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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
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☒ |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐ |
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Title of each class
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Name of each exchange on which registered
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American Depositary Shares (each representing 4 ‘A’ Ordinary
Shares, par value US$0.0109)
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NASDAQ Global Market
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U.S. GAAP ☐
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International Financial Reporting Standards as issued
by the International Accounting Standards Board ☒
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Other ☐
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Page
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1
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1
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PART I
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1
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1
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1
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27
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43
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43
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67
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72
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74
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74
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76
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87
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89
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PART II
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90
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90
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90
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92
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92
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92
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93
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93
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93
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93
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93
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PART III
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94
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94
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176
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Year ended December 31,
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|||||||||||||||||||
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2018
US$‘000
|
|
2017
US$‘000
|
|
2016
US$‘000
|
|
2015
US$‘000 |
|
2014
US$‘000 |
||||||||||
Revenues
|
97,035
|
99,140
|
99,611
|
100,195
|
104,872
|
|||||||||||||||
Cost of sales
|
(55,586
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)
|
(57,250
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)
|
(56,127
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)
|
(53,683
|
)
|
(55,496
|
)
|
||||||||||
|
||||||||||||||||||||
Gross profit
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41,449
|
41,890
|
43,484
|
46,512
|
49,376
|
|||||||||||||||
Other operating income
|
102
|
100
|
239
|
288
|
424
|
|||||||||||||||
Research and development expenses
|
(5,369
|
)
|
(5,657
|
)
|
(5,040
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)
|
(5,069
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)
|
(4,291
|
)
|
||||||||||
Selling, general and administrative expenses
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(29,477
|
)
|
(32,246
|
)
|
(30,366
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)
|
(28,225
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)
|
(30,071
|
)
|
||||||||||
Selling, general and administrative expenses - impairment charges and inventory write-off/provision
|
(26,932
|
)
|
(41,755
|
)
|
(48,165
|
)
|
—
|
—
|
||||||||||||
|
||||||||||||||||||||
Operating (loss)/profit
|
(20,227
|
)
|
(37,668
|
)
|
(39,848
|
)
|
13,506
|
15,438
|
||||||||||||
Financial income
|
2,124
|
3,198
|
3,147
|
13,491
|
97
|
|||||||||||||||
Financial expenses
|
(5,080
|
)
|
(5,405
|
)
|
(5,439
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)
|
(4,054
|
)
|
(132
|
)
|
||||||||||
|
||||||||||||||||||||
Net financing (expense)/income
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(2,956
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)
|
(2,207
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)
|
(2,292
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)
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9,437
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(35
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)
|
|||||||||||
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||||||||||||||||||||
(Loss)/Profit before tax
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(23,183
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)
|
(39,875
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)
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(42,140
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)
|
22,943
|
15,403
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||||||||||||
Income tax credit/(expense)
|
525
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1,214
|
3,557
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(756
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)
|
(479
|
)
|
|||||||||||||
|
||||||||||||||||||||
(Loss)/Profit for the year
|
(22,658
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)
|
(38,661
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)
|
(38,583
|
)
|
22,187
|
14,924
|
||||||||||||
|
||||||||||||||||||||
(Loss)/Profit for the year on discontinued operations
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568
|
(1,609
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)
|
(62,042
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)
|
(391
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)
|
2,290
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||||||||||||
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||||||||||||||||||||
(Loss)/Profit for the year (all attributable to owners of the parent)
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(22,090
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)
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(40,270
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)
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(100,625
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)
|
21,796
|
17,214
|
||||||||||||
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||||||||||||||||||||
Basic (loss)/earnings per ADS (US Dollars)
|
(1.06
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)
|
(1.86
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)
|
(4.38
|
)
|
0.94
|
0.76
|
||||||||||||
Diluted (loss)/earnings per ADS (US Dollars)
|
(1.06
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)
|
(1.86
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)
|
(4.38
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)
|
0.46
|
0.73
|
||||||||||||
Basic (loss)/earnings per ‘A’ ordinary share
(US Dollars) |
(0.26
|
)
|
(0.47
|
)
|
(1.10
|
)
|
0.24
|
0.19
|
||||||||||||
Diluted (loss)/earnings per ‘A’ ordinary share
(US Dollars) |
(0.26
|
)
|
(0.47
|
)
|
(1.10
|
)
|
0.12
|
0.18
|
||||||||||||
Weighted average number of shares used in computing basic EPS per ADS
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20,903,227
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21,621,602
|
22,964,703
|
23,161,773
|
22,749,726
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|||||||||||||||
Weighted average number of shares used in computing diluted EPS per ADS
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25,877,205
|
26,877,544
|
28,299,399
|
27,407,793
|
23,717,747
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|||||||||||||||
Weighted average number of shares used in computing basic EPS per ‘A’ ordinary share
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83,612,908
|
86,486,409
|
91,858,813
|
92,647,091
|
90,998,904
|
|||||||||||||||
Weighted average number of shares used in computing diluted EPS per ‘A’ ordinary share
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103,508,820
|
107,510,179
|
113,197,598
|
109,631,172
|
94,870,988
|
|
December 31,
2018 US$’000
|
December 31,
2017 US$’000
|
December 31,
2016 US$’000
|
December 31,
2015 US$’000
|
December 31,
2014 US$’000
|
|||||||||||||||
Net current assets (current assets less current liabilities)
|
69,057
|
91,362
|
108,208
|
143,085
|
46,888
|
|||||||||||||||
Non-current liabilities
|
(90,001
|
)
|
(106,549
|
)
|
(115,585
|
)
|
(129,646
|
)
|
(23,809
|
)
|
||||||||||
Total assets
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151,659
|
192,974
|
249,592
|
363,683
|
242,838
|
|||||||||||||||
Capital stock
|
1,213
|
1,213
|
1,213
|
1,209
|
1,192
|
|||||||||||||||
Shareholders’ equity
|
44,054
|
65,196
|
108,727
|
213,892
|
196,972
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• |
Our long-term viability and growth will depend upon the successful discovery, development and commercialization of other products from our research and development (“R&D”) activities. In order to remain competitive, we are committed to significant expenditures on R&D and the commercialization of new or enhanced products. The R&D process generally takes a significant amount of time from product inception to commercial launch. However, there is no certainty that this investment in research and development will yield technically feasible or commercially viable products. We may have to abandon a new or enhanced product or a product during its development phase in which we have invested substantial time and money. During the fiscal years ended December 31, 2018, 2017 and 2016, we incurred US$9.9 million, US$10.4 million and US$17.4 million, respectively, in capitalised R&D expenses. We expect to continue to incur significant costs related to our research and development activities.
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Successful products require significant development and investment, including testing to demonstrate their performance capabilities, cost-effectiveness or other benefits prior to commercialization. In addition, unless exempt, regulatory clearance or approval must be obtained before our medical device products may be sold. Additional development efforts on these products may be required before we are ready to submit applications for marketing authorisation to any regulatory authority. Regulatory authorities may not clear or approve these products for commercial sale or may substantially delay or condition clearance or approval. In addition, even if a product is successfully developed and all applicable regulatory clearances or approvals are obtained, there may be little or no market for the product. Accordingly, if we fail to develop and gain commercial acceptance for our products, or if we have to abandon a new product during its development phase, or if competitors develop more effective products or a greater number of successful new products, customers may decide to use products developed by our competitors. This would result in a loss of revenues and adversely affect our results of operations, cash flow and business.
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Our future growth in the United States is dependent in part on Food and Drug Administration (“FDA”) clearance of products. If FDA clearance is delayed or not achieved for these products, it could have a material impact on the future growth of our business. Similarly, future growth outside of USA is dependent on clearance of products by the relevant regulatory authorities in those countries.
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We have invested in research and development but there can be no guarantees that our R&D programmes will not be rendered technologically obsolete or financially non-viable by the technological advances of our competitors, which would also adversely affect our existing product lines and inventory. The main competitors of Trinity Biotech (and their principal products with which Trinity Biotech competes) include: Abbott Diagnostics (AxSYM™, IMx™, i-STAT®, Determine™, Wampole™, Athena™, Biosite Triag®), Arkray (HA-8180), Bio-Rad (Bio-Plex™, Variant II, Turbo and D10™), Diasorin Inc. (Liasion™, ETIMAX™), The Carlyle Group – Ortho Clinical Diagnostics (Vitros™), OraSure Technologies, Inc. (OraQuick®), Roche Diagnostics (COBAS AMPLICOR™, Ampliscreen™, Accutrend™, Tina Quant™), Siemens – Beckman Coulter (Uni-Cel), Siemens – Dade-Behring (BEP 2000, Enzygnost®), Siemens – Bayer (Centaur™), Siemens – DPC (Immulite™), Thermo Fisher (Konelab™) and Tosoh (G8™).
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The diagnostics industry is focused on the testing of biological specimens in a laboratory or at the point-of-care and is highly competitive and rapidly changing. As new products enter the market, our products may become obsolete or a competitor’s products may be more effective or more effectively marketed and sold than ours. If we fail to maintain and enhance our competitive position, our customers may decide to use products developed by competitors which could result in a loss of revenues.
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We may in certain instances also face competition from products that are sold at a lower price. Where this occurs, customers may choose to buy lower cost products from third parties or we may be forced to sell our products at a lower price, both of which could result in a loss of revenues or a lower gross margin contribution from the sale of our products. We may also be required to increase our marketing efforts in order to compete effectively, which would increase our costs.
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Our tests compete with products made by our competitors. Multiple competitors are making investments in competing technologies and products, and a number of our competitors may have a competitive advantage because of their greater financial, technical, research and other resources. Some competitors offer broader product lines and may have greater market presence or name recognition than we have. If we receive FDA clearance, and in order to achieve market acceptance, we and/or our distributors will likely be required to undertake substantial marketing efforts and spend significant funds to inform potential customers and the public of the existence and perceived benefits of our products. Our marketing efforts for these products may not be successful. As such, there can be no assurance that these products will obtain significant market acceptance and fill the market needs that are perceived to exist on a timely basis, or at all.
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• |
Our medical device products and operations are subject to rigorous government regulation in the United States by the FDA, and numerous other federal, state and foreign governmental authorities, as well as and by comparable regulatory authorities in other jurisdictions such as the Health Products Regulatory Authority (“HPRA”) in Ireland. In particular, we are subject to strict governmental controls on the development, manufacture, labelling, storage, testing, advertising, promotion, marketing, distribution and import and export of our products. In addition, we or our distributors are often required to register with and/or obtain clearances or approvals from foreign governments or regulatory bodies before we can import and sell our products in foreign countries. The clearance and approval process for our products, while variable across countries, is generally lengthy, time consuming, detailed and expensive.
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• |
The process of obtaining regulatory clearances or approvals to market a medical device can be costly and time consuming, and we may not be able to obtain these clearances or approvals on a timely basis, if at all. In particular, the FDA permits commercial distribution of a new medical device only after the device has received clearance under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), or is the subject of an approved premarket approval application (“PMA”) unless the device is specifically exempt from those requirements. The FDA will clear marketing of a lower risk medical device through the 510(k) process if the manufacturer demonstrates that the new product is substantially equivalent to other 510(k)-cleared products. High risk devices deemed to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices, or devices not deemed substantially equivalent to a previously cleared device, require the approval of a PMA.
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• |
In the United States, the majority of our currently commercialized products have received pre-market clearance under Section 510(k) of the FDCA. If the FDA requires us to go through a lengthier, more rigorous examination for future products or modifications to existing products than we had expected, our product introductions or modifications could be delayed or cancelled, which could cause our sales to decline. In addition, the FDA may determine that future products will require the more costly, lengthy and uncertain PMA process. Although we currently market only one device pursuant to an approved PMA, the FDA may demand that we obtain a PMA prior to marketing certain of our future products.
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• |
The FDA can delay, limit or deny clearance or approval of a device for many reasons, including:
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• |
our ability to demonstrate to the FDA’s satisfaction that our products are safe and effective for their intended users;
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• |
insufficient data from our pre-clinical studies and clinical trials to support clearance or approval, where required; and
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• |
the failure of the manufacturing process or facilities we use to meet applicable requirements.
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• |
In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval or clearance of our products under development or impact our ability to modify our currently cleared products on a timely basis. For example, in response to industry and healthcare provider concerns regarding the predictability, consistency and rigor of the 510(k) regulatory pathway, the FDA initiated an evaluation of the program, and in January 2011, announced several proposed actions intended to reform the review process governing the clearance of medical devices. FDA’s review of its 510(k) clearance process could result in additional changes to regulatory requirements or guidance documents which could increase the costs of compliance, or restrict our ability to maintain current clearances. In addition, as part of the Food and Drug Administration Safety and Innovation Act (“FDASIA”), Congress reauthorised the Medical Device User Fee Amendments with various FDA performance goal commitments and enacted several “Medical Device Regulatory Improvements” and miscellaneous reforms which are further intended to clarify and improve medical device regulation both pre- and post-clearance and approval.
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• |
Our continued success is dependent on our ability to develop and market new products, some of which are currently awaiting clearance or approval from the applicable regulatory authorities. There is no certainty that such clearance or approval will be granted or, even once granted, will not be revoked during the continuing review and monitoring process. Further, regulatory authorities, including the FDA, may not approve or clear our future products for the indications that are necessary or desirable for successful commercialization. A regulatory authority may impose requirements as a condition to granting a marketing authorisation, may include significant restrictions or limitations as part of a marketing authorisation it grants and may delay or refuse to authorise a product for marketing, even though a product has been authorised for marketing without restrictions or limitations in another country or by another agency. Failure to receive clearance or approval for our new products, or commercially undesirable limitations on our clearances or approvals, would have an adverse effect on our ability to expand our business.
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• |
Initiating and completing clinical trials necessary to support approval of future products under development, is time consuming and expensive and the outcome uncertain. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product we advance into clinical trials may not have favorable results in later clinical trials.
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• |
Conducting successful clinical studies will require the enrollment of patients who may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population, the nature of the trial protocol, and the availability of appropriate clinical trial investigators. Patients may not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products.
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• |
Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy are required and we may not adequately develop such protocols to support clearance and approval. Further, the FDA may require us to submit data on a greater number of patients than we originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis applicable to our clinical trials. Any challenges to patient enrollment may cause an increase in costs and delays in the approval and attempted commercialization of our products or result in the failure of the clinical trial. In addition, despite considerable time and expense invested in our clinical trials, FDA may not consider our data adequate to demonstrate safety and efficacy. Such increased costs and delays or failures could adversely affect our business, operating results and prospects.
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• |
Our facilities and our clinical investigational sites operate under procedures that govern the conduct and management of FDA-regulated clinical studies under 21 CFR Parts 50, 56 and 812, and Good Clinical Practices. Although the majority of our in-vitro diagnostic (“IVD”) clinical studies meet the definition of exempted investigations under 21 Part 812 and are exempt from the Investigational Device Exemption (“IDE”) regulations in 21 CFR Part 812, we are still required to meet the requirements of 21 CFR Parts 50 and 56 for informed consent and Institutional Review Board (“IRB”) approval. FDA may conduct Bioresearch Monitoring (“BiMo”) inspections of us and/or our clinical sites to assess compliance with FDA regulations, our procedures, and the clinical protocol. If the FDA were to find that we or our clinical investigators are not operating in compliance with applicable regulations, we could be subject to the above FDA enforcement action as well as refusal to accept all or part of our data in support of a 510(k) or PMA and/or we may need to conduct additional studies.
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• |
We may not have the ability to independently conduct our pre-clinical studies and clinical trials for our products and we may rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our pre-clinical or clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our products on a timely basis, if at all, and our business, operating results and prospects may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.
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• |
Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product candidate claims or that the FDA or foreign authorities will agree with our conclusions regarding them. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product candidate and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues.
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• |
Even after we obtain clearance or approval for our medical devices, we are still subject to ongoing and extensive post market regulatory requirements. Regulation by the FDA and other federal, state and foreign regulatory agencies, such as the HPRA in E.U., impacts many aspects of our operations, and the operations of our suppliers and distributors, including manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, marketing, record keeping, import and export. For example, the manufacture of medical devices must comply with the FDA’s Quality System Regulation (“QSR”), which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products. Our manufacturing facilities and those of our suppliers and distributors are, or can be, subject to periodic regulatory inspections by the FDA to assess compliance with the QSR and other regulations, and by other comparable foreign regulatory authorities with respect to similar requirements in other jurisdictions. The FDA and foreign regulatory agencies may require post-marketing testing and surveillance to monitor the performance of approved products or place conditions on any product clearances or approvals that could restrict the commercial applications of those products. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, any of the following enforcement actions:
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• |
untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
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• |
unanticipated expenditures to address or defend such actions;
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• |
customer notifications for repair, replacement, refunds;
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• |
recall, detention or seizure of our products;
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• |
operating restrictions or partial suspension or total shutdown of production;
|
• |
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;
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• |
refusal to grant export approval for our products; or
|
• |
criminal prosecution.
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• |
Even if regulatory clearance or approval of a product is granted, such clearance or approval may be subject to limitations on the intended uses for which the product may be marketed and reduce our potential to successfully commercialize the product and generate revenue from the product. If the FDA determines that our promotional materials, labeling, training or other marketing or educational activities constitute promotion of an unapproved use, it could request that we cease or modify our training or promotional materials or subject us to regulatory enforcement actions. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our training or other promotional materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.
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• |
In addition, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products. Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.
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• |
In the ordinary course of business, we must frequently make subjective judgments with respect to compliance with applicable laws and regulations. If regulators subsequently disagree with the manner in which we have sought to comply with these regulations, we could be subjected to substantial civil and criminal penalties, as well as product recall, seizure or injunction with respect to the sale of our products. The assessment of any civil and criminal penalties against us could severely impair our reputation within the industry and any limitation on our ability to manufacture and market our products could have a material adverse effect on our business.
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• |
In addition to the FDA and other regulations described above, laws and regulations in some countries may restrict our ability to sell products in those countries. While we intend to comply with any applicable restrictions, there is no guarantee we will be successful in these efforts.
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• |
We must also comply with numerous laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, disposal of hazardous substances and labour or employment practices. Compliance with these laws or any new or changed laws regulating our business could result in substantial costs. Because of the number and extent of the laws and regulations affecting our industry, and the number of governmental agencies whose actions could affect our operations, it is impossible to reliably predict the full nature and impact of these requirements. To the extent the costs and procedures associated with complying with these laws and requirements are substantial or it is determined that we do not comply, our business and results of operations could be adversely affected.
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• |
Manufacturers may, on their own initiative, initiate actions, including a non-reportable market withdrawal or a reportable product recall, for the purpose of correcting a material deficiency, improving device performance, or for other reasons. Additionally, the FDA and similar foreign health or governmental authorities have the authority to require an involuntary recall of commercialized products in the event of material deficiencies or defects in design, manufacturing or labeling or in the event that a product poses an unacceptable risk to health. In the case of the FDA, the authority to require a recall must be based on an FDA finding that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of component failures, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial condition and results of operations. The FDA requires that certain classifications of recalls be reported to FDA within 10 working days after the recall is initiated.
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• |
Companies are required to maintain certain records of post-market actions, even if they determine such actions are not reportable to the FDA. If we determine that certain actions do not require notification of the FDA, the FDA may disagree with our determinations and require us to report those actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect our sales. In addition, the FDA could take enforcement action for failing to report the recalls when they were conducted or failing to timely report or initiate a reportable product action. Further, depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new approvals or clearances before we may market or distribute the corrected device. Seeking such approvals or clearances may delay our ability to replace the recalled devices in a timely manner.
|
• |
We are also required to comply with the FDA’s Medical Device Reporting (“MDR”), requirements in the United States and comparable regulations worldwide, such as the HPRA. For example, under the FDA’s MDR regulations, we are required to report to the FDA any incident in which our product may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. In addition, all manufacturers placing medical devices in European Union markets are legally bound to report any serious or potentially serious incidents involving devices they produce or sell to the Competent Authority in whose jurisdiction the incident occurred.
|
• |
We have reported MDRs in the past, and we anticipate that in the future it is likely that we may experience events that would require reporting to the FDA pursuant to the MDR regulations. Any adverse event involving our products could result in future voluntary corrective actions, or agency actions, such as inspection, mandatory recall or other enforcement action.
|
• |
Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.
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Any modification to a 510(k)-cleared device in the United States that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design or manufacture, requires a new 510(k) clearance or, possibly, approval of a PMA. The FDA requires every manufacturer to make this determination in the first instance, but the FDA may review any manufacturer’s decision. The FDA may not agree with our decisions regarding whether new clearances or approvals are necessary.
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For example, we obtained 510(k) clearance for our Primus Variant System for the separation and quantification of normal and abnormal haemoglobin species as an aid in the diagnosis of haemoglobinopathies. The sample type used by this system was blood tubes. We subsequently introduced two systems based on the original Primus Variant System and they were named as ultra² GeneSys Variant System and ultra² Resolution Variant System. The primary focus of the GeneSys was on newborn screening using Dried Blood Spots as the sample type, while the Resolution was intended for confirmatory testing on the adult population using blood tubes as the sample type. We determined that these modifications to the indications for use were within our existing clearance and did not require the submission of a new 510(k) notification. The FDA stated that the use of Dried Blood Spots was not part of the original submission and represented a new modified Intended Use. The FDA informed us that it disagreed with our decision not to seek new 510(k) clearances for these modifications, and we filed new 510(k) notifications to obtain clearance for these indications. The FDA rejected our filing on the basis that the predicate devise chosen did not meet their requirements. Additionally the FDA asked us to withdraw our product from the market. This has been done in order to stay compliant. A new filing is underway using the predicate device indicated by the FDA. The new application is expected to be filed in the second quarter of 2019.
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Furthermore, the FDA’s ongoing review of the 510(k) program may make it more difficult for us to make modifications to any products for which we obtain clearance, either by imposing more strict requirements on when a manufacturer must submit a new 510(k) notification for a modification to a previously cleared product, or by applying more onerous review criteria to such submissions. For example, in accordance with FDASIA, the FDA was obligated to prepare a report for Congress on the FDA’s approach for determining when a new 510(k) clearance will be required for modifications or changes to a previously cleared device. The FDA issued this report and indicated that manufacturers should continue to adhere to the FDA’s 1997 Guidance on this topic when making a determination as to whether or not a new 510(k) clearance is required for a change or modification to a device. However, the practical impact of the FDA’s continuing scrutiny of the 510(k) program remains unclear.
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Our promotional materials must comply with FDA and other applicable laws and regulations. We believe that the specific uses for which our products are marketed fall within the scope of the indications for use that have been cleared or approved by the FDA. However, the FDA could disagree and require us to stop promoting our products for those specific uses until we obtain FDA clearance or approval for them. In addition, if the FDA determines that our promotional materials constitutes promotion of an unapproved use, it could request that we modify our promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine and criminal penalties.
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Although the FDA has statutory authority to assure that medical devices are safe and effective for their intended uses, the FDA has generally exercised its enforcement discretion and not enforced applicable regulations with respect to laboratory developed tests (“LDTs”), although reagents, instruments, software or components provided by third parties and used to perform LDTs may be subject to FDA regulation.
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We cannot provide any assurance that FDA regulation, including premarket review, will not be required in the future for any of our LDTs, whether through additional guidance or regulations issued by the FDA, new enforcement policies adopted by the FDA or new legislation enacted by Congress. It is possible that legislation will be enacted into law, regulations could be promulgated or guidance could be issued by the FDA which may result in increased regulatory burdens for us to continue to offer our current LDTs or to develop and introduce new LDTs. We cannot predict the timing or content of future legislation enacted, regulations promulgated or guidance issued regarding LDTs, or how it will affect our business.
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If FDA premarket review, including clearance or approval, is required for our current or future LDTs (either alone or together with sample collection devices), products or services we may develop, or we decide to voluntarily pursue FDA clearance or approval, we may be forced to stop selling our LDTs while we work to obtain such FDA clearance or approval. Our business would be negatively affected until such review was completed and clearance to market or approval was obtained. The regulatory process may involve, among other things, successfully completing additional clinical studies and submitting premarket notification or filing a premarket approval application with the FDA. If premarket review is required by the FDA or if we decide to voluntarily pursue FDA premarket review of our LDTs, there can be no assurance that any tests, products or services we may develop in the future will be cleared or approved on a timely basis, if at all, nor can there be assurance that labeling claims will be consistent with our current claims or adequate to support continued adoption of for our LDTs. If our LDTs are allowed to remain on the market but there is uncertainty in the marketplace about our tests, if we are required by the FDA to label them investigational and we cannot offer the LDTs for diagnostic purposes, or if labeling claims the FDA allows us to make are limited, orders may decline.
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Ongoing compliance with FDA regulations would increase the cost of conducting our business, and subject us to heightened regulation by the FDA and penalties for failure to comply with these requirements.
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If we fail to comply with federal and state health care laws, including fraud and abuse, false claims, physician payment transparency and privacy and security laws, we could face substantial penalties and our business, operations and financial condition could be adversely affected. We are subject to anti-kickback laws, self-referral laws, false claims laws, and laws constraining the sales, marketing and other promotional activities of manufacturers of medical devices by limiting the kinds of financial arrangements we may enter into with physicians, hospitals, laboratories and other potential purchasers of our products. The laws that may affect our ability to operate include, but are not limited to:
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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and wilfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;
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the Physician Self-Referral Law, also known as the “Stark Law”, which provides for strict liability for referrals by physicians to entities with which they or their immediate family members have a financial arrangement for certain designated health services, including clinical laboratory services provided by our CLIA-certified laboratory owned and operated by our subsidiary Immco Diagnostics Inc., that are reimbursable by federal healthcare programs, unless an exception applies. Penalties for violating the Stark Law include denial of payment, civil monetary penalties of up to fifteen thousand dollars per claim submitted, and exclusion from federal health care programs, as well as a penalty of up to one-hundred thousand dollars for attempts to circumvent the law;
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federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal third-party payors 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;
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the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;
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federal criminal laws that prohibit executing a scheme to defraud any federal healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;
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the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;
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the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare & Medicaid Services (“CMS”), information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other “transfers of value” to such physician owners. Manufacturers are required to submit reports to CMS by the 90th day of each calendar year. We cannot assure you that we have and will successfully report all transfers of value by us, and any failure to comply could result in significant fines and penalties. Failure to submit the required information may result in civil monetary penalties up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for “knowing failures”) for all payments, transfers of value or ownership or investment interests not reported in an annual submission, and may result in liability under other federal laws or regulations;
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federal and state laws governing the certification and licensing of clinical laboratories, including operational, personnel and quality requirements designed to ensure that testing services are accurate and timely, and federal and state laws governing the health and safety of clinical laboratory employees;
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the U.S. Foreign Corrupt Practices Act, or the FCPA, which prohibits corporations and individuals from paying, offering to pay or authorising the payment of anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity; the UK Bribery Act, which prohibits both domestic and international bribery, as well as bribery across both public and private sectors; and bribery provisions contained in the German Criminal Code, which makes the corruption and corruptibility of physicians in private practice and other healthcare professionals a criminal offense; and
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analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any payor, including commercial insurers; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
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Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbours available under such laws, it is possible that some of our business activities, including our relationships with physicians and other healthcare providers, some of whom may recommend, purchase and/or order our tests, our sales and marketing efforts and certain arrangements with customers, including those where we provide our instrumentation for free in exchange for minimum purchase requirements of our reagents, and our billing and claims processing practices, could be subject to challenge under one or more of such laws. By way of example, some of our consulting arrangements with physicians do not meet all of the criteria of the personal services safe harbour under the federal Anti-Kickback Statute. Accordingly, they do not qualify for safe harbour protection from government prosecution. A business arrangement that does not substantially comply with a safe harbour, however, is not necessarily illegal under the Anti-Kickback Statute, but may be subject to additional scrutiny by the government. We are also exposed to the risk that our employees, independent contractors, principal investigators, consultants, vendors and distributors may engage in fraudulent or other illegal activity. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.
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To enforce compliance with the federal laws, the U.S. Department of Justice (“DOJ”), has recently increased its scrutiny of interactions between health care companies and health care providers, which has led to a number of investigations, prosecutions, convictions and settlements in the health care industry. Dealing with investigations can be time and resource consuming and can divert management’s attention from the business. In addition, settlements with the DOJ or other law enforcement agencies have forced healthcare providers to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.
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Many of the existing requirements are new and have not been definitively interpreted by state authorities or courts, and available guidance is limited. In addition, changes in or evolving interpretations of these laws, regulations, or administrative or judicial interpretations, may require us to change our business practices or subject our business practices to legal challenges, which could have a material adverse effect on our business, financial condition and results of operations.
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We have not yet developed a comprehensive compliance program that establishes internal controls to facilitate adherence to the rules and program requirements to which we are or may become subject. Although the development and implementation of such compliance programs can mitigate the risk of investigation, prosecution, and penalties assessed for violations of these laws, or any other laws that may apply to us, the risks cannot be entirely eliminated.
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The diagnostics industry is in transition with a number of changes that affect the market for diagnostic test products. The diagnostics industry has experienced considerable consolidation through mergers and acquisitions in the past several years. For example, major consolidation among reference laboratories and the formation of multi-hospital alliances, reducing the number of institutional customers for diagnostic test products. There can be no assurance that we will be able to enter into and/or sustain contractual or other marketing or distribution arrangements on a satisfactory commercial basis with these institutional customers.
Further, this consolidation trend may result in the remaining companies having greater financial resources and technological capabilities, thereby intensifying competition in the industry, which could have a material adverse effect on our business.
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Our debt may:
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limit our ability to borrow additional funds for working capital, capital expenditures, acquisitions or other general business purposes;
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limit our ability to use our cash flow or obtain additional financing for working capital, capital expenditures, acquisitions or other general business purposes;
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require us to use a substantial portion of our cash flow from operations to make debt service payments;
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limit our flexibility to plan for, or react to, changes in our business and industry;
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result in dilution to our existing shareholders in the event exchanges of the exchangeable notes are settled in our ordinary shares;
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place us at a competitive disadvantage compared to our less leveraged competitors; and
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increase our vulnerability to the impact of adverse economic and industry conditions.
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Trinity Biotech has historically grown organically and through the acquisition of, and investment in, other companies, product lines and technologies. We may enter into strategic acquisitions or investments as a way to expand our business. These activities, and their impact on our business, are subject to many risks, including the following:
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Suitable acquisitions or investments may not be found or consummated on terms or schedules that are satisfactory to us or consistent with our objectives;
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The benefits expected to be derived from an acquisition may not materialize and could be affected by numerous factors, such as regulatory developments, insurance reimbursement, general economic conditions and increased competition;
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We may be unable to successfully integrate an acquired company’s personnel, assets, management systems, products and/or technology into our business;
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Worse than expected performance of an acquired business may result in the impairment of intangible assets;
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Acquisitions may require substantial expense and management time and could disrupt our business;
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We may not be able to accurately forecast the performance or ultimate impact of an acquired business;
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An acquisition and subsequent integration activities may require greater capital and other resources than originally anticipated at the time of acquisition;
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An acquisition may result in the incurrence of unexpected expenses, the dilution of our earnings or our existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an indemnification from the seller(s) of the acquired business;
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An acquisition may result in the loss of our or the acquired company’s key personnel, customers, distributors or suppliers;
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An acquisition of a foreign business may involve additional risks, including, but not limited to, foreign currency exposure, liability or restrictions under foreign laws or regulations, and our inability to successfully assimilate differences in foreign business practices or overcome language or cultural barriers; and
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Our ability to integrate future acquisitions may be adversely affected by inexperience in dealing with new technologies.
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Trinity Biotech currently distributes its product portfolio through distributors in approximately 100 countries worldwide. Our continuing economic success and financial security is dependent on our ability to secure effective channels of distribution on favourable trading terms with suitable distributors.
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The loss or termination of our relationship with these key distributors could significantly disrupt our business unless suitable alternatives were timely found or lost sales to one distributor are absorbed by another distributor.
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We sell our products into the public health market, which consists of state, county and other governmental public health agencies, community based organizations, service organizations and similar entities. Many of these customers depend to a significant degree on grants or funding provided by governments or governmental agencies to run their operations, including programs that use our products, such as our HIV testing products. In international markets, we often sell our products to parties funded by such agencies. The level of available government grants or funding is unpredictable, and certain organizations may not have their contracts renewed for funding. Available funding may be affected by various factors including future economic conditions, legislative and regulatory developments, political changes, civil unrest and changing priorities for research and development activities. Any reduction or delay in government funding or change in organizational contracts could cause our customers to delay, reduce or forego purchases of our products or cause short term or long term fluctuations in our product revenues through these channels.
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Trinity Biotech may be subject to claims for personal injuries or other damages if any of our products, or any product which is made with the use or incorporation of any of our technologies, causes injury of any type or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or usage. There is no assurance that we would be successful in defending any product liability lawsuits brought against us. Regardless of merit or eventual outcome, product liability claims could result in:
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Decreased demand for our products;
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Lost revenues;
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Damage to our image or reputation;
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Costs related to litigation;
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Diversion of management time and attention; and
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Incurrence of damages payable to plaintiffs.
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Trinity Biotech has global product liability insurance in place for its manufacturing subsidiaries up to a maximum of €6,500,000 (US$7,440,000) for any one accident, limited to a maximum of €6,500,000 (US$7,440,000) in any one year period of insurance. A deductible of €5,000 ($5,700) for each claim and every claim increasing to US$25,000 in respect of USA/Canada is applicable to each insurance event that may arise. There can be no assurance that our product liability insurance is sufficient to protect us against liability that could have a material adverse effect on our business. In addition, although we believe that we will be able to continue to obtain adequate coverage in the future, there is no assurance that we will be able to do so at acceptable costs.
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Products manufactured at our facilities in Bray, Ireland, Jamestown and Buffalo, New York, Kansas City, Missouri and Carlsbad, California comprised approximately 81% of revenues during the fiscal year ended December 31, 2018. Our global supply of these products and services is dependent on the uninterrupted and efficient operation of these facilities. In addition, we currently rely on a small number of third-party manufacturers to produce certain of our diagnostic products and product components.
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If we do not negotiate long-term contracts, our suppliers will likely not be required to provide us with any guaranteed minimum production levels. As a result, we cannot assure you that we will be able to obtain sufficient quantities of product in the future.
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contract manufacturers or suppliers may fail to comply with regulatory requirements or make errors in manufacturing that could negatively affect the efficacy or safety of our products or cause delays in shipments of our products;
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we or our contract manufacturers and suppliers may not be able to respond to unanticipated changes in customer orders, and if orders do not match forecasts, we or our suppliers may have excess or inadequate inventory of materials and components;
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we or our contract manufacturers and suppliers may be subject to price fluctuations due to a lack of long-term supply arrangements for key components;
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we or our contract manufacturers and suppliers may lose access to critical services and components, resulting in an interruption in the manufacture, assembly and shipment of our systems;
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we may experience delays in delivery by our contract manufacturers and suppliers due to changes in demand from us or their other customers;
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fluctuations in demand for products that our contract manufacturers and suppliers manufacture for others may affect their ability or willingness to deliver components to us in a timely manner;
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our suppliers or those of our contract manufacturer may wish to discontinue supplying components or services to us for risk management reasons;
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we may not be able to find new or alternative components or reconfigure our system and manufacturing processes in a timely manner if the necessary components become unavailable; and
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our contract manufacturers and suppliers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements.
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The operations of our facilities or these third-party manufacturing facilities could be adversely affected by fire, power failures, natural or other disasters, such as earthquakes, floods, or terrorist threats. Although we carry insurance to protect against certain business interruptions at our facilities, some pieces of manufacturing equipment are difficult to replace and could require substantial replacement lead-time. There can be no assurance that such coverage will be adequate or that such coverage will continue to remain available on acceptable terms, if at all.
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If any of these risks materialize, it could significantly increase our costs and impact our ability to meet demand for our products. If we are unable to satisfy commercial demand for our products in a timely manner, our ability to generate revenue would be impaired, market acceptance of our products could be adversely affected, and customers may instead purchase or use our competitors’ products. In addition, we could be forced to secure new or alternative contract manufacturers or suppliers. Securing a replacement contract manufacturer or supplier could be difficult. The introduction of new or alternative manufacturers or suppliers also may require design changes to our products that are subject to FDA and other regulatory clearances or approvals.
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Trinity Biotech’s success is dependent to a large extent upon the contributions of certain key management personnel. Our key employees at December 31, 2018 were Ronan O’Caoimh, our CEO and Chairman, Jim Walsh, Executive Director, and Kevin Tansley, our CFO/Executive Director. We may not be able to attract or retain a sufficient number of qualified employees in the future due to the intense competition for qualified personnel among medical products and other life science businesses.
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If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that will adversely affect our ability to effectively manufacture, sell and market our products, to meet the demands of our strategic partners in a timely fashion, or to support research, development and clinical programs. Although we believe we will be successful in attracting and retaining qualified personnel, competition for experienced scientists and other personnel from numerous companies and academic and other research institutions may limit our ability to do so on acceptable terms.
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The primary raw materials required for Trinity Biotech’s test kits consist of antibodies, antigens or other reagents, glass fibre and packaging materials which are acquired from third parties. If our third-party suppliers are unable or unwilling to supply or manufacture a required component or product or if they make changes to a component, product or manufacturing process or do not supply materials meeting our specifications, we may need to find another source and/or manufacturer. This could require that we perform additional development work.
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Some of our products, which we acquire from third parties, are highly technical and are required to meet exacting specifications, and any quality control problems that we experience with respect to the products supplied by third-party vendors could adversely and materially affect our reputation, our attempts to complete our clinical trials or commercialization of our products and adversely and materially affect our business, operating results and prospects. We may also need to obtain FDA or other regulatory authorisations for the use of an alternative component or for certain changes to our products or manufacturing process. We may also have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or foreign regulatory authorities and the failure of our suppliers to comply with strictly enforced regulatory requirements could expose us to regulatory action including, warning letters, product recalls, termination of distribution, product seizures, or civil penalties. Completing that development and obtaining such authorisations could require significant time and expense and we may not obtain such authorisations on a timely basis, or at all. The availability of critical components and products from other third parties could also reduce our control over pricing, quality and timely delivery. These events could either disrupt our ability to manufacture and sell certain of our products into one or more markets or completely prevent us from doing so, and could increase our costs. Any such event could have a material adverse effect on our results of operations, cash flow and business. Furthermore, since some of these suppliers are located outside of the United States, we are subject to foreign export laws and United States import and customs regulations, which complicate and could delay shipments of components to us.
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Although Trinity Biotech does not expect to be dependent upon any one source for these critical components or raw materials, alternative sources of antibodies with the characteristics and quality desired by Trinity Biotech may not be available. Such unavailability could affect the quality of our products and our ability to meet orders for specific products.
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We currently generate significant operating cash flows, which combined with access to the credit markets provides us with discretionary funding capacity for research and development and other strategic activities. Uncertainty in global economic conditions may continue for the foreseeable future and intensify. This uncertainty poses a risk to the overall economy that could impact demand for our products, as well as our ability to manage normal commercial relationships with our customers, suppliers and creditors, including financial institutions. Volatile economic conditions have adversely affected and could continue to adversely affect our financial performance and condition or those of our customers and suppliers. These circumstances could adversely affect our access to liquidity needed to conduct or expand our business or conduct future acquisitions or make other discretionary investments. Many of our customers rely on public funding provided by federal, state and local governments, and this funding has been and may continue to be reduced or deferred as a result of economic conditions.
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If global economic conditions deteriorate significantly, our business could be negatively impacted, including such areas as reduced demand for our products from a slow-down in the general economy, supplier or customer disruptions resulting from tighter credit markets and/or temporary interruptions in our ability to conduct day-to-day transactions through our financial intermediaries involving the payment to or collection of funds from our customers, vendors and suppliers. These circumstances may adversely impact our customers and suppliers, which, in turn, could adversely affect their ability to purchase our products or supply us with necessary equipment, raw materials or components. Even with the improvement of economic conditions, it may take time for our customers and suppliers to establish new budgets and return to normal purchasing and shipping patterns. We cannot predict the reoccurrence of any economic slowdown or the strength or sustainability of the economic recovery.
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Our international sales and operations are subject to various United States and foreign laws and regulations relating to export controls (including, without limitation, the U.S. Commerce Department’s Export Administration Regulations), economic sanctions (including, without limitation, various sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control), and anti-corruption (including, without limitation, the United States Foreign Corrupt Practice Act). Failure to comply with such applicable laws and regulations could subject us to civil or criminal penalties, government investigations, debarment from export privileges, and reputational harm, which could have a material adverse effect on our business.
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The United Kingdom (“U.K.”) held a referendum in June 2016 which resulted in a majority voting in favor of the U.K. withdrawing from the E.U. (commonly referred to as “Brexit”). The U.K. will continue to be a member of the E.U. until the expiration of a two-year notice period, following the U.K.’s formal notification to the European Council under Article 50 of the Treaty on European Union (which occurred on March 29, 2017), or until such other date as is agreed by all 28 member states of the E.U., unless prior to any such date the U.K. elects to revoke its formal Article 50 notification to the European Council. While the U.K. government and the European Commission have agreed to the terms of a withdrawal agreement, on January 16, 2019, the U.K. Parliament voted against the withdrawal agreement in its current form. There is currently no certainty that the withdrawal agreement will be ratified by, in particular, the U.K. Parliament or the European Parliament or the European Council. Consequently, the terms on which, and the date on which, the U.K. will withdraw from the E.U. (if at all) remain difficult to predict. In addition, it is expected that, if and when the U.K. withdraws from the E.U., the U.K. and the E.U. will hold further negotiations seeking to establish the terms of the long-term trading relationship between the U.K. and the E.U.
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The referendum and the political negotiation surrounding the terms of the U.K.’s withdrawal from the E.U. have created significant uncertainty about the future relationship between the U.K. and the E.U., including with respect to the laws and regulations that will apply. This is because if the U.K. withdraws from the E.U. (and subject to the terms of any withdrawal agreement), the U.K. will determine which E.U.-derived laws to replace or replicate in the event of a withdrawal. The referendum has also given rise to calls for the governments of other E.U. member states to consider withdrawal, while the U.K.’s withdrawal negotiation process has increased the risk of governmental change in the U.K. as well as the possibility of a further referendum concerning Scotland’s independence from the rest of the U.K.
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If the U.K. does not hold European Parliament elections in May 2019, it will leave the E.U. on June 1, 2019. This exit date appears to be unlikely as the elections are planned to take place. If no withdrawal agreement is reached by October 31, 2019, the U.K.’s membership of the E.U. could terminate under a so-called “hard Brexit.” Under this scenario, there could be increased costs from the imposition of tariffs on trade or non-tariff barriers between the U.K. and E.U., shipping delays because of the need for customs inspections and temporary shortages of certain goods. Any of the foregoing might cause our U.K. suppliers to pass along these increased costs, if realized, to us in the U.K. In addition, trade and investment between the U.K., the E.U. and other countries would be impacted by the fact that the U.K. currently operates under tax and trade treaties concluded between the E.U. and other countries. Following a “hard Brexit”, the U.K. would need to negotiate its own tax and trade treaties with other countries, as well as with the E.U.
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These developments, or the perception that any of them could occur, have had and may continue to have a material adverse effect on global, regional and/or national economic conditions and the stability of global financial markets, and may significantly reduce global market liquidity and restrict the ability of key market participants to operate in certain financial markets. Any of these factors could depress economic activity, result in changes to currency exchange rates, tariffs, treaties, taxes, import/export regulations, laws and other regulatory matters, and/or restrict our access to capital and the free movement of our employees, which could have a material adverse effect on our financial position, operating results or cash flows. Approximately 0.8% of our total revenues were generated in the U.K. for the year ended December 31, 2018.
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A substantial portion of our operations is based in Ireland and Europe is one of our main sales territories. As a result, changes in the exchange rate between the U.S. Dollar and the Euro can have significant effects on our results of operations. In addition, in markets where we invoice in U.S. Dollars but where the local currency has weakened, we have been required to reduce our pricing in order to preserve our competiveness. The Group has an exposure to the Canadian Dollar through its two Canadian entities (Nova Century Scientific and Phoenix Biotech) and to the Brazilian Real through its Brazilian entity. The Group also has revenues and costs denominated in British Sterling. The discontinued operation in Sweden, Fiomi Diagnostics, also gives us a Swedish Krona exposure.
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In the future, we may enter into hedging instruments to manage our currency exchange rate risk. However, our attempts to hedge against these risks may not be successful. If we are unable to successfully hedge against unfavourable foreign currency exchange rate movements, our consolidated financial results may be adversely impacted.
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The total share options exercisable at December 31, 2018, as described in Item 18, Note 20 to the consolidated financial statements, are convertible into American Depository Shares (ADSs), 1 ADS representing 4 “A” Ordinary Shares. The exercise of the share options exercisable will likely occur only when the conversion price is below the trading price of our ADSs and will dilute the ownership interests of existing shareholders. For instance, should the options of the 6,091,864 “A” Ordinary Shares (1,522,966 ADSs) exercisable at December 31, 2018 be exercised, Trinity Biotech would have to issue 6,091,864 additional “A” Ordinary Shares (1,522,966 ADSs). On the basis of 96,162,410 “A” Ordinary Shares outstanding at December 31, 2018, this would effectively dilute the ownership interest of the existing shareholders by approximately 6%.
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• |
At present, no treaty exists between the United States and Ireland for the reciprocal enforcement of foreign judgments. The laws of Ireland do however, as a general rule, provide that the judgments of the courts of the United States have in Ireland the same validity as if rendered by Irish Courts. Certain important requirements must be satisfied before the Irish Courts will recognise the United States judgment. The originating court must have been a court of competent jurisdiction, the judgment may not be recognised if it is based on public policy, was obtained by fraud or its recognition would be contrary to Irish public policy. Any judgment obtained in contravention of the rules of natural justice will not be enforced in Ireland.
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• |
The materials and processes used to manufacture our products must meet detailed specifications, performance standards and quality requirements to ensure our products will perform in accordance with their label claims, our customers’ expectations and applicable regulatory requirements.
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• |
As a result, our products and the materials used in their manufacture or assembly undergo regular inspections and quality testing. Factors such as defective materials or processes, mechanical failures, human errors, environmental conditions, changes in materials or production methods by our vendors, and other events or conditions could cause our products or the materials used to produce or assemble our products to fail inspections and quality testing or otherwise not perform in accordance with our label claims or the expectations of our customers.
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• |
Any failure or delay in our ability to meet the applicable specifications, performance standards, quality requirements or customer expectations could adversely affect our ability to manufacture and sell our products or comply with regulatory requirements. These events could, in turn, adversely affect our revenues and results of operations.
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• |
Many laws and regulations impose obligations on public companies, which have increased the scope, complexity and cost of corporate governance, reporting and disclosure practices. Our implementation of certain aspects of these laws and regulations has required and will continue to require substantial management time and oversight and may require us to incur significant additional accounting and legal costs. We continually evaluate and monitor developments with respect to new and proposed rules and cannot predict or estimate the ultimate amount of additional costs we may incur or the timing of such costs. These laws and regulations are also subject to varying interpretations, in many cases due to their lack of specificity, and as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. Although we are committed to maintaining high standards of corporate governance and public disclosure, if we fail to comply with any of these requirements, legal proceedings may be initiated against us, which may adversely affect our business.
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• |
As a result of any number of risk factors identified herein, no assurance can be given that we will be successful in implementing our financial and strategic objectives. In addition, the funds for research, clinical development and other projects have in the past come primarily from our business operations. If our business slows and we have less money available to fund research and development and clinical programs, we will have to decide at that time which programs to cut, and by how much. Similarly, if adequate financial, personnel, equipment or other resources are not available, we may be required to delay or scale back our business. Our operations will be adversely affected if our total revenue and gross profits do not correspondingly increase or if our technology, product, clinical and market development efforts are unsuccessful or delayed.
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• |
Furthermore, our failure to successfully introduce new or enhanced products and develop new markets could have a material adverse effect on our business and prospects.
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• |
Our future liquidity and ability to meet our future capital requirements will depend on numerous factors, including, but not limited to, the following:
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• |
The costs and timing of expansion of sales and marketing activities;
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• |
The timing and success of the commercial launch of new products;
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• |
The extent to which we gain or expand market acceptance for existing, new or enhanced products;
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• |
The costs and timing of the expansion of our manufacturing capacity;
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• |
The success of our research and product development efforts;
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• |
The time, cost and degree of success of conducting clinical trials and obtaining regulatory approvals;
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• |
The magnitude of capital expenditures;
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• |
Changes in existing and potential relationships with distributors and other business partners;
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• |
The costs involved in obtaining and enforcing patents, proprietary rights and necessary licenses;
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• |
The costs and liability associated with patent infringement or other types of litigation;
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• |
Competing technological and market developments; and
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• |
The scope and timing of strategic acquisitions.
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• |
If additional financing is needed, we may seek to raise funds through the sale of equity or other securities or through bank borrowings. There can be no assurance that financing through the sale of securities, bank borrowings or otherwise will be available to us on satisfactory terms, or at all.
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• |
As directed by the Sarbanes-Oxley Act of 2002, we are required to include a report in our Annual Reports on Form 20-F that contains an assessment by management of the effectiveness of our internal control over financial reporting. In addition, our independent registered public accounting firm must report on the effectiveness of these internal controls.
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• |
We expect that our internal controls will continue to evolve as our business activities change. Although we seek to diligently and vigorously review our internal control over financial reporting in an effort to ensure compliance with the Section 404 requirements, any control system, regardless of how well designed, operated and evaluated, can provide only reasonable, not absolute, assurance that its objectives will be met. In addition, the overall quality of our internal controls may be affected by the internal control over financial reporting implemented by any business we acquire and our ability to assess and successfully integrate the internal controls of any such business.
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• |
If, during any year, our independent registered public accounting firm is not satisfied with our internal control over financial reporting or the level at which our controls are documented, designed, operated, tested or assessed, then it may issue a report that is adverse. We also could conclude that our internal control over financial reporting is not effective. These events could result in an adverse reaction in the financial marketplace due to a loss of investor confidence in the reliability of our financial statements and effectiveness of our internal controls, which ultimately could negatively impact the market price of our common stock.
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We regularly review our long-lived assets, including identifiable intangible assets and goodwill, for impairment. Goodwill and acquired indefinite life intangible assets are subject to impairment review on an annual basis and whenever potential impairment indicators are present. Other long-lived assets are reviewed when there is an indication that an impairment may have occurred. The amount of goodwill and identifiable intangible assets on our consolidated balance sheet is US$53 million (2017: US$65 million). In 2018, we recorded total impairment charges of US$27 million (2017: US$42 million). We may record further significant impairment charges in the future if there are changes in market conditions, a significant reduction in share price or other changes in the future outlook. In addition, we may from time to time sell assets that we determine are not critical to our strategy or execution. Future events or decisions may lead to asset impairments and/or related charges. Certain non-cash impairments may result from a change in our strategic goals, business direction or other factors relating to the overall business environment. Any significant impairment charges could have a material adverse effect on our results of operations.
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To the extent that we or our strategic partners fail to maintain a high quality level of service and support for diagnostic products, there is a risk that the perceived quality of our products will be diminished in the marketplace. Likewise, we may fail to provide the level, quantity or quality of service expected by the marketplace. This could result in slower adoption rates and lower than anticipated utilisation of our products which could have a material adverse effect on our business, financial condition and results of operations.
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The health care industry has undergone significant consolidation resulting in increased purchasing leverage for customers and consequently increased pricing pressures on our business. Additionally, some of our customers have become affiliated with group purchasing organisations. Group purchasing organisations typically offer members price discounts on laboratory supplies and equipment if they purchase a bundled group of one supplier’s products, which results in a reduction in the number of manufacturers selected to supply products to the group purchasing organization and increases the group purchasing organization’s ability to influence its members’ buying decisions. Further consolidation among customers or their continued affiliation with group purchasing organizations may result in significant pricing pressures and correspondingly reduce the gross margins of our business or may cause our customers to reduce their purchases of our products, thereby adversely affecting our business, prospects, operating results or financial condition.
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In developing and manufacturing our products, we employ a variety of proprietary and patented technologies. In addition, we have licensed, and expect to continue to license, various complementary technologies and methods from academic institutions and public and private companies. We cannot provide any assurance that the technologies that we own or license provide protection from competitive threats or from challenges to our intellectual property. In addition, we cannot provide any assurances that we will be successful in obtaining licenses or proprietary or patented technologies in the future, or that licenses granted to us by third parties will not be granted to other third parties who could potentially compete with us.
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• |
Filing, prosecuting and defending patents covering our current and future products throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may obtain patent protection, but where patent enforcement is not as strong as that in the United States. These products may compete with our products in jurisdictions where we do not have any issued or licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.
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• |
Trinity Biotech currently owns 6 U.S. patents with remaining patent lives varying from 2 years to 15 years.
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• |
We may fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. The patent applications that we own or in-license may fail to result in issued patents with claims that cover our current products or any future products in the United States or in other foreign countries. There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application.
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• |
We can provide no assurance that third parties will not challenge the validity, enforceability or scope of the patents Trinity Biotech may apply for, or obtain, which may result in such patents being narrowed, invalidated, or held unenforceable. Any successful opposition to these patents or any other patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization of any products covered by those patents.
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• |
Trade secrets and confidential know-how are important to our scientific and commercial success. Although we seek to protect our proprietary information through confidentiality agreements and other contracts, we can provide no assurance that others will not independently develop the same or similar information or gain access to our proprietary information.
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• |
Periodic maintenance fees on any issued patent are due to be paid to the United States Patent and Trademark Organization (“USPTO”) and other foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign national or international patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalise and submit formal documents. If we or our licensors fail to maintain the patents and patent applications covering our current or future products, our competitors might be able to enter the market, which would have an adverse effect on our business.
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• |
Depending on actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have licensed or that we might obtain in the future.
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• |
For example, the United States has enacted and implemented wide-ranging patent reform legislation, which could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defence of our issued patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications are prosecuted and may also affect patent litigation. The United States Patent Office recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, only became effective on March 16, 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defence of our issued patents, all of which could have an adverse effect on our business and financial condition.
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• |
Additionally, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.
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• |
Litigation over intellectual property rights is prevalent in the diagnostic industry, including patent infringement lawsuits, interferences, derivation and administrative law proceedings, inter party review, and post-grant review before the USPTO, as well as oppositions and similar processes in foreign jurisdictions.
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• |
If we need to obtain a license as a result of litigation, we cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialisation of our products. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialise one or more of our products, which could harm our business significantly.
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• |
Competitors may infringe or otherwise violate our patents, the patents of our licensors or our other intellectual property rights. To counter infringement or unauthorised use, we may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defence proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing. The initiation of a claim against a third party may also cause the third party to bring counter claims against us such as claims asserting that our patents are invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte re-examinations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
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• |
We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For the patents and patent applications that we have licensed, we may have limited or no right to participate in the defence of any licensed patents against challenge by a third party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our current or future products. Such a loss of patent protection could harm our business.
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• |
We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States. Our business could be harmed if in litigation the prevailing party does not offer us a license on commercially reasonable terms. Any litigation or other proceedings to enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.
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• |
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our ordinary shares.
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• |
We are highly dependent on information technology networks and systems, including the Internet, to securely process, transmit and store electronic information, including personal information of our customers. Security breaches of this infrastructure, including physical or electronic break-ins, computer viruses, malware attacks by hackers and similar breaches, can cause all or portions of our websites to be unavailable, create system disruptions, shutdowns, erasure of critical data and software or unauthorised disclosure of confidential information. We invest in security technology to protect our data against risks of data security breaches and cyber-attacks and we have implemented solutions, processes, and procedures to help mitigate these risks, such as encryption, virus protection, security firewalls and comprehensive information security and privacy policies. However, despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. The age of our information technology systems, as well as the level of our protection and business continuity or disaster recovery capability, varies from site to site, and there can be no guarantee that any such plans, to the extent they are in place, will be effective. In addition, a security breach or privacy violation that leads to disclosure of consumer information (including personally identifiable information or protected health information) could harm our reputation, compel us to comply with disparate state breach notification laws and otherwise subject us to liability under laws that protect personal data, resulting in increased costs or loss of revenue. If we are unable to prevent further security breaches or privacy violations or implement satisfactory remedial measures, our operations could be disrupted, we may be subject to legal claims or proceedings, or we may suffer loss of reputation, financial loss and other regulatory penalties because of lost or misappropriated information, including sensitive consumer data, which could have a material adverse impact on our business, financial condition and results of operations. While we currently expend resources to protect against cyber-attacks and security breaches, hackers and other cyber criminals are using increasingly sophisticated and constantly evolving techniques, and we may need to expend additional resources to continue to protect against potential security breaches or to address problems caused by such attacks or any breach of our safeguards. In addition, a data security breach could distract management or other key personnel from performing their primary operational duties.
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• |
In addition, the interpretation and application of consumer and data protection laws in the United States, Europe and elsewhere are often uncertain, contradictory and in flux. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our data practices. If so, this could result in government-imposed fines or orders requiring that we change our data practices, which could have an adverse effect on our business. Complying with these various laws could cause us to incur substantial costs or require us to change our business practices in a manner adverse to our business.
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• |
We sell our products into the public health market, which consists of state, county and other governmental public health agencies, community based organisations, service organisations and similar entities. Many of these customers depend to a significant degree on grants or funding provided by governmental agencies to run their operations including programs that use our products. In international markets, we often sell our products to parties funded by such agencies. The level of available government grants or funding is unpredictable and may be affected by various factors including future economic conditions, legislative and regulatory developments, political changes, civil unrest and changing priorities for research and development activities. Any reduction or delay in government funding could cause our customers to delay, reduce or forego purchases of our products.
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• |
In the United States in recent years, there have been numerous initiatives at the federal and state level for comprehensive reforms affecting the payment for, the availability of and reimbursement for healthcare services. These initiatives have ranged from proposals to fundamentally change federal and state healthcare reimbursement programs, including providing comprehensive healthcare coverage to the public under government-funded programs, to minor modifications to existing programs. One example is the Patient Protection and Affordable Care Act, the Federal healthcare reform law enacted in 2010 (the “Affordable Care Act”). Similar reforms may occur internationally.
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Legislative and regulatory bodies are likely to continue to pursue healthcare reform initiatives in many forms and may continue to reduce funding in an effort to lower overall federal healthcare spending. The U.S. government recently enacted legislation that eliminated what is known as the “individual mandate” under the Affordable Care Act and may enact other changes in the future. The ultimate content and timing of any of these types of changes in other healthcare reform legislation and the resulting impact on us are impossible to predict. If significant reforms are made to the healthcare system in the U.S., or in other jurisdictions, those reforms may increase our costs or otherwise have an adverse effect on our financial condition and results of operations.
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The Affordable Care Act imposes a 2.3% excise tax on certain transactions, including U.S. sales of many medical devices, which includes domestic sales of certain of our products. This new tax became effective in January 2013. However, the Consolidated Appropriations Act of 2016, which was enacted late 2015, suspended the tax beginning January 1, 2016, and this suspension was recently extended until December 31, 2019. It is unclear whether and to what extent this tax will impact our business, if and when the suspension is lifted.
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We are subject to regular reviews, examinations, and audits by tax authorities in a number of jurisdictions across the world with respect to our taxes. Although we believe our tax estimates are reasonable, if a taxing authority disagrees with the positions we have taken, we could face additional tax liability, including interest and penalties. There can be no assurance that payment of such additional amounts upon final adjudication of any disputes will not have a material impact on our results of operations and financial position.
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• |
A significant portion of our business is located in the U.S. and is subject to income and other taxes in the U.S. and our operations, plans and results are affected by tax and other initiatives. In December, 2017, the U.S. Government enacted comprehensive tax legislation known as the Tax Cuts and Jobs Act. This legislation made broad and complex changes to the U.S. tax code, including but not limited to reducing the corporate tax rate from 35% to 21%, requiring a one-time mandatory deemed repatriation of certain deferred foreign earnings tax on and accelerating first year expensing of certain capital expenditures. The legislation also introduced new tax laws affecting our taxable income, which includes, but is not limited to, a new provision designed to tax global intangible low taxed income, limitations on the deductibility of certain executive compensation, creating a base erosion anti-abuse tax and modifying or repealing many deductions and credits. The ultimate impacts of the Tax Act may differ from the Company’s estimates due to changes in the interpretations and assumptions made, as well as any forthcoming regulatory guidance. The changes to the tax code could also affect our valuation of deferred tax assets and liabilities. Any such change in valuation would have a material impact on our income tax expense and deferred tax balances.
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• |
Our laboratory operated by our subsidiary Immco Diagnostics Inc. is subject to CLIA, which is administered by CMS and extends federal oversight to virtually all clinical laboratories by requiring that they be certified by the federal government or by a federally-approved accreditation agency. CLIA is designed to ensure the quality and reliability of clinical laboratories by, among other things, mandating specific standards in the areas of personnel qualifications, administration, and participation in proficiency testing, patient test management, quality control, quality assurance and inspections. Laboratories must undergo on-site surveys at least every two years, which may be conducted by the Federal CLIA program or by a private CMS approved accrediting agency such as the College of American Pathologists, among others. The sanction for failure to comply with CLIA requirements may be suspension, revocation or limitation of a laboratory’s CLIA certificate, which is necessary to conduct business, as well as significant fines and/or criminal penalties.
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We are also subject to regulation of laboratory operations under state clinical laboratory laws of New York and of certain other states from where we accept specimens. State clinical laboratory laws may require that laboratories and/or laboratory personnel meet certain qualifications, specify certain quality controls or require maintenance of certain records. For example, California requires that we maintain a license to conduct testing in California, and California law establishes standards for our day-to-day laboratory operations, including the training and skill required of laboratory personnel and quality control.
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• |
In some respects, notably with respect to qualifications of testing personnel, California’s clinical laboratory laws impose more rigorous standards than does CLIA. Certain other states, including Florida, Maryland, New York and Pennsylvania, require that we hold licenses to test specimens from patients residing in those states, and additional states may require similar licenses in the future. Potential sanctions for violation of these statutes and regulations include significant fines and the suspension or loss of various licenses, certificates and authorisations, which could adversely affect our business and results of operations.
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Point-Of-Care
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Clinical Laboratory
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Infectious Diseases
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Infectious Diseases
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Haemoglobin
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Autoimmune
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Clinical Chemistry
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Blood Bank Screening
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UniGold™
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MarDx®
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Premier™
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ImmuBlot™
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EZ™
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Captia™
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Recombigen®
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MarBlot®
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Ultra2TM
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ImmuGlo™
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ImmuLisa™
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OTOblot™
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• |
Infectious diseases,
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• |
Haemoglobin, haemoglobin variants and glycated haemoglobin used in monitoring diabetes, and
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• |
Autoimmune diseases
|
• |
Lyme disease,
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• |
sexually transmitted diseases, including Syphilis and Herpes simplex virus,
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• |
respiratory infections, including legionella,
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• |
Epstein Barr virus, and
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• |
other viral pathogens, including measles, mumps, toxoplasmosis, cytomegalovirus, rubella and varicella.
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• |
Immunofluorescence Assay (“IFA”),
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• |
Enzyme-linked immunosorbent (“ELISA”),
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• |
Western Blot (“WB”) and
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Line immunoassay (“LIA”).
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• |
Its Clinical Chemistry product range directly to hospitals and laboratories in Germany and France;
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• |
Infectious Diseases and Clinical Chemistry product ranges directly to hospitals and laboratories in the UK; and
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• |
All product lines through independent distributors and strategic partners in a further 114 countries.
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· |
untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
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unanticipated expenditures to address or defend such actions
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· |
customer notifications for repair, replacement, refunds;
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· |
recall, detention or seizure of our products;
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· |
operating restrictions or partial suspension or total shutdown of production;
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· |
refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;
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· |
operating restrictions;
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withdrawing 510(k) clearances or PMA approvals that have already been granted;
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· |
refusal to grant export approval for our products; or
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· |
criminal prosecution.
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· |
product design, development and manufacture;
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product safety, testing, labeling and storage;
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· |
record keeping procedures;
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· |
product marketing, sales and distribution; and
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· |
post-marketing surveillance, complaint handling, medical device reporting, reporting of deaths, serious injuries or device malfunctions and repair or recall of products.
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· | 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; |
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Are not to be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure; and
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· | Comply with the labeling requirements for IUO devices, as outlined in 21 C.F.R. § 812.2(c)(3). |
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product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;
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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;
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labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;
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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;
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approval of product modifications that affect the safety or effectiveness of one of our approved devices;
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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;
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post-approval restrictions or conditions, including post-approval study commitments;
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post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device;
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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;
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regulations pertaining to voluntary recalls; and
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notices of corrections or removals.
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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;
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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
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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.
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day-to-day operation of a clinical laboratory, including training and skill levels required of laboratory personnel;
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physical requirements of a facility;
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equipment; and
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validation and quality control.
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• |
Trinity Biotech Manufacturing Limited, based in Bray, Ireland;
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• |
Clark Laboratories Inc, based in Jamestown, New York;
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• |
MarDx Diagnostics Inc, based in Carlsbad, California;
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• |
Primus Corporation, based in Kansas City;
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• |
Biopool US Inc (trading as Trinity Biotech USA), based in Jamestown, New York;
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• |
Immco Diagnostics Inc, based in Amherst and Buffalo, New York;
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• |
Nova Century Scientific Inc, based in Burlington, Canada; and
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• |
Trinity Biotech Brazil based in Sao Paulo, Brazil.
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• |
Significant underperformance relative to expected, historical or projected future operating results;
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• |
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;
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• |
Obsolescence of products;
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• |
Significant decline in our stock price for a sustained period; and
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• |
Our market capitalisation relative to net book value.
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• |
In the event that there was a variation of 10% in the assumed level of future growth in revenues, which would represent a reasonably likely range of outcomes, there would be an additional impairment loss of US$319,000 at December 31, 2018.
|
• |
In the event there was a 10% variation 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 an additional impairment loss of US$3,663,000 at December 31, 2018.
|
• |
The entity’s operations in future financial years;
|
• |
The results of those operations in future financial years; or
|
• |
The entity’s state of affairs in future financial years.
|
1. |
Overview
|
2. |
Revenues
|
3. |
Operating Loss
|
4. |
Loss for the year
|
5. |
Discontinued operations
|
|
Year ended December 31,
|
|||||||||||
|
|
2018
US$’000
|
|
2017
US$’000
|
% Change
|
|||||||
Revenues
|
||||||||||||
Clinical Laboratory
|
71,618
|
73,366
|
(2.4
|
)%
|
||||||||
Point-of-Care
|
14,836
|
16,774
|
(11.6
|
)%
|
||||||||
Laboratory Services
|
10,581
|
9,000
|
17.6
|
%
|
||||||||
|
||||||||||||
Total
|
97,035
|
99,140
|
(2.1
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
|
2018
US$‘000
|
|
2017
US$‘000
|
% Change
|
|||||||
Revenues
|
||||||||||||
Americas
|
57,559
|
59,539
|
(3.3
|
)%
|
||||||||
Asia/Africa
|
29,466
|
27,131
|
8.6
|
%
|
||||||||
Europe
|
10,010
|
12,470
|
(19.7
|
)%
|
||||||||
|
||||||||||||
Total
|
97,035
|
99,140
|
(2.1
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
|
2018
US$’000
|
|
2017
US$’000
|
% Change
|
|||||||
Revenues
|
97,035
|
99,140
|
(2.1
|
)%
|
||||||||
Cost of sales
|
(55,586
|
)
|
(57,250
|
)
|
(2.9
|
)%
|
||||||
|
||||||||||||
Gross profit
|
41,449
|
41,890
|
(1.1
|
)%
|
||||||||
Other operating income
|
102
|
100
|
2.0
|
%
|
||||||||
Research & development
|
(5,369
|
)
|
(5,657
|
)
|
(5.1
|
)%
|
||||||
SG&A expenses
|
(29,477
|
)
|
(32,246
|
)
|
(8.6
|
)%
|
||||||
Selling, general and administrative expenses - impairment charges and inventory write-off/provision
|
(26,932
|
)
|
(41,755
|
)
|
(35.5
|
)%
|
||||||
|
||||||||||||
Operating loss on continuing operations
|
(20,227
|
)
|
(37,668
|
)
|
(46.3
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
|
2018
US$’000
|
|
2017
US$’000
|
% Change
|
|||||||
SG&A (excl. share-based payments and amortisation)
|
25,317
|
28,050
|
(9.7
|
)%
|
||||||||
Share-based payments
|
1,335
|
893
|
(49.5
|
)%
|
||||||||
Amortisation
|
2,825
|
3,303
|
(14.5
|
)%
|
||||||||
|
||||||||||||
Total
|
29,477
|
32,246
|
(8.6
|
)%
|
· |
flood damage incident at one of our U.S. plants in 2017 (US$894,000),
|
· |
a settlement in relation to a licence royalty dispute in 2017 (US$497,000),
|
· |
a gain on the purchase of a portion of our exchangeable notes in 2018 (US$463,000),
|
· |
cost savings implemented in 2018 as part of a cost saving programme.
|
·
|
the Company’s market capitalisation at the end of the year that was lower when compared to the end of 2017.
|
·
|
the inclusion of the latest cash flow projections and net asset values for each cash generating unit; and
|
·
|
increased volatility in the Company’s share price and higher market interest rates which resulted in a higher discount factor being applied to the Company’s expected future cash flows.
|
|
Year ended December 31,
|
|||||||||||
|
|
2018
US$‘000
|
|
2017
US$‘000
|
% Change
|
|||||||
Operating loss
|
(20,277
|
)
|
(37,668
|
)
|
(46.2
|
)%
|
||||||
Net financing expense
|
(2,956
|
)
|
(2,207
|
)
|
33.9
|
%
|
||||||
|
||||||||||||
Loss before tax
|
(23,183
|
)
|
(39,875
|
)
|
(41.9
|
)%
|
||||||
Income tax credit
|
525
|
1,214
|
(56.8
|
)%
|
||||||||
|
||||||||||||
Loss for the year from continuing operations
|
(22,658
|
)
|
(38,661
|
)
|
(41.4
|
)%
|
|
Year ended December 31,
|
|||||||
|
|
2018
US$‘000
|
|
2017
US$‘000
|
||||
Profit/(Loss) on discontinued operations
|
568
|
(1,609
|
)
|
6. |
Overview
|
7. |
Revenues
|
8. |
Operating Loss
|
9. |
Loss for the year
|
10. |
Discontinued operations
|
• |
a non-cash impairment charge of US$41.8 million in the statement of operations relating to the carrying value of goodwill and other intangible assets, property, plant and equipment and prepayments.
|
• |
a loss on discontinued operations for the year of US$1.3 million before tax, relating to the discontinuation of our Cardiac point-of-care operation.
|
• |
certain once-off costs totalling US$1.4 million relating to a flood damage incident and a settlement of a licence royalty dispute. See section 3, operating loss, for further details.
|
Year ended December 31, 2017 | ||||||||||||
Impairment
Charges – continuing operations
US$’000
|
Discontinued Operation
US$000
|
Total
US$‘000
|
||||||||||
Property, plant & equipment (Item 18, Note 12)
|
10,437
|
-
|
10,437
|
|||||||||
Goodwill and other intangible assets (Item 18, Note 13)
|
29,667
|
-
|
29,667
|
|||||||||
Prepayments (Item 18, Note 17)
|
1,651
|
-
|
1,651
|
|||||||||
Loss for the year including write off of foreign currency translation reserve - discontinued operation (Item 18, Note 10)
|
-
|
1,286
|
1,286
|
|||||||||
Total loss on discontinued operation and impairment charges and inventory provisioning before tax
|
41,755
|
1,286
|
43,041
|
|||||||||
Income tax (credit)/expense
|
(517
|
)
|
323
|
(194
|
)
|
|||||||
Total loss on discontinued operation and impairment charges after tax
|
41,238
|
1,609
|
42,847
|
|
Year ended December 31,
|
|||||||||||
|
|
2017
US$’000
|
|
2016
US$’000
|
% Change
|
|||||||
Revenues
|
||||||||||||
Clinical Laboratory
|
73,366
|
74,166
|
(1.1
|
)%
|
||||||||
Point-of-Care
|
16,774
|
16,908
|
(0.8
|
)%
|
||||||||
Laboratory Services
|
9,000
|
8,537
|
5.4
|
%
|
||||||||
|
||||||||||||
Total
|
99,140
|
99,611
|
(0.5
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
|
2017
US$‘000
|
|
2016
US$‘000
|
% Change
|
|||||||
Revenues
|
||||||||||||
Americas
|
59,539
|
61,613
|
(3.4
|
)%
|
||||||||
Asia/Africa
|
27,131
|
25,501
|
6.4
|
%
|
||||||||
Europe
|
12,470
|
12,497
|
(0.2
|
)%
|
||||||||
|
||||||||||||
Total
|
99,140
|
99,611
|
(0.5
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
|
2017
US$’000
|
$
|
2016
US$’000
|
% Change
|
|||||||
Revenues
|
99,140
|
99,611
|
(0.5
|
)%
|
||||||||
Cost of sales
|
(57,250
|
)
|
(56,127
|
)
|
2.0
|
%
|
||||||
|
||||||||||||
Gross profit
|
41,890
|
43,484
|
(3.7
|
)%
|
||||||||
Other operating income
|
100
|
239
|
(58.2
|
)%
|
||||||||
Research & development
|
(5,657
|
)
|
(5,040
|
)
|
12.2
|
%
|
||||||
SG&A expenses
|
(32,246
|
)
|
(30,366
|
)
|
6.2
|
%
|
||||||
Selling, general and administrative expenses - impairment charges and inventory write-off/provision
|
(41,755
|
)
|
(48,165
|
)
|
(13.3
|
)%
|
||||||
|
||||||||||||
Operating loss on continuing operations
|
(37,668
|
)
|
(39,848
|
)
|
(5.5
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
|
2017
US$’000
|
|
2016
US$’000
|
% Change
|
|||||||
SG&A (excl. share-based payments and amortisation)
|
28,050
|
26,044
|
7.7
|
%
|
||||||||
Share-based payments
|
893
|
1,349
|
(33.8
|
)%
|
||||||||
Amortisation
|
3,303
|
2,973
|
11.1
|
%
|
||||||||
|
||||||||||||
Total
|
32,246
|
30,366
|
6.2
|
%
|
|
Year ended December 31,
|
|||||||||||
|
2017
US$‘000
|
2016
US$‘000
|
% Change
|
|||||||||
Operating loss
|
(37,668
|
)
|
(39,848
|
)
|
(5.5
|
)%
|
||||||
Net financing expense
|
(2,207
|
)
|
(2,292
|
)
|
(3.7
|
)%
|
||||||
Loss before tax
|
(39,875
|
)
|
(42,140
|
)
|
(5.4
|
)%
|
||||||
Income tax credit
|
1,214
|
3,557
|
(65.9
|
)%
|
||||||||
|
||||||||||||
Loss of the year from continuing operations
|
(38,661
|
)
|
(38,583
|
)
|
0.2
|
%
|
|
Year ended December 31,
|
|||||||
|
$
|
2017
US‘000
|
$
|
2016
US‘000
|
||||
Loss on discontinued operations
|
(1,609
|
)
|
(62,042
|
)
|
• |
The ability of the Group to continue to generate revenue growth from its existing product lines;
|
• |
The ability of the Group to generate revenues from new products following the successful completion of its development projects;
|
• |
The extent to which capital expenditure is incurred on additional property plant and equipment;
|
• |
The level of investment required to undertake both new and existing development projects; and
|
• |
Successful working capital management in the context of a growing business.
|
• |
An increase in trade and other receivables of US$5,960,000 partially due to the increase, year on year, in the debtors days number;
|
• |
A decrease in trade and other payables balance of US$3,419,000 due to timing of payments; and
|
• |
A decrease in inventory of US$1,988,000 due to the strategic management of inventory levels during the course of the year.
|
• |
Payments to acquire intangible assets of US$9,863,000 (2017: US$10,229,000), 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$7,528,000 (2017: US$4,839,000) incurred as part of the Group’s investment programme for its manufacturing and distribution activities, and placement of instruments.
|
|
Payments due by Period
|
|||||||||||||||||||
Contractual Obligations
|
Total
US$’000 |
less than 1
year US$’000 |
1-3 Years
US$’000 |
4-5 Years
US$’000 |
more than
5 years US$’000 |
|||||||||||||||
Exchangeable note*
|
99,900
|
—
|
—
|
—
|
99,900
|
|||||||||||||||
Exchangeable note interest
|
105,894
|
3,996
|
7,992
|
7,992
|
85,914
|
|||||||||||||||
Operating lease obligations
|
25,717
|
2,922
|
4,815
|
3,731
|
14,249
|
|||||||||||||||
Finance lease obligations
|
1,038
|
473
|
379
|
186
|
—
|
|||||||||||||||
|
||||||||||||||||||||
Total
|
232,549
|
7,391
|
13,186
|
11,909
|
200,063
|
|
2018
|
2017
|
Total project
costs to December 31, 2018 ¹ |
|||||||||
Product Name
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Premier Instrument for Haemoglobin A1c testing
|
2,653
|
2,601
|
30,097
|
|||||||||
HIV screening rapid test
|
1,657
|
1,803
|
5,887
|
|||||||||
G-6-PDH test
|
850
|
812
|
1,662
|
|||||||||
Uni-gold test enhancement
|
796
|
1,134
|
4,342
|
|||||||||
Autoimmune Smart Reader
|
746
|
-
|
746
|
|||||||||
Tri-stat Point-of-Care instrument
|
727
|
764
|
8,668
|
|
Total estimated
cost to complete |
Estimated date
for completion |
||||||
Product Name
|
US$’000
|
|||||||
Premier Instrument for Haemoglobin A1c testing
|
1,470
|
2019
|
||||||
HIV screening rapid test
|
1,685
|
2019
|
||||||
G-6-PDH test
|
200
|
2019
|
||||||
Autoimmune Smart Reader
|
1,700
|
2021
|
Name
|
Age
|
Title
|
Ronan O’Caoimh
|
63
|
Chairman and Chief Executive Officer
|
Jim Walsh, PhD
|
60
|
Executive Director
|
Kevin Tansley
|
48
|
Executive Director, Chief Financial Officer & Company Secretary
|
Denis R. Burger, PhD
|
75
|
Non Executive Director / Lead Director
|
Clint Severson
|
70
|
Non Executive Director
|
James D. Merselis
|
65
|
Non Executive Director
|
Executive Director
|
Salary/
Benefits
US$’000
|
Performance
related bonus
US$’000
|
Defined
contribution
pension
US$’000
|
Total
2018
US$’000
|
Total
2017
US$’000
|
|||||||||||||||
Ronan O’Caoimh1
|
466
|
119
|
—
|
585
|
774
|
|||||||||||||||
Jim Walsh2
|
9
|
—
|
—
|
9
|
117
|
|||||||||||||||
Kevin Tansley3
|
388
|
91
|
44
|
523
|
553
|
|||||||||||||||
|
863
|
210
|
44
|
1,117
|
1,444
|
Non-executive Director
|
Fees
US$’000
|
Total
2018
US$’000
|
Total
2017
US$’000
|
|||||||||
Denis R. Burger
|
—
|
—
|
100
|
|||||||||
Peter Coyne4
|
38
|
38
|
100
|
|||||||||
James Merselis
|
75
|
75
|
100
|
|||||||||
Clint Severson
|
75
|
75
|
100
|
|||||||||
|
188
|
188
|
400
|
1
|
Represents payments to Ronan O’Caoimh for director fees and to Darnick Company in respect of CEO services.
|
2
|
2017 includes payments made to Diagnostic Polymers, a company wholly-owned by Jim Walsh and members of his immediate family. Represents payments to Jim Walsh for director fees and to Diagnostic Polymers in respect of executive services.
|
3
|
Kevin Tansley was appointed to the board in September 2016 as Executive Director. Remuneration also includes remuneration paid to Kevin Tansley in respect of his roles as Chief Financial Officer and Company Secretary.
|
4
|
Peter Coyne resigned as Non-executive Director on June 5, 2018.
|
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*
|
800,000
|
200,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||||||
800,000
|
200,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||||||
2,244,000
|
561,000
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||||||
Denis Burger
|
60,000
|
15,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
||||||||
662,000
|
165,500
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||||||
Jim Walsh
|
500,000
|
125,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||||||
160,000
|
40,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||||||
750,000
|
187,500
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||||||
Peter Coyne
|
60,000
|
15,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||||||
60,000
|
15,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||||||
95,000
|
23,750
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||||||
Clint Severson
|
20,000
|
5,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||||||
60,000
|
15,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||||||
210,000
|
23,750
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||||||
James Merselis
|
40,000
|
10,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||||||
60,000
|
15,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||||||
210,000
|
52,500
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||||||
Kevin Tansley
|
500,000
|
125,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||||||
500,000
|
125,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||||||
864,000
|
216,000
|
US$1.34
|
US$5.35
|
7 September 2024
|
|
Number of ‘A’
Ordinary Shares
Subject to Option
|
Range of
Exercise Price
per Ordinary Share
|
Range of Exercise Price
per ADS
|
|||||||||
Total options outstanding
|
10,788,190
|
$
|
US0.67-US$4.36
|
$
|
US2.68-US$17.44
|
|
Number of ‘A’
Ordinary Shares Beneficially Owned
|
Number of
ADSs Beneficially Owned |
Percentage
‘A’ Ordinary
Shares (8) |
Percentage
Total Voting
Power |
||||||||||||
Stonehill Capital Management, LLC
|
6,555,384
|
1,638,846
|
6.1
|
%
|
6.1
|
%
|
||||||||||
Paradice Investment Management, LLC
|
6,335,384
|
1,583,846
|
5.9
|
%
|
5.9
|
%
|
||||||||||
Janus Capital Management, LLC
|
5,556,972
|
1,389,243
|
5.2
|
%
|
5.2
|
%
|
||||||||||
Ronan O’Caoimh
|
10,901,501(1
|
)
|
2,725,375
|
10.2
|
%
|
10.2
|
%
|
|||||||||
Jim Walsh
|
2,803,611(2
|
)
|
700,903
|
2.6
|
%
|
2.6
|
%
|
|||||||||
Denis Burger
|
754,000(3
|
)
|
188,500
|
0.7
|
%
|
0.7
|
%
|
|||||||||
Clint Severson
|
578,000(4
|
)
|
144,500
|
0.5
|
%
|
0.5
|
%
|
|||||||||
James Merselis
|
498,600(5
|
)
|
124,650
|
0.5
|
%
|
0.5
|
%
|
|||||||||
Kevin Tansley
|
2,014,000(6
|
)
|
503,500
|
1.9
|
%
|
1.9
|
%
|
|||||||||
Directors & Co. Secretary as a group (7 persons)
|
17,549,712(1
|
)(2)(3)(4)(5)(6)
|
4,387,428
|
16.4
|
%
|
16.4
|
%
|
(1) |
Includes 3,844,000 ‘A’ Ordinary shares issuable upon exercise of options issued to Darnick Company.
|
(2)
|
Includes 1,410,000 ‘A’ Ordinary shares issuable upon exercise of options. Note that 1,200,000 ‘A’ Ordinary shares (300,000 ADSs) of Dr Walsh’s shares are held in trust for the benefit of Dr Walsh’s immediate family.
|
(3) |
Includes 722,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(4) |
Includes 290,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(5) |
Includes 310,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(6) |
Includes 1,864,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(7)
|
Percentage ‘A’ Ordinary shares is based upon total outstanding ‘A’ Ordinary shares and total number of shares issuable upon exercise of options.
|
Year Ended December 31
|
High
|
Low
|
||
2014
|
US$28.06
|
US$14.00
|
||
2015
|
US$20.24
|
US$10.74
|
||
2016
|
US$13.68
|
US$5.76
|
||
2017
|
US$7.04
|
US$4.50
|
||
2018
|
US$6.06
|
US$2.14
|
2017
|
High
|
Low
|
||
Quarter ended March 31
|
US$7.04
|
US$5.31
|
||
Quarter ended June 30
|
US$6.15
|
US$5.25
|
||
Quarter ended September 30
|
US$6.13
|
US$5.16
|
||
Quarter ended December 31
|
US$5.77
|
US$4.50
|
2018
|
High
|
Low
|
||
Quarter ended March 31
|
US$6.06
|
US$5.08
|
||
Quarter ended June 30
|
US$5.20
|
US$4.46
|
||
Quarter ended September 30
|
US$5.08
|
US$3.76
|
||
Quarter ended December 31
|
US$4.26
|
US$2.14
|
Month Ended
|
High
|
Low
|
||
March 31, 2018
|
US$6.06
|
US$5.15
|
||
April 30, 2018
|
US$5.20
|
US$4.48
|
||
May 31, 2018
|
US$4.92
|
US$4.46
|
||
June 30, 2018
|
US$5.00
|
US$4.61
|
||
July 31, 2018
|
US$5.08
|
US$4.65
|
||
August 31, 2018
|
US$4.65
|
US$3.80
|
||
September 30, 2018
|
US$4.13
|
US$3.76
|
||
October 31, 2018
|
US$4.26
|
US$2.86
|
||
November 30, 2018
|
US$3.66
|
US$2.83
|
||
December 31, 2018
|
US$2.88
|
US$2.14
|
||
January 31, 2019
|
US$2.79
|
US$2.31
|
||
February 28, 2019
|
US$3.16
|
US$2.53
|
• |
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.
|
• |
Cash consideration of US$31,652,000;
|
• |
Issuance of share option as at the acquisition date with a fair value of US$1,121,000; and
|
• |
The transfer of 5,566 Trinity Biotech ADSs as at the acquisition date (fair value of US$110,000).
|
• |
An up-front cash payment of US$5.6m;
|
• |
The transfer of 408,000 Trinity Biotech ADSs as at the acquisition date (fair value of US$4.1m); and
|
• |
Contingent cash consideration (net present value) of US$3.2m.
|
• |
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.
|
Service
|
Rate
|
By whom paid
|
(1) Issuance of ADSs upon deposit of ordinary shares.
|
Up to $10.00 per 100 ADSs (or portion thereof) issued.
|
Persons depositing ordinary shares or person receiving ADSs.
|
(2) Delivery of deposited securities against surrender of ADSs.
|
Up to $10.00 per 100 ADSs (or portion thereof) issued.
|
Persons surrendering ADSs for the purpose of withdrawal of deposited securities or persons to whom deposited securities are delivered.
|
(3) Issuance of ADSs in connection with a distribution of shares.
|
Up to $10.00 per 100 ADSs (or portion thereof) issued.
|
Person to whom distribution is made.
|
(4) Distribution of cash dividends or other cash distributions, including distribution of cash proceeds following the sale of rights, shares or other property in accordance with the deposit agreement
|
Up to $0.02 per 1 ADS
|
Person to whom distribution is made.
|
(5) Transfer of ADSs
|
Up to $1.50 per certificate for ADRs or ADRs transferred
|
Person to whom Receipt is transferred.
|
• |
transfer and registration fees of securities on Trinity Biotech’s securities register to or from the name of the depositary or its agent when ADS holders deposit or withdrawal securities;
|
• |
expenses for cable, telex and fax transmissions and for delivery of securities;
|
• |
expenses incurred for converting foreign currency into U.S. dollars; and
|
• |
taxes and duties upon the transfer of securities (i.e., when ordinary shares are deposited or withdrawn from deposit, other than taxes for which Trinity Biotech is liable).
|
|
Year ended December 31,
2018
|
Year ended December 31,
2017
|
||||||||||||||
|
US$’000
|
%
|
US$’000
|
%
|
||||||||||||
Audit
|
562
|
97
|
%
|
507
|
87
|
%
|
||||||||||
Audit-related
|
-
|
-
|
%
|
-
|
-
|
%
|
||||||||||
Tax
|
17
|
3
|
%
|
73
|
13
|
%
|
||||||||||
|
||||||||||||||||
Total
|
579
|
580
|
|
Year ended December 31
|
|||||||||||||||
|
Notes
|
2018
Total
US$‘000
|
2017
Total
US$‘000
|
2016
Total
US$‘000
|
||||||||||||
Revenues
|
2
|
97,035
|
99,140
|
99,611
|
||||||||||||
Cost of sales
|
(55,586
|
)
|
(57,250
|
)
|
(56,127
|
)
|
||||||||||
|
||||||||||||||||
Gross profit
|
41,449
|
41,890
|
43,484
|
|||||||||||||
Other operating income
|
4
|
102
|
100
|
239
|
||||||||||||
Research and development expenses
|
(5,369
|
)
|
(5,657
|
)
|
(5,040
|
)
|
||||||||||
Selling, general and administrative expenses
|
(29,477
|
)
|
(32,246
|
)
|
(30,366
|
)
|
||||||||||
Impairment charges and inventory provisioning
|
6
|
(26,932
|
)
|
(41,755
|
)
|
(48,165
|
)
|
|||||||||
|
||||||||||||||||
Operating loss
|
(20,227
|
)
|
(37,668
|
)
|
(39,848
|
)
|
||||||||||
Financial income
|
2,3
|
2,124
|
3,198
|
3,147
|
||||||||||||
Financial expenses
|
2, 3
|
(5,080
|
)
|
(5,405
|
)
|
(5,439
|
)
|
|||||||||
|
||||||||||||||||
Net financing expense
|
(2,956
|
)
|
(2,207
|
)
|
(2,292
|
)
|
||||||||||
|
||||||||||||||||
Loss before tax
|
5
|
(23,183
|
)
|
(39,875
|
)
|
(42,140
|
)
|
|||||||||
Total income tax credit
|
2, 9
|
525
|
1,214
|
3,557
|
||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
2
|
(22,658
|
)
|
(38,661
|
)
|
(38,583
|
)
|
|||||||||
|
||||||||||||||||
Profit/(Loss) for the year on discontinued operations
|
10
|
568
|
(1,609
|
)
|
(62,042
|
)
|
||||||||||
|
||||||||||||||||
Loss for the year (all attributable to owners of the parent)
|
2
|
(22,090
|
)
|
(40,270
|
)
|
(100,625
|
)
|
|||||||||
|
||||||||||||||||
Basic (loss)/earnings per ADS (US Dollars) – continuing operations
|
11
|
(1.08
|
)
|
(1.79
|
)
|
(1.68
|
)
|
|||||||||
Diluted (loss)/earnings per ADS (US Dollars) – continuing operations
|
11
|
(1.08
|
)
|
(1.79
|
)
|
(1.68
|
)
|
|||||||||
Basic (loss)/earnings per ‘A’ ordinary share (US Dollars) –continuing operations
|
11
|
(0.27
|
)
|
(0.45
|
)
|
(0.42
|
)
|
|||||||||
Diluted earnings per ‘A’ ordinary share (US Dollars) – continuing operations
|
11
|
(0.27
|
)
|
(0.45
|
)
|
(0.42
|
)
|
|||||||||
Basic (loss)/earnings per ADS (US Dollars) – group
|
11
|
(1.06
|
)
|
(1.86
|
)
|
(4.38
|
)
|
|||||||||
Diluted (loss)/earnings per ADS (US Dollars) – group
|
11
|
(1.06
|
)
|
(1.86
|
)
|
(4.38
|
)
|
|||||||||
Basic (loss)/earnings per ‘A’ ordinary share (US Dollars) – group
|
11
|
(0.26
|
)
|
(0.47
|
)
|
(1.10
|
)
|
|||||||||
Diluted (loss)/earnings per ‘A’ ordinary share (US Dollars) –group
|
11
|
(0.26
|
)
|
(0.47
|
)
|
(1.10
|
)
|
|
Year ended December 31
|
|||||||||||||||
|
Notes
|
|
2018
US$‘000
|
|
2017
US$‘000
|
|
2016
US$‘000
|
|||||||||
Loss for the year
|
2
|
(22,090
|
)
|
(40,270
|
)
|
(100,625
|
)
|
|||||||||
Other comprehensive (loss)/income
|
||||||||||||||||
Items that will be reclassified subsequently to profit or loss
|
||||||||||||||||
Foreign exchange translation differences
|
(520
|
)
|
3,086
|
3,122
|
||||||||||||
|
||||||||||||||||
Other comprehensive income
|
(520
|
)
|
3,086
|
3,122
|
||||||||||||
|
||||||||||||||||
Total Comprehensive Loss (all attributable to owners of the parent)
|
(22,610
|
)
|
(37,184
|
)
|
(97,503
|
)
|
|
At December 31
|
|||||||||||
|
Notes
|
|
2018
US$‘000
|
|
2017
US$‘000
|
|||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property, plant and equipment
|
12
|
5,362
|
5,800
|
|||||||||
Goodwill and intangible assets
|
13
|
52,951
|
64,754
|
|||||||||
Deferred tax assets
|
14
|
6,127
|
8,698
|
|||||||||
Derivative financial instruments
|
24
|
-
|
360
|
|||||||||
Other assets
|
15
|
558
|
771
|
|||||||||
|
||||||||||||
Total non-current assets
|
64,998
|
80,383
|
||||||||||
|
||||||||||||
Current assets
|
||||||||||||
Inventories
|
16
|
30,359
|
32,805
|
|||||||||
Trade and other receivables
|
17
|
24,441
|
20,740
|
|||||||||
Income tax receivable
|
1,584
|
1,439
|
||||||||||
Cash and cash equivalents
|
18
|
30,277
|
23,564
|
|||||||||
Short-term investments
|
19
|
-
|
34,043
|
|||||||||
|
||||||||||||
Total current assets
|
86,661
|
112,591
|
||||||||||
|
||||||||||||
TOTAL ASSETS
|
2
|
151,659
|
192,974
|
|||||||||
|
||||||||||||
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
|
)
|
(24,783
|
)
|
|||||||
Accumulated surplus
|
20
|
55,319
|
75,802
|
|||||||||
Translation reserve
|
20
|
(3,766
|
)
|
(3,246
|
)
|
|||||||
Other reserves
|
20
|
23
|
23
|
|||||||||
|
||||||||||||
Total equity
|
44,054
|
65,196
|
||||||||||
|
||||||||||||
Current liabilities
|
||||||||||||
Income tax payable
|
210
|
310
|
||||||||||
Trade and other payables
|
22
|
16,908
|
20,515
|
|||||||||
Provisions
|
23
|
50
|
50
|
|||||||||
Finance lease liabilities
|
25
|
436
|
354
|
|||||||||
|
||||||||||||
Total current liabilities
|
17,604
|
21,229
|
||||||||||
|
||||||||||||
Non-current liabilities
|
||||||||||||
Exchangeable notes
|
24
|
81,382
|
92,955
|
|||||||||
Derivative financial instruments
|
24
|
238
|
2,230
|
|||||||||
Finance lease liabilities
|
25
|
526
|
532
|
|||||||||
Deferred tax liabilities
|
14
|
7,855
|
10,832
|
|||||||||
|
||||||||||||
Total non-current liabilities
|
90,001
|
106,549
|
||||||||||
|
||||||||||||
TOTAL LIABILITIES
|
2
|
107,605
|
127,778
|
|||||||||
|
||||||||||||
TOTAL EQUITY AND LIABILITIES
|
151,659
|
192,974
|
|
Other reserves
|
|||||||||||||||||||||||||||||||
|
Share capital
‘A’ ordinary shares US$’000 |
Share
premium US$’000 |
Treasury
Shares US$’000 |
Translation
reserve US$’000 |
Warrant
reserve US$’000 |
Hedging
reserves US$’000 |
Accumulated
surplus US$’000 |
Total
US$’000 |
||||||||||||||||||||||||
Balance at January 1, 2016
|
1,209
|
15,526
|
(7,367
|
)
|
(9,454
|
)
|
4,529
|
23
|
209,426
|
213,892
|
||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
—
|
—
|
(100,625
|
)
|
(100,625
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
—
|
—
|
—
|
3,122
|
—
|
—
|
—
|
3,122
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total comprehensive income
|
—
|
—
|
—
|
3,122
|
—
|
—
|
(100,625
|
)
|
(97,503
|
)
|
||||||||||||||||||||||
Share-based payments (Note 21)
|
—
|
—
|
—
|
—
|
—
|
—
|
1,633
|
1,633
|
||||||||||||||||||||||||
Options or warrants exercised
|
4
|
669
|
—
|
—
|
—
|
—
|
—
|
673
|
||||||||||||||||||||||||
Shares purchased
|
—
|
—
|
(9,960
|
)
|
—
|
—
|
—
|
—
|
(9,960
|
)
|
||||||||||||||||||||||
Share issue expenses
|
—
|
(8
|
)
|
—
|
—
|
—
|
—
|
—
|
(8
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2016
|
1,213
|
16,187
|
(17,327
|
)
|
(6,332
|
)
|
4,529
|
23
|
110,434
|
108,727
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at January 1, 2017
|
1,213
|
16,187
|
(17,327
|
)
|
(6,332
|
)
|
4,529
|
23
|
110,434
|
108,727
|
||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
—
|
—
|
(40,270
|
)
|
(40,270
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
—
|
—
|
—
|
3,086
|
—
|
—
|
—
|
3,086
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total comprehensive income/(loss)
|
—
|
—
|
—
|
3,086
|
—
|
—
|
(40,270
|
)
|
(37,184
|
)
|
||||||||||||||||||||||
Transfer of warrant reserve (Note 21)
|
—
|
—
|
—
|
—
|
(4,529
|
)
|
—
|
4,529
|
—
|
|||||||||||||||||||||||
Share-based payments (Note 21)
|
—
|
—
|
—
|
—
|
—
|
—
|
1,109
|
1,109
|
||||||||||||||||||||||||
Shares purchased
|
—
|
—
|
(7,456
|
)
|
—
|
—
|
—
|
—
|
(7,456
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2017
|
1,213
|
16,187
|
(24,783
|
)
|
(3,246
|
)
|
—
|
23
|
75,802
|
65,196
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at January 1, 2018
|
1,213
|
16,187
|
(24,783
|
)
|
(3,246
|
)
|
—
|
23
|
75,802
|
65,196
|
||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
—
|
—
|
(22,090
|
)
|
(22,090
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
—
|
—
|
—
|
(520
|
)
|
—
|
—
|
—
|
(520
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total comprehensive income/(loss)
|
—
|
—
|
—
|
(520
|
)
|
—
|
—
|
(22,090
|
)
|
(22,610
|
)
|
|||||||||||||||||||||
Share-based payments (Note 21)
|
—
|
—
|
—
|
—
|
—
|
—
|
1,607
|
1,607
|
||||||||||||||||||||||||
Shares purchased
|
—
|
—
|
(139
|
)
|
—
|
—
|
—
|
—
|
(139
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2018
|
1,213
|
16,187
|
(24,922
|
)
|
(3,766
|
)
|
—
|
23
|
55,319
|
44,054
|
|
Year ended December 31,
|
|||||||||||||||
|
Notes
|
|
2018
US$‘000
|
|
2017
US$‘000
|
|
2016
US$‘000
|
|||||||||
Cash flows from operating activities
|
||||||||||||||||
Loss for the year
|
(22,090
|
)
|
(40,270
|
)
|
(100,625
|
)
|
||||||||||
Adjustments to reconcile net profit to cash provided by operating activities:
|
||||||||||||||||
Depreciation
|
5
|
1,296
|
1,896
|
3,159
|
||||||||||||
Amortisation
|
5,13
|
2,825
|
3,303
|
2,973
|
||||||||||||
Income tax credit
|
(1,115
|
)
|
(374
|
)
|
(8,630
|
)
|
||||||||||
Financial income
|
3
|
(2,124
|
)
|
(3,198
|
)
|
(3,147
|
)
|
|||||||||
Financial expense
|
3
|
5,080
|
5,405
|
5,444
|
||||||||||||
Share-based payments
|
21
|
1,369
|
928
|
1,414
|
||||||||||||
Foreign exchange (gains)/losses on operating cash flows
|
311
|
307
|
(226
|
)
|
||||||||||||
Loss on disposal or retirement of property, plant and equipment
|
5
|
15
|
3
|
15
|
||||||||||||
Movement in inventory provision
|
16
|
300
|
2,275
|
(533
|
)
|
|||||||||||
Impairment of inventory
|
—
|
—
|
7,405
|
|||||||||||||
Impairment of prepayments
|
6, 17
|
1,608
|
1,651
|
757
|
||||||||||||
Impairment of property, plant and equipment
|
6, 12
|
6,112
|
10,437
|
9,029
|
||||||||||||
Impairment of intangible assets
|
6, 13
|
19,212
|
29,667
|
87,673
|
||||||||||||
Provision for closure costs
|
10
|
—
|
(1,794
|
)
|
3,431
|
|||||||||||
Other non-cash items
|
570
|
(728
|
)
|
4,087
|
||||||||||||
|
||||||||||||||||
Operating cash flows before changes in working capital
|
13,369
|
9,508
|
12,226
|
|||||||||||||
(Increase) / decrease in trade and other receivables
|
(5,960
|
)
|
306
|
682
|
||||||||||||
Decrease / (increase) in inventories
|
1,988
|
(2,461
|
)
|
(3,622
|
)
|
|||||||||||
(Decrease) / increase in trade and other payables
|
(3,419
|
)
|
2,017
|
1,270
|
||||||||||||
|
||||||||||||||||
Cash generated from operations
|
5,978
|
9,370
|
10,556
|
|||||||||||||
Interest paid
|
(39
|
)
|
(53
|
)
|
(60
|
)
|
||||||||||
Interest received
|
874
|
776
|
901
|
|||||||||||||
Income taxes received / (paid)
|
416
|
(843
|
)
|
(1,169
|
)
|
|||||||||||
|
||||||||||||||||
Net cash generated by operating activities
|
7,229
|
9,250
|
10,228
|
|||||||||||||
|
||||||||||||||||
Cash flows from investing activities
|
||||||||||||||||
Payments to acquire intangible assets
|
(9,863
|
)
|
(10,229
|
)
|
(16,548
|
)
|
||||||||||
Acquisition of property, plant and equipment
|
(7,528
|
)
|
(4,839
|
)
|
(4,215
|
)
|
||||||||||
Licence fees
|
22
|
—
|
(1,112
|
)
|
(1,112
|
)
|
||||||||||
|
||||||||||||||||
Net cash used in investing activities
|
(17,391
|
)
|
(16,180
|
)
|
(21,875
|
)
|
||||||||||
|
||||||||||||||||
Cash flows from financing activities
|
||||||||||||||||
Proceeds from issue of ordinary share capital
|
—
|
—
|
857
|
|||||||||||||
Share buyback
|
(434
|
)
|
(7,799
|
)
|
(9,322
|
)
|
||||||||||
Expenses paid in connection with share issue and debt financing
|
—
|
—
|
(8
|
)
|
||||||||||||
Interest payment on exchangeable notes
|
29
|
(4,503
|
)
|
(4,600
|
)
|
(4,600
|
)
|
|||||||||
Purchase of exchangeable notes
|
29
|
(12,042
|
)
|
—
|
—
|
|||||||||||
Proceeds from sale & leaseback transactions
|
481
|
51
|
—
|
|||||||||||||
Payment of finance lease liabilities
|
(374
|
)
|
(295
|
)
|
(282
|
)
|
||||||||||
|
||||||||||||||||
Net cash used in financing activities
|
(16,872
|
)
|
(12,643
|
)
|
(13,355
|
)
|
||||||||||
|
||||||||||||||||
Decrease in cash and cash equivalents and short term investments
|
(27,034
|
)
|
(19,573
|
)
|
(25,002
|
)
|
||||||||||
Effects of exchange rate movements on cash held
|
(296
|
)
|
71
|
158
|
||||||||||||
Cash and cash equivalents and short-term investments at beginning of year
|
57,607
|
77,109
|
101,953
|
|||||||||||||
|
||||||||||||||||
Cash and cash equivalents and short term investments at end of year
|
18,19
|
30,277
|
57,607
|
77,109
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES
|
i) |
General information
|
ii) |
Statement of compliance
|
iii) |
Basis of preparation
|
iv) |
Basis of consolidation
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
v) |
Property, plant and equipment
|
• Leasehold improvements
|
5-15 years
|
|
• Buildings
|
50 years
|
|
• Office equipment and fittings
|
10 years
|
|
• Computer equipment
|
3-5 years
|
|
• Plant and equipment
|
5-15 years
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
vi) |
Goodwill
|
vii) |
Intangibles, including research and development (other than goodwill)
|
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 many 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.
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
viii) |
Impairment
|
ix) |
Inventories
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
x) |
Trade and other receivables
|
xi) |
Trade and other payables
|
xii) |
Cash and cash equivalents
|
xiii) |
Short-term investments
|
xiv) |
Share-based payments
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
xv) |
Government grants
|
xvi) |
Revenue recognition
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
xvii) |
Employee benefits
|
xviii) |
Foreign currency
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
xix) |
Hedging
|
xx) |
Exchangeable notes and derivative financial instruments
|
xxi) |
Segment reporting
|
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
|
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
|
International Financial Reporting Standards (IFRS/IAS)
|
Effective date
|
|
IFRS 16
|
Leases
|
January 1, 2019 (issued by the IASB with effectivity date of January 1, 2019)
|
IFRIC 23
|
Uncertainty over income tax
|
January 1, 2019 (issued by the IASB with effectivity date of January 1, 2019)
|
• |
Depreciation charge for Right-of-Use assets
|
• |
Additions to Right-of-Use assets
|
• |
Financial expense for lease liabilities
|
• |
Expense recognised for short term leases (<12mths)
|
• |
Expense recognised for low value leases
|
• |
Income from subletting Right-of-Use assets
|
• |
Total cash outflow for leases
|
• |
IFRS 2 Share-based Payments – Classification and Measurement of Share-based Payment Transactions
|
• |
IFRS 15 Revenue from Contracts with Customers
|
• |
IFRS 9 Financial Instruments
|
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, 2018
|
US$‘000
|
US$‘000
|
US$‘000
|
US$’000
|
US$‘000
|
|||||||||||||||
Revenue from external customers
|
65,863
|
31,172
|
—
|
—
|
97,035
|
|||||||||||||||
Inter-segment revenue
|
38,665
|
2,899
|
—
|
(41,564
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total revenue
|
104,528
|
34,071
|
—
|
(41,564
|
)
|
97,035
|
||||||||||||||
|
Rest of World
|
|||||||||||||||||||
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
Year ended December 31, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$’000
|
US$‘000
|
|||||||||||||||
Revenue from external customers
|
66,092
|
33,048
|
—
|
—
|
99,140
|
|||||||||||||||
Inter-segment revenue
|
42,147
|
3,587
|
—
|
(45,734
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total revenue
|
108,239
|
36,635
|
—
|
(45,734
|
)
|
99,140
|
||||||||||||||
|
Rest of World
|
|||||||||||||||||||
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
Year ended December 31, 2016
|
US$‘000
|
US$‘000
|
US$‘000
|
US$’000
|
US$‘000
|
|||||||||||||||
Revenue from external customers
|
63,889
|
35,718
|
4
|
—
|
99,611
|
|||||||||||||||
Inter-segment revenue
|
39,322
|
5,349
|
348
|
(45,019
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total revenue
|
103,211
|
41,067
|
352
|
(45,019
|
)
|
99,611
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
ii) |
The distribution of revenue by customers’ geographical area was as follows:
|
Revenue
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Americas
|
57,559
|
59,539
|
61,613
|
|||||||||
Asia / Africa
|
29,466
|
27,131
|
25,501
|
|||||||||
Europe (including Ireland) *
|
10,010
|
12,470
|
12,497
|
|||||||||
|
||||||||||||
|
97,035
|
99,140
|
99,611
|
* |
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, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Clinical laboratory
|
71,618
|
73,366
|
74,166
|
|||||||||
Point-of-Care
|
14,836
|
16,774
|
16,908
|
|||||||||
Laboratory services
|
10,581
|
9,000
|
8,537
|
|||||||||
|
||||||||||||
|
97,035
|
99,140
|
99,611
|
iv) |
The group has recognised the following amounts relating to revenue in the consolidated statement of operations:
|
Revenue
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Revenue from contracts with customers (a)
|
97,035
|
99,140
|
99,611
|
|||||||||
Revenue from other sources
|
—
|
—
|
—
|
|||||||||
|
||||||||||||
|
97,035
|
99,140
|
99,611
|
(a) |
Disaggregation of revenue from contracts with customers:
|
Timing of revenue recognition
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2018
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
64,941
|
31,172
|
—
|
96,113
|
||||||||||||
Over time
|
922
|
—
|
—
|
922
|
||||||||||||
|
||||||||||||||||
Total
|
65,863
|
31,172
|
—
|
97,035
|
Timing of revenue recognition
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
65,164
|
33,048
|
—
|
98,212
|
||||||||||||
Over time
|
928
|
—
|
—
|
928
|
||||||||||||
|
||||||||||||||||
Total
|
66,092
|
33,048
|
—
|
99,140
|
Timing of revenue recognition
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2016
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
63,015
|
35,718
|
4
|
98,737
|
||||||||||||
Over time
|
874
|
—
|
—
|
874
|
||||||||||||
|
||||||||||||||||
Total
|
63,889
|
35,718
|
4
|
99,611
|
(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, 2018
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
56,637
|
29,466
|
10,010
|
96,113
|
||||||||||||
Over time
|
922
|
—
|
—
|
922
|
||||||||||||
|
||||||||||||||||
Total
|
57,559
|
29,466
|
10,010
|
97,035
|
Timing of revenue recognition
|
Americas
|
Asia / Africa
|
Europe
|
Total
|
||||||||||||
Year ended December 31, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
58,611
|
27,131
|
12,470
|
98,212
|
||||||||||||
Over time
|
928
|
—
|
—
|
928
|
||||||||||||
|
||||||||||||||||
Total
|
59,539
|
27,131
|
12,470
|
99,140
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
Timing of revenue recognition
|
Americas
|
Asia / Africa
|
Europe
|
Total
|
||||||||||||
Year ended December 31, 2016
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
60,739
|
25,501
|
12,497
|
98,737
|
||||||||||||
Over time
|
874
|
—
|
—
|
874
|
||||||||||||
|
||||||||||||||||
Total
|
61,613
|
25,501
|
12,497
|
99,611
|
v) |
The distribution of segment results by geographical area was as follows:
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2018
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result before impairment
|
5,514
|
1,900
|
(44
|
)
|
7,370
|
|||||||||||
Impairment
|
(19,095
|
)
|
(7,837
|
)
|
—
|
(26,932
|
)
|
|||||||||
|
||||||||||||||||
Result after impairment
|
(13,581
|
)
|
(5,937
|
)
|
(44
|
)
|
(19,562
|
)
|
||||||||
Unallocated expenses *
|
(665
|
)
|
||||||||||||||
|
||||||||||||||||
Operating loss
|
(20,227
|
)
|
||||||||||||||
Net financing expense (Note 3)
|
(2,956
|
)
|
||||||||||||||
|
||||||||||||||||
Loss before tax
|
(23,183
|
)
|
||||||||||||||
Income tax credit (Note 9)
|
525
|
|||||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
(22,658
|
)
|
||||||||||||||
Profit for the year on discontinued operations (Note 10)
|
568
|
|||||||||||||||
|
||||||||||||||||
Loss for the year
|
(22,090
|
)
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result before impairment
|
3,744
|
1,125
|
(44
|
)
|
4,825
|
|||||||||||
Impairment
|
(9,194
|
)
|
(32,561
|
)
|
—
|
(41,755
|
)
|
|||||||||
|
||||||||||||||||
Result after impairment
|
(5,450
|
)
|
(31,436
|
)
|
(44
|
)
|
(36,930
|
)
|
||||||||
Unallocated expenses *
|
(738
|
)
|
||||||||||||||
|
||||||||||||||||
Operating loss
|
(37,668
|
)
|
||||||||||||||
Net financing expense (Note 3)
|
(2,207
|
)
|
||||||||||||||
|
||||||||||||||||
Loss before tax
|
(39,875
|
)
|
||||||||||||||
Income tax credit (Note 9)
|
1,214
|
|||||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
(38,661
|
)
|
||||||||||||||
Loss for the year on discontinued operations (Note 10)
|
(1,609
|
)
|
||||||||||||||
|
||||||||||||||||
Loss for the year
|
(40,270
|
)
|
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2016
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result before exceptional expenses
|
4,564
|
4,270
|
384
|
9,218
|
||||||||||||
Impairment
|
(22,989
|
)
|
(20,390
|
)
|
—
|
(43,379
|
)
|
|||||||||
Inventory provision
|
(335
|
)
|
(4,451
|
)
|
—
|
(4,786
|
)
|
|||||||||
|
||||||||||||||||
Result after exceptional expenses
|
(18,760
|
)
|
(20,571
|
)
|
384
|
(38,947
|
)
|
|||||||||
Unallocated expenses *
|
(901
|
)
|
||||||||||||||
|
||||||||||||||||
Operating profit
|
(39,848
|
)
|
||||||||||||||
Net financing expense (Note 3)
|
(2,292
|
)
|
||||||||||||||
|
||||||||||||||||
Loss before tax
|
(42,140
|
)
|
||||||||||||||
Income tax credit (Note 9)
|
3,557
|
|||||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
(38,583
|
)
|
||||||||||||||
Loss for the year on discontinued operations (Note 10)
|
(62,042
|
)
|
||||||||||||||
|
||||||||||||||||
Loss for the year
|
(100,625
|
)
|
* |
Unallocated expenses represent head office general and administration costs of the Group which cannot be allocated to the results of any specific geographical area.
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
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, 2018
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Assets and liabilities
|
||||||||||||||||
Segment assets
|
75,658
|
38,009
|
4
|
113,671
|
||||||||||||
Unallocated assets:
|
||||||||||||||||
Income tax assets (current and deferred)
|
7,711
|
|||||||||||||||
Cash and cash equivalents and short-term investments
|
30,277
|
|||||||||||||||
Total assets as reported in the Group balance sheet
|
151,659
|
|||||||||||||||
|
||||||||||||||||
Segment liabilities
|
8,946
|
90,444
|
150
|
99,540
|
||||||||||||
Unallocated liabilities:
|
||||||||||||||||
Income tax liabilities (current and deferred)
|
8,065
|
|||||||||||||||
|
||||||||||||||||
Total liabilities as reported in the Group balance sheet
|
107,605
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
As at December 31, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Assets and liabilities
|
||||||||||||||||
Segment assets
|
88,714
|
36,513
|
3
|
125,230
|
||||||||||||
Unallocated assets:
|
||||||||||||||||
Income tax assets (current and deferred)
|
10,137
|
|||||||||||||||
Cash and cash equivalents and short-term investments
|
57,607
|
|||||||||||||||
|
||||||||||||||||
Total assets as reported in the Group balance sheet
|
192,974
|
|||||||||||||||
|
||||||||||||||||
Segment liabilities
|
11,486
|
104,901
|
249
|
116,636
|
||||||||||||
Unallocated liabilities:
|
||||||||||||||||
Income tax liabilities (current and deferred)
|
11,142
|
|||||||||||||||
|
||||||||||||||||
Total liabilities as reported in the Group balance sheet
|
127,778
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
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), by geographical area was as follows:
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
||||||
Rest of World – Ireland
|
14,864
|
15,873
|
||||||
Rest of World – Other
|
—
|
—
|
||||||
Americas
|
44,007
|
55,812
|
||||||
|
||||||||
|
58,871
|
71,685
|
viii) |
The distribution of depreciation and amortisation by geographical area was as follows:
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Depreciation:
|
||||||||||||
Rest of World – Ireland
|
74
|
1,186
|
1,072
|
|||||||||
Rest of World – Other
|
—
|
—
|
304
|
|||||||||
Americas
|
1,301
|
1,238
|
2,197
|
|||||||||
|
||||||||||||
|
1,375
|
2,424
|
3,573
|
|||||||||
|
||||||||||||
Amortisation:
|
||||||||||||
Rest of World – Ireland
|
655
|
1,164
|
1,533
|
|||||||||
Americas
|
2,170
|
2,139
|
1,440
|
|||||||||
|
||||||||||||
|
2,825
|
3,303
|
2,973
|
ix) |
The distribution of share-based payment expense by geographical area was as follows:
|
|
December 31, 2018
US$‘000 |
December 31, 2017
US$‘000 |
December 31, 2016
US$‘000 |
|||||||||
Rest of World – Ireland
|
1,265
|
841
|
1,187
|
|||||||||
Rest of World – Other
|
—
|
—
|
41
|
|||||||||
Americas
|
104
|
87
|
153
|
|||||||||
|
||||||||||||
|
1,369
|
928
|
1,381
|
|||||||||
Share based-payments – discontinued operations
|
—
|
—
|
33
|
|||||||||
|
||||||||||||
|
1,369
|
928
|
1,414
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
x) |
The distribution of interest income and interest expense by geographical area was as follows:
|
|
Rest of World
|
|||||||||||||||||||
Interest Income
Year ended December 31, 2018
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$‘000
|
Total
US$‘000
|
|||||||||||||||
Interest income earned
|
32
|
704
|
—
|
—
|
736
|
|||||||||||||||
Non-cash financial income
|
—
|
1,388
|
—
|
—
|
1,388
|
|||||||||||||||
Inter-segment interest income
|
—
|
—
|
4,853
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
32
|
2,092
|
4,853
|
(4,853
|
)
|
2,124
|
|
Rest of World
|
|||||||||||||||||||
Interest Expense
Year ended December 31, 2018
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$‘000
|
Total
US$’000
|
|||||||||||||||
Interest on finance leases
|
7
|
32
|
—
|
—
|
39
|
|||||||||||||||
Cash interest on exchangeable notes
|
—
|
4,352
|
—
|
—
|
4,352
|
|||||||||||||||
Non-cash interest on exchangeable notes ( Note 24)
|
—
|
689
|
—
|
—
|
689
|
|||||||||||||||
Inter-segment interest expense
|
4,853
|
—
|
—
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
4,860
|
5,073
|
—
|
(4,853
|
)
|
5,080
|
|
Rest of World
|
|||||||||||||||||||
Interest Income
Year ended December 31, 2017
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
US$‘000
|
US$‘000
|
US$‘000
|
US$’000
|
US$‘000
|
||||||||||||||||
Interest income earned
|
44
|
764
|
—
|
—
|
808
|
|||||||||||||||
Non-cash financial income
|
—
|
2,390
|
—
|
—
|
2,390
|
|||||||||||||||
Inter-segment interest income
|
—
|
—
|
4,853
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
44
|
3,154
|
4,853
|
(4,853
|
)
|
3,198
|
|
Rest of World
|
|||||||||||||||||||
Interest Expense
Year ended December 31, 2017
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$’000
|
Total
US$‘000
|
|||||||||||||||
Interest on deferred consideration and licence fee
|
—
|
40
|
—
|
—
|
40
|
|||||||||||||||
Interest on finance leases
|
—
|
42
|
—
|
—
|
42
|
|||||||||||||||
Cash interest on exchangeable notes
|
—
|
4,600
|
—
|
—
|
4,600
|
|||||||||||||||
Non-cash interest on exchangeable notes ( Note 24)
|
—
|
723
|
—
|
—
|
723
|
|||||||||||||||
Inter-segment interest expense
|
4,853
|
—
|
—
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
4,853
|
5,405
|
—
|
(4,853
|
)
|
5,405
|
|
Rest of World
|
|||||||||||||||||||
Interest Income
Year ended December 31, 2016
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$’000
|
Total
US$‘000
|
|||||||||||||||
Interest income earned
|
21
|
856
|
—
|
—
|
877
|
|||||||||||||||
Non-cash financial income
|
—
|
2,270
|
—
|
—
|
2,270
|
|||||||||||||||
Inter-segment interest income
|
—
|
—
|
4,853
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
21
|
3,126
|
4,853
|
(4,853
|
)
|
3,147
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
|
Rest of World
|
|||||||||||||||||||
Interest Expense
Year ended December 31, 2016
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$’000
|
Total
US$‘000
|
|||||||||||||||
Interest on deferred consideration and licence fee
|
—
|
66
|
—
|
—
|
66
|
|||||||||||||||
Interest on finance leases
|
—
|
55
|
—
|
—
|
55
|
|||||||||||||||
Cash interest on exchangeable notes
|
—
|
4,600
|
—
|
—
|
4,600
|
|||||||||||||||
Non-cash interest on exchangeable notes
|
—
|
718
|
—
|
—
|
718
|
|||||||||||||||
Inter-segment interest expense
|
4,853
|
—
|
—
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
4,853
|
5,439
|
—
|
(4,853
|
)
|
5,439
|
xi) |
The distribution of taxation (expense)/credit by geographical area was as follows:
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Rest of World – Ireland
|
(59
|
)
|
192
|
2,038
|
||||||||
Rest of World – Other
|
(3
|
)
|
(81
|
)
|
(48
|
)
|
||||||
Americas
|
587
|
1,103
|
1,567
|
|||||||||
|
||||||||||||
|
525
|
1,214
|
3,557
|
xii) |
During 2018, 2017 and 2016 there were no customers generating 10% or more of total revenues.
|
xiii) |
The distribution of capital expenditure by geographical area was as follows:
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
||||||
Rest of World – Ireland
|
7,148
|
7,602
|
||||||
Rest of World – Other
|
1,746
|
—
|
||||||
Americas
|
8,911
|
8,080
|
||||||
|
||||||||
|
17,805
|
15,682
|
3. |
FINANCIAL INCOME AND EXPENSES
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Financial income:
|
||||||||||||
Non-cash financial income
|
1,388
|
2,390
|
2,270
|
|||||||||
Interest income
|
736
|
808
|
877
|
|||||||||
|
||||||||||||
|
2,124
|
3,198
|
3,147
|
|||||||||
|
||||||||||||
Financial expense:
|
||||||||||||
Interest on finance leases
|
(39
|
)
|
(42
|
)
|
(55
|
)
|
||||||
Cash interest on exchangeable notes
|
(4,352
|
)
|
(4,600
|
)
|
(4,600
|
)
|
||||||
Non-cash interest on exchangeable notes (Note 24)
|
(689
|
)
|
(723
|
)
|
(718
|
)
|
||||||
Interest on deferred consideration and licence fee
|
-
|
(40
|
)
|
(66
|
)
|
|||||||
|
||||||||||||
|
(5,080
|
)
|
(5,405
|
)
|
(5,439
|
)
|
||||||
Net Financing Expense
|
(2,956
|
)
|
(2,207
|
)
|
(2,292
|
)
|
4. |
OTHER OPERATING INCOME
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Rental income from premises
|
3
|
-
|
135
|
|||||||||
Other income
|
99
|
100
|
104
|
|||||||||
|
||||||||||||
|
102
|
100
|
239
|
5. |
LOSS BEFORE TAX
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Directors’ emoluments (including non- executive directors):
|
||||||||||||
Remuneration
|
1,261
|
1,800
|
1,946
|
|||||||||
Pension
|
44
|
44
|
41
|
|||||||||
Share based payments
|
1,204
|
727
|
1,121
|
|||||||||
Auditor’s remuneration
|
||||||||||||
Audit fees
|
506
|
568
|
469
|
|||||||||
Tax fees
|
15
|
73
|
33
|
|||||||||
Other non audit fees
|
-
|
-
|
19
|
|||||||||
Depreciation*
|
1,296
|
1,896
|
2,856
|
|||||||||
Amortisation
|
2,825
|
3,303
|
2,973
|
|||||||||
Loss on the disposal of property, plant and equipment
|
15
|
3
|
15
|
|||||||||
Net foreign exchange differences**
|
344
|
(17
|
)
|
888
|
||||||||
Operating lease rentals:
|
||||||||||||
Land and buildings
|
2,792
|
2,846
|
2,811
|
|||||||||
Other equipment
|
158
|
163
|
114
|
* |
Note that US$79,000 (2017: US$528,000) (2016: US$414,000) of depreciation was capitalised to research and development projects during 2018 in line with the Group’s capitalisation policy for Intangible projects.
|
** |
The net foreign exchange differences in 2017 do not include US$440,000 (2016: US$253,000) which were included in the operating expenses that were stated in Note 10 in respect of the discontinued operations in Fiomi.
|
6. |
IMPAIRMENT CHARGES AND INVENTORY PROVISIONING
|
· |
The Company’s market capitalisation at the end of the year that was lower when compared to the end of 2017.
|
· |
The inclusion of the latest cash flow projections and net asset values for each cash generating unit; and
|
· |
Increased volatility in the Company’s share price and higher market interest rates which resulted in a higher discount factor being applied to the Company’s expected future cash flows.
|
December
|
December
|
December
|
||||||||||
31, 2018 | 31, 2017 | 31, 2016 | ||||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Selling, general & administration expenses
|
||||||||||||
Impairment of PP&E (Note 12)
|
6,112
|
10,437
|
4,382
|
|||||||||
Impairment of goodwill and other intangible assets (Note 13)
|
19,212
|
29,667
|
38,240
|
|||||||||
Impairment of prepayments (Note 17)
|
1,608
|
1,651
|
757
|
|||||||||
Product discontinuation (Note 16)
|
—
|
—
|
4,786
|
|||||||||
|
||||||||||||
Total impairment loss and inventory provisioning before tax
|
26,932
|
41,755
|
48,165
|
|||||||||
|
(
|
(
|
||||||||||
Income tax impact of impairment loss and inventory provisioning
|
(1,752
|
)
|
(517
|
)
|
(3,783
|
)
|
||||||
|
||||||||||||
Total impairment loss after tax
|
25,180
|
41,238
|
44,382
|
7. |
PERSONNEL EXPENSES
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Wages and salaries
|
26,475
|
26,316
|
25,901
|
|||||||||
Social welfare costs
|
2,585
|
2,424
|
2,542
|
|||||||||
Pension costs
|
490
|
459
|
552
|
|||||||||
Share-based payments
|
1,369
|
928
|
1,414
|
|||||||||
Restructuring costs
|
-
|
-
|
1,276
|
|||||||||
|
||||||||||||
|
30,919
|
30,127
|
31,685
|
|
December 31, 2018
|
December 31, 2017
|
December 31, 2016
|
|||||||||
Research and development
|
59
|
60
|
73
|
|||||||||
Administration and sales
|
163
|
162
|
161
|
|||||||||
Manufacturing and quality
|
353
|
334
|
348
|
|||||||||
|
||||||||||||
|
575
|
556
|
582
|
8. |
PENSION SCHEMES
|
9. |
INCOME TAX (CREDIT)/EXPENSE
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Current tax (credit)/expense
|
||||||||||||
Irish Corporation tax
|
(258
|
)
|
(51
|
)
|
(240
|
)
|
||||||
Foreign taxes (a)
|
195
|
358
|
222
|
|||||||||
Adjustment in respect of prior years
|
(56
|
)
|
150
|
(271
|
)
|
|||||||
|
||||||||||||
Total current tax (credit)/expense
|
(119
|
)
|
457
|
(289
|
)
|
|||||||
|
||||||||||||
Deferred tax credit (b)
|
||||||||||||
Origination and reversal of temporary differences (see Note 14)
|
(2,031
|
)
|
(5,969
|
)
|
(2,872
|
)
|
||||||
Origination and reversal of net operating losses (see Note 14)
|
1,625
|
4,298
|
(396
|
)
|
||||||||
|
||||||||||||
Total deferred tax credit
|
(406
|
)
|
(1,671
|
)
|
(3,268
|
)
|
||||||
|
||||||||||||
Total income tax credit on continuing operations in statement of operations
|
(525
|
)
|
(1,214
|
)
|
(3,557
|
)
|
||||||
|
||||||||||||
Tax (credit)/charge on discontinued operations (see Note 10)
|
(590
|
)
|
323
|
(4,887
|
)
|
|||||||
|
||||||||||||
Total tax credit
|
(1,115
|
)
|
(891
|
)
|
(8,444
|
)
|
(a) |
In 2018, the foreign taxes relate primarily to Canada.
|
(b) |
In 2018, there was a deferred tax charge of US$369,000 (2017: credit of US$170,000; 2016: credit of US$1,804,000) recognised in respect of Ireland and a deferred tax credit of US$775,000 (2017: credit of US$1,501,000; 2016: credit of US$1,464,000) recognised in respect of overseas tax jurisdictions.
|
Effective tax rate
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Loss before taxation
|
(23,183
|
)
|
(39,875
|
)
|
(42,140
|
)
|
||||||
As a percentage of loss before tax:
|
||||||||||||
Current tax
|
(0.51
|
)%
|
1.14
|
%
|
(0.69
|
)%
|
||||||
Total (current and deferred)
|
(2.26
|
)%
|
(3.05
|
)%
|
(8.44
|
)%
|
|
December 31, 2018
|
December 31, 2017
|
December 31, 2016
|
|||||||||
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)
|
15.76
|
)%
|
12.05
|
%
|
6.22
|
%
|
||||||
Effect of tax rates on overseas earnings
|
(6.10
|
)%
|
(2.09
|
)%
|
(1.39
|
)%
|
||||||
Effect of Irish income taxable at higher tax rate
|
0.05
|
%
|
-
|
0.05
|
%
|
|||||||
Adjustments in respect of prior years
|
0.94
|
%
|
0.38
|
%
|
(0.64
|
)%
|
||||||
Effect of changes in US tax code (b)
|
-
|
(1.89
|
)%
|
-
|
||||||||
R&D tax credits
|
(1.70
|
)%
|
(0.17
|
)%
|
(0.65
|
)%
|
||||||
Other items (c)
|
1.29
|
%
|
1.17
|
%
|
0.47
|
%
|
||||||
|
||||||||||||
Effective tax rate
|
(2.26
|
)%
|
(3.05
|
)%
|
(8.44
|
)%
|
9. |
INCOME TAX (CREDIT)/EXPENSE (CONTINUED)
|
(a) |
The effect of current year net operating losses and temporary differences for which no deferred tax asset was recognised is analyzed further in the table below (see also Note 14). No deferred tax asset was recognised because there was no reversing deferred tax liability in the same jurisdiction reversing in the same period and no future taxable income in the same jurisdiction.
|
(b) |
In 2017, a number of changes were made to the USA tax code, the most significant of which was the reduction in the federal corporation tax rate to 21%. This resulted in a once-off tax credit in 2017 of US$753,000 arising from the reduction in deferred tax balances due to the tax rate change, partially offset by the effect of mandatory deemed repatriation of certain deferred foreign earnings. The other changes to the USA tax code did not have a material impact on the Group.
|
(c) |
Other items comprise items not chargeable to tax/expenses not deductible for tax. In 2018, other items mainly comprise the movement in the exchangeable notes’ embedded derivatives value and the accretion of notional interest on the Loan Note’s host contract, both of which are exempt from deferred taxation recognition under IAS 12, Income Taxes.
|
Unrecognised deferred tax assets – continuing operations
|
Effect in
2018
US$’000
|
Percentage
effect in
2018
|
Effect in
2017
US$’000
|
Percentage
effect in
2017
|
||||||||||||
Increase in net operating losses arising in US
|
2,174
|
9.38
|
%
|
-
|
-
|
|||||||||||
Temporary differences arising in US
|
19
|
0.08
|
%
|
68
|
0.17
|
%
|
||||||||||
Decrease in net operating losses arising in Brazil
|
(20
|
)
|
(0.09
|
)%
|
(714
|
)
|
(1.79
|
)%
|
||||||||
Increase in net operating losses arising in Ireland
|
1,482
|
6.39
|
%
|
5,452
|
13.67
|
%
|
||||||||||
|
||||||||||||||||
|
3,655
|
15.76
|
%
|
4,806
|
12.05
|
%
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Rest of World – Ireland
|
(9,590
|
)
|
(35,821
|
)
|
(23,787
|
)
|
||||||
Rest of World – Other
|
4,809
|
4,809
|
5,241
|
|||||||||
Americas
|
(18,402
|
)
|
(8,863
|
)
|
(23,594
|
)
|
||||||
|
||||||||||||
|
(23,183
|
)
|
(39,875
|
)
|
(42,140
|
)
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
USA
|
2,382
|
7,737
|
8,896
|
|||||||||
Ireland
|
60,629
|
57,206
|
40,652
|
|||||||||
Brazil
|
4,001
|
4,060
|
6,159
|
|||||||||
|
||||||||||||
|
67,012
|
69,003
|
55,707
|
9. |
INCOME TAX (CREDIT)/EXPENSE (CONTINUED)
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Ireland – unused tax losses
|
9,953
|
8,471
|
3,019
|
|||||||||
US – unused tax credits
|
2,538
|
345
|
277
|
|||||||||
Brazil – unused tax losses
|
1,360
|
1,380
|
2,094
|
|||||||||
|
||||||||||||
Unrecognised deferred tax asset
|
13,851
|
10,196
|
5,390
|
10. |
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATIONS
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Revenues
|
—
|
—
|
—
|
|||||||||
Operating expenses
|
—
|
—
|
(827
|
)
|
||||||||
|
||||||||||||
Operating loss
|
—
|
—
|
(827
|
)
|
||||||||
Interest expenses
|
—
|
—
|
(5
|
)
|
||||||||
|
||||||||||||
Loss from discontinued operations before tax
|
—
|
—
|
(832
|
)
|
||||||||
Income tax credit/(expense)
|
—
|
—
|
186
|
|||||||||
|
||||||||||||
Loss for the year
|
—
|
—
|
(646
|
)
|
||||||||
Profit/(Loss) on remeasurement of assets and liabilities:
|
||||||||||||
Property, plant and equipment (note 12)
|
—
|
—
|
(4,647
|
)
|
||||||||
Goodwill and intangible assets (note 13)
|
—
|
—
|
(49,433
|
)
|
||||||||
Inventories
|
—
|
—
|
(2,578
|
)
|
||||||||
Closure costs
|
(22
|
)
|
1,794
|
(5,846
|
)
|
|||||||
Foreign currency translation reserve
|
—
|
(3,080
|
)
|
(3,779
|
)
|
|||||||
Tax credit/(expense)
|
590
|
(323
|
)
|
4,887
|
||||||||
|
||||||||||||
Total profit/(loss)
|
568
|
(1,609
|
)
|
(61,396
|
)
|
|||||||
Profit/(Loss) for the year from discontinued operations
|
568
|
(1,609
|
)
|
(62,042
|
)
|
10. |
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATIONS (CONTINUED)
|
|
December 31,
2018 |
December 31,
2017 |
December 31,
2016 |
|||||||||
Basic earnings/(loss) per ADS (US Dollars) – discontinued operations
|
0.03
|
(0.07
|
)
|
(2.70
|
)
|
|||||||
Diluted earnings/(loss per ADS (US Dollars) – discontinued operations
|
0.02
|
(0.07
|
)
|
(2.70
|
)
|
|||||||
Basic earnings/(loss) per ‘A’ share (US Dollars) – discontinued operations
|
0.01
|
(0.02
|
)
|
(0.68
|
)
|
|||||||
Diluted earnings/(loss) per ‘A’ share (US Dollars) – discontinued operations
|
0.01
|
(0.02
|
)
|
(0.68
|
)
|
|
December 31,
2018 |
December 31,
2017 |
December 31,
2016 |
|||||||||
Cash flows from operating activities
|
527
|
(2,847
|
)
|
(1,623
|
)
|
|||||||
Cash flows from investing activities
|
-
|
-
|
(8,989
|
)
|
11. |
(LOSS)/EARNINGS PER SHARE
|
|
December 31,
2018 |
December 31,
2017 |
December 31,
2016 |
|||||||||
‘A’ ordinary shares
|
83,612,908
|
86,486,409
|
91,858,813
|
|||||||||
|
||||||||||||
Basic earnings per share denominator
|
83,612,908
|
86,486,409
|
91,858,813
|
|||||||||
|
||||||||||||
Reconciliation to weighted average earnings per share denominator:
|
||||||||||||
Number of ‘A’ ordinary shares at January 1 (Note 20)
|
96,162,410
|
96,162,410
|
95,840,138
|
|||||||||
Weighted average number of shares issued during the year*
|
-
|
-
|
120,396
|
|||||||||
Weighted average number of treasury shares
|
(12,549,502
|
)
|
(9,676,001
|
)
|
(4,101,721
|
)
|
||||||
|
||||||||||||
Basic earnings per share denominator
|
83,612,908
|
86,486,409
|
91,858,813
|
|
December 31,
2018
|
December 31,
2017
|
December 31,
2016
|
|||||||||
Basic earnings per share denominator (see above)
|
83,612,908
|
86,486,409
|
91,858,813
|
|||||||||
Issuable on exercise of options and warrants
|
22,359
|
-
|
315,019
|
|||||||||
Issuable on conversion of exchangeable notes
|
19,873,553
|
21,023,770
|
21,023,766
|
|||||||||
|
||||||||||||
Diluted earnings per share denominator
|
103,508,820
|
107,510,179
|
113,197,598
|
11. |
(LOSS)/EARNINGS PER SHARE (CONTINUED)
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
|||||||||
Loss after tax for the year
|
(22,090
|
)
|
(40,270
|
)
|
(100,625
|
)
|
||||||
Non-cash financial income
|
(1,388
|
)
|
(2,390
|
)
|
(2,270
|
)
|
||||||
Cash interest expense
|
4,352
|
4,600
|
4,600
|
|||||||||
Non-cash interest on exchangeable notes
|
689
|
723
|
718
|
|||||||||
|
||||||||||||
Adjusted loss after tax
|
(18,437
|
)
|
(37,337
|
)
|
(97,577
|
)
|
|
December 31,
2018
|
December 31,
2017
|
December 31,
2016
|
|||||||||
ADS
|
20,903,227
|
21,621,602
|
22,964,703
|
|||||||||
|
||||||||||||
Basic earnings per share denominator
|
20,903,227
|
21,621,602
|
22,964,703
|
|||||||||
|
||||||||||||
Reconciliation to weighted average earnings per share denominator:
|
||||||||||||
Number of ADS at January 1 (Note 20)
|
24,040,602
|
24,040,602
|
23,960,035
|
|||||||||
Weighted average number of shares issued during the year*
|
-
|
-
|
30,098
|
|||||||||
Weighted average number of treasury shares
|
(3,137,375
|
)
|
(2,419,000
|
)
|
(1,025,430
|
)
|
||||||
|
||||||||||||
Basic earnings per share denominator
|
20,903,227
|
21,621,602
|
22,964,703
|
|
December 31,
2018
|
December 31,
2017
|
December 31,
2016
|
|||||||||
Basic earnings per share denominator (see above)
|
20,903,227
|
21,621,602
|
22,964,703
|
|||||||||
Issuable on exercise of options and warrants
|
5,590
|
-
|
78,755
|
|||||||||
Issuable on conversion of exchangeable notes
|
4,968,388
|
5,255,942
|
5,255,941
|
|||||||||
|
||||||||||||
Diluted earnings per share denominator
|
25,877,205
|
26,877,544
|
28,299,399
|
12. |
PROPERTY, PLANT AND EQUIPMENT
|
|
Freehold land
and buildings
US$‘000
|
Leasehold
improvements
US$‘000
|
Computers,
fixtures and
fittings
US$‘000
|
Plant and
equipment
US$‘000
|
Total
US$‘000
|
|||||||||||||||
Cost
|
||||||||||||||||||||
At January 1, 2017
|
2,603
|
3,031
|
5,995
|
36,484
|
48,113
|
|||||||||||||||
Additions
|
—
|
465
|
302
|
4,491
|
5,258
|
|||||||||||||||
Disposals or retirements
|
(9
|
)
|
(488
|
)
|
(404
|
)
|
(3,083
|
)
|
(3,984
|
)
|
||||||||||
Exchange adjustments
|
30
|
(4
|
)
|
1
|
3
|
30
|
||||||||||||||
|
||||||||||||||||||||
At December 31, 2017
|
2,624
|
3,004
|
5,894
|
37,895
|
49,417
|
|||||||||||||||
|
||||||||||||||||||||
At January 1, 2018
|
2,624
|
3,004
|
5,894
|
37,895
|
49,417
|
|||||||||||||||
Additions
|
19
|
1,609
|
829
|
5,068
|
7,525
|
|||||||||||||||
Disposals or retirements
|
—
|
(1
|
)
|
(131
|
)
|
(1,804
|
)
|
(1,936
|
)
|
|||||||||||
Exchange adjustments
|
(38
|
)
|
(52
|
)
|
(7
|
)
|
(1,095
|
)
|
(1,192
|
)
|
||||||||||
|
||||||||||||||||||||
At December 31, 2018
|
2,605
|
4,560
|
6,585
|
40,064
|
53,814
|
|||||||||||||||
|
||||||||||||||||||||
Accumulated depreciation and impairment losses
|
||||||||||||||||||||
At January 1, 2017
|
(1,206
|
)
|
(2,716
|
)
|
(5,064
|
)
|
(25,724
|
)
|
(34,710
|
)
|
||||||||||
Charge for the year
|
(82
|
)
|
(165
|
)
|
(263
|
)
|
(1,914
|
)
|
(2,424
|
)
|
||||||||||
Impairment loss
|
—
|
(267
|
)
|
(383
|
)
|
(9,787
|
)
|
(10,437
|
)
|
|||||||||||
Disposals or retirements
|
9
|
488
|
402
|
3,062
|
3,961
|
|||||||||||||||
Exchange adjustments
|
(4
|
)
|
1
|
—
|
(4
|
)
|
(7
|
)
|
||||||||||||
|
||||||||||||||||||||
At December 31, 2017
|
(1,283
|
)
|
(2,659
|
)
|
(5,308
|
)
|
(34,367
|
)
|
(43,617
|
)
|
||||||||||
|
||||||||||||||||||||
At January 1, 2018
|
(1,283
|
)
|
(2,659
|
)
|
(5,308
|
)
|
(34,367
|
)
|
(43,617
|
)
|
||||||||||
Charge for the year
|
(80
|
)
|
(47
|
)
|
(185
|
)
|
(1,063
|
)
|
(1,375
|
)
|
||||||||||
Impairment loss
|
(578
|
)
|
(543
|
)
|
(423
|
)
|
(4,568
|
)
|
(6,112
|
)
|
||||||||||
Disposals or retirements
|
—
|
—
|
130
|
1,679
|
1,809
|
|||||||||||||||
Exchange adjustments
|
7
|
6
|
3
|
827
|
843
|
|||||||||||||||
|
||||||||||||||||||||
At December 31, 2018
|
(1,934
|
)
|
(3,243
|
)
|
(5,783
|
)
|
(37,492
|
)
|
(48,452
|
)
|
||||||||||
7
|
||||||||||||||||||||
Carrying amounts
|
||||||||||||||||||||
At December 31, 2018
|
671
|
1,317
|
802
|
2,572
|
5,362
|
|||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
At December 31, 2017
|
1,341
|
345
|
586
|
3,528
|
5,800
|
12. |
PROPERTY, PLANT AND EQUIPMENT (CONTINUED)
|
13. |
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, 2017
|
81,689
|
126,619
|
9,925
|
33,701
|
251,934
|
|||||||||||||||
Additions
|
—
|
10,402
|
22
|
—
|
10,424
|
|||||||||||||||
Disposals
|
—
|
—
|
—
|
(15
|
)
|
(15
|
)
|
|||||||||||||
Reclassification
|
—
|
(132
|
)
|
—
|
132
|
—
|
||||||||||||||
Exchange adjustments
|
—
|
29
|
—
|
—
|
29
|
|||||||||||||||
At December 31, 2017
|
81,689
|
136,918
|
9,947
|
33,818
|
262,372
|
|||||||||||||||
|
||||||||||||||||||||
At January 1, 2018
|
81,689
|
136,918
|
9,947
|
33,818
|
262,372
|
|||||||||||||||
Additions
|
—
|
9,871
|
—
|
410
|
10,281
|
|||||||||||||||
Disposals
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Reclassification
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Exchange adjustments
|
—
|
(17
|
)
|
—
|
—
|
(17
|
)
|
|||||||||||||
|
||||||||||||||||||||
At December 31, 2018
|
81,689
|
146,772
|
9,947
|
34,228
|
272,636
|
|||||||||||||||
|
||||||||||||||||||||
Accumulated amortisation and Impairment losses
|
||||||||||||||||||||
At January 1, 2017
|
(55,915
|
)
|
(79,653
|
)
|
(9,538
|
)
|
(19,553
|
)
|
(164,659
|
)
|
||||||||||
Charge for the year
|
—
|
(1,708
|
)
|
(17
|
)
|
(1,578
|
)
|
(3,303
|
)
|
|||||||||||
Disposals
|
—
|
—
|
—
|
8
|
8
|
|||||||||||||||
Impairment losses
|
(7,876
|
)
|
(20,782
|
)
|
(173
|
)
|
(836
|
)
|
(29,667
|
)
|
||||||||||
Exchange adjustments
|
—
|
3
|
—
|
—
|
3
|
|||||||||||||||
|
||||||||||||||||||||
At December 31, 2017
|
(63,791
|
)
|
(102,140
|
)
|
(9,728
|
)
|
(21,959
|
)
|
(197,618
|
)
|
||||||||||
|
||||||||||||||||||||
At January 1, 2018
|
(63,791
|
)
|
(102,140
|
)
|
(9,728
|
)
|
(21,959
|
)
|
(197,618
|
)
|
||||||||||
Charge for the year
|
—
|
(1,564
|
)
|
—
|
(1,261
|
)
|
(2,825
|
)
|
||||||||||||
Disposals
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Impairment losses
|
(1,757
|
)
|
(16,773
|
)
|
(86
|
)
|
(596
|
)
|
(19,212
|
)
|
||||||||||
Exchange adjustments
|
—
|
(30
|
)
|
—
|
—
|
(30
|
)
|
|||||||||||||
|
||||||||||||||||||||
At December 31, 2018
|
(65,548
|
)
|
(120,507
|
)
|
(9,814
|
)
|
(23,816
|
)
|
(219,685
|
)
|
||||||||||
|
||||||||||||||||||||
Carrying amounts
|
||||||||||||||||||||
At December 31, 2018
|
16,141
|
26,265
|
133
|
10,412
|
52,951
|
|||||||||||||||
|
||||||||||||||||||||
At December 31, 2017
|
17,898
|
34,778
|
219
|
11,859
|
64,754
|
13. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
Product Name
|
|
2018
US$’000 |
|
2017
US$’000 |
||||
Premier Instrument for Haemoglobin A1c testing1
|
2,653
|
2,601
|
||||||
HIV screening rapid test
|
1,657
|
1,803
|
||||||
G-6-PDH test
|
850
|
812
|
||||||
Uni-gold test enhancement
|
796
|
1,134
|
||||||
Autoimmune Smart Reader
|
746
|
-
|
||||||
Tri-stat Point-of-Care instrument
|
727
|
764
|
||||||
Uni-Gold antigen improvement
|
453
|
258
|
||||||
Sjogrens monoclonal antibodies
|
414
|
376
|
||||||
Column enhancement
|
292
|
252
|
||||||
Ultra Genesys
|
263
|
188
|
||||||
US Lyme
|
-
|
1,156
|
||||||
Autoimmune FDA registrations
|
-
|
273
|
||||||
Other projects
|
1,020
|
785
|
||||||
Total capitalised development costs
|
9,871
|
10,402
|
1 |
The Premier project entails the development of a High Performance Liquid Chromotography (HPLC) instrument for testing haemoglobin A1c (HbA1c). A number of versions of the instrument have been developed including an Ion Exchange version (Premier Resolution). At December 31, 2018 this project had a total carrying amount of US$16,010,000. Amortisation will occur over a 15 year period, commencing on commercialisation of each version of the instrument.
|
13. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
(a) |
The Group only develops products within its field of expertise. The R&D team is experienced in developing new products in this field and this experience means that only products which have a high probability of technical success are put forward for consideration as potential new products.
|
(b) |
A technical feasibility study is undertaken in advance of every project. The feasibility study for each project is reviewed by the R&D team leader, and by other senior management depending on the size of the project. The feasibility study occurs in the initial research phase of the project and costs in this phase are not capitalised.
|
(c) |
Nearly all of our new product developments involve the transfer of our existing product know-how to a new application. The Group does not engage in pure research. Every development project is undertaken with the intention of bringing a particular new product to market for which there is a known demand.
|
(d) |
The commercial feasibility of each new product is established prior to commencement of a project by ensuring it is projected to achieve an acceptable income after applying appropriate discount rates.
|
· |
the Company’s market capitalisation at the end of the year, which was lower when compared to the end of 2017,
|
· |
the inclusion of the latest cash flow projections and net asset values for each cash generating unit; and
|
· |
increased volatility in the Company’s share price and higher market interest rates which resulted in a higher discount factor being applied to the Company’s expected future cash flows.
|
13. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
|
US$’000
|
|||
Primus Corp
|
12,424
|
|||
Trinity Biotech Manufacturing Limited
|
7,837
|
|||
Clark Laboratories Inc.
|
3,377
|
|||
Trinity Biotech Do Brasil
|
2,785
|
|||
Biopool US Inc.
|
509
|
|||
Phoenix Bio-tech Corp
|
-
|
|||
|
||||
Total impairment loss
|
26,932
|
|
US$’000
|
|||
Goodwill and other intangible assets (see Note 13)
|
19,212
|
|||
Property, plant and equipment (see Note 12)
|
6,112
|
|||
Prepayments (see Note 17)
|
1,608
|
|||
|
||||
Total impairment loss
|
26,932
|
13. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
• |
In the event that there was a variation of 10% in the assumed level of future growth in revenues, which would represent a reasonably likely range of outcomes, there would be an additional impairment loss of US$319,000 at December 31, 2018.
|
• |
In the event there was a 10% variation 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 an additional impairment loss of US$3,663,000 at December 31, 2018.
|
Fitzgerald Industries
|
Immco Diagnostics
|
|||||||||||||||
|
December 31,
2018 |
December 31,
2017 |
December 31,
2018 |
December 31,
2017 |
||||||||||||
Carrying amount of goodwill (US$’000)
|
12,592
|
12,592
|
3,575
|
3,575
|
||||||||||||
Discount rate applied (real pre-tax)
|
19.80
|
%
|
17.70
|
%
|
25.38
|
%
|
21.17
|
%
|
||||||||
Excess value-in-use over carrying amount (US$’000)
|
8,847
|
8,397
|
2,502
|
n/a
|
*
|
|||||||||||
% EBITDA would need to decrease for an impairment to arise
|
32.6
|
%
|
30.4
|
%
|
6.9
|
%
|
n/a
|
*
|
||||||||
Long-term growth rate
|
2.0
|
%
|
2.0
|
%
|
2.0
|
%
|
2.0
|
%
|
Intangible Assets with Indefinite Useful lives
(included in other intangibles)
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
||||||
Fitzgerald Industries International CGU
|
||||||||
Fitzgerald trade name
|
970
|
970
|
||||||
RDI trade name
|
560
|
560
|
||||||
Primus Corporation CGU
|
||||||||
Primus trade name
|
547
|
670
|
||||||
Immco Diagnostic CGU
|
||||||||
Immco Diagnostic trade name
|
3,393
|
3,393
|
||||||
Total
|
5,470
|
5,593
|
14. |
DEFERRED TAX ASSETS AND LIABILITIES
|
|
Assets
|
Liabilities
|
Net
|
|||||||||||||||||||||
|
|
2018
US$’000 |
|
2017
US$’000 |
|
2018
US$’000 |
|
2017
US$’000 |
|
2018
US$’000 |
|
2017
US$’000 |
||||||||||||
Property, plant and equipment
|
815
|
448
|
(37
|
)
|
(98
|
)
|
778
|
350
|
||||||||||||||||
Intangible assets
|
—
|
—
|
(7,189
|
)
|
(9,443
|
)
|
(7,189
|
)
|
(9,443
|
)
|
||||||||||||||
Inventories
|
668
|
1,006
|
—
|
—
|
668
|
1,006
|
||||||||||||||||||
Provisions
|
4,311
|
3,510
|
—
|
—
|
4,311
|
3,510
|
||||||||||||||||||
Other items
|
333
|
2,109
|
(629
|
)
|
(1,291
|
)
|
(296
|
)
|
818
|
|||||||||||||||
Tax value of loss carryforwards recognised
|
—
|
1,625
|
—
|
—
|
—
|
1,625
|
||||||||||||||||||
|
||||||||||||||||||||||||
Deferred tax assets/(liabilities)
|
6,127
|
8,698
|
(7,855
|
)
|
(10,832
|
)
|
(1,728
|
)
|
(2,134
|
)
|
14. |
DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED)
|
|
December 31,
2018 |
December 31,
2017 |
||||||
|
US$’000
|
US$’000
|
||||||
Capital losses
|
8,293
|
8,293
|
||||||
Net operating losses
|
67,012
|
61,264
|
||||||
US alternative minimum tax credits
|
1,674
|
-
|
||||||
Other temporary timing differences
|
3,880
|
-
|
||||||
US state credit carryforwards
|
364
|
345
|
||||||
|
||||||||
|
81,223
|
69,902
|
Movement in unrecognised deferred tax assets
|
Increase /
(decrease) US$’000
|
Applicable
tax rate
%
|
Tax
effect US$’000
|
|||||||||
Net operating losses in US
|
2,382
|
21
|
%
|
500
|
||||||||
Alternative minimum tax credit in US
|
1,674
|
n/a
|
1,674
|
|||||||||
Net operating losses in Brazil
|
(59
|
)
|
34
|
%
|
(20
|
)
|
||||||
Net operating losses in Ireland
|
3,425
|
12.5% -25
|
%
|
997
|
||||||||
Other deferred tax assets in Ireland
|
3,880
|
12.5
|
%
|
485
|
||||||||
US state credit carryforwards
|
19
|
n/a
|
19
|
|||||||||
|
||||||||||||
Total – continuing operations
|
11,321
|
3,655
|
14. |
DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED)
|
|
Balance
January, 1
2018 |
Recognised
in income |
Recognised
in loss on discontinued operations |
Foreign
Exchange movement |
Balance
December 31,
2018 |
|||||||||||||||
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||
Property, plant and equipment
|
350
|
428
|
—
|
—
|
778
|
|||||||||||||||
Intangible assets
|
(9,443
|
)
|
2,254
|
—
|
—
|
(7,189
|
)
|
|||||||||||||
Inventories
|
1,006
|
(338
|
)
|
—
|
—
|
668
|
||||||||||||||
Provisions
|
3,510
|
801
|
—
|
—
|
4,311
|
|||||||||||||||
Other items
|
818
|
(1,114
|
)
|
—
|
—
|
(296
|
)
|
|||||||||||||
Tax value of loss carryforwards recognised
|
1,625
|
(1,625
|
)
|
—
|
—
|
—
|
||||||||||||||
|
||||||||||||||||||||
|
(2,134
|
)
|
406
|
—
|
—
|
(1,728
|
)
|
|
Balance
January, 1
2017 |
Recognised
in income |
Recognised
in loss on discontinued operations |
Foreign
Exchange movement |
Balance
December 31,
2017 |
|||||||||||||||
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||
Property, plant and equipment
|
(574
|
)
|
924
|
—
|
—
|
350
|
||||||||||||||
Intangible assets
|
(16,430
|
)
|
6,987
|
—
|
—
|
(9,443
|
)
|
|||||||||||||
Inventories
|
897
|
109
|
—
|
—
|
1,006
|
|||||||||||||||
Provisions
|
5,701
|
(2,191
|
)
|
—
|
—
|
3,510
|
||||||||||||||
Other items
|
678
|
140
|
—
|
—
|
818
|
|||||||||||||||
Tax value of loss carryforwards recognised
|
5,923
|
(4,298
|
)
|
—
|
—
|
1,625
|
||||||||||||||
|
||||||||||||||||||||
|
(3,805
|
)
|
1,671
|
—
|
—
|
(2,134
|
)
|
15. |
OTHER ASSETS
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
||||||
Finance lease receivables (see Note 17)
|
476
|
685
|
||||||
Other assets
|
82
|
86
|
||||||
|
||||||||
|
558
|
771
|
16. |
INVENTORIES
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
||||||
Raw materials and consumables
|
10,556
|
10,345
|
||||||
Work-in-progress
|
8,239
|
7,236
|
||||||
Finished goods
|
11,564
|
15,224
|
||||||
|
||||||||
|
30,359
|
32,805
|
|
December 31,
2018
US$‘000
|
December 31,
2017
US$‘000
|
December 31,
2016 US$‘000
|
|||||||||
Opening provision at January 1
|
7,543
|
10,017
|
4,822
|
|||||||||
Charged during the year
|
480
|
2,561
|
6,390
|
|||||||||
Utilised during the year
|
(1,544
|
)
|
(4,749
|
)
|
(1,065
|
)
|
||||||
Released during the year
|
(180
|
)
|
(286
|
)
|
(130
|
)
|
||||||
|
||||||||||||
Closing provision at December 31
|
6,299
|
7,543
|
10,017
|
17. |
TRADE AND OTHER RECEIVABLES
|
|
December 31,
2018
US$‘000
|
December 31,
2017
US$‘000
|
||||||
Trade receivables, net of impairment losses
|
21,318
|
17,242
|
||||||
Prepayments
|
807
|
891
|
||||||
Contract assets
|
1,894
|
2,107
|
||||||
Value added tax
|
63
|
-
|
||||||
Finance lease receivables
|
359
|
500
|
||||||
|
||||||||
|
24,441
|
20,740
|
17. |
TRADE AND OTHER RECEIVABLES (CONTINUED)
|
|
December 31, 2018
US$‘000
|
|||||||||||
|
Gross
investment |
Unearned
income |
Minimum
payments receivable |
|||||||||
Less than one year
|
617
|
258
|
359
|
|||||||||
Between one and five years (Note 15)
|
888
|
412
|
476
|
|||||||||
|
||||||||||||
|
1,505
|
670
|
835
|
|
December 31, 2017
US$‘000
|
|||||||||||
|
Gross
investment |
Unearned
income |
Minimum
payments receivable |
|||||||||
Less than one year
|
860
|
360
|
500
|
|||||||||
Between one and five years (Note 15)
|
1,204
|
519
|
685
|
|||||||||
|
||||||||||||
|
2,064
|
879
|
1,185
|
17. |
TRADE AND OTHER RECEIVABLES (CONTINUED)
|
December 31, 2018
US$‘000
|
||||||||
|
Instruments
|
Total
|
||||||
Less than one year
|
3,498
|
3,498
|
||||||
Between one and five years
|
32
|
32
|
||||||
|
||||||||
|
3,530
|
3,530
|
|
December 31, 2017
US$‘000
|
|||||||
|
Instruments
|
Total
|
||||||
Less than one year
|
3,959
|
3,959
|
||||||
Between one and five years
|
90
|
90
|
||||||
|
||||||||
|
4,049
|
4,049
|
18. |
CASH AND CASH EQUIVALENTS
|
|
December 31, 2018
US$’000
|
December 31, 2017
US$’000
|
||||||
Cash at bank and in hand
|
6,854
|
9,561
|
||||||
Short-term deposits
|
23,423
|
14,003
|
||||||
|
||||||||
Cash and cash equivalents
|
30,277
|
23,564
|
19. |
SHORT-TERM INVESTMENTS
|
|
December 31, 2018
US$’000
|
December 31, 2017
US$’000
|
||||||
Investments (deposits)
|
-
|
34,043
|
20. |
CAPITAL AND RESERVES
|
|
Class ‘A’
Ordinary shares |
Class ‘A’
Ordinary shares |
||||||
In thousands of shares
|
2018
|
2017
|
||||||
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
|
2018
|
2017
|
||||||
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
|
2018
|
2017
|
||||||
Balance at January 1
|
12,448
|
7,073
|
||||||
Purchased during the year
|
108
|
5,375
|
||||||
|
||||||||
Balance at December 31
|
12,556
|
12,448
|
|
ADS
Treasury shares
|
ADS
Treasury shares |
||||||
In thousands of ADSs
|
2018
|
2017
|
||||||
Balance at January 1
|
3,112
|
1,768
|
||||||
Purchased during the year
|
27
|
1,344
|
||||||
|
||||||||
Balance at December 31
|
3,139
|
3,112
|
20. |
CAPITAL AND RESERVES (CONTINUED)
|
(a) |
During 2018, the Group did not issue any shares from the exercise of employee options (2017: nil). At December 31, 2018, there were no amounts receivable on issuance share capital (2017: US$nil) relating to the exercise of share options.
|
(b) |
During 2018, the Group repurchased 107,740 ‘A’ ordinary shares (26,935 ADS’s) under its share buyback program. (2017: 5,374,692 ‘A’ ordinary shares or 1,343,673 ADS’s).
|
(c) |
There were no dividends paid during 2018 in respect of the 2017 financial year, (nil in respect of the 2016 financial year), (nil in respect of the 2015 financial year). As provided in the Articles of Association of the Company, dividends or other distributions are declared and paid in US Dollars.
|
21. |
SHARE OPTIONS AND SHARE WARRANTS
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
|
Options and
warrants |
Weighted-
average exercise price US$
|
Range
US$
|
|||||||||
|
‘A’ Ordinary
Shares |
Per ‘A’ Ordinary
Share
|
Per ‘A’ Ordinary
Share |
|||||||||
Outstanding January 1, 2016
|
8,158,452
|
3.36
|
0.66 –4.47
|
|||||||||
Granted
|
2,160,000
|
2.39
|
1.67 –2.80
|
|||||||||
Exercised
|
(322,272
|
)
|
2.09
|
0.66 –2.65
|
||||||||
Forfeited
|
(165,997
|
)
|
3.39
|
2.52 –3.61
|
||||||||
|
||||||||||||
Outstanding at end of year
|
9,830,183
|
3.19
|
0.66 –4.47
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
5,838,851
|
3.31
|
0.75 –4.23
|
|||||||||
|
||||||||||||
Outstanding January 1, 2017
|
9,830,183
|
3.19
|
0.66 –4.47
|
|||||||||
Granted
|
5,630,000
|
1.31
|
1.24 –1.44
|
|||||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Forfeited
|
(4,732,807
|
)
|
3.86
|
0.75 –4.47
|
||||||||
|
||||||||||||
Outstanding at end of year
|
10,727,376
|
1.92
|
1.24 –4.36
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
3,268,707
|
2.57
|
1.66 –4.36
|
|||||||||
|
||||||||||||
Outstanding January 1, 2018
|
10,727,376
|
1.92
|
1.24 –4.36
|
|||||||||
Granted
|
720,000
|
1.07
|
0.67 –1.37
|
|||||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Forfeited
|
(539,176
|
)
|
2.50
|
1.34 –4.23
|
||||||||
|
||||||||||||
Outstanding at end of year
|
10,908,200
|
1.83
|
0.67 –4.36
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
6,091,864
|
2.09
|
1.24 –4.36
|
|
Options and
warrants |
Weighted-
average exercise price US$
|
Range
US$
|
|||||||||
|
‘ADS’ Equivalent
|
Per ‘ADS’
|
Per ‘ADS’
|
|||||||||
Outstanding January 1, 2016
|
2,039,613
|
13.44
|
2.63 –17.88
|
|||||||||
Granted
|
540,000
|
9.57
|
6.69 –11.20
|
|||||||||
Exercised
|
(80,568
|
)
|
8.35
|
2.64 –10.61
|
||||||||
Forfeited
|
(41,499
|
)
|
13.58
|
10.08 –14.44
|
||||||||
|
||||||||||||
Outstanding at end of year
|
2,457,546
|
12.76
|
2.64 –17.88
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
1,459,713
|
13.24
|
3.00 –16.92
|
|||||||||
|
||||||||||||
Outstanding January 1, 2017
|
2,457,546
|
12.76
|
2.64 - 17.88
|
|||||||||
Granted
|
1,407,500
|
5.25
|
4.95 – 5.75
|
|||||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Forfeited
|
(1,183,202
|
)
|
10.26
|
3.00 –17.88
|
||||||||
|
||||||||||||
Outstanding at end of year
|
2,681,844
|
7.69
|
4.96–17.44
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
817,179
|
10.29
|
6.64 –17.45
|
|||||||||
|
||||||||||||
Outstanding January 1, 2018
|
2,681,844
|
7.69
|
4.96 - 17.44
|
|||||||||
Granted
|
180,000
|
4.28
|
2.68 – 5.48
|
|||||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Forfeited
|
(134,794
|
)
|
10.00
|
5.36 – 16.92
|
||||||||
|
||||||||||||
Outstanding at end of year
|
2,727,050
|
7.32
|
2.68–17.44
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
1,522,966
|
8.36
|
4.96 –17.44
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
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$0.66-US$0.99
|
430,000
|
0.88
|
6.79
|
-
|
-
|
-
|
|||||||||||||||||||
|
US$1.00-US$2.05
|
6,111,800
|
1.35
|
5.64
|
2,476,133
|
1.35
|
5.57
|
|||||||||||||||||||
|
US$2.06- US$2.99
|
4,168,400
|
2.51
|
2.23
|
3,437,731
|
2.51
|
1.83
|
|||||||||||||||||||
|
US$3.00 -US$4.47
|
198,000
|
4.20
|
2.97
|
178,000
|
4.20
|
2.93
|
|||||||||||||||||||
10,908,200
|
6,091,864
|
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$2.64-US$3.96
|
107,500
|
3.52
|
6.79
|
-
|
-
|
-
|
|||||||||||||||||||
|
US$4.00-US$8.20
|
1,527,950
|
5.40
|
5.64
|
619,033
|
5.40
|
5.57
|
|||||||||||||||||||
|
US$8.24- US$11.96
|
1,042,100
|
10.04
|
2.23
|
859,433
|
10.04
|
1.83
|
|||||||||||||||||||
|
US$12.00 -US$17.88
|
49,500
|
16.80
|
2.97
|
44,500
|
16.80
|
2.93
|
|||||||||||||||||||
2,727,050
|
1,522,966
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
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$1.00-US$2.05
|
6,075,644
|
1.38
|
6.52
|
215,652
|
1.69
|
2.57
|
|||||||||||||||||||
|
US$2.06- US$2.99
|
4,333,732
|
2.52
|
3.20
|
2,861,061
|
2.53
|
2.20
|
|||||||||||||||||||
|
US$3.00 -US$4.47
|
318,000
|
4.21
|
3.95
|
192,002
|
4.21
|
3.92
|
|||||||||||||||||||
10,727,376
|
3,268,715
|
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$4.00-US$8.20
|
1,518,911
|
5.52
|
6.52
|
53,913
|
6.76
|
2.57
|
|||||||||||||||||||
|
US$8.24- US$11.96
|
1,083,433
|
10.08
|
3.20
|
715,265
|
10.12
|
2.20
|
|||||||||||||||||||
|
US$12.00 -US$17.88
|
79,500
|
16.84
|
3.95
|
48,001
|
16.84
|
3.92
|
|||||||||||||||||||
2,681,844
|
817,179
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
|
December 31,
2018
US$‘000
|
December 31,
2017
US$‘000
|
December 31,
2016
US$‘000
|
|||||||||
Share-based payments – cost of sales
|
34
|
35
|
32
|
|||||||||
Share-based payments – selling, general and administrative
|
1,335
|
893
|
1,349
|
|||||||||
|
||||||||||||
Total – continuing operations
|
1,369
|
928
|
1,381
|
|||||||||
Share-based payments – discontinued operations
|
-
|
-
|
33
|
|||||||||
|
||||||||||||
Total
|
1,369
|
928
|
1,414
|
|
Key
management personnel |
Other
employees |
Key
management personnel |
Other
employees |
Key
management personnel |
Other
employees |
||||||||||||||||||
|
2018
|
2018
|
2017
|
2017
|
2016
|
2016
|
||||||||||||||||||
Weighted average fair value at measurement date per ‘A’ share / (per ADS)
|
-
|
$
|
US0.41 /(US$1.64
|
)
|
$
|
US0.43 /(US$1.72
|
)
|
$
|
US0.44 /(US$1.76
|
)
|
$
|
US0.58 /(US$2.32
|
)
|
$
|
US0.57 /(US$2.28
|
)
|
||||||||
Total ‘A’ share options granted / (ADS’s equivalent)
|
-
|
720,000 /(180,000
|
)
|
5,150,000/(1,287,500
|
)
|
480,000 /(120,000
|
)
|
1,700,000/(425,000
|
)
|
460,000 /(115,000
|
)
|
|||||||||||||
Weighted average share price per ‘A’ share / (per ADS)
|
-
|
$
|
US1.07 /(US$4.28
|
)
|
$
|
US1.34 /(US$5.36
|
)
|
$
|
US1.31 /(US$5.24
|
)
|
$
|
US2.43 /(US$9.72
|
)
|
$
|
US2.25 /(US$9.00
|
)
|
||||||||
Weighted average exercise price per ‘A’ share / (per ADS)
|
-
|
$
|
US1.07 /(US$4.28
|
)
|
$
|
US1.34 /(US$5.36
|
)
|
$
|
US1.31 /(US$5.24
|
)
|
$
|
US2.43 /(US$9.72
|
)
|
$
|
US2.25 /(US$9.00
|
)
|
||||||||
Weighted average expected volatility
|
-
|
42.69
|
%
|
40.62
|
%
|
40.48
|
%
|
29.63
|
%
|
36.73
|
%
|
|||||||||||||
Weighted average expected life
|
-
|
4.55
|
4.45
|
4.69
|
4.81
|
3.74
|
||||||||||||||||||
Weighted average risk free interest rate
|
-
|
2.72
|
%
|
1.59
|
%
|
1.91
|
%
|
1.21
|
%
|
1.29
|
%
|
|||||||||||||
Expected dividend yield
|
-
|
-
|
0.81
|
%
|
0.81
|
%
|
1.14
|
%
|
0.96
|
%
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
22. |
TRADE AND OTHER PAYABLES
|
|
December 31, 2018
US$’000
|
December 31, 2017
US$’000
|
||||||
Trade payables
|
8,116
|
8,045
|
||||||
Payroll taxes
|
448
|
423
|
||||||
Employee related social insurance
|
154
|
151
|
||||||
Accrued liabilities
|
7,878
|
11,618
|
||||||
Deferred income
|
312
|
278
|
||||||
|
||||||||
|
16,908
|
20,515
|
23. |
PROVISIONS
|
|
December 31, 2018
US$’000
|
December 31, 2017
US$’000
|
||||||
Provisions
|
50
|
50
|
24. |
EXCHANGEABLE NOTES
|
|
December 31,
2018 US$’000
|
December 31,
2017 US$’000
|
||||||
Non-current assets
|
||||||||
Exchangeable note bond call option
|
-
|
360
|
||||||
|
||||||||
Non-current liabilities
|
||||||||
Exchangeable note equity conversion option
|
238
|
1,790
|
||||||
Exchangeable note bond put option
|
-
|
440
|
||||||
|
||||||||
|
238
|
2,230
|
||||||
|
||||||||
Total value of embedded derivatives – net liability
|
238
|
1,870
|
|
December 31,
2018 US$’000
|
December 31,
2017 US$’000
|
||||||
Balance at 1 January
|
92,955
|
92,232
|
||||||
Accretion interest
|
689
|
723
|
||||||
Less: purchased during the year at fair value
|
(12,262
|
)
|
-
|
|||||
|
||||||||
|
81,382
|
92,955
|
||||||
|
|
December 31,
2018 US$’000
|
December 31,
2017 US$’000
|
||||||
Exchangeable senior notes
|
81,382
|
92,955
|
||||||
Total value of embedded derivatives – liability
|
238
|
2,230
|
||||||
|
||||||||
Total non-current liabilities
|
81,620
|
95,185
|
24. |
EXCHANGEABLE NOTES (CONTINUED)
|
25. |
FINANCE LEASE LIABILITIES
|
|
December 31, 2018
US$’000
|
December 31, 2017
US$’000
|
||||||
Current liabilities
|
||||||||
Finance lease liabilities
|
436
|
354
|
||||||
|
||||||||
|
436
|
354
|
||||||
|
||||||||
Non-current liabilities
|
526
|
532
|
||||||
|
||||||||
Finance lease liabilities
|
526
|
532
|
|
December 31, 2018
US$’000
|
|||||||||||
|
Minimum
lease
payments
|
Interest
|
Principal
|
|||||||||
Less than one year
|
473
|
37
|
436
|
|||||||||
In more than one year, but not more than two
|
271
|
19
|
252
|
|||||||||
In more than two years but not more than five
|
294
|
20
|
274
|
|||||||||
|
||||||||||||
|
1,038
|
76
|
962
|
|
December 31, 2017
US$’000
|
|||||||||||
|
Minimum
lease
payments
|
Interest
|
Principal
|
|||||||||
Less than one year
|
387
|
33
|
354
|
|||||||||
In more than one year, but not more than two
|
381
|
17
|
364
|
|||||||||
In more than two years but not more than five
|
170
|
2
|
168
|
|||||||||
|
||||||||||||
|
938
|
52
|
886
|
Facility
|
Currency
|
Nominal
interest
rate |
Year of
maturity
|
Fair
Value
|
Carrying
Value
|
||||||||||||
Finance lease liabilities
|
Euro
|
4.53
|
%
|
2023
|
648
|
648
|
|||||||||||
Finance lease liabilities
|
USD
|
5.51
|
%
|
2023
|
314
|
314
|
|||||||||||
|
|
||||||||||||||||
Total interest-bearing loans and borrowings
|
|
962
|
962
|
25. |
FINANCE LEASE LIABILITIES (CONTINUED)
|
Facility
|
Currency
|
Nominal
interest
rate |
Year of
maturity
|
Fair
Value
|
Carrying
Value
|
||||||||||||
Finance lease liabilities
|
Euro
|
4.54
|
%
|
2020
|
835
|
835
|
|||||||||||
Finance lease liabilities
|
USD
|
5.51
|
%
|
2019
|
51
|
51
|
|||||||||||
|
|
||||||||||||||||
Total interest-bearing loans and borrowings
|
|
886
|
886
|
26. |
COMMITMENTS AND CONTINGENCIES
|
(a) |
Capital Commitments
|
(b) |
Leasing Commitments
|
|
Year ended
|
|||
|
2018
|
|||
|
Operating leases
|
|||
|
US$’000
|
|||
2019
|
2,922
|
|||
2020
|
2,565
|
|||
2021
|
2,250
|
|||
2022
|
1,990
|
|||
2023
|
1,741
|
|||
Later years
|
14,249
|
|||
|
||||
Total lease obligations
|
25,717
|
|
Year ended
|
|||
|
2017
|
|||
|
Operating leases
|
|||
|
US$’000
|
|||
2018
|
2,693
|
|||
2019
|
2,409
|
|||
2020
|
1,947
|
|||
2021
|
1,776
|
|||
2022
|
1,654
|
|||
Later years
|
11,660
|
|||
|
||||
Total lease obligations
|
22,139
|
26. |
COMMITMENTS AND CONTINGENCIES (CONTINUED)
|
(c) |
Bank Security
|
(d) |
Group Company Guarantees
|
(e) |
Government Grant Contingencies
|
(f) |
Litigation
|
(g) |
Taxation
|
27. |
RELATED PARTY TRANSACTIONS
|
|
December 31, 2018
|
December 31, 2017
|
||||||
|
US$’000
|
US$’000
|
||||||
Short-term employee benefits
|
863
|
1,177
|
||||||
Performance related bonus
|
210
|
223
|
||||||
Post-employment benefits
|
44
|
44
|
||||||
Share-based compensation benefits
|
1,041
|
663
|
||||||
|
||||||||
|
2,158
|
2,107
|
27. |
RELATED PARTY TRANSACTIONS (CONTINUED)
|
|
‘A’ Ordinary Shares
|
Share options
|
||||||
At January 1, 2018
|
5,719,706
|
8,770,004
|
||||||
Shares purchased during the year
|
3,420,000
|
—
|
||||||
Expired
|
—
|
(115,000
|
)
|
|||||
|
||||||||
At December 31, 2018
|
9,139,706
|
8,655,004
|
|
‘A’ Ordinary Shares
|
Share options
|
||||||
At January 1, 2017
|
5,719,706
|
7,655,004
|
||||||
Granted
|
—
|
5,150,000
|
||||||
Expired
|
—
|
(315,000
|
)
|
|||||
Forfeited
|
—
|
(3,720,000
|
)
|
|||||
|
||||||||
At December 31, 2017
|
5,719,706
|
8,770,004
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS
|
As at December 31, 2018
|
Note
|
Effective
interest
rate |
Total
US$’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$’000
|
||||||||||||||||||||||||
Cash and cash equivalents
|
18
|
1.8
|
%
|
30,277
|
30,277
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||
Short-term investments
|
19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Finance lease receivable
|
17
|
4.0
|
%
|
835
|
191
|
168
|
238
|
238
|
—
|
|||||||||||||||||||||||
Licence payments
|
22
|
3.0
|
%
|
(1,207
|
)
|
(1,207
|
)
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Finance lease payable
|
25
|
4.8
|
%
|
(962
|
)
|
(217
|
)
|
(219
|
)
|
(252
|
)
|
(274
|
)
|
—
|
||||||||||||||||||
Exchangeable note
|
24
|
4.8
|
%
|
(81,382
|
)
|
—
|
—
|
—
|
—
|
(81,382
|
)
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total
|
(52,439
|
)
|
29,044
|
(51
|
)
|
(14
|
)
|
(36
|
)
|
(81,382
|
)
|
As at December 31, 2017
|
Note
|
Effective
interest
rate |
Total
US$’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$’000
|
||||||||||||||||||||||||
Cash and cash equivalents
|
18
|
1.4
|
%
|
23,564
|
23,564
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||
Short-term investments
|
19
|
1.4
|
%
|
34,043
|
—
|
34,043
|
—
|
—
|
—
|
|||||||||||||||||||||||
Finance lease receivable
|
17
|
4.0
|
%
|
1,185
|
267
|
233
|
333
|
352
|
—
|
|||||||||||||||||||||||
Licence payments
|
22
|
3.0
|
%
|
(1,112
|
)
|
(1,112
|
)
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Finance lease payable
|
25
|
4.6
|
%
|
(886
|
)
|
(176
|
)
|
(178
|
)
|
(364
|
)
|
(168
|
)
|
—
|
||||||||||||||||||
Exchangeable note
|
24
|
4.8
|
%
|
(92,955
|
)
|
—
|
—
|
—
|
—
|
(92,955
|
)
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total
|
(36,161
|
)
|
22,543
|
34,098
|
(31
|
)
|
184
|
(92,955
|
)
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
||||||
Fixed rate instruments
|
||||||||
Fixed rate financial liabilities (licence fees)
|
(1,207
|
)
|
(1,112
|
)
|
||||
Fixed rate financial liabilities (exchangeable note)
|
(81,382
|
)
|
(92,955
|
)
|
||||
Fixed rate financial liabilities (finance lease payables)
|
(962
|
)
|
(886
|
)
|
||||
Financial assets (short-term deposits and short-term investments)
|
23,423
|
48,046
|
||||||
Financial assets (finance lease receivables)
|
835
|
1,185
|
||||||
Variable rate instruments
|
||||||||
Financial assets (cash)
|
6,854
|
9,561
|
||||||
|
||||||||
|
(52,439
|
)
|
(36,161
|
)
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
As at December 31, 2018
US$’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$’000
|
|||||||||||||||||||||
Financial liabilities
|
||||||||||||||||||||||||||||
Trade & other payables
|
16,908
|
16,908
|
16,908
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Exchangeable notes
|
81,382
|
99,900
|
—
|
—
|
—
|
—
|
99,900
|
|||||||||||||||||||||
Exchangeable note interest
|
999
|
105,894
|
1,998
|
1,998
|
3,996
|
11,988
|
85,914
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
99,289
|
222,702
|
18,906
|
1,998
|
3,996
|
11,988
|
185,814
|
As at December 31, 2017
US$’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$’000
|
|||||||||||||||||||||
Financial liabilities
|
||||||||||||||||||||||||||||
Trade & other payables
|
20,515
|
20,515
|
20,515
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Exchangeable notes
|
92,955
|
115,000
|
—
|
—
|
—
|
—
|
115,000
|
|||||||||||||||||||||
Exchangeable note interest
|
1,150
|
126,500
|
2,300
|
2,300
|
4,600
|
13,800
|
103,500
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
114,620
|
262,015
|
22,815
|
2,300
|
4,600
|
13,800
|
218,500
|
As at December 31, 2018
|
EUR
|
GBP
|
SEK
|
CAD
|
BRL
|
Other
|
||||||||||||||||||
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
|||||||||||||||||||
Cash
|
81
|
122
|
9
|
2,512
|
322
|
6
|
||||||||||||||||||
Trade and other receivable
|
894
|
113
|
38
|
430
|
2,065
|
6
|
||||||||||||||||||
Trade and other payables
|
(1,995
|
)
|
(51
|
)
|
(146
|
)
|
(103
|
)
|
(1,621
|
)
|
(2
|
)
|
||||||||||||
|
||||||||||||||||||||||||
Total exposure
|
(1,020
|
)
|
184
|
(99
|
)
|
2,839
|
766
|
10
|
||||||||||||||||
|
||||||||||||||||||||||||
As at December 31, 2017
|
EUR
|
GBP
|
SEK
|
CAD
|
BRL
|
Other
|
||||||||||||||||||
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
|||||||||||||||||||
Cash
|
235
|
443
|
5
|
2,107
|
443
|
16
|
||||||||||||||||||
Trade and other receivable
|
1,396
|
101
|
—
|
298
|
1,958
|
6
|
||||||||||||||||||
Trade and other payables
|
(1,936
|
)
|
(16
|
)
|
(239
|
)
|
(86
|
)
|
(2,235
|
)
|
—
|
|||||||||||||
|
||||||||||||||||||||||||
Total exposure
|
(305
|
)
|
528
|
(234
|
)
|
2,319
|
166
|
22
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
Profit or loss
US$’000
|
|||
December 31, 2018
|
||||
Euro
|
1,818
|
|||
December 31, 2017
|
||||
Euro
|
2,158
|
|
Profit or loss
US$’000
|
|||
December 31, 2018
|
||||
Euro
|
(2,222
|
)
|
||
December 31, 2017
|
||||
Euro
|
(2,637
|
)
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
Carrying ValueDecember 31, 2018US$’000
|
Carrying ValueDecember 31, 2017US$’000
|
||||||
Third party trade receivables (Note 17)
|
21,318
|
17,242
|
||||||
Finance lease income receivable (Note 17)
|
835
|
1,185
|
||||||
Cash & cash equivalents (Note 18)
|
30,277
|
23,564
|
||||||
Short-term investments (Note 19)
|
—
|
34,043
|
||||||
|
||||||||
|
52,430
|
76,034
|
|
Carrying Value
December 31, 2018 US$’000 |
Carrying Value
December 31, 2017
US$’000
|
||||||
United States
|
10,049
|
8,682
|
||||||
Euro-zone countries
|
1,502
|
1,789
|
||||||
United Kingdom
|
132
|
185
|
||||||
Other European countries
|
84
|
21
|
||||||
Other regions
|
10,963
|
7,750
|
||||||
|
||||||||
|
22,730
|
18,427
|
|
Carrying ValueDecember 31, 2018US$’000
|
Carrying Value
December 31, 2017
US$’000
|
||||||
End-user customers
|
9,830
|
8,200
|
||||||
Distributors
|
11,860
|
10,003
|
||||||
Non-governmental organisations
|
1,040
|
224
|
||||||
|
||||||||
|
22,730
|
18,427
|
|
Gross
|
Impairment
|
Expected Credit Loss Rate
|
Gross
|
Impairment
|
Expected Credit Loss Rate
|
||||||||||||||||||
|
2018
|
2018
|
2018
|
2017
|
2017
|
2017
|
||||||||||||||||||
|
US$’000
|
US$’000
|
%
|
US$’000
|
US$’000
|
%
|
||||||||||||||||||
Not past due
|
14,494
|
4
|
—
|
10,770
|
—
|
—
|
||||||||||||||||||
Past due 0-30 days
|
3,761
|
17
|
0.5
|
%
|
3,190
|
31
|
1.0
|
%
|
||||||||||||||||
Past due 31-120 days
|
3,438
|
36
|
1.0
|
%
|
1,906
|
50
|
2.6
|
%
|
||||||||||||||||
Greater than 120 days
|
4,404
|
4,145
|
94.1
|
%
|
4,966
|
3,509
|
70.7
|
%
|
||||||||||||||||
|
||||||||||||||||||||||||
|
26,097
|
4,202
|
—
|
20,832
|
3,590
|
—
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
2018
|
2017
|
2016
|
|||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Balance at January 1
|
3,590
|
3,171
|
2,812
|
|||||||||
Charged to costs and expenses
|
682
|
662
|
415
|
|||||||||
Amounts written off during the year
|
(70
|
)
|
(243
|
)
|
(56
|
)
|
||||||
|
||||||||||||
Balance at December 31
|
4,202
|
3,590
|
3,171
|
• |
the aggregate nominal value of the shares authorised to be acquired shall not exceed 10% of the aggregate nominal value of the issued share capital of the Company at the close of business on the date of the passing of the resolution:
|
• |
the minimum price (exclusive of taxes and expenses) which may be paid for a share shall be the nominal value of that share:
|
• |
the maximum price (exclusive of taxes and expenses) which may be paid for a share shall not be more than the average of the closing bid price on NASDAQ in respect of the ten business days immediately preceding the day on which the share is purchased.
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
Level 1
|
Level 2
|
Total
carrying
amount
|
Fair
Value
|
||||||||||||||||
|
Note
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||
December 31, 2018
|
||||||||||||||||||||
Loans and receivables
|
||||||||||||||||||||
Trade receivables
|
17
|
21,318
|
—
|
21,318
|
21,318
|
|||||||||||||||
Cash and cash equivalents
|
18
|
30,277
|
—
|
30,277
|
30,277
|
|||||||||||||||
Finance lease receivable
|
15,17
|
835
|
—
|
835
|
835
|
|||||||||||||||
|
||||||||||||||||||||
|
52,430
|
—
|
52,430
|
52,430
|
||||||||||||||||
|
||||||||||||||||||||
Liabilities at amortised cost
|
||||||||||||||||||||
Exchangeable note
|
24
|
—
|
(81,382
|
)
|
(81,382
|
)
|
(81,382
|
)
|
||||||||||||
Finance lease payable
|
25
|
(962
|
)
|
—
|
(962
|
)
|
(962
|
)
|
||||||||||||
Trade and other payables (excluding deferred income)
|
22
|
(16,596
|
)
|
—
|
(16,596
|
)
|
(16,596
|
)
|
||||||||||||
Provisions
|
23
|
(50
|
)
|
—
|
(50
|
)
|
(50
|
)
|
||||||||||||
|
||||||||||||||||||||
|
(17,608
|
)
|
(81,382
|
)
|
(98,990
|
)
|
(98,990
|
)
|
||||||||||||
|
||||||||||||||||||||
Fair value through profit and loss (FVPL)
|
||||||||||||||||||||
Exchangeable note bond call option
|
24
|
—
|
—
|
—
|
—
|
|||||||||||||||
Exchangeable note equity conversion option
|
24
|
—
|
(238
|
)
|
(238
|
)
|
(238
|
)
|
||||||||||||
Exchangeable note bond put option
|
24
|
—
|
—
|
—
|
—
|
|||||||||||||||
|
||||||||||||||||||||
|
—
|
(238
|
)
|
(238
|
)
|
(238
|
)
|
|||||||||||||
|
||||||||||||||||||||
|
34,822
|
(81,620
|
)
|
(46,798
|
)
|
(46,798
|
)
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
Level 1
|
Level 2
|
Total
carrying
amount
|
Fair
Value
|
||||||||||||||||
|
Note
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||
December 31, 2017
|
||||||||||||||||||||
Loans and receivables
|
||||||||||||||||||||
Trade receivables
|
17
|
17,242
|
—
|
17,242
|
17,242
|
|||||||||||||||
Cash and cash equivalents
|
18
|
23,564
|
—
|
23,564
|
23,564
|
|||||||||||||||
Short-term investments
|
19
|
34,043
|
—
|
34,043
|
34,043
|
|||||||||||||||
Finance lease receivable
|
15,17
|
1,185
|
—
|
1,185
|
1,185
|
|||||||||||||||
|
||||||||||||||||||||
|
76,034
|
—
|
76,034
|
76,034
|
||||||||||||||||
|
||||||||||||||||||||
Liabilities at amortised cost
|
||||||||||||||||||||
Exchangeable note
|
24
|
—
|
(92,955
|
)
|
(92,955
|
)
|
(92,955
|
)
|
||||||||||||
Finance lease payable
|
25
|
(886
|
)
|
—
|
(886
|
)
|
(886
|
)
|
||||||||||||
Trade and other payables (excluding deferred income)
|
22
|
(20,237
|
)
|
—
|
(20,237
|
)
|
(20,237
|
)
|
||||||||||||
Provisions
|
23
|
(50
|
)
|
—
|
(50
|
)
|
(50
|
)
|
||||||||||||
|
||||||||||||||||||||
|
(21,173
|
)
|
(92,955
|
)
|
(114,128
|
)
|
(114,128
|
)
|
||||||||||||
|
||||||||||||||||||||
Fair value through profit and loss (FVPL)
|
||||||||||||||||||||
Exchangeable note bond call option
|
24
|
—
|
360
|
360
|
360
|
|||||||||||||||
Exchangeable note equity conversion option
|
24
|
—
|
(440
|
)
|
(440
|
)
|
(440
|
)
|
||||||||||||
Exchangeable note bond put option
|
24
|
—
|
(1,790
|
)
|
(1,790
|
)
|
(1,790
|
)
|
||||||||||||
|
||||||||||||||||||||
|
—
|
(1,870
|
)
|
(1,870
|
)
|
(1,870
|
)
|
|||||||||||||
|
||||||||||||||||||||
|
54,861
|
(94,825
|
)
|
(39,964
|
)
|
(39,964
|
)
|
29. |
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES
|
|
Note
|
Borrowings & derivative financial instruments
US$’000 |
Short-term lease liabilities
US$’000 |
Long-term lease liabilities
US$’000 |
||||||||||||
Balance at 1 January 2018
|
24,25
|
95,185
|
354
|
532
|
||||||||||||
Cash-flows:
|
||||||||||||||||
Interest paid
|
(4,503
|
)
|
—
|
—
|
||||||||||||
Repurchase
|
(12,042
|
)
|
—
|
—
|
||||||||||||
Repayment.
|
—
|
(374
|
)
|
—
|
||||||||||||
Proceeds
|
—
|
112
|
369
|
|||||||||||||
Non-cash:
|
||||||||||||||||
Interest charged
|
4,352
|
—
|
—
|
|||||||||||||
Reduction in accrued interest payable
|
150
|
—
|
—
|
|||||||||||||
Exchange adjustment
|
—
|
(30
|
)
|
(1
|
)
|
|||||||||||
Accretion interest
|
689
|
—
|
—
|
|||||||||||||
Fair value
|
(2,211
|
)
|
—
|
—
|
||||||||||||
Reclassification
|
—
|
374
|
(374
|
)
|
||||||||||||
|
||||||||||||||||
Balance at 31 December 2018
|
24,25
|
81,620
|
436
|
526
|
|
Note
|
Borrowings & derivative financial instruments
US$’000 |
Short-term lease liabilities
US$’000 |
Long-term lease liabilities
US$’000 |
||||||||||||
Balance at 1 January 2017
|
24,25
|
96,492
|
273
|
732
|
||||||||||||
Cash-flows:
|
||||||||||||||||
Interest paid
|
(4,600
|
)
|
—
|
—
|
||||||||||||
Repayment
|
—
|
(295
|
)
|
—
|
||||||||||||
Proceeds
|
—
|
28
|
24
|
|||||||||||||
Non-cash:
|
||||||||||||||||
Interest charged
|
4,600
|
—
|
—
|
|||||||||||||
Exchange adjustment
|
—
|
53
|
71
|
|||||||||||||
Accretion interest
|
723
|
—
|
—
|
|||||||||||||
Fair value
|
(2,030
|
)
|
—
|
—
|
||||||||||||
Reclassification
|
—
|
295
|
(295
|
)
|
||||||||||||
|
||||||||||||||||
Balance at 31 December 2017
|
24,25
|
95,185
|
354
|
532
|
30. |
POST BALANCE SHEET EVENTS
|
• |
The entity’s operations in future financial years;
|
• |
The results of those operations in future financial years; or
|
• |
The entity’s state of affairs in future financial years.
|
31. |
ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED)
|
• |
Significant underperformance relative to expected historical or projected future operating results;
|
• |
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;
|
• |
Obsolescence of products;
|
• |
Significant decline in our stock price for a sustained period; and
|
• |
Our market capitalisation relative to net book value.
|
31. |
ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED)
|
32. |
GROUP UNDERTAKINGS
|
Name and registered office
|
Principal activity
|
Principal Country of
incorporation and operation |
Group % holding
|
|||
Trinity Biotech plc
IDA Business Park, Bray
Co. Wicklow, Ireland
|
Investment and holding
company |
Ireland
|
Holding
company |
|||
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%
|
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.
|
Manufacture and sale of
diagnostic test kits |
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 |
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%
|
33. |
AUTHORISATION FOR ISSUE
|
TRINITY BIOTECH PLC
|
|
By
|
/s/ RONAN O’CAOIMH
|
|
Mr Ronan O’Caoimh
|
|
Director/
|
|
Chief Executive Officer
|
|
Date: May 14, 2019
|
By:
|
/s/ KEVIN TANSLEY
|
|
Mr Kevin Tansley
|
|
Company secretary/
|
|
Chief Financial Officer
|
|
Date: May 14, 2019
|
Exhibit No.
|
Description of Exhibit
|
/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/ KEVIN TANSLEY*
|
Kevin Tansley
|
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/ KEVIN TANSLEY*
|
Kevin Tansley
|
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
|
333-166590
|
5/6/2010
|
||
Form S-8
|
333-124384
|
4/15/2011
|
||
Form S-8
|
333-182279
|
6/22/2012
|
||
Form S-8
|
333-195232
|
4/11/2014
|
||
Form F-3
|
333-203555
|
4/26/2017
|
/s/ GRANT THORNTON
|
Dublin, Ireland
|
May 14, 2019
|
Document and Entity Information |
12 Months Ended |
---|---|
Dec. 31, 2018
shares
| |
Document And Entity Information | |
Entity Registrant Name | TRINITY BIOTECH PLC |
Entity Central Index Key | 0000888721 |
Document Type | 20-F |
Document Period End Date | Dec. 31, 2018 |
Amendment Flag | false |
Current Fiscal Year End Date | --12-31 |
Is Entity a Well-known Seasoned Issuer? | No |
Is Entity a Voluntary Filer? | No |
Is Entity's Reporting Status Current? | Yes |
Entity Filer Category | Accelerated Filer |
Entity Emerging Growth Company | false |
Entity Shell Company | false |
Entity Common Stock, Shares Outstanding | 96,162,410 |
Document Fiscal Period Focus | FY |
Document Fiscal Year Focus | 2018 |
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Consolidated Statement Of Comprehensive Income | |||
Loss for the year | $ (22,090) | $ (40,270) | $ (100,625) |
Other comprehensive (loss)/income | |||
Items that will be reclassified subsequently to profit or loss | |||
Foreign exchange translation differences | (520) | 3,086 | 3,122 |
Other comprehensive income | (520) | 3,086 | 3,122 |
Total Comprehensive Loss (all attributable to owners of the parent) | $ (22,610) | $ (37,184) | $ (97,503) |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Non-current assets | ||
Property, plant and equipment | $ 5,362 | $ 5,800 |
Goodwill and intangible assets | 52,951 | 64,754 |
Deferred tax assets | 6,127 | 8,698 |
Derivative financial instruments | 360 | |
Other assets | 558 | 771 |
Total non-current assets | 64,998 | 80,383 |
Current assets | ||
Inventories | 30,359 | 32,805 |
Trade and other receivables | 24,441 | 20,740 |
Income tax receivable | 1,584 | 1,439 |
Cash and cash equivalents | 30,277 | 23,564 |
Short-term investments | 34,043 | |
Total current assets | 86,661 | 112,591 |
TOTAL ASSETS | 151,659 | 192,974 |
Equity attributable to the equity holders of the parent | ||
Share capital | 1,213 | 1,213 |
Share premium | 16,187 | 16,187 |
Treasury shares | (24,922) | (24,783) |
Accumulated surplus | 55,319 | 75,802 |
Translation reserve | (3,766) | (3,246) |
Other reserves | 23 | 23 |
Total equity | 44,054 | 65,196 |
Current liabilities | ||
Income tax payable | 210 | 310 |
Trade and other payables | 16,908 | 20,515 |
Provisions | 50 | 50 |
Finance lease liabilities | 436 | 354 |
Total current liabilities | 17,604 | 21,229 |
Non-current liabilities | ||
Exchangeable notes | 81,382 | 92,955 |
Derivative financial instruments | 238 | 2,230 |
Finance lease liabilities | 526 | 532 |
Deferred tax liabilities | 7,855 | 10,832 |
Total non-current liabilities | 90,001 | 106,549 |
TOTAL LIABILITIES | 107,605 | 127,778 |
TOTAL EQUITY AND LIABILITIES | $ 151,659 | $ 192,974 |
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY - USD ($) $ in Thousands |
Share Capital 'A' Ordinary shares [Member] |
Share premium [Member] |
Treasury Shares [Member] |
Translation reserve [Member] |
Other reserves Warrant reserve [Member] |
Other reserves Hedging reserves [Member] |
Accumulated surplus [Member] |
Total |
---|---|---|---|---|---|---|---|---|
Balance at Dec. 31, 2015 | $ 1,209 | $ 15,526 | $ (7,367) | $ (9,454) | $ 4,529 | $ 23 | $ 209,426 | $ 213,892 |
Loss for the period | (100,625) | (100,625) | ||||||
Other comprehensive income | 3,122 | 3,122 | ||||||
Total comprehensive income/(loss) | 3,122 | (100,625) | (97,503) | |||||
Share-based payments | 1,633 | 1,663 | ||||||
Options or warrants exercised | 4 | 669 | 673 | |||||
Shares purchased | (9,960) | (9,960) | ||||||
Share issue expenses | (8) | (8) | ||||||
Dividends | ||||||||
Balance at Dec. 31, 2016 | 1,213 | 16,187 | (17,327) | (6,332) | 4,529 | 23 | 110,434 | 108,727 |
Loss for the period | (40,270) | (40,270) | ||||||
Other comprehensive income | 3,086 | 3,086 | ||||||
Total comprehensive income/(loss) | 3,086 | (40,270) | (37,184) | |||||
Transfer of warrant reserve | (4,529) | 4,529 | ||||||
Share-based payments | 1,109 | 1,109 | ||||||
Shares purchased | (7,456) | (7,456) | ||||||
Balance at Dec. 31, 2017 | 1,213 | 16,187 | (24,783) | (3,246) | 23 | 75,802 | 65,196 | |
Loss for the period | (22,090) | (22,090) | ||||||
Other comprehensive income | (520) | (520) | ||||||
Total comprehensive income/(loss) | (520) | (22,090) | (22,610) | |||||
Share-based payments | 1,607 | 1,607 | ||||||
Shares purchased | (139) | (139) | ||||||
Balance at Dec. 31, 2018 | $ 1,213 | $ 16,187 | $ (24,922) | $ (3,766) | $ 23 | $ 55,319 | $ 44,054 |
CONSOLIDATED STATEMENT OF CASH FLOWS - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Cash flows from operating activities | |||
Loss for the year | $ (22,090) | $ (40,270) | $ (100,625) |
Adjustments to reconcile net profit to cash provided by operating activities: | |||
Depreciation | 1,296 | 1,896 | 3,159 |
Amortisation | 2,825 | 3,303 | 2,973 |
Income tax credit | (1,115) | (374) | (8,630) |
Financial income | (2,124) | (3,198) | (3,147) |
Financial expense | 5,080 | 5,405 | 5,444 |
Share-based payments | 1,369 | 928 | 1,414 |
Foreign exchange (gains)/losses on operating cash flows | 311 | 307 | (226) |
Loss on disposal or retirement of property, plant and equipment | 15 | 3 | 15 |
Movement in inventory provision | 300 | 2,275 | (533) |
Impairment of inventory | 7,405 | ||
Impairment of prepayments | 1,608 | 1,651 | 757 |
Impairment of property, plant and equipment | 6,112 | 10,437 | 9,029 |
Impairment of intangible assets | 19,212 | 29,667 | 87,673 |
Provision for closure costs | (1,794) | 3,431 | |
Other non-cash items | 570 | (728) | 4,087 |
Operating cash flows before changes in working capital | 13,369 | 9,508 | 12,226 |
(Increase) / decrease in trade and other receivables | (5,960) | 306 | 682 |
Decrease / (increase) in inventories | 1,988 | (2,461) | (3,622) |
(Decrease) / increase in trade and other payables | (3,419) | 2,017 | 1,270 |
Cash generated from operations | 5,978 | 9,370 | 10,556 |
Interest paid | (39) | (53) | (60) |
Interest received | 874 | 776 | 901 |
Income taxes received / (paid) | 416 | (843) | (1,169) |
Net cash generated by operating activities | 7,229 | 9,250 | 10,228 |
Cash flows from investing activities | |||
Payments to acquire intangible assets | (9,863) | (10,229) | (16,548) |
Acquisition of property, plant and equipment | (7,528) | (4,839) | (4,215) |
Licence fees | (1,112) | (1,112) | |
Net cash used in investing activities | (17,391) | (16,180) | (21,875) |
Cash flows from financing activities | |||
Proceeds from issue of ordinary share capital | 857 | ||
Share buyback | (434) | (7,799) | (9,322) |
Expenses paid in connection with share issue and debt financing | (8) | ||
Interest payment on exchangeable notes | (4,503) | (4,600) | (4,600) |
Purchase of exchangeable notes | (12,042) | ||
Proceeds from sale & leaseback transactions | 481 | 51 | |
Payment of finance lease liabilities | (374) | (295) | (282) |
Net cash used in financing activities | (16,872) | (12,643) | (13,355) |
Decrease in cash and cash equivalents and short term investments | (27,034) | (19,573) | (25,002) |
Effects of exchange rate movements on cash held | (296) | 71 | 158 |
Cash and cash equivalents and short-term investments at beginning of year | 23,564 | 77,109 | 101,953 |
Cash and cash equivalents and short term investments at end of year | $ 30,277 | $ 23,564 | $ 77,109 |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Disclosure of basis of preparation and significant accounting policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES |
The principal accounting policies adopted by Trinity Biotech plc (“the Company”) and its subsidiaries (“the Group”) are set out below.
Trinity Biotech develops, acquires, manufactures and markets medical diagnostic products for the clinical laboratory and point-of-care segments of the diagnostic market. These products are used to detect autoimmune, infectious and sexually transmitted diseases, diabetes and disorders of the liver and intestine. Trinity Biotech is a significant provider of raw materials to the life sciences and research industries globally. Trinity Biotech also operates a licenced reference laboratory that specializes in diagnostics for autoimmune diseases.
The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) both as issued by the International Accounting Standards Board (“IASB”) and as subsequently adopted by the European Union (“EU”) (together “IFRS”). The IFRS applied are those effective for accounting periods beginning January 1, 2018. Consolidated financial statements are required by Irish law to comply with IFRS as adopted by the EU which differ in certain respects from IFRS as issued by the IASB. These differences predominantly relate to the timing of adoption of new standards by the EU. However, in relation to the 2018 consolidated financial statements there are no differences regarding the effective date of new IFRS relevant to Trinity Biotech as issued by the IASB and as adopted by the EU. In relation to prior periods presented, none of the differences are relevant in the context of Trinity Biotech and the consolidated financial statements comply with IFRS both as issued by the IASB and as adopted by the EU.
The consolidated financial statements have been prepared in United States Dollars (US$), rounded to the nearest thousand, under the historical cost basis of accounting, except for derivative financial instruments, certain balances arising on acquisition of subsidiary entities and share-based payments which are initially recorded at fair value. Derivative financial instruments are also subsequently revalued and carried at fair value.
The preparation of financial statements in conformity with IFRS requires management to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods.
Judgements made by management that have a significant effect on the financial statements and estimates with a significant risk of material adjustment in the next year are discussed in Note 31.
Having considered the Group’s current financial position and cashflow projections, the directors believe that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these consolidated financial statements and that it is appropriate to continue to prepare the consolidated financial statements on a going concern basis.
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.
Subsidiaries
Subsidiaries are entities controlled by the Company. Control exists when the Company has the power, directly or indirectly, to govern the financial and reporting policies of an entity so as to obtain benefits from its activities. In assessing control, potential voting rights that presently are exercisable or convertible are taken into account. The financial statements of subsidiaries are included in the consolidated financial statements from the date that control commences until the date that control ceases.
Transactions eliminated on consolidation
Intra-group balances and any unrealised gains or losses or income and expenses arising from intra-group transactions are eliminated in preparing the consolidated financial statements.
Owned assets
Items of property, plant and equipment are stated at cost less any accumulated depreciation and any impairment losses (see Note 1(viii)). The cost of self-constructed assets includes the cost of materials, direct labour and attributable overheads. It is not Group policy to revalue any items of property, plant and equipment.
Depreciation is charged to the statement of operations on a straight-line basis to write-off the cost of the assets over their expected useful lives as follows:
Land is not depreciated. The residual values, if not insignificant, useful lives and depreciation methods of property, plant and equipment are reviewed and adjusted if appropriate on a prospective basis, at each balance sheet date. There were no changes to useful lives in the year.
Leased assets – as lessee
Leases under terms of which the Group assumes substantially all the risks and rewards of ownership are classified as finance leases. Property, plant and equipment acquired by way of finance lease is stated at an amount equal to the lower of its fair value and present value of the minimum lease payments at inception of the lease, less accumulated depreciation and any impairment losses. Lease payments are apportioned between finance charges and reduction of the lease liability so as to achieve a constant rate of interest on the remaining balance of the liability. Finance charges are recognised in financial expenses in the statement of operations.
Depreciation is calculated in order to write-off the amounts capitalised over the estimated useful lives of the assets, or the lease term if shorter, by equal annual instalments. The excess of the total rentals under a lease over the amount capitalised is treated as interest, which is charged to the statement of operations in proportion to the amount outstanding under the lease. Leased assets are reviewed for impairment (see Note 1(viii)).
Leases other than finance leases are classified as “operating leases”, and the rentals thereunder are charged to the statement of operations on a straight-line basis over the period of the leases. Lease incentives are recognised in the statement of operations on a straight-line basis over the lease term.
Leased assets – as lessor
Leases where the Group substantially transfers the risks and benefits of ownership of the asset to the customer are classified as finance leases within finance lease receivables. The Group recognises the amount receivable from assets leased under finance leases at an amount equal to the net investment in the lease. Finance lease income is recognised as revenue in the statement of operations reflecting a constant periodic rate of return on the Group’s net investment in the lease.
Assets provided to customers under leases other than finance leases are classified as operating leases and carried in property, plant and equipment at cost and are depreciated on a straight-line basis over the useful life of the asset or the lease term, if shorter.
Subsequent costs
The Group recognises in the carrying amount of an item of property, plant and equipment the cost of replacing part of such an item when that cost is incurred if it is probable that the future economic benefits embodied within the item will flow to the Group and the cost of the replaced item can be measured reliably. All other costs are recognised in the statement of operations as an expense as incurred.
In respect of business combinations that have occurred since January 1, 2004 (being the transition date to IFRS), goodwill represents the difference between the cost of the acquisition and the fair value of the net identifiable assets acquired.
In respect of acquisitions prior to this date, goodwill is included on the basis of its deemed cost, which represents the amount recorded under the old basis of accounting, Irish GAAP, (“Previous GAAP”). Save for retrospective restatement of deferred tax as an adjustment to retained earnings in accordance with IAS 12, Income Taxes, the classification and accounting treatment of business combinations undertaken prior to the transition date were not reconsidered in preparing the Group’s opening IFRS balance sheet as at January 1, 2004.
To the extent that the Group’s interest in the net fair value of the identifiable assets, liabilities and contingent liabilities acquired exceeds the cost of a business combination, the identification and measurement of the related assets, liabilities and contingent liabilities are revisited accompanied by a reassessment of the cost of the transaction, and any remaining balance is immediately recognised in the statement of operations.
At the acquisition date, any goodwill is allocated to each of the cash generating units expected to benefit from the combination’s synergies. Following initial recognition, goodwill is stated at cost less any accumulated impairment losses (see Note 1(viii)).
An intangible asset, which is an identifiable non-monetary asset without physical substance, is recognised to the extent that it is probable that the expected future economic benefits attributable to the asset will flow to the Group and that its cost can be measured reliably. The asset is deemed to be identifiable when it is separable (that is, capable of being divided from the entity and sold, transferred, licensed, rented or exchanged, either individually or together with a related contract, asset or liability) or when it arises from contractual or other legal rights, regardless of whether those rights are transferable or separable from the Group or from other rights and obligations.
Intangible assets acquired as part of a business combination are capitalised separately from goodwill if the intangible asset meets the definition of an asset and the fair value can be reliably measured on initial recognition. Subsequent to initial recognition, these intangible assets are carried at cost less any accumulated amortisation and any accumulated impairment losses (Note 1(viii)). Intangible assets with definite useful lives are reviewed for indicators of impairment annually while intangible assets with indefinite useful lives and those not yet brought into use are tested for impairment annually, either individually or at the cash generating unit level.
Expenditure on development activities, whereby research findings are applied to a plan or design for the production of new or substantially improved products and processes, is capitalised if the product or process is technically and commercially feasible and the Group has sufficient resources to complete the development. The expenditure capitalised includes the cost of materials, direct labour and attributable overheads and third party costs. Subsequent expenditure on capitalised intangible assets is capitalised only when it increases the future economic benefits embodied in the specific asset to which it relates.
The technical feasibility of a new product is determined by a specific feasibility study undertaken at the first stage of any development project. The majority of our new product developments involve the transfer of existing product know-how to a new application. Since the technology is already proven in an existing product which is being used by customers, this facilitates the proving of the technical feasibility of that same technology in a new product.
The results of the feasibility study are reviewed by a design review committee comprising senior managers. The feasibility study occurs in the initial research phase of a project and costs in this phase are not capitalised.
The commercial feasibility of a new product is determined by preparing a discounted cash flow projection. This projection compares the discounted sales revenues for future periods with the relevant costs. As part of preparing the cash flow projection, the size of the relevant market is determined, feedback is sought from customers and the strength of the proposed new product is assessed against competitors’ offerings. Once the technical and commercial feasibility has been established and the project has been approved for commencement, the project moves into the development phase.
All other development expenditure is expensed as incurred. Subsequent to initial recognition, the capitalised development expenditure is carried at cost less any accumulated amortisation and any accumulated impairment losses (Note 1(viii)).
Expenditure on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, is recognised in the statement of operations as an expense as incurred.
Expenditure on internally generated goodwill and brands is recognised in the statement of operations as an expense as incurred.
Amortisation
Amortisation is charged to the statement of operations on a straight-line basis over the estimated useful lives of intangible assets, unless such lives are indefinite. Intangible assets are amortised from the date they are available for use in its intended market. The estimated useful lives are as follows:
The Group uses a useful economic life of 15 years for capitalised development costs. This is a conservative estimate of the likely life of the products. The Group is confident that products have a minimum of 15 years life given the inertia that characterizes the medical diagnostics industry and the barriers to enter into the industry. The following factors have been considered in estimating the useful life of developed products:
Certain trade names acquired are deemed to have an indefinite useful life as there is no foreseeable limit to the period over which these assets are expected to generate cash inflows for the Group.
Where amortisation is charged on assets with finite lives, this expense is taken to the statement of operations through the ‘selling, general and administrative expenses’ line.
Useful lives are examined on an annual basis and adjustments, where applicable, are made on a prospective basis.
The carrying amount of the Group’s assets, other than inventories, accounts receivable, cash and cash equivalents, short-term investments and deferred tax assets, are reviewed at each balance sheet date to determine whether there is any indication of impairment. If any such indication exists, the asset’s recoverable amount (being the greater of fair value less costs to sell and value in use) is assessed at each balance sheet date.
Fair value less costs to sell is defined as the amount obtainable from the sale of an asset or cash-generating unit in an arm’s length transaction between knowledgeable and willing parties, less the costs that would be incurred on disposal. Value in use is defined as the present value of the future cash flows expected to be derived through the continued use of an asset or cash-generating unit. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the future cash flow estimates have not yet been adjusted. The estimates of future cash flows exclude cash inflows or outflows attributable to financing activities. For an asset that does not generate largely independent cash flows, the recoverable amount is determined by reference to the cash generating unit to which the asset belongs.
For goodwill, assets that have an indefinite useful life and intangible assets that are not yet available for use, the recoverable amount is estimated at each balance sheet date at the cash generating unit level. The goodwill and indefinite-lived assets were reviewed for impairment at December 31, 2017 and December 31, 2018. See Note 13.
In-process research and development (IPR&D) is tested for impairment on an annual basis, in the fourth quarter, or more frequently if impairment indicators are present, using projected discounted cash flow models. If IPR&D becomes impaired or is abandoned, the carrying value of the IPR&D is written down to its revised fair value with the related impairment charge recognised in the period in which the impairment occurs. If the fair value of the asset becomes impaired as the result of unfavorable data from any ongoing or future clinical trial, changes in assumptions that negatively impact projected cash flows, or because of any other information regarding the prospects of successfully developing or commercializing our programs, we could incur significant charges in the period in which the impairment occurs. The valuation techniques utilized in performing impairment tests incorporate significant assumptions and judgments to estimate the fair value, as described above. The use of different valuation techniques or different assumptions could result in materially different fair value estimates.
An impairment loss is recognised whenever the carrying amount of an asset or its cash-generating unit exceeds its recoverable amount. Impairment losses are recognised in the statement of operations.
Impairment losses recognised in respect of cash-generating units are allocated first to reduce the carrying amount of any goodwill allocated to cash-generating units and then to reduce the carrying amount of other assets in the cash-generating units on a pro-rata basis.
An impairment loss is reversed only to the extent that the asset’s carrying amount does not exceed the carrying amount that would have been determined, net of depreciation or amortisation, if no impairment loss had been recognised.
An impairment loss in respect of goodwill is not reversed.
Following recognition of any impairment loss (and on recognition of an impairment loss reversal), the depreciation or amortisation charge applicable to the asset or cash generating unit is adjusted prospectively with the objective of systematically allocating the revised carrying amount, net of any residual value, over the remaining useful life.
Inventories are stated at the lower of cost and net realisable value. Cost is based on the first-in, first-out principle and includes all expenditure which has been incurred in bringing the products to their present location and condition, and includes an appropriate allocation of manufacturing overhead based on the normal level of operating capacity. Net realisable value is the estimated selling price of inventory on hand in the ordinary course of business less all further costs to completion and costs expected to be incurred in selling these products.
The Group provides for inventory, based on estimates of the expected realisability. The estimated realisability is evaluated on a case-by-case basis and any inventory that is approaching its “use-by” date and for which no further re-processing can be performed is written off. Any reversal of an inventory provision is recognised in the statement of operations in the year in which the reversal occurs.
Trade receivables are amounts due from customers for products sold or services provided in the ordinary course of business. Trade and other receivables are stated at their amortised cost less impairment losses incurred. Cost approximates fair value given the short term nature of these assets. The Group records the loss allowance as lifetime expected credit losses. These are the expected shortfalls in contractual cash flows, considering the potential for default at any point during the life of the financial instrument. Expected credit losses are recorded on all of trade receivables based on an assessment of each individual debtor taking into account the probability of default or delinquency in payments and the probability that debtor will enter into financial difficulties or bankruptcy.
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business. Trade and other payables are stated at cost. Cost approximates fair value given the short term nature of these liabilities.
Cash and cash equivalents comprise cash balances and short-term deposits which are readily available at year-end. Deposits with maturities less than six months as at the year end date are recognised as cash and cash equivalents and are carried at fair value. The Group has no short-term bank overdraft facilities. Where restrictions are imposed by third parties, such as lending institutions, on cash balances held by the Group these are treated as financial assets in the financial statements.
Short-term investments comprise short-term bank deposits which have maturities greater than six months as at the year-end date. Short-term deposits made for varying periods depending on the immediate cash requirements of the Group and earn interest at the respective deposit rates in place. Where restrictions are imposed by third parties, such as lending institutions, on short-term deposits held by the Group these are treated as financial assets in the financial statements.
For equity-settled share-based payments (share options), the Group measures the services received and the corresponding increase in equity at fair value at the measurement date (which is the grant date) using a trinomial model. Given that the share options granted do not vest until the completion of a specified period of service, the fair value, which is assessed at the grant date, is recognised on the basis that the services to be rendered by employees as consideration for the granting of share options will be received over the vesting period.
The share options issued by the Group are not subject to market-based vesting conditions as defined in IFRS 2, Share-based Payment. Non-market vesting conditions are not taken into account when estimating the fair value of share options as at the grant date; such conditions are taken into account through adjusting the number of equity instruments included in the measurement of the transaction amount so that, ultimately, the amount recognised equates to the number of equity instruments that actually vest. The expense in the statement of operations in relation to share options represents the product of the total number of options anticipated to vest and the fair value of those options; this amount is allocated to accounting periods on a straight-line basis over the vesting period. Given that the performance conditions underlying the Group’s share options are non-market in nature, the cumulative charge to the statement of operations is only reversed where the performance condition is not met or where an employee in receipt of share options relinquishes service prior to completion of the expected vesting period. Share based payments, to the extent they relate to direct labour involved in development activities, are capitalised, see Note 1(vii).
The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the options are exercised. The Group does not operate any cash-settled share-based payment schemes or share-based payment transactions with cash alternatives as defined in IFRS 2.
Grants that compensate the Group for expenses incurred such as research and development, employment and training are recognised as income in the statement of operations on a systematic basis in the same periods in which the expenses are incurred. Grants that compensate the Group for the cost of an asset are recognised in the statement of operations as other operating income on a systematic basis over the useful life of the asset.
Goods sold and services rendered
The Group recognises revenue when it transfers control over a good or service to a customer. Revenue is recognised to the extent that it is probable that economic benefit will flow to the Group and the revenue can be measured. No revenue is recognised if there is uncertainty regarding recovery of the consideration due at the outset of the transaction or the possible return of goods. Revenue, including any amounts invoiced for shipping and handling costs, represents the value of goods and services supplied to external customers, net of discounts and rebates and excluding sales taxes.
Revenue from products is generally recorded as of the date of shipment, consistent with typical ex-works shipment terms. Where the shipment terms do not permit revenue to be recognised as of the date of shipment, revenue is recognised when the Group has satisfied all of its performance obligations to the customer in accordance with the shipping terms. Some contracts oblige the Group to ship product to the customer ahead of the agreed payment schedule. For these shipments, a contract asset is recognised when control over the goods has transferred to the customer. The financing component is insignificant as invoicing for these shipments occurs within a short period of time after shipment has occurred and standard 30 day credit terms apply.
The Group operates a licensed referenced laboratory in the US, which provides testing services to institutional customers and insurance companies. In the US, there are rules requiring all insurance companies to be billed the same amount per test. However, the amount that each insurance company pays for a particular test varies according to their own internal policies and this can typically be considerably less than the amount invoiced. We recognise lab services revenue for insurance companies by taking the invoiced amount and reducing it by an estimated percentage based on historical payment data. We review the percentage reduction annually based on the latest data. As a practical expedient, and in accordance with IFRS, we apply a portfolio approach to the insurance companies as they have similar characteristics. We judge that the effect on the financial statements of using a portfolio approach for the insurance companies will not differ materially from applying IFRS 15 to the individual contracts within that portfolio.
Revenue from services rendered is recognised in the statement of operations in proportion to the stage of completion of the transaction at the balance sheet date.
The Group leases instruments to customers typically as part of a bundled package. Where a contract has multiple performance obligations and its duration is greater than one year, the transaction price is allocated to the performance obligations in the contract by reference to their relative standalone selling prices. For contracts where control of the instrument is transferred to the customer, the fair value of the instrument is recognised as revenue at the commencement of the lease and is matched by the related cost of sale. Fair value is determined on the basis of standalone selling price. In the case where control of the instrument does not transfer to the customer, revenue is recognised on the basis of customer usage of the instrument. See also Note 1(v).
In obtaining these contracts, the Group incurs a number of incremental costs, such as sales bonus paid to sales staff commissions paid to distributors and royalty payments. As the amortisation period of these costs, if capitalised, would be less than one year, the Group makes use of the practical expedient in IFRS 15.94 and expenses them as they incur.
A receivable is recognised when the goods are delivered as this is the point in time that the consideration is unconditional because only the passage of time is required before the payment is due.
The Group’s obligation to provide a refund for faulty products under the standard warranty terms is recognised as a provision, see Note 23 for details.
Other operating income
Other operating income mainly comprises income recognised under Transitional Services Agreements (TSA) with Diagnostica Stago. As part of the divestiture of the Coagulation product line in April 2010, the Group entered into a TSA. The services provided by the Group to Stago under the TSA comprise canteen services. This income has not been treated as revenue since the TSA activities are incidental to the main revenue-generating activities of the Group.
Defined contribution plans
The Group operates defined contribution schemes in various locations where its subsidiaries are based. Contributions to the defined contribution schemes are recognised in the statement of operations in the period in which the related service is received from the employee.
Other long-term benefits
Where employees participate in the Group’s other long-term benefit schemes (such as permanent health insurance schemes under which the scheme insures the employees), or where the Group contributes to insurance schemes for employees, the Group pays an annual fee to a service provider, and accordingly the Group expenses such payments as incurred.
Termination benefits
Termination benefits are recognised as an expense when the Group is demonstrably committed, without realistic possibility of withdrawal, to a formal detailed plan to either terminate employment before normal retirement date, or to provide termination benefits as a result of an offer made to encourage voluntary redundancy.
A majority of the revenue of the Group is generated in US Dollars. The Group’s management has determined that the US Dollar is the primary currency of the economic environment in which the Company and its subsidiaries (with the exception of the Group’s subsidiaries in Brazil, Canada and Sweden) principally operate. Thus the functional currency of the Company and its subsidiaries (other than the Brazilian, Canadian and Swedish subsidiaries) is the US Dollar. The functional currency of the Brazilian entity is the Brazilian Real, the functional currency of the Canadian subsidiary, Nova Century Scientific Inc, is the Canadian Dollar and the functional currency of the Swedish subsidiary is the Swedish Kroner. The presentation currency of the Company and Group is the US Dollar. Monetary assets and liabilities denominated in foreign currencies are translated at the rates of exchange ruling at the balance sheet date. The resulting gains and losses are included in the statement of operations. Non-monetary assets and liabilities that are measured in terms of historical cost in a foreign currency are translated using the exchange rate at the date of the transaction.
Results and cash flows of subsidiary undertakings, which have a functional currency other than the US Dollar, are translated into US Dollars at average exchange rates for the year, and the related balance sheets have been translated at the rates of exchange ruling on the balance sheet date. Any exchange differences arising from the translations are recognised in the currency translation reserve via the statement of changes in equity.
Where Euro, Brazilian Real, Canadian Dollar or Swedish Kroner amounts have been referenced in this document, their corresponding US Dollar equivalent has also been included and these equivalents have been calculated with reference to the foreign exchange rates prevailing at December 31, 2018.
The activities of the Group expose it primarily to changes in foreign exchange rates and interest rates. The Group uses derivative financial instruments, from time to time, such as forward foreign exchange contracts to hedge these exposures.
The Group enters into forward contracts to sell US Dollars forward for Euro. The principal exchange risk identified by the Group is with respect to fluctuations in the Euro as a substantial portion of its expenses are denominated in Euro but its revenues are primarily denominated in US Dollars. Trinity Biotech monitors its exposure to foreign currency movements and may use these forward contracts as cash flow hedging instruments whose objective is to cover a portion of this Euro expense.
At the inception of a hedging transaction entailing the use of derivatives, the Group documents the relationship between the hedged item and the hedging instrument together with its risk management objective and the strategy underlying the proposed transaction. The Group also documents its quarterly assessment of the effectiveness of the hedge in offsetting movements in the cash flows of the hedged items.
Derivative financial instruments are recognised at fair value. Where derivatives do not fulfil the criteria for hedge accounting, they are classified as held-for-trading and changes in fair values are reported in the statement of operations. The fair value of forward exchange contracts is calculated by reference to current forward exchange rates for contracts with similar maturity profiles and equates to the current market price at the balance sheet date.
The portion of the gain or loss on a hedging instrument that is deemed to be an effective cash flow hedge is recognised directly in the hedging reserve in equity and the ineffective portion is recognised in the statement of operations. As the forward contracts are exercised the net cumulative gain or loss recognised in the hedging reserve is transferred to the statement of operations and reflected in the same line as the hedged item.
The Company’s exchangeable notes are treated as a host debt instrument with embedded derivatives attached. On initial recognition, the host debt instrument is recognised at the residual value of the total net proceeds of the bond issue less fair value of the embedded derivatives. Subsequently, the host debt instrument is measured at amortised cost using the effective interest rate method.
The embedded derivatives are initially recognised at fair value and are restated at their fair value at each reporting date. The fair value changes of the embedded derivatives are recognised in the statement of operations, except for changes in fair value related to the Group’s own credit risk, which are recorded in the statement of comprehensive income.
Where the exchangeable notes are redeemed early or repurchased in a way that does not alter the original conversion privileges, the consideration paid is allocated to the respective components and the amount of any gain or loss is recognised in the consolidated statement of operations.
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the Board of Directors.
Income tax on the profit or loss for the year comprises current and deferred tax. Income tax is recognised in the statement of operations except to the extent that it relates to items recognised directly in equity, in which case it is recognised in equity.
Current tax represents the expected tax payable or recoverable on the taxable profit for the year using tax rates enacted or substantively enacted at the balance sheet date in the countries where the company and its subsidiaries operate and generate income, and taking into account any adjustments stemming from prior years.
Deferred tax is provided on the basis of the balance sheet liability method on all temporary differences at the balance sheet date which is defined as the difference between the tax bases of assets and liabilities and their carrying amounts in the financial statements. Deferred tax assets and liabilities are not subject to discounting and are measured at the tax rates that are anticipated to apply in the period in which the asset is realised or the liability is settled based on tax rates and tax laws that have been enacted or substantively enacted at the balance sheet date. Deferred tax assets are recognised when it is probable that future taxable profits will be available to utilize the associated losses or temporary differences. The amount of deferred tax provided is based on the expected manner of realisation or settlement of the carrying amount of assets and liabilities.
Deferred tax assets and liabilities are recognised for all temporary differences (that is, differences between the carrying amount of the asset or liability and its tax base) with the exception of the following:
Where goodwill is tax deductible, a deferred tax liability is not recognised on initial recognition of goodwill. It is recognised subsequently for the taxable temporary difference which arises when the goodwill is amortised for tax with no corresponding adjustment to the carrying value of the goodwill.
The carrying amounts of deferred tax assets are subject to review at each balance sheet date and are derecognised to the extent that future taxable profits are considered to be inadequate to allow all or part of any deferred tax asset to be utilised.
A provision is recognised in the balance sheet when the Group has a present legal or constructive obligation as a result of a past event, and it is probable that an outflow of economic benefits will be required to settle the obligation.
Cost of sales comprises product cost including manufacturing and payroll costs, quality control, shipping, handling, and packaging costs and the cost of services provided.
Financing expenses comprise interest costs payable on leases and exchangeable notes. Interest payable on finance leases is allocated to each period during the lease term so as to produce a constant periodic rate of interest on the remaining balance of the liability. Financing expenses also includes the financing element of long term liabilities which have been discounted.
Finance income includes interest income on deposits and is recognised in the statement of operations as it accrues, using the effective interest method. Finance income also includes fair value adjustments to embedded derivatives associated with exchangeable notes.
When the Group purchases its own equity instruments (treasury shares), the costs, including any directly attributable incremental costs, are deducted from equity. No gain or loss is recognised in the statement of operations on the purchase, sale, issue or cancellation of the Group’s own equity instruments. Any difference between the carrying amount and the consideration, if reissued, is recognised in share premium. Voting rights related to treasury shares are nullified for the Group and no dividends are allocated to them.
Share capital represents the nominal (par) value of shares that have been issued. Share premium includes any premiums received on issue of share capital. Any transaction costs associated with the issuing of shares are deducted from share premium, net of any related income tax benefits.
A discontinued operation is a component of the Group that either has been disposed of, or is classified as held for sale. Profit or loss from discontinued operations comprises the post-tax profit or loss of discontinued operations and the post-tax gain or loss resulting from the measurement and disposal of assets classified as held for sale.
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: quoted prices (unadjusted) in active markets for identical assets or liabilities
Level 2: valuation techniques for which the lowest level of inputs which have a significant effect on the recorded fair value are observable, either directly or indirectly
Level 3: valuation techniques for which the lowest level of inputs that have a significant effect on the recorded fair value are not based on observable market data
The IASB and IFRIC have issued additional standards and interpretations which are effective for periods starting after January 1, 2018, all of which have not yet been adopted by the EU. IFRS as adopted by the EU differ in certain respects from IFRS as issued by the IASB. However, the Group’s consolidated financial statements for the financial years presented would be no different had IFRS as issued by the IASB been applied. The following standards and interpretations have yet to be adopted by the Group:
IFRS 16 Leases was issued in January 2016 and replaces IAS 17 Leases, IFRIC 4 Determining Whether an Arrangement Contains a Lease, SIC-15 – Operating Leases – Incentives and SIC-27 – Evaluating the Substance of Transactions Involving the Legal Form of a Lease. The Group will adopt IFRS 16 on January 1, 2019 and will apply the modified retrospective approach on transition. Comparative results will not be restated.
IFRS 16 sets out the principles for the recognition, measurement, presentation and disclosure of leases and requires lessees to account for the majority of leases under a single on-balance sheet model, similar to the accounting for finance leases under IAS 17. The standard includes two recognition exemptions for lessees which will be availed of by the Group – leases of ‘low-value’ assets (e.g. computers, small copiers costing less than US$5,000) and short-term leases (i.e. leases with a term of 12 months or less). It also includes an election, which permits a lessee not to separate non-lease components (e.g. maintenance) from lease components and instead capitalise both the lease cost and associated non-lease cost.
At the commencement date of a lease, a lessee will recognise a liability to make lease payments (i.e. the lease liability) and an asset representing the right to use the underlying asset during the lease term (i.e. the right-of-use asset). Lessees will be required to recognise separately the interest expense on the lease liability and the depreciation expense on the right-of-use asset. Under IFRS 16, lessees will also be required to remeasure the lease liability upon the occurrence of certain events (e.g. a change in lease term or a change in future lease payments resulting from a change in an index or rate used to determine those payments). The lessee will generally recognise the amount of the remeasurement of the lease liability as an adjustment to the right-of-use asset. Trinity Biotech has entered into operating leases for a range of assets, principally relating to premises, plant and machinery, vehicles and equipment.
The adoption of the new standard will have a material impact on the Group’s consolidated financial statements, as follows:
Statement of Operations
The adoption of the new standard will lead to a reduction in profit in the short term but this will reverse over the life of the leases. The Group currently recognises operating lease expenses in operating costs. The Group’s lease expense for 2018 was US$3.0 million (2017 US$3.0 million) and is disclosed in Note 5 to the consolidated financial statements. A significant majority of these lease expenses will not be recognised in the Group’s statement of operations beginning January 1, 2019. Instead, right-of-use assets will be capitalised and depreciated over the term of the lease with an associated finance cost applied to the lease liability. In 2019, the depreciation and finance cost for right-of-use assets will exceed what would have been the charged for operating lease expenses and therefore profit will decrease.
Balance Sheet
At transition date, the Group will determine the lease payments outstanding at that date and apply the appropriate discount rate to calculate the present value of the lease payments. The Group’s commitments outstanding on all leases as at December 31, 2018 is US$25.7 million (2017: US$22.1 million) (see Note 26(b) to the consolidated financial statements). The related right-of-use assets will be recognised within Property, Plant and equipment. Our existing finance lease liabilities (refer Note 25) are not affected by the new standard. Similarly, our lessor accounting will not be impacted by IFRS 16 (refer to finance lease receivable in Note 17).
The Group has assessed the impact of the new standard but the exact financial impact of the standard is as yet unknown. The Group’s commitment as at December 31, 2018 provides an indication of the scale of leases held and how significant leases currently are to Trinity Biotech’s business.
In addition to the impacts above, there will also be significantly increased disclosures when the Group adopts IFRS 16, including the following:
The Group has adopted the following standards and amendments during the year:
The Group has adopted IFRS 2, Share-based Payments for its 2018 financial year. The amended standard had no impact on the financial statements.
The Group has adopted IFRS 15, Revenue from Contracts with Customers for its 2018 financial year. As permitted by the standard, the Group has adopted the modified transitional provisions and as such the 2017 results remain as previously reported. As expected, the new standard did not lead to a material difference in the timing of recognising revenue. The main impact on the financial statements is the increased disclosure obligations including expanded disclosure in respect of disaggregated revenue from contracts with customers and separate disclosure of contract assets. We have also updated our accounting policy for revenue recognition.
The Group has adopted IFRS 9, Financial Instruments for its 2018 financial year. The new standard affects the recording of fair value movements of the put and call options in our exchangeable notes. Movements in fair value related to the Group’s own credit risk are recorded in the statement of comprehensive income. There were no such movements in 2018. There have been no changes in classifications as a result of the application of IFRS 9. |
SEGMENT INFORMATION |
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Disclosure of operating segments [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SEGMENT INFORMATION |
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is responsible for allocating resources and assessing the performance of the operating segments, has been identified as the Board of Directors. Management has determined the operating segments based on the reports reviewed by the Board of Directors, which are used to make strategic decisions. The Board considers the business from a geographic perspective based on the Group’s management and internal reporting structure. Sales of product between companies in the Group are made on commercial terms which reflect the nature of the relationship between the relevant companies. Segment results, assets and liabilities include items directly attributable to a segment as well as those that can be allocated on a reasonable basis. Unallocated items comprise interest-bearing loans, borrowings and expenses and corporate expenses. Segment capital expenditure is the total cost during the year to acquire segment plant, property and equipment and intangible assets that are expected to be used for more than one period, whether acquired on acquisition of a business combination or through acquisitions as part of the current operations.
The Group comprises two main geographical segments (i) the Americas and (ii) Rest of World. The Group’s geographical segments are determined by the location of the Group’s assets and operations. The Group has also presented a geographical analysis of the segmental data for Ireland as is consistent with the information used by the Board of Directors.
The reportable operating segments derive their revenue primarily from one source (i.e. the market for diagnostic tests for a range of diseases and other medical conditions). In determining the nature of its segmentation, the Group has considered the nature of the products, their risks and rewards, the nature of the production base, the customer base and the nature of the regulatory environment. The Group acquires, manufactures and markets a range of diagnostic products. The Group’s products are sold to a similar customer base and the main body whose regulation the Group’s products must comply with is the Food and Drug Administration (“FDA”) in the US.
The following presents revenue and profit information and certain asset and liability information regarding the Group’s geographical segments.
The Group derives revenue from the transfer of goods and services over time and at a point in time in the following geographical areas:
See Note 21 for further information on share-based payments.
Interest expense in 2016 does not include US$5,000 that has been stated in Note 10 in respect of the discontinued operations in Fiomi.
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FINANCIAL INCOME AND EXPENSES |
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Disclosure of financial income and expenses [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FINANCIAL INCOME AND EXPENSES |
Exchangeable note interest expense and non-cash financial income and expense relate to the exchangeable senior notes issued in 2015. For further information, refer to Note 24. Interest expense in 2016 does not include US$5,000 that has been stated in Note 10 in respect of the discontinued operations in Fiomi. |
OTHER OPERATING INCOME |
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Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of other operating income [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
OTHER OPERATING INCOME |
Other income mainly comprises income recognised under Transitional Services Agreements (TSA) with Diagnostica Stago. As part of the divestiture of the Coagulation product line in April 2010, the Group entered into a TSA. The services provided by the Group to Stago under the TSA comprise canteen services. This income has not been treated as revenue since the TSA activities are incidental to the main revenue-generating activities of the Group. |
LOSS BEFORE TAX |
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Disclosure of loss profit before tax [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LOSS BEFORE TAX |
The following amounts were charged / (credited) to the statement of operations:
In 2016, the depreciation expense did not include the amount of US$303,000 that was included in the operating expenses that were stated in Note 10 in respect of the discontinued operations in Fiomi. In 2017 and 2018, no depreciation expense arose for the discontinued operation.
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IMPAIRMENT CHARGES AND INVENTORY PROVISIONING |
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Disclosure of impairment charges and inventory provisioning [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
IMPAIRMENT CHARGES AND INVENTORY PROVISIONING |
In accordance with IAS 36, Impairment of Assets, the Group carries out an annual impairment review of the asset valuations. In determining whether a potential asset impairment exists, a range of internal and external factors are considered. A number of factors affected this calculation including:
The impact of the above items on the statement of operations for the year ended December 31, 2018, December 31, 2017 and December 31, 2016 was as follows:
In 2016, the decision to withdraw the Meritas Troponin premarket submission to the U.S. Food and Drug Administration, Trinity Biotech’s led to a significant reduction in the Group’s share price. Given that the market capitalisation was then significantly below the book value of the net assets, the Group decided to recognise at December 31, 2016 a non-cash impairment charge of US$28,390,000. The impairment was taken against goodwill and other intangible assets, property, plant and equipment and prepayments (see Notes 12, 13 and 17). Certain capitalised development projects were judged to be specifically impaired and their total carrying value of US$14,989,000 was expensed. Total impairment charges were US$43,379,000.
Also in 2016, the Group recognised a charge of US$4,786,000 in relation to a number of products that were culled. This mainly represented inventory provisioning for the Bartels and Microtrak product lines that were acquired over 15 years. Revenues for these products had been declining significantly over the last number of years and had reached the end of their economic life, especially given the level of technical support required to keep older products of this nature on the market. |
PERSONNEL EXPENSES |
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Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PERSONNEL EXPENSES |
Personnel expenses are shown net of capitalisations. Total personnel expenses, inclusive of amounts capitalised for wages and salaries, social welfare costs and pension costs, for the year ended December 31, 2018 amounted to US$38,002,000 (2017: US$37,351,000) (2016: US$40,980,000). Total share based payments, inclusive of amounts capitalised in the balance sheet, amounted to US$1,607,000 for the year ended December 31, 2018 (2017: US$1,109,000) (2016: US$1,633,000). See Note 21 for further details.
There were no restructuring costs incurred for the years ended December 31, 2018 and December 31, 2017. Restructuring costs for the year ended December 31, 2016 were US$1,276,000 and related to Swedish operations.
The average number of persons employed by the Group in the financial year was 575 (2017: 556) (2016: 582) and is analysed into the following categories:
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PENSION SCHEMES |
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Dec. 31, 2018 | ||||
Disclosure of pension schemes [Abstract] | ||||
PENSION SCHEMES |
The Group operates defined contribution pension schemes for certain of its full time employees. The benefits under these schemes are financed by both Group and employee contributions. Total contributions made by the Group in the financial year and charged against income amounted to US$490,000 (2017: US$458,000) (2016: US$708,000) of which $Nil (2017: $Nil) (2016: US$156,000) is included within the restructuring costs in Note 7. The pension accrual for the Group at December 31, 2018 was US$45,000 (2017: US$33,000), (2016: US$83,000).
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INCOME TAX (CREDIT)/EXPENSE |
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Income Tax Creditexpense Schedule Of Statutory Tax Rate | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INCOME TAX (CREDIT)/EXPENSE |
The charge for tax based on the profit comprises:
The following table reconciles the applicable Republic of Ireland statutory tax rate to the effective total tax rate for the Group:
The distribution of loss before taxes by geographical area was as follows:
At December 31, 2018, the Group had unutilised net operating losses as follows:
In the USA, the utilisation of net operating loss carryforwards is limited to future profits in the USA. The net operating losses for the US arising prior to January 1, 2019 have a maximum carryforward of 20 years. In respect of the US, US$589,000 will expire by December 31, 2035, US$1,753,000 will expire by December 31, 2036, and US$40,000 will expire by December 31, 2037.
At December 31, 2018, the Group had unrecognised deferred tax assets in respect of unused tax losses and unused tax credits as follows:
The accounting policy for deferred tax is to calculate the deferred tax asset that is deemed recoverable, considering all sources for future taxable profits. The deferred tax assets in the above table have not been recognised due to uncertainty regarding the full utilization of these losses in the related tax jurisdiction in future periods. Only when it is probable that future profits will be available to utilize the forward losses or temporary differences is a deferred tax asset recognised. When there is a reversing deferred tax liability in that jurisdiction that reverses in the same period, the deferred tax asset is restricted so that it equals the reversing deferred tax liability.
The Group has US state credit carryforwards of US$461,000 at December 31, 2018 (2017: US$436,000; 2016: US$420,000). A deferred tax asset of US$364,000 (2017: US$345,000; 2016: US$277,000) in respect of US state credit carryforwards was not recognised in 2018 due to uncertainties regarding future full utilisation of these state credit carryforwards in the related tax jurisdiction in future periods.
We are subject to periodic audits in the various tax jurisdictions in which we operate. There is an on going audit by the tax authorities of one of the tax jurisdictions in which we operate. The outcome of this tax audit is unknown but it is possible the final tax outcome will be different than that which is reflected in our historical income tax provisions and accruals. Such differences could have a material effect on our income tax provision and profit in the period in which such determination is made. |
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATIONS |
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Disclosure of loss on discontinued operations [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PROFIT/(LOSS) ON DISCONTINUED OPERATIONS |
In 2016, management decided to cease the development of Cardiac point-of-care tests on the Meritas platform. These products were being developed by the Group’s subsidiary Fiomi Diagnostics (“Fiomi”) located in Sweden. The decision to cease the development work and to close the Swedish operation came after the company held a meeting with the U.S. Food and Drug Administration (“FDA”) in order to obtain an update on the Meritas Troponin premarket submission. At that meeting the FDA suggested that the submission should be withdrawn. The FDA made it known that any new point-of-care Troponin product would be required to demonstrate performance equivalent to the most recently cleared laboratory-based device. As there was no certainty that this level of performance could ever be achieved by the point-of-care Meritas product, even with the benefit of further development efforts, management decided to cease the development work on Troponin I and the analyzer and its sister products, BNP and D-dimer.
Expenses, gains and losses relating to the discontinuation of the Cardiac point-of-care tests operation have been eliminated from profit or loss from the Group’s continuing operations and are shown as a single line item (net of related taxes) on the face of the Consolidated Statement of Operations. The discontinued operation had no revenues since commencement as the products were still in their development phase. In 2016, the loss on discontinued operations included the write off of the carrying value of all capitalised development costs, goodwill, property, plant and equipment, inventories and other assets associated with the Meritas project. It also included a provision for the cost of closing the Swedish facility, mainly consisting of contractual obligations associated with terminating premises and supplier contracts, as well as redundancy costs for 41 employees.
In 2017, settlements were negotiated with a number of counterparties that were lower than had been estimated in the previous years’ financial statements. The resultant excess provision for closure costs was released to the Consolidated Statement of Operations. During 2017, all remaining employees and all operating lease obligations were terminated. The loss on discontinued operations in 2017 also included a charge in relation to foreign translation reserves that had been recognised in previous periods as a reserve movement. In 2018, taxes paid to the Swedish tax authorities were recovered and there was a resulting tax credit of US$590,000.
The operating loss for the Cardiac point-of-care tests operation in Sweden and the profit/(loss) on remeasurement of its assets and liabilities are summarised as follows:
Basic earnings per ordinary share – discontinued operations
Basic earnings/(loss) per ordinary share for discontinued operations is computed by dividing the profit/(loss) after taxation on discontinued operations of US$568,000 (2017: loss US$1,609,000) (2016: loss US$62,042,000) for the financial year by the weighted average number of ‘A’ ordinary shares in issue. As at December 31, 2018, this amounted to 83,612,908 shares (2017: 86,486,409 shares) (2016: 91,858,813 shares), see note 11 for further details.
Diluted earnings per ordinary share – discontinued operations
Diluted earnings/(loss) per ordinary share for discontinued operations is computed by dividing the profit/(loss) after taxation on discontinued operations of US$568,000 (2017: loss US$1,609,000) (2016: loss US$62,042,000) for the financial year by the diluted weighted average number of ordinary shares in issue of 103,508,820 (2017: 107,510,179) (2016: 113,197,598), see note 11 for further details. Under IAS 33 Earnings per Share, diluted earnings per share cannot be anti-dilutive. Therefore, diluted loss per ADS in accordance with IFRS is equal to basic earnings per ADS.
Earnings per ADS
In June 2005, Trinity Biotech adjusted its ADS ratio from 1 ADS: 1 ordinary share to 1 ADS: 4 ordinary shares. Earnings per ADS for all periods presented have been restated to reflect this exchange ratio.
Basic earnings/(loss) per ADS for discontinued operations is computed by dividing the profit after taxation on discontinued operations of US$568,000 (2017: loss US$1,609,000) (2016: loss US$62,042,000) for the financial year by the weighted average number of ADS in issue of 20,903,227 (2017: 21,621,602); (2016: 22,964,703), see note 11 for further details.
Diluted earnings/(loss) per ADS for discontinued operations is computed by dividing the profit after taxation on discontinued operations of US$568,000 (2017: loss US$1,609,000) (2016: loss US$62,042,000) for the financial year, by the diluted weighted average number of ADS in issue of 25,877,205 (2017: 26,877,544) (2016: 28,299,399), see note 11 for further details.
Cash flows
The cash flows attributable to discontinued operations are as follows:
There were no cash flows from financing activities attributable to discontinued operations for the years ended December 31, 2018, 2017 or 2016. |
(LOSS)/EARNINGS PER SHARE |
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Earnings per share [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LOSS EARNINGS PER SHARE |
Basic earnings per ordinary share
Basic earnings per ordinary share for the group is computed by dividing the loss after taxation of US$22,090,000 (2017: loss of US$40,270,000) (2016: loss of US$100,625,000) for the financial year by the weighted average number of ‘A’ ordinary shares in issue. Basic earnings per ordinary share for continuing operations is computed by dividing the loss after taxation for continued operations of US$22,658,000 (2017: loss of US$38,661,000) (2016: profit of US$38,583,000) for the financial year by the weighted average number of ‘A’ ordinary shares in issue.
As at December 31, 2018, this amounted to 83,612,908 shares (2017: 86,486,409 shares) (2016: 91,858,813 shares).
*The weighted average number of shares issued during the year is calculated by taking the number of shares issued multiplied by the number of days in the year each share is in issue, divided by 365 days.
Diluted earnings per ordinary share
Diluted earnings per ordinary share for the group is computed by dividing the adjusted loss after tax of US$18,437,000 (2017: loss of US$37,337,000) (2016: loss of US$97,577,000) for the financial year by the diluted weighted average number of ordinary shares in issue of 103,508,820 (2017: 107,510,179) (2016: 113,197,598). Diluted earnings per ordinary share for continuing operations is computed by dividing the adjusted loss after tax on continuing operations of US$19,006,000 (2017: loss of US$35,728,000) (2016: loss of US$35,536,000) for the financial year by the diluted weighted average number of ordinary shares in issue of 103,508,820 (2017: 107,510,179) (2016: 113,197,598). The adjusted loss after tax on continuing operations is computed by adding back the interest expense, accretion interest and movements in the fair value of the derivatives on the exchangeable notes to the loss after taxation for continuing operations.
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 earnings per ordinary share.
The basic weighted average number of ordinary shares for the Group may be reconciled to the number used in the diluted earnings per ordinary share calculation as follows:
The loss after tax for the year may be reconciled to the amount used in the diluted earnings per ordinary share calculation as follows:
Earnings per ADS
In June 2005, Trinity Biotech adjusted its ADS ratio from 1 ADS: 1 ordinary share to 1 ADS: 4 ordinary shares. Earnings per ADS for all periods presented have been restated to reflect this exchange ratio.
Basic earnings per ADS for the Group is computed by dividing the loss after taxation of US$22,090,000 (2017: loss of US$40,270,000) (2016: loss of US$100,625,000) for the financial year by the weighted average number of ADS in issue of 20,903,227 (2017: 21,621,602); (2016: 22,964,703). Basic earnings per ADS for continuing operations is computed by dividing the loss after taxation of US$22,658,000 (2017: loss of US$38,661,000) (2016: loss of US$38,583,000) for the financial year by the weighted average number of ADS in issue of 20,903,227 (2017: 21,621,602); (2016: 22,964,703).
Diluted earnings per ADS for the Group is computed by dividing the adjusted loss after taxation of US$18,437,000 (2017: loss of US$37,337,000) (2016: loss of US$97,577,000) for the financial year, by the diluted weighted average number of ADS in issue of 25,877,205 (2017: 26,877,544) (2016: 28,299,399).
Under IAS 33 Earnings per Share, diluted earnings per share cannot be anti-dilutive. Therefore, diluted loss per ADS in accordance with IFRS would be equal to basic earnings per ADS.
*The weighted average number of shares issued during the year is calculated by taking the number of shares issued multiplied by the number of days in the year each share is in issue, divided by 365 days.
The basic weighted average number of ADS shares for the Group may be reconciled to the number used in the diluted earnings per ADS share calculation as follows:
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PROPERTY, PLANT AND EQUIPMENT |
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Disclosure of detailed information about property, plant and equipment [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PROPERTY, PLANT AND EQUIPMENT |
The annual impairment review performed at December 31, 2018 showed that the carrying value of the Group’s assets exceeded the amount to be recovered through use or sale of the assets by a total of US$57,794,000. The details of the impairment review are described in Note 13. When an impairment loss is identified in a cash generating unit, it must be first allocated to reduce the carrying amount of any goodwill allocated to the cash generating unit and then to the other assets of the unit pro rata on the basis of the carrying amount of each asset in the unit. In this manner, an impairment loss of US$6,112,000 was allocated to property, plant and equipment in 2018. The recoverable amount of property, plant and equipment was determined to be the value in use of each cash generating unit.
The annual impairment review performed at December 31, 2017 showed that the carrying value of the Group’s assets exceeded the amount to be recovered through use or sale of the assets by a total of US$85,603,000. The details of the impairment review are described in Note 13. When an impairment loss is identified in a cash generating unit, it must be first allocated to reduce the carrying amount of any goodwill allocated to the cash generating unit and then to the other assets of the unit pro rata on the basis of the carrying amount of each asset in the unit. In this manner, an impairment loss of US$10,437,000 was allocated to property, plant and equipment in 2017. The recoverable amount of property, plant and equipment was determined to be the value in use of each cash generating unit.
Assets held under operating leases (where the Company is the lessor)
The Company has a number of assets included in plant and equipment which generate operating lease revenue for the Group. The net book value of these assets as at December 31, 2018 and 2017 is US$Nil following full write down of the assets due to group impairment (refer to Note 13). Depreciation charged on these assets in 2018 amounted to US$8,000 (2017: US$30,000).
Included in disposals/retirements in 2018 is US$12,000 (2017: US$Nil) relating to the net book value of leased instruments reclassified as inventory on return from customers.
Property, plant and equipment under construction
Included in property, plant and equipment at December 31, 2018 is an amount of US$204,000 (2017: US$561,000) relating to assets in the course of construction.
Assets held under finance leases
Included in the carrying amount of property, plant and equipment is an amount for capitalised leased assets of US$372,000 (2017: US$51,000). Movement in the carrying amount of capitalised leased assets during 2018 is due to additions. The depreciation charge in respect of capitalised leased assets for the year ended December 31, 2018 was US$37,000 (2017: US$181,000). |
GOODWILL AND INTANGIBLE ASSETS |
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Disclosure of goodwill and intangible assets [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS |
Included within development costs are costs of US$4,192,000 which were not amortised in 2018 (2017: US$31,904,000). These development costs are not being amortised as the projects to which the costs relate were not fully complete at December 31, 2018 or at December 31, 2017. As at December 31, 2018 these projects are expected to be completed during the period from January 1, 2019 to December 31, 2021 at an expected further cost of approximately US$5,718,000.
The following represents the costs incurred during each period presented for each of the principal development projects:
All of the development projects for which costs have been capitalised are judged to be technically feasible, commercially viable and likely to produce future economic benefits. In reaching this conclusion, many factors have been considered including the following:
Other intangible assets
Other intangible assets consist primarily of acquired customer and supplier lists, trade names, website and software costs.
Amortisation
Amortisation is charged to the statement of operations through the selling, general and administrative expenses line.
Impairment testing for intangibles including goodwill and indefinite lived assets
Goodwill and other intangibles are subject to impairment testing on an annual basis. In determining whether a potential asset impairment exists, a range of internal and external factors are considered. A number of factors impacted this calculation including:
As the future discounted cash flows for a number of cash generating units (“CGUs”) was below the carrying value of their net assets, the Group decided to recognise at December 31, 2018 a non-cash impairment charge of US$26,932,000.
The impairment test performed as at December 31, 2018 identified a total impairment loss of US$57,794,000 in six CGUs, of which US$26,932,000 has been recorded in the 2018 financial statements. Not all of the total impairment loss was recorded in the financial statements due to the allocation method proscribed in IAS 36, Impairment of Assets. According to the accounting standard, the impairment loss for each CGU is first allocated to reduce the carrying amount of any goodwill allocated to the CGU, then to other assets of the unit pro rata on the basis of the carrying amount of each asset in the CGU. The full impairment loss for Biopool US Inc, Trinity Biotech Manufacturing Limited, Phoenix Biotech Corp and Trinity Biotech Do Brasil could not be reflected in the 2018 financial statements for these entities because each of these entities had insufficient assets to write down after excluding those assets with a known recoverable amount. The amount of impairment loss that could not be recorded for Biopool US Inc, Trinity Biotech Manufacturing Limited, Phoenix Bio-tech Corp and Trinity Biotech Do Brasil was US$19,026,000, US$10,860,000, US$286,000 and US$690,000 respectively. As a result, the impairment loss that was recorded in the 2018 financial statements was US$26,932,000, being the total impairment loss of US$57,794,000 less the amounts which could not be recorded.
The impairment loss arose from the impairment review performed on Trinity Biotech Manufacturing Limited, Clark Laboratories Inc, Primus Corp, Phoenix Bio-tech Corp, Biopool US Inc and Trinity Biotech Do Brasil. An impairment loss arose in these entities due to the carrying value of their net assets exceeding the entity’s discounted future cashflows. The recoverable amount of each of the CGUs is determined based on a value-in-use computation, which is the only methodology applied by the Group and which has been selected due to the impracticality of obtaining fair value less costs to sell measurements for each reporting period. For the purpose of the annual impairment tests, goodwill is allocated to the relevant CGU. The annual impairment analysis is based on a valuation technique involving level 3 inputs, see Note 1 (xxix).
The value-in-use calculations use cash flow projections based on the 2019 budget and projections for a further four years using projected revenue and cost growth rates of between 0% and 5.5%. At the end of the five year forecast period, terminal values for each CGU, based on a long term growth rate of 2%, are used in the value-in-use calculations. The value-in-use represents the present value of the future cash flows, including the terminal value, discounted at a rate appropriate to each CGU. The key assumptions employed in arriving at the estimates of future cash flows are subjective and include projected EBITDA, net cash flows, discount rates and the duration of the discounted cash flow model. The assumptions and estimates used were derived from a combination of internal and external factors based on historical experience. The pre-tax discount rates used range from 20% to 35% (2017: 15% to 26%).
The table below sets forth the impairment loss recorded for each of the CGU’s at December 31, 2018:
The table below sets forth the breakdown of the impairment loss for each class of asset at December 31, 2018:
The impairment loss at December 31, 2018 allocated to goodwill arose in Clark Laboratories Inc.
The value-in-use calculation is subject to significant estimation, uncertainty and accounting judgements and is particularly sensitive in the following areas;
Significant Goodwill and Intangible Assets with Indefinite Useful Lives
CGUs or combinations of CGUs for which the carrying amount of goodwill is significant for the purposes of impairment testing in comparison with the Group’s total carrying amount of goodwill are those where the percentage is greater than 20% of the total.
The additional disclosures required for the CGU with significant goodwill are as follows:
* The goodwill of Immco Diagnostics was partially impaired in the year ended December 31, 2017.
The key assumptions and methodology used in respect of this CGU are consistent with those described above. The assumptions and estimates used are specific to the individual CGU and were derived from a combination of internal and external factors based on historical experience.
The trade name assets purchased as part of the acquisition of Fitzgerald in 2004, Primus and RDI in 2005 and Immco Diagnostics in 2013 were valued using the relief from royalty method and based on factors such as (1) the market and competitive trends and (2) the expected usage of the name. It was considered that these trade names will generate net cash inflows for the Group for an indefinite period. In 2018 an impairment loss of US$123,000 was allocated against the Primus trade name as the carrying value of Primus’ net assets exceeded its discounted future cashflows. |
DEFERRED TAX ASSETS AND LIABILITIES |
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Disclosure of deferredc tax assets and liabilities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DEFERRED TAX ASSETS AND LIABILITIES |
Recognised deferred tax assets and liabilities
Deferred tax assets and liabilities of the Group are attributable to the following:
The deferred tax asset in 2018 is mainly due to deductible temporary differences relating to provisions, property, plant and equipment, share-based payments and the elimination of unrealised intercompany inventory profit. In 2018, the deferred tax asset decreased by US$2,571,000. Due to the impairment loss in 2018, the amount of deferred tax assets recoverable through the reversal of taxable timing differences is lower because the deferred tax liability relating to impaired assets was significantly reduced. In other words, deferred tax assets were derecognized as they exceeded the amount of reversing deferred tax liabilities.
The deferred tax liability is caused by the net book value of non-current assets being greater than the tax written down value of non-current assets, temporary differences due to the acceleration of the recognition of certain charges in calculating taxable income permitted in Ireland and the US and deferred tax recognised on fair value asset uplifts in connection with business combinations. The deferred tax liability decreased by US$2,977,000 in 2018, principally because of the impairment of intangible assets on which the deferred tax liabilities were recognised.
Deferred tax assets and liabilities are only offset when the entity has a legally enforceable right to set off current tax assets against current tax liabilities and where the intention is to settle current tax liabilities and assets on a net basis or to realise the assets and settle the liabilities simultaneously. At December 31, 2018 and at December 31, 2017 no deferred tax assets and liabilities are offset as it is not certain as to whether there is a legally enforceable right to set off current tax assets against current tax liabilities and it is also uncertain as to what current tax assets may be set off against current tax liabilities and in what periods.
The vast majority of temporary differences are expected to reverse after 2021.
Unrecognised deferred tax assets
Deferred tax assets have not been recognised by the Group in respect of the following items:
There was an increase of US$11,321,000 in the unrecognised deferred tax assets during the year ended December 31, 2018. For comments on the uncertainty prompting less than full recognition refer to Note 9. The movement in the unrecognised deferred tax assets during the year ended December 31, 2018 is analysed as follows:
A deferred tax asset of US$1,360,000 (2017: US$1,380,000) was not recognised in respect of net operating losses in Brazil. In 2018, the tax losses in Brazilian Real increased but in US Dollar there was a decrease in the unrecognized deferred tax asset due to currency movements. The entity in Brazil was incorporated in 2012 and has cumulative losses to date. The deferred tax asset has not been recognised for Brazil due to uncertainty regarding the full utilization of these losses in the related tax jurisdiction in future periods. Only when it is probable that future profits will be available to utilize the forward losses or temporary differences is a deferred tax asset recognised.
A deferred tax asset of US$3,564,000 (2017: US$2,641,000) was not recognised in respect of net operating losses of Trinity Biotech Investments Ltd. (“TBIL”). TBIL, which is tax resident in Ireland, issued an exchangeable note of US$115 million in 2015 following its incorporation earlier in that year. To date this entity has interest expenses and no income apart from a gain on the repurchase of part of the exchangeable note. The deferred tax asset has not been recognised due to uncertainty regarding the full utilization of these losses in future periods. Only when it is probable that future profits will be available to utilize the forward losses is a deferred tax asset recognised. In accordance with IAS 12, Income Taxes, both the movement in the exchangeable note’s embedded derivatives value and the movement on the exchangeable note’s host contract, being the accretion of notional interest, are exempt from deferred taxation recognition.
A deferred tax asset of US$5,691,000 (2017: US$5,829,875) was not recognised in respect of net operating losses in Trinity Biotech Manufacturing Ltd. An additional US$485,000 (2017: US$nil) was not recognized in respect of other temporary timing differences. The total unrecognized deferred tax asset is US$6,176,000. The deferred tax assets in respect of net operating losses and other temporary timing differences have not been recognised due to insufficient deferred tax liabilities following the impairment charge relating to fixed assets in this entity. When there is a reversing deferred tax liability in a jurisdiction that reverses in the same period, the deferred tax asset is restricted so that it equals the reversing deferred tax liability.
A deferred tax asset of US$213,000 (2017: US$nil) was not recognised in respect of net operating losses in Trinity Biotech Plc. The deferred tax asset has not been recognised due to uncertainty regarding the full utilization of these losses in future periods. Only when it is probable that future profits will be available to utilize the forward losses or temporary differences is a deferred tax asset recognised.
A deferred tax asset of US$2,174,000 (2017: US$nil) was not recognised in respect of net operating losses and alternative minimum tax credits in US. The deferred tax asset has not been recognised due to insufficient deferred tax liabilities following the impairment charge relating to property, plant and equipment and intangible assets. When there is a reversing deferred tax liability in a jurisdiction that reverses in the same period, the deferred tax asset is restricted so that it equals the reversing deferred tax liability. A deferred tax asset of US$364,000 (2017: US$345,000) in respect of US state credit carryforwards was also not recognised due to uncertainties regarding the timing of the utilisation of these state credit carryforwards in the related tax jurisdiction in future periods.
No deferred tax asset is recognised in respect of a capital loss forward of US$8,293,000 (2017: US$8,293,000) in Ireland as it is not probable that there will be future capital gains against which to offset these capital losses.
Unrecognised deferred tax liabilities
At December 31, 2018 and 2017, there was no recognised or unrecognised deferred tax liability for taxes that would be payable on the unremitted earnings of certain of the Group’s subsidiaries. The Company is able to control the timing of the reversal of the temporary differences of its subsidiaries and it is probable that these temporary differences will not reverse in the foreseeable future.
Movement in temporary differences during the year
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OTHER ASSETS |
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Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of other assets [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||
OTHER ASSETS |
The Group leases instruments as part of its business. For details of future minimum finance lease receivables with non-cancellable terms, please refer to Note 17. |
INVENTORIES |
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Classes of current inventories [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INVENTORIES |
All inventories are stated at the lower of cost or net realisable value. The replacement cost of inventories does not differ from cost. Total inventories for the Group are shown net of provisions of US$6,299,000 (2017: US$7,543,000). Cost of sales in 2018 includes inventories expensed of US$55,285,000 (2017: US$54,904,000), (2016: US$50,259,000).
The movement on the inventory provision for the three year period to December 31, 2018 is as follows:
During 2018, US$180,000 (2017: US$286,000), (2016: US$130,000) of inventory provision relating to net realisable value was released to the statement of operations following a current year review of inventory usage.
In 2016, a provision was created of US$4,786,000 in relation to a number of products which were culled during that year. This mainly relates to the Bartels and Microtrak product lines which were acquired previously. Revenues for these products had been declining significantly over the last number of years and had reached the end of their economic life, especially given the level of technical support required to keep older products of this nature on the market. |
TRADE AND OTHER RECEIVABLES |
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Trade and other current receivables [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
TRADE AND OTHER RECEIVABLES |
Trade receivables are shown net of an impairment losses provision of US$4,202,000 (2017: US$3,590,000) (see Note 28). Prepayments are shown net of impairment of US$1,608,000 (2017: US$1,651,000) (see Note 6).
Contract assets have decreased compared to the prior year as the Group shipped less product to customers with cost per test contracts in the last month of the year.
Leases as lessor
(i) Finance lease commitments – Group as lessor
The Group leases instruments as part of its business. Future minimum finance lease receivables with non-cancellable terms are as follows:
The Group classified future minimum lease receivables between one and five years of US$476,000 (2017: US$685,000) as Other Assets, see Note 15. Under the terms of the lease arrangements, no contingent rents are receivable.
(ii) Operating lease commitments – Group as lessor
The Group leases instruments under operating leases as part of its business.
Future minimum rentals receivable under non-cancellable operating leases are as follows:
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CASH AND CASH EQUIVALENTS |
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Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||
Cash and cash equivalents [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||
CASH AND CASH EQUIVALENTS |
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SHORT-TERM INVESTMENTS |
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Disclosure of short-term investments [Abstract] | |||||||||||||||||||||
SHORT-TERM INVESTMENTS |
All liquid investments with a maturity greater than six months are considered to be short-term investments. As of December 31, 2018, there were no short-term investments (2017: deposits amounting to US$34,043,000).
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CAPITAL AND RESERVES |
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Disclosure of classes of share capital [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
CAPITAL AND RESERVES |
Share capital
The Group had authorised share capital of 200,700,000 ‘A’ ordinary shares of US$0.0109 each (2017: 200,700,000 ‘A’ ordinary shares of US$0.0109 each) as at December 31, 2018.
Translation reserve
The translation reserve comprises all foreign exchange differences arising from the translation of the financial statements of foreign currency denominated operations of the Group since January 1, 2004.
Warrant reserve
The Group calculates the fair value of warrants at the date of issue taking the amount directly to a separate reserve within equity. The fair value is calculated using the trinomial model. The fair value which is assessed at the grant date is calculated on the basis of the contractual term of the warrants.
Hedging reserve
The hedging reserve comprises the effective portion of the cumulative net change in the fair value of cash flow hedging instruments related to hedged transactions entered into but not yet crystallised.
The warrant and hedging reserves form Other Reserves in the Consolidated Statement of Financial Position.
Treasury shares
During 2018, the Group purchased 107,740 (2017: 5,374,692) ‘A’ Ordinary shares (26,935 ADS’s) (2017: 1,343,673 ADS’s) ‘Treasury shares’. The total cost of these shares was US$139,000 (2017: US$ 7,456,000).
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SHARE OPTIONS AND SHARE WARRANTS |
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Disclosure of share options and share warrants [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHARE OPTIONS AND SHARE WARRANTS |
Warrants
There were no warrants outstanding at the beginning of 2018, and there were no warrants granted in either 2018 or 2017. As there were no warrants outstanding, the warrant reserve was transferred to the accumulated surplus reserve during 2017.
Options
Under the terms of the Company’s Employee Share Option Plans, options to purchase 10,908,190 ‘A’ Ordinary Shares (2,727,048 ADS’s) were outstanding at December 31, 2018. Under these Plans, options are granted to officers, employees and consultants of the Group at the discretion of the Compensation Committee (designated by the Board of Directors), under the terms outlined below.
Certain options have been granted to consultants of the Group and, where this is the case, the Group has measured the fair value of the services provided by these consultants by reference to the fair value of the equity instruments granted. This approach has been adopted in these cases as it is impractical for the Group to reliably estimate the fair value of such services.
The terms and conditions of the grants are as follows, whereby all options are settled by physical delivery of shares:
Vesting conditions
The options vest following a period of service by the officer or employee. The required period of service is determined by the Compensation Committee at the date of grant of the options (usually the date of approval by the Compensation Committee) and it is generally over a three to four year period. There are no market conditions associated with the share option vesting periods.
Contractual life
The term of an option is determined by the Board, Compensation Committee and Remuneration Committee provided that the term may not exceed a period of between seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group (or one year after such termination because of death or disability) except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, the Compensation Committee may accelerate the exercisability and termination of options.
The number and weighted average exercise price of share options and warrants per ordinary share is as follows (as required by IFRS 2, this information relates to all grants of share options and warrants by the Group):
There were no share options exercised during 2018 or 2017. The weighted average share price per ‘A’ Ordinary share at the date of exercise for options exercised in 2016 was: US$2.96 per ‘A’ Ordinary share (US$11.84 per ADS).
The opening share price per ‘A’ Ordinary share at the start of the financial year was US$1.28 or US$5.10 per ADS (2017: US$1.73 or US$6.93 per ADS) (2016: US$2.92 or US$11.69 per ADS) and the closing share price at December 31, 2018 was US$0.57 or US$2.29 per ADS (2017: US$1.28 or US$5.10 per ADS) (2016: US$1.73 or US$6.92 per ADS). The average share price for the year ended December 31, 2018 was US$1.10 per ‘A’ Ordinary share or US$4.42 per ADS.
A summary of the range of prices for the Company’s stock options for the year ended December 31, 2018 follows:
The weighted-average remaining contractual life of options outstanding at December 31, 2018 was 4.33 years (2017: 5.10 years).
A summary of the range of prices for the Company’s stock options for the year ended December 31, 2017 follows:
Charge for the year under IFRS 2
The charge for the year is calculated based on the fair value of the options granted which have not yet vested.
The fair value of the options is expensed over the vesting period of the option. US$1,369,000 was charged to the statement of operations in 2018, (2017: US$928,000), (2016: US$1,381,446) split as follows:
The total share based payments charge for the year was US$1,607,000 (2017: US$1,109,000) (2016: US$1,633,000). However, a total of US$238,000 (2017: US$181,000) (2016: US$219,000) of share based payments was capitalised in intangible development project assets during the year.
The fair value of services received in return for share options granted are measured by reference to the fair value of share options granted. The estimate of the fair value of services received is measured based on a trinomial model. The following are the input assumptions used in determining the fair value of share options granted in 2018, 2017 and 2016:
The expected life of the options is based on historical data and is not necessarily indicative of exercise patterns that may occur. The expected volatility is based on the historic volatility (calculated based on the expected life of the options). The Group has considered how future experience may affect historical volatility.
The profile and activities of the Group are not expected to change in the immediate future and therefore Trinity Biotech would expect estimated volatility to be consistent with historical volatility. |
TRADE AND OTHER PAYABLES |
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Trade and other current payables [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
TRADE AND OTHER PAYABLES |
Accrued liabilities include US$1,207,000 (2017: US$1,112,000) relating to contracted licence payments. |
PROVISIONS |
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Provisions [abstract] | |||||||||||||||||||||
PROVISIONS |
During 2018 and 2017 the Group experienced no significant product warranty claims. However, the Group believes that it is appropriate to retain a product warranty provision to cover any future claims. The provision at December 31, 2018 represents the estimated cost of product warranties, the exact amount which cannot be determined. US$50,000 represents management’s best estimate of these obligations at December 31, 2018. |
EXCHANGEABLE NOTES |
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Borrowings [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EXCHANGEABLE NOTES |
During 2015, the Group issued US$115,000,000 of exchangeable senior notes which will mature on April 1, 2045, subject to earlier repurchase, redemption or exchange. The notes are senior unsecured obligations and accrue interest at an annual rate of 4%, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on October 1, 2015. The notes are convertible into ordinary shares of the parent entity at the applicable exchange rate, at any time prior to the close of business on the second business day immediately preceding the maturity date, at the option of the holder, or repayable on April 1, 2045. The conversion rate is 47.112 ADSs per $1,000 principal amount of notes, equivalent to an exchange price of approximately $21.88 per ADS. The exchange rate is subject to adjustment upon the occurrence of certain events, but will not be adjusted for any accrued and unpaid interest. The notes include a number of non-financial covenants, all of which were complied with at December 31, 2018.
In August 2018, the Group purchased US$15,100,000 of the exchangeable notes, at a rate of 79.75 cents in the Dollar. The amount paid was US$12,042,000 plus accrued interest of US$205,000. The gain on the purchase was US$463,000 and this is shown within selling, general and administrative expenses in the statement of operations. The nominal amount of the debt after the purchase is US$99,900,000.
The notes include a number of put and call options, and these embedded derivatives are measured at fair value through the Consolidated Statement of Operations. The first date on which holders can exercise their put option is April 1, 2022. If the put option is exercised, the issuer has to repurchase the notes at par. The embedded derivatives are summarised as follows:
Financial income in the consolidated statement of operations for the year includes US$1,388,000 (2017: US$2,390,000) arising from the revaluation of embedded derivatives at fair value at December 31, 2018. US$245,000 of the embedded derivatives balance was eliminated due to the purchase of exchangeable notes during 2018.
The exchangeable notes are treated as a host debt instrument with embedded derivatives attached. On initial recognition, the host debt instrument is recognised at the residual value of the total net proceeds of the bond issue less fair value of the embedded derivatives. Subsequently, the host debt instrument is measured at amortised cost using the effective interest rate method. The carrying value of exchangeable senior notes is calculated as follows:
This liability will accrete back to its nominal value of US$99,900,000 over the term of the debt using an effective interest rate methodology. Financial expense in the consolidated statement of operations for the year includes US$689,000 (2017: US$723,000) of accretion interest. |
FINANCE LEASE LIABILITIES |
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Disclosure of finance lease liabilities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FINANCE LEASE LIABILITIES |
Certain manufacturing equipment are held under finance lease arrangements following sale and leaseback transactions during the year, with a carrying value of US$372,000 as of December 31, 2018 (2017: US$51,000). The repayment period of finance leases is between 2 and 5 years. Finance leases are secured by the related assets held under the finance lease, and the carrying values of finance lease liabilities at December 31, 2018 are as follows:
Finance lease liabilities
Finance lease liabilities are payable as follows:
Terms and debt repayment schedule
The terms and conditions of outstanding interest bearing loans and borrowings at December 31, 2018 are as follows:
The terms and conditions of outstanding interest bearing loans and borrowings at December 31, 2017 were as follows:
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COMMITMENTS AND CONTINGENCIES |
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Disclosure of commitments and contingencies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMMITMENTS AND CONTINGENCIES |
The Group has capital commitments authorised and contracted for of US$187,000 as at December 31, 2018 (2017: US$121,000).
The Group leases a number of premises under operating leases. The leases typically run for periods up to 25 years. Lease payments are reviewed periodically (typically on a 5 year basis) to reflect market rentals. Operating lease commitments payable during the next 12 months amount to US$2,922,000 (2017: US$2,693,000) payable on leases of buildings at Bray, Ireland, Jamestown, Buffalo and Amherst, New York, Acton, Massachusetts, Carlsbad, California, Sao Paulo, Brazil and Extrema, Brazil. US$168,000 (2017: US$92,000) of these operating lease commitments relates to leases whose remaining term will expire within one year, US$426,000 (2017: US$182,000) relates to leases whose remaining term expires between one and two years, US$654,000 (2017: US$1,014,000) between two and five years and the balance of US$1,674,000 (2017: US$1,405,000) relates to leases which expire after more than five years. On January 28, 2018 the Group’s subsidiary, Immco Diagnostics, Inc., entered a lease agreement as tenant of a building located at 10 Earhart Drive, Suite 100, Amherst, New York over a fifteen year term. The Group has guaranteed to the landlord the payment of base rent specified in the lease agreement. Future minimum base rent over the lease term as at December 31, 2018 is $6,425,460. See Note 27 for related party leasing arrangements.
Future minimum operating lease commitments with non-cancellable terms in excess of one year are as follows:
For future minimum finance lease commitments, in respect of which the lessor has a charge over the related assets, see Note 25.
The Group repaid in full its bank borrowings in April 2010, at which point all previous charges against Group assets were released. At December 31, 2018 Group borrowings were at fixed rates of interest and consisted Euro and USD denominated finance leases, refer to Note 25. The banks providing the finance leases have a charge over the equipment for which the lease pertains.
Pursuant to the provisions of Section 357, Irish Companies Act, 2014, the Company has guaranteed the liabilities of Trinity Biotech Manufacturing Limited, Trinity Research Limited, Benen Trading Limited and Trinity Biotech Financial Services Limited subsidiary undertakings in the Republic of Ireland, for the financial year to December 31, 2018 and, as a result, these subsidiary undertakings have been exempted from the filing provisions of Section 357, Irish Companies Act, 2014. Where the Company enters into these guarantees of the indebtedness of other companies within its Group, the Company considers these to be insurance arrangements and accounts for them as such. The Company treats the guarantee contract as a contingent liability until such time as it becomes probable that the company will be required to make a payment under the guarantee. The Company does not enter into financial guarantees with third parties.
The Group has received training and employment grant income from Irish development agencies. Subject to existence of certain conditions specified in the grant agreements, this income may become repayable. No such conditions existed as at December 31, 2018. However if the income were to become repayable, the maximum amounts repayable as at December 31, 2018 would amount to US$2,892,000 (2017: US$3,033,000).
There are also a small number of legal cases being brought against the Group by certain of its former employees. There is a provision for cases where payment is considered by management to be probable. The ultimate resolution of the aforementioned proceedings is not expected to have a material adverse effect on the Group’s financial position, results of operations or cash flows.
As described in Notes 9 and 31, there is a tax audit on going currently in one of the jurisdictions in which we operate. Audits by taxation authorities can involve complex issues that may require an extended period of time for resolution. Although we believe that our estimates are reasonable, no assurance can be given that the final tax outcome of these matters will not be different than that which is reflected in our historical income tax provisions and accruals. Such differences could have a material effect on our income tax provision and profit in the period in which such determination is made. In management’s opinion, adequate provisions for income taxes have been made. The provision amount has not been disclosed as this would be prejudicial to the Company’s interests, given that the tax audit is on going. |
RELATED PARTY TRANSACTIONS |
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Disclosure of transactions between related parties [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RELATED PARTY TRANSACTIONS |
The Group has related party relationships with its subsidiaries, and with its directors and executive officers.
Leasing arrangements with related parties
The Group has entered into various arrangements with JRJ Investments (“JRJ”), a partnership owned by Mr O’Caoimh and Dr Walsh, directors of the Company, to provide for current and potential future needs to extend its premises at IDA Business Park, Bray, Co. Wicklow, Ireland.
The Group has entered into an agreement for a 25 year lease with JRJ for offices that have been constructed adjacent to its premises at IDA Business Park, Bray, Co. Wicklow, Ireland. The annual rent of €381,000 (US$449,000) is payable from January 1, 2004. This lease expires in 2027. There was a rent review performed on this premises in 2009 and further to this review, there was no change to the annual rental charge.
The Group is leasing an additional 43,860 square foot manufacturing facility in Bray, Ireland at a rate of € 17.94 per square foot (including fit out) giving a total annual rent of €787,000 (US$927,000). This facility is owned by Mr O’Caoimh and the lease expires in 2028.
Trinity Biotech and its directors (excepting Mr O’Caoimh and Dr Walsh who express no opinion on this point) believe that the arrangements entered into represent a fair and reasonable basis on which the Group can meet its ongoing requirements for premises. At December 31, 2018 there were no rental payments outstanding (2017: Nil).
Compensation of key management personnel of the Group
At December 31, 2018, 2017 and 2016 the key management personnel of the Group were made up of three key personnel: the two executive directors; Mr Ronan O’Caoimh and Dr Jim Walsh and Mr Kevin Tansley, our Chief Financial Officer/Executive Director. Kevin Tansley was appointed to the board in September 2016 as an Executive Director.
Compensation for the year ended December 31, 2018 of these personnel is detailed below:
The amounts disclosed in respect of directors’ emoluments in Note 5 includes non-executive directors’ fees of US$188,000 (2017: US$400,000) and share-based compensation benefits of US$313,000 (2017: US$156,000). Total directors’ remuneration is also included in “personnel expenses” (Note 7) and “loss before tax” (Note 5). Share-based compensation benefits included in Note 5 exclude capitalised amounts of US$149,000 (2017: US$92,000).
On March 30, 2011, the service agreement with Ronan O’Caoimh as Chief Executive Officer was terminated and replaced by an agreement with Darnick Company, a company wholly-owned by members of Mr O’Caoimh’s immediate family. Directors’ compensation includes payments made to Darnick Company.
Directors’ compensation also includes payments made to Diagnostic Polymers, a company wholly-owned by Jim Walsh and members of his immediate family.
Directors’ interests in the Company’s shares and share option plan
Rayville Limited, an Irish registered company, which is wholly owned by the three executive directors and certain other executives of the Group, owns all of the ‘B’ non-voting Ordinary Shares in Trinity Research Limited, one of the Group’s subsidiaries. The ‘B’ shares do not entitle the holders thereof to receive any assets of the company on a winding up. All of the ‘A’ voting ordinary shares in Trinity Research Limited are held by the Group. Trinity Research Limited may, from time to time, declare dividends to Rayville Limited and Rayville Limited may declare dividends to its shareholders out of those amounts.
Any such dividends paid by Trinity Research Limited are ordinarily treated as a compensation expense by the Group in the consolidated financial statements prepared in accordance with IFRS, notwithstanding their legal form of dividends to minority interests, as this best represents the substance of the transactions.
The last dividend paid by Trinity Research Limited to Rayville Limited was in June 2009 for US$2,830,000. At the time this amount was immediately lent back by Rayville Limited to Trinity Research Limited. Since then US$1,788,000 of these loans have been repaid and recognised as a compensation expense by the Group. As of December 31, 2017 and December 31, 2018, the remaining amount of the loan was US$1,042,000. As this remaining amount of the original dividend is matched by a loan from Rayville Limited to Trinity Research Limited which is repayable solely at the discretion of the Remuneration Committee of the Board and is unsecured and interest free, the Group netted the dividend paid to Rayville Limited against the corresponding loan from Rayville Limited in the 2017 and 2018 consolidated financial statements. |
DERIVATIVES AND FINANCIAL INSTRUMENTS |
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Disclosure of detailed information about financial instruments [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DERIVATIVES AND FINANCIAL INSTRUMENTS |
The Group uses a range of financial instruments (including cash, finance leases, receivables, payables and derivatives) to fund its operations. These instruments are used to manage the liquidity of the Group in a cost effective, low-risk manner. Working capital management is a key additional element in the effective management of overall liquidity. The Group does not trade in financial instruments or derivatives. The main risks arising from the utilization of these financial instruments are interest rate risk, liquidity risk and credit risk.
Interest rate risk
Effective and repricing analysis
The following table sets out all interest-earning financial assets and interest bearing financial liabilities held by the Group at December 31, indicating their effective interest rates and the period in which they re-price:
In broad terms, a one-percentage point increase in interest rates would increase interest income by US234,000 (2017: US$480,000) and would not affect the interest expense (2017: nil) resulting in an increase in net interest income of US$234,000 (2017: increase in net interest income of US$480,000).
Interest rate profile of financial assets / liabilities
The interest rate profile of financial assets/liabilities of the Group was as follows:
Financial assets comprise cash and cash equivalents and short-term investments as at December 31, 2018 and December 31, 2017 (see Note 18 and 19).
Fair value sensitivity analysis for fixed rate instruments
The Group does not account for any fixed rate financial liabilities at fair value through profit and loss. Therefore a change in interest rates at December 31, 2018 would not affect profit or loss.
Cash flow sensitivity analysis for variable rate instruments
A change of 100 basis points in interest rates at the reporting date would increase interest income by US$234,000 (2017: US$480,000) and would not affect the interest expense in 2018 or 2017; resulting in an increase in interest income of US$234,000 (2017: US480,000). This assumes that all other variables, in particular foreign currency rates, remain constant.
There was no significant difference between the fair value and carrying value of the Group’s trade receivables and trade and other payables at December 31, 2018 and December, 31 2017 as all fell due within 6 months.
Liquidity risk
The Group’s operations are cash generating. Short-term flexibility is achieved through the management of the Group’s short-term deposits.
The following are the contractual maturities of financial liabilities, including estimated interest payments:
Foreign exchange risk
The majority of the Group’s activities are conducted in US Dollars. Foreign exchange risk arises from the fluctuating value of the Group’s Euro denominated expenses as a result of the movement in the exchange rate between the US Dollar and the Euro. Arising from this, where considered necessary, the Group pursues a treasury policy which periodically aims to sell US Dollars forward to match a portion of its uncovered Euro expenses at exchange rates lower than budgeted exchange rates. These forward contracts are primarily cashflow hedging instruments whose objective is to cover a portion of these Euro forecasted transactions. Forward contracts normally have maturities of less than one year after the balance sheet date. There were no forward contracts in place as at December 31, 2018.
Foreign currency short term financial assets and liabilities which expose the Group to currency risk are disclosed below. The amounts shown are those reported to key management translated into US Dollars at the closing rate:
The Group states its forward exchange contracts at fair value in the balance sheet. The Group classifies its forward exchange contracts as hedging forecasted transactions and thus accounts for them as cash flow hedges.
There were no forward exchange contracts in place at December 31, 2018 or December 31, 2017.
Sensitivity analysis
A 10% strengthening of the US Dollar against the Euro at December 31, 2018 would have increased profit and other equity by the amounts shown below. This analysis assumes that all other variables, in particular interest rates, remain constant.
A 10% weakening of the US Dollar against the Euro at December 31, 2018 would have decreased profit and other equity by the amounts shown below. This analysis assumes that all other variables, in particular interest rates, remain constant.
Credit Risk
The Group has no significant concentrations of credit risk. Exposure to credit risk is monitored on an ongoing basis. The Group maintains specific provisions for potential credit losses. To date such losses have been within management’s expectations. Due to the large number of customers and the geographical dispersion of these customers, the Group has no significant concentrations of accounts receivable.
With respect to credit risk arising from the other financial assets of the Group, which comprise cash and cash equivalents and deferred consideration, the Group’s exposure to credit risk arises from default of the counter-party, with a maximum exposure equal to the carrying amount of these instruments. The Group’s management considers that all of the above financial assets that are not impaired or past due for each of the 31 December reporting dates under review are of good credit quality.
The Group maintains cash and cash equivalents and enters into forward contracts, when necessary, with various financial institutions. The Group performs regular and detailed evaluations of these financial institutions to assess their relative credit standing. The carrying amount reported in the balance sheet for cash and cash equivalents and forward contracts approximate their fair value.
Exposure to credit risk
The carrying amount of financial assets represents the maximum credit exposure. The maximum exposure to credit risk is as follows:
The maximum exposure to credit risk for trade receivables and finance lease income receivable by geographic location is as follows:
The maximum exposure to credit risk for trade receivables and finance lease income receivable by type of customer is as follows:
Due to the large number of customers and the geographical dispersion of these customers, the Group has no significant concentrations of accounts receivable.
Impairment Losses
The ageing of trade receivables at December 31, 2018 is as follows:
The movement in the allowance for impairment in respect of trade receivables during the year was as follows:
The allowance for impairment in respect of trade receivables is used to record impairment losses unless the Group is satisfied that no recovery of the account owing is possible. At this point the amount is considered irrecoverable and is written off against the financial asset directly.
Capital Management
The Group’s policy is to maintain a strong capital base so as to maintain investor, creditor and market confidence and to sustain future development of the business. The Board of Directors monitors earnings per share as a measure of performance, which the Group defines as profit after tax divided by the weighted average number of shares in issue.
Following the divestiture of the Coagulation product line in 2010, the Group eliminated all bank debt. In the past, the Group has funded acquisitions using both equity and long term debt depending on the size of the acquisition and the capital structure in place at the time of the acquisition.
Although at December 31, 2018 the Group has no bank debt, it maintains a relationship with a number of lending banks and Trinity Biotech is listed on the NASDAQ which allows the Group to raise funds through equity financing where necessary. During 2015, the Group raised US$115,000,000 through the issuance of 30 year exchangeable senior notes. During 2018 the Group repurchased $15,100,000 of the exchangeable senior notes. The remaining exchangeable senior notes which will mature on April 1, 2045, subject to earlier repurchase, redemption or exchange
The Board of Directors is authorised to purchase its own shares on the market on the following conditions;
Fair Values
The table below sets out the Group’s classification of each class of financial assets/liabilities, their fair values and under which valuation method they are valued:
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: quoted prices (unadjusted) in active markets for identical assets or liabilities
Level 2: valuation techniques for which the lowest level of inputs which have a significant effect on the recorded fair value are observable, either directly or indirectly
Level 3: valuation techniques for which the lowest level of inputs that have a significant effect on the recorded fair value are not based on observable market data
The valuation techniques used for instruments categorised as level 2 are described below:
The fair values of the options associated with the exchangeable notes are calculated in consultation with third-party valuation specialists due to the complexity of their nature. There are a number of inputs utilised in the valuation of the options, including share price, historical share price volatility, risk-free rate and the expected borrowing cost spread over the risk-free rate. |
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES |
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Disclosure of reconciliation of liabilities arising from financing activities [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES |
The changes in the Group’s liabilities arising from financing activities can be classified as follows:
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POST BALANCE SHEET EVENTS |
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Dec. 31, 2018 | ||||||||||||
Disclosure of post balance sheet events [Abstract] | ||||||||||||
POST BALANCE SHEET EVENTS |
There are no other matters or circumstances that have arisen since the end of the year that have significantly affected or may significantly affect either:
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ACCOUNTING ESTIMATES AND JUDGEMENTS |
12 Months Ended | |||||||||||||||||
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Dec. 31, 2018 | ||||||||||||||||||
Disclosure of accounting estimates and judgements [Abstract] | ||||||||||||||||||
ACCOUNTING ESTIMATES AND JUDGEMENTS |
The preparation of these financial statements requires the Group to make estimates and judgements that affect the reported amount of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
On an on-going basis, the Group evaluates these estimates, including those related to intangible assets, contingencies and litigation. The estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Key sources of estimation uncertainty
Note 13 contains information about the assumptions and the risk factors relating to goodwill impairment. Note 21 outlines information regarding the valuation of share options and warrants. Note 24 outlines the valuation techniques used by the Company in determining the fair value of exchangeable notes and the associated embedded derivatives. In Note 28, detailed analysis is given about the interest rate risk, credit risk, liquidity risk and foreign exchange risk of the Group. The Group recognises revenue when it transfers control over a good or service to a customer.
Critical accounting judgements in applying the Group’s accounting policies
Certain critical accounting judgements in applying the Group’s accounting policies are described below:
Research and development expenditure
Under IFRS as issued by IASB, the Group writes off research and development expenditure as incurred, with the exception of expenditure on projects whose outcome has been assessed with reasonable certainty as to technical feasibility, commercial viability and recovery of costs through future revenues. Such expenditure is capitalised at cost within intangible assets and amortised over its expected useful life of 15 years, which commences when commercial production starts. For further information, refer to Note 13.
Acquired in-process research and development (IPR&D) is valued at its fair value at acquisition date in accordance with IFRS 3. The Company determines this fair value by adopting the income approach valuation technique. Once the fair value has been determined, the Company will recognise the IPR&D as an intangible asset when it: (a) meets the definition of an asset and (b) is identifiable (i.e. is separable or arises from contractual or other legal rights).
Factors which impact our judgement to capitalise certain research and development expenditure include the degree of regulatory approval for products and the results of any market research to determine the likely future commercial success of products being developed. We review these factors each year to determine whether our previous estimates as to feasibility, viability and recovery should be changed.
Impairment of intangible assets and goodwill
Definite lived intangible assets are reviewed for indicators of impairment annually while goodwill and indefinite lived assets are tested for impairment annually, individually or at the cash generating unit level.
Factors considered important, as part of an impairment review, include the following:
When we determine that the carrying value of intangibles, non-current assets and related goodwill may not be recoverable based upon the existence of one or more of the above indicators of impairment, any impairment is measured based on our estimates of projected net discounted cash flows expected to result from that asset, including eventual disposition. Our estimated impairment could prove insufficient if our analysis overestimated the cash flows or conditions change in the future. For further information, refer to Note 13.
Allowance for slow-moving and obsolete inventory
We evaluate the realisability of our inventory on a case-by-case basis and make adjustments to our inventory provision based on our estimates of expected losses. We write-off any inventory that is approaching its “use-by” date and for which no further re-processing can be performed. We also consider recent trends in revenues for various inventory items and instances where the realisable value of inventory is likely to be less than its carrying value. For further information, refer to Note 16.
Allowance for impairment of receivables
Revenue is recognised to the extent that it is probable that economic benefit will flow to the Group and the revenue can be measured. No revenue is recognised if there is uncertainty regarding recovery of the consideration due at the outset of the transaction or the possible return of goods. We make judgements as to our ability to collect outstanding receivables and where necessary make allowances for impairment. Such impairments are made based upon a specific review of all significant outstanding receivables. In determining the allowance, we analyse our historical collection experience and current economic trends. If the historical data we use to calculate the allowance for impairment of receivables does not reflect the future ability to collect outstanding receivables, additional allowances for impairment of receivables may be needed and the future results of operations could be materially affected. For further information, refer to Note 28.
Accounting for income taxes
Significant judgement is required in determining our worldwide income tax expense provision. In the ordinary course of a global business, there are many transactions and calculations where the ultimate tax outcome is uncertain. Some of these uncertainties arise as a consequence of revenue sharing and cost reimbursement arrangements among related entities, the process of identifying items of revenue and expense that qualify for preferential tax treatment and segregation of foreign and domestic income and expense to avoid double taxation. In addition, we operate within multiple taxing jurisdictions and are subject to periodic audits in these jurisdictions. There is a tax audit on going currently in one of the jurisdictions in which we operate. These audits can involve complex issues that may require an extended period of time for resolution. Although we believe that our estimates are reasonable, no assurance can be given that the final tax outcome of these matters will not be different than that which is reflected in our historical income tax provisions and accruals. Such differences could have a material effect on our income tax provision and profit in the period in which such determination is made. In management’s opinion, adequate provisions for income taxes have been made.
Deferred tax assets and liabilities are determined for the effects of net operating losses and temporary differences between the book and tax bases of assets and liabilities, using tax rates projected to be in effect for the year in which the differences are expected to reverse. While we have considered future taxable income and ongoing prudent and feasible tax planning strategies in assessing whether deferred tax assets can be recognised, there is no assurance that these deferred tax assets may be realisable. The extent to which recognised deferred tax assets are not realisable could have a material adverse impact on our income tax provision and net income in the period in which such determination is made.
Note 14 to the consolidated financial statements outlines the basis for the deferred tax assets and liabilities and includes details of the unrecognised deferred tax assets at year end. The Group derecognised deferred tax assets arising on unused tax losses except to the extent that there are sufficient taxable temporary differences relating to the same taxation authority and the same taxable entity which will result in taxable amounts against which the unused tax losses can be utilized before they expire. The derecognition of these deferred tax assets was considered appropriate in light of the increased tax losses caused by the restructuring and uncertainty over the timing of the utilization of the tax losses. Except for the derecognition of deferred tax assets there were no material changes in estimates used to calculate the income tax expense provision during 2018, 2017 or 2016.
Revenue Recognition
No revenue is recognised if there is uncertainty regarding recovery of the consideration due at the outset of the transaction or the possible return of goods. We make a judgement as to the collectability of invoiced sales based on an assessment of the individual debtor taking into account past payment history, the probability of default or delinquency in payments and the probability that debtor will enter into financial difficulties or bankruptcy.
We operate a licenced reference laboratory in New York, USA that specializes in diagnostics for autoimmune diseases. The laboratory provides testing services to two types of customers. Firstly, institutional customers, such as hospitals and commercial diagnostic testing providers, and secondly insurance companies on behalf of their policyholders. The revenue recognition for services provided to insurance companies requires some judgement. In the US, there are rules requiring all insurance companies to be billed the same amount per test. However, the amount that each insurance company pays for a particular test varies according to their own internal policies and this can typically be considerably less than the amount invoiced. We recognise lab services revenue for insurance companies by taking the invoiced amount and reducing it by an estimated percentage based on historical payment data. We review the percentage reduction annually based on the latest data. As a practical expedient, and in accordance with IFRS, we apply a portfolio approach to the insurance companies as they have similar characteristics. We judge that the effect on the financial statements of using a portfolio approach for the insurance companies will not differ materially from applying IFRS 15 to the individual contracts within that portfolio. |
GROUP UNDERTAKINGS |
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Disclosure of group undertakings [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GROUP UNDERTAKINGS |
The consolidated financial statements include the financial statements of Trinity Biotech plc and the following principal subsidiary undertakings:
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AUTHORISATION FOR ISSUE |
12 Months Ended | ||
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Dec. 31, 2018 | |||
Disclosure of authorisation for issue [Abstract] | |||
AUTHORISATION FOR ISSUE |
These Group consolidated
financial statements were authorised for issue by the Board of Directors on May 14, 2019. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (POLICIES) |
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Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||
Disclosure of basis of preparation and significant accounting policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||
General information |
Trinity Biotech develops, acquires, manufactures and markets medical diagnostic products for the clinical laboratory and point-of-care segments of the diagnostic market. These products are used to detect autoimmune, infectious and sexually transmitted diseases, diabetes and disorders of the liver and intestine. Trinity Biotech is a significant provider of raw materials to the life sciences and research industries globally. Trinity Biotech also operates a licenced reference laboratory that specializes in diagnostics for autoimmune diseases. |
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Statement of compliance |
The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) both as issued by the International Accounting Standards Board (“IASB”) and as subsequently adopted by the European Union (“EU”) (together “IFRS”). The IFRS applied are those effective for accounting periods beginning January 1, 2018. Consolidated financial statements are required by Irish law to comply with IFRS as adopted by the EU which differ in certain respects from IFRS as issued by the IASB. These differences predominantly relate to the timing of adoption of new standards by the EU. However, in relation to the 2018 consolidated financial statements there are no differences regarding the effective date of new IFRS relevant to Trinity Biotech as issued by the IASB and as adopted by the EU. In relation to prior periods presented, none of the differences are relevant in the context of Trinity Biotech and the consolidated financial statements comply with IFRS both as issued by the IASB and as adopted by the EU. |
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Basis of preparation |
The consolidated financial statements have been prepared in United States Dollars (US$), rounded to the nearest thousand, under the historical cost basis of accounting, except for derivative financial instruments, certain balances arising on acquisition of subsidiary entities and share-based payments which are initially recorded at fair value. Derivative financial instruments are also subsequently revalued and carried at fair value.
The preparation of financial statements in conformity with IFRS requires management to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods.
Judgements made by management that have a significant effect on the financial statements and estimates with a significant risk of material adjustment in the next year are discussed in Note 31.
Having considered the Group’s current financial position and cashflow projections, the directors believe that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these consolidated financial statements and that it is appropriate to continue to prepare the consolidated financial statements on a going concern basis.
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. |
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Basis of consolidation |
Subsidiaries
Subsidiaries are entities controlled by the Company. Control exists when the Company has the power, directly or indirectly, to govern the financial and reporting policies of an entity so as to obtain benefits from its activities. In assessing control, potential voting rights that presently are exercisable or convertible are taken into account. The financial statements of subsidiaries are included in the consolidated financial statements from the date that control commences until the date that control ceases.
Transactions eliminated on consolidation
Intra-group balances and any unrealised gains or losses or income and expenses arising from intra-group transactions are eliminated in preparing the consolidated financial statements. |
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Property, plant and equipment |
Owned assets
Items of property, plant and equipment are stated at cost less any accumulated depreciation and any impairment losses (see Note 1(viii)). The cost of self-constructed assets includes the cost of materials, direct labour and attributable overheads. It is not Group policy to revalue any items of property, plant and equipment.
Depreciation is charged to the statement of operations on a straight-line basis to write-off the cost of the assets over their expected useful lives as follows:
Land is not depreciated. The residual values, if not insignificant, useful lives and depreciation methods of property, plant and equipment are reviewed and adjusted if appropriate on a prospective basis, at each balance sheet date. There were no changes to useful lives in the year.
Leased assets – as lessee
Leases under terms of which the Group assumes substantially all the risks and rewards of ownership are classified as finance leases. Property, plant and equipment acquired by way of finance lease is stated at an amount equal to the lower of its fair value and present value of the minimum lease payments at inception of the lease, less accumulated depreciation and any impairment losses. Lease payments are apportioned between finance charges and reduction of the lease liability so as to achieve a constant rate of interest on the remaining balance of the liability. Finance charges are recognised in financial expenses in the statement of operations.
Depreciation is calculated in order to write-off the amounts capitalised over the estimated useful lives of the assets, or the lease term if shorter, by equal annual instalments. The excess of the total rentals under a lease over the amount capitalised is treated as interest, which is charged to the statement of operations in proportion to the amount outstanding under the lease. Leased assets are reviewed for impairment (see Note 1(viii)).
Leases other than finance leases are classified as “operating leases”, and the rentals thereunder are charged to the statement of operations on a straight-line basis over the period of the leases. Lease incentives are recognised in the statement of operations on a straight-line basis over the lease term.
Leased assets – as lessor
Leases where the Group substantially transfers the risks and benefits of ownership of the asset to the customer are classified as finance leases within finance lease receivables. The Group recognises the amount receivable from assets leased under finance leases at an amount equal to the net investment in the lease. Finance lease income is recognised as revenue in the statement of operations reflecting a constant periodic rate of return on the Group’s net investment in the lease.
Assets provided to customers under leases other than finance leases are classified as operating leases and carried in property, plant and equipment at cost and are depreciated on a straight-line basis over the useful life of the asset or the lease term, if shorter.
Subsequent costs
The Group recognises in the carrying amount of an item of property, plant and equipment the cost of replacing part of such an item when that cost is incurred if it is probable that the future economic benefits embodied within the item will flow to the Group and the cost of the replaced item can be measured reliably. All other costs are recognised in the statement of operations as an expense as incurred. |
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Goodwill |
In respect of business combinations that have occurred since January 1, 2004 (being the transition date to IFRS), goodwill represents the difference between the cost of the acquisition and the fair value of the net identifiable assets acquired.
In respect of acquisitions prior to this date, goodwill is included on the basis of its deemed cost, which represents the amount recorded under the old basis of accounting, Irish GAAP, (“Previous GAAP”). Save for retrospective restatement of deferred tax as an adjustment to retained earnings in accordance with IAS 12, Income Taxes, the classification and accounting treatment of business combinations undertaken prior to the transition date were not reconsidered in preparing the Group’s opening IFRS balance sheet as at January 1, 2004.
To the extent that the Group’s interest in the net fair value of the identifiable assets, liabilities and contingent liabilities acquired exceeds the cost of a business combination, the identification and measurement of the related assets, liabilities and contingent liabilities are revisited accompanied by a reassessment of the cost of the transaction, and any remaining balance is immediately recognised in the statement of operations.
At the acquisition date, any goodwill is allocated to each of the cash generating units expected to benefit from the combination’s synergies. Following initial recognition, goodwill is stated at cost less any accumulated impairment losses (see Note 1(viii)). |
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Intangibles, including research and development (other than goodwill) |
An intangible asset, which is an identifiable non-monetary asset without physical substance, is recognised to the extent that it is probable that the expected future economic benefits attributable to the asset will flow to the Group and that its cost can be measured reliably. The asset is deemed to be identifiable when it is separable (that is, capable of being divided from the entity and sold, transferred, licensed, rented or exchanged, either individually or together with a related contract, asset or liability) or when it arises from contractual or other legal rights, regardless of whether those rights are transferable or separable from the Group or from other rights and obligations.
Intangible assets acquired as part of a business combination are capitalised separately from goodwill if the intangible asset meets the definition of an asset and the fair value can be reliably measured on initial recognition. Subsequent to initial recognition, these intangible assets are carried at cost less any accumulated amortisation and any accumulated impairment losses (Note 1(viii)). Intangible assets with definite useful lives are reviewed for indicators of impairment annually while intangible assets with indefinite useful lives and those not yet brought into use are tested for impairment annually, either individually or at the cash generating unit level.
Expenditure on development activities, whereby research findings are applied to a plan or design for the production of new or substantially improved products and processes, is capitalised if the product or process is technically and commercially feasible and the Group has sufficient resources to complete the development. The expenditure capitalised includes the cost of materials, direct labour and attributable overheads and third party costs. Subsequent expenditure on capitalised intangible assets is capitalised only when it increases the future economic benefits embodied in the specific asset to which it relates.
The technical feasibility of a new product is determined by a specific feasibility study undertaken at the first stage of any development project. The majority of our new product developments involve the transfer of existing product know-how to a new application. Since the technology is already proven in an existing product which is being used by customers, this facilitates the proving of the technical feasibility of that same technology in a new product.
The results of the feasibility study are reviewed by a design review committee comprising senior managers. The feasibility study occurs in the initial research phase of a project and costs in this phase are not capitalised.
The commercial feasibility of a new product is determined by preparing a discounted cash flow projection. This projection compares the discounted sales revenues for future periods with the relevant costs. As part of preparing the cash flow projection, the size of the relevant market is determined, feedback is sought from customers and the strength of the proposed new product is assessed against competitors’ offerings. Once the technical and commercial feasibility has been established and the project has been approved for commencement, the project moves into the development phase.
All other development expenditure is expensed as incurred. Subsequent to initial recognition, the capitalised development expenditure is carried at cost less any accumulated amortisation and any accumulated impairment losses (Note 1(viii)).
Expenditure on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, is recognised in the statement of operations as an expense as incurred.
Expenditure on internally generated goodwill and brands is recognised in the statement of operations as an expense as incurred.
Amortisation
Amortisation is charged to the statement of operations on a straight-line basis over the estimated useful lives of intangible assets, unless such lives are indefinite. Intangible assets are amortised from the date they are available for use in its intended market. The estimated useful lives are as follows:
The Group uses a useful economic life of 15 years for capitalised development costs. This is a conservative estimate of the likely life of the products. The Group is confident that products have a minimum of 15 years life given the inertia that characterizes the medical diagnostics industry and the barriers to enter into the industry. The following factors have been considered in estimating the useful life of developed products:
Certain trade names acquired are deemed to have an indefinite useful life as there is no foreseeable limit to the period over which these assets are expected to generate cash inflows for the Group.
Where amortisation is charged on assets with finite lives, this expense is taken to the statement of operations through the ‘selling, general and administrative expenses’ line.
Useful lives are examined on an annual basis and adjustments, where applicable, are made on a prospective basis. |
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Impairment |
The carrying amount of the Group’s assets, other than inventories, accounts receivable, cash and cash equivalents, short-term investments and deferred tax assets, are reviewed at each balance sheet date to determine whether there is any indication of impairment. If any such indication exists, the asset’s recoverable amount (being the greater of fair value less costs to sell and value in use) is assessed at each balance sheet date.
Fair value less costs to sell is defined as the amount obtainable from the sale of an asset or cash-generating unit in an arm’s length transaction between knowledgeable and willing parties, less the costs that would be incurred on disposal. Value in use is defined as the present value of the future cash flows expected to be derived through the continued use of an asset or cash-generating unit. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the future cash flow estimates have not yet been adjusted. The estimates of future cash flows exclude cash inflows or outflows attributable to financing activities. For an asset that does not generate largely independent cash flows, the recoverable amount is determined by reference to the cash generating unit to which the asset belongs.
For goodwill, assets that have an indefinite useful life and intangible assets that are not yet available for use, the recoverable amount is estimated at each balance sheet date at the cash generating unit level. The goodwill and indefinite-lived assets were reviewed for impairment at December 31, 2017 and December 31, 2018. See Note 13.
In-process research and development (IPR&D) is tested for impairment on an annual basis, in the fourth quarter, or more frequently if impairment indicators are present, using projected discounted cash flow models. If IPR&D becomes impaired or is abandoned, the carrying value of the IPR&D is written down to its revised fair value with the related impairment charge recognised in the period in which the impairment occurs. If the fair value of the asset becomes impaired as the result of unfavorable data from any ongoing or future clinical trial, changes in assumptions that negatively impact projected cash flows, or because of any other information regarding the prospects of successfully developing or commercializing our programs, we could incur significant charges in the period in which the impairment occurs. The valuation techniques utilized in performing impairment tests incorporate significant assumptions and judgments to estimate the fair value, as described above. The use of different valuation techniques or different assumptions could result in materially different fair value estimates.
An impairment loss is recognised whenever the carrying amount of an asset or its cash-generating unit exceeds its recoverable amount. Impairment losses are recognised in the statement of operations.
Impairment losses recognised in respect of cash-generating units are allocated first to reduce the carrying amount of any goodwill allocated to cash-generating units and then to reduce the carrying amount of other assets in the cash-generating units on a pro-rata basis.
An impairment loss is reversed only to the extent that the asset’s carrying amount does not exceed the carrying amount that would have been determined, net of depreciation or amortisation, if no impairment loss had been recognised.
An impairment loss in respect of goodwill is not reversed.
Following recognition of any impairment loss (and on recognition of an impairment loss reversal), the depreciation or amortisation charge applicable to the asset or cash generating unit is adjusted prospectively with the objective of systematically allocating the revised carrying amount, net of any residual value, over the remaining useful life. |
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Inventories |
Inventories are stated at the lower of cost and net realisable value. Cost is based on the first-in, first-out principle and includes all expenditure which has been incurred in bringing the products to their present location and condition, and includes an appropriate allocation of manufacturing overhead based on the normal level of operating capacity. Net realisable value is the estimated selling price of inventory on hand in the ordinary course of business less all further costs to completion and costs expected to be incurred in selling these products.
The Group provides for inventory, based on estimates of the expected realisability. The estimated realisability is evaluated on a case-by-case basis and any inventory that is approaching its “use-by” date and for which no further re-processing can be performed is written off. Any reversal of an inventory provision is recognised in the statement of operations in the year in which the reversal occurs. |
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Trade and other receivables |
Trade receivables are amounts due from customers for products sold or services provided in the ordinary course of business. Trade and other receivables are stated at their amortised cost less impairment losses incurred. Cost approximates fair value given the short term nature of these assets. The Group records the loss allowance as lifetime expected credit losses. These are the expected shortfalls in contractual cash flows, considering the potential for default at any point during the life of the financial instrument. Expected credit losses are recorded on all of trade receivables based on an assessment of each individual debtor taking into account the probability of default or delinquency in payments and the probability that debtor will enter into financial difficulties or bankruptcy. |
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Trade and other payables |
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business. Trade and other payables are stated at cost. Cost approximates fair value given the short term nature of these liabilities. |
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Cash and cash equivalents |
Cash and cash equivalents comprise cash balances and short-term deposits which are readily available at year-end. Deposits with maturities less than six months as at the year end date are recognised as cash and cash equivalents and are carried at fair value. The Group has no short-term bank overdraft facilities. Where restrictions are imposed by third parties, such as lending institutions, on cash balances held by the Group these are treated as financial assets in the financial statements. |
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Short-term investments |
Short-term investments comprise short-term bank deposits which have maturities greater than six months as at the year-end date. Short-term deposits made for varying periods depending on the immediate cash requirements of the Group and earn interest at the respective deposit rates in place. Where restrictions are imposed by third parties, such as lending institutions, on short-term deposits held by the Group these are treated as financial assets in the financial statements. |
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Share-based payments |
For equity-settled share-based payments (share options), the Group measures the services received and the corresponding increase in equity at fair value at the measurement date (which is the grant date) using a trinomial model. Given that the share options granted do not vest until the completion of a specified period of service, the fair value, which is assessed at the grant date, is recognised on the basis that the services to be rendered by employees as consideration for the granting of share options will be received over the vesting period.
The share options issued by the Group are not subject to market-based vesting conditions as defined in IFRS 2, Share-based Payment. Non-market vesting conditions are not taken into account when estimating the fair value of share options as at the grant date; such conditions are taken into account through adjusting the number of equity instruments included in the measurement of the transaction amount so that, ultimately, the amount recognised equates to the number of equity instruments that actually vest. The expense in the statement of operations in relation to share options represents the product of the total number of options anticipated to vest and the fair value of those options; this amount is allocated to accounting periods on a straight-line basis over the vesting period. Given that the performance conditions underlying the Group’s share options are non-market in nature, the cumulative charge to the statement of operations is only reversed where the performance condition is not met or where an employee in receipt of share options relinquishes service prior to completion of the expected vesting period. Share based payments, to the extent they relate to direct labour involved in development activities, are capitalised, see Note 1(vii).
The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the options are exercised. The Group does not operate any cash-settled share-based payment schemes or share-based payment transactions with cash alternatives as defined in IFRS 2. |
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Government grants |
Grants that compensate the Group for expenses incurred such as research and development, employment and training are recognised as income in the statement of operations on a systematic basis in the same periods in which the expenses are incurred. Grants that compensate the Group for the cost of an asset are recognised in the statement of operations as other operating income on a systematic basis over the useful life of the asset. |
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Revenue recognition |
Goods sold and services rendered
The Group recognises revenue when it transfers control over a good or service to a customer. Revenue is recognised to the extent that it is probable that economic benefit will flow to the Group and the revenue can be measured. No revenue is recognised if there is uncertainty regarding recovery of the consideration due at the outset of the transaction or the possible return of goods. Revenue, including any amounts invoiced for shipping and handling costs, represents the value of goods and services supplied to external customers, net of discounts and rebates and excluding sales taxes.
Revenue from products is generally recorded as of the date of shipment, consistent with typical ex-works shipment terms. Where the shipment terms do not permit revenue to be recognised as of the date of shipment, revenue is recognised when the Group has satisfied all of its performance obligations to the customer in accordance with the shipping terms. Some contracts oblige the Group to ship product to the customer ahead of the agreed payment schedule. For these shipments, a contract asset is recognised when control over the goods has transferred to the customer. The financing component is insignificant as invoicing for these shipments occurs within a short period of time after shipment has occurred and standard 30 day credit terms apply.
The Group operates a licensed referenced laboratory in the US, which provides testing services to institutional customers and insurance companies. In the US, there are rules requiring all insurance companies to be billed the same amount per test. However, the amount that each insurance company pays for a particular test varies according to their own internal policies and this can typically be considerably less than the amount invoiced. We recognise lab services revenue for insurance companies by taking the invoiced amount and reducing it by an estimated percentage based on historical payment data. We review the percentage reduction annually based on the latest data. As a practical expedient, and in accordance with IFRS, we apply a portfolio approach to the insurance companies as they have similar characteristics. We judge that the effect on the financial statements of using a portfolio approach for the insurance companies will not differ materially from applying IFRS 15 to the individual contracts within that portfolio.
Revenue from services rendered is recognised in the statement of operations in proportion to the stage of completion of the transaction at the balance sheet date.
The Group leases instruments to customers typically as part of a bundled package. Where a contract has multiple performance obligations and its duration is greater than one year, the transaction price is allocated to the performance obligations in the contract by reference to their relative standalone selling prices. For contracts where control of the instrument is transferred to the customer, the fair value of the instrument is recognised as revenue at the commencement of the lease and is matched by the related cost of sale. Fair value is determined on the basis of standalone selling price. In the case where control of the instrument does not transfer to the customer, revenue is recognised on the basis of customer usage of the instrument. See also Note 1(v).
In obtaining these contracts, the Group incurs a number of incremental costs, such as sales bonus paid to sales staff commissions paid to distributors and royalty payments. As the amortisation period of these costs, if capitalised, would be less than one year, the Group makes use of the practical expedient in IFRS 15.94 and expenses them as they incur.
A receivable is recognised when the goods are delivered as this is the point in time that the consideration is unconditional because only the passage of time is required before the payment is due.
The Group’s obligation to provide a refund for faulty products under the standard warranty terms is recognised as a provision, see Note 23 for details.
Other operating income
Other operating income mainly comprises income recognised under Transitional Services Agreements (TSA) with Diagnostica Stago. As part of the divestiture of the Coagulation product line in April 2010, the Group entered into a TSA. The services provided by the Group to Stago under the TSA comprise canteen services. This income has not been treated as revenue since the TSA activities are incidental to the main revenue-generating activities of the Group. |
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Employee benefits |
Defined contribution plans
The Group operates defined contribution schemes in various locations where its subsidiaries are based. Contributions to the defined contribution schemes are recognised in the statement of operations in the period in which the related service is received from the employee.
Other long-term benefits
Where employees participate in the Group’s other long-term benefit schemes (such as permanent health insurance schemes under which the scheme insures the employees), or where the Group contributes to insurance schemes for employees, the Group pays an annual fee to a service provider, and accordingly the Group expenses such payments as incurred.
Termination benefits
Termination benefits are recognised as an expense when the Group is demonstrably committed, without realistic possibility of withdrawal, to a formal detailed plan to either terminate employment before normal retirement date, or to provide termination benefits as a result of an offer made to encourage voluntary redundancy. |
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Foreign currency |
A majority of the revenue of the Group is generated in US Dollars. The Group’s management has determined that the US Dollar is the primary currency of the economic environment in which the Company and its subsidiaries (with the exception of the Group’s subsidiaries in Brazil, Canada and Sweden) principally operate. Thus the functional currency of the Company and its subsidiaries (other than the Brazilian, Canadian and Swedish subsidiaries) is the US Dollar. The functional currency of the Brazilian entity is the Brazilian Real, the functional currency of the Canadian subsidiary, Nova Century Scientific Inc, is the Canadian Dollar and the functional currency of the Swedish subsidiary is the Swedish Kroner. The presentation currency of the Company and Group is the US Dollar. Monetary assets and liabilities denominated in foreign currencies are translated at the rates of exchange ruling at the balance sheet date. The resulting gains and losses are included in the statement of operations. Non-monetary assets and liabilities that are measured in terms of historical cost in a foreign currency are translated using the exchange rate at the date of the transaction.
Results and cash flows of subsidiary undertakings, which have a functional currency other than the US Dollar, are translated into US Dollars at average exchange rates for the year, and the related balance sheets have been translated at the rates of exchange ruling on the balance sheet date. Any exchange differences arising from the translations are recognised in the currency translation reserve via the statement of changes in equity.
Where Euro, Brazilian Real, Canadian Dollar or Swedish Kroner amounts have been referenced in this document, their corresponding US Dollar equivalent has also been included and these equivalents have been calculated with reference to the foreign exchange rates prevailing at December 31, 2018. |
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Hedging |
The activities of the Group expose it primarily to changes in foreign exchange rates and interest rates. The Group uses derivative financial instruments, from time to time, such as forward foreign exchange contracts to hedge these exposures.
The Group enters into forward contracts to sell US Dollars forward for Euro. The principal exchange risk identified by the Group is with respect to fluctuations in the Euro as a substantial portion of its expenses are denominated in Euro but its revenues are primarily denominated in US Dollars. Trinity Biotech monitors its exposure to foreign currency movements and may use these forward contracts as cash flow hedging instruments whose objective is to cover a portion of this Euro expense.
At the inception of a hedging transaction entailing the use of derivatives, the Group documents the relationship between the hedged item and the hedging instrument together with its risk management objective and the strategy underlying the proposed transaction. The Group also documents its quarterly assessment of the effectiveness of the hedge in offsetting movements in the cash flows of the hedged items.
Derivative financial instruments are recognised at fair value. Where derivatives do not fulfil the criteria for hedge accounting, they are classified as held-for-trading and changes in fair values are reported in the statement of operations. The fair value of forward exchange contracts is calculated by reference to current forward exchange rates for contracts with similar maturity profiles and equates to the current market price at the balance sheet date.
The portion of the gain or loss on a hedging instrument that is deemed to be an effective cash flow hedge is recognised directly in the hedging reserve in equity and the ineffective portion is recognised in the statement of operations. As the forward contracts are exercised the net cumulative gain or loss recognised in the hedging reserve is transferred to the statement of operations and reflected in the same line as the hedged item. |
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Exchangeable notes and derivative financial instruments |
The Company’s exchangeable notes are treated as a host debt instrument with embedded derivatives attached. On initial recognition, the host debt instrument is recognised at the residual value of the total net proceeds of the bond issue less fair value of the embedded derivatives. Subsequently, the host debt instrument is measured at amortised cost using the effective interest rate method.
The embedded derivatives are initially recognised at fair value and are restated at their fair value at each reporting date. The fair value changes of the embedded derivatives are recognised in the statement of operations, except for changes in fair value related to the Group’s own credit risk, which are recorded in the statement of comprehensive income.
Where the exchangeable notes are redeemed early or repurchased in a way that does not alter the original conversion privileges, the consideration paid is allocated to the respective components and the amount of any gain or loss is recognised in the consolidated statement of operations. |
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Segment reporting |
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the Board of Directors. |
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Tax (current and deferred) |
Income tax on the profit or loss for the year comprises current and deferred tax. Income tax is recognised in the statement of operations except to the extent that it relates to items recognised directly in equity, in which case it is recognised in equity.
Current tax represents the expected tax payable or recoverable on the taxable profit for the year using tax rates enacted or substantively enacted at the balance sheet date in the countries where the company and its subsidiaries operate and generate income, and taking into account any adjustments stemming from prior years.
Deferred tax is provided on the basis of the balance sheet liability method on all temporary differences at the balance sheet date which is defined as the difference between the tax bases of assets and liabilities and their carrying amounts in the financial statements. Deferred tax assets and liabilities are not subject to discounting and are measured at the tax rates that are anticipated to apply in the period in which the asset is realised or the liability is settled based on tax rates and tax laws that have been enacted or substantively enacted at the balance sheet date. Deferred tax assets are recognised when it is probable that future taxable profits will be available to utilize the associated losses or temporary differences. The amount of deferred tax provided is based on the expected manner of realisation or settlement of the carrying amount of assets and liabilities.
Deferred tax assets and liabilities are recognised for all temporary differences (that is, differences between the carrying amount of the asset or liability and its tax base) with the exception of the following:
Where goodwill is tax deductible, a deferred tax liability is not recognised on initial recognition of goodwill. It is recognised subsequently for the taxable temporary difference which arises when the goodwill is amortised for tax with no corresponding adjustment to the carrying value of the goodwill.
The carrying amounts of deferred tax assets are subject to review at each balance sheet date and are derecognised to the extent that future taxable profits are considered to be inadequate to allow all or part of any deferred tax asset to be utilised. |
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Provisions |
A provision is recognised in the balance sheet when the Group has a present legal or constructive obligation as a result of a past event, and it is probable that an outflow of economic benefits will be required to settle the obligation. |
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Cost of sales |
Cost of sales comprises product cost including manufacturing and payroll costs, quality control, shipping, handling, and packaging costs and the cost of services provided. |
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Finance income and costs |
Financing expenses comprise interest costs payable on leases and exchangeable notes. Interest payable on finance leases is allocated to each period during the lease term so as to produce a constant periodic rate of interest on the remaining balance of the liability. Financing expenses also includes the financing element of long term liabilities which have been discounted.
Finance income includes interest income on deposits and is recognised in the statement of operations as it accrues, using the effective interest method. Finance income also includes fair value adjustments to embedded derivatives associated with exchangeable notes. |
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Treasury shares |
When the Group purchases its own equity instruments (treasury shares), the costs, including any directly attributable incremental costs, are deducted from equity. No gain or loss is recognised in the statement of operations on the purchase, sale, issue or cancellation of the Group’s own equity instruments. Any difference between the carrying amount and the consideration, if reissued, is recognised in share premium. Voting rights related to treasury shares are nullified for the Group and no dividends are allocated to them. |
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Equity |
Share capital represents the nominal (par) value of shares that have been issued. Share premium includes any premiums received on issue of share capital. Any transaction costs associated with the issuing of shares are deducted from share premium, net of any related income tax benefits. |
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Profit or loss from discontinued operations |
A discontinued operation is a component of the Group that either has been disposed of, or is classified as held for sale. Profit or loss from discontinued operations comprises the post-tax profit or loss of discontinued operations and the post-tax gain or loss resulting from the measurement and disposal of assets classified as held for sale. |
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Fair values |
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: quoted prices (unadjusted) in active markets for identical assets or liabilities
Level 2: valuation techniques for which the lowest level of inputs which have a significant effect on the recorded fair value are observable, either directly or indirectly
Level 3: valuation techniques for which the lowest level of inputs that have a significant effect on the recorded fair value are not based on observable market data |
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New IFRS Standards and Interpretations not applied |
The IASB and IFRIC have issued additional standards and interpretations which are effective for periods starting after January 1, 2018, all of which have not yet been adopted by the EU. IFRS as adopted by the EU differ in certain respects from IFRS as issued by the IASB. However, the Group’s consolidated financial statements for the financial years presented would be no different had IFRS as issued by the IASB been applied. The following standards and interpretations have yet to be adopted by the Group:
IFRS 16 Leases was issued in January 2016 and replaces IAS 17 Leases, IFRIC 4 Determining Whether an Arrangement Contains a Lease, SIC-15 – Operating Leases – Incentives and SIC-27 – Evaluating the Substance of Transactions Involving the Legal Form of a Lease. The Group will adopt IFRS 16 on January 1, 2019 and will apply the modified retrospective approach on transition. Comparative results will not be restated.
IFRS 16 sets out the principles for the recognition, measurement, presentation and disclosure of leases and requires lessees to account for the majority of leases under a single on-balance sheet model, similar to the accounting for finance leases under IAS 17. The standard includes two recognition exemptions for lessees which will be availed of by the Group – leases of ‘low-value’ assets (e.g. computers, small copiers costing less than US$5,000) and short-term leases (i.e. leases with a term of 12 months or less). It also includes an election, which permits a lessee not to separate non-lease components (e.g. maintenance) from lease components and instead capitalise both the lease cost and associated non-lease cost.
At the commencement date of a lease, a lessee will recognise a liability to make lease payments (i.e. the lease liability) and an asset representing the right to use the underlying asset during the lease term (i.e. the right-of-use asset). Lessees will be required to recognise separately the interest expense on the lease liability and the depreciation expense on the right-of-use asset. Under IFRS 16, lessees will also be required to remeasure the lease liability upon the occurrence of certain events (e.g. a change in lease term or a change in future lease payments resulting from a change in an index or rate used to determine those payments). The lessee will generally recognise the amount of the remeasurement of the lease liability as an adjustment to the right-of-use asset. Trinity Biotech has entered into operating leases for a range of assets, principally relating to premises, plant and machinery, vehicles and equipment.
The adoption of the new standard will have a material impact on the Group’s consolidated financial statements, as follows:
Statement of Operations
The adoption of the new standard will lead to a reduction in profit in the short term but this will reverse over the life of the leases. The Group currently recognises operating lease expenses in operating costs. The Group’s lease expense for 2018 was US$3.0 million (2017 US$3.0 million) and is disclosed in Note 5 to the consolidated financial statements. A significant majority of these lease expenses will not be recognised in the Group’s statement of operations beginning January 1, 2019. Instead, right-of-use assets will be capitalised and depreciated over the term of the lease with an associated finance cost applied to the lease liability. In 2019, the depreciation and finance cost for right-of-use assets will exceed what would have been the charged for operating lease expenses and therefore profit will decrease.
Balance Sheet
At transition date, the Group will determine the lease payments outstanding at that date and apply the appropriate discount rate to calculate the present value of the lease payments. The Group’s commitments outstanding on all leases as at December 31, 2018 is US$25.7 million (2017: US$22.1 million) (see Note 26(b) to the consolidated financial statements). The related right-of-use assets will be recognised within Property, Plant and equipment. Our existing finance lease liabilities (refer Note 25) are not affected by the new standard. Similarly, our lessor accounting will not be impacted by IFRS 16 (refer to finance lease receivable in Note 17).
The Group has assessed the impact of the new standard but the exact financial impact of the standard is as yet unknown. The Group’s commitment as at December 31, 2018 provides an indication of the scale of leases held and how significant leases currently are to Trinity Biotech’s business.
In addition to the impacts above, there will also be significantly increased disclosures when the Group adopts IFRS 16, including the following:
The Group has adopted the following standards and amendments during the year:
The Group has adopted IFRS 2, Share-based Payments for its 2018 financial year. The amended standard had no impact on the financial statements.
The Group has adopted IFRS 15, Revenue from Contracts with Customers for its 2018 financial year. As permitted by the standard, the Group has adopted the modified transitional provisions and as such the 2017 results remain as previously reported. As expected, the new standard did not lead to a material difference in the timing of recognising revenue. The main impact on the financial statements is the increased disclosure obligations including expanded disclosure in respect of disaggregated revenue from contracts with customers and separate disclosure of contract assets. We have also updated our accounting policy for revenue recognition.
The Group has adopted IFRS 9, Financial Instruments for its 2018 financial year. The new standard affects the recording of fair value movements of the put and call options in our exchangeable notes. Movements in fair value related to the Group’s own credit risk are recorded in the statement of comprehensive income. There were no such movements in 2018. There have been no changes in classifications as a result of the application of IFRS 9. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (Tables) |
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Dec. 31, 2018 | ||||||||||||||||||||||||||||
Disclosure of basis of preparation and significant accounting policies [Abstract] | ||||||||||||||||||||||||||||
Schedule of Estimated Useful Lives of Owned Assets | Depreciation is charged to the statement of operations on a straight-line basis to write-off the cost of the assets over their expected useful lives as follows:
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Schedule of Estimated Useful Lives of Intangible Assets | Amortisation is charged to the statement of operations on a straight-line basis over the estimated useful lives of intangible assets, unless such lives are indefinite. Intangible assets are amortised from the date they are available for use in its intended market. The estimated useful lives are as follows:
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SEGMENT INFORMATION (Tables) |
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Disclosure of operating segments [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Revenue by Geographical Area Based on Location of Assets |
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Schedule of Revenue by Customers' Geographical Area |
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Schedule of Revenue by Major Product Group |
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Schedule of Amount Relating From Revenue |
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Schedule of Revenue Derives From Transfer of Goods and Services | The Group derives revenue from the transfer of goods and services over time and at a point in time in the following geographical areas:
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Schedule of Segment Results by Geographical Area |
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Schedule of Segment Assets and Segment Liabilities by Geographical Area |
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Schedule of Long-Lived Assets |
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Schedule of Depreciation and Amortisation by Geographical Area |
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Schedule of Share-Based Payment Expense by Geographical Area |
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Schedule of Interest Income and Interest Expense by Geographical Area |
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Schedule of Taxation Expense by Geographical Area |
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Schedule of Capital Expenditure by Geographical Area |
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FINANCIAL INCOME AND EXPENSES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of financial income and expenses [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Financial Income and Expenses |
|
OTHER OPERATING INCOME (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of other operating income [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Other Operating Income |
|
LOSS BEFORE TAX (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of loss profit before tax [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Loss Before Tax | The following amounts were charged / (credited) to the statement of operations:
In 2016, the depreciation expense did not include the amount of US$303,000 that was included in the operating expenses that were stated in Note 10 in respect of the discontinued operations in Fiomi. In 2017 and 2018, no depreciation expense arose for the discontinued operation.
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IMPAIRMENT CHARGES AND INVENTORY PROVISIONING (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of impairment charges and inventory provisioning [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Impairment Charges and Inventory Provisioning | The impact of the above items on the statement of operations for the year ended December 31, 2018, December 31, 2017 and December 31, 2016 was as follows:
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PERSONNEL EXPENSES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Personnel Expenses |
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Schedule of Persons Employed by the Group in the Financial Year | The average number of persons employed by the Group in the financial year was 575 (2017: 556) (2016: 582) and is analysed into the following categories:
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INCOME TAX (CREDIT)/EXPENSE (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Creditexpense Schedule Of Statutory Tax Rate | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Charge for Tax | The charge for tax based on the profit comprises:
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Schedule of Overseas Tax Jurisdictions |
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Schedule of Statutory Tax Rate | The following table reconciles the applicable Republic of Ireland statutory tax rate to the effective total tax rate for the Group:
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Schedule of Unrecognised Deferred Tax Assets |
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Schedule of (Loss)/Profit Before Taxes | The distribution of loss before taxes by geographical area was as follows:
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Schedule of Unutilised Net Operating Losses | At December 31, 2018, the Group had unutilised net operating losses as follows:
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Schedule of Unused Tax Losses and Unused Tax Credits | At December 31, 2018, the Group had unrecognised deferred tax assets in respect of unused tax losses and unused tax credits as follows:
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PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATIONS (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of loss on discontinued operations [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Loss on Remeasurement of Assets and Liabilities | The operating loss for the Cardiac point-of-care tests operation in Sweden and the profit/(loss) on remeasurement of its assets and liabilities are summarised as follows:
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Schedule of Earnings Per ADS for Discontinued Operations |
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Schedule of Cash Flows Attributable to Discontinued Operations | The cash flows attributable to discontinued operations are as follows:
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(LOSS)/EARNINGS PER SHARE (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings per share [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Basic Earnings Per Ordinary Share | As at December 31, 2018, this amounted to 83,612,908 shares (2017: 86,486,409 shares) (2016: 91,858,813 shares).
*The weighted average number of shares issued during the year is calculated by taking the number of shares issued multiplied by the number of days in the year each share is in issue, divided by 365 days. |
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Schedule of Diluted Earnings Per Ordinary Share | The basic weighted average number of ordinary shares for the Group may be reconciled to the number used in the diluted earnings per ordinary share calculation as follows:
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Schedule of Profit After Tax Diluted Earnings Per Ordinary Share Calculation | The loss after tax for the year may be reconciled to the amount used in the diluted earnings per ordinary share calculation as follows:
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Schedule of Basic Earning per ADS |
*The weighted average number of shares issued during the year is calculated by taking the number of shares issued multiplied by the number of days in the year each share is in issue, divided by 365 days. |
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Schedule of Diluted Earning per ADS | The basic weighted average number of ADS shares for the Group may be reconciled to the number used in the diluted earnings per ADS share calculation as follows:
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PROPERTY, PLANT AND EQUIPMENT (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of detailed information about property, plant and equipment [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property, Plant and Equipment |
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GOODWILL AND INTANGIBLE ASSETS (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of goodwill and intangible assets [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Goodwill and Intangible Assets |
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Schedule of Principal Development Projects | The following represents the costs incurred during each period presented for each of the principal development projects:
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Schedule of Impairment Loss Recorded on Discontinued Assets | The table below sets forth the impairment loss recorded for each of the CGU’s at December 31, 2018:
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Schedule of Impairment Loss for Each Class of Asset | The table below sets forth the breakdown of the impairment loss for each class of asset at December 31, 2018:
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Schedule of Significant Goodwill | The additional disclosures required for the CGU with significant goodwill are as follows:
* The goodwill of Immco Diagnostics was partially impaired in the year ended December 31, 2017. |
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Schedule of Internal and External Factors Based on Historical Experience |
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DEFERRED TAX ASSETS AND LIABILITIES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of deferredc tax assets and liabilities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Deferred Tax Assets and Liabilities | Deferred tax assets and liabilities of the Group are attributable to the following:
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Schedule of Deferred Tax Assets Not Recognised | Deferred tax assets have not been recognised by the Group in respect of the following items:
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Schedule of Unrecognised Deferred Tax Assets | The movement in the unrecognised deferred tax assets during the year ended December 31, 2018 is analysed as follows:
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Schedule of Unrecognised Deferred Tax Liabilities | Movement in temporary differences during the year
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OTHER ASSETS (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of other assets [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Other Assets |
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INVENTORIES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Classes of current inventories [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventories |
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Schedule of Movement on Inventory Provision | The movement on the inventory provision for the three year period to December 31, 2018 is as follows:
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TRADE AND OTHER RECEIVABLES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trade and other receivables [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Trade and Other Receivables |
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Schedule of Future Minimum Finance Lease Receivables | The Group leases instruments as part of its business. Future minimum finance lease receivables with non-cancellable terms are as follows:
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Schedule of Future Minimum Rentals Receivable Under Non-Cancellable Operating Leases | Future minimum rentals receivable under non-cancellable operating leases are as follows:
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CASH AND CASH EQUIVALENTS (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||
Cash and cash equivalents [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Cash and Cash Equivalents |
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SHORT-TERM INVESTMENTS (Tables) |
12 Months Ended | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||
Disclosure of short-term investments [Abstract] | |||||||||||||||||||
Schedule of Short-Term Investments |
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CAPITAL AND RESERVES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of classes of share capital [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share Capital |
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SHARE OPTIONS AND SHARE WARRANTS (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Disclosure of share options and share warrants [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Grants of Share Options and Warrants | The number and weighted average exercise price of share options and warrants per ordinary share is as follows (as required by IFRS 2, this information relates to all grants of share options and warrants by the Group):
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Summary of Range of Prices of Stock Options | A summary of the range of prices for the Company’s stock options for the year ended December 31, 2018 follows:
The weighted-average remaining contractual life of options outstanding at December 31, 2018 was 4.33 years (2017: 5.10 years).
A summary of the range of prices for the Company’s stock options for the year ended December 31, 2017 follows:
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Schedule of Fair Value of the Options Vesting Period | The fair value of the options is expensed over the vesting period of the option. US$1,369,000 was charged to the statement of operations in 2018, (2017: US$928,000), (2016: US$1,381,446) split as follows:
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Schedule of Assumption Determining Fair Value of Share Options | The estimate of the fair value of services received is measured based on a trinomial model. The following are the input assumptions used in determining the fair value of share options granted in 2018, 2017 and 2016:
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TRADE AND OTHER PAYABLES (Tables) |
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Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trade and other current payables [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Trade and Other Payables |
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PROVISIONS (Tables) |
12 Months Ended | ||||||||||||||||||
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Dec. 31, 2018 | |||||||||||||||||||
Provisions [abstract] | |||||||||||||||||||
Schedule of Provisions |
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EXCHANGEABLE NOTES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Borrowings [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Exchangeable Notes | The first date on which holders can exercise their put option is April 1, 2022. If the put option is exercised, the issuer has to repurchase the notes at par. The embedded derivatives are summarised as follows:
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Schedule of Carrying Value of Exchangeable Senior Notes | Subsequently, the host debt instrument is measured at amortised cost using the effective interest rate method. The carrying value of exchangeable senior notes is calculated as follows:
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FINANCE LEASE LIABILITIES (Tables) |
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Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of finance lease liabilities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Carrying Values of Finance Lease Liabilities | Finance leases are secured by the related assets held under the finance lease, and the carrying values of finance lease liabilities at December 31, 2018 are as follows:
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Schedule of Finance Lease Liabilities Payable | Finance lease liabilities are payable as follows:
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Schedule of Outstanding Interest Bearing Loans and Borrowings | The terms and conditions of outstanding interest bearing loans and borrowings at December 31, 2018 are as follows:
The terms and conditions of outstanding interest bearing loans and borrowings at December 31, 2017 were as follows:
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COMMITMENTS AND CONTINGENCIES (Tables) |
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Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of commitments and contingencies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Operating Lease Commitments with Non-Cancellable | Future minimum operating lease commitments with non-cancellable terms in excess of one year are as follows:
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RELATED PARTY TRANSACTIONS (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of transactions between related parties [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Compensation | Compensation for the year ended December 31, 2018 of these personnel is detailed below:
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Schedule of Company's Shares and Share Option Plan | Directors’ interests in the Company’s shares and share option plan
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DERIVATIVES AND FINANCIAL INSTRUMENTS (Tables) |
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Disclosure of detailed information about financial instruments [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Interest Rate Risk Effective and Repricing Analysis | The following table sets out all interest-earning financial assets and interest bearing financial liabilities held by the Group at December 31, indicating their effective interest rates and the period in which they re-price:
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Schedule of Interest Rate Profile of Financial Assets/Liabilities | The interest rate profile of financial assets/liabilities of the Group was as follows:
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Schedule of Liquidity Risk Estimated Interest Payments of Maturities | The following are the contractual maturities of financial liabilities, including estimated interest payments:
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Schedule of Foreign Currency Risk Short Term Financial Assets and Liabilities | Foreign currency short term financial assets and liabilities which expose the Group to currency risk are disclosed below. The amounts shown are those reported to key management translated into US Dollars at the closing rate:
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Schedule of Sensitivity Analysis | A 10% strengthening of the US Dollar against the Euro at December 31, 2018 would have increased profit and other equity by the amounts shown below. This analysis assumes that all other variables, in particular interest rates, remain constant.
A 10% weakening of the US Dollar against the Euro at December 31, 2018 would have decreased profit and other equity by the amounts shown below. This analysis assumes that all other variables, in particular interest rates, remain constant.
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Schedule of Maximum Credit Exposure of Financial Assets | The carrying amount of financial assets represents the maximum credit exposure. The maximum exposure to credit risk is as follows:
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Schedule of Exposure of Trade Receivables by Geographic Location | The maximum exposure to credit risk for trade receivables and finance lease income receivable by geographic location is as follows:
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Schedule of Exposure of Trade Receivables by Customer | The maximum exposure to credit risk for trade receivables and finance lease income receivable by type of customer is as follows:
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Schedule of Ageing of Trade Receivables | The ageing of trade receivables at December 31, 2018 is as follows:
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Schedule of Movement in Allowance for Impairment of Trade Receivables | The movement in the allowance for impairment in respect of trade receivables during the year was as follows:
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Schedule of Fair Values of Financial Assets/Liabilities | The table below sets out the Group’s classification of each class of financial assets/liabilities, their fair values and under which valuation method they are valued:
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: quoted prices (unadjusted) in active markets for identical assets or liabilities
Level 2: valuation techniques for which the lowest level of inputs which have a significant effect on the recorded fair value are observable, either directly or indirectly
Level 3: valuation techniques for which the lowest level of inputs that have a significant effect on the recorded fair value are not based on observable market data
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RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of reconciliation of liabilities arising from financing activities [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Liabilities Arising from Financing Activities | The changes in the Group’s liabilities arising from financing activities can be classified as follows:
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BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of basis of preparation and significant accounting policies [Abstract] | ||
Group leases of low value assets | $ 5,000 | |
Group lease expense | 3,000 | $ 3,000 |
Outstanding commitments on lease | $ 25,700 | $ 22,100 |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (Schedule of Owned Assets) (Details) |
12 Months Ended |
---|---|
Dec. 31, 2018 | |
Leasehold improvements [Member] | |
Disclosure of detailed information about property, plant and equipment [line items] | |
Estimated useful lives of owned assets (In years) | 5-15 years |
Buildings [Member] | |
Disclosure of detailed information about property, plant and equipment [line items] | |
Estimated useful lives of owned assets (In years) | 50 years |
Office equipment and fittings [Member] | |
Disclosure of detailed information about property, plant and equipment [line items] | |
Estimated useful lives of owned assets (In years) | 10 years |
Computers, fixtures and fittings [Member] | |
Disclosure of detailed information about property, plant and equipment [line items] | |
Estimated useful lives of owned assets (In years) | 3-5 years |
Plant and equipment [Member] | |
Disclosure of detailed information about property, plant and equipment [line items] | |
Estimated useful lives of owned assets (In years) | 5-15 years |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (Schedule of Amortisation) (Details) |
12 Months Ended |
---|---|
Dec. 31, 2018 | |
Capitalised development costs [Member] | |
Disclosure of intangible assets with indefinite useful life [line items] | |
Estimated useful lives of intangible assets (In years) | 15 years |
Patents and licences [Member] | |
Disclosure of intangible assets with indefinite useful life [line items] | |
Estimated useful lives of intangible assets (In years) | 6-15 years |
Intangible assets [Member] | |
Disclosure of intangible assets with indefinite useful life [line items] | |
Estimated useful lives of intangible assets (In years) | 6-15 years |
SEGMENT INFORMATION (Narrative) (Details) $ in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2016
USD ($)
| |
Fiomi [Member] | |
Disclosure of transactions recognised separately from acquisition of assets and assumption of liabilities in business combination [line items] | |
Interest expense from discontinued operations | $ 5 |
SEGMENT INFORMATION (Schedule of Revenue by Geographical Area Based on Location of Assets) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Revenue from external customers | [1] | $ 97,035 | $ 99,140 | $ 99,611 | |
Inter-segment revenue | |||||
Total revenue | 97,035 | 99,140 | 99,611 | ||
USA [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Revenue from external customers | 65,863 | 66,092 | 63,889 | ||
Inter-segment revenue | 38,665 | 42,147 | 39,322 | ||
Total revenue | 104,528 | 108,239 | 103,211 | ||
Ireland [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Revenue from external customers | 31,172 | 33,048 | 35,718 | ||
Inter-segment revenue | 2,899 | 3,587 | 5,349 | ||
Total revenue | 34,071 | 36,635 | 41,067 | ||
Eliminations [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Revenue from external customers | |||||
Inter-segment revenue | (41,564) | (45,734) | (45,019) | ||
Total revenue | (41,564) | (45,734) | (45,019) | ||
Other Countries [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Revenue from external customers | 4 | ||||
Inter-segment revenue | 348 | ||||
Total revenue | $ 352 | ||||
|
SEGMENT INFORMATION (Schedule of Revenue by Customers Geographical Area) (Details) - USD ($) $ in Thousands |
12 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
||||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||||||||
Revenue from external customers | [1] | $ 97,035 | $ 99,140 | $ 99,611 | ||||
Americas [Member] | ||||||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||||||||
Revenue from external customers | 57,559 | 59,539 | 61,613 | |||||
Asia / Africa [Member] | ||||||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||||||||
Revenue from external customers | 29,466 | 27,131 | 25,501 | |||||
Europe (including Ireland) [Member] | ||||||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||||||||
Revenue from external customers | [2] | $ 10,010 | $ 12,470 | $ 12,497 | ||||
|
SEGMENT INFORMATION (Schedule of Revenue by Major Product Group) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of products and services [line items] | |||
Revenues | $ 97,035 | $ 99,140 | $ 99,611 |
Clinical laboratory [Member] | |||
Disclosure of products and services [line items] | |||
Revenues | 71,618 | 73,366 | 74,166 |
Point-of-Care [Member] | |||
Disclosure of products and services [line items] | |||
Revenues | 14,836 | 16,774 | 16,908 |
Laboratory services [Member] | |||
Disclosure of products and services [line items] | |||
Revenues | $ 10,581 | $ 9,000 | $ 8,537 |
SEGMENT INFORMATION (Schedule of Amount Relating From Revenue) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|||
Disclosure of operating segments [abstract] | |||||
Revenue from contracts with customers | [1] | $ 97,035 | $ 99,140 | $ 99,611 | |
Revenue from other sources | |||||
Total revenue | $ 97,035 | $ 99,140 | $ 99,611 | ||
|
SEGMENT INFORMATION (Schedule of Revenue Derives From Transfer of Goods and Services) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|---|
Timing of revenue recognition | |||
At a point in time | $ 96,113 | $ 98,212 | $ 98,737 |
Over time | 922 | 928 | 874 |
Total | 97,035 | 99,140 | 99,611 |
Customer [Member] | |||
Timing of revenue recognition | |||
At a point in time | 96,113 | 98,212 | 98,737 |
Over time | 922 | 928 | 874 |
Total | 97,035 | 99,140 | 99,611 |
Americas [Member] | |||
Timing of revenue recognition | |||
At a point in time | 64,941 | 65,164 | 63,015 |
Over time | 922 | 928 | 874 |
Total | 65,863 | 66,092 | 63,889 |
Americas [Member] | Customer [Member] | |||
Timing of revenue recognition | |||
At a point in time | 56,637 | 58,611 | 60,739 |
Over time | 922 | 928 | 874 |
Total | 57,559 | 59,539 | 61,613 |
Ireland [Member] | |||
Timing of revenue recognition | |||
At a point in time | 31,172 | 33,048 | 35,718 |
Over time | |||
Total | 31,172 | 33,048 | 35,718 |
Asia / Africa [Member] | Customer [Member] | |||
Timing of revenue recognition | |||
At a point in time | 29,466 | 27,131 | 25,501 |
Over time | |||
Total | 29,466 | 27,131 | 25,501 |
Europe [Member] | Customer [Member] | |||
Timing of revenue recognition | |||
At a point in time | 10,010 | 12,470 | 12,497 |
Over time | |||
Total | 10,010 | 12,470 | 12,497 |
Other Countries [Member] | |||
Timing of revenue recognition | |||
At a point in time | 4 | ||
Over time | |||
Total | $ 4 |
SEGMENT INFORMATION (Schedule of Segment Results by Geographical Area) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Result before impairment | $ 7,370 | $ 4,825 | $ 9,218 | ||
Impairment | (26,932) | (41,755) | (43,379) | ||
Inventory provision | (4,786) | ||||
Result after impairment | (19,562) | (36,930) | (38,947) | ||
Unallocated expenses | [1] | (665) | (738) | (901) | |
Operating profit loss | (20,227) | (37,668) | (39,848) | ||
Net financing expense (Note 3) | (2,956) | (2,207) | (2,292) | ||
Loss before tax | (23,183) | (39,875) | (42,140) | ||
Income tax credit (Note 9) | 525 | 1,214 | 3,557 | ||
Loss for the year on continuing operations | (22,658) | (38,661) | (38,583) | ||
Profit for the year on discontinued operations (Note 10) | 568 | (1,609) | (62,042) | ||
(Loss)/Profit for the year | (22,090) | (40,270) | (100,625) | ||
Americas [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Result before impairment | 5,514 | 3,744 | 4,564 | ||
Impairment | (19,095) | (9,194) | (22,989) | ||
Inventory provision | (335) | ||||
Result after impairment | (13,581) | (5,450) | (18,760) | ||
Loss before tax | (18,402) | (8,863) | (23,594) | ||
Ireland [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Result before impairment | 1,900 | 1,125 | 4,270 | ||
Impairment | (7,837) | (32,561) | (20,390) | ||
Inventory provision | (4,451) | ||||
Result after impairment | (5,937) | (31,436) | (20,571) | ||
Loss before tax | (9,590) | (35,821) | (23,787) | ||
Other Countries [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Result before impairment | (44) | (44) | 384 | ||
Impairment | |||||
Inventory provision | |||||
Result after impairment | (44) | (44) | 384 | ||
Loss before tax | $ 4,809 | $ 4,809 | $ 5,241 | ||
|
SEGMENT INFORMATION (Schedule of Segment Assets and Segment Liabilities by Geographical Area) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|---|---|
Assets and liabilities | ||||
Segment assets | $ 113,671 | $ 125,230 | ||
Unallocated assets: | ||||
Income tax assets (current and deferred) | 7,711 | 10,137 | ||
Cash and cash equivalents and short-term investments | 30,277 | 23,564 | $ 77,109 | $ 101,953 |
Total assets as reported in the Group balance sheet | 151,659 | 192,974 | ||
Segment liabilities | 99,540 | 116,636 | ||
Unallocated liabilities: | ||||
Income tax liabilities (current and deferred) | 8,065 | 11,142 | ||
Total liabilities as reported in the Group balance sheet | 107,605 | 127,778 | ||
Americas [Member] | ||||
Assets and liabilities | ||||
Segment assets | 75,658 | 88,714 | ||
Unallocated assets: | ||||
Segment liabilities | 8,946 | 11,486 | ||
Ireland [Member] | ||||
Assets and liabilities | ||||
Segment assets | 38,009 | 36,513 | ||
Unallocated assets: | ||||
Segment liabilities | 90,444 | 104,901 | ||
Other Countries [Member] | ||||
Assets and liabilities | ||||
Segment assets | 4 | 3 | ||
Unallocated assets: | ||||
Segment liabilities | $ 150 | $ 249 |
SEGMENT INFORMATION (Schedule of Long Lived Assets) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Long lived asstes | $ 58,871 | $ 71,685 |
Ireland [Member] | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Long lived asstes | 14,864 | 15,873 |
Americas [Member] | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Long lived asstes | 44,007 | 55,812 |
Other Countries [Member] | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Long lived asstes |
SEGMENT INFORMATION (Schedule of Depreciation and Amortisation by Geographical Area) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Depreciation | $ 1,375 | $ 2,424 | $ 3,573 |
Amortisation | 2,825 | 3,303 | 2,973 |
Ireland [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Depreciation | 74 | 1,186 | 1,072 |
Amortisation | 655 | 1,164 | 1,533 |
Americas [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Depreciation | 1,301 | 1,238 | 2,197 |
Amortisation | 2,170 | 2,139 | 1,440 |
Other Countries [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Depreciation | $ 304 |
SEGMENT INFORMATION (Schedule of Share Based Payment Expense by Geographical Area) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Share-based payments - continuing operations | $ 1,369 | $ 928 | $ 1,381 |
Share-based payments - discontinued operations | 33 | ||
Total Share-based payments | 1,369 | 928 | 1,414 |
Ireland [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Share-based payments - continuing operations | 1,265 | 841 | 1,187 |
Americas [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Share-based payments - continuing operations | 104 | 87 | 153 |
Other Countries [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Share-based payments - continuing operations | $ 41 |
SEGMENT INFORMATION (Schedule of Interest Income and Interest Expense by Geographical Area) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Interest Income | |||
Interest income earned | $ 736 | $ 808 | $ 877 |
Non-cash financial income | 1,388 | 2,390 | 2,270 |
Inter-segment interest income | |||
Total | 2,124 | 3,198 | 3,147 |
Interest Expense | |||
Interest on licence fee | 40 | 66 | |
Interest on finance leases | 39 | 42 | 55 |
Cash interest on exchangeable notes | (4,352) | 4,600 | 4,600 |
Non-cash interest on exchangeable notes (Note 24) | 689 | 723 | 718 |
Inter-segment interest expense | |||
Total | 5,080 | 5,405 | 5,439 |
Americas [Member] | |||
Interest Income | |||
Interest income earned | 32 | 44 | 21 |
Non-cash financial income | |||
Inter-segment interest income | |||
Total | 32 | 44 | 21 |
Interest Expense | |||
Interest on licence fee | |||
Interest on finance leases | 7 | ||
Cash interest on exchangeable notes | |||
Non-cash interest on exchangeable notes (Note 24) | |||
Inter-segment interest expense | 4,853 | 4,853 | 4,853 |
Total | 4,860 | 4,853 | 4,853 |
Ireland [Member] | |||
Interest Income | |||
Interest income earned | 704 | 764 | 856 |
Non-cash financial income | 1,388 | 2,390 | 2,270 |
Inter-segment interest income | |||
Total | 2,092 | 3,154 | 3,126 |
Interest Expense | |||
Interest on licence fee | 40 | 66 | |
Interest on finance leases | 32 | 42 | 55 |
Cash interest on exchangeable notes | 4,352 | 4,600 | 4,600 |
Non-cash interest on exchangeable notes (Note 24) | 689 | 723 | 718 |
Inter-segment interest expense | |||
Total | 5,073 | 5,405 | 5,439 |
Eliminations [Member] | |||
Interest Income | |||
Interest income earned | |||
Non-cash financial income | |||
Inter-segment interest income | (4,853) | (4,853) | (4,853) |
Total | (4,853) | (4,853) | (4,853) |
Interest Expense | |||
Interest on licence fee | |||
Interest on finance leases | |||
Cash interest on exchangeable notes | |||
Non-cash interest on exchangeable notes (Note 24) | |||
Inter-segment interest expense | (4,853) | (4,853) | (4,853) |
Total | (4,853) | (4,853) | (4,853) |
Other Countries [Member] | |||
Interest Income | |||
Interest income earned | |||
Non-cash financial income | |||
Inter-segment interest income | 4,853 | 4,853 | 4,853 |
Total | 4,853 | 4,853 | 4,853 |
Interest Expense | |||
Interest on licence fee | |||
Interest on finance leases | |||
Cash interest on exchangeable notes | |||
Non-cash interest on exchangeable notes (Note 24) | |||
Inter-segment interest expense | |||
Total |
SEGMENT INFORMATION (Schedule of Taxation Expense by Geographical Area) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Taxation expense | $ 525 | $ 1,214 | $ 3,557 |
Ireland [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Taxation expense | (59) | 192 | 2,038 |
Americas [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Taxation expense | 587 | 1,103 | 1,567 |
Other Countries [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Taxation expense | $ (3) | $ (81) | $ (48) |
SEGMENT INFORMATION (Schedule of Capital Expenditure by Geographical Area) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Capital expenditure | $ 1,780 | $ 15,682 |
Ireland [Member] | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Capital expenditure | 7,148 | 7,602 |
Americas [Member] | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Capital expenditure | 8,911 | 8,080 |
Other Countries [Member] | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Capital expenditure | $ 1,746 |
FINANCIAL INCOME AND EXPENSES (Narrative) (Details) $ in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2016
USD ($)
| |
Fiomi [Member] | |
Disclosure of transactions recognised separately from acquisition of assets and assumption of liabilities in business combination [line items] | |
Interest expense from discontinued operations | $ 5 |
FINANCIAL INCOME AND EXPENSES (Schedule of Financial Income (Expenses), Net) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Financial income: | |||
Non-cash financial income | $ 1,388 | $ 2,390 | $ 2,270 |
Interest income | 736 | 808 | 877 |
Financial expense | 2,124 | 3,198 | 3,147 |
Financial expense: | |||
Interest on finance leases | (39) | (42) | (55) |
Cash interest on exchangeable notes | 4,352 | (4,600) | (4,600) |
Non-cash interest on exchangeable notes (Note 24) | (689) | (723) | (718) |
Interest on deferred consideration and licence fee | (40) | (66) | |
Financial expense | (5,080) | (5,405) | (5,439) |
Net Financing Expense | $ (2,956) | $ (2,207) | $ (2,292) |
OTHER OPERATING INCOME (Schedule of Other Operating Income) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of other operating income [Abstract] | |||
Rental income from premises | $ 3 | $ 135 | |
Other income | 99 | 100 | 104 |
Other operating income | $ 102 | $ 100 | $ 239 |
LOSS BEFORE TAX (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of detailed information about business combination [line items] | |||
Depreciation on capitalised Intangible projects | $ 79 | $ 528 | $ 414 |
Fiomi [Member] | |||
Disclosure of detailed information about business combination [line items] | |||
Operating expense | 303 | ||
Fiomi [Member] | Foreign Exchange Differences [Member] | |||
Disclosure of detailed information about business combination [line items] | |||
Operating expense | $ 440 | $ 253 |
LOSS BEFORE TAX (Schedule of Amount Charged to Statement of Operation) (Details) - USD ($) $ in Thousands |
12 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
||||||
Directors' emoluments (including non- executive directors): | ||||||||
Remuneration | $ 1,261 | $ 1,800 | $ 1,946 | |||||
Pension | 44 | 44 | 41 | |||||
Share based payments | 1,204 | 727 | 1,121 | |||||
Auditor's remuneration | ||||||||
Audit fees | 506 | 568 | 469 | |||||
Tax fees | 15 | 73 | 33 | |||||
Other non audit fees | 19 | |||||||
Depreciation | [1] | 1,296 | 1,896 | 2,856 | ||||
Amortisation | 2,825 | 3,303 | 2,973 | |||||
Loss on the disposal of property, plant and equipment | 15 | 3 | 15 | |||||
Net foreign exchange differences | [2] | 344 | (17) | 888 | ||||
Freehold land and buildings [Member] | ||||||||
Operating lease rentals: | ||||||||
Operating lease rentals | 2,792 | 2,846 | 2,811 | |||||
Property, plant and equipment [Member] | ||||||||
Operating lease rentals: | ||||||||
Operating lease rentals | $ 158 | $ 163 | $ 114 | |||||
|
IMPAIRMENT CHARGES AND INVENTORY PROVISIONING (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2016 |
|
Disclosure of impairment charges and inventory provisioning [Abstract] | ||
Non-cash impairment charge | $ 28,390 | |
Capitalised development projects - impaired | $ 43,379 | 14,989 |
Cost incured on product selection | $ 4,786 |
IMPAIRMENT CHARGES AND INVENTORY PROVISIONING (Schedule of Statement of Operation) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of detailed information about property, plant and equipment [line items] | |||
Impairment of PP&E (Note 12) | $ 6,112 | $ 10,437 | $ 4,382 |
Impairment of goodwill and other intangible assets (Note 13) | 19,212 | 29,667 | 38,240 |
Impairment of prepayments (Note 17) | 1,608 | 1,651 | 757 |
Product discontinuation (Note 16) | 4,786 | ||
Total impairment loss and inventory provisioning before tax | 26,932 | 41,755 | 48,165 |
Income tax impact of impairment loss and inventory provisioning | (1,752) | (517) | (3,783) |
Total impairment loss after tax | $ 25,180 | $ 41,238 | $ 44,382 |
PERSONNEL EXPENSES (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [abstract] | |||
Total personnel expenses, inclusive of amounts capitalised for wages and salaries, social welfare costs and pension costs | $ 38,002 | $ 37,351 | $ 40,980 |
Total share based payments, inclusive of amounts capitalised | $ 1,607 | $ 1,109 | $ 1,663 |
PERSONNEL EXPENSES (Schedule of Personnel Expenses) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [abstract] | |||
Wages and salaries | $ 26,475 | $ 26,316 | $ 25,901 |
Social welfare costs | 2,585 | 2,424 | 2,542 |
Pension costs | 490 | 459 | 552 |
Share-based payments | 1,369 | 928 | 1,414 |
Restructuring costs | 1,276 | ||
PERSONNEL EXPENSES | $ 30,919 | $ 30,127 | $ 31,685 |
PERSONNEL EXPENSES (Schedule of Average Number of Persons Employed) (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of defined benefit plans [line items] | |||
Number of persons employed | 575 | 556 | 582 |
Research and development [Member] | |||
Disclosure of defined benefit plans [line items] | |||
Number of persons employed | 59 | 60 | 73 |
Administration and sales [Member] | |||
Disclosure of defined benefit plans [line items] | |||
Number of persons employed | 163 | 162 | 161 |
Manufacturing and quality [Member] | |||
Disclosure of defined benefit plans [line items] | |||
Number of persons employed | 353 | 334 | 348 |
PENSION SCHEMES (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of pension schemes [Abstract] | |||
Employees contribution | $ 490 | $ 458 | $ 708 |
Restructuring costs | 156 | ||
Pension accrual | $ 45 | $ 33 | $ 83 |
INCOME TAX (CREDIT)/EXPENSE (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Total deferred tax (credit)/expense | [1] | $ (406) | $ (1,671) | $ (3,268) | |
Corporation tax rate | (12.50%) | (12.50%) | (12.50%) | ||
Federal corporation tax rate [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Once-off tax credit | $ 753 | ||||
Corporation tax rate | 21.00% | ||||
Ireland [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Total deferred tax (credit)/expense | $ 369 | $ 170 | $ 1,804 | ||
USA [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Total deferred tax (credit)/expense | 364 | 345 | 277 | ||
Net operating loss carryforwards | $ 461 | 436 | 420 | ||
Net operating loss period | 20 Years | ||||
USA [Member] | December 31, 2035 [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Net operating loss carryforwards | $ 589 | ||||
USA [Member] | December 31, 2036 [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Net operating loss carryforwards | 1,753 | ||||
USA [Member] | December 31, 2037 [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Net operating loss carryforwards | 40 | ||||
Other Countries [Member] | |||||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||||
Total deferred tax (credit)/expense | $ 775 | $ 1,501 | $ 1,464 | ||
|
INCOME TAX (CREDIT)/EXPENSE (Schedule of Charge for Tax) (Details) - USD ($) $ in Thousands |
12 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
||||||
Current tax (credit)/ expense | ||||||||
Irish Corporation tax | $ (258) | $ (51) | $ (240) | |||||
Foreign taxes | [1] | 195 | 358 | 222 | ||||
Adjustment in respect of prior years | (56) | 150 | (271) | |||||
Total current tax (credit)/expense | (119) | 457 | (289) | |||||
Deferred tax credit | ||||||||
Origination and reversal of temporary differences (see Note 14) | [2] | (2,031) | (5,969) | (2,872) | ||||
Origination and reversal of net operating losses (see Note 14) | [2] | 1,625 | 4,298 | (396) | ||||
Total deferred tax credit | [2] | (406) | (1,671) | (3,268) | ||||
Total income tax credit on continuing operations in statement of operations | [2] | (525) | (1,214) | (3,557) | ||||
Tax (credit)/charge on discontinued operations (see Note 10) | [2] | (590) | 323 | (4,887) | ||||
Total tax credit | [2] | $ (1,115) | $ (891) | $ (8,444) | ||||
|
INCOME TAX (CREDIT)/EXPENSE (Schedule of Overseas Tax Jurisdictions) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Effective tax rate | |||
Loss before taxation | $ (23,183) | $ (39,875) | $ (42,140) |
As a percentage of loss before tax: | |||
Current tax | (0.51%) | 1.14% | (0.69%) |
Total (current and deferred) | (2.26%) | (3.05%) | (8.44%) |
INCOME TAX (CREDIT)/EXPENSE (Schedule of Statutory Tax Rate) (Details) |
12 Months Ended | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
||||||||||
Income Tax Creditexpense Schedule Of Statutory Tax Rate | ||||||||||||
Irish corporation tax | (12.50%) | (12.50%) | (12.50%) | |||||||||
Effect of current year net operating losses and temporary differences for which no deferred tax asset was recognised (a) | [1] | 15.76% | 12.05% | 6.22% | ||||||||
Effect of tax rates on overseas earnings | (6.10%) | (2.09%) | (1.39%) | |||||||||
Effect of Irish income taxable at higher tax rate | 0.05% | 0.05% | ||||||||||
Adjustments in respect of prior years | 0.94% | 0.38% | (0.64%) | |||||||||
Effect of changes in US tax code | [2] | (1.89%) | ||||||||||
R&D tax credits | [3] | (1.70%) | (0.17%) | (0.65%) | ||||||||
Other items | [4] | 1.29% | 1.17% | 0.47% | ||||||||
Effective tax rate | (2.26%) | (3.05%) | (8.44%) | |||||||||
|
INCOME TAX (CREDIT)/EXPENSE (Schedule of Income Taxes) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Unrecognised deferred tax assets - continuing operations | ||
Increase in net operating losses | $ 406 | $ 1,671 |
Increase (Decrease) in net operating losses | $ 3,655 | $ 4,806 |
Increase (Decrease) in net operating losses, percentage | 15.76% | 12.05% |
USA [Member] | ||
Unrecognised deferred tax assets - continuing operations | ||
Increase in net operating losses | $ 2,174 | |
Increase in net operating losses, percentage | 9.38% | |
Temporary differences | $ 19 | $ 68 |
Temporary differences, percentage | 0.08% | 0.17% |
Brazil [Member] | ||
Unrecognised deferred tax assets - continuing operations | ||
Increase (Decrease) in net operating losses | $ (20) | $ (714) |
Increase (Decrease) in net operating losses, percentage | (0.09%) | (1.79%) |
Ireland [Member] | ||
Unrecognised deferred tax assets - continuing operations | ||
Increase (Decrease) in net operating losses | $ 1,482 | $ 5,452 |
Increase (Decrease) in net operating losses, percentage | 6.39% | 13.67% |
INCOME TAX (CREDIT)/EXPENSE (Schedule of Loss Profit Before Taxes) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Loss profit before taxes | $ (23,183) | $ (39,875) | $ (42,140) |
Ireland [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Loss profit before taxes | (9,590) | (35,821) | (23,787) |
Americas [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Loss profit before taxes | $ (18,402) | $ (8,863) | $ (23,594) |
INCOME TAX (CREDIT)/EXPENSE (Schedule of Net Operating Losses) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unutilised net operating losses | $ 67,012 | $ 69,003 | $ 55,707 |
USA [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unutilised net operating losses | 2,382 | 7,737 | 8,896 |
Ireland [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unutilised net operating losses | 60,629 | 57,206 | 40,652 |
Brazil [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unutilised net operating losses | $ 4,001 | $ 4,060 | $ 6,159 |
INCOME TAX (CREDIT)/EXPENSE (Schedule of Unrecognised Deferred Tax Assets) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unrecognised deferred tax asset | $ 13,851 | $ 10,196 | $ 5,390 |
Ireland [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unrecognised deferred tax asset | 9,953 | 8,471 | 3,019 |
USA [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unrecognised deferred tax asset | 2,538 | 345 | 277 |
Brazil [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unrecognised deferred tax asset | $ 1,360 | $ 1,380 | $ 2,094 |
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATIONS (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|||
Disclosure of classes of share capital [line items] | |||||
Profit/(Loss) for the year from discontinued operations | $ 568 | $ (1,609) | $ (62,042) | ||
Basic weighted average number of ordinary shares | 83,612,908 | 86,486,409 | 91,858,813 | ||
Diluted weighted average number of ordinary shares | 103,508,820 | 107,510,179 | 113,197,598 | ||
Tax credit recovered | [1] | $ (590) | $ 323 | $ (4,887) | |
Class A Ordinary shares [Member] | |||||
Disclosure of classes of share capital [line items] | |||||
Profit/(Loss) for the year from discontinued operations | $ 568 | $ (1,609) | $ (62,042) | ||
Basic weighted average number of ordinary shares | 83,612,908 | 86,486,409 | 91,858,813 | ||
American depositary share [Member] | |||||
Disclosure of classes of share capital [line items] | |||||
Basic weighted average number of ordinary shares | 20,903,227 | 21,621,602 | 22,964,703 | ||
Diluted weighted average number of ordinary shares | 25,877,205 | 26,877,544 | 28,299,399 | ||
|
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATIONS (Schedule of Operating Profit/(Loss) for Cardiac) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Revenues | $ 97,035 | $ 99,140 | $ 99,611 |
Operating loss | (20,227) | (37,668) | (39,848) |
Loss for the year | (22,658) | (38,661) | (38,583) |
Profit/(Loss) on remeasurement of assets and liabilities: | |||
Inventories | 1,988 | (2,461) | (3,622) |
Tax credit/(expense) | (1,115) | (374) | (8,630) |
Profit/(Loss) for the year from discontinued operations | 568 | (1,609) | (62,042) |
Sweden [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Revenues | |||
Operating expenses | (827) | ||
Operating loss | (827) | ||
Interest expenses | (5) | ||
Loss from discontinued operations before tax | (832) | ||
Income tax credit/(expense) | 186 | ||
Loss for the year | (646) | ||
Profit/(Loss) on remeasurement of assets and liabilities: | |||
Property, plant and equipment (note 12) | (4,647) | ||
Goodwill and intangible assets (note 13) | (49,433) | ||
Inventories | (2,578) | ||
Closure costs | (22) | 1,794 | (5,846) |
Foreign currency translation reserve | (3,080) | (3,779) | |
Tax credit/(expense) | 590 | (323) | 4,887 |
Total profit/(loss) | 568 | (1,609) | (61,396) |
Profit/(Loss) for the year from discontinued operations | $ 568 | $ (1,609) | $ (62,042) |
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATIONS (Schedule of Earnings Per ADS) (Details) - $ / shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
American depositary share [Member] | |||
Disclosure of classes of share capital [line items] | |||
Basic earnings/(loss) per (US Dollars) - discontinued operations | $ 0.03 | $ (0.07) | $ (2.70) |
Diluted earnings/(loss) per (US Dollars) - discontinued operations | 0.02 | (0.07) | (2.70) |
Class A Ordinary shares [Member] | |||
Disclosure of classes of share capital [line items] | |||
Basic earnings/(loss) per (US Dollars) - discontinued operations | 0.01 | (0.02) | (0.68) |
Diluted earnings/(loss) per (US Dollars) - discontinued operations | $ 0.01 | $ (0.02) | $ (0.68) |
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATIONS (Schedule of Cash Flows Attributable) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of loss on discontinued operations [Abstract] | |||
Cash flows from operating activities | $ 527 | $ (2,847) | $ (1,623) |
Cash flows from investing activities | $ (8,989) |
(LOSS)/EARNINGS PER SHARE (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of classes of share capital [line items] | |||
(Loss)/Profit for the year | $ (22,090) | $ (40,270) | $ (100,625) |
Diluted earnings per share denominator | 103,508,820 | 107,510,179 | 113,197,598 |
Diluted earnings per ordinary share for continuing operations | $ (19,006) | $ (35,728) | $ (35,536) |
Adjusted (loss)/profit after tax | (18,437) | (37,337) | (97,577) |
Class A Ordinary shares [Member] | |||
Disclosure of classes of share capital [line items] | |||
Basic earnings per ordinary share for continuing operations | 22,658 | 38,661 | 38,583 |
American depositary share [Member] | |||
Disclosure of classes of share capital [line items] | |||
Basic earnings per ordinary share for continuing operations | $ 22,658 | $ 38,661 | $ 38,583 |
Diluted earnings per share denominator | 25,877,205 | 26,877,544 | 28,299,399 |
Adjusted (loss)/profit after tax | $ 18,437 | $ 37,337 | $ 97,577 |
(LOSS)/EARNINGS PER SHARE (Schedule of Basic Earnings Per Ordinary Share) (Details) - shares |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|||
Disclosure of classes of share capital [line items] | |||||
Basic earnings per share denominator | 83,612,908 | 86,486,409 | 91,858,813 | ||
Reconciliation to weighted average earnings per share denominator: | |||||
In issue at January 1 | 96,162,410 | 96,162,410 | 95,840,138 | ||
Weighted average number of shares issued | [1] | 120,396 | |||
Weighted average number of treasury shares | (12,549,502) | (9,676,001) | (4,101,721) | ||
Basic earnings per share denominator | 83,612,908 | 86,486,409 | 91,858,813 | ||
Class A Ordinary shares [Member] | |||||
Disclosure of classes of share capital [line items] | |||||
Basic earnings per share denominator | 83,612,908 | 86,486,409 | 91,858,813 | ||
Reconciliation to weighted average earnings per share denominator: | |||||
In issue at January 1 | 96,162,410 | 96,162,410 | 95,840,138 | ||
Basic earnings per share denominator | 83,612,908 | 86,486,409 | 91,858,813 | ||
|
(LOSS)/EARNINGS PER SHARE (Schedule of Diluted Earnings Per Ordinary Share) (Details) - shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Earnings per share [abstract] | |||
Basic earnings per share denominator | 83,612,908 | 86,486,409 | 91,858,813 |
Issuable on exercise of options and warrants | 22,359 | 315,019 | |
Issuable on conversion of exchangeable notes | 19,873,553 | 21,023,770 | 21,023,766 |
Diluted earnings per share denominator | 103,508,820 | 107,510,179 | 113,197,598 |
(LOSS)/EARNINGS PER SHARE (Schedule of Profit After Tax Diluted Earnings Per Ordinary Share Calculation) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Earnings per share [abstract] | |||
Loss for the year | $ (22,090) | $ (40,270) | $ (100,625) |
Non-cash financial income | (1,388) | (2,390) | (2,270) |
Cash interest expense | (4,352) | 4,600 | 4,600 |
Non-cash interest on exchangeable notes | 689 | 723 | 718 |
Adjusted loss) after tax | $ (18,437) | $ (37,337) | $ (97,577) |
(LOSS)/EARNINGS PER SHARE (Schedule of Earnings Per ADS) (Details) - shares |
12 Months Ended | |||||
---|---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2018 |
|||
Disclosure of classes of share capital [line items] | ||||||
Ordinary shares | 96,162,410 | 96,162,410 | 95,840,138 | |||
Basic earnings per share denominator | 83,612,908 | 86,486,409 | 91,858,813 | |||
Reconciliation to weighted average earnings per share denominator: | ||||||
In issue at January 1 | 96,162,410 | 96,162,410 | 95,840,138 | |||
Weighted average number of shares issued during the year | [1] | 120,396 | ||||
Weighted average number of treasury shares | (12,549,502) | (9,676,001) | (4,101,721) | |||
Basic earnings per share denominator | 83,612,908 | 86,486,409 | 91,858,813 | |||
American depositary share [Member] | ||||||
Disclosure of classes of share capital [line items] | ||||||
Ordinary shares | 24,040,602 | 24,040,602 | 23,960,035 | 20,903,227 | ||
Basic earnings per share denominator | 20,903,227 | 21,621,602 | 22,964,703 | |||
Reconciliation to weighted average earnings per share denominator: | ||||||
In issue at January 1 | 24,040,602 | 24,040,602 | 23,960,035 | |||
Weighted average number of shares issued during the year | 30,098 | |||||
Weighted average number of treasury shares | 3,137,375 | (2,419,000) | (1,025,430) | |||
Basic earnings per share denominator | 20,903,227 | 21,621,602 | 22,964,703 | |||
|
(LOSS)/EARNINGS PER SHARE (Schedule of Diluted Earnings Per ADS Share Calculation) (Details) - shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of classes of share capital [line items] | |||
Basic earnings per share denominator | 83,612,908 | 86,486,409 | 91,858,813 |
Issuable on exercise of options and warrants | 22,359 | 315,019 | |
Issuable on conversion of exchangeable notes | 19,873,553 | 21,023,770 | 21,023,766 |
Diluted earnings per share denominator | 103,508,820 | 107,510,179 | 113,197,598 |
American depositary share [Member] | |||
Disclosure of classes of share capital [line items] | |||
Basic earnings per share denominator | 20,903,227 | 21,621,602 | 22,964,703 |
Issuable on exercise of options and warrants | 5,590 | 78,755 | |
Issuable on conversion of exchangeable notes | 4,968,388 | 5,255,942 | 5,255,941 |
Diluted earnings per share denominator | 25,877,205 | 26,877,544 | 28,299,399 |
PROPERTY, PLANT AND EQUIPMENT (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of detailed information about property, plant and equipment [abstract] | |||
Impairment through use or sale of the assets | $ 57,794 | $ 85,603 | |
Impairment loss | 6,112 | 10,437 | $ 4,382 |
Net book value of assets held under operating lease | 12,000 | ||
Depreciation charged on assets under operating lease | 8 | 30 | |
Lease instruments reclassified as inventory on return from customers | 25,700 | 22,100 | |
Property, plant and equipment under construction | 204 | 561 | |
Assets held under finance leases | 372 | 51 | |
Depreciation charge of capitalized leased assets | $ 37 | $ 181 |
PROPERTY AND EQUIPMENT (Schedule of Composition of Property and Equipment and Related to Accumulated Depreciation) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | $ 5,800 | ||
Impairment loss | 6,112 | $ 10,437 | $ 4,382 |
Balance at end of year | 5,362 | 5,800 | |
Cost [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 49,417 | 48,113 | |
Additions | 7,525 | 5,258 | |
Disposals or retirements | (1,936) | (3,984) | |
Exchange adjustments | (1,195) | 30 | |
Balance at end of year | 53,814 | 49,417 | 48,113 |
Cost [Member] | Freehold land and buildings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 2,624 | 2,603 | |
Additions | 19 | ||
Disposals or retirements | (9) | ||
Exchange adjustments | (38) | 30 | |
Balance at end of year | 2,605 | 2,624 | 2,603 |
Cost [Member] | Leasehold improvements [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 3,004 | 3,031 | |
Additions | 1,609 | 465 | |
Disposals or retirements | (1) | (488) | |
Exchange adjustments | (52) | (4) | |
Balance at end of year | 4,560 | 3,004 | 3,031 |
Cost [Member] | Computers, fixtures and fittings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 5,894 | 5,995 | |
Additions | 829 | 302 | |
Disposals or retirements | (131) | (404) | |
Exchange adjustments | (7) | 1 | |
Balance at end of year | 6,585 | 5,894 | 5,995 |
Cost [Member] | Office equipment and fittings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 37,895 | 36,484 | |
Additions | 5,068 | 4,491 | |
Disposals or retirements | (1,804) | (3,083) | |
Exchange adjustments | (1,095) | 3 | |
Balance at end of year | 40,064 | 37,895 | 36,484 |
Accumulated depreciation and impairment losses [member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | (43,617) | (34,710) | |
Charge for the year | (1,375) | (2,424) | |
Impairment loss | (6,112) | (10,437) | |
Disposals or retirements | 1,809 | 3,961 | |
Exchange adjustments | 843 | (7) | |
Balance at end of year | (48,452) | (43,617) | (34,710) |
Accumulated depreciation and impairment losses [member] | Freehold land and buildings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | (1,283) | (1,206) | |
Charge for the year | (80) | (82) | |
Impairment loss | (578) | ||
Disposals or retirements | 9 | ||
Exchange adjustments | 7 | (4) | |
Balance at end of year | (1,934) | (1,283) | (1,206) |
Accumulated depreciation and impairment losses [member] | Leasehold improvements [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | (2,659) | (2,716) | |
Charge for the year | (47) | (165) | |
Impairment loss | (543) | (267) | |
Disposals or retirements | 488 | ||
Exchange adjustments | 6 | 1 | |
Balance at end of year | (3,243) | (2,659) | (2,716) |
Accumulated depreciation and impairment losses [member] | Computers, fixtures and fittings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | (5,308) | (5,064) | |
Charge for the year | (185) | (263) | |
Impairment loss | (423) | (383) | |
Disposals or retirements | 130 | 402 | |
Exchange adjustments | 3 | ||
Balance at end of year | (5,783) | (5,308) | (5,064) |
Accumulated depreciation and impairment losses [member] | Office equipment and fittings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | (34,367) | (25,724) | |
Charge for the year | (1,063) | (1,914) | |
Impairment loss | (4,568) | (9,787) | |
Disposals or retirements | 1,679 | 3,062 | |
Exchange adjustments | 827 | (4) | |
Balance at end of year | (37,492) | (34,367) | (25,724) |
Carrying amounts [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 5,362 | 13,403 | |
Balance at end of year | 5,800 | 5,362 | 13,403 |
Carrying amounts [Member] | Freehold land and buildings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 671 | 1,397 | |
Balance at end of year | 1,341 | 671 | 1,397 |
Carrying amounts [Member] | Leasehold improvements [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 1,317 | 315 | |
Balance at end of year | 345 | 1,317 | 315 |
Carrying amounts [Member] | Computers, fixtures and fittings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 802 | 931 | |
Balance at end of year | 586 | 802 | 931 |
Carrying amounts [Member] | Office equipment and fittings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 2,572 | 10,760 | |
Balance at end of year | $ 3,528 | $ 2,572 | $ 10,760 |
GOODWILL AND INTANGIBLE ASSETS (Narrative) (Details) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018
USD ($)
yr
|
Dec. 31, 2017
USD ($)
|
Dec. 31, 2016
USD ($)
|
|
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Development costs not amortised | $ 4,192 | $ 31,904 | |
Description of project completion period | January 1, 2019 to December 31, 2021 | ||
Additional project cost | $ 5,718 | ||
Amortisation period for project | yr | 15 | ||
Non-cash impairment charge | $ 28,390 | ||
Impairment through use or sale of the assets | $ 57,794 | 85,603 | |
Total impairment loss allocated to goodwill | 26,932 | ||
Additional impairment loss due to growth in revenues | $ 319 | ||
Variation in discount rate | 10.00% | ||
Additional impairment loss | $ 3,663 | ||
Impairment loss | $ 19,212 | $ 29,667 | $ 87,673 |
Top of range [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Cash flow projections | 0.00% | ||
Pre tax discount rates | 0.35 | 0.26 | |
Bottom of range [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Cash flow projections | (5.50%) | ||
Pre tax discount rates | 0.20 | 0.15 | |
Premier Instrument for Haemoglobin A1c Testing [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Carrying amount | $ 16,010 | ||
Biopool US Inc [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Impairment through use or sale of the assets | 19,026 | ||
Total impairment loss allocated to goodwill | 26,932 | ||
Trinity Biotech Manufacturing Limited [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Impairment through use or sale of the assets | 10,860 | ||
Total impairment loss allocated to goodwill | 57,794 | ||
Mardx Diagnostic Inc [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Impairment through use or sale of the assets | 690 | ||
Primus trade name [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Impairment loss | $ 123 |
GOODWILL AND INTANGIBLE ASSETS (Schedule of Goodwill and Intangible Assets) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | $ 64,754 | ||
Impairment losses | 19,212 | $ 29,667 | $ 87,673 |
Balance at end of year | 52,951 | 64,754 | |
Cost [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 262,372 | 251,934 | |
Additions | 10,281 | 10,424 | |
Disposals | (15) | ||
Reclassification | |||
Exchange adjustments | (17) | (29) | |
Balance at end of year | 272,636 | 262,372 | 251,934 |
Carrying amounts [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 64,754 | 87,275 | |
Balance at end of year | 52,951 | 64,754 | 87,275 |
Accumulated depreciation and impairment losses [member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | (197,618) | (164,659) | |
Disposals | 8 | 8 | |
Charge for the year | 2,825 | (3,303) | |
Impairment losses | (19,212) | (29,667) | |
Exchange adjustments | (30) | 3 | |
Balance at end of year | (219,685) | (197,618) | (164,659) |
Goodwill [Member] | Cost [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 81,689 | 81,689 | |
Additions | |||
Disposals | |||
Reclassification | |||
Exchange adjustments | |||
Balance at end of year | 81,689 | 81,689 | 81,689 |
Goodwill [Member] | Carrying amounts [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 17,898 | 25,774 | |
Balance at end of year | 16,141 | 17,898 | 25,774 |
Goodwill [Member] | Accumulated depreciation and impairment losses [member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | (63,791) | (55,915) | |
Disposals | |||
Charge for the year | |||
Impairment losses | (1,757) | (7,876) | |
Exchange adjustments | |||
Balance at end of year | (65,548) | (63,791) | (55,915) |
Development cost [Member] | Cost [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 136,918 | 126,619 | |
Additions | 9,871 | 10,402 | |
Reclassification | (132) | ||
Exchange adjustments | (17) | 29 | |
Balance at end of year | 146,772 | 136,918 | 126,619 |
Development cost [Member] | Carrying amounts [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 34,778 | 46,966 | |
Balance at end of year | 26,265 | 34,778 | 46,966 |
Development cost [Member] | Accumulated depreciation and impairment losses [member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | (102,140) | (79,653) | |
Disposals | |||
Charge for the year | (1,564) | (1,708) | |
Impairment losses | (16,773) | (20,782) | |
Exchange adjustments | (30) | 3 | |
Balance at end of year | (120,507) | (102,140) | (79,653) |
Patents and licences [Member] | Cost [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 9,947 | 9,925 | |
Additions | 22 | ||
Reclassification | |||
Exchange adjustments | |||
Balance at end of year | 9,947 | 9,947 | 9,925 |
Patents and licences [Member] | Carrying amounts [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 219 | 387 | |
Balance at end of year | 133 | 219 | 387 |
Patents and licences [Member] | Accumulated depreciation and impairment losses [member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | (9,728) | (9,538) | |
Disposals | |||
Charge for the year | (17) | ||
Impairment losses | (86) | (173) | |
Exchange adjustments | |||
Balance at end of year | (9,814) | (9,728) | (9,538) |
Intangible assets [Member] | Cost [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 33,818 | 33,701 | |
Additions | 410 | ||
Disposals | (15) | ||
Reclassification | 132 | ||
Exchange adjustments | |||
Balance at end of year | 34,228 | 33,818 | 33,701 |
Intangible assets [Member] | Carrying amounts [Member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | 11,859 | 14,148 | |
Balance at end of year | 10,412 | 11,859 | 14,148 |
Intangible assets [Member] | Accumulated depreciation and impairment losses [member] | |||
Disclosure of detailed information about intangible assets [line items] | |||
Balance at beginning year | (21,959) | (19,553) | |
Disposals | 8 | 8 | |
Charge for the year | (1,261) | (1,578) | |
Impairment losses | (596) | (836) | |
Exchange adjustments | |||
Balance at end of year | $ (23,816) | $ (21,959) | $ (19,553) |
GOODWILL AND INTANGIBLE ASSETS (Schedule of Principal Development Projects) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | $ 9,871 | $ 10,402 |
Premier Instrument for Haemoglobin A1c Testing [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 2,653 | 2,601 |
HIV screening rapid test [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 1,657 | 1,803 |
G-6-PDH test [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 850 | 812 |
Uni-Gold Test Enhancement [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 796 | 1,134 |
Autoimmune Smart Reader [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 746 | |
Tri-stat Point-of-Care instrument [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 727 | 764 |
Uni-Gold Antigen Improvement [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 453 | 258 |
Sjogrens monoclonal antibodies [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 414 | 376 |
Column Enhancement [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 292 | 252 |
Ultra Genesys [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 263 | 188 |
US Lyme [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 1,156 | |
Autoimmune FDA Registrations [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | 273 | |
Other Projects [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Capitalised development costs | $ 1,020 | $ 785 |
GOODWILL AND INTANGIBLE ASSETS (Schedule of Impairment Loss) (Details) $ in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2018
USD ($)
| |
Disclosure of detailed information about intangible assets [line items] | |
Total impairment loss | $ 26,932 |
Primus Corp [Member] | |
Disclosure of detailed information about intangible assets [line items] | |
Total impairment loss | 12,424 |
Trinity Biotech Manufacturing Limited [Member] | |
Disclosure of detailed information about intangible assets [line items] | |
Total impairment loss | 7,837 |
Clark Laboratories Inc [Member] | |
Disclosure of detailed information about intangible assets [line items] | |
Total impairment loss | 3,377 |
Trinity Biotech Do Brasil [Member] | |
Disclosure of detailed information about intangible assets [line items] | |
Total impairment loss | 2,785 |
Biopool US Inc [Member] | |
Disclosure of detailed information about intangible assets [line items] | |
Total impairment loss | 509 |
Phoenix Bio-tech Corp [Member] | |
Disclosure of detailed information about intangible assets [line items] | |
Total impairment loss |
GOODWILL AND INTANGIBLE ASSETS (Schedule of Breakdown of Impairment Loss) (Details) (USD $) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of goodwill and intangible assets [Abstract] | ||
Goodwill and other intangible assets (see Note 13) | $ 19,212 | |
Property, plant and equipment (see Note 12) | 6,112 | |
Prepayments (see Note 17) | 1,608 | $ 1,651 |
Total impairment loss | $ 26,932 |
GOODWILL AND INTANGIBLE ASSETS (Schedule of Significant Goodwill and Intangible Assets) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
||||
Fitzgerald Industries International CGU Trade Name [Member] | |||||
Statement Line Items [Line Items] | |||||
Carrying amount of goodwill | $ 12,592 | $ 12,592 | |||
Discount rate applied (real pre-tax) | 19.80% | 17.70% | |||
Excess value-in-use over carrying amount | $ 8,847 | $ 8,397 | |||
EBITDA would need to decrease for an impairment to arise | 32.60% | 30.40% | |||
Long-term growth rate | 2.00% | 2.00% | |||
Immco Diagnostic CGU Trade Name [Member] | |||||
Statement Line Items [Line Items] | |||||
Carrying amount of goodwill | $ 12,592 | $ 3,575 | |||
Discount rate applied (real pre-tax) | 23.38% | 21.17% | |||
Excess value-in-use over carrying amount | $ 2,502 | ||||
EBITDA would need to decrease for an impairment to arise | 6.90% | [1] | |||
Long-term growth rate | 2.00% | 2.00% | |||
|
GOODWILL AND INTANGIBLE ASSETS (Schedule of Intangible Assets with Indefinite Useful lives) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | ||
Intangible assets with indefinite useful lives | $ 5,470 | $ 5,593 |
Fitzgerald Industries International CGU Trade Name [Member] | ||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | ||
Intangible assets with indefinite useful lives | 970 | 970 |
Fitzgerald Industries International CGU RDI Trade Name [Member] | ||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | ||
Intangible assets with indefinite useful lives | 560 | 560 |
Primus Corporation CGU Trade Name [Member] | ||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | ||
Intangible assets with indefinite useful lives | 547 | 670 |
Immco Diagnostic CGU Trade Name [Member] | ||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | ||
Intangible assets with indefinite useful lives | $ 3,393 | $ 3,393 |
DEFERRED TAX ASSETS AND LIABILITIES (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2015 |
|
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset increased due to increase in provision | $ 2,571 | ||
Deferred tax liability decreased | 2,977 | ||
Increased in unrecognised deferred tax assets | 11,321 | ||
Deferred tax asset | 6,127 | $ 8,698 | |
Issuence of exchangeable note | $ 115,000 | ||
Unrecognized deferred tax asset | 6,176 | ||
USA [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 364 | 345 | |
Unrecognized deferred tax asset | 485 | ||
Brazil [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 1,360 | 1,380 | |
TBIL [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 3,564 | 2,641 | |
TBML [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 5,691 | 5,829 | |
Ireland [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 8,293 | 8,293 | |
Trinity Biotech Plc [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 213 | ||
Alternative minimum tax credit [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | $ 2,174 |
DEFERRED TAX ASSETS AND LIABILITIES (Schedule of Recognised Deferred Tax Assets and Liabilities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|---|
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Deferred tax assets | $ 6,127 | $ 8,698 | |
Deferred tax liabilities | (7,855) | (10,832) | |
Net deferred tax assets/(liabilities) | (1,728) | (2,134) | $ (3,805) |
Property, plant and equipment [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Deferred tax assets | 815 | 448 | |
Deferred tax liabilities | (37) | (98) | |
Net deferred tax assets/(liabilities) | 778 | 350 | (574) |
Intangible assets [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Deferred tax assets | |||
Deferred tax liabilities | (7,189) | (9,443) | |
Net deferred tax assets/(liabilities) | (7,189) | (9,443) | (16,430) |
Inventories [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Deferred tax assets | 668 | 1,006 | |
Deferred tax liabilities | |||
Net deferred tax assets/(liabilities) | 668 | 1,006 | 897 |
Provisions [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Deferred tax assets | 4,311 | 3,510 | |
Deferred tax liabilities | |||
Net deferred tax assets/(liabilities) | 4,311 | 3,510 | 5,701 |
Other items [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Deferred tax assets | 333 | 2,109 | |
Deferred tax liabilities | (629) | (1,291) | |
Net deferred tax assets/(liabilities) | (296) | 818 | 678 |
Tax value of loss carryforwards recognised [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Deferred tax assets | 1,625 | ||
Deferred tax liabilities | |||
Net deferred tax assets/(liabilities) | $ 1,625 | $ 5,923 |
DEFERRED TAX ASSETS AND LIABILITIES (Schedule of Unrecognised Deferred Tax Assets) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of deferredc tax assets and liabilities [Abstract] | ||
Capital losses | $ 8,293 | $ 8,293 |
Net operating losses | 67,012 | 61,264 |
US alternative minimum tax credits | 1,674 | |
Other temporary timing differences | 3,880 | |
US state credit carryforwards | 364 | 345 |
Unrecognised deferred tax assets | $ 81,223 | $ 69,902 |
DEFERRED TAX ASSETS AND LIABILITIES (Schedule of Movement In Deferred Tax Assets) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Increase (decrease) in deferred tax assets - continuing operations | $ 11,321 | ||
Tax effect - continuing operations | $ 3,655 | ||
Applicable tax rate | (12.50%) | (12.50%) | (12.50%) |
Operating Losses US [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Increase (decrease) in deferred tax assets - continuing operations | $ 2,382 | ||
Tax effect - continuing operations | $ 500 | ||
Applicable tax rate | 21.00% | ||
Alternative minimum tax credit [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Increase (decrease) in deferred tax assets - continuing operations | $ 1,674 | ||
Tax effect - continuing operations | $ 1,674 | ||
Applicable tax rate | |||
Operating Losses Brazil [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Increase (decrease) in deferred tax assets - continuing operations | $ (59) | ||
Tax effect - continuing operations | $ (20) | ||
Applicable tax rate | 34.00% | ||
Operating Losses Ireland [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Increase (decrease) in deferred tax assets - continuing operations | $ 3,425 | ||
Tax effect - continuing operations | $ 997 | ||
Operating Losses Ireland [Member] | Bottom of range [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Applicable tax rate | 12.50% | ||
Operating Losses Ireland [Member] | Top of range [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Applicable tax rate | 25.00% | ||
Other deferred tax assets in Ireland [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Increase (decrease) in deferred tax assets - continuing operations | $ 3,880 | ||
Tax effect - continuing operations | $ 485 | ||
Applicable tax rate | 12.50% | ||
US state credit carryforwards [Member] | |||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | |||
Increase (decrease) in deferred tax assets - continuing operations | $ 19 | ||
Tax effect - continuing operations | $ 19 | ||
Applicable tax rate |
DEFERRED TAX ASSETS AND LIABILITIES (Schedule of Unrecognised Deferred Tax Liabilities) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Balance at beginning of year | $ (2,134) | $ (3,805) |
Recognised in income | 406 | 1,671 |
Recognised in loss on discontinued operations | ||
Foreign Exchange movement | ||
Balance at end of year | (1,728) | (2,134) |
Property, plant and equipment [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Balance at beginning of year | 350 | (574) |
Recognised in income | 428 | 924 |
Recognised in loss on discontinued operations | ||
Foreign Exchange movement | ||
Balance at end of year | 778 | 350 |
Intangible assets [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Balance at beginning of year | (9,443) | (16,430) |
Recognised in income | 2,254 | 6,987 |
Recognised in loss on discontinued operations | ||
Foreign Exchange movement | ||
Balance at end of year | (7,189) | (9,443) |
Inventories [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Balance at beginning of year | 1,006 | 897 |
Recognised in income | (338) | 109 |
Recognised in loss on discontinued operations | ||
Foreign Exchange movement | ||
Balance at end of year | 668 | 1,006 |
Provisions [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Balance at beginning of year | 3,510 | 5,701 |
Recognised in income | 801 | (2,191) |
Recognised in loss on discontinued operations | ||
Foreign Exchange movement | ||
Balance at end of year | 4,311 | 3,510 |
Other items [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Balance at beginning of year | 818 | 678 |
Recognised in income | (1,114) | 140 |
Recognised in loss on discontinued operations | ||
Foreign Exchange movement | ||
Balance at end of year | (296) | 818 |
Tax value of loss carryforwards recognised [Member] | ||
Disclosure of temporary difference, unused tax losses and unused tax credits [line items] | ||
Balance at beginning of year | 1,625 | 5,923 |
Recognised in income | (1,625) | (4,298) |
Recognised in loss on discontinued operations | ||
Foreign Exchange movement | ||
Balance at end of year | $ 1,625 |
OTHER ASSETS (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of other assets [Abstract] | ||
Finance lease receivables | $ 476 | $ 685 |
Other assets | 82 | 86 |
Total other assets | $ 558 | $ 771 |
INVENTORIES (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Classes of current inventories [abstract] | |||
Cost of sales | $ 55,285 | $ 54,904 | $ 50,259 |
Provision | $ 4,786 |
INVENTORIES (Schedule of inventories) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Classes of current inventories [abstract] | ||
Raw materials and consumables | $ 10,556 | $ 10,345 |
Work-in-progress | 8,239 | 7,236 |
Finished goods | 11,564 | 15,224 |
Total inventories | $ 30,359 | $ 32,805 |
INVENTORIES (Schedule of Movement on the Inventory Provision) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of other provisions [line items] | |||
Released during the year | $ 4,786 | ||
Provision for inventories [Member] | |||
Disclosure of other provisions [line items] | |||
Opening provision at January 1 | $ 7,543 | $ 10,017 | 4,822 |
Charged during the year | 480 | 2,561 | 6,390 |
Utilised during the year | (1,544) | (4,749) | (1,065) |
Released during the year | (180) | (286) | (130) |
Closing provision at December 31 | $ 6,299 | $ 7,543 | $ 10,017 |
TRADE AND OTHER RECEIVABLES (Narrative) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|---|---|
Disclosure of finance lease and operating lease by lessor [line items] | ||||
Trade receivables, net impairment losses provision | $ 4,202 | $ 3,590 | $ 3,171 | $ 2,812 |
Prepayments of impairment | 1,608 | 1,651 | ||
Finance lease receivable | 835 | 1,185 | ||
More than five years [Member] | ||||
Disclosure of finance lease and operating lease by lessor [line items] | ||||
Finance lease receivable | $ 476 | $ 685 |
TRADE AND OTHER RECEIVABLES (Schedule of Trade and Other Receivables) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Trade and other current receivables [abstract] | ||
Trade receivables, net of impairment losses | $ 21,318 | $ 17,242 |
Prepayments | 807 | 891 |
Contract assets | 1,894 | 2,107 |
Value added tax | 63 | |
Finance lease receivables | 359 | 500 |
Total and other receivables | $ 24,441 | $ 20,740 |
TRADE AND OTHER RECEIVABLES (Schedule of Future Minimum Finance Lease Receivables) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of finance lease and operating lease by lessor [line items] | ||
Gross investment | $ 1,505 | $ 2,064 |
Unearned income | 670 | 879 |
Finance lease receivable | 835 | 1,185 |
Less than one year [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Gross investment | 617 | 860 |
Unearned income | 258 | 360 |
Finance lease receivable | 359 | 500 |
Between one and five years [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Gross investment | 888 | 1,204 |
Unearned income | 412 | 519 |
Finance lease receivable | $ 476 | $ 685 |
TRADE AND OTHER RECEIVABLES (Schedule of Future Minimum Rentals Receivable Under Non-Cancellable Operating Leases) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of finance lease and operating lease by lessor [line items] | ||
Future minimum rentals receivable under non-cancellable operating leases | $ 3,530 | $ 4,049 |
Instruments [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Future minimum rentals receivable under non-cancellable operating leases | 3,530 | 4,049 |
Less than one year [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Future minimum rentals receivable under non-cancellable operating leases | 3,498 | 3,959 |
Less than one year [Member] | Instruments [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Future minimum rentals receivable under non-cancellable operating leases | 3,498 | 3,959 |
Between one and five years [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Future minimum rentals receivable under non-cancellable operating leases | 32 | 90 |
Between one and five years [Member] | Instruments [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Future minimum rentals receivable under non-cancellable operating leases | $ 32 | $ 90 |
CASH AND CASH EQUIVALENTS (Schedule of Cash and Cash Equivalents) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|---|---|
Cash and cash equivalents [abstract] | ||||
Cash at bank and in hand | $ 6,854 | $ 9,561 | ||
Short-term deposits | 23,423 | 48,046 | ||
Cash and cash equivalents | $ 30,277 | $ 23,564 | $ 77,109 | $ 101,953 |
SHORT-TERM INVESTMENTS (Schedule of Short-Term Investments) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of short-term investments [Abstract] | ||
Investments (deposits) | $ 34,043 |
CAPITAL AND RESERVES (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Class A Ordinary shares [Member] | ||
Disclosure of classes of share capital [line items] | ||
Authorised share capital | 200,700,000 | 200,700,000 |
Par value of share | $ 0.0109 | $ 0.0109 |
Share issued | ||
Cost incurred issue of shares | $ 139,000 | $ 7,456,000 |
Treasury shares purchased | 107,740 | 5,374,692 |
ADS Treasury shares [Member] | ||
Disclosure of classes of share capital [line items] | ||
Treasury shares purchased | 26,935 | 1,343,673 |
CAPITAL AND RESERVES (Schedule of Share Capital) (Details) - shares |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of classes of share capital [line items] | ||
In issue at January 1 | 96,162,410 | 96,162,410 |
In issue at December 31 | 96,162,410 | |
Class A Ordinary shares [Member] | ||
Disclosure of classes of share capital [line items] | ||
In issue at January 1 | 96,162,410 | 96,162,410 |
Issued for cash | ||
In issue at December 31 | 96,162,410 | 96,162,410 |
American depositary share [Member] | ||
Disclosure of classes of share capital [line items] | ||
In issue at January 1 | 24,040,602 | 24,040,602 |
Issued for cash | ||
In issue at December 31 | 20,903,227 | 24,040,602 |
Class A Treasury shares [Member] | ||
Disclosure of classes of share capital [line items] | ||
Balance at January 1 | 12,448,000 | 7,073,000 |
Purchased during the year | 108,000 | 5,375,000 |
Balance at December 31 | 12,556,000 | 12,448,000 |
ADS Treasury shares [Member] | ||
Disclosure of classes of share capital [line items] | ||
Balance at January 1 | 3,112,000 | 1,768,000 |
Purchased during the year | 27,000 | 1,344,000 |
Balance at December 31 | 12,448,000 | 3,112,000 |
SHARE OPTIONS AND SHARE WARRANTS (Narrative) (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018
USD ($)
yr
|
Dec. 31, 2017
USD ($)
yr
|
Dec. 31, 2016
USD ($)
|
|
Disclosure of classes of share capital [line items] | |||
Weighted-average remaining contractual life of options outstanding | yr | 4.33 | 5.10 | |
Share based payments charge | $ 1,607,000 | $ 1,109,000 | $ 1,663,000 |
share based payments capitalised in intangible development project assets | 238,000 | 181,000 | 219,000 |
Class A Ordinary shares [Member] | |||
Disclosure of classes of share capital [line items] | |||
Weighted average share price date of exercise for options exercised | 2.96 | ||
Opening share price | 1.28 | 1.73 | 2.92 |
Closing share price | 0.57 | 1.28 | 1.73 |
Average share price | 1.1 | ||
American depositary share [Member] | |||
Disclosure of classes of share capital [line items] | |||
Weighted average share price date of exercise for options exercised | 11.84 | ||
Opening share price | 5.1 | 6.92 | 11.69 |
Closing share price | 2.29 | $ 5.1 | $ 6.92 |
Average share price | $ 4.42 |
SHARE OPTIONS AND SHARE WARRANTS (Schedule of Grants of Share Options and Warrants) (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018
USD ($)
shares
|
Dec. 31, 2017
USD ($)
shares
|
Dec. 31, 2016
USD ($)
shares
|
|
Class A Ordinary shares [Member] | |||
Disclosure of classes of share capital [line items] | |||
Outstanding Beginning Balance | shares | 10,727,376 | 9,830,183 | 8,158,452 |
Granted | shares | 720,000 | 5,630,000 | 2,160,000 |
Exercised | shares | (322,272) | ||
Forfeited | shares | (539,176) | (4,732,807) | (165,997) |
Outstanding at end of year | shares | 10,908,200 | 10,727,376 | 9,830,183 |
Exercisable at end of year | shares | 6,091,864 | 3,268,707 | 5,838,851 |
Weighted Average exercise price | |||
Outstanding Beginning Balance | $ 1.92 | $ 3.19 | $ 3.36 |
Granted | 1.07 | 1.31 | 2.39 |
Exercised | 2.09 | ||
Forfeited | 2.5 | 3.86 | 3.39 |
Outstanding at end of year | 1.83 | 1.92 | 3.19 |
Exercisable at end of year | 2.09 | 2.57 | 3.31 |
Class A Ordinary shares [Member] | Bottom of range [Member] | |||
Weighted Average exercise price | |||
Outstanding Beginning Balance | 1.24 | 0.66 | 0.66 |
Granted | 0.67 | 1.24 | 1.67 |
Exercised | 0.66 | ||
Forfeited | 1.34 | 0.75 | 2.52 |
Outstanding at end of year | 0.67 | 1.24 | 0.66 |
Exercisable at end of year | 1.24 | 1.66 | 0.75 |
Class A Ordinary shares [Member] | Top of range [Member] | |||
Weighted Average exercise price | |||
Outstanding Beginning Balance | 4.36 | 4.47 | 4.47 |
Granted | 1.37 | 1.44 | 2.8 |
Exercised | 2.65 | ||
Forfeited | 4.23 | 4.47 | 3.61 |
Outstanding at end of year | 4.36 | 4.36 | 4.47 |
Exercisable at end of year | $ 4.36 | $ 4.36 | $ 4.23 |
American depositary share [Member] | |||
Disclosure of classes of share capital [line items] | |||
Outstanding Beginning Balance | shares | 2,681,844 | 2,457,546 | 2,039,613 |
Granted | shares | 180,000 | 1,407,500 | 540,000 |
Exercised | shares | (80,568) | ||
Forfeited | shares | (134,794) | (1,183,202) | (41,499) |
Outstanding at end of year | shares | 2,727,050 | 2,681,844 | 2,457,546 |
Exercisable at end of year | shares | 1,522,966 | 817,179 | 1,459,713 |
Weighted Average exercise price | |||
Outstanding Beginning Balance | $ 7.69 | $ 12.76 | $ 13.44 |
Granted | 4.28 | 5.25 | 9.57 |
Exercised | 8.35 | ||
Forfeited | 10 | 10.26 | 13.58 |
Outstanding at end of year | 7.32 | 7.69 | 12.76 |
Exercisable at end of year | 8.36 | 10.29 | 13.24 |
American depositary share [Member] | Bottom of range [Member] | |||
Weighted Average exercise price | |||
Outstanding Beginning Balance | 4.96 | 2.64 | 2.63 |
Granted | 2.68 | 4.95 | 6.69 |
Exercised | 2.64 | ||
Forfeited | 5.36 | 3 | 10.08 |
Outstanding at end of year | 2.68 | 4.96 | 2.64 |
Exercisable at end of year | 4.96 | 6.64 | 3 |
American depositary share [Member] | Top of range [Member] | |||
Weighted Average exercise price | |||
Outstanding Beginning Balance | 17.44 | 17.88 | 17.88 |
Granted | 5.48 | 5.75 | 11.2 |
Exercised | 10.61 | ||
Forfeited | 16.92 | 17.88 | 14.44 |
Outstanding at end of year | 17.44 | 17.44 | 17.88 |
Exercisable at end of year | $ 17.44 | $ 17.45 | $ 16.92 |
SHARE OPTIONS AND SHARE WARRANTS (Summary of Range of Prices of Stock Options) (Details) |
12 Months Ended | |||
---|---|---|---|---|
Dec. 31, 2018
USD ($)
shares
yr
|
Dec. 31, 2017
USD ($)
shares
yr
|
Dec. 31, 2016
USD ($)
shares
|
Dec. 31, 2015
shares
|
|
Outstanding | ||||
Weighted average contractual life remaining (years) | yr | 4.33 | 5.10 | ||
Class A Ordinary shares [Member] | ||||
Outstanding | ||||
Number of Options | 10,908,200 | 10,727,376 | 9,830,183 | 8,158,452 |
Exercisable | ||||
Number of Options | 6,091,864 | 3,268,707 | 5,838,851 | |
Weighted average exercise price | $ | $ 2.09 | |||
Class A Ordinary shares [Member] | US$1.00-US$2.05 [Member] | ||||
Outstanding | ||||
Number of Options | 6,111,800 | 6,075,644 | ||
Weighted average exercise price | $ | $ 1.35 | $ 1.38 | ||
Weighted average contractual life remaining (years) | yr | 5.64 | 6.52 | ||
Exercisable | ||||
Number of Options | 2,476,133 | 215,652 | ||
Weighted average exercise price | $ | $ 1.35 | $ 1.69 | ||
Weighted average contractual life remaining (years) | yr | 5.57 | 2.57 | ||
Class A Ordinary shares [Member] | US$2.06- US$2.99 [Member] | ||||
Outstanding | ||||
Number of Options | 4,168,400 | 4,333,732 | ||
Weighted average exercise price | $ | $ 2.51 | $ 2.52 | ||
Weighted average contractual life remaining (years) | yr | 2.23 | 3.20 | ||
Exercisable | ||||
Number of Options | 3,437,731 | 2,861,061 | ||
Weighted average exercise price | $ | $ 2.51 | $ 2.53 | ||
Weighted average contractual life remaining (years) | yr | 1.83 | 2.20 | ||
Class A Ordinary shares [Member] | US$3.00 -US$4.47 [Member] | ||||
Outstanding | ||||
Number of Options | 198,000 | 318,000 | ||
Weighted average exercise price | $ | $ 4.2 | $ 4.21 | ||
Weighted average contractual life remaining (years) | yr | 2.97 | 3.95 | ||
Exercisable | ||||
Number of Options | 178,000 | 192,002 | ||
Weighted average exercise price | $ | $ 4.2 | $ 4.21 | ||
Weighted average contractual life remaining (years) | yr | 2.93 | 3.92 | ||
Class A Ordinary shares [Member] | US$0.66-US$0.99 [Member] | ||||
Outstanding | ||||
Number of Options | 430,000 | |||
Weighted average exercise price | $ | $ 0.88 | |||
Weighted average contractual life remaining (years) | yr | 6.79 | |||
Exercisable | ||||
Number of Options | ||||
Weighted average exercise price | $ | ||||
Weighted average contractual life remaining (years) | yr | ||||
American depositary share [Member] | ||||
Outstanding | ||||
Number of Options | 2,727,050 | 2,681,844 | 2,457,546 | 2,039,613 |
Exercisable | ||||
Number of Options | 1,522,966 | 817,179 | 1,459,713 | |
Weighted average exercise price | $ | $ 8.35 | |||
American depositary share [Member] | US$4.00-US$8.20 [Member] | ||||
Outstanding | ||||
Number of Options | 1,527,950 | 1,518,911 | ||
Weighted average exercise price | $ | $ 5.4 | $ 5.52 | ||
Weighted average contractual life remaining (years) | yr | 5.64 | 6.52 | ||
Exercisable | ||||
Number of Options | 619,033 | 53,913 | ||
Weighted average exercise price | $ | $ 5.4 | $ 6.76 | ||
Weighted average contractual life remaining (years) | yr | 5.57 | 2.57 | ||
American depositary share [Member] | US$8.24- US$11.96 [Member] | ||||
Outstanding | ||||
Number of Options | 1,042,100 | 1,083,433 | ||
Weighted average exercise price | $ | $ 10.04 | $ 10.08 | ||
Weighted average contractual life remaining (years) | yr | 2.23 | 3.20 | ||
Exercisable | ||||
Number of Options | 859,433 | 715,265 | ||
Weighted average exercise price | $ | $ 10.04 | $ 10.12 | ||
Weighted average contractual life remaining (years) | yr | 1.83 | 2.20 | ||
American depositary share [Member] | US$12.00 -US$17.88 [Member] | ||||
Outstanding | ||||
Number of Options | 49,500 | 79,500 | ||
Weighted average exercise price | $ | $ 16.8 | $ 16.84 | ||
Weighted average contractual life remaining (years) | yr | 2.97 | 3.95 | ||
Exercisable | ||||
Number of Options | 44,500 | 48,001 | ||
Weighted average exercise price | $ | $ 16.8 | $ 16.84 | ||
Weighted average contractual life remaining (years) | yr | 2.93 | 3.92 | ||
American depositary share [Member] | US$2.64-US$3.96 [Member] | ||||
Outstanding | ||||
Number of Options | 107,500 | |||
Weighted average exercise price | $ | $ 3.52 | |||
Weighted average contractual life remaining (years) | yr | 6.79 | |||
Exercisable | ||||
Number of Options | ||||
Weighted average exercise price | $ | ||||
Weighted average contractual life remaining (years) | yr |
SHARE OPTIONS AND SHARE WARRANTS (Schedule of Fair Value of the Options Vesting Period) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of share options and share warrants [Abstract] | |||
Share-based payments - cost of sales | $ 34 | $ 35 | $ 32 |
Share-based payments - selling, general and administrative | 1,335 | 893 | 1,349 |
Total - continuing operations | 1,369 | 928 | 1,381 |
Share-based payments - discontinued operations | 33 | ||
Total Share-based payments | $ 1,369 | $ 928 | $ 1,414 |
SHARE OPTIONS AND SHARE WARRANTS (Schedule of Assumption Determining Fair Value of Share Options) (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018
USD ($)
shares
yr
|
Dec. 31, 2017
USD ($)
shares
yr
|
Dec. 31, 2016
USD ($)
shares
yr
|
|
Key management personnel [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Weighted average expected volatility | 40.62% | 29.63% | |
Weighted average expected life | yr | 4.45 | 4.81 | |
Weighted average risk free interest rate | 1.59% | 1.21% | |
Expected dividend yield | 0.81% | 1.14% | |
Key management personnel [Member] | Bottom of range [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Weighted average fair value at measurement date per 'A' share / (per ADS) | $ 0.43 | $ 0.58 | |
Total 'A' share options granted / (ADS's equivalent) | shares | 5,150,000 | 1,700,000 | |
Weighted average share price per 'A' share / (per ADS) | $ 1.34 | $ 2.43 | |
Weighted average exercise price per 'A' share / (per ADS) | 1.34 | 2.43 | |
Key management personnel [Member] | Top of range [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Weighted average fair value at measurement date per 'A' share / (per ADS) | $ 1.72 | $ 2.32 | |
Total 'A' share options granted / (ADS's equivalent) | shares | (1,287,500) | (425,000) | |
Weighted average share price per 'A' share / (per ADS) | $ 5.36 | $ 9.72 | |
Weighted average exercise price per 'A' share / (per ADS) | $ 5.36 | $ 9.72 | |
Other employees [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Weighted average expected volatility | 42.69% | 40.48% | 36.73% |
Weighted average expected life | yr | 4.55 | 4.69 | 3.74 |
Weighted average risk free interest rate | 2.72% | 1.91% | 1.29% |
Expected dividend yield | 0.81% | 0.96% | |
Other employees [Member] | Bottom of range [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Weighted average fair value at measurement date per 'A' share / (per ADS) | $ 0.41 | $ 0.44 | $ 0.57 |
Total 'A' share options granted / (ADS's equivalent) | shares | 720,000 | 480,000 | 460,000 |
Weighted average share price per 'A' share / (per ADS) | $ 1.07 | $ 1.31 | $ 2.25 |
Weighted average exercise price per 'A' share / (per ADS) | 1.07 | 1.31 | 2.25 |
Other employees [Member] | Top of range [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Weighted average fair value at measurement date per 'A' share / (per ADS) | $ 1.64 | $ 1.76 | $ 2.28 |
Total 'A' share options granted / (ADS's equivalent) | shares | (180,000) | (120,000) | (115,000) |
Weighted average share price per 'A' share / (per ADS) | $ 4.28 | $ 5.24 | $ 9 |
Weighted average exercise price per 'A' share / (per ADS) | $ 4.28 | $ 5.24 | $ 9 |
TRADE AND OTHER PAYABLES (Narrative) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Trade and other current payables [abstract] | ||
Accrued liabilities to contracted licence payments | $ 1,207 | $ 1,112 |
TRADE AND OTHER PAYABLES (Schedule of Trade and Other Payables) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Trade and other current payables [abstract] | ||
Trade payables | $ 8,116 | $ 8,045 |
Payroll taxes | 448 | 423 |
Employee related social insurance | 154 | 151 |
Accrued liabilities | 7,878 | 11,618 |
Deferred income | 312 | 278 |
Total trade and other payables | $ 16,908 | $ 20,515 |
PROVISIONS (Narrative) (Details) $ in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2018
USD ($)
| |
Provisions [abstract] | |
Provision for reduced warranty claims | $ 50 |
PROVISIONS (Schedule of Provisions) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Provisions [abstract] | ||
Provisions | $ 50 | $ 50 |
EXCHANGEABLE NOTES (Narrative) (Details) - USD ($) |
1 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|
Aug. 31, 2018 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Disclosure of detailed information about borrowings [line items] | |||||
Notes maturity | April 1, 2045 | ||||
Accrue interest | 4.00% | ||||
Conversion rate per ADS | $ 47 | ||||
Principal amount | $ 1,042,000 | $ 1,042,000 | 1,000 | ||
Exchange rate price per ADS | $ 80 | 22 | |||
Financial income | 1,388,000 | 2,390,000 | $ 2,270,000 | ||
Nominal value | 151,000 | 99,900 | $ 115,000 | ||
Financial expense | 5,080,000 | 5,405,000 | 5,439,000 | ||
Purchase of exchangeable notes | 12,042,000 | ||||
Accrued interest on notes | 205,000 | ||||
Gain on purchase | $ 463,000 | ||||
Derivatives balance | 245,000 | ||||
Senior Notes [Member] | |||||
Disclosure of detailed information about borrowings [line items] | |||||
Financial expense | $ 689,000 | $ 723,000 |
EXCHANGEABLE NOTES (Schedule of Exchangeable Notes) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Non-current assets | ||
Exchangeable note bond call option | $ 360 | |
Non-current liabilities | ||
Exchangeable note equity conversion option | 238 | 440 |
Exchangeable note bond put option | 1,790 | |
Total non-current liabilities | 238 | 2,230 |
Total value of embedded derivatives - net liability | $ 238 | $ 1,870 |
EXCHANGEABLE NOTES (Schedule of Carrying Value of Exchangeable Senior Notes) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Borrowings [abstract] | |||
Balance at 1 January | $ 92,955 | $ 92,232 | |
Accretion interest | 689 | 723 | $ 718 |
Less: purchased during the year at fair value | (12,262) | ||
Balance at 31 December | $ 81,382 | $ 92,955 | $ 92,232 |
EXCHANGEABLE NOTES (Schedule of Carrying Value of Exchangeable Notes) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|---|
Borrowings [abstract] | |||
Exchangeable senior notes | $ 81,382 | $ 92,955 | $ 92,232 |
Total value of embedded derivatives - liability | 238 | 2,230 | |
Total non-current liabilities | $ 81,620 | $ 95,185 |
FINANCE LEASE LIABILITIES (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of finance lease liabilities [Abstract] | ||
Finance lease transaction, Carrying value | $ 372 | $ 51 |
Repayment of finance lease | 2 and 5 years |
FINANCE LEASE LIABILITIES (Schedule of Carrying Values of Finance Lease Liabilities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Current liabilities | ||
Finance lease liabilities | $ 436 | $ 354 |
Total current liabilities | 436 | 354 |
Non-current liabilities | 526 | 532 |
Finance lease liabilities | $ 526 | $ 532 |
FINANCE LEASE LIABILITIES (Schedule of Finance Lease Liabilities Payable) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of finance lease and operating lease by lessee [line items] | ||
Minimum lease payments | $ 1,038 | $ 938 |
Interest | 76 | 52 |
Principal | 962 | 886 |
Less than one year [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Minimum lease payments | 473 | 387 |
Interest | 37 | 33 |
Principal | 436 | 354 |
In more than one year, but not more than two [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Minimum lease payments | 271 | 381 |
Interest | 19 | 17 |
Principal | 252 | 364 |
In more than two years but not more than five [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Minimum lease payments | 294 | 170 |
Interest | 20 | 2 |
Principal | $ 274 | $ 52 |
FINANCE LEASE LIABILITIES (Schedule of Outstanding Interest Bearing Loans and Borrowings) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2015 |
|
Statement Line Items [Line Items] | |||
Nominal interest rate | 4.00% | ||
Year of maturity | April 1, 2045 | ||
Fair value | $ 962 | $ 886 | |
Carrying value | $ 962 | $ 886 | |
Finance lease liabilities [Member] | |||
Statement Line Items [Line Items] | |||
Currency | Euro | Euro | |
Nominal interest rate | 4.53% | 4.54% | |
Year of maturity | 2023 | 2020 | |
Fair value | $ 648 | $ 835 | |
Carrying value | $ 648 | $ 835 | |
Finance lease liabilities Two [Member] | |||
Statement Line Items [Line Items] | |||
Currency | USD | USD | |
Nominal interest rate | 5.51% | 5.51% | |
Year of maturity | 2023 | 2019 | |
Fair value | $ 314 | $ 51 | |
Carrying value | $ 314 | $ 51 |
COMMITMENTS AND CONTINGENCIES (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of finance lease and operating lease by lessor [line items] | ||
Capital Commitments | $ 187 | $ 121 |
Term of operating lease | 25 Years | |
Operating lease commitments payable | $ 2,922 | 2,693 |
Grant contingencies maximum amount payable | 2,892 | 3,033 |
Future minimum base rent over lease term | 6,425,460 | |
Less than one year [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Operating lease commitments payable | 168 | 92 |
In more than one year, but not more than two [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Operating lease commitments payable | 426 | 182 |
In more than two years but not more than five [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Operating lease commitments payable | 654 | 1,014 |
More than five years [Member] | ||
Disclosure of finance lease and operating lease by lessor [line items] | ||
Operating lease commitments payable | $ 1,674 | $ 1,405 |
COMMITMENTS AND CONTINGENCIES (Schedule of Future Minimum Operating Lease Commitments with Non-Cancellable) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of finance lease and operating lease by lessee [line items] | ||
Total lease obligations | $ 25,717 | $ 22,139 |
2018 [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Total lease obligations | 2,693 | |
2019 [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Total lease obligations | 2,922 | 2,409 |
2020 [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Total lease obligations | 2,565 | 1,947 |
2021 [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Total lease obligations | 2,250 | 1,776 |
2022 [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Total lease obligations | 1,990 | 1,654 |
Later years [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Total lease obligations | 14,249 | $ 11,660 |
2023 [Member] | ||
Disclosure of finance lease and operating lease by lessee [line items] | ||
Total lease obligations | $ 1,741 |
RELATED PARTY TRANSACTIONS (Narrative) (Details) - USD ($) |
12 Months Ended | ||||
---|---|---|---|---|---|
Jun. 06, 2009 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Disclosure of transactions between related parties [line items] | |||||
Non executive directors fees | $ 1,261,000 | $ 1,800,000 | $ 1,946,000 | ||
share-based compensation benefits | 663,000 | 663,000 | |||
Adjustment for share-based compensation benefits | 1,369,000 | 928,000 | $ 1,414,000 | ||
Remaining amount of loan | $ 1,042,000 | 1,042,000 | $ 1,000 | ||
JRJ [Member] | |||||
Disclosure of transactions between related parties [line items] | |||||
Term of lease | 25 Years | ||||
Maturity date | 2027 | ||||
Annual rent payable | $ 449,000 | ||||
JRJ [Member] | Euro [Member] | |||||
Disclosure of transactions between related parties [line items] | |||||
Annual rent payable | $ 381,000 | ||||
Mr. O'Caoimh and Dr Walsh [Member] | |||||
Disclosure of transactions between related parties [line items] | |||||
Maturity date | 2028 | ||||
Annual rent payable | $ 927,000 | ||||
Mr. O'Caoimh and Dr Walsh [Member] | Euro [Member] | |||||
Disclosure of transactions between related parties [line items] | |||||
Annual rent payable | 787,000 | ||||
Rate of rent per squre foot | 18 | ||||
Director [Member] | |||||
Disclosure of transactions between related parties [line items] | |||||
Non executive directors fees | 188,000 | 400,000 | |||
share-based compensation benefits | 13,000 | 156,000 | |||
Adjustment for share-based compensation benefits | $ 149,000 | $ 92,000 | |||
Rayville Limited [Member] | |||||
Disclosure of transactions between related parties [line items] | |||||
Payment of dividend | $ 2,830,000 | ||||
Compensation expense | $ 1,788,000 |
RELATED PARTY TRANSACTIONS (Schedule of Compensation) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of transactions between related parties [abstract] | ||
Short-term employee benefits | $ 863 | $ 1,177 |
Performance related bonus | 210 | 223 |
Post-employment benefits | 44 | 44 |
Share-based compensation benefits | 663 | 663 |
Total compensation | $ 2,158 | $ 2,107 |
RELATED PARTY TRANSACTIONS (Schedule of Company's Shares and Share Option Plan) (Details) - shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Class A Ordinary shares [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Outstanding Beginning Balance | 10,727,376 | 9,830,183 | 8,158,452 |
Granted | 720,000 | 5,630,000 | 2,160,000 |
Exercised | 322,272 | ||
Fortified | (539,176) | (4,732,807) | (165,997) |
Outstanding at end of year | 10,908,200 | 10,727,376 | 9,830,183 |
Class A Ordinary shares [Member] | Directors' and Company Secretary's [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Outstanding Beginning Balance | 5,719,706 | 5,719,706 | |
Granted | |||
Shares purchased during the year | 3,420,000 | ||
Expired | |||
Fortified | |||
Outstanding at end of year | 9,139,706 | 5,719,706 | 5,719,706 |
Share Option [Member] | Directors' and Company Secretary's [Member] | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Outstanding Beginning Balance | 8,770,004 | 7,655,004 | |
Granted | 5,150,000 | ||
Shares purchased during the year | |||
Expired | (115,000) | (315,000) | |
Fortified | (3,720,000) | ||
Outstanding at end of year | 8,655,004 | 8,770,004 | 7,655,004 |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2015 |
|
Disclosure of detailed information about financial instruments [abstract] | |||
Increase interest income | $ 234 | $ 480 | |
Issuance of exchangeable senior notes | $ 115,000 | ||
Repurchased of exchangeable senior notes | $ 15,100 | ||
Term of exchangeable senior notes | 30 years | ||
Maturity date of exchangeable senior notes | April 1, 2045 |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Interest Rate Risk Effective and Repricing Analysis) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|---|---|
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Cash and cash equivalents | $ 30,277 | $ 23,564 | $ 77,109 | $ 101,953 |
Short-term investments | 34,043 | |||
Finance lease receivable | 835 | 1,185 | ||
Licence payments | (1,207) | (1,112) | ||
Finance lease payable | (962) | (886) | ||
Exchangeable notes | (81,382) | (92,955) | $ (92,232) | |
Total interest earning financial and interest bearing financial liabilities | $ (52,439) | $ (36,161) | ||
Cash and cash equivalents [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Effective interest rate | 1.80% | 1.40% | ||
Short-term investments [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Effective interest rate | 1.40% | |||
Finance lease receivable [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Effective interest rate | 4.00% | 4.00% | ||
Licence payments [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Effective interest rate | 3.00% | 3.00% | ||
Finance lease payable [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Effective interest rate | 4.80% | 4.60% | ||
Exchangeable note [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Effective interest rate | 4.80% | 4.80% | ||
6 mths or less [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Cash and cash equivalents | $ 30,277 | $ 23,564 | ||
Short-term investments | ||||
Finance lease receivable | 191 | 267 | ||
Licence payments | (1,207) | (1,112) | ||
Finance lease payable | (217) | (176) | ||
Exchangeable notes | ||||
Total interest earning financial and interest bearing financial liabilities | 29,044 | 22,543 | ||
6 mths - 12 mths [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Cash and cash equivalents | ||||
Short-term investments | 34,043 | |||
Finance lease receivable | 168 | 233 | ||
Licence payments | ||||
Finance lease payable | (219) | (178) | ||
Exchangeable notes | ||||
Total interest earning financial and interest bearing financial liabilities | (51) | 34,098 | ||
1-2 years [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Cash and cash equivalents | ||||
Short-term investments | ||||
Finance lease receivable | 238 | 333 | ||
Licence payments | ||||
Finance lease payable | (252) | (364) | ||
Exchangeable notes | ||||
Total interest earning financial and interest bearing financial liabilities | (14) | (31) | ||
2-5 years [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Cash and cash equivalents | ||||
Short-term investments | ||||
Finance lease receivable | 238 | 352 | ||
Licence payments | ||||
Finance lease payable | (274) | (168) | ||
Exchangeable notes | ||||
Total interest earning financial and interest bearing financial liabilities | (36) | 184 | ||
>5 years [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Cash and cash equivalents | ||||
Short-term investments | ||||
Finance lease receivable | ||||
Deferred consideration | ||||
Licence payments | ||||
Finance lease payable | ||||
Exchangeable notes | (81,382) | (92,955) | ||
Total interest earning financial and interest bearing financial liabilities | $ (81,382) | $ (92,955) |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of interest Rate Profile of Financial Assets/Liabilities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|---|
Fixed rate instruments | |||
Fixed rate financial liabilities (licence fees) | $ (1,207) | $ (1,112) | |
Fixed rate financial liabilities (exchangeable note) | (81,382) | (92,955) | $ (92,232) |
Fixed rate financial liabilities (finance lease payables) | (962) | (886) | |
Financial assets (short-term deposits and short-term investments) | 23,423 | 48,046 | |
Financial assets (finance lease receivables) | 835 | 1,185 | |
Variable rate instruments | |||
Financial assets (cash and short-term deposits) | 6,854 | 9,561 | |
Total interest earning financial and interest bearing financial liabilities | $ (52,439) | $ (36,161) |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Liquidity Risk Estimated Interest Payments of Maturities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|---|
Financial liabilities | |||
Exchangeable notes | $ 81,382 | $ 92,955 | $ 92,232 |
Carrying Amount [Member] | Liquidity risk [Member] | |||
Financial liabilities | |||
Trade & other payables | 16,908 | 20,515 | |
Exchangeable notes | 81,382 | 92,955 | |
Exchangeable note interest | 999 | 1,150 | |
Total maturities of financial liabilities | 99,289 | 114,620 | |
Contractual cash flows [Member] | Liquidity risk [Member] | |||
Financial liabilities | |||
Trade & other payables | 16,908 | 20,515 | |
Exchangeable notes | 99,900 | 115,000 | |
Exchangeable note interest | 105,894 | 126,500 | |
Total maturities of financial liabilities | 222,702 | 262,015 | |
6 mths or less [Member] | |||
Financial liabilities | |||
Exchangeable notes | |||
6 mths or less [Member] | Liquidity risk [Member] | |||
Financial liabilities | |||
Trade & other payables | 16,908 | 20,515 | |
Exchangeable notes | |||
Exchangeable note interest | 1,998 | 2,300 | |
Total maturities of financial liabilities | 18,906 | 22,815 | |
6 mths - 12 mths [Member] | |||
Financial liabilities | |||
Exchangeable notes | |||
6 mths - 12 mths [Member] | Liquidity risk [Member] | |||
Financial liabilities | |||
Trade & other payables | |||
Exchangeable notes | |||
Exchangeable note interest | 1,998 | 2,300 | |
Total maturities of financial liabilities | 1,998 | 2,300 | |
1-2 years [Member] | |||
Financial liabilities | |||
Exchangeable notes | |||
1-2 years [Member] | Liquidity risk [Member] | |||
Financial liabilities | |||
Trade & other payables | |||
Exchangeable notes | |||
Exchangeable note interest | 3,996 | 4,600 | |
Total maturities of financial liabilities | 3,996 | 4,600 | |
2-5 years [Member] | |||
Financial liabilities | |||
Exchangeable notes | |||
2-5 years [Member] | Liquidity risk [Member] | |||
Financial liabilities | |||
Trade & other payables | |||
Exchangeable notes | |||
Exchangeable note interest | 11,988 | 13,800 | |
Total maturities of financial liabilities | 11,988 | 13,800 | |
>5 years [Member] | |||
Financial liabilities | |||
Exchangeable notes | 81,382 | 92,955 | |
>5 years [Member] | Liquidity risk [Member] | |||
Financial liabilities | |||
Trade & other payables | |||
Exchangeable notes | 99,900 | 115,000 | |
Exchangeable note interest | 85,914 | 103,500 | |
Total maturities of financial liabilities | $ 185,814 | $ 218,500 |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Foreign Currency Risk Short Term Financial Assets and Liabilities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of detailed information about financial instruments [line items] | ||
Cash | $ 6,854 | $ 9,561 |
Euro [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Cash | 81 | 235 |
Trade and other receivable | 894 | 1,396 |
Trade and other payables | (1,995) | (1,936) |
Total exposure | (1,020) | (305) |
GBP [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Cash | 122 | 443 |
Trade and other receivable | 113 | 101 |
Trade and other payables | (51) | (16) |
Total exposure | 184 | 528 |
SEK [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Cash | 9 | 5 |
Trade and other receivable | 38 | |
Trade and other payables | (146) | (239) |
Total exposure | (99) | (234) |
CAD [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Cash | 2,512 | 2,107 |
Trade and other receivable | 430 | 298 |
Trade and other payables | (103) | (86) |
Total exposure | 2,839 | 2,319 |
BRL [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Cash | 322 | 443 |
Trade and other receivable | 2,065 | 1,958 |
Trade and other payables | (1,621) | (2,235) |
Total exposure | 766 | 166 |
Other [Member] | ||
Disclosure of detailed information about financial instruments [line items] | ||
Cash | 6 | 16 |
Trade and other receivable | 6 | 6 |
Trade and other payables | (2) | |
Total exposure | $ 10 | $ 22 |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Sensitivity Analysis) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of information about amounts that affected statement of comprehensive income as result of hedge accounting [line items] | |||
Profit or loss | $ (22,658) | $ (38,661) | $ (38,583) |
Euro [Member] | 10% Strengthening US Dollar [Member] | |||
Disclosure of information about amounts that affected statement of comprehensive income as result of hedge accounting [line items] | |||
Profit or loss | 1,818 | 2,158 | |
Euro [Member] | 10% Weakening US Dollar [Member] | |||
Disclosure of information about amounts that affected statement of comprehensive income as result of hedge accounting [line items] | |||
Profit or loss | $ (2,222) | $ (2,637) |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Maximum Credit Exposure of Financial Assets) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|---|---|
Disclosure of detailed information about financial instruments [abstract] | ||||
Third party trade receivables (Note 17) | $ 21,318 | $ 17,242 | ||
Finance lease income receivable (Note 17) | 835 | 1,185 | ||
Cash & cash equivalents (Note 18) | 30,277 | 23,564 | $ 77,109 | $ 101,953 |
Short-term investments (Note 19) | 34,043 | |||
Total maximum credit exposure | $ 52,430 | $ 76,034 |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Exposure of Trade Receivables by Geographic Location) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | $ 22,730 | $ 18,427 |
United States [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | 10,049 | 8,682 |
Euro-zone countries [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | 1,502 | 1,789 |
United Kingdom [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | 132 | 185 |
Other European countries [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | 84 | 21 |
Other regions [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | $ 10,963 | $ 7,750 |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Exposure of Trade Receivables by Customer) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
---|---|---|
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | $ 22,730 | $ 18,427 |
End-user customers [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | 9,830 | 8,200 |
Distributors [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | 11,860 | 10,003 |
Non-government customers [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | $ 1,040 | $ 224 |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Ageing of Trade Receivables) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|---|---|
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | $ 4,202 | $ 3,590 | $ 3,171 | $ 2,812 |
Not past due [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Expected credit loss rate | ||||
Past due 0-30 days [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Expected credit loss rate | 0.50% | 1.00% | ||
Past due 31-120 days [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Expected credit loss rate | 1.00% | 2.60% | ||
Greater than 120 days [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Expected credit loss rate | 94.10% | 70.70% | ||
Cost [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | $ 26,097 | $ 20,832 | ||
Cost [Member] | Not past due [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | 14,494 | 10,770 | ||
Cost [Member] | Past due 0-30 days [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | 3,761 | 3,190 | ||
Cost [Member] | Past due 31-120 days [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | 3,438 | 1,906 | ||
Cost [Member] | Greater than 120 days [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | 4,404 | 4,966 | ||
Impairment [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | 4,202 | 3,590 | ||
Impairment [Member] | Not past due [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | 4 | |||
Impairment [Member] | Past due 0-30 days [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | 17 | 31 | ||
Impairment [Member] | Past due 31-120 days [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | 36 | 50 | ||
Impairment [Member] | Greater than 120 days [Member] | ||||
Disclosure of reconciliation of changes in loss allowance and explanation of changes in gross carrying amount for financial instruments [line items] | ||||
Trade receivables | $ 4,145 | $ 3,509 |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Movement in the Allowance for Impairment of Trade Receivables) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Disclosure of detailed information about financial instruments [abstract] | |||
Balance at January 1 | $ 3,590 | $ 3,171 | $ 2,812 |
Charged to costs and expenses | 682 | 662 | 415 |
Amounts written off during the year | (70) | (243) | (56) |
Balance at December 31 | $ 4,202 | $ 3,590 | $ 3,171 |
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Fair Values of Financial Assets/Liabilities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
---|---|---|---|---|
Loans and receivables | ||||
Trade receivables | $ (4,202) | $ (3,590) | $ (3,171) | $ (2,812) |
Cash and cash equivalents | (30,277) | (23,564) | (77,109) | $ (101,953) |
Short-term investments | 34,043 | |||
Finance lease receivable | (835) | (1,185) | ||
Total maximum credit exposure | 52,430 | 76,034 | ||
Liabilities at amortised cost | ||||
Exchangeable notes | (81,382) | (92,955) | $ (92,232) | |
Finance lease payable | 962 | 886 | ||
Provisions | 50 | 50 | ||
Fair value through profit and loss (FVPL) | ||||
Exchangeable note bond call option | (360) | |||
Exchangeable note equity conversion option | 238 | 440 | ||
Exchangeable note bond put option | 1,790 | |||
Level 1 [Member] | ||||
Loans and receivables | ||||
Trade receivables | 21,318 | 17,242 | ||
Cash and cash equivalents | 30,277 | 23,564 | ||
Short-term investments | 34,043 | |||
Finance lease receivable | 835 | 1,185 | ||
Total maximum credit exposure | 52,430 | 76,034 | ||
Liabilities at amortised cost | ||||
Exchangeable notes | ||||
Finance lease payable | (962) | (886) | ||
Trade and other payables (excluding deferred income) | (16,596) | (20,237) | ||
Provisions | (50) | (50) | ||
Total Liabilities at amortised cost | (17,608) | (21,173) | ||
Fair value through profit and loss (FVPL) | ||||
Exchangeable note bond call option | ||||
Exchangeable note equity conversion option | ||||
Exchangeable note bond put option | ||||
Total fair value through profit and loss (FVPL) | ||||
Total fair value of financial assets liabilities | 34,822 | (54,861) | ||
Level 2 [Member] | ||||
Loans and receivables | ||||
Trade receivables | ||||
Cash and cash equivalents | ||||
Short-term investments | ||||
Finance lease receivable | ||||
Total maximum credit exposure | ||||
Liabilities at amortised cost | ||||
Exchangeable notes | (81,382) | (92,955) | ||
Finance lease payable | ||||
Trade and other payables (excluding deferred income) | ||||
Provisions | (92,955) | |||
Total Liabilities at amortised cost | (81,382) | |||
Fair value through profit and loss (FVPL) | ||||
Exchangeable note bond call option | (360) | |||
Exchangeable note equity conversion option | (238) | (440) | ||
Exchangeable note bond put option | (1,790) | |||
Total fair value through profit and loss (FVPL) | (238) | (1,870) | ||
Total fair value of financial assets liabilities | (81,620) | (94,825) | ||
Carrying Amount [Member] | ||||
Loans and receivables | ||||
Trade receivables | 21,318 | 17,242 | ||
Cash and cash equivalents | 30,277 | 23,564 | ||
Short-term investments | 34,043 | |||
Finance lease receivable | 835 | 1,185 | ||
Total maximum credit exposure | 52,430 | 76,034 | ||
Liabilities at amortised cost | ||||
Exchangeable notes | (81,382) | (92,955) | ||
Finance lease payable | (962) | (886) | ||
Trade and other payables (excluding deferred income) | (16,596) | (20,237) | ||
Provisions | (50) | (50) | ||
Total Liabilities at amortised cost | (98,990) | (114,128) | ||
Fair value through profit and loss (FVPL) | ||||
Exchangeable note bond call option | 360 | |||
Exchangeable note equity conversion option | (238) | (440) | ||
Exchangeable note bond put option | (1,790) | |||
Total fair value through profit and loss (FVPL) | (238) | (1,870) | ||
Total fair value of financial assets liabilities | (46,798) | (39,964) | ||
Fair Value [Member] | ||||
Loans and receivables | ||||
Trade receivables | 21,318 | 17,242 | ||
Cash and cash equivalents | 30,277 | 23,564 | ||
Short-term investments | 34,043 | |||
Finance lease receivable | 835 | 1,185 | ||
Total maximum credit exposure | 52,430 | 76,034 | ||
Liabilities at amortised cost | ||||
Exchangeable notes | (81,382) | (92,955) | ||
Finance lease payable | (962) | (886) | ||
Trade and other payables (excluding deferred income) | (16,596) | (20,237) | ||
Provisions | (50) | (50) | ||
Total Liabilities at amortised cost | (98,990) | (114,128) | ||
Fair value through profit and loss (FVPL) | ||||
Exchangeable note bond call option | 360 | |||
Exchangeable note equity conversion option | (238) | (440) | ||
Exchangeable note bond put option | (1,790) | |||
Total fair value through profit and loss (FVPL) | (238) | (1,870) | ||
Total fair value of financial assets liabilities | $ (46,798) | $ (39,964) |
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES (Schedule of Liabilities Arising from Financing) (Details) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Cash-flows: | |||
Interest paid | $ 4,503,000 | $ 4,600,000 | $ 4,600,000 |
Borrowings & derivative financial instruments [Member] | |||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |||
Balance at 1 January 2017 | 95,185 | 96,492 | |
Cash-flows: | |||
Interest paid | (4,503) | (4,600) | |
Repurchase | (12,042) | ||
Repayment | |||
Proceeds | |||
Non-cash: | |||
Interest charged | 4,352 | 4,600 | |
Reduction in accrued interest payable | 150 | ||
Exchange adjustment | |||
Accretion interest | 689 | 723 | |
Fair value | (2,211) | (2,030) | |
Reclassification | |||
Balance at 31 December 2017 | 81,620 | 95,185 | 96,492 |
Short-term lease liabilities [Member] | |||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |||
Balance at 1 January 2017 | 354 | 273 | |
Cash-flows: | |||
Interest paid | |||
Repurchase | |||
Repayment | (374) | (295) | |
Proceeds | 112 | 28 | |
Non-cash: | |||
Interest charged | |||
Reduction in accrued interest payable | |||
Exchange adjustment | (30) | 53 | |
Accretion interest | |||
Fair value | |||
Reclassification | 374 | 295 | |
Balance at 31 December 2017 | 436 | 354 | 273 |
Long-term lease liabilities [Member] | |||
Disclosure of reconciliation of liabilities arising from financing activities [line items] | |||
Balance at 1 January 2017 | 532 | 732 | |
Cash-flows: | |||
Interest paid | |||
Repurchase | |||
Repayment | |||
Proceeds | 369 | 24 | |
Non-cash: | |||
Interest charged | |||
Reduction in accrued interest payable | |||
Exchange adjustment | (1) | 71 | |
Accretion interest | |||
Fair value | |||
Reclassification | (374) | (295) | |
Balance at 31 December 2017 | $ 526 | $ 532 | $ 732 |
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