|
(6.83 |
)%
|
(0.55 |
)%
| ||||||
Total
(current and deferred) % |
(23.70 |
)%
|
(9.35 |
)%
|
(3.36 |
)%
|
120
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
9.
|
INCOME
TAX CREDIT (CONTINUED) |
|
December
31, 2021 |
December
31, 2020 |
December
31, 2019 |
|||||||||
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)
|
49.63 |
%
|
24.13 |
%
|
13.21 |
%
| ||||||
Effect
of tax rates on overseas earnings |
(0.22 |
)%
|
(9.92 |
)%
|
(3.05 |
)%
| ||||||
Effect
of Irish income taxable at higher tax rate |
98.68 |
%
|
5.92 |
%
|
0.04 |
%
| ||||||
Adjustments
in respect of prior years |
(0.01 |
)%
|
(10.66 |
)%
|
(0.17 |
)%
| ||||||
R&D
tax credits |
(79.22 |
)%
|
(11.00 |
)%
|
(2.69 |
)%
| ||||||
Other
items (b) |
(105.06 |
)%
|
4.68 |
%
|
1.80 |
%
| ||||||
|
||||||||||||
Effective
tax rate |
(23.70 |
)%
|
(9.35 |
)%
|
(3.36 |
)%
|
(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/expenses not deductible for tax purposes. In 2021, this mainly comprises the income from the Paycheck Protection Program loans which is not chargeable for tax purposes. |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Rest
of World – Ireland |
1,862 | 296 | (20,318 |
)
| ||||||||
Rest
of World – Other |
3,939 | 3,304 | 4,760 | |||||||||
Americas
|
(5,050 |
)
|
(10,233 |
)
|
(14,439 |
)
| ||||||
|
||||||||||||
|
751 |
|
(6,633 |
)
|
(29,997 |
)
|
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Rest of World – Ireland |
68,132 | 78,700 | 73,754 | |||||||||
Rest of World – Other |
1,000 | 2,185 | - | |||||||||
Americas |
4,761 | 4,313 | 6,823 | |||||||||
|
||||||||||||
|
73,893 | 85,198 | 80,577 |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Rest of World – Ireland – unused tax losses |
9,272 | 12,514 | 12,062 | |||||||||
Rest of World – Other – unused tax losses |
279 | 546 | - | |||||||||
Americas – unused tax losses |
5,891 | 1,466 | 5,259 | |||||||||
Americas – unused tax credits |
3,368 | 2,862 | 493 | |||||||||
Unrecognised
deferred tax asset |
18,810 | 17,388 | 17,814 |
10. |
(LOSS)/PROFIT FOR THE
YEAR ON DISCONTINUED OPERATION |
122
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
10. |
(LOSS)/PROFIT FOR THE
YEAR ON DISCONTINUED OPERATION (CONTINUED) |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
(Loss)/Profit
on re-measurement of assets and liabilities: |
||||||||||||
Closure
provision |
(42 | ) | 127 | (8 |
)
| |||||||
Foreign
currency translation reserve |
- | (64 |
)
|
85 | ||||||||
Tax
(expense)/credit |
(12 |
)
|
(438 |
)
|
- | |||||||
|
||||||||||||
Total
(loss)/profit |
(54 |
)
|
(375 |
)
|
77 | |||||||
(Loss)/Profit
for the year from discontinued operations |
(54 |
)
|
(375 |
)
|
77 |
Basic (loss)/earnings per ADS for discontinued operations is computed by dividing the loss after taxation on discontinued operations of US$54,000 (2020: loss US$375,000) (2019: profit US$77,000) for the financial year by the weighted average number of ADS in issue of 20,901,703 (2020: 20,901,703) (2019: 20,901,703), see note 12 for further details.
123
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
10. |
(LOSS)/PROFIT FOR THE YEAR ON DISCONTINUED
OPERATION (CONTINUED) |
December
31, 2021 |
December
31, 2020 |
December
31, 2019 | ||||||||||
Basic
earnings/(loss) per ADS (US Dollars) – discontinued operations
|
0.00 | (0.02 |
)
|
0.00 | ||||||||
Diluted
earnings/(loss) per ADS (US Dollars) – discontinued operations
|
0.00 | (0.02 |
)
|
0.00 | ||||||||
Basic
earnings/(loss) per ‘A’ share (US Dollars) – discontinued
operations |
0.00 | 0.00 | 0.00 | |||||||||
Diluted
earnings/(loss) per ‘A’ share (US Dollars) – discontinued
operations |
0.00 | 0.00 | 0.00 |
|
December
31, 2021 |
December
31, 2020 |
December
31, 2019 |
|||||||||
US$000
|
US$000
|
US$000
|
||||||||||
Cash
flows from operating activities |
(40 |
)
|
(22 |
)
|
(5 |
)
|
11.
|
PROFIT/LOSS
BEFORE TAX |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Directors’
emoluments (including non- executive directors): |
||||||||||||
Remuneration
|
1,390 | 2,020 | 1,238 | |||||||||
Pension
|
24 | 41 | 42 | |||||||||
Share
based payments |
986 | 678 | 624 | |||||||||
Auditor’s
remuneration |
||||||||||||
Audit
fees |
549 | 533 | 523 | |||||||||
Tax
fees |
77 | 146 | 172 | |||||||||
Other
non-audit fees |
31 | 25 | - | |||||||||
Depreciation*
|
1,827 | 1,674 | 2,526 | |||||||||
Amortisation
(Note 14) |
917 | 1,403 | 2,368 | |||||||||
(Gain)/Loss
on the disposal of property, plant and equipment |
(1 | ) | 30 | 17 | ||||||||
Net
foreign exchange differences |
(789 |
)
|
583 |
(179
|
) |
* |
Note that
US$39,000
(2020: US$40,000)
(2019: US$4,000)
of depreciation was capitalised to research and development projects during 2021 in line with the Group’s capitalisation policy
for Intangible projects. |
124
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
12. |
PROFIT/(LOSS) PER SHARE
|
|
December
31, 2021 |
December
31, 2020 |
December
31, 2019 |
|||||||||
‘A’
ordinary shares |
83,606,810 | 83,606,810 | 83,606,810 | |||||||||
|
||||||||||||
Basic
earnings per share denominator |
83,606,810 | 83,606,810 | 83,606,810 | |||||||||
|
||||||||||||
Reconciliation
to weighted average earnings per share denominator: |
||||||||||||
Number
of ‘A’ ordinary shares at January 1 (Note 20) |
96,162,410 | 96,162,410 | 96,162,410 | |||||||||
Weighted
average number of shares issued during the year* |
- | - | - | |||||||||
Weighted
average number of treasury shares |
(12,555,600 |
)
|
(12,555,600 |
)
|
(12,555,600 |
)
| ||||||
|
||||||||||||
Basic
earnings per share denominator |
83,606,810 | 83,606,810 | 83,606,810 |
Under IAS 33 Earnings per Share, diluted earnings per share cannot be anti-dilutive. Therefore, diluted loss per ordinary share in accordance with IFRS would be equal to basic loss per ordinary share when a loss occurs.
|
December
31,
2021
|
December
31,
2020
|
December
31,
2019
|
|||||||||
Basic
earnings per share denominator (see above) |
83,606,810 | 83,606,810 | 83,606,810 | |||||||||
Issuable
on exercise of options and warrants |
4,648,586 | 3,154,668 | - | |||||||||
Issuable
on conversion of exchangeable notes |
18,263,254 | 18,263,254 | 18,263,254 | |||||||||
|
||||||||||||
Diluted
earnings per share denominator |
106,518,650 | 105,024,732 | 101,870,064 |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
December
31, 2019
US$‘000
|
|||||||||
Profit/(Loss)
after tax for the year |
875 | (6,388 |
)
|
(28,914 |
)
| |||||||
Non-cash
financial (income)/expense
(Note 8) |
(1,220 |
)
|
1,216 | (233 |
)
| |||||||
Cash
interest expense (Note 8) |
3,996 | 3,996 | 3,996 | |||||||||
Non-cash
interest on exchangeable notes (Note 8) |
648 | 643 | 639 | |||||||||
|
||||||||||||
Adjusted
profit/(loss) after tax |
4,299 | (533 |
)
|
(24,512 |
)
|
|
December
31,
2021
|
December
31,
2020
|
December
31,
2019
|
|||||||||
ADS
|
20,901,703 | 20,901,703 | 20,901,703 | |||||||||
|
||||||||||||
Basic
earnings per share denominator |
20,901,703 | 20,901,703 | 20,901,703 | |||||||||
|
||||||||||||
Reconciliation
to weighted average earnings per share denominator: |
||||||||||||
Number
of ADS at January 1 (Note 20) |
24,040,602
|
24,040,602
|
24,040,602
|
|||||||||
Weighted
average number of shares issued during the year* |
- | - | - | |||||||||
Weighted
average number of treasury shares |
(3,138,899 |
)
|
(3,138,899 |
)
|
(3,138,899 |
)
| ||||||
|
||||||||||||
Basic
earnings per share denominator |
20,901,703 | 20,901,703 | 20,901,703 |
Under IAS 33 Earnings per Share, diluted earnings per share cannot be anti-dilutive. Therefore, diluted earnings/(loss) per ADS in accordance with IFRS would be equal to basic loss per ADS when a loss occurs.
|
December
31,
2021
|
December
31,
2020
|
December
31,
2019
|
|||||||||
Basic
earnings per share denominator (see above) |
20,901,703 | 20,901,703 | 20,901,703 | |||||||||
Issuable
on exercise of options and warrants |
1,162,146 | 788,666 | - | |||||||||
Issuable
on conversion of exchangeable notes |
4,565,814 | 4,565,814 | 4,565,814 | |||||||||
|
||||||||||||
Diluted
earnings per share denominator |
26,629,663 | 26,256,183 | 25,467,517 |
13. |
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, 2020 |
24,269
|
3,005
|
4,292
|
38,676
|
70,242
|
|||||||||||||||
Additions
|
8
|
41
|
96
|
2,766
|
2,911
|
|||||||||||||||
Disposals
or retirements |
-
|
(299
|
)
|
(66
|
)
|
(5,758
|
)
|
(6,123
|
)
| |||||||||||
Exchange adjustments
|
10
|
(77
|
)
|
(13
|
)
|
(1,845
|
)
|
(1,925
|
)
| |||||||||||
At
December 31, 2020 |
24,287
|
2,670
|
4,309
|
33,839
|
65,105
|
|||||||||||||||
|
||||||||||||||||||||
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
|
)
| |||||||||||
Reallocations/
reclassifications |
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Exchange
adjustments |
1
|
(18
|
)
|
2
|
(484
|
)
|
(499
|
)
| ||||||||||||
|
||||||||||||||||||||
At
December 31, 2021 |
24,334
|
2,592
|
4,200
|
32,337
|
63,463
|
|||||||||||||||
|
||||||||||||||||||||
Accumulated
amortisation and Impairment losses |
||||||||||||||||||||
At
January 1, 2020 |
(18,493
|
)
|
(2,037
|
)
|
(3,682
|
)
|
(36,740
|
)
|
(60,952
|
)
| ||||||||||
Charge
for the year |
(783
|
)
|
(146
|
)
|
(181
|
)
|
(604
|
)
|
(1,714
|
)
| ||||||||||
Impairment
losses as at December 31, 2020 |
(347
|
)
|
(78
|
)
|
(180
|
)
|
(1,190
|
)
|
(1,795
|
)
| ||||||||||
Disposals
or retirements |
-
|
299
|
84
|
5,590
|
5,973
|
|||||||||||||||
Exchange
adjustments |
(6
|
)
|
78
|
13
|
1,845
|
1,930
|
||||||||||||||
|
||||||||||||||||||||
At
December 31, 2020 |
(19,629
|
)
|
(1,884
|
)
|
(3,946
|
)
|
(31,099
|
)
|
(56,558
|
)
| ||||||||||
|
||||||||||||||||||||
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
|
)
| ||||||||||
Reallocations/
reclassifications |
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Exchange
adjustments |
21
|
(5
|
)
|
(46
|
)
|
566
|
536
|
|||||||||||||
|
||||||||||||||||||||
At
December 31, 2021 |
(21,432
|
)
|
(2,131
|
)
|
(3,950
|
)
|
(30,032
|
)
|
(57,545
|
)
| ||||||||||
|
||||||||||||||||||||
Carrying
amounts |
||||||||||||||||||||
At
December 31, 2021 |
2,902
|
461
|
250
|
2,305
|
5,918
|
|||||||||||||||
|
||||||||||||||||||||
At
December 31, 2020 |
4,658
|
786
|
363
|
2,740
|
8,547
|
127
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
13. |
PROPERTY,
PLANT AND EQUIPMENT (CONTINUED) |
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 |
- | - | - | |||||||||
2,572 | (614 |
)
|
(1,089 |
)
|
Carrying
amount |
Depreciation
Charge |
Impairment
Charge |
||||||||||
At
December 31, 2020 |
Year
ended December 31, 2020 |
Year
ended December 31, 2020 |
||||||||||
US$000
|
US$000
|
US$000
|
||||||||||
Buildings
|
4,200 | (673 |
)
|
(347 |
)
| |||||||
Computer
equipment |
3 | (4 |
)
|
- | ||||||||
Plant and
Equipment |
- | (70 |
)
|
(154 |
)
| |||||||
4,203 | (747 |
)
|
(501 |
)
|
Right-of-Use
assets at 31 December 2021 |
No.
of Right-of-Use leased assets |
Range
of remaining term in years |
Average
remaining lease term (years) |
No.
of Leases with extension options |
No.
of Leases with options to purchase |
No.
of leases with variable payments linked to index |
No.
of leases with termination options |
||||||||||||||||||
Building
|
11 |
1
to 12
|
3 | 1 | - | 2 | 4 | ||||||||||||||||||
Vehicle
|
16 |
1
to 3
|
2 | - | 16 | - | 16 | ||||||||||||||||||
I.T.
and office equipment |
2 |
1
to 5
|
4 | - | - | - | - |
13. |
PROPERTY, PLANT AND EQUIPMENT (CONTINUED)
|
Right-of-Use
assets at 31 December 2020 |
No.
of Right-of-Use leased assets |
Range
of remaining term in years |
Average
remaining lease term (years) |
No.
of Leases with extension options |
No.
of Leases with options to purchase |
No.
of leases with variable payments linked to index |
No.
of leases with termination options |
||||||||||||||||||
Building
|
12 |
1
to 13
|
4 | 1 | - | 2 | 4 | ||||||||||||||||||
Vehicle
|
16 |
1
to 3
|
2 | - | 16 | - | 16 | ||||||||||||||||||
I.T.
and office equipment |
10 |
1
to 2
|
1 | - | - | - | 1 |
14. |
GOODWILL AND
INTANGIBLE ASSETS |
|
Goodwill
US$‘000
|
Development
costs
US$‘000
|
Patents
and
licences
US$‘000
|
Other
US$‘000
|
Total
US$‘000
|
|||||||||||||||
Cost
|
||||||||||||||||||||
At
January 1, 2020 |
81,689 | 156,377 | 9,951 | 34,266 | 282,283 | |||||||||||||||
Additions
|
- | 6,896 | 30 | 89 | 7,015 | |||||||||||||||
Disposals
or retirements |
(2,507 |
)
|
(34,318 |
)
|
(1,034 |
)
|
(1,044 |
)
|
(38,903 |
)
| ||||||||||
Exchange
adjustments |
- | 22 | - | - | 22 | |||||||||||||||
At
December 31, 2020 |
79,182 | 128,977 | 8,947 | 33,311 | 250,417 | |||||||||||||||
|
||||||||||||||||||||
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 | |||||||||||||||
|
||||||||||||||||||||
Accumulated
amortisation and Impairment losses |
||||||||||||||||||||
At
January 1, 2020 |
(69,098 |
)
|
(133,599 |
)
|
(9,819 |
)
|
(26,113 |
)
|
(238,629 |
)
| ||||||||||
Charge
for the year |
- | (959 |
)
|
(5 |
)
|
(439 |
)
|
(1,403 |
)
| |||||||||||
Disposals
or retirements |
2,507 | 34,318 | 1,034 | 1,044 | 38,903 | |||||||||||||||
Impairment
losses |
- | (15,287 |
)
|
- | (135 |
)
|
(15,422 |
)
| ||||||||||||
Exchange
adjustments |
- | (6 |
)
|
- | - | (6 |
)
| |||||||||||||
|
||||||||||||||||||||
At
December 31, 2020 |
(66,591 |
)
|
(115,533 |
)
|
(8,790 |
)
|
(25,643 |
)
|
(216,557 |
)
| ||||||||||
|
||||||||||||||||||||
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 |
)
| ||||||||||
|
||||||||||||||||||||
Carrying
amounts |
||||||||||||||||||||
At
December 31, 2021 |
12,537 | 17,679 | 146 | 5,619 | 35,981 | |||||||||||||||
|
||||||||||||||||||||
At
December 31, 2020 |
12,591 | 13,444 | 157 | 7,668 | 33,860 |
130
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
14. |
GOODWILL AND
INTANGIBLE ASSETS (CONTINUED) |
The following represents the costs incurred during each period presented for each of the principal development projects:
Product
Name |
2021
US$’000 |
2020
US$’000 |
||||||
Premier
Instrument for Haemoglobin A1c testing |
2,538
|
1,359
|
||||||
HIV
screening rapid test |
1,488
|
2,278
|
||||||
COVID
tests |
1,320
|
467
|
||||||
Autoimmune
Smart Reader |
550
|
666
|
||||||
Mid-tier
haemoglobins instrument |
303
|
243
|
||||||
Tri-stat
point-of-care instrument |
245
|
203
|
||||||
Uni-gold
raw material stabilisation |
144
|
-
|
||||||
Sjögrens
tests |
88
|
99
|
||||||
Uni-Gold
antigen improvement |
-
|
556
|
||||||
Syphilis
point-of-care test |
-
|
618
|
||||||
Column
enhancement |
-
|
151
|
||||||
Other
projects |
95
|
256
|
||||||
Total
capitalised development costs |
6,771
|
6,896
|
(a) |
The Group
only develops products within its field of expertise. The R&D team is experienced in developing new products in this field and this
experience means that only products which have a high probability of technical success are put forward for consideration as potential
new products. |
(b) |
A technical
feasibility study is undertaken in advance of every project. The feasibility study for each project is reviewed by the R&D team leader,
and by other senior management depending on the size of the project. The feasibility study occurs in the initial research phase of the
project and costs in this phase are not capitalised. |
(c) |
Nearly all
of our new product developments involve the transfer of our existing product know-how to a new application. The Group does not engage
in pure research. Every development project is undertaken with the intention of bringing a particular new product to market for which
there is an expected demand. |
(d) |
The commercial
feasibility of each new product is established prior to commencement of a project by ensuring it is projected to achieve an acceptable
income after applying appropriate discount rates. |
131
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
14. |
GOODWILL AND
INTANGIBLE ASSETS (CONTINUED) |
December
31, 2021 |
December
31, 2020 |
|||||||
US$’000
|
US$’000
|
|||||||
Immco
Diagnostics Inc |
4,979
|
-
|
||||||
Trinity
Biotech Manufacturing Limited |
856
|
-
|
||||||
Trinity
Biotech Do Brasil |
956
|
919
|
||||||
Biopool
US Inc. |
153
|
154
|
||||||
Primus
Corp |
-
|
16,706
|
||||||
Total
impairment loss |
6,944
|
17,779
|
132
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
14. |
GOODWILL AND
INTANGIBLE ASSETS (CONTINUED) |
|
December
31, 2021 |
December
31, 2020 |
||||||
US$’000
|
US$’000
|
|||||||
Goodwill
and other intangible assets (see Note 14) |
3,853 | 15,422 | ||||||
Property,
plant and equipment (see Note 13) |
2,508 | 1,795 | ||||||
Prepayments
(see Note 18) |
583 | 562 | ||||||
Total
impairment loss |
6,944 | 17,779 |
• |
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, 2021. |
• |
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, 2021.
|
133
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
14. |
GOODWILL AND
INTANGIBLE ASSETS (CONTINUED) |
Fitzgerald
Industries |
December
31, 2021 |
December
31, 2020 |
||||||
Carrying
amount of goodwill (US$’000) |
12,591 | 12,591 | ||||||
Discount
rate applied (real pre-tax) |
19.66 |
%
|
19.98 |
%
| ||||
Excess
value-in-use over carrying amount (US$’000) |
3,496 | 7,915 | ||||||
%
EBITDA would need to decrease for an impairment to arise |
18.15 |
%
|
31.98 |
%
| ||||
Long-term
growth rate |
2.0 |
%
|
2.0 |
%
|
Intangible
Assets with Indefinite Useful lives
(included
in other intangibles) |
December
31, 2021
US$‘000
|
December
31, 2020
US$‘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 | 2,938 | ||||||
Total
|
3,964 | 4,833 |
134
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Assets
|
Liabilities
|
Net
|
|||||||||||||||||||||
|
2021
US$’000 |
2020
US$’000 |
2021
US$’000 |
2020
US$’000 |
2021
US$’000 |
2020
US$’000 |
||||||||||||||||||
Property,
plant and equipment |
477 | 733 | (11 |
)
|
(9 |
)
|
466 | 724 | ||||||||||||||||
Intangible
assets |
- | - | (3,969 |
)
|
(4,072 |
)
|
(3,969 |
)
|
(4,072 |
)
| ||||||||||||||
Inventories
|
620 | 750 | - | - | 620 | 750 | ||||||||||||||||||
Provisions
|
1,871 | 2,159 | - | - | 1,871 | 2,159 | ||||||||||||||||||
Tax
value of loss carry-forwards |
1,016 | 433 | - | - | 1,016 | 433 | ||||||||||||||||||
Other
items |
117 | 110 | (878 |
)
|
(824 |
)
|
(761 |
)
|
(714 |
)
| ||||||||||||||
|
||||||||||||||||||||||||
Deferred
tax assets/(liabilities) |
4,101 | 4,185 | (4,858 |
)
|
(4,905 |
)
|
(757 |
)
|
(720 |
)
|
|
Balance
January,
1 2021 |
Recognised in income |
Balance
December
31, 2021 |
|||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Property,
plant and equipment |
724 | (258 |
)
|
466 | ||||||||
Intangible
assets |
(4,072 |
)
|
103 | (3,969 |
)
| |||||||
Inventories
|
750 | (130 |
)
|
620 | ||||||||
Provisions
|
2,159 | (288 |
)
|
1,871 | ||||||||
Tax
value of loss carry-forwards |
433 | 583 | 1,016 | |||||||||
Other
items |
(714 |
)
|
(47 |
)
|
(761 |
)
| ||||||
|
||||||||||||
|
(720 |
)
|
(37 |
)
|
(757 |
)
|
135
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
|
Balance
January,
1 2020 |
Recognised in income |
Balance
December
31, 2020 |
|||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Property,
plant and equipment |
1,018 | (294 |
)
|
724 | ||||||||
Intangible
assets |
(6,099 |
)
|
2,027 | (4,072 |
)
| |||||||
Inventories
|
642 | 108 | 750 | |||||||||
Provisions
|
3,622 | (1,463 |
)
|
2,159 | ||||||||
Tax
value of loss carry-forwards |
216 | 217 | 433 | |||||||||
Other
items |
(286 |
)
|
(428 |
)
|
(714 |
)
| ||||||
|
|
|||||||||||
|
(887 |
)
|
167 | (720 |
)
|
|
December
31, 2021 |
December
31, 2020 |
||||||
|
US$’000
|
US$’000
|
||||||
Capital
losses |
8,293 | 8,293 | ||||||
Net
operating losses |
73,893 | 85,198 | ||||||
US
alternative minimum tax credits |
1,704 | 1,848 | ||||||
Other
temporary timing differences |
21,301 | 21,878 | ||||||
US
state credit carry-forwards |
1,664 | 802 | ||||||
|
||||||||
|
106,855 | 118,019 |
16. |
OTHER NON-CURRENT ASSETS |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
||||||
Finance
lease receivables (see Note 18) |
151 | 291 | ||||||
Other
assets |
56 | 64 | ||||||
|
||||||||
|
207 | 355 |
136
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
17. |
INVENTORIES
|
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
||||||
Raw
materials and consumables |
13,650 | 12,168 | ||||||
Work-in-progress
|
5,546 | 5,169 | ||||||
Finished
goods |
9,927 | 12,882 | ||||||
|
||||||||
|
29,123 | 30,219 |
|
December
31,
2021
US$‘000
|
December
31,
2020
US$‘000
|
December
31,
2019
US$‘000
|
|||||||||
Opening
provision at January 1 |
9,781 | 6,716 | 6,299 | |||||||||
Charged
during the year |
5,589 | 5,179 | 1,567 | |||||||||
Utilised
during the year |
(3,307 |
)
|
(1,994 |
)
|
(1,150 |
)
| ||||||
Released
during the year |
- | (120 |
)
|
- | ||||||||
|
||||||||||||
Closing
provision at December 31 |
12,063 | 9,781 | 6,716 |
After January 27, 2022, the assets of the Group are pledged as security for the term loan from Perceptive Advisors. Refer to Note 30, Post Balance Sheet events.
18. |
TRADE AND OTHER RECEIVABLES
|
|
December
31,
2021
US$‘000
|
December
31,
2020
US$‘000
|
||||||
Trade
receivables, net of impairment losses |
13,290 | 20,025 | ||||||
Prepayments
|
1,945 | 1,159 | ||||||
Contract
assets |
739 | 1,177 | ||||||
Value
added tax |
- | 92 | ||||||
Finance
lease receivables |
142 | 215 | ||||||
|
||||||||
|
16,116 | 22,668 |
137
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
18. |
TRADE AND OTHER RECEIVABLES (CONTINUED)
|
|
December
31, 2021
US$‘000
|
|||||||||||
|
Gross
investment |
Unearned
income |
Minimum
payments receivable |
|||||||||
Less
than one year |
292 | 150 | 142 | |||||||||
Between
one and five years (Note 16) |
310 | 159 | 151 | |||||||||
|
||||||||||||
|
602 | 309 | 293 |
138
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
19. |
CASH AND CASH EQUIVALENTS |
|
December
31, 2021
US$’000
|
December
31, 2020
US$’000
|
||||||
Cash
at bank and in hand |
22,790
|
24,209
|
||||||
Short-term
deposits |
3,120
|
3,118
|
||||||
|
||||||||
Cash
and cash equivalents |
25,910
|
27,327
|
20. |
CAPITAL AND RESERVES |
Share capital |
|
Class
‘A’ Ordinary shares |
Class
‘A’ Ordinary shares |
||||||
In
thousands of shares |
2021
|
2020
|
||||||
In
issue at January 1 |
96,162 | 96,162 | ||||||
Issued
for cash |
- | - | ||||||
|
||||||||
In
issue at December 31 |
96,162 | 96,162 |
|
ADS
|
ADS
|
||||||
In
thousands of ADSs |
2021
|
2020
|
||||||
Balance
at January 1 |
24,041 | 24,041 | ||||||
Issued
for cash |
- | - | ||||||
|
||||||||
Balance
at December 31 |
24,041 | 24,041 |
Class
‘A’ Treasury shares |
Class
‘A’ Treasury shares |
|||||||
In
thousands of shares |
2021
|
2020
|
||||||
Balance
at January 1 |
12,556 | 12,556 | ||||||
Purchased
during the year |
- | - | ||||||
|
||||||||
Balance
at December 31 |
12,556 | 12,556 |
ADS
Treasury
shares |
ADS
Treasury
shares |
|||||||
In
thousands of ADSs |
2021
|
2020
|
||||||
Balance
at January 1 |
3,139 | 3,139 | ||||||
Purchased
during the year |
- | - | ||||||
|
||||||||
Balance
at December 31 |
3,139 | 3,139 |
The Group had authorised share capital of 200,700,000 ‘A’ ordinary shares of US$0.0109 each (2020: 200,700,000 ‘A’ ordinary shares of US$0.0109 each) as at December 31, 2021. The Group did not issue any shares from the exercise of employee options and did not repurchase any ‘A’ ordinary shares under its share buyback program in either 2020 or 2021. No dividends have been paid in the last five years. The last dividend paid was in respect of the 2014 financial year.
Translation reserve
139
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
20. |
CAPITAL AND RESERVES (CONTINUED) |
Hedging reserve
21. |
SHARE OPTIONS
|
|
Options
and warrants |
Weighted-
average exercise price US$
|
Range
US$
|
|||||||||
|
‘A’
Ordinary Shares |
Per
‘A’ Ordinary
Share
|
Per
‘A’ Ordinary Share |
|||||||||
Outstanding
January 1, 2019 |
10,908,200 | 1.83 |
0.67
–4.36
|
|||||||||
Granted
|
4,370,000 | 0.68 |
0.46
–0.78
|
|||||||||
Exercised
|
- | - | - | |||||||||
Expired
/ Forfeited |
(2,974,210 |
)
|
2.25 |
0.66
–4.23
|
||||||||
|
||||||||||||
Outstanding
at end of year |
12,303,990 | 1.31 |
0.46
–4.36
|
|||||||||
|
||||||||||||
Exercisable
at end of year |
6,622,667 | 1.73 |
1.24
–4.36
|
|||||||||
|
||||||||||||
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 |
|
Options
and warrants |
Weighted-
average exercise price US$
|
Range
US$
|
|||||||||
|
‘ADS’
Equivalent |
Per
‘ADS’ |
Per
‘ADS’ |
|||||||||
Outstanding
January 1, 2019 |
2,727,050
|
7.32
|
2.68
- 17.44
|
|||||||||
Granted
|
1,092,500
|
2.72
|
1.83
– 3.10
|
|||||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Expired
/ Forfeited |
(743,552
|
)
|
8.99
|
2.64
– 16.92
|
||||||||
|
||||||||||||
Outstanding
at end of year |
3,075,998
|
5.24
|
1.83–17.45
|
|||||||||
|
||||||||||||
Exercisable
at end of year |
1,655,667
|
6.92
|
4.95
–17.45
|
|||||||||
|
||||||||||||
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
|
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
|
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
|
13,260,006
|
0.48
|
4.14
|
2,106,673
|
0.69
|
1.44
|
|||||||||||||||||||
US$1.00-US$2.05
|
5,664,000
|
1.34
|
1.11
|
5,290,667
|
1.35
|
2.44
|
|||||||||||||||||||
US$2.06-
US$2.99 |
499,984
|
2.52
|
0.05
|
499,984
|
2.52
|
0.13
|
|||||||||||||||||||
US$3.00
-US$4.36 |
62,000
|
4.17
|
0.00
|
62,000
|
4.17
|
0.01
|
|||||||||||||||||||
19,485,990
|
7,959,324
|
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
|
3,315,002
|
1.92
|
4.17
|
526,668
|
2.76
|
1.44
|
|||||||||||||||||||
US$4.00-US$8.20
|
1,416,000
|
5.36
|
1.10
|
1,322,667
|
5.40
|
2.44
|
|||||||||||||||||||
US$8.24-
US$11.96 |
124,996
|
10.08
|
0.05
|
124,996
|
10.08
|
0.13
|
|||||||||||||||||||
US$12.00
-US$17.45 |
15,500
|
16.68
|
0.00
|
15,500
|
16.68
|
0.01
|
|||||||||||||||||||
4,871,498
|
1,989,831
|
143
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
21. |
SHARE OPTIONS (CONTINUED)
|
|
December
31,
2021
US$‘000
|
December
31,
2020
US$‘000
|
December
31,
2019
US$‘000
|
|||||||||
Share-based
payments – cost of sales |
5
|
12
|
26
|
|||||||||
Share-based
payments – selling, general and administrative |
1,095
|
780
|
732
|
|||||||||
|
||||||||||||
Total
– continuing operations |
1,100
|
792
|
758
|
|||||||||
Share-based
payments – discontinued operations |
-
|
-
|
-
|
|||||||||
|
||||||||||||
Total
|
1,100
|
792
|
758
|
Key
management personnel |
Other
employees |
Key
management personnel |
Other
employees |
Key
management personnel |
Other
employees | ||||||||
|
2021
|
2021
|
2020
|
2020
|
2019
|
2019
| |||||||
Weighted
average fair value at measurement date per ‘A’ share / (per ADS) |
-
/
-
|
-
/
-
|
US$0.20
/
(US$0.80)
|
US$0.27
/
(US$1.08)
|
US$0.14
/
(US$0.56)
|
US$0.25
/
(US$1.02)
| |||||||
Total
‘A’ share options granted / (ADS’s equivalent) |
-
/
-
|
-
/
-
|
8,480,000
/
(2,120,000)
|
620,000
/
(155,000)
|
4,060,000
/
(1,015,000)
|
310,000
/
(77,500)
| |||||||
Weighted
average share price per ‘A’ share / (per ADS) |
-
/
-
|
-
/
-
|
US$0.38
/
(US$1.52)
|
US$0.48
/
(US$1.96)
|
US$0.46
/
(US$1.84) |
US$0.64
/
(US$2.53) | |||||||
Weighted
average exercise price per ‘A’ share / (per ADS) |
-
/
-
|
-
/
-
|
US$0.38
/
(US$1.52)
|
US$0.48
/
(US$1.96)
|
US$0.69
/
(US$2.74) |
US$0.64
/
(US$2.53) | |||||||
Weighted
average expected volatility |
-%
|
-%
|
66.98% | 65.89% | 51.18% | 47.31% | |||||||
Weighted
average expected life |
- | - | 4.34 | 4.35 | 4.15 | 4.42 | |||||||
Weighted
average risk free interest rate |
-%
|
-%
|
0.44% | 0.42% | 1.84% | 2.23% |
144
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
21. |
SHARE OPTIONS (CONTINUED)
|
22. |
TRADE AND OTHER PAYABLES |
|
December
31, 2021
US$’000
|
December
31, 2020
US$’000
|
||||||
Trade
payables |
6,763 | 7,103 | ||||||
Payroll
taxes |
398 | 688 | ||||||
Employee
related social insurance |
130 | 344 | ||||||
Accruals
and other liabilities |
7,595 | 8,850 | ||||||
Deferred
income |
141 | 4,445 | ||||||
Deferred
government grants |
69 | - | ||||||
Other
payables |
31 | - | ||||||
Government
COVID-19 loans (Note 4) |
- | 2,905 | ||||||
|
||||||||
|
15,127 | 24,335 |
145
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
23. |
PROVISIONS |
|
December
31, 2021
US$’000
|
December
31, 2020
US$’000
|
||||||
Product
warranty provision |
50 | 50 | ||||||
Other
provisions |
- | 366 | ||||||
50 | 416 |
24. |
EXCHANGEABLE NOTES AND OTHER BORROWINGS
|
|
December
31,
2021 US$’000
|
December
31,
2020 US$’000
|
||||||
Current
liabilities |
||||||||
Exchangeable
senior notes |
83,312 | - | ||||||
|
||||||||
Total
current liabilities |
83,312 | - |
|
December
31,
2021 US$’000
|
December
31,
2020 US$’000
|
||||||
Non-Current
liabilities |
||||||||
Exchangeable
senior notes |
- | 82,664 | ||||||
Other
borrowings |
- | 31 | ||||||
Total
value of embedded derivatives – liability |
- | 1,370 | ||||||
|
||||||||
Total
non-current liabilities |
- | 84,065 |
146
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
24. |
EXCHANGEABLE NOTES AND OTHER BORROWINGS (CONTINUED)
|
|
December
31,
2021 US$’000
|
December
31,
2020 US$’000
|
||||||
Balance
at 1 January |
82,664 | 82,021 | ||||||
Accretion
interest (Note 8) |
648 | 643 | ||||||
|
||||||||
83,312 | 82,664 |
|
December
31,
2021 US$’000
|
December
31,
2020 US$’000
|
||||||
Non-current
assets |
||||||||
Exchangeable
note bond call option |
- | 150 | ||||||
|
||||||||
Non-current
liabilities |
||||||||
Exchangeable
note equity conversion option |
- | 1,370 | ||||||
Exchangeable
note bond put option |
- | - | ||||||
|
||||||||
|
- | 1,370 | ||||||
|
||||||||
Total
value of embedded derivatives – net liability |
- | 1,220 |
147
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
24. |
EXCHANGEABLE NOTES AND OTHER BORROWINGS (CONTINUED)
|
25. |
LEASE LIABILITIES
|
|
December
31, 2021
US$’000
|
December
31, 2020
US$’000
|
||||||
Current
liabilities |
||||||||
Lease
liabilities related to Right of Use assets |
1,878 | 2,054 | ||||||
Sale
and leaseback liabilities |
102 | 99 | ||||||
|
||||||||
|
1,980 | 2,153 | ||||||
|
||||||||
Non-Current
liabilities |
||||||||
Lease
liabilities related to Right of Use assets |
13,790 | 16,407 | ||||||
Sale
and leaseback liabilities |
75 | 181 | ||||||
13,865 | 16,588 |
|
December
31, 2021
US$’000
|
December
31, 2021
US$’000
|
||||||||||||||||||||||
Lease
liabilities related to
Right
of Use assets |
Sale
and leaseback
Liabilities
|
|||||||||||||||||||||||
|
Minimum
lease
payments
|
Interest
|
Principal
|
Minimum
lease
payments
|
Interest
|
Principal
|
||||||||||||||||||
Less
than one year |
2,575 | 697 | 1,878 | 109 | 7 | 102 | ||||||||||||||||||
In
more than one year, but not more than two |
2,175 | 621 | 1,554 | 77 | 2 | 75 | ||||||||||||||||||
In
more than two years but not more than five |
5,985 | 1,469 | 4,516 | - | - | - | ||||||||||||||||||
more
than five years |
8,992 | 1,272 | 7,720 | - | - | - | ||||||||||||||||||
|
||||||||||||||||||||||||
|
19,727 | 4,059 | 15,668 | 186 | 9 | 177 |
|
December
31, 2020
US$’000
|
December
31, 2020
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 |
2,877 | 823 | 2,054 | 111 | 12 | 99 | ||||||||||||||||||
In
more than one year, but not more than two |
2,644 | 730 | 1,914 | 111 | 7 | 104 | ||||||||||||||||||
In
more than two years but not more than five |
6,621 | 1,765 | 4,856 | 79 | 2 | 77 | ||||||||||||||||||
more
than five years |
11,389 | 1,752 | 9,637 | - | - | - | ||||||||||||||||||
|
||||||||||||||||||||||||
|
23,531 | 5,070 | 18,461 | 301 | 21 | 280 |
Lease payments not recognised as a liability
No short term lease expenses were incurred for the year ended December 31, 2021. In 2020 the Group elected not to recognise a lease liability for short term leases (leases with an expected term of 12 months or less) or for leases of low value assets. Payments made under such leases are expensed on a straight-line basis. In addition, certain variable lease payments are not permitted to be recognised as lease liabilities and are expensed as incurred.
149
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
25.
|
LEASE
LIABILITIES (CONTINUED) |
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
interest-bearing loans and borrowings |
|
176 | 176 |
Facility
|
Currency
|
Nominal
interest
rate |
Year
of
maturity
|
Fair
Value
|
Carrying
Value
|
|||||||||||||
Sale
and leaseback liabilities |
Euro
|
4.53 |
%
|
2023 | 106 | 106 | ||||||||||||
Sale
and leaseback liabilities |
USD
|
5.51 |
%
|
2023 | 174 | 174 | ||||||||||||
|
|
|||||||||||||||||
Total
interest-bearing loans and borrowings |
|
280 | 280 |
26. |
COMMITMENTS AND CONTINGENCIES
|
(a) |
Capital
Commitments |
(b) |
Leasing
Commitments |
(d) |
Group
Company Guarantees |
150
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
26. |
COMMITMENTS AND CONTINGENCIES (CONTINUED)
|
(e)
|
Contingent
Asset |
(f) |
Government
Grant Contingencies |
To mitigate the financial impact of the Covid-19 outbreak, the Company has availed of governmental supports. In 2020, the Company received US$4.5 million of Paycheck Protection Program (“PPP”) loans and in 2021, a further US$1.8 million of PPP loans were received. All of the loans received to date under the program have been forgiven by the US government before December 31, 2021 and therefore no liability for these loans exists at December 31, 2021.
(g) |
Other
Contingencies |
27. |
RELATED PARTY TRANSACTIONS |
151
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
27. |
RELATED PARTY TRANSACTIONS (CONTINUED) |
The
Group has entered into an agreement for a 25-year
lease with JRJ for offices that adjacent to its then premises at IDA Business Park, Bray, Co. Wicklow, Ireland. The annual rent of €381,000
(US$432,000)
is payable from January 1, 2004. Upward-only rent reviews are carried out every five years and there have been no increases arising from
these rent reviews.
The
Group has also entered into lease agreements with Ronan O’Caoimh for a 43,860
square foot manufacturing facility in Bray, Ireland and an adjacent warehouse of 16,000
square feet. The annual rent for the manufacturing facility is €787,000
(US$891,000)
and the annual rent for the warehouse is €144,000
(US$163,000).
These two leases expire in and
respectively. At the time, independent valuers advised the Group that the rent in respect of each of the leases represents a fair market
rent. Upward-only rent reviews are carried out every five years and there have been no increases arising from these rent reviews.
|
|
December
31, 2021 |
December
31, 2020 |
||||||
|
US$’000
|
US$’000
|
||||||
Short-term
employee benefits |
1,065 | 1,274 | ||||||
Performance
related bonus |
227 | 584 | ||||||
Post-employment
benefits |
24 | 41 | ||||||
Share-based
compensation benefits |
965 | 626 | ||||||
|
||||||||
|
2,281 | 2,525 |
|
‘A’
Ordinary Shares |
Share
options |
||||||
At
January 1, 2021 |
9,077,706 | 17,394,004 | ||||||
Shares
of retired director |
- | - | ||||||
Options
of retired director |
- | (656,000 |
)
| |||||
Shares
purchased during the year |
- | - | ||||||
Shares
sold during the year |
- | - | ||||||
Granted
|
- | - | ||||||
Expired
/ forfeited |
- | - | ||||||
|
||||||||
At
December 31, 2021 |
9,077,706 | 16,738,004 |
|
‘A’
Ordinary Shares |
Share
options |
||||||
At
January 1, 2020 |
9,077,709 | 10,414,004 | ||||||
Shares
of retired director |
- | - | ||||||
Options
of retired director |
- | - | ||||||
Shares
purchased during the year |
- | - | ||||||
Shares
sold during the year |
- | - | ||||||
Granted
|
- | 8,480,000 | ||||||
Expired
/ forfeited |
- | (1,500,000 |
)
| |||||
|
||||||||
At
December 31, 2020 |
9,077,706 | 17,394,004 |
153
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
28. |
CAPITAL AND FINANCIAL RISK MANAGEMENT
|
|
Level
1 |
Level
2 |
Total
carrying
amount
|
Fair
Value
|
||||||||||||||||
|
Note
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||
December
31, 2021 |
||||||||||||||||||||
Loans
and receivables at amortised cost |
||||||||||||||||||||
Trade
receivables |
18
|
13,290 | - | 13,290 | 13,290 | |||||||||||||||
Cash
and cash equivalents |
19
|
25,910 | - | 25,910 | 25,910 | |||||||||||||||
Finance
lease receivable |
16,
18 |
293 | - | 293 | 293 | |||||||||||||||
|
||||||||||||||||||||
|
39,493 | - | 39,493 | 39,493 | ||||||||||||||||
|
||||||||||||||||||||
Liabilities
at amortised cost |
||||||||||||||||||||
Exchangeable
note¹ |
24
|
- | (83,312 |
)
|
(83,312 |
)
|
(83,312 |
)
| ||||||||||||
Lease
liabilities |
25
|
(15,845 |
)
|
- | (15,845 |
)
|
(15,845 |
)
| ||||||||||||
Trade
and other payables (excluding deferred income) |
22
|
(14,986 |
)
|
- | (14,986 |
)
|
(14,986 |
)
| ||||||||||||
Provisions
|
23
|
(50 |
)
|
- | (50 |
)
|
(50 |
)
| ||||||||||||
|
||||||||||||||||||||
|
(30,881 |
)
|
(83,312 |
)
|
(114,193 |
)
|
(114,193 |
)
| ||||||||||||
|
||||||||||||||||||||
Fair
value through profit and loss (FVPL) |
||||||||||||||||||||
Exchangeable
note bond call option |
24
|
- | - | - | - | |||||||||||||||
Exchangeable
note equity conversion option |
24
|
- | - | - | - | |||||||||||||||
|
||||||||||||||||||||
|
- | - | - | - | ||||||||||||||||
|
||||||||||||||||||||
|
8,612 | (83,312 |
)
|
(74,700 |
)
|
(74,700 |
)
|
¹ The maturity of the Exchangeable Notes is based on the contractual maturity date of April 1, 2045 and does not take into account the potential exercise of put and call options in the next five years or the exchange agreements entered into with five exchangeable note holders in December 2021.
154
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
28. |
CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED)
|
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:
|
Level
1 |
Level
2 |
Total
carrying
amount
|
Fair
Value
|
|||||||||||||||
|
Note
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
||||||||||||||
December
31, 2020 |
|||||||||||||||||||
Loans
and receivables at amortised cost |
|||||||||||||||||||
Trade
receivables |
18
|
20,025 | - | 20,025 | 20,025 | ||||||||||||||
Cash
and cash equivalents |
19
|
27,327 | - | 27,327 | 27,327 | ||||||||||||||
Finance
lease receivable |
16,
18 |
506 | - | 506 | 506 | ||||||||||||||
|
|||||||||||||||||||
|
47,858 | - | 47,858 | 47,858 | |||||||||||||||
|
|||||||||||||||||||
Liabilities
at amortised cost |
|||||||||||||||||||
Exchangeable
note |
24
|
- | (82,664 |
)
|
(82,664 |
)
|
(82,664 |
)
| |||||||||||
Lease
liabilities |
25
|
(18,741 |
)
|
- | (18,741 |
)
|
(18,741 |
)
| |||||||||||
Trade
and other payables (excluding deferred income) |
22
|
(19,890 |
)
|
- | (19,890 |
)
|
(19,890 |
)
| |||||||||||
Provisions
|
23
|
(416 |
)
|
- | (416 |
)
|
(416 |
)
| |||||||||||
|
|||||||||||||||||||
|
(39,047 |
)
|
(82,664 |
)
|
(121,711 |
)
|
(121,711 |
)
| |||||||||||
|
|||||||||||||||||||
Fair
value through profit and loss (FVPL) |
|||||||||||||||||||
Exchangeable
note bond call option |
24
|
- | 150 | 150 | 150 | ||||||||||||||
Exchangeable
note equity conversion option |
24
|
- | (1,370 |
)
|
(1,370 |
)
|
(1,370 |
)
| |||||||||||
|
|||||||||||||||||||
|
-
|
(1,220
|
)
|
(1,220
|
)
|
(1,220
|
)
| ||||||||||||
|
|||||||||||||||||||
|
8,811 | (83,884 |
)
|
(75,073 |
)
|
(75,073 |
)
|
¹ The maturity of the Exchangeable Notes is based on the contractual maturity date of April 1, 2045 and does not take into account the potential exercise of put and call options in the next five years or the exchange agreements entered into with five exchangeable note holders in December 2021.
The valuation techniques used for instruments categorised as level 2 are described below:
155
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
28. |
CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED)
|
As
at December 31, 2021 |
Note
|
Effective
interest
rate |
Total
US$’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$’000
|
|||||||||||||||||||||||
Cash
and cash equivalents |
19
|
0.01 |
%
|
25,910 | 25,910 | - | - | - | - | ||||||||||||||||||||||
Lease
receivable |
16,18
|
4.0 |
%
|
293 | 81 | 61 | 89 | 62 | - | ||||||||||||||||||||||
Exchangeable note¹
|
24
|
4.8 |
%
|
(83,312 |
)
|
- | - | - | - | (83,312 |
)
| ||||||||||||||||||||
Other
borrowings |
22
|
0 |
%
|
(31 |
)
|
- | (31 |
)
|
- | - | - | ||||||||||||||||||||
Lease payable on Right of Use assets |
25
|
5.0 |
%
|
(15,668 |
)
|
(973 |
)
|
(905 |
)
|
(1,554 |
)
|
(4,516 |
)
|
(7,720 | ) | ||||||||||||||||
Lease payable on sale & leaseback transactions |
25
|
5.0 |
%
|
(177 |
)
|
(51 |
)
|
(51 |
)
|
(75 |
)
|
- | - | ||||||||||||||||||
Total
|
(72,985 |
)
|
24,967 | (926 |
)
|
(1,540 |
)
|
(4,454 |
)
|
(91,032 |
)
|
¹ The maturity of the Exchangeable Notes is based on the contractual maturity date of April 1, 2045 and does not take into account the potential exercise of put and call options in the next five years or the exchange agreements entered into with five exchangeable note holders in December 2021.
As
at December 31, 2020 |
Note
|
Effective
interest
rate |
Total
US$’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$’000
|
|||||||||||||||||||||||
Cash
and cash equivalents |
19
|
0.1 |
%
|
27,327 | 27,327 | - | - | - | - | ||||||||||||||||||||||
Lease
receivable |
16,18
|
4.0 |
%
|
506 | 120 | 95 | 142 | 149 | - | ||||||||||||||||||||||
Licence
payments |
23
|
8.1 |
%
|
(194 |
)
|
(194 |
)
|
- | - | - | - | ||||||||||||||||||||
Exchangeable
note |
24
|
4.8 |
%
|
(82,664 |
)
|
- | - | - | - | (82,664 |
)
| ||||||||||||||||||||
Other
borrowings |
22
|
0 |
%
|
(31 |
)
|
- | - | (31 |
)
|
- | - | ||||||||||||||||||||
Lease payable on Right of Use assets |
25
|
5.0 |
%
|
(18,461 |
)
|
(1,022 |
)
|
(1,032 |
)
|
(1,914 |
)
|
(4,856 |
)
|
(9,637 |
)
| ||||||||||||||||
Lease payable on sale & leaseback transactions |
25
|
5.0 |
%
|
(280 |
)
|
(49 |
)
|
(50 |
)
|
(104 |
)
|
(77 |
)
|
- | |||||||||||||||||
Total
|
(73,797 |
)
|
26,182 | (987 |
)
|
(1,907 |
)
|
(4,784 |
)
|
(92,301 |
)
|
¹ The maturity of the Exchangeable Notes is based on the contractual maturity date of April 1, 2045 and does not take into account the potential exercise of put and call options in the next five years or the exchange agreements entered into with five exchangeable note holders in December 2021.
156
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
28.
|
CAPITAL AND FINANCIAL
RISK MANAGEMENT (CONTINUED) |
|
December
31, 2021
US$‘000
|
December
31, 2020
US$‘000
|
||||||
Fixed
rate instruments |
||||||||
Fixed
rate financial liabilities (licence fees) |
- | (194 |
)
| |||||
Fixed
rate financial liabilities (exchangeable note) |
(83,312 |
)
|
(82,664 |
)
| ||||
Fixed
rate financial liabilities (borrowings) |
(31 |
)
|
(31 |
)
| ||||
Fixed
rate financial liabilities (lease payables) |
(15,844 |
)
|
(18,741 |
)
| ||||
Financial
assets (short-term deposits and short-term investments) |
3,121 | 3,118 | ||||||
Financial
assets (lease receivables) |
293 | 506 | ||||||
|
||||||||
|
(95,773
|
)
|
(98,006
|
)
|
As
at December 31, 2021
US$’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$’000
|
|||||||||||||||||||||
Financial
liabilities |
||||||||||||||||||||||||||||
Trade
& other payables |
15,127 | 15,127 | 15,127 | - | - | - | - | |||||||||||||||||||||
Lease
payable on Right of Use assets |
15,668 | 15,668 | 973 | 905 | 1,554 | 4,516 | 7,720 | |||||||||||||||||||||
Lease
payable on sale & leaseback transactions |
177 | 177 | 51 | 51 | 75 | - | - | |||||||||||||||||||||
Other
borrowings |
31 | 31 | - | 31 | - | - | - | |||||||||||||||||||||
Exchangeable
notes ¹ |
83,312 | 99,900 | - | - | - | - | 99,900 | |||||||||||||||||||||
Exchangeable
note interest |
999 | 93,906 | 1,998 | 1,998 | 3,996 | 11,988 | 73,926 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
115,314
|
224,809
|
18,149
|
2,985
|
5,625
|
16,504
|
181,546
|
157
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
28. |
CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED)
|
As
at December 31, 2020
US$’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$’000
|
|||||||||||||||||||||
Financial
liabilities |
||||||||||||||||||||||||||||
Trade
& other payables |
24,335 | 24,335 | 24,335 | - | - | - | - | |||||||||||||||||||||
Lease
payable on Right of Use assets |
18,461 | 18,461 | 1,022 | 1,032 | 1,914 | 4,856 | 9,637 | |||||||||||||||||||||
Lease
payable on sale & leaseback transactions |
280 | 280 | 49 | 50 | 104 | 77 | - | |||||||||||||||||||||
Other
borrowings |
31 | 31 | - | - | 31 | - | - | |||||||||||||||||||||
Exchangeable
notes ¹ |
82,664 | 99,900 | - | - | - | - | 99,900 | |||||||||||||||||||||
Exchangeable
note interest |
999 | 97,902 | 1,998 | 1,998 | 3,996 | 11,988 | 77,922 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
126,770 | 240,909 | 27,404 | 3,080 | 6,045 | 16,921 | 187,459 |
EUR
|
GBP
|
SEK
|
CAD
|
BRL
|
Other
|
|||||||||||||||||||
As
at December 31, 2021 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||||||||
Cash
|
327 | 115 | 5 | 4,617 | 1,370 | - | ||||||||||||||||||
Trade
and other receivable |
464 | 58 | - | 488 | 1,538 | - | ||||||||||||||||||
Trade
and other payables |
(2,456 |
)
|
(28 |
)
|
(11 |
)
|
(166 |
)
|
(629 |
)
|
- | |||||||||||||
|
||||||||||||||||||||||||
Total
exposure |
(1,665 |
)
|
145 | (6 |
)
|
4,939 | 2,279 | - |
EUR
|
GBP
|
SEK
|
CAD
|
BRL
|
Other
|
|||||||||||||||||||
As
at December 31, 2020 |
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||||||||
Cash
|
1,229 | 152 | 9 | 2,859 | 776 | - | ||||||||||||||||||
Trade
and other receivable |
1,105 | 63 | - | 3,191 | 1,357 | - | ||||||||||||||||||
Trade
and other payables |
(2,821 |
)
|
(57 |
)
|
(1 |
)
|
(449 |
)
|
(529 |
)
|
- | |||||||||||||
|
||||||||||||||||||||||||
Total
exposure |
(487 |
)
|
158 | 8 | 5,601 | 1,604 | - |
158
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
28. |
CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED)
|
Profit
or Loss
US$000
|
||||
December
31, 2021 |
||||
Euro
|
(953
|
)
| ||
December
31, 2020 |
||||
Euro
|
(661
|
)
|
159
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
28. |
CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED)
|
|
Carrying
Value December 31, 2021 US$’000 |
Carrying
Value December 31, 2020 US$’000 |
||||||
Third
party trade receivables (Note 18) |
13,290 | 20,025 | ||||||
Finance
lease income receivable (Note 18) |
293 | 506 | ||||||
Cash
and cash equivalents (Note 19) |
25,910 | 27,327 | ||||||
|
||||||||
|
39,493
|
47,858
|
|
Carrying
Value December 31, 2021 US$’000 |
Carrying
Value December 31, 2020 US$’000 |
||||||
United
States |
5,822 | 10,730 | ||||||
Euro-zone
countries |
1,072 | 1,360 | ||||||
United
Kingdom |
118 | 98 | ||||||
Other
European countries |
- | 13 | ||||||
Other
regions |
6,571 | 8,330 | ||||||
|
||||||||
|
13,583
|
20,531
|
|
Carrying
Value December 31, 2021 US$’000 |
Carrying
Value December 31, 2020 US$’000 |
||||||
End-user
customers |
6,923 | 11,812 | ||||||
Distributors
|
6,220 | 8,186 | ||||||
Non-governmental
organisations |
440 | 533 | ||||||
|
||||||||
|
13,583
|
20,531
|
160
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
28. |
CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED)
|
|
Gross
|
Impairment
|
Expected
Credit Loss Rate |
Gross
|
Impairment
|
Expected
Credit Loss Rate |
||||||||||||||||||
|
2021
|
2021
|
2021
|
2020
|
2020
|
2020
|
||||||||||||||||||
|
US$’000
|
US$’000
|
%
|
US$’000
|
US$’000
|
%
|
||||||||||||||||||
Not
past due |
8,461 | - | - |
%
|
16,754 | 112 | 0.7 |
%
| ||||||||||||||||
Past
due 0-30 days |
2,423 | 1 | 0.1 |
%
|
1,829 | 222 | 12.1 |
%
| ||||||||||||||||
Past
due 31-120 days |
1,981 | 97 | 4.9 |
%
|
1,755 | 60 | 3.4 |
%
| ||||||||||||||||
Greater
than 120 days |
3,011 | 2,888 | 73.0 |
%
|
3,609 | 3,528 | 97.8 |
%
| ||||||||||||||||
|
||||||||||||||||||||||||
|
15,876 | 2,986 | - | 23,947 | 3,922 | - |
|
2021
|
2020
|
2019
|
|||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Balance
at January 1 |
3,922 | 5,443 | 4,202 | |||||||||
Charged
to costs and expenses |
76 | 166 | 1,276 | |||||||||
Amounts
written off during the year |
(1,012 |
)
|
(1,687 |
)
|
(35 |
)
| ||||||
|
||||||||||||
Balance
at December 31 |
2,986 | 3,922 | 5,443 |
161
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
29.
|
RECONCILIATION
OF LIABILITIES ARISING FROM FINANCING ACTIVITIES |
|
Note
|
Borrowings
& derivative financial instruments US$’000 |
Lease
liabilities US$’000 |
||||||||
Balance
at January 1, 2021 |
22,24,25 |
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 |
8
|
(1,370 |
)
|
- | |||||||
|
|||||||||||
Balance at December
31, 2021 |
22,
24,25 |
83,343 | 15,845 |
162
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
29.
|
RECONCILIATION
OF LIABILITIES ARISING FROM FINANCING ACTIVITIES (CONTINUED) |
|
Note
|
Borrowings
& derivative financial instruments US$’000 |
Lease
liabilities US$’000 |
||||||||
Balance
at 1 January 2020 |
22,24,25 |
82,025 | 20,149 | ||||||||
Cash-flows:
|
|||||||||||
Interest
paid |
(3,996 |
)
|
- |
| |||||||
Proceeds
from government Covid-19 loan (Note 24) |
31 | - | |||||||||
Repayment
|
- | (3,240 |
)
| ||||||||
Non-cash:
|
|||||||||||
Interest
charged |
3,996 | - | |||||||||
Additions
(related to Right of Use assets) |
- | 224 | |||||||||
Disposals¹
|
- | (216 | ) | ||||||||
Exchange
adjustment |
- | 928 |
| ||||||||
Accretion
interest |
8
|
643 | 896 | ||||||||
Fair
value |
1,366 |
|
- | ||||||||
|
|||||||||||
Balance at 31 December
2020 |
22,
24,25 |
84,065 | 18,741 |
¹ Disposal of Lease liabilities relates to the early termination of a lease for a right-of-use building asset in Carlsbad, California. This facility was closed in June 2020.
30. |
POST BALANCE SHEET EVENTS
|
• |
the Group paid a total
amount of US$86,730,000
to retire Exchangeable Notes with a carrying value of US$83,312,000 at December 31, 2021. Each holder that was party to the agreement
received US$0.87
of cash per $1
nominal value of the Notes, and |
• |
the Company also issued
5,333,000
ADSs (21,332,000
‘A’ Ordinary shares) representing the equivalent of $0.08
of the Company’s ADS (based upon the 5-day trailing VWAP of the ADSs on NASDAQ on December 9, 2021, discounted by 13%) per $1
nominal value of the Notes, as partial consideration for the exchange of the notes. |
163
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
30. |
POST BALANCE SHEET EVENTS (CONTINUED)
|
164
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
31. |
ACCOUNTING ESTIMATES AND
JUDGEMENTS (CONTINUED) |
At December 31, 2021 the carrying value of capitalised development costs was US$17,679,000 (2020: US$13,444,000) (see Item 18, Note 14 to the consolidated financial statements). The increase in 2021 was mainly as a result of additions of US$6,771,000. In 2021, an impairment charge of US$2,053,000 was incurred. This charge was partially offset by additions of US$6,771,000 and amortisation of US$482,000.
• |
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. |
165
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
31. |
ACCOUNTING ESTIMATES AND
JUDGEMENTS (CONTINUED) |
The impairment testing performed during year ended December 31, 2021 identified an impairment loss in four CGUs, namely Trinity Biotech Manufacturing Limited, Biopool US Inc, Immco Diagnostics, and Trinity Biotech Do Brazil. For further information, refer to Note 14.
166
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
31. |
ACCOUNTING ESTIMATES AND JUDGEMENTS
(CONTINUED) |
• |
Determining whether or
not a contract contains a lease. Company assessed if the contract conveys the right to control the use of an identified asset for a period
of time in exchange for consideration. |
• |
Significant judgement
is also required in establishing whether or not it is reasonably certain that an extension option will be exercised, considering whether
or not it is reasonably certain that a termination option will not be exercised. In making this decision, management considered the facts
and circumstances that create a significant economic incentive. Factors specific to the asset, the entity and the wider market were also
considered. |
• |
Further,
critical judgement is involved in determining whether or not variable lease payments are truly variable, or in-substance fixed. In-substance
variable lease payments are treated as fixed lease payments. |
167
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
32. |
GROUP UNDERTAKINGS |
Name
and registered office |
Principal
activity |
Principal
Country of incorporation and operation |
Group
% holding | |||
Trinity
Biotech Manufacturing Limited
IDA Business Park, Bray
Co. Wicklow, Ireland
|
Manufacture
and sale of diagnostic test kits |
Ireland
|
100%
| |||
Trinity
Research Limited
IDA Business Park, Bray
Co. Wicklow, Ireland
|
Research
and development |
Ireland
|
100%
| |||
Benen
Trading Limited
IDA Business Park, Bray
Co. Wicklow, Ireland
|
Trading
|
Ireland
|
100%
| |||
Trinity
Biotech Manufacturing Services Limited
IDA Business Park, Bray
Co. 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
|
Manufacture
and sale of diagnostic test kits |
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%
|
168
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
32. |
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 activties |
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%
|
TRINITY
BIOTECH PLC | ||
By |
/s/
Ronan O’Caoimh | |
|
Mr
Ronan O’Caoimh | |
|
Director/ | |
|
Chief
Executive Officer | |
|
Date: May
2, 2022 | |
By: |
/s/
John Gillard | |
|
Mr
John Gillard | |
|
Company
secretary/ | |
|
Chief
Financial Officer | |
|
Date: May
2, 2022 |
Item 19 |
Exhibits |
Exhibit No. |
Description
of Exhibit |
• |
which would have an effect of delaying, deferring or preventing a change in control of the Company and which would operate only with respect to a merger, acquisition or corporate restructuring involving the Company (or any of its
subsidiaries); or
|
• |
governing the ownership threshold above which a shareholder ownership must be disclosed; or
|
• |
imposing conditions governing changes in the capital which are more stringent than is required by Irish law.
|
/s/ Ronan O’Caoimh*
|
|
Ronan O’Caoimh
|
|
Chief Executive Officer
|
* |
The originally executed copy of this Certification will be maintained at the Company’s offices and will be made available for inspection upon request.
|
/s/ John Gillard*
|
|
John Gillard
|
|
Chief Financial Officer
|
* |
The originally executed copy of this Certification will be maintained at the Company’s offices and will be made available for inspection upon request.
|
/s/ Ronan O’Caoimh*
|
|
Ronan O’Caoimh
|
|
Chief Executive Officer
|
* |
The originally executed copy of this Certification will be maintained at the Company’s offices and will be made available for inspection upon request.
|
/s/ John Gillard*
|
|
John Gillard
|
|
Chief Financial Officer
|
* |
The originally executed copy of this Certification will be maintained at the Company’s offices and will be made available for inspection upon request.
|
Form Type
|
File Number
|
Effective Date
|
Form S-8
|
333-182279
|
6/22/2012
|
Form S-8
|
333-195232
|
4/11/2014
|
Form S-8
|
333-253070
|
2/12/2021
|
/s/ GRANT THORNTON
|
Dublin, Ireland
|
May 2, 2022
|