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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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24 | ||
39
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39
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61 |
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65
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67
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67
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69 | ||
80
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82
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PART II
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83
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83
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83
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85
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85
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85
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86
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86
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86
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86
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86
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PART III
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87
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87
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166
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Item 2 |
Offer Statistics and Expected Timetable
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Item 3 |
Key Information
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Year ended December 31,
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|||||||||||||||||||
|
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2019
US$ ‘000
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2018
US$‘000
|
2017
US$‘000
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2016
US$‘000
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2015 US$‘000 |
||||||||||||||
Revenues
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90,435
|
97,035
|
99,140
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99,611
|
100,195
|
|||||||||||||||
Cost of sales
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(52,315
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)
|
(55,586
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)
|
(57,250
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)
|
(56,127
|
)
|
(53,683
|
)
|
||||||||||
|
||||||||||||||||||||
Gross profit
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38,120
|
41,449
|
41,890
|
43,484
|
46,512
|
|||||||||||||||
Other operating income
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91
|
102
|
100
|
239
|
288
|
|||||||||||||||
Research and development expenses
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(5,325
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)
|
(5,369
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)
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(5,657
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)
|
(5,040
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)
|
(5,069
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)
|
||||||||||
Selling, general and administrative expenses
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(27,661
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)
|
(29,477
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)
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(32,246
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)
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(30,366
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)
|
(28,225
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)
|
||||||||||
Selling, general and administrative expenses - impairment charges and inventory write-off/provision
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(24,295
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)
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(26,932
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)
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(41,755
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)
|
(48,165
|
)
|
—
|
|||||||||||
Selling, general and administrative expenses – tax audit settlement
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(5,042
|
)
|
—
|
—
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—
|
—
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||||||||||||||
|
||||||||||||||||||||
Operating (loss)/profit
|
(24,112
|
)
|
(20,227
|
)
|
(37,668
|
)
|
(39,848
|
)
|
13,506
|
|||||||||||
Financial income
|
697
|
2,144
|
3,198
|
3,147
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13,491
|
|||||||||||||||
Financial expenses
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(6,582
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)
|
(5,080
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)
|
(5,405
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)
|
(5,439
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)
|
(4,054
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)
|
||||||||||
Net financing (expense)/income
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(5,885
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)
|
(2,956
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)
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(2,207
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)
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(2,292
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)
|
9,437
|
|||||||||||
(Loss)/Profit before tax
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(29,997
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)
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(23,183
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)
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(39,875
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)
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(42,140
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)
|
22,943
|
|||||||||||
Income tax credit/(expense)
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1,006
|
525
|
1,214
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3,557
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(756
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)
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||||||||||||||
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||||||||||||||||||||
(Loss)/Profit for the year
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(28,991
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)
|
(22,658
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)
|
(38,661
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)
|
(38,583
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)
|
22,187
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|||||||||||
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||||||||||||||||||||
(Loss)/Profit for the year on discontinued operations
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77
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568
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(1,609
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)
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(62,042
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)
|
(391
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)
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||||||||||||
(Loss)/Profit for the year (all attributable to owners of the parent)
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(28,914
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)
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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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)
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21,796
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|||||||||||
Basic (loss)/earnings per ADS (US Dollars)
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(1.38
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)
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(1.06
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)
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(1.86
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)
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(4.38
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)
|
0.94
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|||||||||||
Diluted (loss)/earnings per ADS (US Dollars)
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(1.38
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)
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(1.06
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)
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(1.86
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)
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(4.38
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)
|
0.46
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|||||||||||
Basic (loss)/earnings per ‘A’ ordinary share
(US Dollars) |
(0.35
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)
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(0.27
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)
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(0.47
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)
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(1.10
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)
|
0.24
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|||||||||||
Diluted (loss)/earnings per ‘A’ ordinary share
(US Dollars) |
(0.35
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)
|
(0.27
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)
|
(0.47
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)
|
(1.10
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)
|
0.12
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Weighted average number of shares used in computing basic EPS per ADS
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20,901,703
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20,903,227
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21,621,602
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22,964,703
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23,161,773
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|||||||||||||||
Weighted average number of shares used in computing diluted EPS per ADS
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25,467,516
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25,877,205
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26,877,544
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28,299,399
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27,407,793
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|||||||||||||||
Weighted average number of shares used in computing basic EPS per ‘A’ ordinary share
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83,606,810
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83,612,908
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86,486,409
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91,858,813
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92,647,091
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|||||||||||||||
Weighted average number of shares used in computing diluted EPS per ‘A’ ordinary share
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101,870,064
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103,508,820
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107,510,179
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113,197,598
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109,631,172
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December 31,
2019 US$’000
|
December 31,
2018 US$’000
|
December 31,
2017 US$’000
|
December 31,
2016 US$’000
|
December 31,
2015 US$’000
|
|||||||||||||||
Net current assets (current assets less current liabilities)
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51,941
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69,057
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91,362
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108,208
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143,085
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|||||||||||||||
Non-current liabilities
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(106,909
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)
|
(90,001
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)
|
(106,549
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)
|
(115,585
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)
|
(129,646
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)
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||||||||||
Total assets
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131,071
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151,659
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192,974
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249,592
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363,683
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|||||||||||||||
Capital stock
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1,213
|
1,213
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1,213
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1,213
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1,209
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|||||||||||||||
Shareholders’ equity
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4,713
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44,054
|
65,196
|
108,727
|
213,892
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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, 2019, 2018 and 2017, we incurred US$9.6 million, US$9.9 million and US$10.4 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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• |
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;
|
• |
unanticipated expenditures to address or defend such actions;
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• |
customer notifications for repair, replacement, refunds;
|
• |
recall, detention or seizure of our products;
|
• |
operating restrictions or partial suspension or total shutdown of production;
|
• |
refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;
|
• |
operating restrictions;
|
• |
withdrawing 510(k) clearances 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.
|
• |
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.
|
• |
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.
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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.
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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.
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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 half of 2020.
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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.
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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 existing business unless suitable alternatives were quickly found or lost sales to one distributor are absorbed by another
distributor. Finding a suitable alternative to a lost or terminated distributor may pose challenges in our industry’s competitive environment, and another suitable distributor may not be found on satisfactory terms, if at all. For
instance, some distributors already have exclusive arrangements with our competitors, and others do not have the same level of penetration into our target markets as our existing distributors. If total revenue from these or any of our
other significant distributors were to decrease in any material amount in the future or we are not successful in timely transitioning business to new distributors, our business, operating results and financial condition could be
materially and adversely affected.
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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$7,291,000) for any one accident, limited to a maximum of €6,500,000 (US$7,291,000) in any one year
period of insurance. A deductible of €5,000 ($5,600) 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 85% of revenues during the fiscal year ended December 31, 2019. 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, 2019 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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In December 2019, Covid-19 began to impact the population of Wuhan, China, a disease caused by a novel and highly contagious form of coronavirus. While initially the outbreak was largely concentrated in China and caused significant
disruptions to its economy, it has now spread to several other countries and infections have been reported globally. The severity of the outbreak resulted in travel restrictions, quarantine and social distancing measures imposed by
governments in virtually all of the countries in which we market our products. The Covid-19 outbreak made it difficult to carry out our marketing activities to promote our products to potential customers and gave rise to sudden
significant changes in regional and global economic conditions that could interfere with purchases of products or services. We currently are unable to predict the duration and severity of the spread of the Covid-19, and responses
thereto, and the impact on our business, results of operations, financial condition, cash flows and liquidity, as these depend on rapidly evolving developments, which are highly uncertain. Many factors are beyond our control, such as
the continued spread or recurrence of contagion, the implementation of effective preventative and containment measures, the development of effective medical solutions, financial and other market reactions to the foregoing, and
reactions and responses of communities and societies. However, we know the Covid-19 outbreak will result in lower revenues in 2020 and potentially beyond.
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Any similar future outbreak of a contagious disease, other adverse public health developments around the world, or the measures taken by the governments around the world in response to a future outbreak of a contagious disease may
restrict economic activities in affected regions, resulting in reduced business volume, temporary closure of our facilities and offices or otherwise disrupt our business operations and adversely affect our results of operations.
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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.”) exited the E.U. on January 31, 2020. There is now a transition period until the end of 2020 while the U.K. and E.U. negotiate additional arrangements. The existing rules on trade, travel, and business for the
U.K. and E.U. continue to apply during the transition period. Our business in the U.K., the E.U. and world-wide could be affected by the impact of U.K.’s withdrawal from membership of the E.U. The U.K.’s exit from the E.U. could cause
volatility in global financial markets, including in global currency exchange rates, resulting in a slow-down in economic activity in the U.K., Europe or globally, negatively impact new trade agreements between the U.K and other countries,
and result in significant regulatory changes and uncertainty. One or more of these events could make it more difficult or costly to sell our products, particularly in the U.K. and Europe, and negatively affect our revenues and results of
operations. The U.K.’s exit may also influence other countries and result in additional countries deciding to leave the E.U. This in turn could result in additional changes and uncertainty, any or all of which could negatively impact our
business.
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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.
|
• |
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.
|
• |
The total share options exercisable at December 31, 2019, 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 6,622,667 “A” Ordinary Shares (1,655,667ADSs) exercisable at December 31, 2019 be exercised, Trinity
Biotech would have to issue 6,622,667 additional “A” Ordinary Shares (1,655,667 ADSs). On the basis of 96,162,410 “A” Ordinary Shares outstanding at December 31, 2019, this would effectively dilute the ownership interest of the existing shareholders by approximately 7%.
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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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
Our future liquidity and ability to meet our future capital requirements will depend on numerous factors, including, but not limited to, the following:
|
• |
The costs and timing of expansion of sales and marketing activities;
|
• |
The timing and success of the commercial launch of new products;
|
• |
The extent to which we gain or expand market acceptance for existing, new or enhanced products;
|
• |
The costs and timing of the expansion of our manufacturing capacity;
|
• |
The success of our research and product development efforts;
|
• |
The time, cost and degree of success of conducting clinical trials and obtaining regulatory approvals;
|
• |
The magnitude of capital expenditures;
|
• |
Changes in existing and potential relationships with distributors and other business partners;
|
• |
The costs involved in obtaining and enforcing patents, proprietary rights and necessary licenses;
|
• |
The costs and liability associated with patent infringement or other types of litigation;
|
• |
Competing technological and market developments; and
|
• |
The scope and timing of strategic acquisitions.
|
• |
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.
|
• |
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.
|
• |
We 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.
|
• |
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$44 million (2018: US$53 million). In 2019, we recorded total impairment charges of US$24 million (2018: US$27 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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
Trinity Biotech currently owns 6 U.S. patents with remaining patent lives varying from 1 year to 14 years.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
As the market for diagnostics continues to grow and the number of participants in the market increases, we may increasingly be subject to patent infringement claims. It is possible that a third-party may claim infringement against us.
For example, because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our products may infringe. Defence of these claims, regardless of their
merit, would involve substantial litigation expense and would be a substantial diversion of managerial and financial resources from our business. Parties making claims against us may obtain injunctive or other equitable relief, which could
effectively block our ability to further develop and commercialise one or more of our products. The pendency of any litigation may cause our distributors and customers to reduce or terminate purchases of our products. If found to infringe,
we may have to pay substantial damages, including treble damages and attorneys’ fees for wilful infringement, obtain one or more licenses from third parties, pay royalties or redesign our affected products, which may be impossible or
require substantial time and monetary expenditure. Any substantial loss resulting from such a claim could cause our revenues to decrease and have a material adverse affect on our profitability, and the damage to our reputation in the
industry could have a material adverse affect on our business.
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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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• |
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.
|
Point-Of-Care
|
Clinical Laboratory
|
|||||||||
Infectious Diseases
|
Infectious Diseases
|
Haemoglobin
|
Autoimmune
|
Clinical Chemistry
|
Blood Bank Screening
|
|||||
UniGold™
|
MarDx®
|
Premier™
|
ImmuBlot™
|
EZ™
|
Captia™
|
|||||
Recombigen®
|
MarBlot®
|
Ultra™
|
ImmuGlo™
|
|
|
|||||
|
|
ImmuLisa™
|
|
|
||||||
|
|
OTOblot™
|
|
|
• |
Infectious diseases;
|
• |
Glycated haemoglobin (for diabetes monitoring and diagnosis) and haemoglobin variants for the detection of haemoglobinopathies (haemoglobin abnormalities);
|
• |
Autoimmune diseases
|
• |
Lyme disease,
|
• |
Sexually transmitted diseases, including Syphilis and Herpes.
|
• |
Markers for Epstein Barr, measles, mumps, toxoplasmosis, cytomegalovirus, rubella, varicella and other viral pathogens.
|
• |
Immunofluorescence Assay (“IFA”),
|
• |
Enzyme-linked immunosorbent (“ELISA”),
|
• |
Western Blot (“WB”) and
|
• |
Line immunoassay (“LIA”).
|
• |
Its Clinical Chemistry product range directly to hospitals and laboratories in Germany and France;
|
• |
Infectious Diseases and Clinical Chemistry product ranges directly to hospitals and laboratories in the UK; and
|
• |
All product lines through independent distributors and strategic partners in a further approximately 100 countries.
|
• |
untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
|
• |
unanticipated expenditures to address or defend such actions
|
• |
customer notifications for repair, replacement, refunds;
|
• |
recall, detention or seizure of our products;
|
• |
operating restrictions or partial suspension or total shutdown of production;
|
• |
refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;
|
• |
operating restrictions;
|
• |
withdrawing 510(k) clearances or PMA approvals that have already been granted;
|
• |
refusal to grant export approval for our products; or
|
• |
criminal prosecution.
|
• |
product design, development and manufacture;
|
• |
product safety, testing, labeling and storage;
|
• |
record keeping procedures;
|
• |
product marketing, sales and distribution; and
|
• |
post-marketing surveillance, complaint handling, medical device reporting, reporting of deaths, serious injuries or device malfunctions and repair or recall of products.
|
• |
Are not to be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure; and
|
• |
product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;
|
• |
Quality System Regulation, (“QSR”), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the
manufacturing process;
|
• |
labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;
|
• |
clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices;
|
• |
approval of product modifications that affect the safety or effectiveness of one of our approved devices;
|
• |
medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely
cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur;
|
• |
post-approval restrictions or conditions, including post-approval study commitments;
|
• |
post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device;
|
• |
the FDA's recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations;
|
• |
regulations pertaining to voluntary recalls; and
|
• |
notices of corrections or removals.
|
• |
includes a reduction in the annual update factor used to adjust payments under the CLFS for inflation. This update factor reflects the consumer price index for all urban consumers, or CPI-U, and the ACA
reduces the CPI-U by 1.75% for the years 2011 through 2015. The Affordable Care Act also imposes a multifactor productivity adjustment in addition to the CPI-U, which may further reduce payment rates;
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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
|
• |
requires the coordination and promotion of research on comparative clinical effectiveness of different technologies and procedures, initiatives to revise Medicare payment methodologies, such as bundling of
payments across the continuum of care by providers and clinicians and initiatives to promote quality indicators in payment methodologies.
|
• |
day-to-day operation of a clinical laboratory, including training and skill levels required of laboratory personnel;
|
• |
physical requirements of a facility;
|
• |
equipment; and
|
• |
validation and quality control.
|
• |
Trinity Biotech Manufacturing Limited, based in Bray, Ireland;
|
• |
Clark Laboratories Inc, based in Jamestown, New York;
|
• |
MarDx Diagnostics Inc, based in Carlsbad, California;
|
• |
Primus Corporation, based in Kansas City;
|
• |
Biopool US Inc (trading as Trinity Biotech USA), based in Jamestown, New York;
|
• |
Immco Diagnostics Inc, based in Amherst and Buffalo, New York;
|
• |
Nova Century Scientific Inc, based in Burlington, Canada; and
|
• |
Trinity Biotech Brazil based in Sao Paulo, Brazil.
|
Item 5 |
Operating and Financial Review and Prospects
|
• |
Significant underperformance relative to expected, historical or projected future operating results;
|
• |
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;
|
• |
Obsolescence of products;
|
• |
Significant decline in our stock price for a sustained period; and
|
• |
Our market capitalisation relative to net book value.
|
• |
In the event that there was a 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$743,000 at December 31,
2019
|
• |
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$5,420,000 at December 31, 2019.
|
• |
Haemoglobins revenues – including both instrument and consumables revenues with the impact being greater on diabetes (A1c) rather than on haemoglobin variant revenues.
|
• |
Autoimmune revenues – testing volumes were particularly impacted at our reference laboratory in Buffalo, New York but there were also lower product sales in all major markets.
|
• |
HIV, Infectious Diseases and Clinical chemistry product sales.
|
• |
The company furloughed a large percentage of its work forces in the USA, Ireland and Canada in April, 2020. Meanwhile, in Brazil and other locations, staff costs were also significantly reduced by means of
pay cuts.
|
• |
The elimination of virtually all travel costs and significant reductions in discretionary sales and marketing expenditure.
|
• |
Availing of governmental supports. This included the receipt of US$4.5 million of loans under the U.S. government’s Paycheck Protection Program (“PPP”). Under the provisions of the PPP, these loans will be
partially or totally forgiven, based on the extent to which a borrower’s workforce returns to normal levels in the eight-week period immediately following the loans being granted. Upon receipt of these loans, the Company ended the
furloughing of all staff in the USA and therefore expects that a large percentage of these loans will be forgiven later in 2020, once the necessary verification has taken place. In Ireland, the company also availed of economic support
mechanisms being provided by the Irish Government though a significant level of furloughing continued into June, 2020, mainly due to the expected lower demand for HIV products for the African market.
|
1. |
Overview
|
2. |
Revenues
|
3. |
Operating Loss
|
4. |
Loss for the year
|
5. |
Discontinued operations
|
i. |
Lyme disease revenues decreased following the loss of certain large customers that migrated their Lyme testing away from Western Blot assays to alternative testing platforms,
|
ii. |
HIV point-of-care sales decreased following our decision to discontinue sales of the Unigold HIV test in the USA and
|
iii. |
Revenues for our Fitzgerald business, which sells antibodies to the life sciences and research industries, reduced following higher than average revenues in 2018.
|
Year ended December 31,
|
||||||||||||
2019
US$ ’000
|
|
2018
US$’000
|
% Change
|
|||||||||
Revenues
|
||||||||||||
Clinical Laboratory
|
68,127
|
71,618
|
(4.9
|
)%
|
||||||||
Point-of-Care
|
11,393
|
14,836
|
(23.2
|
)%
|
||||||||
Laboratory Services
|
10,915
|
10,581
|
3.2
|
%
|
||||||||
|
||||||||||||
Total
|
90,435
|
97,035
|
6.8
|
%
|
Year ended December 31,
|
||||||||||||
|
2019
US$‘000
|
|
2018
US$‘000
|
% Change
|
||||||||
Revenues
|
||||||||||||
Americas
|
52,183
|
57,559
|
(9.3
|
)%
|
||||||||
Asia/Africa
|
27,686
|
29,466
|
(6.0
|
)%
|
||||||||
Europe
|
10,566
|
10,010
|
5.6
|
%
|
||||||||
|
||||||||||||
Total
|
90,435
|
97,035
|
(6.8
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
|
2019
US$’000
|
|
2018
US$’000
|
% Change
|
|||||||
Revenues
|
90,435
|
97,035
|
(6.8
|
)%
|
||||||||
Cost of sales
|
(52,315
|
)
|
(55,586
|
)
|
(5.9
|
)%
|
||||||
|
||||||||||||
Gross profit
|
38,120
|
41,449
|
(8.0
|
)%
|
||||||||
Other operating income
|
91
|
102
|
(10.8
|
)%
|
||||||||
Research & development
|
(5,325
|
)
|
(5,369
|
)
|
(0.8
|
)%
|
||||||
SG&A expenses
|
(27,661
|
)
|
(29,477
|
)
|
(6.2
|
)%
|
||||||
Selling, general and administrative expenses – tax audit settlement
|
(5,042
|
)
|
—
|
—
|
||||||||
Selling, general and administrative expenses - impairment charges
|
(24,295
|
)
|
(26,932
|
)
|
(9.8
|
)%
|
||||||
|
||||||||||||
Operating loss on continuing operations
|
(24,112
|
)
|
(20,227
|
)
|
19.2
|
%
|
Year ended December 31,
|
||||||||||||
|
|
2018
US$’000
|
|
2018
US$’000
|
% Change
|
|||||||
SG&A (excl. share-based payments and amortisation)
|
24,561
|
25,317
|
(3.0
|
)%
|
||||||||
Share-based payments
|
732
|
1,335
|
(45.2
|
)%
|
||||||||
Amortisation
|
2,368
|
2,825
|
(16.2
|
)%
|
||||||||
|
||||||||||||
Total
|
27,661
|
29,477
|
(6.2
|
)%
|
• |
full year effect of cost savings implemented in 2018 as part of a cost saving programme. This resulted in lower costs under a wide range of headings including salaries, I.T. costs and discretionary sales and marketing costs and
commission payments,
|
• |
lower pay for employees as a consequence of lower revenues,
|
• |
the foreign currency impact which resulted in Euro-denominated and Brazilian-denominated costs being lower by 5% and 7% respectively,
|
• |
partly offset by a gain on the purchase of a portion of our exchangeable notes recorded in 2018 (US$463,000) and higher legal fees and tax professional fees mainly associated with the tax audit which was concluded in 2019 in one of the
jurisdictions in which the Group operates.
|
•
|
the Company’s market capitalisation at the end of the year which was lower when compared to the end of 2018.
|
•
|
the inclusion of the latest cash flow projections and net asset values for each cash generating unit; and
|
•
|
increased volatility in the Company’s share price and higher market interest rates which resulted in a higher discount factor being applied to the Company’s expected
future cash flows.
|
Year ended December 31,
|
||||||||||||
|
|
2019
US$‘000
|
|
2018
US$‘000
|
% Change
|
|||||||
Operating loss
|
(24,112
|
)
|
(20,227
|
)
|
19.2
|
%
|
||||||
Net financing expense
|
(5,885
|
)
|
(2,956
|
)
|
99.1
|
%
|
||||||
|
||||||||||||
Loss before tax
|
(29,997
|
)
|
(23,183
|
)
|
29.4
|
%
|
||||||
Income tax credit
|
1,006
|
525
|
91.6
|
%
|
||||||||
|
||||||||||||
Loss for the year from continuing operations
|
(28,991
|
)
|
(22,658
|
)
|
28.0
|
%
|
|
Year ended December 31,
|
|||||||
|
|
2019
US$‘000
|
|
2018
US$‘000
|
||||
Profit on discontinued operations
|
77
|
568
|
1. |
Overview
|
2. |
Revenues
|
3. |
Operating Loss
|
4. |
Loss for the year
|
5. |
Discontinued operations
|
Year ended December 31,
|
||||||||||||
|
2018
US$’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$‘000
|
% Change
|
|||||||
Operating loss
|
(20,227
|
)
|
(37,668
|
)
|
(46.2
|
)%
|
||||||
Net financing expense
|
(2,956
|
)
|
(2,207
|
)
|
33.9
|
%
|
||||||
|
||||||||||||
Loss before tax
|
(23,183
|
)
|
(39,875
|
)
|
(41.9
|
)%
|
||||||
Income tax credit
|
525
|
1,214
|
(56.8
|
)%
|
||||||||
|
||||||||||||
Loss for the year from continuing operations
|
(22,658
|
)
|
(38,661
|
)
|
(41.4
|
)%
|
|
Year ended December 31,
|
|||||||
|
|
2018
US$‘000
|
|
2017
US$‘000
|
||||
Profit/(Loss) on discontinued operations
|
568
|
(1,609
|
)
|
• |
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 decrease in trade and other receivables of US$445,000 partially due to the decrease, year on year, in the debtors days number;
|
• |
An increase in trade and other payables balance of US$151,000 due to timing of payments; and
|
• |
An increase in inventory of US$2,959,000 due to the strategic management of inventory levels during the course of the year.
|
• |
Payments to acquire intangible assets of US$9,718,000 (2018: US$9,863,000), 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$2,118,000 (2018: US$7,528,000) incurred as part of the Group’s investment programme for its manufacturing and distribution activities, and placement of instruments.
|
• |
Disposal of property, plant and equipment of US$17,000 (2018: US$nil) 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 |
1-2 Years
US$’000 |
2-5 Years
US$’000 |
more than
5 years US$’000 |
|||||||||||||||
Exchangeable note*
|
99,900
|
—
|
—
|
—
|
99,900
|
|||||||||||||||
Exchangeable note interest
|
101,898
|
3,996
|
3,996
|
11,988
|
81,918
|
|||||||||||||||
Right of asset leases obligations
|
19,630
|
2,156
|
2,012
|
4,840
|
10,622
|
|||||||||||||||
Sale and leaseback lease obligations
|
519
|
247
|
95
|
177
|
—
|
|||||||||||||||
|
||||||||||||||||||||
Total
|
221,947
|
6,399
|
6,103
|
17,005
|
192,440
|
|
2019
|
2018
|
Total project
costs to December 31, 2019 ¹ |
|||||||||
Product Name
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
HIV screening rapid test
|
2,587
|
1,657
|
8,474
|
|||||||||
Premier Instrument for Haemoglobin A1c testing
|
1,930
|
2,653
|
32,027
|
|||||||||
Autoimmune Smart Reader
|
1,325
|
746
|
2,071
|
|||||||||
Syphilis point-of-care test
|
870
|
454
|
1,324
|
|||||||||
Uni-Gold antigen improvement
|
691
|
453
|
2,362
|
|||||||||
G-6-PDH test
|
582
|
850
|
2,244
|
|||||||||
Uni-gold test enhancement
|
376
|
796
|
4,718
|
|||||||||
Tri-stat Point-of-Care instrument
|
361
|
727
|
9,029
|
Total estimated
cost to complete |
Estimated date
for completion |
|||||||
Product Name
|
US$’000
|
|||||||
Premier Instrument for Haemoglobin A1c testing²
|
900
|
2020
|
||||||
HIV screening rapid test
|
1,250
|
2020
|
||||||
Autoimmune Smart Reader
|
1,315
|
2021
|
||||||
Name
|
Age
|
Title
|
Ronan O’Caoimh
|
64
|
Chairman and Chief Executive Officer
|
Jim Walsh, PhD
|
61
|
Executive Director
|
Kevin Tansley
|
49
|
Executive Director, Chief Financial Officer & Company Secretary
|
Denis R. Burger, PhD
|
76
|
Non Executive Director / Lead Director
|
Clint Severson
|
71
|
Non Executive Director
|
James D. Merselis
|
66
|
Non Executive Director
|
Executive Director
|
Salary/
Benefits
US$’000
|
Performance
related bonus
US$’000
|
Defined
contribution
pension
US$’000
|
Total
2019
US$’000
|
Total
2018
US$’000
|
|||||||||||||||
Ronan O’Caoimh1
|
425
|
—
|
—
|
425
|
585
|
|||||||||||||||
Jim Walsh
|
—
|
—
|
—
|
—
|
9
|
|||||||||||||||
Kevin Tansley
|
375
|
213
|
42
|
630
|
523
|
|||||||||||||||
|
800
|
213
|
42
|
1,055
|
1,117
|
Non-executive Director
|
Fees
US$’000
|
Total
2019
US$’000
|
Total
2018
US$’000
|
|||||||||
Denis R. Burger
|
75
|
75
|
—
|
|||||||||
Peter Coyne2
|
—
|
—
|
38
|
|||||||||
James Merselis
|
75
|
75
|
75
|
|||||||||
Clint Severson
|
75
|
75
|
75
|
|||||||||
|
225
|
225
|
188
|
1 |
Represents payments to Ronan O’Caoimh for director fees and to Darnick Company in respect of CEO services.
|
2 |
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
Option |
||||||||||||
Ronan O’Caoimh*
|
266,667
|
66,667
|
2.43
|
9.73
|
24/02/2023
|
||||||||||||
266,667
|
66,667
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
266,666
|
66,667
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
1,000,000
|
250,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
1,000,000
|
250,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
244,000
|
61,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
2,030,000
|
507,500
|
0.69
|
2.74
|
14/06/2026
|
|||||||||||||
2,030,000
|
507,500
|
0.69
|
2.74
|
14/06/2026
|
|||||||||||||
Denis Burger
|
20,000
|
5,000
|
2.43
|
9.73
|
24/02/2023
|
||||||||||||
20,000
|
5,000
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
20,000
|
5,000
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
321,000
|
80,250
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
95,000
|
23,750
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
20,000
|
5,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
Jim Walsh
|
53,333
|
13,333
|
2.43
|
9.73
|
24/02/2023
|
||||||||||||
53,333
|
13,333
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
53,334
|
13,334
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
360,000
|
90,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
360,000
|
90,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
30,000
|
7,500
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
Kevin Tansley
|
166,667
|
41,667
|
2.43
|
9.73
|
24/02/2023
|
||||||||||||
166,667
|
41,667
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
166,666
|
41,667
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
340,000
|
85,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
340,000
|
85,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
184,000
|
46,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
Jim Merselis
|
20,000
|
5,000
|
2.43
|
9.73
|
24/02/2023
|
||||||||||||
20,000
|
5,000
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
20,000
|
5,000
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
95,000
|
23,750
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
95,000
|
23,750
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
20,000
|
5,000
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
Clint Severson
|
20,000
|
5,000
|
2.43
|
9.73
|
24/02/2023
|
||||||||||||
20,000
|
5,000
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
20,000
|
5,000
|
2.43
|
9.73
|
24/02/2023
|
|||||||||||||
95,000
|
23,750
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
95,000
|
23,750
|
1.34
|
5.35
|
07/09/2024
|
|||||||||||||
20,000
|
5,000
|
1.34
|
5.35
|
07/09/2024
|
Number of ‘A’
Ordinary Shares
Subject to Option
|
Range of
Exercise Price
per Ordinary Share
|
Range of Exercise Price
per ADS
|
||||||||||
Total options outstanding
|
12,303,990
|
|
US$0.46-US$4.36
|
|
US$1.83-US$17.45
|
Number of ‘A’
Ordinary Shares Beneficially Owned
|
Number of
ADSs Beneficially Owned |
Percentage
‘A’ Ordinary
Shares (8) |
Percentage
Total Voting
Power |
|||||||||||||
Stonehill Capital Management, LLC
|
12,010,288
|
3,002,572
|
11.1
|
%
|
11.1
|
%
|
||||||||||
Paradice Investment Management, LLC
|
6,172,460
|
1,543,115
|
5.7
|
%
|
5.7
|
%
|
||||||||||
Hunter Associates, Inc.
|
5,918,000
|
1,479,500
|
5.5
|
%
|
5.5
|
%
|
||||||||||
Ronan O’Caoimh
|
14,161,496
|
(1)
|
3,540,374
|
13.1
|
%
|
13.1
|
%
|
|||||||||
Jim Walsh
|
2,303,611
|
(2)
|
575,903
|
2.1
|
%
|
2.1
|
%
|
|||||||||
Denis Burger
|
496,000
|
(3)
|
124,000
|
0.5
|
%
|
0.5
|
%
|
|||||||||
Clint Severson
|
558,000
|
(4)
|
139,500
|
0.5
|
%
|
0.5
|
%
|
|||||||||
James Merselis
|
458,600
|
(5)
|
114,650
|
0.4
|
%
|
0.4
|
%
|
|||||||||
Kevin Tansley
|
1,514,000
|
(6)
|
378,500
|
1.4
|
%
|
1.4
|
%
|
|||||||||
Directors & Co. Secretary as a group (6 persons)
|
19,491,707
|
(1)(2)(3)(4)(5)(6)(7)
|
4,872,927
|
18.0
|
%
|
18.0
|
%
|
(1) |
Includes 7,104,000 ‘A’ Ordinary shares issuable upon exercise of options issued to Darnick Company.
|
(2) |
Includes 910,000 ‘A’ Ordinary shares issuable upon exercise of options. Note that 1,200,000 ‘A’ Ordinary shares (300,000 ADSs) of Dr Walsh’s shares are held in trust for the benefit of Dr Walsh’s immediate family.
|
(3) |
Includes 496,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(4) |
Includes 250,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(5) |
Includes 250,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(6) |
Includes 1,364,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(7) |
Percentage ‘A’ Ordinary shares is based upon total outstanding ‘A’ Ordinary shares and total number of shares issuable upon exercise of options.
|
Year Ended December 31
|
High
|
Low
|
||||||
US$
|
US$
|
|||||||
2015
|
20.24
|
10.74
|
||||||
2016
|
13.68
|
5.76
|
||||||
2017
|
7.04
|
4.50
|
||||||
2018
|
6.06
|
2.14
|
||||||
2019
|
3.22
|
0.69
|
2019
|
High
|
Low
|
||||||
US$
|
US$
|
|||||||
Quarter ended March 31
|
3.22
|
2.31
|
||||||
Quarter ended June 30
|
3.02
|
1.57
|
||||||
Quarter ended September 30
|
2.59
|
1.21
|
||||||
Quarter ended December 31
|
1.20
|
0.69
|
Month Ended
|
High
|
Low
|
||||||
March 31, 2019
|
3.22
|
2.40
|
||||||
April 30, 2019
|
3.02
|
2.68
|
||||||
May 31, 2019
|
2.83
|
2.15
|
||||||
June 30, 2019
|
2.16
|
1.57
|
||||||
July 31, 2019
|
2.59
|
1.63
|
||||||
August 31, 2019
|
2.22
|
1.30
|
||||||
September 30, 2019
|
1.42
|
1.21
|
||||||
October 31, 2019
|
1.20
|
0.69
|
||||||
November 30, 2019
|
1.03
|
0.80
|
||||||
December 31, 2019
|
1.09
|
0.92
|
||||||
January 31, 2020
|
1.47
|
1.03
|
||||||
February 28, 2020
|
1.43
|
0.95
|
||||||
March 31, 2020
|
1.40
|
0.62
|
||||||
April 30, 2020
|
1.59
|
0.88
|
||||||
May 31, 2020
|
1.77
|
1.26
|
• |
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 $1.50 per certificate for ADRs or ADRs transferred
|
Person to whom Receipt is transferred.
|
• |
transfer and registration fees of securities on Trinity Biotech’s securities register to or from the name of the depositary or its agent when ADS holders deposit or withdrawal securities;
|
• |
expenses for cable, telex and fax transmissions and for delivery of securities;
|
• |
expenses incurred for converting foreign currency into U.S. dollars; and
|
• |
taxes and duties upon the transfer of securities (i.e., when ordinary shares are deposited or withdrawn from deposit, other than taxes for which Trinity Biotech is liable).
|
Item 14 |
Material Modifications to the Rights of Security Holders and Use of Proceeds
|
Item 15 |
Controls and Procedures
|
|
Year ended December 31,
2019
|
Year ended December 31,
2018
|
||||||||||||||
|
US$’000
|
US$’000
|
US$’000
|
%
|
||||||||||||
Audit
|
508
|
67
|
%
|
562
|
97
|
%
|
||||||||||
Audit-related
|
-
|
-
|
%
|
-
|
-
|
%
|
||||||||||
Tax
|
248
|
33
|
%
|
17
|
3
|
%
|
||||||||||
|
||||||||||||||||
Total
|
756
|
579
|
|
Year ended December 31
|
|||||||||||||||
|
Notes
|
2019
Total
US$‘000
|
2018
Total
US$‘000
|
2017
Total
US$‘000
|
||||||||||||
Revenues
|
2
|
90,435
|
97,035
|
99,140
|
||||||||||||
Cost of sales
|
(52,315
|
)
|
(55,586
|
)
|
(57,250
|
)
|
||||||||||
|
||||||||||||||||
Gross profit
|
38,120
|
41,449
|
41,890
|
|||||||||||||
Other operating income
|
5
|
91
|
102
|
100
|
||||||||||||
Research and development expenses
|
(5,325
|
)
|
(5,369
|
)
|
(5,657
|
)
|
||||||||||
Selling, general and administrative expenses
|
(27,661
|
)
|
(29,477
|
)
|
(32,246
|
)
|
||||||||||
Selling, general and administrative expenses – tax audit settlement
|
6
|
(5,042
|
)
|
-
|
-
|
|||||||||||
Impairment charges
|
7
|
(24,295
|
)
|
(26,932
|
)
|
(41,755
|
)
|
|||||||||
|
||||||||||||||||
Operating loss
|
(24,112
|
)
|
(20,227
|
)
|
(37,668
|
)
|
||||||||||
Financial income
|
2,8
|
697
|
2,124
|
3,198
|
||||||||||||
Financial expenses
|
2, 8
|
(6,582
|
)
|
(5,080
|
)
|
(5,405
|
)
|
|||||||||
|
||||||||||||||||
Net financing expense
|
(5,885
|
)
|
(2,956
|
)
|
(2,207
|
)
|
||||||||||
|
||||||||||||||||
Loss before tax
|
11
|
(29,997
|
)
|
(23,183
|
)
|
(39,875
|
)
|
|||||||||
Total income tax credit
|
2, 9
|
1,006
|
525
|
1,214
|
||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
2
|
(28,991
|
)
|
(22,658
|
)
|
(38,661
|
)
|
|||||||||
|
||||||||||||||||
Profit/(Loss) for the year on discontinued operations
|
10
|
77
|
568
|
(1,609
|
)
|
|||||||||||
|
||||||||||||||||
Loss for the year (all attributable to owners of the parent)
|
2
|
(28,914
|
)
|
(22,090
|
)
|
(40,270
|
)
|
|||||||||
|
||||||||||||||||
Basic loss per ADS (US Dollars) – continuing operations
|
12
|
(1.39
|
)
|
(1.08
|
)
|
(1.79
|
)
|
|||||||||
Diluted loss per ADS (US Dollars) – continuing operations
|
12
|
(1.39
|
)
|
(1.08
|
)
|
(1.79
|
)
|
|||||||||
Basic loss per ‘A’ ordinary share (US Dollars) –continuing operations
|
12
|
(0.35
|
)
|
(0.27
|
)
|
(0.45
|
)
|
|||||||||
Diluted loss per ‘A’ ordinary share (US Dollars) – continuing operations
|
12
|
(0.35
|
)
|
(0.27
|
)
|
(0.45
|
)
|
|||||||||
Basic loss per ADS (US Dollars) – group
|
12
|
(1.38
|
)
|
(1.06
|
)
|
(1.86
|
)
|
|||||||||
Diluted loss per ADS (US Dollars) – group
|
12
|
(1.38
|
)
|
(1.06
|
)
|
(1.86
|
)
|
|||||||||
Basic loss per ‘A’ ordinary share (US Dollars) – group
|
12
|
(0.35
|
)
|
(0.26
|
)
|
(0.47
|
)
|
|||||||||
Diluted loss per ‘A’ ordinary share (US Dollars) –group
|
12
|
(0.35
|
)
|
(0.26
|
)
|
(0.47
|
)
|
|
Year ended December 31
|
|||||||||||||||
|
Notes
|
2019
US$‘000
|
2018
US$‘000
|
2017
US$‘000
|
||||||||||||
Loss for the year
|
2
|
(28,914
|
)
|
(22,090
|
)
|
(40,270
|
)
|
|||||||||
Other comprehensive (loss)/income
|
||||||||||||||||
Items that will be reclassified subsequently to profit or loss
|
||||||||||||||||
Foreign exchange translation differences
|
(167
|
)
|
(520
|
)
|
3,086
|
|||||||||||
|
||||||||||||||||
Other comprehensive (loss)/income
|
(167
|
)
|
(520
|
)
|
3,086
|
|||||||||||
|
||||||||||||||||
Total Comprehensive Loss (all attributable to owners of the parent)
|
(29,081
|
)
|
(22,610
|
)
|
(37,184
|
)
|
|
At December 31
|
|||||||||||
|
Notes
|
2019
US$‘000
|
2018
US$‘000
|
|||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property, plant and equipment
|
13
|
9,290
|
5,362
|
|||||||||
Goodwill and intangible assets
|
14
|
43,654
|
52,951
|
|||||||||
Deferred tax assets
|
15
|
6,252
|
6,127
|
|||||||||
Other assets
|
16
|
485
|
558
|
|||||||||
|
||||||||||||
Total non-current assets
|
59,681
|
64,998
|
||||||||||
|
||||||||||||
Current assets
|
||||||||||||
Inventories
|
17
|
32,021
|
30,359
|
|||||||||
Trade and other receivables
|
18
|
20,987
|
24,441
|
|||||||||
Income tax receivable
|
1,982
|
1,584
|
||||||||||
Cash and cash equivalents
|
19
|
15,231
|
30,277
|
|||||||||
Short term investments
|
20
|
1,169
|
-
|
|||||||||
|
||||||||||||
Total current assets
|
71,390
|
86,661
|
||||||||||
|
||||||||||||
TOTAL ASSETS
|
2
|
131,071
|
151,659
|
|||||||||
|
||||||||||||
EQUITY AND LIABILITIES
|
||||||||||||
Equity attributable to the equity holders of the parent
|
||||||||||||
Share capital
|
21
|
1,213
|
1,213
|
|||||||||
Share premium
|
21
|
16,187
|
16,187
|
|||||||||
Treasury shares
|
21
|
(24,922
|
)
|
(24,922
|
)
|
|||||||
Accumulated surplus
|
21
|
16,145
|
55,319
|
|||||||||
Translation reserve
|
21
|
(3,933
|
)
|
(3,766
|
)
|
|||||||
Other reserves
|
21
|
23
|
23
|
|||||||||
|
||||||||||||
Total equity
|
4,713
|
44,054
|
||||||||||
|
||||||||||||
Current liabilities
|
||||||||||||
Income tax payable
|
48
|
210
|
||||||||||
Trade and other payables
|
23
|
16,947
|
16,908
|
|||||||||
Provisions
|
24
|
50
|
50
|
|||||||||
Lease liabilities
|
26
|
2,404
|
436
|
|||||||||
|
||||||||||||
Total current liabilities
|
19,449
|
17,604
|
||||||||||
|
||||||||||||
Non-current liabilities
|
||||||||||||
Exchangeable notes
|
25
|
82,021
|
81,382
|
|||||||||
Derivative financial instruments
|
25
|
4
|
238
|
|||||||||
Lease liabilities
|
26
|
17,745
|
526
|
|||||||||
Deferred tax liabilities
|
15
|
7,139
|
7,855
|
|||||||||
|
||||||||||||
Total non-current liabilities
|
106,909
|
90,001
|
||||||||||
|
||||||||||||
TOTAL LIABILITIES
|
2
|
126,358
|
107,605
|
|||||||||
|
||||||||||||
TOTAL EQUITY AND LIABILITIES
|
131,071
|
151,659
|
|
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, 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 22)
|
-
|
-
|
-
|
-
|
(4,529
|
)
|
-
|
4,529
|
-
|
|||||||||||||||||||||||
Share-based payments (Note 22)
|
-
|
-
|
-
|
-
|
-
|
-
|
1,109
|
1,109
|
||||||||||||||||||||||||
Shares purchased (Note 21)
|
-
|
-
|
(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 loss
|
-
|
-
|
-
|
(520
|
)
|
-
|
-
|
(22,090
|
)
|
(22,610
|
)
|
|||||||||||||||||||||
Share-based payments (Note 22)
|
-
|
-
|
-
|
-
|
-
|
-
|
1,607
|
1,607
|
||||||||||||||||||||||||
Shares purchased (Note 21)
|
-
|
-
|
(139
|
)
|
-
|
-
|
-
|
-
|
(139
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2018
|
1,213
|
16,187
|
(24,922
|
)
|
(3,766
|
)
|
-
|
23
|
55,319
|
44,054
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at January 1, 2019
|
1,213
|
16,187
|
(24,922
|
)
|
(3,766
|
)
|
-
|
23
|
55,319
|
44,054
|
||||||||||||||||||||||
Loss for the period
|
-
|
-
|
-
|
-
|
-
|
-
|
(28,914
|
)
|
(28,914
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
-
|
-
|
-
|
(167
|
)
|
-
|
-
|
-
|
(167
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total comprehensive loss
|
-
|
-
|
-
|
(167
|
)
|
-
|
-
|
(28,914
|
)
|
(29,081
|
)
|
|||||||||||||||||||||
Share-based payments (Note 22)
|
-
|
-
|
-
|
-
|
-
|
-
|
839
|
839
|
||||||||||||||||||||||||
Adjustment on transition to IFRS 16 (Note 13)
|
-
|
-
|
-
|
-
|
-
|
-
|
(11,099
|
)
|
(11,099
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2019
|
1,213
|
16,187
|
(24,922
|
)
|
(3,933
|
)
|
-
|
23
|
16,145
|
4,713
|
|
Year ended December 31,
|
|||||||||||||||
|
Notes
|
|
2019
US$‘000
|
|
2018
US$‘000
|
|
2017
US$‘000
|
|||||||||
Cash flows from operating activities
|
||||||||||||||||
Loss for the year
|
(28,914
|
)
|
(22,090
|
)
|
(40,270
|
)
|
||||||||||
Adjustments to reconcile net loss to cash provided by operating activities:
|
||||||||||||||||
Depreciation
|
11
|
2,526
|
1,296
|
1,896
|
||||||||||||
Amortisation
|
11,14
|
2,368
|
2,825
|
3,303
|
||||||||||||
Income tax (credit) / expense
|
(1,006
|
)
|
(1,115
|
)
|
(374
|
)
|
||||||||||
Financial income
|
8
|
(697
|
)
|
(2,124
|
)
|
(3,198
|
)
|
|||||||||
Financial expense
|
8
|
6,582
|
5,080
|
5,405
|
||||||||||||
Share-based payments
|
22
|
758
|
1,369
|
928
|
||||||||||||
Foreign exchange (gains)/losses on operating cash flows
|
(93
|
)
|
311
|
307
|
||||||||||||
Loss on disposal or retirement of property, plant and equipment
|
11
|
17
|
15
|
3
|
||||||||||||
Movement in inventory provision
|
17
|
1,567
|
300
|
2,275
|
||||||||||||
Impairment of prepayments
|
7, 18
|
1,376
|
1,608
|
1,651
|
||||||||||||
Impairment of property, plant and equipment
|
7, 13
|
6,349
|
6,112
|
10,437
|
||||||||||||
Impairment of intangible assets
|
7, 14
|
16,570
|
19,212
|
29,667
|
||||||||||||
Provision for closure costs
|
10
|
-
|
-
|
(1,794
|
)
|
|||||||||||
Other non-cash items
|
835
|
570
|
(728
|
)
|
||||||||||||
Operating cash flows before changes in working capital
|
8,238
|
13,369
|
9,508
|
|||||||||||||
(Increase) / decrease in trade and other receivables
|
445
|
(5,960
|
)
|
306
|
||||||||||||
Decrease / (increase) in inventories
|
(2,959
|
)
|
1,988
|
(2,461
|
)
|
|||||||||||
(Decrease) / increase in trade and other payables
|
151
|
(3,419
|
)
|
2,017
|
||||||||||||
|
||||||||||||||||
Cash generated from operations
|
5,875
|
5,978
|
9,370
|
|||||||||||||
Interest paid
|
(1,000
|
)
|
(39
|
)
|
(53
|
)
|
||||||||||
Interest received
|
560
|
874
|
776
|
|||||||||||||
Income taxes received / (paid)
|
(18
|
)
|
416
|
(843
|
)
|
|||||||||||
Net cash generated by operating activities
|
5,417
|
7,229
|
9,250
|
|||||||||||||
|
||||||||||||||||
Cash flows from investing activities
|
||||||||||||||||
Payments to acquire intangible assets
|
(9,718
|
)
|
(9,863
|
)
|
(10,229
|
)
|
||||||||||
Acquisition of property, plant and equipment
|
(2,118
|
)
|
(7,528
|
)
|
(4,839
|
)
|
||||||||||
Disposal of property, plant and equipment
|
(17
|
)
|
||||||||||||||
Licence fees
|
23
|
-
|
-
|
(1,112
|
)
|
|||||||||||
|
||||||||||||||||
Net cash used in investing activities
|
(11,853
|
)
|
(17,391
|
)
|
(16,180
|
)
|
||||||||||
|
||||||||||||||||
Cash flows from financing activities
|
||||||||||||||||
Share buyback
|
-
|
(434
|
)
|
(7,799
|
)
|
|||||||||||
Interest payment on exchangeable notes
|
30
|
(3,996
|
)
|
(4,503
|
)
|
(4,600
|
)
|
|||||||||
Purchase of exchangeable notes
|
30
|
-
|
(12,042
|
)
|
-
|
|||||||||||
Proceeds from sale & leaseback transactions
|
-
|
481
|
51
|
|||||||||||||
Payment of lease liabilities
|
30
|
(3,533
|
)
|
(374
|
)
|
(295
|
)
|
|||||||||
|
||||||||||||||||
Net cash used in financing activities
|
(7,529
|
)
|
(16,872
|
)
|
(12,643
|
)
|
||||||||||
|
||||||||||||||||
Decrease in cash and cash equivalents and short term investments
|
(13,965
|
)
|
(27,034
|
)
|
(19,573
|
)
|
||||||||||
Effects of exchange rate movements on cash held
|
88
|
(296
|
)
|
71
|
||||||||||||
Cash and cash equivalents and short-term investments at beginning of year
|
30,277
|
57,607
|
77,109
|
|||||||||||||
|
||||||||||||||||
Cash and cash equivalents and short term investments at end of year
|
19,20
|
16,400
|
30,277
|
57,607
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES
|
i) |
General information
|
ii) |
Statement of compliance
|
iii) |
Basis of preparation
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
iv) |
Basis of consolidation
|
v) |
Property, plant and equipment
|
• Leasehold improvements
|
5-15 years
|
|
• Buildings
|
50 years
|
|
• Office equipment and fittings
|
10 years
|
|
• Computer equipment
|
3-5 years
|
|
• Plant and equipment
|
5-15 years
|
• |
the contract contains an identified asset, which is either explicitly identified in the contract or implicitly specified by being identified at the time the asset is made available to the Group
|
• |
the Group has the right to obtain substantially all of the economic benefits from use of the identified asset throughout the period of use, considering its rights within the defined scope of the contract
|
• |
the Group has the right to direct the use of the identified asset throughout the period of use. The Group assess whether it has the right to direct ‘how and for what purpose’ the asset is used throughout the period of use.
|
1.
|
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
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
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
ix) |
Inventories
|
x) |
Trade and other receivables
|
xi) |
Trade and other payables
|
xii) |
Cash and cash equivalents
|
xiii) |
Short-term investments
|
xiv) |
Share-based payments
|
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 3
|
Business Combinations
|
January 1, 2020 (issued by the IASB with effectivity date of January 1, 2020)
|
IFRS 8
|
Operating Segments
|
January 1, 2020 (issued by the IASB with effectivity date of January 1, 2020)
|
IFRS 9
|
Financial Instruments
|
January 1, 2020 (issued by the IASB with effectivity date of January 1, 2020)
|
IAS 39
|
Financial Instruments
|
January 1, 2020 (issued by the IASB with effectivity date of January 1, 2020)
|
1.
|
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
Carrying amount at December 31, 2018
|
Re-measurement
|
Impairment
|
IFRS 16 carrying amount at January 1, 2019
|
|||||||||||||
US$000
|
US$000
|
US$000
|
US$000
|
|||||||||||||
Property, plant & equipment
|
5,362
|
21,185
|
(11,099
|
)
|
15,448
|
|||||||||||
Lease liabilities
|
(962
|
)
|
(21,185
|
)
|
-
|
(22,147
|
)
|
|||||||||
Retaining earnings
|
(55,319
|
)
|
-
|
11,099
|
(44,220
|
)
|
||||||||||
Total
|
(50,919
|
)
|
-
|
-
|
(50,919
|
)
|
2. |
SEGMENT INFORMATION
|
i) |
The distribution of revenue by geographical area based on location of assets was as follows:
|
|
Rest of World
|
|||||||||||||||||||
Revenue
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
Year ended December 31, 2019
|
US$‘000
|
US$‘000
|
US$‘000
|
US$’000
|
US$‘000
|
|||||||||||||||
Revenue from external customers
|
64,045
|
26,390
|
-
|
-
|
90,435
|
|||||||||||||||
Inter-segment revenue
|
39,563
|
1,629
|
-
|
(41,192
|
)
|
-
|
||||||||||||||
|
||||||||||||||||||||
Total revenue
|
103,608
|
28,019
|
-
|
(41,192
|
)
|
90,435
|
|
Rest of World
|
|||||||||||||||||||
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
Year ended December 31, 2018
|
US$‘000
|
US$‘000
|
US$‘000
|
US$’000
|
US$‘000
|
|||||||||||||||
Revenue from external customers
|
65,863
|
31,172
|
-
|
-
|
97,035
|
|||||||||||||||
Inter-segment revenue
|
38,665
|
2,899
|
-
|
(41,564
|
)
|
-
|
||||||||||||||
|
||||||||||||||||||||
Total revenue
|
104,528
|
34,071
|
-
|
(41,564
|
)
|
97,035
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
|
Rest of World
|
|||||||||||||||||||
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
Year ended December 31, 2017
|
US$‘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
|
ii) |
The distribution of revenue by customers’ geographical area was as follows:
|
Revenue
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Americas
|
52,183
|
57,559
|
59,539
|
|||||||||
Asia / Africa
|
27,686
|
29,466
|
27,131
|
|||||||||
Europe (including Ireland) *
|
10,566
|
10,010
|
12,470
|
|||||||||
|
||||||||||||
|
90,435
|
97,035
|
99,140
|
* |
Revenue from customers in Ireland is not disclosed separately due to the immateriality of these revenues.
|
iii) |
The distribution of revenue by major product group was as follows:
|
Revenue
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Clinical laboratory
|
68,127
|
71,618
|
73,366
|
|||||||||
Point-of-Care
|
11,393
|
14,836
|
16,774
|
|||||||||
Laboratory services
|
10,915
|
10,581
|
9,000
|
|||||||||
|
||||||||||||
|
90,435
|
97,035
|
99,140
|
iv) |
The group has recognised the following amounts relating to revenue in the consolidated statement of operations:
|
Revenue
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Revenue from contracts with customers (a)
|
90,435
|
97,035
|
99,140
|
|||||||||
Revenue from other sources
|
-
|
-
|
-
|
|||||||||
|
||||||||||||
|
90,435
|
97,035
|
99,140
|
(a) |
Disaggregation of revenue from contracts with customers:
|
Timing of revenue recognition
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2019
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
63,300
|
26,390
|
—
|
89,690
|
||||||||||||
Over time
|
745
|
—
|
—
|
745
|
||||||||||||
|
||||||||||||||||
Total
|
64,045
|
26,390
|
—
|
90,435
|
Timing of revenue recognition
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2018
|
US$‘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$‘000
|
||||||||||||
At a point in time
|
65,164
|
33,048
|
—
|
98,212
|
||||||||||||
Over time
|
928
|
—
|
—
|
928
|
||||||||||||
|
||||||||||||||||
Total
|
66,092
|
33,048
|
—
|
99,140
|
(b) |
The Group derives revenue from the transfer of goods and services over time and at a point in time based on customers’ geographical area as follows:
|
Timing of revenue recognition
|
Americas
|
Asia / Africa
|
Europe
|
Total
|
||||||||||||
Year ended December 31, 2019
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
51,438
|
27,686
|
10,566
|
89,690
|
||||||||||||
Over time
|
745
|
—
|
—
|
745
|
||||||||||||
|
||||||||||||||||
Total
|
52,183
|
27,686
|
10,566
|
90,435
|
Timing of revenue recognition
|
Americas
|
Asia / Africa
|
Europe
|
Total
|
||||||||||||
Year ended December 31, 2018
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
56,637
|
29,466
|
10,010
|
96,113
|
||||||||||||
Over time
|
922
|
—
|
—
|
922
|
||||||||||||
|
||||||||||||||||
Total
|
57,559
|
29,466
|
10,010
|
97,035
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
Timing of revenue recognition
|
Americas
|
Asia / Africa
|
Europe
|
Total
|
||||||||||||
Year ended December 31, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
At a point in time
|
58,611
|
27,131
|
12,470
|
98,212
|
||||||||||||
Over time
|
928
|
-
|
-
|
928
|
||||||||||||
|
||||||||||||||||
Total
|
59,539
|
27,131
|
12,470
|
99,140
|
v) |
The distribution of segment results by geographical area was as follows:
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2019
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result before impairment and unallocated expenses
|
5,239
|
(4,334
|
)
|
(108
|
)
|
797
|
||||||||||
Impairment
|
(14,562
|
)
|
(9,733
|
)
|
—
|
(24,295
|
)
|
|||||||||
|
||||||||||||||||
Result after impairment
|
(9,323
|
)
|
(14,067
|
)
|
(108
|
)
|
(23,498
|
)
|
||||||||
Unallocated expenses *
|
(614
|
)
|
||||||||||||||
|
||||||||||||||||
Operating loss
|
(24,112
|
)
|
||||||||||||||
Net financing expense (Note 8)
|
(5,885
|
)
|
||||||||||||||
|
||||||||||||||||
Loss before tax
|
(29,997
|
)
|
||||||||||||||
Income tax credit (Note 9)
|
1,006
|
|||||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
(28,991
|
)
|
||||||||||||||
Profit for the year on discontinued operations (Note 10)
|
77
|
|||||||||||||||
|
||||||||||||||||
Loss for the year
|
(28,914
|
)
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2018
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result before impairment and unallocated expenses
|
5,514
|
1,900
|
(44
|
)
|
7,370
|
|||||||||||
Impairment
|
(19,095
|
)
|
(7,837
|
)
|
—
|
(26,932
|
)
|
|||||||||
|
||||||||||||||||
Result after impairment
|
(13,581
|
)
|
(5,937
|
)
|
(44
|
)
|
(19,562
|
)
|
||||||||
Unallocated expenses *
|
(665
|
)
|
||||||||||||||
|
||||||||||||||||
Operating loss
|
(20,227
|
)
|
||||||||||||||
Net financing expense (Note 8)
|
(2,956
|
)
|
||||||||||||||
|
||||||||||||||||
Loss before tax
|
(23,183
|
)
|
||||||||||||||
Income tax credit (Note 9)
|
525
|
|||||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
(22,658
|
)
|
||||||||||||||
Loss for the year on discontinued operations (Note 10)
|
568
|
|||||||||||||||
|
||||||||||||||||
Loss for the year
|
(22,090
|
)
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result before exceptional expenses
|
3,744
|
1,125
|
(44
|
)
|
4,825
|
|||||||||||
Impairment
|
(9,194
|
)
|
(32,561
|
)
|
—
|
(41,755
|
)
|
|||||||||
|
||||||||||||||||
Result after exceptional expenses
|
(5,450
|
)
|
(31,436
|
)
|
(44
|
)
|
(36,930
|
)
|
||||||||
Unallocated expenses *
|
(738
|
)
|
||||||||||||||
|
||||||||||||||||
Operating profit
|
(37,668
|
)
|
||||||||||||||
Net financing expense (Note 8)
|
(2,207
|
)
|
||||||||||||||
|
||||||||||||||||
Loss before tax
|
(39,875
|
)
|
||||||||||||||
Income tax credit (Note 9)
|
1,214
|
|||||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
(38,661
|
)
|
||||||||||||||
Loss for the year on discontinued operations (Note 10)
|
(1,609
|
)
|
||||||||||||||
|
||||||||||||||||
Loss for the year
|
(40,270
|
)
|
* |
Unallocated expenses represent head office general and administration costs of the Group, which cannot be allocated to the results of any specific geographical area.
|
vi) |
The distribution of segment assets and segment liabilities by geographical area was as follows:
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
As at December 31, 2019
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Assets and liabilities
|
||||||||||||||||
Segment assets
|
69,224
|
37,212
|
1
|
106,437
|
||||||||||||
Unallocated assets:
|
||||||||||||||||
Income tax assets (current and deferred)
|
8,234
|
|||||||||||||||
Cash and cash equivalents and short-term investments
|
16,400
|
|||||||||||||||
Total assets as reported in the Group balance sheet
|
131,071
|
|||||||||||||||
|
||||||||||||||||
Segment liabilities
|
14,575
|
104,396
|
200
|
119,171
|
||||||||||||
Unallocated liabilities:
|
||||||||||||||||
Income tax liabilities (current and deferred)
|
7,187
|
|||||||||||||||
|
||||||||||||||||
Total liabilities as reported in the Group balance sheet
|
126,358
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
As at December 31, 2018
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Assets and liabilities
|
||||||||||||||||
Segment assets
|
75,658
|
38,009
|
4
|
113,671
|
||||||||||||
Unallocated assets:
|
||||||||||||||||
Income tax assets (current and deferred)
|
7,711
|
|||||||||||||||
Cash and cash equivalents and short-term investments
|
30,277
|
|||||||||||||||
|
||||||||||||||||
Total assets as reported in the Group balance sheet
|
151,659
|
|||||||||||||||
|
||||||||||||||||
Segment liabilities
|
||||||||||||||||
Unallocated liabilities:
|
8,946
|
90,444
|
150
|
99,540
|
||||||||||||
Income tax liabilities (current and deferred)
|
8,065
|
|||||||||||||||
|
||||||||||||||||
Total liabilities as reported in the Group balance sheet
|
107,605
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
vii) |
The distribution of long-lived assets, which are property, plant and equipment, goodwill and intangible assets and other non-current assets (excluding deferred tax assets), by geographical area was as follows:
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
||||||
Rest of World – Ireland
|
14,626
|
14,864
|
||||||
Americas
|
38,803
|
44,007
|
||||||
|
||||||||
|
53,429
|
58,871
|
viii) |
The distribution of depreciation and amortisation by geographical area was as follows:
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Depreciation:
|
||||||||||||
Rest of World – Ireland
|
322
|
74
|
1,186
|
|||||||||
Americas
|
2,208
|
1,301
|
1,238
|
|||||||||
|
||||||||||||
|
2,530
|
1,375
|
2,424
|
|||||||||
|
||||||||||||
Amortisation:
|
||||||||||||
Rest of World – Ireland
|
642
|
655
|
1,164
|
|||||||||
Americas
|
1,726
|
2,170
|
2,139
|
|||||||||
|
||||||||||||
|
2,368
|
2,825
|
3,303
|
ix) |
The distribution of share-based payment expense by geographical area was as follows:
|
|
December 31, 2019
US$‘000 |
December 31, 2018
US$‘000 |
December 31, 2017
US$‘000 |
|||||||||
Rest of World – Ireland
|
659
|
1,265
|
841
|
|||||||||
Americas
|
99
|
104
|
87
|
|||||||||
|
||||||||||||
|
758
|
1,369
|
928
|
|||||||||
Share based-payments – discontinued operations
|
—
|
—
|
—
|
|||||||||
|
||||||||||||
|
758
|
1,369
|
928
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
x) |
The distribution of interest income and interest expense by geographical area was as follows:
|
|
Rest of World
|
|||||||||||||||||||
Interest Income
Year ended December 31, 2019
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$‘000
|
Total
US$‘000
|
|||||||||||||||
Interest income earned
|
47
|
417
|
—
|
—
|
464
|
|||||||||||||||
Non-cash financial income
|
—
|
233
|
—
|
—
|
233
|
|||||||||||||||
Inter-segment interest income
|
—
|
—
|
4,853
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
47
|
650
|
4,853
|
(4,853
|
)
|
697
|
|
Rest of World
|
|||||||||||||||||||
Interest Expense
Year ended December 31, 2019
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$‘000
|
Total
US$’000
|
|||||||||||||||
Interest on finance leases
|
294
|
653
|
—
|
—
|
947
|
|||||||||||||||
Interest on tax audit settlement (Note 6)
|
—
|
1,000
|
—
|
—
|
1,000
|
|||||||||||||||
Cash interest on exchangeable notes
|
—
|
3,996
|
—
|
—
|
3,996
|
|||||||||||||||
Non-cash interest on exchangeable notes ( Note 25)
|
—
|
639
|
—
|
—
|
639
|
|||||||||||||||
Inter-segment interest expense
|
4,853
|
—
|
—
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
5,147
|
6,288
|
—
|
(4,853
|
)
|
6,582
|
|
Rest of World
|
|||||||||||||||||||
Interest Income
Year ended December 31, 2018
|
Americas
|
Ireland
|
Other
|
Eliminations
|
Total
|
|||||||||||||||
US$‘000
|
US$‘000
|
US$‘000
|
US$’000
|
US$‘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$‘000
|
|||||||||||||||
Interest on finance leases
|
7
|
32
|
—
|
—
|
39
|
|||||||||||||||
Cash interest on exchangeable notes
|
—
|
4,352
|
—
|
—
|
4,352
|
|||||||||||||||
Non-cash interest on exchangeable notes ( Note 25)
|
—
|
689
|
—
|
—
|
689
|
|||||||||||||||
Inter-segment interest expense
|
4,853
|
—
|
—
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
4,860
|
5,073
|
—
|
(4,853
|
)
|
5,080
|
|
Rest of World
|
|||||||||||||||||||
Interest Income
Year ended December 31, 2017
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$’000
|
Total
US$‘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
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
|
Rest of World
|
|||||||||||||||||||
Interest Expense
Year ended December 31, 2017
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$’000
|
Total
US$‘000
|
|||||||||||||||
Interest on deferred consideration and licence fee
|
—
|
40
|
—
|
—
|
40
|
|||||||||||||||
Interest on finance leases
|
—
|
42
|
—
|
—
|
42
|
|||||||||||||||
Cash interest on exchangeable notes
|
—
|
4,600
|
—
|
—
|
4,600
|
|||||||||||||||
Non-cash interest on exchangeable notes (Note 25)
|
—
|
723
|
—
|
—
|
723
|
|||||||||||||||
Inter-segment interest expense
|
4,853
|
—
|
—
|
(4,853
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
4,853
|
5,405
|
—
|
(4,853
|
)
|
5,405
|
xi) |
The distribution of taxation (expense)/credit by geographical area was as follows:
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Rest of World – Ireland
|
831
|
(59
|
)
|
192
|
||||||||
Rest of World – Other
|
—
|
(3
|
)
|
(81
|
)
|
|||||||
Americas
|
175
|
587
|
1,103
|
|||||||||
|
||||||||||||
|
1,006
|
525
|
1,214
|
xii) |
During 2019, 2018 and 2017 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, 2019
US$‘000
|
December 31, 2018
US$‘000
|
||||||
Rest of World – Ireland
|
20,758
|
7,148
|
||||||
Rest of World – Other
|
-
|
1,746
|
||||||
Americas
|
12,863
|
8,911
|
||||||
|
||||||||
|
33,621
|
17,805
|
3. |
PERSONNEL EXPENSES
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Wages and salaries
|
25,885
|
26,475
|
26,316
|
|||||||||
Social welfare costs
|
2,538
|
2,585
|
2,424
|
|||||||||
Pension costs
|
503
|
490
|
459
|
|||||||||
Tax settlement (Note 6)
|
5,094
|
—
|
—
|
|||||||||
Share-based payments
|
758
|
1,369
|
928
|
|||||||||
|
||||||||||||
|
34,778
|
30,919
|
30,127
|
3. |
PERSONNEL EXPENSES (CONTINUED)
|
|
December 31, 2019
|
December 31, 2018
|
December 31, 2017
|
|||||||||
Research and development
|
57
|
59
|
60
|
|||||||||
Administration and sales
|
159
|
163
|
162
|
|||||||||
Manufacturing and quality
|
363
|
353
|
334
|
|||||||||
|
||||||||||||
|
579
|
575
|
556
|
4. |
PENSION SCHEMES
|
5. |
OTHER OPERATING INCOME
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Rental income from premises
|
3
|
3
|
-
|
|||||||||
Other income
|
88
|
99
|
100
|
|||||||||
|
||||||||||||
|
91
|
102
|
100
|
6. |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES – TAX AUDIT SETTLEMENT
|
7. |
IMPAIRMENT CHARGES
|
• |
The Company’s market capitalisation at the end of the year that was lower when compared to the end of 2018.
|
• |
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, 2019
|
31, 2018
|
31, 2017
|
||||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Selling, general & administration expenses
|
||||||||||||
Impairment of PP&E (Note 13)
|
6,349
|
6,112
|
10,437
|
|||||||||
Impairment of goodwill and other intangible assets (Note 14)
|
16,570
|
19,212
|
29,667
|
|||||||||
Impairment of prepayments (Note 18)
|
1,376
|
1,608
|
1,651
|
|||||||||
|
||||||||||||
Total impairment loss
|
24,295
|
26,932
|
41,755
|
|||||||||
|
(
|
|||||||||||
Income tax impact of impairment loss
|
148
|
(1,752
|
)
|
(517
|
)
|
|||||||
|
||||||||||||
Total impairment loss after tax
|
24,443
|
25,180
|
41,238
|
8. |
FINANCIAL INCOME AND EXPENSES
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Financial income:
|
||||||||||||
Non-cash financial income
|
233
|
1,388
|
2,390
|
|||||||||
Interest income
|
464
|
736
|
808
|
|||||||||
|
||||||||||||
|
697
|
2,124
|
3,198
|
|||||||||
|
||||||||||||
Financial expense:
|
||||||||||||
Interest on leases
|
(947
|
)
|
(39
|
)
|
(42
|
)
|
||||||
Interest on tax audit settlement (Note 6)
|
(1,000
|
)
|
-
|
-
|
||||||||
Cash interest on exchangeable notes
|
(3,996
|
)
|
(4,352
|
)
|
(4,600
|
)
|
||||||
Non-cash interest on exchangeable notes (Note 25)
|
(639
|
)
|
(689
|
)
|
(723
|
)
|
||||||
Interest on deferred consideration and licence fee
|
-
|
-
|
(40
|
)
|
||||||||
|
||||||||||||
|
(6,582
|
)
|
(5,080
|
)
|
(5,405
|
)
|
||||||
Net Financing Expense
|
(5,885
|
)
|
(2,956
|
)
|
(2,207
|
)
|
9. |
INCOME TAX CREDIT
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Current tax (credit)/expense
|
||||||||||||
Irish Corporation tax
|
(312
|
)
|
(258
|
)
|
(51
|
)
|
||||||
Foreign taxes (a)
|
197
|
195
|
358
|
|||||||||
Adjustment in respect of prior years
|
(50
|
)
|
(56
|
)
|
150
|
|||||||
|
||||||||||||
Total current tax (credit)/expense
|
(165
|
)
|
(119
|
)
|
457
|
|||||||
|
||||||||||||
Deferred tax credit (b)
|
||||||||||||
Origination and reversal of temporary differences (see Note 15)
|
(841
|
)
|
(2,031
|
)
|
(5,969
|
)
|
||||||
Origination and reversal of net operating losses (see Note 15)
|
-
|
1,625
|
4,298
|
|||||||||
|
||||||||||||
Total deferred tax credit
|
(841
|
)
|
(406
|
)
|
(1,671
|
)
|
||||||
|
||||||||||||
Total income tax credit on continuing operations in statement of operations
|
(1,006
|
)
|
(525
|
)
|
(1,214
|
)
|
||||||
|
||||||||||||
Tax (credit)/charge on discontinued operations (see Note 10)
|
-
|
(590
|
)
|
323
|
||||||||
|
00
|
|||||||||||
Total tax credit
|
(1,006
|
)
|
(1,115
|
)
|
(891
|
)
|
(a) |
In 2019, the foreign taxes relate primarily to Canada.
|
(b) |
In 2019, there was a deferred tax credit of US$444,000 (2018: charge of US$369,000; 2017: credit of US$170,000) recognised in respect of Ireland and a deferred tax credit of US$397,000 (2018: credit of US$775,000; 2017: credit of
US$1,501,000) recognised in respect of overseas tax jurisdictions.
|
Effective tax rate
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Loss before taxation
|
(29,997
|
)
|
(23,183
|
)
|
(39,875
|
)
|
||||||
As a percentage of loss before tax:
|
||||||||||||
Current tax
|
(0.55
|
)%
|
(0.51
|
)%
|
1.14
|
%
|
||||||
Total (current and deferred)
|
(3.36
|
)%
|
(2.26
|
)%
|
(3.05
|
)%
|
|
December 31, 2019
|
December 31, 2018
|
December 31, 2017
|
|||||||||
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)
|
13.21
|
%
|
15.76
|
%
|
12.05
|
%
|
||||||
Effect of tax rates on overseas earnings
|
(3.05
|
)%
|
(6.10
|
)%
|
(2.09
|
)%
|
||||||
Effect of Irish income taxable at higher tax rate
|
0.04
|
%
|
0.05
|
%
|
-
|
|||||||
Adjustments in respect of prior years
|
(0.17
|
)%
|
0.94
|
%
|
0.38
|
%
|
||||||
Effect of changes in US tax code (b)
|
-
|
-
|
(1.89
|
)%
|
||||||||
R&D tax credits
|
(2.69
|
)%
|
(1.70
|
)%
|
(0.17
|
)%
|
||||||
Other items (c)
|
1.80
|
%
|
1.29
|
%
|
1.17
|
%
|
||||||
|
||||||||||||
Effective tax rate
|
(3.36
|
)%
|
(2.26
|
)%
|
(3.05
|
)%
|
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 15). 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$753,000 arising from the
reduction in deferred tax balances due to the tax rate change, partially offset by the effect of mandatory deemed repatriation of certain deferred foreign earnings. The other changes to the USA tax code did not have a material
impact on the Group.
|
(c) |
Other items comprise items not chargeable to tax/expenses not deductible for tax purposes. In 2019, other items mainly comprise the tax audit settlement recorded in Selling, General and Administrative expenses (see also Note
6), which is not deductible for tax. Additionally, the movement in the exchangeable notes’ embedded derivatives value and the accretion of notional interest on the Loan Note’s host contract, both of which are exempt from deferred
taxation recognition under IAS 12, Income Taxes.
|
Unrecognised deferred tax assets – continuing operations
|
Effect in
2019
US$’000
|
Percentage
effect in
2019
|
Effect in
2018
US$’000
|
Percentage
effect in
2018
|
||||||||||||
Increase in net operating losses arising in US
|
1,117
|
3.72
|
%
|
2,174
|
9.38
|
%
|
||||||||||
Temporary differences arising in US
|
129
|
0.43
|
%
|
19
|
0.08
|
%
|
||||||||||
Decrease in net operating losses arising in Brazil
|
608
|
2.03
|
%
|
(20
|
)
|
(0.09
|
)%
|
|||||||||
Increase in net operating losses arising in Ireland
|
2,110
|
7.03
|
%
|
1,482
|
6.39
|
%
|
||||||||||
|
||||||||||||||||
|
3,964
|
13.21
|
%
|
3,655
|
15.76
|
%
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Rest of World – Ireland
|
(20,318
|
)
|
(9,590
|
)
|
(35,821
|
)
|
||||||
Rest of World – Other
|
4,760
|
4,809
|
4,809
|
|||||||||
Americas
|
(14,439
|
)
|
(18,402
|
)
|
(8,863
|
)
|
||||||
|
||||||||||||
|
(29,997
|
)
|
(23,183
|
)
|
(39,875
|
)
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
USA
|
1,034
|
2,382
|
7,737
|
|||||||||
Ireland
|
73,754
|
60,629
|
57,206
|
|||||||||
Brazil
|
5,789
|
4,001
|
4,060
|
|||||||||
|
||||||||||||
|
80,577
|
67,012
|
69,003
|
9. |
INCOME TAX (CREDIT)/EXPENSE (CONTINUED)
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Ireland – unused tax losses
|
12,062
|
9,953
|
8,471
|
|||||||||
US – unused tax losses
|
3,291
|
2,174
|
-
|
|||||||||
US – unused tax credits
|
493
|
364
|
345
|
|||||||||
Brazil – unused tax losses
|
1,968
|
1,360
|
1,380
|
|||||||||
|
||||||||||||
Unrecognised deferred tax asset
|
17,814
|
13,851
|
10,196
|
10. |
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATION
|
10. |
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATION (CONTINUED)
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Revenues
|
—
|
—
|
—
|
|||||||||
Operating loss
|
—
|
—
|
—
|
|||||||||
|
||||||||||||
Loss for the year
|
—
|
—
|
—
|
|||||||||
Profit/(Loss) on re-measurement of assets and liabilities:
|
||||||||||||
Closure costs
|
(8
|
)
|
(22
|
)
|
1,794
|
|||||||
Foreign currency translation reserve
|
85
|
—
|
(3,080
|
)
|
||||||||
Tax credit/(expense)
|
—
|
590
|
(323
|
)
|
||||||||
|
||||||||||||
Total profit/(loss)
|
77
|
568
|
(1,609
|
)
|
||||||||
Profit/(Loss) for the year from discontinued operations
|
77
|
568
|
(1,609
|
)
|
10. | PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATION (CONTINUED) |
|
December 31,
2019 |
December 31,
2018 |
December 31,
2017 |
|||||||||
Basic earnings/(loss) per ADS (US Dollars) – discontinued operations
|
0.00
|
0.03
|
(0.07
|
)
|
||||||||
Diluted earnings/(loss per ADS (US Dollars) – discontinued operations
|
0.00
|
0.02
|
(0.07
|
)
|
||||||||
Basic earnings/(loss) per ‘A’ share (US Dollars) – discontinued operations
|
0.00
|
0.01
|
(0.02
|
)
|
||||||||
Diluted earnings/(loss) per ‘A’ share (US Dollars) – discontinued operations
|
0.00
|
0.01
|
(0.02
|
)
|
|
December 31,
2019 |
December 31,
2018 |
December 31,
2017 |
|||||||||
US$000
|
US$000
|
US$000
|
||||||||||
Cash flows from operating activities
|
(5
|
)
|
527
|
(2,847
|
)
|
|||||||
Cash flows from investing activities
|
-
|
-
|
-
|
11. |
LOSS BEFORE TAX
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Directors’ emoluments (including non- executive directors):
|
||||||||||||
Remuneration
|
1,238
|
1,261
|
1,800
|
|||||||||
Pension
|
42
|
44
|
44
|
|||||||||
Share based payments
|
624
|
1,204
|
727
|
|||||||||
Auditor’s remuneration
|
||||||||||||
Audit fees
|
523
|
506
|
568
|
|||||||||
Tax fees
|
172
|
15
|
73
|
|||||||||
Other non-audit fees
|
-
|
-
|
-
|
|||||||||
Depreciation*
|
2,526
|
1,296
|
1,896
|
|||||||||
Amortisation
|
2,368
|
2,825
|
3,303
|
|||||||||
Loss on the disposal of property, plant and equipment
|
17
|
15
|
3
|
|||||||||
Net foreign exchange differences**
|
(179
|
)
|
344
|
(17
|
)
|
* |
Note that US$4,000 (2018: US$79,000) (2017: US$528,000) of depreciation was capitalised to research and development projects during 2019 in line with the Group’s capitalisation policy for Intangible projects.
|
** |
The net foreign exchange differences in 2017 do not include US$440,000 which were included in the operating expenses that were stated in Note 10 in respect of the discontinued operations in Fiomi.
|
12. |
LOSS PER SHARE
|
|
December 31,
2019 |
December 31,
2018 |
December 31,
2017 |
|||||||||
‘A’ ordinary shares
|
83,606,810
|
83,612,908
|
86,486,409
|
|||||||||
|
||||||||||||
Basic earnings per share denominator
|
83,606,810
|
83,612,908
|
86,486,409
|
|||||||||
|
||||||||||||
Reconciliation to weighted average earnings per share denominator:
|
||||||||||||
Number of ‘A’ ordinary shares at January 1 (Note 21)
|
96,162,410
|
96,162,410
|
96,162,410
|
|||||||||
Weighted average number of shares issued during the year*
|
-
|
-
|
||||||||||
Weighted average number of treasury shares
|
(12,555,600
|
)
|
(12,549,502
|
)
|
(9,676,001
|
)
|
||||||
|
||||||||||||
Basic earnings per share denominator
|
83,606,810
|
83,612,908
|
86,486,409
|
|
December 31,
2019
|
December 31,
2018
|
December 31,
2017
|
|||||||||
Basic earnings per share denominator (see above)
|
83,606,810
|
83,612,908
|
86,486,409
|
|||||||||
Issuable on exercise of options and warrants
|
-
|
22,359
|
-
|
|||||||||
Issuable on conversion of exchangeable notes
|
18,263,254
|
19,873,553
|
21,023,770
|
|||||||||
|
||||||||||||
Diluted earnings per share denominator
|
101,870,064
|
103,508,820
|
107,510,179
|
12. |
LOSS PER SHARE (CONTINUED)
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
December 31, 2017
US$‘000
|
|||||||||
Loss after tax for the year
|
(28,914
|
)
|
(22,090
|
)
|
(40,270
|
)
|
||||||
Non-cash financial income (Note 8)
|
(233
|
)
|
(1,388
|
)
|
(2,390
|
)
|
||||||
Cash interest expense (Note 8)
|
3,996
|
4,352
|
4,600
|
|||||||||
Non-cash interest on exchangeable notes (Note 8)
|
639
|
689
|
723
|
|||||||||
|
||||||||||||
Adjusted loss after tax
|
(24,512
|
)
|
(18,437
|
)
|
(37,337
|
)
|
|
December 31,
2019
|
December 31,
2018
|
December 31,
2017
|
|||||||||
ADS
|
20,901,703
|
20,903,227
|
21,621,602
|
|||||||||
|
||||||||||||
Basic earnings per share denominator
|
20,901,703
|
20,903,227
|
21,621,602
|
|||||||||
|
||||||||||||
Reconciliation to weighted average earnings per share denominator:
|
||||||||||||
Number of ADS at January 1 (Note 21)
|
24,040,602
|
24,040,602
|
24,040,602
|
|||||||||
Weighted average number of shares issued during the year*
|
-
|
-
|
-
|
|||||||||
Weighted average number of treasury shares
|
(3,138,899
|
)
|
(3,137,375
|
)
|
(2,419,000
|
)
|
||||||
|
||||||||||||
Basic earnings per share denominator
|
20,901,703
|
20,903,227
|
21,621,602
|
|
December 31,
2019
|
December 31,
2018
|
December 31,
2017
|
|||||||||
Basic earnings per share denominator (see above)
|
20,901,703
|
20,903,227
|
21,621,602
|
|||||||||
Issuable on exercise of options and warrants
|
-
|
5,590
|
-
|
|||||||||
Issuable on conversion of exchangeable notes
|
4,565,814
|
4,968,388
|
5,255,942
|
|||||||||
|
||||||||||||
Diluted earnings per share denominator
|
25,467,517
|
25,877,205
|
26,877,544
|
13. |
PROPERTY, PLANT AND EQUIPMENT
|
|
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, 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
|
|||||||||||||||
|
||||||||||||||||||||
At January 1, 2019
|
2,605
|
4,560
|
6,585
|
40,064
|
53,814
|
|||||||||||||||
Adjustment on transition to IFRS 16
|
20,961
|
—
|
149
|
75
|
21,185
|
|||||||||||||||
Additions
|
681
|
71
|
168
|
1,905
|
2,825
|
|||||||||||||||
Disposals or retirements
|
—
|
(1,626
|
)
|
(2,610
|
)
|
(3,314
|
)
|
(7,550
|
)
|
|||||||||||
Exchange adjustments
|
22
|
—
|
—
|
(54
|
)
|
(32
|
)
|
|||||||||||||
|
||||||||||||||||||||
At December 31, 2019
|
24,269
|
3,005
|
4,292
|
38,676
|
70,242
|
|||||||||||||||
|
||||||||||||||||||||
Accumulated depreciation and impairment losses
|
||||||||||||||||||||
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
|
)
|
||||||||||
|
||||||||||||||||||||
At January 1, 2019
|
(1,934
|
)
|
(3,243
|
)
|
(5,783
|
)
|
(37,492
|
)
|
(48,452
|
)
|
||||||||||
Charge for the year
|
(1,545
|
)
|
(105
|
)
|
(200
|
)
|
(680
|
)
|
(2,530
|
)
|
||||||||||
Adjustment on transition to IFRS 16
|
(10,984
|
)
|
—
|
(40
|
)
|
(75
|
)
|
(11,099
|
)
|
|||||||||||
Impairment loss as at December 31, 2019
|
(4,024
|
)
|
(233
|
)
|
(276
|
)
|
(1,816
|
)
|
(6,349
|
)
|
||||||||||
Disposals or retirements
|
—
|
1,544
|
2,618
|
3,331
|
7,493
|
|||||||||||||||
Reallocations / reclassifications
|
—
|
—
|
—
|
(5
|
)
|
(5
|
)
|
|||||||||||||
Exchange adjustments
|
(6
|
)
|
—
|
(1
|
)
|
(3
|
)
|
(10
|
)
|
|||||||||||
|
||||||||||||||||||||
At December 31, 2019
|
(18,493
|
)
|
(2,037
|
)
|
(3,682
|
)
|
(36,740
|
)
|
(60,952
|
)
|
||||||||||
|
||||||||||||||||||||
Carrying amounts
|
||||||||||||||||||||
At December 31, 2019
|
5,776
|
968
|
610
|
1,936
|
9,290
|
|||||||||||||||
|
||||||||||||||||||||
At December 31, 2018
|
671
|
1,317
|
802
|
2,572
|
5,362
|
13. |
PROPERTY, PLANT AND EQUIPMENT (CONTINUED)
|
US$000
|
||||
Right-of-use assets cost at transition before impairment
|
21,185
|
|||
Impairment adjustment on transition
|
(11,099
|
)
|
||
Right-of-use assets value at transition after impairment
|
10,086
|
Carrying amount at December 31, 2018
|
Remeasurement
|
Impairment
|
IFRS 16 carrying amount at January 1, 2019
|
|||||||||||||
US$000
|
US$000
|
US$000
|
US$000
|
|||||||||||||
Property, plant & equipment
|
5,362
|
21,185
|
(11,099
|
)
|
15,448
|
|||||||||||
Lease liabilities
|
(962
|
)
|
(21,185
|
)
|
-
|
(22,147
|
)
|
|||||||||
Retaining earnings
|
(55,319
|
)
|
-
|
11,099
|
(44,220
|
)
|
||||||||||
Total
|
(50,919
|
)
|
-
|
-
|
(50,919
|
)
|
Carrying amount
|
Depreciation
|
Impairment
|
||||||||||
At December 31, 2019
|
Year ended December 31, 2019
|
Year ended December 31, 2019
|
||||||||||
US$000
|
US$000
|
US$000
|
||||||||||
Buildings
|
5,220
|
(1,523
|
)
|
(3,913
|
)
|
|||||||
Computer equipment
|
7
|
(39
|
)
|
(63
|
)
|
|||||||
5,227
|
(1,562
|
)
|
(3,976
|
)
|
13. |
PROPERTY, PLANT AND EQUIPMENT (CONTINUED)
|
Right-of-Use assets
|
No. of Right-of-Use leased assets
|
Range of remaining term in years
|
Average remaining lease term (years)
|
No. of Leases with extension options
|
No. of Leases with options to purchase
|
No. of leases with variable payments linked to index
|
No. of leases with termination options
|
||||||||||||||||||
Building
|
13
|
1 to 14
|
5
|
1
|
-
|
2
|
4
|
||||||||||||||||||
Vehicle
|
9
|
1 to 2
|
1
|
-
|
9 |
-
|
9
|
||||||||||||||||||
I.T. and office equipment
|
11
|
1 to 2
|
2
|
-
|
-
|
-
|
1
|
14. |
GOODWILL AND INTANGIBLE ASSETS
|
|
Goodwill
US$‘000
|
Development
costs
US$‘000
|
Patents and
licences
US$‘000
|
Other
US$‘000
|
Total
US$‘000
|
|||||||||||||||
Cost
|
||||||||||||||||||||
At January 1, 2018
|
81,689
|
136,918
|
9,947
|
33,818
|
262,372
|
|||||||||||||||
Additions
|
—
|
9,871
|
—
|
410
|
10,281
|
|||||||||||||||
Disposals
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Exchange adjustments
|
—
|
(17
|
)
|
—
|
—
|
(17
|
)
|
|||||||||||||
At December 31, 2018
|
81,689
|
146,772
|
9,947
|
34,228
|
272,636
|
|||||||||||||||
|
||||||||||||||||||||
At January 1, 2019
|
81,689
|
146,772
|
9,947
|
34,228
|
272,636
|
|||||||||||||||
Additions
|
—
|
9,569
|
4
|
38
|
9,611
|
|||||||||||||||
Disposals
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Reclassification
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Exchange adjustments
|
—
|
36
|
—
|
—
|
36
|
|||||||||||||||
|
||||||||||||||||||||
At December 31, 2019
|
81,689
|
156,377
|
9,951
|
34,266
|
282,283
|
|||||||||||||||
|
||||||||||||||||||||
Accumulated amortisation and Impairment losses
|
||||||||||||||||||||
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
|
)
|
||||||||||
|
||||||||||||||||||||
At January 1, 2019
|
(65,548
|
)
|
(120,507
|
)
|
(9,814
|
)
|
(23,816
|
)
|
(219,685
|
)
|
||||||||||
Charge for the year
|
—
|
(1,182
|
)
|
(2
|
)
|
(1,184
|
)
|
(2,368
|
)
|
|||||||||||
Disposals
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Impairment losses
|
(3,550
|
)
|
(11,904
|
)
|
(3
|
)
|
(1,113
|
)
|
(16,570
|
)
|
||||||||||
Exchange adjustments
|
—
|
(6
|
)
|
—
|
—
|
(6
|
)
|
|||||||||||||
|
||||||||||||||||||||
At December 31, 2019
|
(69,098
|
)
|
(133,599
|
)
|
(9,819
|
)
|
(26,113
|
)
|
(238,629
|
)
|
||||||||||
|
||||||||||||||||||||
Carrying amounts
|
||||||||||||||||||||
At December 31, 2019
|
12,591
|
22,778
|
132
|
8,153
|
43,654
|
|||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
At December 31, 2018
|
16,141
|
26,265
|
133
|
10,412
|
52,951
|
14. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
Product Name |
|
2019
US$’000 |
|
2018
US$’000 |
||||
HIV screening rapid test
|
2,587
|
1,657
|
||||||
Premier Instrument for Haemoglobin A1c testing
|
1,930
|
2,653
|
||||||
Autoimmune Smart Reader
|
1,325
|
746
|
||||||
Syphilis point-of-care test
|
870
|
454
|
||||||
Uni-Gold antigen improvement
|
691
|
453
|
||||||
G-6-PDH test
|
582
|
850
|
||||||
Uni-gold test
|
376
|
796
|
||||||
Tri-stat Point-of-Care instrument
|
361
|
727
|
||||||
Ultra Genesys
|
237
|
263
|
||||||
Column enhancement
|
236
|
292
|
||||||
Sjogrens tests
|
135
|
414
|
||||||
Other projects
|
239
|
566
|
||||||
Total capitalised development costs
|
9,569
|
9,871
|
(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.
|
14. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
• |
the Company’s market capitalisation at the end of the year, which was lower when compared to the end of 2018,
|
• |
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.
|
14. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
December 31, 2019
|
December 31, 2018
|
|||||||
US$’000
|
US$’000
|
|||||||
Trinity Biotech Manufacturing Limited
|
9,732
|
7 ,837
|
||||||
Immco Diagnostics Inc
|
6,332
|
-
|
||||||
Primus Corp
|
5,321
|
12,424
|
||||||
Trinity Biotech Do Brasil
|
1,253
|
2,785
|
||||||
Clark Laboratories Inc.
|
727
|
3,377
|
||||||
Mardx Diagnostics Inc.
|
720
|
-
|
||||||
Biopool US Inc.
|
210
|
509
|
||||||
Total impairment loss
|
24,295
|
26,932
|
|
December 31, 2019
|
December 31, 2018
|
||||||
US$’000
|
US$’000
|
|||||||
Goodwill and other intangible assets (see Note 14)
|
16,570
|
19,212
|
||||||
Property, plant and equipment (see Note 13)
|
6,349
|
6,112
|
||||||
Prepayments (see Note 18)
|
1,376
|
1,608
|
||||||
Total impairment loss
|
24,295
|
26,932
|
• |
In the event that there was a variation of 10% in the assumed level of future growth in revenue growth rate, which would represent a reasonably likely range of outcomes, there would be an additional impairment loss of
US$743,000 at December 31, 2019.
|
• |
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$5,420,000 at December 31, 2019.
|
14. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
Fitzgerald Industries
|
December 31,
2019 |
December 31,
2018 |
||||||
Carrying amount of goodwill (US$’000)
|
12,592
|
12,592
|
||||||
Discount rate applied (real pre-tax)
|
20.42
|
%
|
19.80
|
%
|
||||
Excess value-in-use over carrying amount (US$’000)
|
2,385
|
8,847
|
||||||
% EBITDA would need to decrease for an impairment to arise
|
12.11
|
%
|
32.6
|
%
|
||||
Long-term growth rate
|
2.0
|
%
|
2.0
|
%
|
Intangible Assets with Indefinite Useful lives
(included in other intangibles)
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
||||||
Fitzgerald Industries International CGU
|
||||||||
Fitzgerald trade name
|
970
|
970
|
||||||
RDI trade name
|
560
|
560
|
||||||
Primus Corporation CGU
|
||||||||
Primus trade name
|
500 |
547
|
||||||
Immco Diagnostic CGU
|
||||||||
Immco Diagnostic trade name
|
2,938
|
3,393
|
||||||
Total
|
4,968
|
5,470
|
15.
|
DEFERRED TAX ASSETS AND LIABILITIES
|
|
Assets
|
Liabilities
|
Net
|
|||||||||||||||||||||
|
|
2019
US$000 |
|
2018
US$’000 |
|
2019
US$’000 |
|
2018
US$’000 |
|
2019
US$’000 |
|
2018
US$’000 |
||||||||||||
Property, plant and equipment
|
1,027
|
815
|
(9
|
)
|
(37
|
)
|
1,018
|
778
|
||||||||||||||||
Intangible assets
|
—
|
—
|
(6,099
|
)
|
(7,189
|
)
|
(6,099
|
)
|
(7,189
|
)
|
||||||||||||||
Inventories
|
642
|
668
|
—
|
—
|
642
|
668
|
||||||||||||||||||
Provisions
|
3,838
|
4,311
|
—
|
—
|
3,838
|
4,311
|
||||||||||||||||||
Other items
|
745
|
333
|
(1,031
|
)
|
(629
|
)
|
(286
|
)
|
(296
|
)
|
||||||||||||||
|
||||||||||||||||||||||||
Deferred tax assets/(liabilities)
|
6,252
|
6,127
|
(7,139
|
)
|
(7,855
|
)
|
(887
|
)
|
(1,728
|
)
|
|
December 31,
2019 |
December 31,
2018 |
||||||
|
US$’000
|
US$’000
|
||||||
Capital losses
|
8,293
|
8,293
|
||||||
Net operating losses
|
80,577
|
67,012
|
||||||
US alternative minimum tax credits
|
1,928
|
1,674
|
||||||
Other temporary timing differences
|
7,399
|
3,880
|
||||||
US state credit carryforwards
|
493
|
364
|
||||||
|
||||||||
|
98,690
|
81,223
|
15. |
DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED)
|
Movement in unrecognised deferred tax assets
|
Increase /
(decrease) US$’000
|
Applicable
tax rate
%
|
Tax
effect US$’000
|
|||||||||
Net operating losses in US
|
(1,348
|
)
|
21
|
%
|
(283
|
)
|
||||||
Alternative minimum tax credit in US
|
254
|
n/a
|
254
|
|||||||||
Net operating losses in Brazil
|
1,788
|
34
|
%
|
608
|
||||||||
Net operating losses in Ireland
|
13,125
|
12.5% -25
|
%
|
2,353
|
||||||||
Other deferred tax assets in Ireland
|
(1,938
|
)
|
12.5
|
%
|
(243
|
)
|
||||||
Other deferred tax assets in US
|
5,457
|
21
|
%
|
1,146
|
||||||||
US state credit carryforwards
|
129
|
n/a
|
129
|
|||||||||
|
||||||||||||
Total – continuing operations
|
17,467
|
3,964
|
15. |
DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED)
|
|
Balance
January, 1
2019 |
Recognised
in income |
Balance
December 31,
2019 |
|||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Property, plant and equipment
|
778
|
240
|
1,018
|
|||||||||
Intangible assets
|
(7,189
|
)
|
1,090
|
(6,099
|
)
|
|||||||
Inventories
|
668
|
(26
|
)
|
642
|
||||||||
Provisions
|
4,311
|
(473
|
)
|
3,838
|
||||||||
Other items
|
(296
|
)
|
10
|
(286
|
)
|
|||||||
|
(887
|
|||||||||||
|
(1,728
|
)
|
841
|
(887
|
)
|
|
Balance
January, 1
2018 |
Recognised
in income |
Balance
December 31,
2018 |
|||||||||
|
US$’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
|
)
|
16. |
OTHER ASSETS
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
||||||
Finance lease receivables (see Note 18)
|
403
|
476
|
||||||
Other assets
|
82
|
82
|
||||||
|
||||||||
|
485
|
558
|
17. |
INVENTORIES
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
||||||
Raw materials and consumables
|
12,654
|
10,556
|
||||||
Work-in-progress
|
6,940
|
8,239
|
||||||
Finished goods
|
12,427
|
11,564
|
||||||
|
||||||||
|
32,021
|
30,359
|
|
December 31,
2019
US$‘000
|
December 31,
2018
US$‘000
|
December 31,
2017
US$‘000
|
|||||||||
Opening provision at January 1
|
6,299
|
7,543
|
10,017
|
|||||||||
Charged during the year
|
1,567
|
480
|
2,561
|
|||||||||
Utilised during the year
|
(1,150
|
)
|
(1,544
|
)
|
(4,749
|
)
|
||||||
Released during the year
|
-
|
(180
|
)
|
(286
|
)
|
|||||||
|
||||||||||||
Closing provision at December 31
|
6,716
|
6,299
|
7,543
|
18. |
TRADE AND OTHER RECEIVABLES
|
|
December 31,
2019
US$‘000
|
December 31,
2018
US$‘000
|
||||||
Trade receivables, net of impairment losses
|
17,754
|
21,318
|
||||||
Prepayments
|
576
|
807
|
||||||
Contract assets
|
2,317
|
1,894
|
||||||
Value added tax
|
59
|
63
|
||||||
Finance lease receivables
|
281
|
359
|
||||||
|
||||||||
|
20,987
|
24,441
|
18. |
TRADE AND OTHER RECEIVABLES (CONTINUED)
|
|
December 31, 2019
US$‘000
|
|||||||||||
|
Gross
investment |
Unearned
income |
Minimum
payments receivable |
|||||||||
Less than one year
|
523
|
242
|
281
|
|||||||||
Between one and five years (Note 16)
|
805
|
402
|
403
|
|||||||||
|
||||||||||||
|
1,328
|
644
|
684
|
|
December 31, 2018
US$‘000
|
|||||||||||
|
Gross
investment |
Unearned
income |
Minimum
payments receivable |
|||||||||
Less than one year
|
617
|
258
|
359
|
|||||||||
Between one and five years (Note 16)
|
888
|
412
|
476
|
|||||||||
|
||||||||||||
|
1,505
|
670
|
835
|
December 31, 2019
US$‘000
|
||||||||
|
Instruments
|
Total
|
||||||
Less than one year
|
3,528
|
3,528
|
||||||
Between one and five years
|
27
|
27
|
||||||
|
||||||||
|
3,555
|
3,555
|
|
December 31, 2018
US$‘000
|
|||||||
|
Instruments
|
Total
|
||||||
Less than one year
|
3,498
|
3,498
|
||||||
Between one and five years
|
32
|
32
|
||||||
|
||||||||
|
3,530
|
3,530
|
19. |
CASH AND CASH EQUIVALENTS
|
|
December 31, 2019
US$’000
|
December 31, 2018
US$’000
|
||||||
Cash at bank and in hand
|
6,275
|
6,854
|
||||||
Short-term deposits
|
8,956
|
23,423
|
||||||
|
||||||||
Cash and cash equivalents
|
15,231
|
30,277
|
20. |
SHORT-TERM INVESTMENTS
|
|
December 31, 2019
US$’000
|
December 31, 2018
US$’000
|
||||||
Investments (deposits)
|
1,169
|
-
|
||||||
|
||||||||
1,169
|
-
|
21. |
CAPITAL AND RESERVES
|
|
Class ‘A’
Ordinary shares |
Class ‘A’
Ordinary shares |
||||||
In thousands of shares
|
2019
|
2018
|
||||||
In issue at January 1
|
96,162
|
96,162
|
||||||
Issued for cash
|
-
|
-
|
||||||
|
||||||||
In issue at December 31
|
96,162
|
96,162
|
|
ADS
|
ADS
|
||||||
In thousands of ADSs
|
2019
|
2018
|
||||||
Balance at January 1
|
24,041
|
24,041
|
||||||
Issued for cash
|
-
|
-
|
||||||
|
||||||||
Balance at December 31
|
24,041
|
24,041
|
|
Class ‘A’
Treasury shares |
Class ‘A’
Treasury shares |
||||||
In thousands of shares
|
2019
|
2018
|
||||||
Balance at January 1
|
12,556
|
12,448
|
||||||
Purchased during the year
|
-
|
108
|
||||||
|
||||||||
Balance at December 31
|
12,556
|
12,556
|
|
ADS
Treasury shares
|
ADS
Treasury shares |
||||||
In thousands of ADSs
|
2019
|
2018
|
||||||
Balance at January 1
|
3,139
|
3,112
|
||||||
Purchased during the year
|
-
|
27
|
||||||
|
||||||||
Balance at December 31
|
3,139
|
3,139
|
21. |
CAPITAL AND RESERVES (CONTINUED)
|
(a) |
During 2019, the Group did not issue any shares from the exercise of employee options (2018: nil). At December 31, 2019, there were no amounts receivable on issuance share capital (2018: US$nil) relating to the exercise of share
options.
|
(b) |
During 2019, the Group did not repurchase any ‘A’ ordinary shares under its share buyback program. (2018: 107,740 ‘A’ ordinary shares or 26,935 ADS’s).
|
(c) |
There were no dividends paid during 2019 in respect of the 2018 financial year, (nil in respect of the 2017 financial year), (nil in respect of the 2016 financial year). As provided in the Articles of Association of the Company,
dividends or other distributions are declared and paid in US Dollars.
|
22. |
SHARE OPTIONS AND SHARE WARRANTS
|
22. |
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, 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
|
|||||||||
|
||||||||||||
Outstanding January 1, 2019
|
10,908,200
|
1.83
|
0.67 –4.36
|
|||||||||
Granted
|
4,370,000
|
0.68
|
0.46 –0.78
|
|||||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Expired / Forfeited
|
(2,974,210
|
)
|
2.25
|
0.66 –4.23
|
||||||||
|
||||||||||||
Outstanding at end of year
|
12,303,990
|
1.31
|
0.46 –4.36
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
6,622,667
|
1.73
|
1.24 –4.36
|
22. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
|
Options and
warrants ‘ADS’ |
Weighted-
average exercise price US$ |
Range US$
|
|||||||||
|
Equivalent
|
Per ‘ADS’
|
Per ‘ADS’
|
|||||||||
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
|
-
|
-
|
-
|
|||||||||
Expired / 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
|
|||||||||
|
||||||||||||
Outstanding January 1, 2019
|
2,727,050
|
7.32
|
2.68–17.44
|
|||||||||
Granted
|
1,092,500
|
2.72
|
1.83 - 3.10
|
|||||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Expired / Forfeited
|
(743,552
|
)
|
8.99
|
2.64 – 16.92
|
||||||||
|
||||||||||||
Outstanding at end of year
|
3,075,998
|
5.24
|
1.83 – 17.45
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
1,655,667
|
6.92
|
4.95 –17.45
|
Outstanding
|
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$0.46-US$0.99
|
4,600,000
|
0.69
|
6.42
|
-
|
-
|
-
|
|||||||||||||||||||
US$1.00-US$2.05
|
5,613,990
|
1.35
|
4.69
|
4,542,667
|
1.34
|
4.68
|
|||||||||||||||||||
US$2.06- US$2.99
|
1,980,000
|
2.48
|
3.13
|
1,970,000
|
2.48
|
3.13
|
|||||||||||||||||||
US$3.00 -US$4.36
|
110,000
|
4.19
|
2.07
|
110,000
|
4.19
|
2.07
|
|||||||||||||||||||
12,303,990
|
6,622,667
|
22. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
Outstanding
|
Exercisable
|
||||||||||||||||||||||||
Exercise price range
|
No. of
options ‘ADS equivalent’ |
Weighted–
average exercise price |
Weighted-
average contractual life remaining (years) |
No. of
options ‘ADS equivalent’ |
Weighted–
average exercise price |
Weighted-
average contractual life remaining (years) |
|||||||||||||||||||
US$1.84-US$3.96
|
1,150,000
|
2.75
|
6.42
|
- | - | - | |||||||||||||||||||
US$4.00-US$8.20
|
1,403,498
|
5.40
|
4.69
|
1,135,667
|
5.38
|
4.68
|
|||||||||||||||||||
US$8.24- US$11.96
|
495,000
|
9.92
|
3.13
|
492,500
|
9.91
|
3.13
|
|||||||||||||||||||
US$12.00 -US$17.45
|
27,500
|
16.75
|
2.07
|
27,500
|
16.75
|
2.07
|
|||||||||||||||||||
3,075,998
|
1,655,667
|
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$17.88
|
49,500
|
16.80
|
2.97
|
44,500
|
16.80
|
2.93
|
|||||||||||||||||||
2,727,050
|
1,522,966
|
22. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
|
December 31,
2019
US$‘000
|
December 31,
2018
US$‘000
|
December 31,
2017
US$‘000
|
|||||||||
Share-based payments – cost of sales
|
26
|
34
|
35
|
|||||||||
Share-based payments – selling, general and administrative
|
732
|
1,335
|
893
|
|||||||||
|
||||||||||||
Total – continuing operations
|
758
|
1,369
|
928
|
|||||||||
Share-based payments – discontinued operations
|
-
|
-
|
-
|
|||||||||
|
||||||||||||
Total
|
758
|
1,369
|
928
|
|
Key
management personnel |
Other
employees |
Key
management personnel |
Other
employees |
Key
management personnel |
Other
employees |
||||||||||||||||||
|
2019
|
2019
|
2018
|
2018
|
2017
|
2017
|
||||||||||||||||||
Weighted average fair value at measurement date per ‘A’ share / (per ADS)
|
|
US$0.14 /
(US$0.56
|
)
|
|
US$0.25 /
(US$1.02
|
)
|
-
|
|
US$0.41 /
(US$1.64
|
)
|
|
US$0.43 /
(US$1.72
|
)
|
|
US$0.44 /
(US$1.76
|
)
|
||||||||
Total ‘A’ share options granted / (ADS’s equivalent)
|
4,060,000 /
(1,015,000
|
)
|
310,000 /
(77,500
|
)
|
-
|
720,000 /
(180,000
|
)
|
5,150,000/
(1,287,500
|
)
|
480,000 /
(120,000
|
)
|
|||||||||||||
Weighted average share price per ‘A’ share / (per ADS)
|
|
US$0.46 /
(US$1.84
|
)
|
|
US$0.64 /
(US$2.53
|
)
|
-
|
|
US$1.07 /
(US$4.28
|
)
|
|
US$1.34 /
(US$5.36 |
)
|
|
US$1.31 /
(US$5.24
|
)
|
||||||||
Weighted average exercise price per ‘A’ share / (per ADS)
|
|
US$0.69 /
(US$2.74
|
)
|
|
US$0.64 /
(US$2.53
|
)
|
-
|
|
US$1.07 /
(US$4.28
|
)
|
|
US$1.34 /
(US$5.36
|
)
|
|
US$1.31 /
(US$5.24
|
)
|
||||||||
Weighted average expected volatility
|
51.18
|
%
|
47.31
|
%
|
-
|
42.69
|
%
|
40.62
|
%
|
40.48
|
%
|
|||||||||||||
Weighted average expected life
|
4.15
|
4.42
|
-
|
4.55
|
4.45
|
4.69
|
||||||||||||||||||
Weighted average risk free interest rate
|
1.84
|
%
|
2.23
|
%
|
-
|
2.72
|
%
|
1.59
|
%
|
1.91
|
%
|
|||||||||||||
Expected dividend yield
|
-
|
-
|
-
|
-
|
0.81
|
%
|
0.81
|
%
|
22. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
23. |
TRADE AND OTHER PAYABLES
|
|
December 31, 2019
US$’000
|
December 31, 2018
US$’000
|
||||||
Trade payables
|
7,833
|
8,116
|
||||||
Payroll taxes
|
519
|
448
|
||||||
Employee related social insurance
|
170
|
154
|
||||||
Accrued liabilities
|
8,133
|
7,878
|
||||||
Deferred income
|
292 |
312
|
||||||
|
||||||||
|
16,947
|
16,908
|
24. |
PROVISIONS
|
|
December 31, 2019
US$’000
|
December 31, 2017
US$’000
|
||||||
Provisions
|
50
|
50
|
25. |
EXCHANGEABLE NOTES
|
25. |
EXCHANGEABLE NOTES (CONTINUED)
|
|
December 31,
2019 US$’000
|
December 31,
2018 US$’000
|
||||||
Non-current assets
|
||||||||
Exchangeable note bond call option
|
-
|
-
|
||||||
|
||||||||
Non-current liabilities
|
||||||||
Exchangeable note equity conversion option
|
4
|
238
|
||||||
Exchangeable note bond put option
|
-
|
-
|
||||||
|
||||||||
|
4
|
238
|
||||||
|
||||||||
Total value of embedded derivatives – net liability
|
4
|
238
|
|
December 31,
2019 US$’000
|
December 31,
2018 US$’000
|
||||||
Balance at 1 January
|
81,382
|
92,955
|
||||||
Accretion interest
|
639
|
689
|
||||||
Less: purchased during the year at fair value
|
-
|
(12,262
|
)
|
|||||
|
||||||||
|
82,021
|
81,382
|
|
December 31,
2019 US$’000
|
December 31,
2018 US$’000
|
||||||
Exchangeable senior notes
|
82,021
|
81,382
|
||||||
Total value of embedded derivatives – liability
|
4
|
238
|
||||||
|
||||||||
Total non-current liabilities
|
82,025
|
81,620
|
26. |
LEASE LIABILITIES
|
|
US$000
|
|||
Operating Lease commitments at December, 31, 2018 (Note 27)
|
27,342
|
|||
Relief option for short term leases
|
(130
|
)
|
||
Relief option for low value assets
|
-
|
|||
Effect of assumed probable lease extension in adoption of IFRS 16
|
573
|
|||
Other
|
(149
|
)
|
||
Gross lease liabilities at January 1, 2019
|
27,636
|
|||
Discounting
|
(6,451
|
)
|
||
Additional Lease liabilities as a result of the initial application of IFRS 16 at January 1, 2019
|
21,185
|
December 31, 2019
US$’000
|
December 31, 2018
US$’000
|
|||||||
Current liabilities
|
||||||||
Lease liabilities related to Right of Use assets
|
2,156
|
-
|
||||||
Sale and leaseback liabilities
|
248
|
436
|
||||||
|
||||||||
|
2,404
|
436
|
||||||
|
||||||||
Non-Current liabilities
|
||||||||
Lease liabilities related to Right of Use assets
|
17,474
|
-
|
||||||
Sale and leaseback liabilities
|
271
|
526
|
||||||
17,745
|
526
|
26. |
LEASE LIABILITIES
|
|
December 31, 2019
US$’000
|
December 31, 2019
US$’000
|
||||||||||||||||||||||
Lease liabilities related to
Right of Use assets
|
Sale and leaseback
liabilities
|
|||||||||||||||||||||||
|
Minimum
lease
payments
|
Interest
|
Principal
|
Minimum
lease
payments
|
Interest
|
Principal
|
||||||||||||||||||
Less than one year
|
3,017
|
861
|
2,156
|
267
|
19
|
248
|
||||||||||||||||||
In more than one year, but not more than two
|
2,787
|
775
|
2,012
|
107
|
12
|
95
|
||||||||||||||||||
In more than two years but not more than five
|
6,700
|
1,861
|
4,840
|
185
|
9
|
176
|
||||||||||||||||||
more than five years
|
12,748
|
2,126
|
10,622
|
-
|
-
|
-
|
||||||||||||||||||
|
||||||||||||||||||||||||
|
25,252
|
5,263
|
19,630
|
559
|
40
|
519
|
|
December 31,
2018
|
December 31, 2018
US$’000
|
||||||||||||||
Operating
Leases
|
Sale and leaseback
liabilities
|
|||||||||||||||
|
Minimum
lease
payments
|
Minimum
lease
payments
|
Interest
|
Principal
|
||||||||||||
Less than one year
|
3,083
|
473
|
37
|
436
|
||||||||||||
In more than one year, but not more than two
|
2,783
|
271
|
19
|
252
|
||||||||||||
In more than two years but not more than five
|
6,777
|
294
|
20
|
274
|
||||||||||||
more than five years
|
14,699
|
-
|
-
|
-
|
||||||||||||
|
||||||||||||||||
|
27,342
|
1,038
|
76
|
962
|
December 31, 2019
|
||||
US$000
|
||||
Short term leases
|
130
|
|||
Leases of low value assets
|
-
|
|||
Variable lease payments
|
-
|
|||
130
|
26. |
LEASE LIABILITIES (CONTINUED)
|
Facility
|
Currency
|
Nominal
interest
rate |
Year of
maturity
|
Fair
Value
|
Carrying
Value
|
||||||||||||
Sale and leaseback liabilities
|
Euro
|
4.53
|
%
|
2023
|
286
|
286
|
|||||||||||
Sale and leaseback liabilities
|
USD
|
5.51
|
%
|
2023
|
233
|
233
|
|||||||||||
|
|
||||||||||||||||
Total interest-bearing loans and borrowings
|
|
519
|
519
|
Facility
|
Currency
|
Nominal
interest
rate |
Year of
maturity
|
Fair
Value
|
Carrying
Value
|
||||||||||||
Sale and leaseback liabilities
|
Euro
|
4.53
|
%
|
2023
|
648
|
648
|
|||||||||||
Sale and leaseback liabilities
|
USD
|
5.51
|
%
|
2023
|
314
|
314
|
|||||||||||
|
|
||||||||||||||||
Total interest-bearing loans and borrowings
|
|
962
|
962
|
27. |
COMMITMENTS AND CONTINGENCIES
|
(a) |
Capital Commitments
|
(b) |
Leasing Commitments
|
|
Year ended
|
|||
|
2018
|
|||
|
Operating leases
|
|||
|
US$’000
|
|||
2019
|
3,083
|
|||
2020
|
2,783
|
|||
2021
|
2,512
|
|||
2022
|
2,255
|
|||
2023
|
2,010
|
|||
Later years
|
14,699
|
|||
|
||||
Total lease obligations
|
27,342
|
27. |
COMMITMENTS AND CONTINGENCIES (CONTINUED)
|
(c) |
Bank Security
|
(d) |
Group Company Guarantees
|
(e) |
Contingent asset
|
(f) |
Government Grant Contingencies
|
(g) |
Litigation
|
28. |
RELATED PARTY TRANSACTIONS
|
28. |
RELATED PARTY TRANSACTIONS (CONTINUED)
|
|
December 31, 2019
|
December 31, 2018
|
||||||
|
US$’000
|
US$’000
|
||||||
Short-term employee benefits
|
800
|
863
|
||||||
Performance related bonus
|
213
|
210
|
||||||
Post-employment benefits
|
42
|
44
|
||||||
Share-based compensation benefits
|
542
|
1,041
|
||||||
|
||||||||
|
1,597
|
2,158
|
|
‘A’ Ordinary Shares
|
Share options
|
||||||
At January 1, 2019
|
9,139,706
|
8,655,004
|
||||||
Shares of retired director
|
(30,000
|
)
|
—
|
|||||
Options of retired director
|
—
|
(215,000
|
)
|
|||||
Shares purchased during the year
|
—
|
—
|
||||||
Shares sold during the year
|
(32,000
|
)
|
—
|
|||||
Granted
|
—
|
4,060,000
|
||||||
Expired / forfeited
|
—
|
(2,086,000
|
)
|
|||||
|
||||||||
At December 31, 2019
|
9,077,706
|
10,414,004
|
28. |
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
|
29. |
DERIVATIVES AND FINANCIAL INSTRUMENTS
|
29. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
As at December 31, 2019
|
Note
|
Effective
interest
rate |
Total
US$’000
|
6 mths or less
US$’000
|
6 –12 mths
US$’000
|
1-2 years
US$’000
|
2-5 years
US$’000
|
> 5 years
US$’000
|
||||||||||||||||||||||||
Cash and cash equivalents
|
19
|
1.1
|
%
|
15,231
|
15,231
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||
Short-term investments
|
20
|
1.3
|
%
|
1,169
|
—
|
1,169
|
—
|
—
|
—
|
|||||||||||||||||||||||
Lease receivable
|
16,18
|
4.0
|
%
|
684
|
157
|
124
|
202
|
201
|
—
|
|||||||||||||||||||||||
Licence payments
|
23
|
8.1
|
%
|
(1,307
|
)
|
(1,307
|
)
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Exchangeable note
|
25
|
4.8
|
%
|
(82,021
|
)
|
—
|
—
|
—
|
—
|
(82,021
|
)
|
|||||||||||||||||||||
Lease payable on Right of Use assets
|
26
|
5.0
|
%
|
(19,630
|
)
|
(1,136
|
)
|
(1,020
|
)
|
(2,012
|
)
|
(4,840
|
)
|
(10,622
|
)
|
|||||||||||||||||
Lease payable on sale & leaseback transactions
|
26
|
5.0
|
%
|
(519
|
)
|
(122
|
)
|
(125
|
)
|
(95
|
)
|
(177
|
)
|
—
|
||||||||||||||||||
Total
|
(86,393
|
)
|
12,823
|
148
|
(1,905
|
)
|
(4,816
|
)
|
(92,643
|
)
|
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
|
19
|
1.8
|
%
|
30,277
|
30,277
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||
Short-term investments
|
20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Lease receivable
|
18
|
4.0
|
%
|
835
|
191
|
168
|
238
|
238
|
—
|
|||||||||||||||||||||||
Licence payments
|
23
|
3.0
|
%
|
(1,207
|
)
|
(1,207
|
)
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Finance lease payable
|
26
|
4.8
|
%
|
(962
|
)
|
(217
|
)
|
(219
|
)
|
(252
|
)
|
(274
|
)
|
—
|
||||||||||||||||||
Exchangeable note
|
25
|
4.8
|
%
|
(81,382
|
)
|
—
|
—
|
—
|
—
|
(81,382
|
)
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total
|
(52,439
|
)
|
29,044
|
(51
|
)
|
(14
|
)
|
(36
|
)
|
(81,382
|
)
|
|
December 31, 2019
US$‘000
|
December 31, 2018
US$‘000
|
||||||
Fixed rate instruments
|
||||||||
Fixed rate financial liabilities (licence fees)
|
(1,307
|
)
|
(1,207
|
)
|
||||
Fixed rate financial liabilities (exchangeable note)
|
(82,021
|
)
|
(81,382
|
)
|
||||
Fixed rate financial liabilities (lease payables)
|
(20,149
|
)
|
(962
|
)
|
||||
Financial assets (short-term deposits and short-term investments)
|
10,125
|
23,423
|
||||||
Financial assets (lease receivables)
|
684
|
835
|
||||||
|
||||||||
|
(92,668
|
)
|
(59,293
|
)
|
29. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
As at December 31, 2019
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
|
16,947
|
16,947
|
16,947
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Lease payable on Right of Use assets
|
19,630
|
19,630
|
1,136
|
1,020
|
2,012
|
4,840
|
10,622
|
|||||||||||||||||||||
Lease payable on sale & leaseback transactions
|
519
|
519
|
122
|
125
|
95
|
177
|
—
|
|||||||||||||||||||||
Exchangeable notes
|
82,021
|
99,900
|
—
|
—
|
—
|
—
|
99,900
|
|||||||||||||||||||||
Exchangeable note interest
|
999
|
101,898
|
1,998
|
1,998
|
3,996
|
11,988
|
81,918
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
120,116
|
238,894
|
20,203
|
3,143
|
6,103
|
17,005
|
192,440
|
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
|
29. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
As at December 31, 2019
|
EUR
|
GBP
|
SEK
|
CAD
|
BRL
|
Other
|
||||||||||||||||||
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
|||||||||||||||||||
Cash
|
394
|
138
|
10
|
3,265
|
238
|
—
|
||||||||||||||||||
Trade and other receivable
|
1,247
|
71
|
—
|
337
|
1,871
|
—
|
||||||||||||||||||
Trade and other payables
|
(2,350
|
)
|
(27
|
)
|
(142
|
)
|
(47
|
)
|
(796
|
)
|
—
|
|||||||||||||
|
||||||||||||||||||||||||
Total exposure
|
(709
|
)
|
182
|
(132
|
)
|
3,555
|
1,313
|
—
|
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
|
|
Profit or loss
US$’000
|
|||
December 31, 2019
|
||||
Euro
|
2,282
|
|||
December 31, 2018
|
||||
Euro
|
1,818
|
29. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
Profit or Loss
US$000
|
||||
December 31, 2019
|
||||
Euro
|
(2,790
|
)
|
||
December 31, 2018
|
||||
Euro
|
(2,222
|
)
|
|
Carrying Value
December 31, 2019 US$’000 |
Carrying Value
December 31, 2018 US$’000 |
||||||
Third party trade receivables (Note 18)
|
17,754
|
21,318
|
||||||
Finance lease income receivable (Note 18)
|
684
|
835
|
||||||
Cash & cash equivalents (Note 19)
|
15,231
|
30,277
|
||||||
Short-term investments (Note 20)
|
1,169
|
—
|
||||||
|
||||||||
|
34,838
|
52,430
|
|
Carrying Value
December 31, 2019 US$’000 |
Carrying Value
December 31, 2018 US$’000 |
||||||
United States
|
8,647
|
9,472
|
||||||
Euro-zone countries
|
786
|
1,502
|
||||||
United Kingdom
|
121
|
132
|
||||||
Other European countries
|
7
|
84
|
||||||
Other regions
|
8,877
|
10,963
|
||||||
|
||||||||
|
18,438
|
22,153
|
29. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
Carrying Value
December 31, 2019 US$’000 |
Carrying Value
December 31, 2018 US$’000 |
||||||
End-user customers
|
9,453
|
9,253
|
||||||
Distributors
|
7,199
|
11,860
|
||||||
Non-governmental organisations
|
1,786
|
1,040
|
||||||
|
||||||||
|
18,438
|
22,153
|
|
Gross
|
Impairment
|
Expected Credit Loss Rate
|
Gross
|
Impairment
|
Expected Credit Loss Rate
|
||||||||||||||||||
|
2019
|
2019
|
2019
|
2018
|
2018
|
2018
|
||||||||||||||||||
|
US$’000
|
US$’000
|
%
|
US$’000
|
US$’000
|
%
|
||||||||||||||||||
Not past due
|
10,924
|
8
|
0.1
|
%
|
13,917
|
4
|
—
|
|||||||||||||||||
Past due 0-30 days
|
3,743
|
6
|
0.2
|
%
|
3,761
|
17
|
0.5
|
%
|
||||||||||||||||
Past due 31-120 days
|
2,115
|
27
|
1.3
|
%
|
3,438
|
36
|
1.0
|
%
|
||||||||||||||||
Greater than 120 days
|
6,415
|
5,402
|
84.2
|
%
|
4,404
|
4,145
|
94.1
|
%
|
||||||||||||||||
|
||||||||||||||||||||||||
|
23,197
|
5,443
|
—
|
25,520
|
4,202
|
—
|
|
2019
|
2018
|
2017
|
|||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Balance at January 1
|
4,202
|
3,590
|
3,171
|
|||||||||
Charged to costs and expenses
|
1,276
|
682
|
662
|
|||||||||
Amounts written off during the year
|
(35
|
)
|
(70
|
)
|
(243
|
)
|
||||||
|
||||||||||||
Balance at December 31
|
5,443
|
4,202
|
3,590
|
• |
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.
|
29. |
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, 2019
|
||||||||||||||||||||
Loans and receivables at amortised cost
|
||||||||||||||||||||
Trade receivables
|
18
|
17,754
|
—
|
17,754
|
17,754
|
|||||||||||||||
Cash and cash equivalents
|
19
|
15,231
|
—
|
15,231
|
15,231
|
|||||||||||||||
Investments (deposits)
|
20
|
1,169
|
—
|
1,169
|
1,169
|
|||||||||||||||
Finance lease receivable
|
16,18
|
684
|
—
|
684
|
684
|
|||||||||||||||
|
||||||||||||||||||||
|
34,838
|
—
|
34,838
|
34,838
|
||||||||||||||||
|
||||||||||||||||||||
Liabilities at amortised cost
|
||||||||||||||||||||
Exchangeable note
|
25
|
—
|
(82,021
|
)
|
(82,021
|
)
|
(82,021
|
)
|
||||||||||||
Lease liabilities
|
26
|
(20,149
|
)
|
—
|
(20,149
|
)
|
(20,149
|
)
|
||||||||||||
Trade and other payables (excluding deferred income)
|
23
|
(16,655
|
)
|
—
|
(16,655
|
)
|
(16,655
|
)
|
||||||||||||
Provisions
|
24
|
(50
|
)
|
—
|
(50
|
)
|
(50
|
)
|
||||||||||||
|
||||||||||||||||||||
|
(36,854
|
)
|
(82,021
|
)
|
(118,875
|
)
|
(118,875
|
)
|
||||||||||||
|
||||||||||||||||||||
Fair value through profit and loss (FVPL)
|
||||||||||||||||||||
Exchangeable note bond call option
|
25
|
—
|
—
|
—
|
—
|
|||||||||||||||
Exchangeable note equity conversion option
|
25
|
—
|
(4
|
)
|
(4
|
)
|
(4
|
)
|
||||||||||||
Exchangeable note bond put option
|
25
|
—
|
—
|
—
|
—
|
|||||||||||||||
|
||||||||||||||||||||
|
—
|
(4
|
)
|
(4
|
)
|
(4
|
)
|
|||||||||||||
|
||||||||||||||||||||
|
(2,016
|
)
|
(82,025
|
)
|
(84,041
|
)
|
(84,041
|
)
|
29. |
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 at amortised cost
|
||||||||||||||||||||
Trade receivables
|
18
|
21,318
|
—
|
21,318
|
21,318
|
|||||||||||||||
Cash and cash equivalents
|
19
|
30,277
|
—
|
30,277
|
30,277
|
|||||||||||||||
Finance lease receivable
|
16,18
|
835
|
—
|
835
|
835
|
|||||||||||||||
|
||||||||||||||||||||
|
52,430
|
—
|
52,430
|
52,430
|
||||||||||||||||
|
||||||||||||||||||||
Liabilities at amortised cost
|
||||||||||||||||||||
Exchangeable note
|
25
|
—
|
(81,382
|
)
|
(81,382
|
)
|
(81,382
|
)
|
||||||||||||
Finance lease payable
|
26
|
(962
|
)
|
—
|
(962
|
)
|
(962
|
)
|
||||||||||||
Trade and other payables (excluding deferred income)
|
23
|
(16,596
|
)
|
—
|
(16,596
|
)
|
(16,596
|
)
|
||||||||||||
Provisions
|
24
|
(50
|
)
|
—
|
(50
|
)
|
(50
|
)
|
||||||||||||
|
||||||||||||||||||||
|
(17,608
|
)
|
(81,382
|
)
|
(98,990
|
)
|
(98,990
|
)
|
||||||||||||
|
||||||||||||||||||||
Fair value through profit and loss (FVPL)
|
||||||||||||||||||||
Exchangeable note bond call option
|
25
|
—
|
—
|
—
|
—
|
|||||||||||||||
Exchangeable note equity conversion option
|
25
|
—
|
(238
|
)
|
(238
|
)
|
(238
|
)
|
||||||||||||
Exchangeable note bond put option
|
25
|
—
|
—
|
—
|
—
|
|||||||||||||||
|
||||||||||||||||||||
|
—
|
(238
|
)
|
(238
|
)
|
(238
|
)
|
|||||||||||||
|
||||||||||||||||||||
|
34,822
|
(81,620
|
)
|
(46,798
|
)
|
(46,798
|
)
|
30. |
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES
|
|
Note
|
Borrowings & derivative financial instruments
US$’000 |
Lease liabilities
US$’000 |
|||||||||
Balance at 1 January 2019
|
25,26
|
81,620
|
962
|
|||||||||
Cash-flows:
|
||||||||||||
Interest paid
|
(3,996
|
)
|
—
|
|||||||||
Repayment
|
—
|
(3,533
|
)
|
|||||||||
Non-cash:
|
||||||||||||
Interest charged
|
3,996
|
—
|
||||||||||
Adoption of IFRS 16 (Note 13)
|
—
|
21,185
|
||||||||||
Additions (related to Right of Use assets)
|
—
|
679
|
||||||||||
Exchange adjustment
|
—
|
(91
|
)
|
|||||||||
Accretion interest
|
639
|
947
|
||||||||||
Fair value
|
(234
|
)
|
—
|
|||||||||
Balance at 31 December 2019
|
25,26
|
82,025
|
20,149
|
|
Note
|
Borrowings & derivative financial instruments
US$’000 |
Lease liabilities
US$’000 |
|||||||||
Balance at 1 January 2018
|
25,26
|
95,185
|
886
|
|||||||||
Cash-flows:
|
||||||||||||
Interest paid
|
(4,503
|
)
|
—
|
|||||||||
Repurchase
|
(12,042
|
)
|
—
|
|||||||||
Repayment.
|
—
|
(374
|
)
|
|||||||||
Proceeds
|
—
|
481
|
||||||||||
Non-cash:
|
||||||||||||
Interest charged
|
4,352
|
—
|
||||||||||
Reduction in accrued interest payable
|
150
|
—
|
||||||||||
Exchange adjustment
|
—
|
(31
|
)
|
|||||||||
Accretion interest
|
689
|
—
|
||||||||||
Fair value
|
(2,211
|
)
|
—
|
|||||||||
|
||||||||||||
Balance at 31 December 2018
|
25,26
|
81,620
|
962
|
31. |
POST BALANCE SHEET EVENTS
|
• |
Haemoglobins revenues – including both instrument and consumables revenues with the impact being greater on diabetes (A1c) rather than on haemoglobin variant revenues.
|
• |
Autoimmune revenues – testing volumes were particularly impacted at our reference laboratory in Buffalo, New York but there were also lower product sales in all major markets.
|
• |
HIV, Infectious Diseases and Clinical chemistry product sales.
|
|
However, there were increases in sales of our transport medium product (used to transport Covid-19 patient samples in a stable environment),
respiratory tests for Legionnaire’s Disease and Strep Pneumoniae and of coronavirus-related antibodies sold by our life sciences supply business, Fitzgerald.
Covid-19 Expenditure Reduction Measures
All of the company’s operations have remained open during the pandemic though at reduced levels of output in line with expected demand. However, in response to the expected
reduction in revenues, the company undertook a number cost cutting measures which included the following:
|
• |
The company furloughed a large percentage of its work forces in the USA, Ireland and Canada in April, 2020. Meanwhile, in Brazil and other locations, staff costs were also significantly reduced by
means of pay cuts.
|
• |
The elimination of virtually all travel costs and significant reductions in discretionary sales and marketing expenditure.
|
• |
Availing of governmental supports. This included the receipt of US$4.5 million of loans under the U.S. government’s Paycheck Protection Program (“PPP”). Under the provisions of the PPP, these loans
will be partially or totally forgiven, based on the extent to which a borrower’s workforce returns to normal levels in the eight-week period immediately following the loans being granted. Upon receipt of these loans, the Company
ended the furloughing of all staff in the USA and therefore expects that a large percentage of these loans will be forgiven later in 2020, once the necessary verification has taken place. In Ireland, the company also availed of
economic support mechanisms being provided by the Irish Government though a significant level of furloughing continued into June, 2020, mainly due to the expected lower demand for HIV products for the African market.
|
31.
|
POST BALANCE SHEET EVENTS (CONTINUED)
|
32. |
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.
|
32. |
ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED)
|
•
|
Determining whether or not a contract contains a lease. Company assessed if the contract conveys the right to control the use of an identified asset for a period of time in exchange
for consideration
|
•
|
Significant judgement is also required in establishing whether or not it is reasonably certain that an extension option will be exercised, considering whether or not it is reasonably certain that a
termination option will not be exercised. In making this decision, management considered the facts and circumstances that create a significant economic incentive. Factors specific to the asset, the entity and the wider market were
also considered.
|
•
|
Further, critical judgement is involved in determining whether or not variable lease payments are truly variable, or in-substance fixed. In-substance variable lease payments are
treated as fixed lease payments.
|
33. |
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: June 15, 2020
|
By:
|
/s/ KEVIN TANSLEY
|
|
Mr Kevin Tansley
|
|
Company secretary/
|
|
Chief Financial Officer
|
|
Date: June 15, 2020
|
Item 19 |
Exhibits
|
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
|
333-182279
|
6/22/2012
|
Form S-8
|
333-195232
|
4/11/2014
|
/s/ GRANT THORNTON
|
Dublin, Ireland
|
June 15, 2020
|
LOSS PER SHARE (Schedule of Earnings Per ADS) (Details) - shares |
12 Months Ended | |||||
---|---|---|---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2019 |
|||
Disclosure of classes of share capital [line items] | ||||||
Ordinary shares | 96,162,410 | 96,162,410 | 96,162,410 | |||
Basic earnings per share denominator | 83,606,810 | 83,612,908 | 86,486,409 | |||
Reconciliation to weighted average earnings per share denominator: | ||||||
In issue at January 1 | 96,162,410 | 96,162,410 | 96,162,410 | |||
Weighted average number of shares issued during the year | [1] | |||||
Weighted average number of treasury shares | (12,555,600) | (12,549,502) | (9,676,001) | |||
Basic earnings per share denominator | 83,606,810 | 83,612,908 | 86,486,409 | |||
American depositary share [Member] | ||||||
Disclosure of classes of share capital [line items] | ||||||
Ordinary shares | 24,040,602 | 24,040,602 | 24,040,602 | 24,040,602 | ||
Basic earnings per share denominator | 20,901,703 | 20,903,227 | 21,621,602 | |||
Reconciliation to weighted average earnings per share denominator: | ||||||
In issue at January 1 | 24,040,602 | 24,040,602 | 24,040,602 | |||
Weighted average number of shares issued during the year | [1] | |||||
Weighted average number of treasury shares | (3,138,899) | (3,137,375) | (2,419,000) | |||
Basic earnings per share denominator | 20,901,703 | 20,903,227 | 21,621,602 | |||
|
RELATED PARTY TRANSACTIONS |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 Trinity
Biotech, and directly with Mr O’Caoimh, 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 adjacent to its then premises at IDA Business Park, Bray, Co.
Wicklow, Ireland. The annual rent of €381,000 (US$427,000) is payable from January 1, 2004. Upward-only rent reviews are carried out every five years and there have been no increases arising from these rent reviews.
The Group has also entered into lease agreements with Ronan O’Caoimh for a 43,860 square foot manufacturing facility in Bray, Ireland and an
adjacent warehouse of 16,000 square feet. The annual rent for the manufacturing facility is €787,000 (US$883,000) and the annual rent for the warehouse is €144,000 (US$162,000). These two leases expire in 2028 and 2026 respectively. At the
time, independent valuers advised the Group that the rent in respect of each of the leases represents a fair market rent. Upward-only rent reviews are carried out every five years and there have been no increases arising from these rent
reviews.
Trinity Biotech and its directors (excepting Mr O’Caoimh and Dr Walsh who express no opinion on this point) believe at the time that the
arrangements entered into represent a fair and reasonable basis on which the Group can meet its ongoing requirements for premises.
Compensation of key management personnel of the Group
At December 31, 2019, 2018 and 2017 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, 2019 of these personnel is detailed below:
The amounts disclosed in respect of directors’ emoluments in Note 11 includes non-executive directors’ fees of US$225,000 (2018: US$188,000) and share-based
compensation benefits of US$82,000 (2018: US$313,000). Total directors’ remuneration is also included in “personnel expenses” (Note 3) and “loss before tax” (Note 11). In 2019, share-based compensation benefits included in Note 11 exclude
capitalised amounts of US$35,000 (2018: US$149,000).
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. This arrangement ceased with effect from December, 31, 2018 with Ronan O’Caoimh returning as an employee of the
company.
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, 2018 and December 31, 2019, 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 2018 and 2019 consolidated financial statements. During 2019, Trinity Research Limited repaid loans to Rayville
Limited of US$159,000 in order to meet its obligations under a tax settlement arising from a tax audit.
As described in Note 6, a settlement was reached with the tax authority in one of the jurisdictions in which the company operates which included the payment of
US$3,863,000 in relation to payments made by Trinity Research Limited to Rayville Limited and US$1,231,000 in relation to payments for CEO services made to Darnick Company. Darnick Company agreed to contribute US$1,231,000 to the above
settlement and this amount was outstanding at December 31, 2019 and was treated as a contingent asset and not recognised in the consolidated statement of financial position at year-end (refer to Note 27). |
PROVISIONS |
12 Months Ended | ||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||
Provisions [abstract] | |||||||||||||||||||||
PROVISIONS |
During 2019 and 2018 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, 2019 represents the estimated cost of product warranties, the exact amount which cannot be determined. US$50,000 represents management’s best estimate of these obligations at December 31, 2019. |
PROPERTY, PLANT AND EQUIPMENT (Schedule of Right-of-use assets) (Details - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Disclosure of comparative information prepared under previous GAAP [line items] | ||
Right-of-use assets | $ 5,227 | $ 10,086 |
Right-of-use assets cost at transition before impairment [Member] | ||
Disclosure of comparative information prepared under previous GAAP [line items] | ||
Right-of-use assets | 21,185 | |
Impairment adjustment on transition [Member] | ||
Disclosure of comparative information prepared under previous GAAP [line items] | ||
Right-of-use assets | $ (11,099) |
ACCOUNTING ESTIMATES AND JUDGEMENTS |
12 Months Ended | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | ||||||||||||||||||||||||
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 14 contains information about the assumptions and the risk factors relating to goodwill impairment. Note 22 outlines information regarding the valuation of share
options and warrants. Note 25 outlines the valuation techniques used by the Company in determining the fair value of exchangeable notes and the associated embedded derivatives. In Note 29, 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 14.
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 14.
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 17.
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 29.
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.
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 15 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 2019, 2018 or 2017.
IFRS 16
IFRS 16, Leases, requires entities to make certain judgements and estimations. Critical judgements was required by the Company
in the following areas:
Key source of estimation and uncertainty is calculation of the appropriate discount rate to use. When making the determination, the company considered the rate of
interest that they would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of a similar value to the right-of-use asset in a similar economic environment.
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. |
INVENTORIES (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Classes of current inventories [abstract] | |||
Cost of sales | $ 50,748 | $ 55,285 | $ 54,904 |
IMPAIRMENT CHARGES |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of impairment charges and inventory provisioning [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
IMPAIRMENT CHARGES |
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, 2019, December 31, 2018 and December 31, 2017 was as follows:
|
LOSS BEFORE TAX |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of loss profit before tax [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LOSS BEFORE TAX |
The following amounts were charged / (credited) to the statement of operations:
|
DEFERRED TAX ASSETS AND LIABILITIES (Schedule of Unrecognised Deferred Tax Assets) (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Disclosure of deferred tax assets and liabilities [Abstract] | ||
Capital losses | $ 8,293 | $ 8,293 |
Net operating losses | 80,577 | 67,012 |
US alternative minimum tax credits | 1,928 | 1,674 |
Other temporary timing differences | 7,399 | 3,880 |
US state credit carryforwards | 493 | 364 |
Unrecognised deferred tax assets | $ 98,690 | $ 81,223 |
TRADE AND OTHER RECEIVABLES (Schedule of Trade and Other Receivables) (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Trade and other current receivables [abstract] | ||
Trade receivables, net of impairment losses | $ 17,754 | $ 21,318 |
Prepayments | 576 | 807 |
Contract assets | 2,317 | 1,894 |
Value added tax | 59 | 63 |
Finance lease receivables | 281 | 359 |
Total and other receivables | $ 20,987 | $ 24,441 |
LEASE LIABILITIES (Schedule of Carrying Values of Finance Lease Liabilities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Current liabilities | ||
Lease liabilities related to Right of Use assets | $ 2,156 | |
Sale and leaseback liabilities | 248 | 436 |
Current liabilities | 2,404 | 436 |
Non-Current liabilities | ||
Lease liabilities related to Right of Use assets | 17,474 | |
Sale and leaseback liabilities | 271 | 526 |
Non-current liabilities | $ 17,745 | $ 526 |
SEGMENT INFORMATION (Schedule of Capital Expenditure by Geographical Area) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Capital expenditure | $ 33,621 | $ 17,805 |
Ireland [Member] | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Capital expenditure | 20,758 | 7,148 |
Other Countries [Member] | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Capital expenditure | 1,746 | |
Americas [Member] | ||
Disclosure of disaggregation of revenue from contracts with customers [line items] | ||
Capital expenditure | $ 12,863 | $ 8,911 |
TRADE AND OTHER PAYABLES (Schedule of Trade and Other Payables) (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Trade and other current payables [abstract] | ||
Trade payables | $ 7,833 | $ 8,116 |
Payroll taxes | 519 | 448 |
Employee related social insurance | 170 | 154 |
Accrued liabilities | 8,133 | 7,878 |
Deferred income | 292 | 312 |
Total trade and other payables | $ 16,947 | $ 16,908 |
SEGMENT INFORMATION (Schedule of Revenue by Major Product Group) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of products and services [line items] | |||
Revenues | $ 90,435 | $ 97,035 | $ 99,140 |
Clinical laboratory [Member] | |||
Disclosure of products and services [line items] | |||
Revenues | 68,127 | 71,618 | 73,366 |
Point-of-Care [Member] | |||
Disclosure of products and services [line items] | |||
Revenues | 11,393 | 14,836 | 16,774 |
Laboratory services [Member] | |||
Disclosure of products and services [line items] | |||
Revenues | $ 10,915 | $ 10,581 | $ 9,000 |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (Schedule of Amortisation) (Details) |
12 Months Ended |
---|---|
Dec. 31, 2019 | |
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 |
EXCHANGEABLE NOTES (Schedule of Exchangeable Notes) (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Non-current assets | ||
Exchangeable note bond call option | ||
Non-current liabilities | ||
Exchangeable note equity conversion option | 4 | 238 |
Exchangeable note bond put option | ||
Total non-current liabilities | 4 | 238 |
Total value of embedded derivatives - net liability | $ 4 | $ 238 |
SEGMENT INFORMATION (Schedule of Depreciation and Amortisation by Geographical Area) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Depreciation | $ 2,530 | $ 1,375 | $ 2,424 |
Amortisation | 2,368 | 2,825 | 3,303 |
Ireland [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Depreciation | 322 | 74 | 1,186 |
Amortisation | 642 | 655 | 1,164 |
Americas [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Depreciation | 2,208 | 1,301 | 1,238 |
Amortisation | $ 1,726 | $ 2,170 | $ 2,139 |
SHORT-TERM INVESTMENTS (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||
Disclosure of short-term investments [Abstract] | |||||||||||||||||||||||||||||||||||||
Schedule of Short-Term Investments |
|
DERIVATIVES AND FINANCIAL INSTRUMENTS (Schedule of Exposure of Trade Receivables by Customer) (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | $ 18,438 | $ 22,153 |
End-user customers [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | 9,453 | 9,253 |
Distributors [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | 7,199 | 11,860 |
Non-government customers [Member] | ||
Disclosure of credit risk exposure [line items] | ||
Maximum Exposure to credit risk for trade receivables and finance lease income receivable | $ 1,786 | $ 1,040 |
LOSS PER SHARE (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings per share [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Basic Earnings Per Ordinary Share | As at December 31, 2019, this amounted to 83,606,810 shares (2018: 83,612,908 shares) (2017: 86,486,409 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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OTHER ASSETS (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of other assets [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Other Assets |
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IMPAIRMENT CHARGES (Schedule of Statement of Operation) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of impairment charges and inventory provisioning [Abstract] | |||
Impairment of PP&E (Note 13) | $ 6,349 | $ 6,112 | $ 10,437 |
Impairment of goodwill and other intangible assets (Note 14) | 16,570 | 19,212 | 29,667 |
Impairment of prepayments (Note 18) | (1,376) | (1,608) | (1,651) |
Total impairment loss | 24,295 | 26,932 | 41,755 |
Income tax impact of impairment loss | (148) | (1,752) | (517) |
Total impairment loss after tax | $ 24,443 | $ 25,180 | $ 41,238 |
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Consolidated Statement Of Comprehensive Income | |||
Loss for the year | $ (28,914) | $ (22,090) | $ (40,270) |
Other comprehensive (loss)/income | |||
Foreign exchange translation differences | (167) | (520) | 3,086 |
Other comprehensive (loss)/income | (167) | (520) | 3,086 |
Total Comprehensive Loss (all attributable to owners of the parent) | $ (29,081) | $ (22,610) | $ (37,184) |
PROVISIONS (Tables) |
12 Months Ended | ||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||
Provisions [abstract] | |||||||||||||||||||
Schedule of Provisions |
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BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES |
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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, 2019. 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 2019 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 32.
The directors have considered the Groups current financial position and cashflow projections, taking into account all known events and developments including the
Covid-19 pandemic. While acknowledging that there will be a temporary decrease in revenues due to Covid-19, the company has taken measures to reduce expenditure, to obtain government pandemic supports in Ireland and USA and to exploit sales
opportunities of products related to coronavirus. (For more information on the impact of Covid-19 refer to Subsequent Events in Note 31). 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
The Group has applied IFRS 16, Leases, using the modified retrospective approach and therefore comparative information has not been restated.
Accounting policy applicable from 1 January 2019
For any new contracts entered into on or after 1 January 2019, the Group considers whether a contract is, or contains a lease. A lease is defined as a contract, or part
of a contract, that conveys the right to use an asset (the underlying asset) for a period of time in exchange for consideration. To apply this definition the Group assesses whether the contract meets three key evaluations which are whether:
At lease commencement date, the Group recognises a right-of-use asset and a lease liability on the balance sheet. The right-of-use asset is measured at cost, which is made
up of the initial measurement of the lease liability, any initial direct costs incurred by the Group, an estimate of any costs to dismantle and remove the asset at the end of the lease, and any lease payments made in advance of the lease
commencement date (net of any incentives received).
The Group depreciates the right-of-use assets on a straight-line basis from the lease commencement date to the earlier of the end of the useful life of the right-of-use
asset or the end of the lease term. The Group also assesses the right-of-use asset for impairment when such indicators exist.
At the commencement date, the Group measures the lease liability at the present value of the lease payments unpaid at that date, discounted using the interest rate
implicit in the lease if that rate is readily available or the Groups incremental borrowing rate. Lease payments included in the measurement of the lease liability are made up of fixed payments (including in substance fixed), variable payments
based on an index or rate, amounts expected to be payable under a residual value guarantee and payments arising from options reasonably certain to be exercised. Subsequent to initial measurement, the liability will be reduced for payments made
and increased for interest. It is remeasured to reflect any reassessment or modification, or if there are changes in in-substance fixed payments.When the lease liability is remeasured, the corresponding adjustment is reflected in the
right-of-use asset, or profit and loss if the right-of-use asset is already reduced to zero.
The Group has elected to account for short-term leases and leases of low-value assets using the practical expedients. Instead of recognising a
right-of-use asset and lease liability, the payments in relation to these are recognised as an expense in profit or loss on a straight-line basis over the lease term. On the statement of financial position, right-of-use assets have been
included in property, plant and equipment and lease liabilities have been included in separate lines within the current liabilities and non-current liabilities sections.
Leased assets - as lessor
The Groups accounting policy under IFRS 16 has not changed from the comparative period. As a lessor, the Group classifies its leases as either operating or finance
leases. A lease is classified as a finance lease if it transfers substantially all the risks and rewards incidental to ownership of the underlying asset, and classified as an operating lease if it does not.
Accounting policy applicable before 1 January 2019
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 Groups 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 Groups opening IFRS balance sheet as at January 1, 2004.
To the extent that the Groups 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 combinations 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 Groups 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 assets 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 arms 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, 2018 and December 31, 2019. See Note 14.
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 assets 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 when there is no expected loss in value on early termination. 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 Groups 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 Groups obligation to provide a refund for faulty products under the standard warranty terms is recognised as a provision, see Note 24 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 Groups 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 Groups 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 Groups 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, 2019.
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 Companys 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 Groups 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 Groups 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, 2019, 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 Groups 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:
The IASB also issued 'Amendments to References to the Conceptual Framework in IFRS Standards'. The amendments in the table above are effective for annual periods beginning on or after 1
January 2020.
The IASB issued amendments to IFRS 3 in October 2018 regarding the definition of a business. The amendments clarify that the process required to meet the definition of a
business must be substantive; and, that the inputs and process must together significantly contribute to creating outputs. The definition of outputs has been narrowed to focus on goods and services provided to customers and other income from
ordinary activities. In addition, the amendments indicate that an acquisition of primarily a single asset or group of similar assets is unlikely to meet the definition of a business. The amendments will be applied prospectively for business
combinations and asset acquisitions occurring on or after January 1, 2020. The Group is finalising its review of the impact of this amendment, but does not expect the clarification to have a material impact on the value of acquisitions or
additions to property, plant and equipment.
In September 2019, the IASB issued amendments to IFRS 9, IAS 39 Financial Instruments: Recognition and Measurement and IFRS 7 Financial Instruments: Disclosures, which
concludes phase one of its work to respond to the effects of Interbank Offered Rates (IBOR) reform on financial reporting. The changes relate to hedge accounting and Group does not expect the amendment to have a material impact.
In 2019, the Group has adopted the new accounting pronouncements which have become effective this year, and are as follows:
IFRS 16 Leases IFRS 16 Leases replaces IAS 17 Leases along with three Interpretations (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 adoption of this new Standard has resulted in the Group recognising a right-of-use asset and related lease liability in connection with each former operating lease
except for those identified as low-value or having a remaining lease term of less than 12 months from the date of initial application.
The new Standard has been applied using the modified retrospective approach, with the cumulative effect of adopting IFRS 16 being recognised in equity as an adjustment
to the opening balance of retained earnings for the current period. Prior periods have not been restated. Right-of-use assets have been assessed for impairment on transition by applying IAS 36, Impairment as at January 1, 2019. This resulted
in an adjustment on transition to IFRS 16 of US$11,099,000, which reduces the value of the assets recorded in property, plant and equipment, with a corresponding movement in Accumulated Surplus. See Note 13.
The Group has elected not to include initial direct costs in the measurement of the right-of-use asset for operating leases in existence at the date of initial
application of IFRS 16, being 1 January 2019. At this date, the Group has also elected to measure the right-of-use assets at an amount equal to the lease liability adjusted for any prepaid or accrued lease payments that existed at the date of
transition.
On transition, for leases previously accounted for as operating leases with a remaining lease term of less than 12 months and for leases of low-value assets the Group
has applied the optional exemptions to not recognise right-of-use assets but to account for the lease expense on a straight line basis over the remaining lease term.
For those leases previously classified as finance leases, the right-of-use asset and lease liability are measured at the date of initial application at the same amounts as
under IAS 17 immediately before the date of initial application.
The following is a reconciliation of the financial statement line items from IAS 17 to IFRS 16 at January 1, 2019:
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RELATED PARTY TRANSACTIONS (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of transactions between related parties [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Compensation | Compensation for the year ended December 31, 2019 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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INCOME TAX (CREDIT)/EXPENSE (Schedule of Overseas Tax Jurisdictions) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
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Effective tax rate | |||
Loss before taxation | $ (29,997) | $ (23,183) | $ (39,875) |
As a percentage of loss before tax: | |||
Current tax | (0.55%) | (0.51%) | 1.14% |
Total (current and deferred) | (3.36%) | (2.26%) | (3.05%) |
SHARE OPTIONS AND SHARE WARRANTS (Schedule of Fair Value of the Options Vesting Period) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
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Disclosure of share options and share warrants [Abstract] | |||
Share-based payments - cost of sales | $ 26 | $ 34 | $ 35 |
Share-based payments - selling, general and administrative | 732 | 1,335 | 893 |
Total - continuing operations | 758 | 1,369 | 928 |
Share-based payments - discontinued operations | |||
Total Share-based payments | $ 758 | $ 1,369 | $ 928 |
PERSONNEL EXPENSES (Tables) |
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 579 (2018: 575) (2017: 556) and is analysed into the following categories:
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COMMITMENTS AND CONTINGENCIES (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
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Disclosure of maturity analysis of operating lease payments [line items] | ||
Capital Commitments | $ 323 | $ 187 |
Grant contingencies maximum amount payable | 2,834 | $ 2,892 |
Darnick Company [Member] | ||
Disclosure of maturity analysis of operating lease payments [line items] | ||
Contribution for tax audit settlement | $ 1,231 |
AUTHORISATION FOR ISSUE |
12 Months Ended | ||
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Dec. 31, 2019 | |||
Disclosure of authorisation for issue [Abstract] | |||
AUTHORISATION FOR ISSUE |
These Group consolidated financial statements were authorised for issue by the Board of Directors on June 13, 2020. |
INCOME TAX (CREDIT)/EXPENSE (Tables) |
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Dec. 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Creditexpense Schedule Of Statutory Tax Rate | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Charge for Tax |
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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, 2019, 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, 2019, the Group had unrecognised deferred tax assets in respect of unused tax losses and unused tax credits as follows:
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TRADE AND OTHER PAYABLES |
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trade and other current payables [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
TRADE AND OTHER PAYABLES |
Accrued liabilities include US$1,307,000 (2018: US$1,207,000) relating to contracted licence payments. |
DEFERRED TAX ASSETS AND LIABILITIES |
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Disclosure of deferred 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 2019 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 2019, the deferred tax asset increased by US$125,000. Due to the impairment loss in 2019, 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$716,000 in 2019, 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, 2019 and at December 31, 2018 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$17,467,000 in the unrecognised deferred tax assets during the year ended December 31, 2019. 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, 2019 is analysed as follows:
A deferred tax asset of US$1,968,000 (2018: US$1,360,000) was not recognised in respect of net operating losses in Brazil. 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$4,820,000 (2018: US$3,564,000) 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 recorded cumulative losses, as its interest expenses is greater than its interest income.
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 notes embedded derivatives value and the movement on the exchangeable notes host contract, being the accretion of notional interest, are exempt
from deferred taxation recognition.
A deferred tax asset of US$6,619,000 (2018: US$5,691,000) was not recognised in respect of net operating losses in Trinity Biotech Manufacturing Ltd. An additional
US$243,000 (2018: US$485,000) was not recognized in respect of other temporary timing differences. The total unrecognized deferred tax asset is US$6,862,000. 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 charges 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$381,000 (2018: US$213,000) 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$3,291,000 (2018: US$2,174,000) was not recognised in respect of net operating losses, alternative minimum tax credits and other deferred tax
assets 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$493,000 (2018: US$364,000) 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 (2018: US$8,293,000) in Ireland as it is not probable that there will be future
capital gains against which to offset these capital losses.
Unrecognised deferred tax liabilities
At December 31, 2019 and 2018, there was no recognised or unrecognised deferred tax liability for taxes that would be payable on the unremitted earnings of certain of the
Groups subsidiaries. The Company is able to control the timing of the reversal of the temporary differences of its subsidiaries and it is probable that these temporary differences will not reverse in the foreseeable future.
Movement in temporary differences during the year
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PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATION (Schedule of Cash Flows Attributable) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of loss on discontinued operation [Abstract] | |||
Cash flows from operating activities | $ (5) | $ 527 | $ (2,847) |
Cash flows from investing activities |
INCOME TAX (CREDIT)/EXPENSE (Schedule of Unrecognised Deferred Tax Assets) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unrecognised deferred tax asset | $ 17,814 | $ 13,851 | $ 10,196 |
Ireland [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unrecognised deferred tax asset | 12,062 | 9,953 | 8,471 |
USA [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unrecognised deferred tax asset | 3,291 | 2,174 | |
USA Tax Credits [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unrecognised deferred tax asset | 493 | 364 | 345 |
Brazil [Member] | |||
Disclosure of disaggregation of revenue from contracts with customers [line items] | |||
Unrecognised deferred tax asset | $ 1,968 | $ 1,360 | $ 1,380 |
CASH AND CASH EQUIVALENTS |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||
Cash and cash equivalents [abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||
CASH AND CASH EQUIVALENTS |
|
GOODWILL AND INTANGIBLE ASSETS (Schedule of Breakdown of Impairment Loss) (Details) (USD $) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Disclosure of goodwill and intangible assets [Abstract] | ||
Goodwill and other intangible assets (see Note 14) | $ 16,570 | $ 19,212 |
Property, plant and equipment (see Note 13) | 6,349 | 6,112 |
Prepayments (see Note 18) | 1,376 | 1,608 |
Total impairment loss | $ 24,295 | $ 26,932 |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES - TAX AUDIT SETTLEMENT (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of products and services [line items] | |||
Selling, general and administrative expenses - tax audit settlement gross | $ 5,442 | ||
Patent dividend scheme amount | 3,863 | ||
R&D tax credits | 75 | ||
Interest credits | 1,000 | ||
Penalties income | 273 | ||
Provision | 400 | ||
Selling, general and administrative expenses - tax audit settlement | 5,042 | ||
Darnick Company [Member] | |||
Disclosure of products and services [line items] | |||
Payments for CEO Services | 1,231 | ||
Contribution amount in settlement | $ 1,231 |
SHARE OPTIONS AND SHARE WARRANTS (Narrative) (Details) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of classes of share capital [line items] | |||
Weighted-average remaining contractual life of options outstanding | 5 years 22 days | 4 years 3 months 29 days | |
Share based payments charge | $ 839,000 | $ 1,607,000 | $ 1,109,000 |
share based payments capitalised in intangible development project assets | $ 80,000 | $ 238,000 | $ 181,000 |
Class A Ordinary shares [Member] | |||
Disclosure of classes of share capital [line items] | |||
Weighted average share price date of exercise for options exercised | |||
Opening share price | $ 0.57 | $ 1.28 | 1.73 |
Closing share price | 0.26 | 0.57 | 1.28 |
Average share price | 0.49 | ||
American depositary share [Member] | |||
Disclosure of classes of share capital [line items] | |||
Weighted average share price date of exercise for options exercised | |||
Opening share price | 2.29 | 5.1 | 6.92 |
Closing share price | 1.03 | $ 2.29 | $ 5.1 |
Average share price | $ 1.95 |
TRADE AND OTHER PAYABLES (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trade and other current payables [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Trade and Other Payables |
|
CONSOLIDATED STATEMENT OF CASH FLOWS - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Cash flows from operating activities | |||
Loss for the year | $ (28,914) | $ (22,090) | $ (40,270) |
Adjustments to reconcile net loss to cash provided by operating activities: | |||
Depreciation | 2,526 | 1,296 | 1,896 |
Amortisation | 2,368 | 2,825 | 3,303 |
Income tax (credit) / expense | (1,006) | (1,115) | (374) |
Financial income | (697) | (2,124) | (3,198) |
Financial expense | 6,582 | 5,080 | 5,405 |
Share-based payments | 758 | 1,369 | 928 |
Foreign exchange (gains)/losses on operating cash flows | (93) | 311 | 307 |
Loss on disposal or retirement of property, plant and equipment | 17 | 15 | 3 |
Movement in inventory provision | 1,567 | 300 | 2,275 |
Impairment of prepayments | 1,376 | 1,608 | 1,651 |
Impairment of property, plant and equipment | 6,349 | 6,112 | 10,437 |
Impairment of intangible assets | 16,570 | 19,212 | 29,667 |
Provision for closure costs | (1,794) | ||
Other non-cash items | 835 | 570 | (728) |
Operating cash flows before changes in working capital | 8,238 | 13,369 | 9,508 |
(Increase) / decrease in trade and other receivables | 445 | (5,960) | 306 |
Decrease / (increase) in inventories | (2,959) | 1,988 | (2,461) |
(Decrease) / increase in trade and other payables | 151 | (3,419) | 2,017 |
Cash generated from operations | 5,875 | 5,978 | 9,370 |
Interest paid | (1,000) | (39) | (53) |
Interest received | 560 | 874 | 776 |
Income taxes received / (paid) | (18) | 416 | (843) |
Net cash generated by operating activities | 5,417 | 7,229 | 9,250 |
Cash flows from investing activities | |||
Payments to acquire intangible assets | (9,718) | (9,863) | (10,229) |
Acquisition of property, plant and equipment | (2,118) | (7,528) | (4,839) |
Disposal of property, plant and equipment | (17) | ||
Licence fees | (1,112) | ||
Net cash used in investing activities | (11,853) | (17,391) | (16,180) |
Cash flows from financing activities | |||
Share buyback | (434) | (7,799) | |
Interest payment on exchangeable notes | (3,996) | (4,503) | (4,600) |
Purchase of exchangeable notes | (12,042) | ||
Proceeds from sale & leaseback transactions | 481 | 51 | |
Payment of lease liabilities | (3,533) | (374) | (295) |
Net cash used in financing activities | (7,529) | (16,872) | (12,643) |
Decrease in cash and cash equivalents and short term investments | (13,965) | (27,034) | (19,573) |
Effects of exchange rate movements on cash held | 88 | (296) | 71 |
Cash and cash equivalents and short-term investments at beginning of year | 30,277 | 57,607 | 77,109 |
Cash and cash equivalents and short term investments at end of year | $ 15,231 | $ 30,277 | $ 57,607 |
COMMITMENTS AND CONTINGENCIES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of commitments and contingencies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Operating Lease Commitments with Non-Cancellable | Future minimum non-cancelable operating lease commitments in
accordance with IAS 17 as at December 31, 2018 were as follows:
|
CASH AND CASH EQUIVALENTS (Schedule of Cash and Cash Equivalents) (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|---|---|
Cash and cash equivalents [abstract] | ||||
Cash at bank and in hand | $ 6,275 | $ 6,854 | ||
Short-term deposits | 8,956 | 23,423 | ||
Cash and cash equivalents | $ 15,231 | $ 30,277 | $ 57,607 | $ 77,109 |
INCOME TAX (CREDIT)/EXPENSE (Schedule of Charge for Tax) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||||
---|---|---|---|---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|||||
Current tax (credit)/ expense | |||||||
Irish Corporation tax | $ (312) | $ (258) | $ (51) | ||||
Foreign taxes | [1] | 197 | 195 | 358 | |||
Adjustment in respect of prior years | (50) | (56) | 150 | ||||
Total current tax (credit)/expense | (165) | (119) | 457 | ||||
Deferred tax credit | |||||||
Origination and reversal of temporary differences (see Note 15) | [2] | (841) | (2,031) | (5,969) | |||
Origination and reversal of net operating losses (see Note 15) | [2] | 1,625 | 4,298 | ||||
Total deferred tax credit | [2] | (841) | (406) | (1,671) | |||
Total income tax credit on continuing operations in statement of operations | [2] | (1,006) | (525) | (1,214) | |||
Tax (credit)/charge on discontinued operations (see Note 10) | [2] | (590) | 323 | ||||
Total tax credit | [2] | $ (1,006) | $ (1,115) | $ (891) | |||
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PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATION (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of loss on discontinued operation [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 re-measurement 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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LEASE LIABILITIES (Schedule of Outstanding Interest Bearing Loans and Borrowings) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2015 |
|
Statement Line Items [Line Items] | |||
Nominal interest rate | 4.00% | ||
Year of maturity | April 1, 2045 | ||
Fair value | $ 20,149 | $ 962 | |
Carrying value | $ 519 | $ 962 | |
Sale and leaseback liabilities [Member] | |||
Statement Line Items [Line Items] | |||
Currency | Euro | Euro | |
Nominal interest rate | 4.53% | 4.53% | |
Year of maturity | 2023 | 2023 | |
Fair value | $ 286 | $ 648 | |
Carrying value | 286 | 648 | |
Total amount paid in respect of lease liabilities | $ 3,533 | $ 374 | |
Sale and leaseback liabilities Two [Member] | |||
Statement Line Items [Line Items] | |||
Currency | USD | USD | |
Nominal interest rate | 5.51% | 5.51% | |
Year of maturity | 2023 | 2023 | |
Fair value | $ 233 | $ 314 | |
Carrying value | $ 233 | $ 314 |
OTHER OPERATING INCOME (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of other operating income [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Other Operating Income |
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BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (POLICIES) |
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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, 2019. 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 2019 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 32.
The directors have considered the Group’s current financial position and cashflow projections, taking into account all known events and developments including the Covid-19
pandemic. While acknowledging that there will be a temporary decrease in revenues due to Covid-19, the company has taken measures to reduce expenditure, to obtain government pandemic supports in Ireland and USA and to exploit sales opportunities of
products related to coronavirus. (For more information on the impact of Covid-19 – refer to Subsequent Events in Note 31). 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
The Group has applied IFRS 16, Leases, using the modified retrospective approach and therefore comparative information has not been restated.
Accounting policy applicable from 1 January 2019
For any new contracts entered into on or after 1 January 2019, the Group considers whether a contract is, or contains a lease. A lease is defined as ‘a contract, or part of a
contract, that conveys the right to use an asset (the underlying asset) for a period of time in exchange for consideration’. To apply this definition the Group assesses whether the contract meets three key evaluations which are whether:
At lease commencement date, the Group recognises a right-of-use asset and a lease liability on the balance sheet. The right-of-use asset is measured at cost, which is made up of
the initial measurement of the lease liability, any initial direct costs incurred by the Group, an estimate of any costs to dismantle and remove the asset at the end of the lease, and any lease payments made in advance of the lease commencement date
(net of any incentives received).
The Group depreciates the right-of-use assets on a straight-line basis from the lease commencement date to the earlier of the end of the useful life of the right-of-use asset or
the end of the lease term. The Group also assesses the right-of-use asset for impairment when such indicators exist.
At the commencement date, the Group measures the lease liability at the present value of the lease payments unpaid at that date, discounted using the interest rate implicit in
the lease if that rate is readily available or the Group’s incremental borrowing rate. Lease payments included in the measurement of the lease liability are made up of fixed payments (including in substance fixed), variable payments based on an index
or rate, amounts expected to be payable under a residual value guarantee and payments arising from options reasonably certain to be exercised. Subsequent to initial measurement, the liability will be reduced for payments made and increased for
interest. It is remeasured to reflect any reassessment or modification, or if there are changes in in-substance fixed payments.When the lease liability is remeasured, the corresponding adjustment is reflected in the right-of-use asset, or profit and
loss if the right-of-use asset is already reduced to zero.
The Group has elected to account for short-term leases and leases of low-value assets using the practical expedients. Instead of recognising a right-of-use asset and lease
liability, the payments in relation to these are recognised as an expense in profit or loss on a straight-line basis over the lease term. On the statement of financial position, right-of-use assets have been included in property, plant and equipment
and lease liabilities have been included in separate lines within the current liabilities and non-current liabilities sections.
Leased assets - as lessor
The Group’s accounting policy under IFRS 16 has not changed from the comparative period. As a lessor, the Group classifies its leases as either operating or finance leases. A
lease is classified as a finance lease if it transfers substantially all the risks and rewards incidental to ownership of the underlying asset, and classified as an operating lease if it does not.
Accounting policy applicable before 1 January 2019
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, 2018 and December 31, 2019. See Note 14.
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 when
there is no expected loss in value on early termination. 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 24 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, 2019.
|
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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, 2019, 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:
The IASB also issued 'Amendments to References to the Conceptual Framework in IFRS Standards'. The amendments in the table above are effective for annual periods beginning on or after 1
January 2020.
The IASB issued amendments to IFRS 3 in October 2018 regarding the definition of a business. The amendments clarify that the process required to meet the definition of a
business must be substantive; and, that the inputs and process must together significantly contribute to creating outputs. The definition of outputs has been narrowed to focus on goods and services provided to customers and other income from
ordinary activities. In addition, the amendments indicate that an acquisition of primarily a single asset or group of similar assets is unlikely to meet the definition of a business. The amendments will be applied prospectively for business
combinations and asset acquisitions occurring on or after January 1, 2020. The Group is finalising its review of the impact of this amendment, but does not expect the clarification to have a material impact on the value of acquisitions or
additions to property, plant and equipment.
In September 2019, the IASB issued amendments to IFRS 9, IAS 39 Financial Instruments: Recognition and Measurement and IFRS 7 Financial Instruments: Disclosures, which
concludes phase one of its work to respond to the effects of Interbank Offered Rates (IBOR) reform on financial reporting. The changes relate to hedge accounting and Group does not expect the amendment to have a material impact.
In 2019, the Group has adopted the new accounting pronouncements which have become effective this year, and are as follows:
IFRS 16 ‘Leases’ IFRS 16 ‘Leases’ replaces IAS 17 ‘Leases’ along with three Interpretations (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 adoption of this new Standard has resulted in the Group recognising a right-of-use asset and related lease liability in connection with each former operating lease
except for those identified as low-value or having a remaining lease term of less than 12 months from the date of initial application.
The new Standard has been applied using the modified retrospective approach, with the cumulative effect of adopting IFRS 16 being recognised in equity as an adjustment
to the opening balance of retained earnings for the current period. Prior periods have not been restated. Right-of-use assets have been assessed for impairment on transition by applying IAS 36, Impairment as at January 1, 2019. This resulted
in an adjustment on transition to IFRS 16 of US$11,099,000, which reduces the value of the assets recorded in property, plant and equipment, with a corresponding movement in Accumulated Surplus. See Note 13.
The Group has elected not to include initial direct costs in the measurement of the right-of-use asset for operating leases in existence at the date of initial
application of IFRS 16, being 1 January 2019. At this date, the Group has also elected to measure the right-of-use assets at an amount equal to the lease liability adjusted for any prepaid or accrued lease payments that existed at the date of
transition.
On transition, for leases previously accounted for as operating leases with a remaining lease term of less than 12 months and for leases of low-value assets the Group
has applied the optional exemptions to not recognise right-of-use assets but to account for the lease expense on a straight line basis over the remaining lease term.
For those leases previously classified as finance leases, the right-of-use asset and lease liability are measured at the date of initial application at the same amounts as
under IAS 17 immediately before the date of initial application.
The following is a reconciliation of the financial statement line items from IAS 17 to IFRS 16 at January 1, 2019:
|
RELATED PARTY TRANSACTIONS (Schedule of Compensation) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Disclosure of transactions between related parties [abstract] | ||
Short-term employee benefits | $ 800 | $ 863 |
Performance related bonus | 213 | 210 |
Post-employment benefits | 42 | 44 |
Share-based compensation benefits | 542 | 1,041 |
Total compensation | $ 1,597 | $ 2,158 |
LOSS BEFORE TAX (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of detailed information about business combination [line items] | |||
Depreciation on capitalised Intangible projects | $ 4 | $ 79 | $ 528 |
Fiomi [Member] | Foreign Exchange Differences [Member] | |||
Disclosure of detailed information about business combination [line items] | |||
Operating expense | $ 440 |
GOODWILL AND INTANGIBLE ASSETS |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Disclosure of goodwill and intangible assets [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS |
Included within development costs are costs of US$3,719,000 which were not amortised in 2019 (2018: US$4,192,000). These development costs are not being amortised as the projects to which the
costs relate were not fully complete at December 31, 2019 or at December 31, 2018. As at December 31, 2019 these projects are expected to be completed during the period from January 1, 2020 to December 31, 2022 at an expected further cost of
approximately US$5,557,000.
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 recognised a non-cash
impairment charge of US$24,295,000 at December 31, 2019.
The impairment test performed as at December 31, 2019 identified a total impairment loss of US$76,740,000 in seven CGUs, of which US$24,295,000 has been recorded in the
2019 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 this
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, Clark Laboratories Inc,, Mardx Diagnostics Inc and Trinity Biotech Do Brasil could not be reflected in the 2019 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, Clark Laboratories Inc,, Mardx Diagnostics Inc and Trinity Biotech Do Brasil was US$29,423,000, US$7,707,000, US$33,000,US$5,817,000 and US$9,465,000 respectively. As a result, the impairment loss that was recorded in the 2019
financial statements was US$24,295,000, being the total impairment loss of US$76,740,000 less the amounts which could not be recorded.
The impairment loss arose from the impairment review performed on Biopool US Inc,, Trinity Biotech Manufacturing Limited, Clark Laboratories Inc,, Mardx Diagnostics Inc,
Immco Diagnostics, Primus Corp. and Trinity Biotech Do Brasil. An impairment loss arose in these entities due to the carrying value of their net assets exceeding the entitys 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 2020 projections for each CGU and a further four years projections using estimated revenue and cost
growth rates of between 0% and 7%. 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 27% (2018: 20% to 35%)
The table below sets forth the impairment loss recorded for each of the CGUs:
The table below sets forth the breakdown of the impairment loss for each class of asset:
The impairment loss at December 31, 2019 allocated to goodwill arose in Immco Diagnostics Inc. 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;
The annual impairment test only takes into account conditions existing at the end of the reporting period. COVID-19 began to impact the population of Wuhan, China in December 2019 and initially the outbreak
was largely concentrated in China. It was declared a pandemic by the World Health Organization in March 2020. The Companys impairment test as at December 31, 2019 therefore does not reflect the downturn in economic activity or the
aforementioned impacts on the Companys revenues and expenditure caused by the Covid-19 pandemic. If the impairment test was reperformed using projections which take into account the aforementioned impacts on revenues and expenditure, the
impairment loss as at December 31, 2019 for Primus Corp. and Immco Diagnostics would be higher by US$1.8 million and US$1.7 million respectively.
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 Groups 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 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 2019, impairment losses of US$47,000 and US$455,000 were allocated against the Primus trade name and the Immco Diagnostic trade name respectively as the carrying
value of the related CGUs net assets exceeded their discounted future cashflows. |
TRADE AND OTHER RECEIVABLES |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trade and other current receivables [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
TRADE AND OTHER RECEIVABLES |
Trade receivables are shown net of an impairment losses provision of US$5,443,000 (2018: US$4,202,000) (see Note 29). Prepayments are shown net of impairment of
US$1,376,000 (2018: US$1,608,000) (see Note 7).
Contract assets have increased compared to the prior year as the Group shipped more product to customers with cost per test contracts in the last month of the year.
Long-term contract receivable
(i) Finance lease commitments Group as lessor
The Group leases instruments as part of its business. Future minimum receivables with non-cancellable terms are as follows:
The
Group classified future minimum lease receivables between one and five years of US$403,000 (2018: US$476,000) as Other Assets, see Note 16. Under the terms of the lease arrangements, no contingent rents are receivable.
(ii) Operating lease commitments Group as lessor
The Group leases instruments under operating leases as part of its business.
Future minimum rentals receivable under non-cancellable operating leases are as follows:
|
PROFIT/(LOSS) FOR THE YEAR ON DISCONTINUED OPERATION (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||||
---|---|---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|||
Disclosure of classes of share capital [line items] | |||||
Profit/(Loss) for the year from discontinued operations | $ 77 | $ 568 | $ (1,609) | ||
Basic weighted average number of ordinary shares | 83,606,810 | 83,612,908 | 86,486,409 | ||
Diluted weighted average number of ordinary shares | 101,870,064 | 103,508,820 | 107,510,179 | ||
Tax credit recovered | [1] | $ (590) | $ 323 | ||
Class A Ordinary shares [Member] | |||||
Disclosure of classes of share capital [line items] | |||||
Profit/(Loss) for the year from discontinued operations | $ 77 | $ 568 | $ (1,609) | ||
Basic weighted average number of ordinary shares | 83,606,810 | 83,612,908 | 86,486,409 | ||
American depositary share [Member] | |||||
Disclosure of classes of share capital [line items] | |||||
Basic weighted average number of ordinary shares | 20,901,703 | 20,903,227 | 21,621,602 | ||
Diluted weighted average number of ordinary shares | 25,467,517 | 25,877,205 | 26,877,544 | ||
|
SHARE OPTIONS AND SHARE WARRANTS |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of share options and share warrants [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHARE OPTIONS AND SHARE WARRANTS |
Warrants
There were no warrants outstanding at the beginning of 2019, and there were no warrants granted in either 2019 or 2018. As there were no warrants outstanding, the warrant
reserve was transferred to the accumulated surplus reserve during 2017.
Options
Under the terms of the Companys Employee Share Option Plans, options to purchase 12,303,990 A Ordinary Shares (3,075,998 ADSs) were outstanding at December 31, 2019.
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 Board and Remuneration 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 holders 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 2019, 2018 or 2017.
The opening share price per A Ordinary share at the start of the financial year was US$0.57 or US$2.29 per ADS (2018: US$1.28 or US$5.10 per ADS) (2017: US$1.73 or
US$6.93 per ADS) and the closing share price at December 31, 2019 was US$0.26 or US$1.03 per ADS (2018: US$0.57 or US$2.29 per ADS) (2017: US$1.28 or US$5.10 per ADS). The average share price for the year ended December 31, 2019 was US$0.49
per A Ordinary share or US$1.95 per ADS.
A summary of the range of prices for the Companys stock options for the year ended December 31, 2019 follows:
The weighted-average remaining contractual life of options outstanding at December 31, 2019 was 5.06 years (2018: 4.33 years).
A summary of the range of prices for the Companys stock options for the year ended December 31, 2018 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$758,000 was charged to the statement of operations in 2019, (2018: US$1,369,000), (2017: US$928,000) split as
follows:
The total share based payments charge for the year was US$839,000 (2018: US$1,607,000) (2017: US$1,109,000). However, a total of US$80,000 (2018: US$238,000) (2017:
US$181,000) 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 2019, 2018 and 2017:
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. |
PROPERTY, PLANT AND EQUIPMENT (Schedule of Income from Sub-letting Right-of-use Buildings) (Details) |
12 Months Ended |
---|---|
Dec. 31, 2019
Assets
Number
| |
Buildings [Member] | |
Disclosure of quantitative information about right-of-use assets [line items] | |
No. of Right-of-Use leased assets | Assets | 13 |
Average remaining lease term (years) | 5 years |
No. of Leases with extension options | 1 |
No. of Leases with options to purchase | |
No. of leases with variable payments linked to index | 2 |
No. of leases with termination options | 4 |
Buildings [Member] | Bottom of range [Member] | |
Disclosure of quantitative information about right-of-use assets [line items] | |
Range of remaining term in years | 1 year |
Buildings [Member] | Top of range [Member] | |
Disclosure of quantitative information about right-of-use assets [line items] | |
Range of remaining term in years | 14 years |
Vehicles [Member] | |
Disclosure of quantitative information about right-of-use assets [line items] | |
No. of Right-of-Use leased assets | Assets | 9 |
Average remaining lease term (years) | 1 year |
No. of Leases with extension options | |
No. of Leases with options to purchase | 9 |
No. of leases with variable payments linked to index | |
No. of leases with termination options | 9 |
Vehicles [Member] | Bottom of range [Member] | |
Disclosure of quantitative information about right-of-use assets [line items] | |
Range of remaining term in years | 1 year |
Vehicles [Member] | Top of range [Member] | |
Disclosure of quantitative information about right-of-use assets [line items] | |
Range of remaining term in years | 2 years |
I.T. and office equipment [Member] | |
Disclosure of quantitative information about right-of-use assets [line items] | |
No. of Right-of-Use leased assets | Assets | 11 |
Average remaining lease term (years) | 2 years |
No. of Leases with extension options | |
No. of Leases with options to purchase | |
No. of leases with variable payments linked to index | |
No. of leases with termination options | 1 |
I.T. and office equipment [Member] | Bottom of range [Member] | |
Disclosure of quantitative information about right-of-use assets [line items] | |
Range of remaining term in years | 1 year |
I.T. and office equipment [Member] | Top of range [Member] | |
Disclosure of quantitative information about right-of-use assets [line items] | |
Range of remaining term in years | 2 years |
GOODWILL AND INTANGIBLE ASSETS (Schedule of Impairment Loss) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Disclosure of detailed information about intangible assets [line items] | ||
Total impairment loss | $ 24,295 | $ 26,932 |
Trinity Biotech Manufacturing Limited [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Total impairment loss | 9,732 | 7,837 |
Immco Diagnostics Inc [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Total impairment loss | 6,332 | |
Primus Corp [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Total impairment loss | 5,321 | 12,424 |
Trinity Biotech Do Brasil [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Total impairment loss | 1,253 | 2,785 |
Clark Laboratories Inc [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Total impairment loss | 727 | 3,377 |
Mardx Diagnostics Inc. [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Total impairment loss | 720 | |
Biopool US Inc [Member] | ||
Disclosure of detailed information about intangible assets [line items] | ||
Total impairment loss | $ 210 | $ 509 |
DEFERRED TAX ASSETS AND LIABILITIES (Narrative) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2015 |
|
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset increased due to increase in provision | $ 125 | ||
Deferred tax liability decreased | 716 | ||
Increased in unrecognised deferred tax assets | 17,467 | ||
Deferred tax asset | 6,252 | $ 6,127 | |
Issuence of exchangeable note | $ 115,000 | ||
Unrecognized deferred tax asset | 6,862 | ||
USA [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 493 | 364 | |
Unrecognized deferred tax asset | 243 | 485 | |
Brazil [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 1,968 | 1,360 | |
TBIL [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 4,820 | 3,564 | |
TBML [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | 6,619 | 5,691 | |
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 | 381 | 213 | |
Alternative minimum tax credit [Member] | |||
Disclosure of reconciliation of changes in intangible assets and goodwill [line items] | |||
Deferred tax asset | $ 3,291 | $ 2,174 |
GROUP UNDERTAKINGS |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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:
|
DERIVATIVES AND FINANCIAL INSTRUMENTS |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 US$101,000 (2018: US234,000) and would not
affect the interest expense (2018: nil) resulting in an increase in net interest income of US$101,000 (2018: increase in net interest income of US$234,000).
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, 2019 and December 31, 2018 (see Note 19 and 20).
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, 2019 would not affect profit or
loss.
There was no significant difference between the fair value and carrying value of the Groups trade receivables and trade and other payables at December 31, 2019 and
December 31, 2018 as all fell due within 6 months.
Liquidity risk
The Groups operations are cash generating. Short-term flexibility is achieved through the management of the Groups short-term deposits.
The following are the contractual maturities of financial liabilities, including estimated interest payments:
Foreign exchange risk
The majority of the Groups activities are conducted in US Dollars. Foreign exchange risk arises from the fluctuating value of the Groups 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, 2019.
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, 2019 or December 31, 2018.
Sensitivity analysis
A 10% strengthening of the US Dollar against the Euro at December 31, 2019 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, 2019 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 managements 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 Groups exposure
to credit risk arises from default of the counter-party, with a maximum exposure equal to the carrying amount of these instruments. The Groups 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, 2019 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 Groups 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, 2019 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 $15,100,000 of the exchangeable senior notes. The remaining exchangeable senior notes which will mature on April 1, 2045, subject to earlier repurchase, redemption or exchange, the earliest which is April 2022.
The Board of Directors is authorised to purchase its own shares on the market on the following conditions;
Fair Values
The table below sets out the Groups classification of each class of financial assets/liabilities, their fair values and under which valuation method they are valued:
For financial reporting purposes, fair value measurements are categorized into Level 1, 2 or 3 based on the degree to which inputs to the fair value measurements are observable and the
significance of the inputs to the fair value measurement in its entirety, which are described as follows:
Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities
Level 2: valuation techniques for which the lowest level of inputs which have a significant effect on the recorded fair value are observable, either directly or indirectly
Level 3: valuation techniques for which the lowest level of inputs that have a significant effect on the recorded fair value are not based on observable market
data.
The valuation techniques used for instruments categorised as level 2 are described below:
The fair values of the options associated with the exchangeable notes are calculated in consultation with third-party valuation specialists due to the complexity of their nature. There are a
number of inputs utilised in the valuation of the options, including share price, historical share price volatility, risk-free rate and the expected borrowing cost spread over the risk-free rate. |
LOSS PER SHARE (Schedule of Profit After Tax Diluted Earnings Per Ordinary Share Calculation) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Earnings per share [abstract] | |||
Loss for the year | $ (28,914) | $ (22,090) | $ (40,270) |
Non-cash financial income (Note 8) | (233) | (1,388) | (2,390) |
Cash interest expense (Note 8) | 3,996 | 4,352 | 4,600 |
Non-cash interest on exchangeable notes (Note 8) | 639 | 689 | 723 |
Adjusted loss after tax | $ (24,512) | $ (18,437) | $ (37,337) |
PROPERTY, PLANT AND EQUIPMENT (Schedule of Composition of Property and Equipment Related to Accumulated Depreciation) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | $ 5,362 | ||
Impairment loss | 6,349 | $ 6,112 | $ 10,437 |
Balance at end of year | 9,290 | 5,362 | |
Cost [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 53,814 | 49,417 | |
Adjustment on transition to IFRS 16 | 21,185 | ||
Additions | 2,825 | 7,525 | |
Disposals or retirements | (7,550) | (1,936) | |
Exchange adjustments | (32) | (1,192) | |
Balance at end of year | 70,242 | 53,814 | 49,417 |
Cost [Member] | Land and buildings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 2,605 | 2,624 | |
Adjustment on transition to IFRS 16 | 20,961 | ||
Additions | 681 | 19 | |
Disposals or retirements | |||
Exchange adjustments | 22 | (38) | |
Balance at end of year | 24,269 | 2,605 | 2,624 |
Cost [Member] | Leasehold improvements [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 4,560 | 3,004 | |
Adjustment on transition to IFRS 16 | |||
Additions | 71 | 1,609 | |
Disposals or retirements | (1,626) | (1) | |
Exchange adjustments | (52) | ||
Balance at end of year | 3,005 | 4,560 | 3,004 |
Cost [Member] | Computers, fixtures and fittings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 6,585 | 5,894 | |
Adjustment on transition to IFRS 16 | 149 | ||
Additions | 168 | 829 | |
Disposals or retirements | (2,610) | (131) | |
Exchange adjustments | (7) | ||
Balance at end of year | 4,292 | 6,585 | 5,894 |
Cost [Member] | Office equipment and fittings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 40,064 | 37,895 | |
Adjustment on transition to IFRS 16 | 75 | ||
Additions | 1,905 | 5,068 | |
Disposals or retirements | (3,314) | (1,804) | |
Exchange adjustments | (54) | (1,095) | |
Balance at end of year | 38,676 | 40,064 | 37,895 |
Accumulated depreciation and impairment losses [member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | (48,452) | (43,617) | |
Charge for the year | (2,530) | (1,375) | |
Adjustment on transition to IFRS 16 | (11,099) | ||
Impairment loss | (6,349) | (6,112) | |
Disposals or retirements | 7,493 | 1,809 | |
Reallocations / reclassifications | (5) | ||
Exchange adjustments | (10) | 843 | |
Balance at end of year | (60,952) | (48,452) | (43,617) |
Accumulated depreciation and impairment losses [member] | Land and buildings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | (1,934) | (1,283) | |
Charge for the year | (1,545) | (80) | |
Adjustment on transition to IFRS 16 | (10,984) | ||
Impairment loss | (4,024) | (578) | |
Disposals or retirements | |||
Reallocations / reclassifications | |||
Exchange adjustments | (6) | 7 | |
Balance at end of year | (18,493) | (1,934) | (1,283) |
Accumulated depreciation and impairment losses [member] | Leasehold improvements [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | (3,243) | (2,659) | |
Charge for the year | (105) | (47) | |
Adjustment on transition to IFRS 16 | |||
Impairment loss | (233) | (543) | |
Disposals or retirements | 1,544 | ||
Reallocations / reclassifications | |||
Exchange adjustments | 6 | ||
Balance at end of year | (2,037) | (3,243) | (2,659) |
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 | (5,783) | (5,308) | |
Charge for the year | (200) | (185) | |
Adjustment on transition to IFRS 16 | (40) | ||
Impairment loss | (276) | (423) | |
Disposals or retirements | 2,618 | 130 | |
Reallocations / reclassifications | |||
Exchange adjustments | (1) | 3 | |
Balance at end of year | (3,682) | (5,783) | (5,308) |
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 | (37,492) | (34,367) | |
Charge for the year | (680) | (1,063) | |
Adjustment on transition to IFRS 16 | (75) | ||
Impairment loss | (1,816) | (4,568) | |
Disposals or retirements | 3,331 | 1,679 | |
Reallocations / reclassifications | (5) | ||
Exchange adjustments | (3) | 827 | |
Balance at end of year | (36,740) | (37,492) | $ (34,367) |
Carrying amounts [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 5,362 | ||
Balance at end of year | 9,290 | 5,362 | |
Carrying amounts [Member] | Land and buildings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 671 | ||
Balance at end of year | 5,776 | 671 | |
Carrying amounts [Member] | Leasehold improvements [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 1,317 | ||
Balance at end of year | 968 | 1,317 | |
Carrying amounts [Member] | Computers, fixtures and fittings [Member] | |||
Disclosure of detailed information about property, plant and equipment [line items] | |||
Balance at beginning year | 802 | ||
Balance at end of year | 610 | 802 | |
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 | ||
Balance at end of year | $ 1,936 | $ 2,572 |
EXCHANGEABLE NOTES |
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Borrowings [abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EXCHANGEABLE NOTES |
The Group issued US$115,000,000 of exchangeable senior notes in 2015, 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,
2019.
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 was shown within selling, general and administrative expenses in the statement of operations for the year ended December 31, 2018. 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$234,000 (2018: US$1,388,000) arising from the revaluation of embedded derivatives at
fair value at December 31, 2019.
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$639,000 (2018: US$689,000) of accretion interest. |
TRADE AND OTHER RECEIVABLES (Schedule of Future Minimum Finance Lease Receivables) (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Disclosure of maturity analysis of operating lease payments [line items] | ||
Gross investment | $ 1,328 | $ 1,505 |
Unearned income | 644 | 670 |
Finance lease receivable | 684 | 835 |
Less than one year [Member] | ||
Disclosure of maturity analysis of operating lease payments [line items] | ||
Gross investment | 523 | 617 |
Unearned income | 242 | 258 |
Finance lease receivable | 281 | 359 |
Between one and five years [Member] | ||
Disclosure of maturity analysis of operating lease payments [line items] | ||
Gross investment | 805 | 888 |
Unearned income | 402 | 412 |
Finance lease receivable | $ 403 | $ 476 |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES - TAX AUDIT SETTLEMENT |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 | |||
Selling General And Administrative Expenses - Tax Audit Settlement | |||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES - TAX AUDIT SETTLEMENT |
Arising
out of a tax audit in one of the jurisdictions in which the company operates, the Company
reached a tax settlement of US$6,442,000 in the year ended December 31, 2019. The
tax audit concluded in late December 2019 and the payment of the settlement amount was
made prior to the financial year end. The settlement consisted of US$3,863,000 in relation
to a patent dividend scheme, which had operated via Rayville Limited from 1995 to 2010,
US$1,231,000 in relation to payments for CEO Services made to Darnick Company (a company
controlled by the family of Ronan O’Caoimh) and US$75,000 in relation to R&D
tax credits. Penalties were US$273,000. Interest was US$1,000,000 and this is shown as
a financial expense. The total settlement excluding interest of US$5,442,000 was partially
offset by a provision of US$400,000, resulting in an expense of US$5,042,000, which is
shown as Selling, general and administrative expenses – tax audit settlement.
Darnick
Company agreed to contribute US$1,231,000 to the above settlement and this amount was
outstanding at December 31, 2019 and was treated as a contingent asset and not recognised
in the consolidated statement of financial position at year-end. |
INVENTORIES (Schedule of inventories) (Details) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Classes of current inventories [abstract] | ||
Raw materials and consumables | $ 12,654 | $ 10,556 |
Work-in-progress | 6,940 | 8,239 |
Finished goods | 12,427 | 11,564 |
Total inventories | $ 32,021 | $ 30,359 |
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