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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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Large accelerated filer ☐
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Accelerated filer ☒
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Non-accelerated filer ☐
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Emerging growth company ☐
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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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26
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42
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43
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66
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71
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73
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73
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75
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86
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88
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PART II
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89
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89
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89
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91
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91
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91
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92
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92
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92
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92
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92
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PART III
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93
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93
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170
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Year ended December 31,
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|||||||||||||||||||
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2017
US$‘000
|
2016
US$‘000
|
2015
US$‘000
|
2014
US$‘000 |
2013
US$‘000 |
|||||||||||||||
Revenues
|
99,140
|
99,611
|
100,195
|
104,872
|
91,216
|
|||||||||||||||
Cost of sales
|
(57,250
|
)
|
(56,127
|
)
|
(53,683
|
)
|
(55,496
|
)
|
(45,996
|
)
|
||||||||||
|
||||||||||||||||||||
Gross profit
|
41,890
|
43,484
|
46,512
|
49,376
|
45,220
|
|||||||||||||||
Other operating income
|
100
|
239
|
288
|
424
|
532
|
|||||||||||||||
Research and development expenses
|
(5,657
|
)
|
(5,040
|
)
|
(5,069
|
)
|
(4,291
|
)
|
(3,691
|
)
|
||||||||||
Selling, general and administrative expenses
|
(32,246
|
)
|
(30,366
|
)
|
(28,225
|
)
|
(30,071
|
)
|
(33,066
|
)
|
||||||||||
Selling, general and administrative expenses - impairment charges and inventory write-off/provision
|
(41,755
|
)
|
(48,165
|
)
|
—
|
—
|
—
|
|||||||||||||
|
||||||||||||||||||||
Operating (loss)/profit
|
(37,668
|
)
|
(39,848
|
)
|
13,506
|
15,438
|
8,995
|
|||||||||||||
Financial income
|
3,198
|
3,147
|
13,491
|
97
|
1,276
|
|||||||||||||||
Financial expenses
|
(5,405
|
)
|
(5,439
|
)
|
(4,054
|
)
|
(132
|
)
|
(51
|
)
|
||||||||||
|
||||||||||||||||||||
Net financing income
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(2,207
|
)
|
(2,292
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)
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9,437
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(35
|
)
|
1,225
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||||||||||||
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||||||||||||||||||||
(Loss)/Profit before tax
|
(39,875
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)
|
(42,140
|
)
|
22,943
|
15,403
|
10,220
|
|||||||||||||
Income tax credit/(expense)
|
1,214
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3,557
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(756
|
)
|
(479
|
)
|
(574
|
)
|
||||||||||||
|
||||||||||||||||||||
(Loss)/Profit for the year
|
(38,661
|
)
|
(38,583
|
)
|
22,187
|
14,924
|
9,646
|
|||||||||||||
|
||||||||||||||||||||
(Loss)/Profit for the year on discontinued operations
|
(1,609
|
)
|
(62,042
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)
|
(391
|
)
|
2,290
|
—
|
||||||||||||
|
||||||||||||||||||||
(Loss)/Profit for the year (all attributable to owners of the parent)
|
(40,270
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)
|
(100,625
|
)
|
21,796
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17,214
|
9,646
|
|||||||||||||
|
||||||||||||||||||||
Basic (loss)/earnings per ADS (US Dollars)
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(1.86
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)
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(4.38
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)
|
0.94
|
0.76
|
0.44
|
|||||||||||||
Diluted (loss)/earnings per ADS (US Dollars)
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(1.86
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)
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(4.38
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)
|
0.46
|
0.73
|
0.41
|
|||||||||||||
Basic (loss)/earnings per ‘A’ ordinary share
(US Dollars) |
(0.47
|
)
|
(1.10
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)
|
0.24
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0.19
|
0.11
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|||||||||||||
Diluted (loss)/earnings per ‘A’ ordinary share
(US Dollars) |
(0.47
|
)
|
(1.10
|
)
|
0.12
|
0.18
|
0.10
|
|||||||||||||
Weighted average number of shares used in computing basic EPS per ADS
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21,621,602
|
22,964,703
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23,161,773
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22,749,726
|
21,936,647
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|||||||||||||||
Weighted average number of shares used in computing diluted EPS per ADS
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26,877,544
|
28,299,399
|
27,407,793
|
23,717,747
|
23,428,175
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|||||||||||||||
Weighted average number of shares used in computing basic EPS per ‘A’ ordinary share
|
86,486,409
|
91,858,813
|
92,647,091
|
90,998,904
|
87,746,588
|
|||||||||||||||
Weighted average number of shares used in computing diluted EPS per ‘A’ ordinary share
|
107,510,179
|
113,197,598
|
109,631,172
|
94,870,988
|
93,712,698
|
|
December 31,
2017
US$’000
|
December 31,
2016
US$’000
|
December 31,
2015
US$’000
|
December 31,
2014
US$’000
|
December 31,
2013
US$’000
|
|||||||||||||||
Net current assets (current assets less current liabilities)
|
91,362
|
108,208
|
143,085
|
46,888
|
55,766
|
|||||||||||||||
Non-current liabilities
|
(106,549
|
)
|
(115,585
|
)
|
(129,646
|
)
|
(23,809
|
)
|
(22,499
|
)
|
||||||||||
Total assets
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192,974
|
249,592
|
363,683
|
242,838
|
226,486
|
|||||||||||||||
Capital stock
|
1,213
|
1,213
|
1,209
|
1,192
|
1,170
|
|||||||||||||||
Shareholders’ equity
|
65,196
|
108,727
|
213,892
|
196,972
|
183,011
|
• |
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, 2017, 2016 and 2015, we incurred US$10.4 million, US$17.4 million and US$19.7 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™), Johnson & Johnson – 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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
The FDA can delay, limit or deny clearance or approval of a device for many reasons, including:
|
• |
our ability to demonstrate to the FDA’s satisfaction that our products are safe and effective for their intended users;
|
• |
insufficient data from our pre-clinical studies and clinical trials to support clearance or approval, where required; and
|
• |
the failure of the manufacturing process or facilities we use to meet applicable requirements.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
Our facility 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.
|
• |
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.
|
• |
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.
|
• |
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:
|
• |
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 on PMA approvals that have already been granted;
|
• |
refusal to grant export approval for our products; or
|
• |
criminal prosecution.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
Companies are required to maintain certain records of post-market actions, even if they determine such actions are not reportable to the FDA. If we determine that certain actions do not require notification of the FDA, the FDA may disagree with our determinations and require us to report those actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect our sales. In addition, the FDA could take enforcement action for failing to report the recalls when they were conducted or failing to timely report or initiate a reportable product action. Further, depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new approvals or clearances before we may market or distribute the corrected device. Seeking such approvals or clearances may delay our ability to replace the recalled devices in a timely manner.
|
• |
We are also required to comply with the FDA’s Medical Device Reporting (“MDR”), requirements in the United States and comparable regulations worldwide, such as the HPRA. For example, under the FDA’s MDR regulations, we are required to report to the FDA any incident in which our product may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. In addition, all manufacturers placing medical devices in European Union markets are legally bound to report any serious or potentially serious incidents involving devices they produce or sell to the Competent Authority in whose jurisdiction the incident occurred.
|
• |
We have reported MDRs in the past, and we anticipate that in the future it is likely that we may experience events that would require reporting to the FDA pursuant to the MDR regulations. Any adverse event involving our products could result in future voluntary corrective actions, or agency actions, such as inspection, mandatory recall or other enforcement action.
|
• |
Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.
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Any modification to a 510(k)-cleared device in the United States that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design or manufacture, requires a new 510(k) clearance or, possibly, approval of a PMA. The FDA requires every manufacturer to make this determination in the first instance, but the FDA may review any manufacturer’s decision. The FDA may not agree with our decisions regarding whether new clearances or approvals are necessary.
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For example, we obtained 510(k) clearance for our Primus Variant System for the separation and quantification of normal and abnormal haemoglobin species as an aid in the diagnosis of haemoglobinopathies. The sample type used by this system was blood tubes. We subsequently introduced two systems based on the original Primus Variant System and they were named as ultra² GeneSys Variant System and ultra² Resolution Variant System. The primary focus of the GeneSys was on newborn screening using Dried Blood Spots as the sample type, while the Resolution was intended for confirmatory testing on the adult population using blood tubes as the sample type. We determined that these modifications to the indications for use were within our existing clearance and did not require the submission of a new 510(k) notification. The FDA stated that the use of Dried Blood Spots was not part of the original submission and represented a new modified Intended Use. The FDA informed us that it disagreed with our decision not to seek new 510(k) clearances for these modifications, and we have agreed to file new 510(k) notifications to obtain clearance for these indications. We have filed the 510(k) submission. The FDA has requested additional method comparison data. The data is being generated and will be resubmitted. We continue to support our current installed base. We will undertake any directive deemed necessary by the FDA as we wait for final approval. If we are not able to obtain new 510(k) clearances, or if the FDA withdraws its authorisation, we may be required to cease marketing for the currently-marketed indications and remove these products from U.S. commercial distribution.
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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 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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Trinity Biotech has historically grown organically and through the acquisition of, and investment in, other companies, product lines and technologies. We may enter into strategic acquisitions or investments as a way to expand our business. These activities, and their impact on our business, are subject to many risks, including the following:
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Suitable acquisitions or investments may not be found or consummated on terms or schedules that are satisfactory to us or consistent with our objectives;
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The benefits expected to be derived from an acquisition may not materialize and could be affected by numerous factors, such as regulatory developments, insurance reimbursement, general economic conditions and increased competition;
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We may be unable to successfully integrate an acquired company’s personnel, assets, management systems, products and/or technology into our business;
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Worse than expected performance of an acquired business may result in the impairment of intangible assets;
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Acquisitions may require substantial expense and management time and could disrupt our business;
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We may not be able to accurately forecast the performance or ultimate impact of an acquired business;
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An acquisition and subsequent integration activities may require greater capital and other resources than originally anticipated at the time of acquisition;
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An acquisition may result in the incurrence of unexpected expenses, the dilution of our earnings or our existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an indemnification from the seller(s) of the acquired business;
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An acquisition may result in the loss of our or the acquired company’s key personnel, customers, distributors or suppliers;
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An acquisition of a foreign business may involve additional risks, including, but not limited to, foreign currency exposure, liability or restrictions under foreign laws or regulations, and our inability to successfully assimilate differences in foreign business practices or overcome language or cultural barriers; and
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Our ability to integrate future acquisitions may be adversely affected by inexperience in dealing with new technologies.
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Trinity Biotech currently distributes its product portfolio through distributors in approximately 100 countries worldwide. Our continuing economic success and financial security is dependent on our ability to secure effective channels of distribution on favourable trading terms with suitable distributors.
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The loss or termination of our relationship with these key distributors could significantly disrupt our business unless suitable alternatives were timely found or lost sales to one distributor are absorbed by another distributor.
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We sell our products into the public health market, which consists of state, county and other governmental public health agencies, community based organizations, service organizations and similar entities. Many of these customers depend to a significant degree on grants or funding provided by governments or governmental agencies to run their operations, including programs that use our products, such as our HIV testing products. In international markets, we often sell our products to parties funded by such agencies. The level of available government grants or funding is unpredictable, and certain organizations may not have their contracts renewed for funding. Available funding may be affected by various factors including future economic conditions, legislative and regulatory developments, political changes, civil unrest and changing priorities for research and development activities. Any reduction or delay in government funding or change in organizational contracts could cause our customers to delay, reduce or forego purchases of our products or cause short term or long term fluctuations in our product revenues through these channels.
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Trinity Biotech may be subject to claims for personal injuries or other damages if any of our products, or any product which is made with the use or incorporation of any of our technologies, causes injury of any type or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or usage. There is no assurance that we would be successful in defending any product liability lawsuits brought against us. Regardless of merit or eventual outcome, product liability claims could result in:
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Decreased demand for our products;
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Lost revenues;
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Damage to our image or reputation;
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Costs related to litigation;
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Diversion of management time and attention; and
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Incurrence of damages payable to plaintiffs.
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Trinity Biotech has global product liability insurance in place for its manufacturing subsidiaries up to a maximum of €6,500,000 (US$6,841,000) for any one accident, limited to a maximum of €6,500,000 (US$6,841,000) in any one year period of insurance. A deductible of €5,000 ($5,300) 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 83% of revenues during the fiscal year ended December 31, 2017. 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, 2017 were Ronan O’Caoimh, our CEO and Chairman, Jim Walsh, Executive Director, and Kevin Tansley, our CFO/Executive Director. We may not be able to attract or retain a sufficient number of qualified employees in the future due to the intense competition for qualified personnel among medical products and other life science businesses.
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If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that will adversely affect our ability to effectively manufacture, sell and market our products, to meet the demands of our strategic partners in a timely fashion, or to support research, development and clinical programs. Although we believe we will be successful in attracting and retaining qualified personnel, competition for experienced scientists and other personnel from numerous companies and academic and other research institutions may limit our ability to do so on acceptable terms.
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The primary raw materials required for Trinity Biotech’s test kits consist of antibodies, antigens or other reagents, glass fibre and packaging materials which are acquired from third parties. If our third-party suppliers are unable or unwilling to supply or manufacture a required component or product or if they make changes to a component, product or manufacturing process or do not supply materials meeting our specifications, we may need to find another source and/or manufacturer. This could require that we perform additional development work.
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Some of our products, which we acquire from third parties, are highly technical and are required to meet exacting specifications, and any quality control problems that we experience with respect to the products supplied by third-party vendors could adversely and materially affect our reputation, our attempts to complete our clinical trials or commercialization of our products and adversely and materially affect our business, operating results and prospects. We may also need to obtain FDA or other regulatory authorisations for the use of an alternative component or for certain changes to our products or manufacturing process. We may also have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or foreign regulatory authorities and the failure of our suppliers to comply with strictly enforced regulatory requirements could expose us to regulatory action including, warning letters, product recalls, termination of distribution, product seizures, or civil penalties. Completing that development and obtaining such authorisations could require significant time and expense and we may not obtain such authorisations on a timely basis, or at all. The availability of critical components and products from other third parties could also reduce our control over pricing, quality and timely delivery. These events could either disrupt our ability to manufacture and sell certain of our products into one or more markets or completely prevent us from doing so, and could increase our costs. Any such event could have a material adverse effect on our results of operations, cash flow and business. Furthermore, since some of these suppliers are located outside of the United States, we are subject to foreign export laws and United States import and customs regulations, which complicate and could delay shipments of components to us.
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Although Trinity Biotech does not expect to be dependent upon any one source for these critical components or raw materials, alternative sources of antibodies with the characteristics and quality desired by Trinity Biotech may not be available. Such unavailability could affect the quality of our products and our ability to meet orders for specific products.
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We currently generate significant operating cash flows, which combined with access to the credit markets provides us with discretionary funding capacity for research and development and other strategic activities. Uncertainty in global economic conditions may continue for the foreseeable future and intensify. This uncertainty poses a risk to the overall economy that could impact demand for our products, as well as our ability to manage normal commercial relationships with our customers, suppliers and creditors, including financial institutions. Volatile economic conditions have adversely affected and could continue to adversely affect our financial performance and condition or those of our customers and suppliers. These circumstances could adversely affect our access to liquidity needed to conduct or expand our business or conduct future acquisitions or make other discretionary investments. Many of our customers rely on public funding provided by federal, state and local governments, and this funding has been and may continue to be reduced or deferred as a result of economic conditions.
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If global economic conditions deteriorate significantly, our business could be negatively impacted, including such areas as reduced demand for our products from a slow-down in the general economy, supplier or customer disruptions resulting from tighter credit markets and/or temporary interruptions in our ability to conduct day-to-day transactions through our financial intermediaries involving the payment to or collection of funds from our customers, vendors and suppliers. These circumstances may adversely impact our customers and suppliers, which, in turn, could adversely affect their ability to purchase our products or supply us with necessary equipment, raw materials or components. Even with the improvement of economic conditions, it may take time for our customers and suppliers to establish new budgets and return to normal purchasing and shipping patterns. We cannot predict the reoccurrence of any economic slowdown or the strength or sustainability of the economic recovery.
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Our international sales and operations are subject to various United States and foreign laws and regulations relating to export controls (including, without limitation, the U.S. Commerce Department’s Export Administration Regulations), economic sanctions (including, without limitation, various sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control), and anti-corruption (including, without limitation, the United States Foreign Corrupt Practice Act). Failure to comply with such applicable laws and regulations could subject us to civil or criminal penalties, government investigations, debarment from export privileges, and reputational harm, which could have a material adverse effect on our business.
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The United Kingdom (“U.K.”) held a referendum on June 23, 2016 and voted in favour of exiting the European Union, or E.U. This “Brexit” referendum has created political and economic uncertainty, particularly in the U.K. and E.U. and this uncertainty may last for a number of years. Until the precise terms of the U.K.’s exit from the E.U. are determined, it will be difficult to predict the impact of the Brexit referendum. Our business in the U.K., the E.U. and world-wide could be affected during this period of uncertainty, and perhaps longer, by the impact of the Brexit referendum. The U.K.’s decision to exit 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, including the United States, 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 Brexit referendum 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 Kroner exposure.
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In the future, we may enter into hedging instruments to manage our currency exchange rate risk. However, our attempts to hedge against these risks may not be successful. If we are unable to successfully hedge against unfavourable foreign currency exchange rate movements, our consolidated financial results may be adversely impacted.
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The total share options exercisable at December 31, 2017, 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 3,268,707 “A” Ordinary Shares (817,177 ADSs) exercisable at December 31, 2017 be exercised, Trinity Biotech would have to issue 3,268,707 additional “A” Ordinary Shares (817,177 ADSs). On the basis of 96,162,410
“A” Ordinary Shares outstanding at December 31, 2017, this would effectively dilute the ownership interest of the existing shareholders by approximately 3%.
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At present, no treaty exists between the United States and Ireland for the reciprocal enforcement of foreign judgments. The laws of Ireland do however, as a general rule, provide that the judgments of the courts of the United States have in Ireland the same validity as if rendered by Irish Courts. Certain important requirements must be satisfied before the Irish Courts will
recognise
the United States judgment. The originating court must have been a court of competent jurisdiction, the judgment may not be
recognised
if it is based on public policy, was obtained by fraud or its recognition would be contrary to Irish public policy. Any judgment obtained in contravention of the rules of natural justice will not be enforced in Ireland.
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The materials and processes used to manufacture our products must meet detailed specifications, performance standards and quality requirements to ensure our products will perform in accordance with their label claims, our customers’ expectations and applicable regulatory requirements.
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As a result, our products and the materials used in their manufacture or assembly undergo regular inspections and quality testing. Factors such as defective materials or processes, mechanical failures, human errors, environmental conditions, changes in materials or production methods by our vendors, and other events or conditions could cause our products or the materials used to produce or assemble our products to fail inspections and quality testing or otherwise not perform in accordance with our label claims or the expectations of our customers.
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Any failure or delay in our ability to meet the applicable specifications, performance standards, quality requirements or customer expectations could adversely affect our ability to manufacture and sell our products or comply with regulatory requirements. These events could, in turn, adversely affect our revenues and results of operations.
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Many laws and regulations impose obligations on public companies, which have increased the scope, complexity and cost of corporate governance, reporting and disclosure practices. Our implementation of certain aspects of these laws and regulations has required and will continue to require substantial management time and oversight and may require us to incur significant additional accounting and legal costs. We continually evaluate and monitor developments with respect to new and proposed rules and cannot predict or estimate the ultimate amount of additional costs we may incur or the timing of such costs. These laws and regulations are also subject to varying interpretations, in many cases due to their lack of specificity, and as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. Although we are committed to maintaining high standards of corporate governance and public disclosure, if we fail to comply with any of these requirements, legal proceedings may be initiated against us, which may adversely affect our business.
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As a result of any number of risk factors identified herein, no assurance can be given that we will be successful in implementing our financial and strategic objectives. In addition, the funds for research, clinical development and other projects have in the past come primarily from our business operations. If our business slows and we have less money available to fund research and development and clinical programs, we will have to decide at that time which programs to cut, and by how much. Similarly, if adequate financial, personnel, equipment or other resources are not available, we may be required to delay or scale back our business. Our operations will be adversely affected if our total revenue and gross profits do not correspondingly increase or if our technology, product, clinical and market development efforts are unsuccessful or delayed.
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Furthermore, our failure to successfully introduce new or enhanced products and develop new markets could have a material adverse effect on our business and prospects.
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• |
Our future liquidity and ability to meet our future capital requirements will depend on numerous factors, including, but not limited to, the following:
|
• |
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.
|
• |
As directed by the Sarbanes-Oxley Act of 2002, we are required to include a report in our Annual Reports on Form 20-F that contains an assessment by management of the effectiveness of our internal control over financial reporting. In addition, our independent registered public accounting firm must report on the effectiveness of these internal controls.
|
• |
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.
|
• |
If, during any year, our independent registered public accounting firm is not satisfied with our internal control over financial reporting or the level at which our controls are documented, designed, operated, tested or assessed, then it may issue a report that is adverse. We also could conclude that our internal control over financial reporting is not effective. These events could result in an adverse reaction in the financial marketplace due to a loss of investor confidence in the reliability of our financial statements and effectiveness of our internal controls, which ultimately could negatively impact the market price of our common stock.
|
• |
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$65 million
(2016: US$87 million).
In 2017, we recorded total impairment charges of US$42 million
(2016: US$48 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.
|
• |
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 7 U.S. patents with remaining patent lives varying from eight months to 15 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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
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.
|
• |
The Affordable Care Act imposes a 2.3% excise tax on certain transactions, including U.S. sales of many medical devices, which includes domestic sales of certain of our products. This new tax became effective in January 2013. However, the Consolidated Appropriations Act of 2016, which was enacted late 2015, suspended the tax beginning January 1, 2016, and this suspension was recently extended until December 31, 2019. It is unclear whether and to what extent this tax will impact our business, if and when the suspension is lifted.
|
• |
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.
|
• |
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. On December 22, 2017, the U.S. Government enacted comprehensive tax legislation known as the Tax Cuts and Jobs Act. This legislation makes 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 introduces new tax laws that may affect our taxable income in 2018, which will include, but not be 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 impact of many provisions of the Tax Cuts and Jobs Act is subject to interpretation until additional Treasury Department guidance is issued. 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 could have a material impact on our income tax expense and deferred tax balances.
|
• |
Our laboratory operated by 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.
|
• |
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.
|
• |
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
2TM
|
ImmuGlo™
|
|
|
|||||
|
|
|
ImmuLisa™
|
|
|
|||||
|
|
|
OTOblot™
|
|
|
• |
Infectious diseases,
|
• |
Haemoglobin, haemoglobin variants and glycated haemoglobin used in monitoring diabetes, and
|
• |
Autoimmune diseases
|
• |
Lyme disease,
|
• |
sexually transmitted diseases, including Syphilis and Herpes simplex virus,
|
• |
respiratory infections, including legionella,
|
• |
Epstein Barr virus, and
|
• |
other viral pathogens, including measles, mumps, toxoplasmosis, cytomegalovirus, rubella and varicella.
|
• |
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 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 noninvasive;
|
•
|
Do not require an invasive sampling procedure that poses a significant risk;
|
•
|
Do not introduce energy into a subject by design or intention;
|
•
|
Are not to be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure; and
|
• |
Comply with the labeling requirements for IUO devices, as outlined in 21 C.F.R. § 812.2(c)(3).
|
· |
product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;
|
· |
Quality System Regulation, (“QSR”), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
|
· |
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;
|
· |
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, 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.
|
• |
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$835,000 at December 31, 2017.
|
• |
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$4,
786
,000 at December 31, 2017.
|
• |
The entity’s operations in future financial years;
|
• |
The results of those operations in future financial years; or
|
• |
The entity’s state of affairs in future financial years.
|
1. |
Overview
|
2. |
Revenues
|
3. |
Operating Loss
|
4. |
Loss for the year
|
5. |
Discontinued operations
|
• |
a non-cash impairment charge of US$41.8 million in the statement of operations relating to the carrying value of goodwill and other intangible assets, property, plant and equipment and prepayments.
|
• |
a loss on discontinued operations for the year of US$1.3 million before tax, relating to the discontinuation of our Cardiac point-of-care operation.
|
• |
certain once-off costs totalling US$1.4 million relating to a flood damage incident and a settlement of a licence royalty dispute. See section 3, operating loss, for further details.
|
Year ended December 31, 2017
|
||||||||||||
Impairment
Charges – continuing operations
US$’000
|
Discontinued Operation
US$000
|
Total
US$‘000
|
||||||||||
Property, plant & equipment (Item 18, Note 12)
|
10,437
|
-
|
10,437
|
|||||||||
Goodwill and other intangible assets (Item 18, Note 13)
|
29,667
|
-
|
29,667
|
|||||||||
Prepayments (Item 18, Note 17)
|
1,651
|
-
|
1,651
|
|||||||||
Loss for the year including write off of foreign currency translation reserve - discontinued operation (Item 18, Note 10)
|
-
|
1,286
|
1,286
|
|||||||||
Total loss on discontinued operation and impairment charges and inventory provisioning before tax
|
41,755
|
1,286
|
43,041
|
|||||||||
Income tax
(credit)/
expense
|
(517
|
)
|
323
|
(194
|
)
|
|||||||
Total loss on discontinued operation and impairment charges after tax
|
41,238
|
1,609
|
42,847
|
|
Year ended December 31,
|
|||||||||||
|
2017
US$’000
|
2016
US$’000
|
% Change
|
|||||||||
Revenues
|
||||||||||||
Clinical Laboratory
|
73,366
|
74,166
|
(1.1
|
)%
|
||||||||
Point-of-Care
|
16,774
|
16,908
|
(0.8
|
)%
|
||||||||
Laboratory Services
|
9,000
|
8,537
|
5.4
|
%
|
||||||||
|
||||||||||||
Total
|
99,140
|
99,611
|
(0.5
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
2017
US$‘000
|
2016
US$‘000
|
% Change
|
|||||||||
Revenues
|
||||||||||||
Americas
|
59,539
|
61,613
|
(3.4
|
)%
|
||||||||
Asia/Africa
|
27,131
|
25,501
|
6.4
|
%
|
||||||||
Europe
|
12,470
|
12,497
|
(0.2
|
)%
|
||||||||
|
||||||||||||
Total
|
99,140
|
99,611
|
(0.5
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
2017
US$’000
|
2016
US$’000
|
% Change
|
|||||||||
Revenues
|
99,140
|
99,611
|
(0.5
|
)%
|
||||||||
Cost of sales
|
(57,250
|
)
|
(56,127
|
)
|
2.0
|
%
|
||||||
|
||||||||||||
Gross profit
|
41,890
|
43,484
|
(3.7
|
)%
|
||||||||
Other operating income
|
100
|
239
|
(58.2
|
)%
|
||||||||
Research & development
|
(5,657
|
)
|
(5,040
|
)
|
12.2
|
%
|
||||||
SG&A expenses
|
(32,246
|
)
|
(30,366
|
)
|
6.2
|
%
|
||||||
Selling, general and administrative expenses - impairment charges and inventory write-off/provision
|
(41,755
|
)
|
(48,165
|
)
|
(13.3
|
)%
|
||||||
|
||||||||||||
Operating loss on continuing operations
|
(37,668
|
)
|
(39,848
|
)
|
(5.5
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
2017
US$’000
|
2016
US$’000
|
% Change
|
|||||||||
SG&A (excl. share-based payments and amortisation)
|
28,050
|
26,044
|
7.7
|
%
|
||||||||
Share-based payments
|
893
|
1,349
|
(33.8
|
)%
|
||||||||
Amortisation
|
3,303
|
2,973
|
11.1
|
%
|
||||||||
|
||||||||||||
Total
|
32,246
|
30,366
|
6.2
|
%
|
|
Year ended December 31,
|
|||||||||||
|
2017
US$‘000
|
2016
US$‘000
|
% Change
|
|||||||||
Operating loss
|
(37,668
|
)
|
(39,848
|
)
|
(5.5
|
)%
|
||||||
Net financing expense
|
(2,207
|
)
|
(2,292
|
)
|
(3.7
|
)%
|
||||||
Loss before tax
|
(39,875
|
)
|
(42,140
|
)
|
(5.4
|
)%
|
||||||
Income tax credit
|
1,214
|
3,557
|
(65.9
|
)%
|
||||||||
|
||||||||||||
Loss of the year from continuing operations
|
(38,661
|
)
|
(38,583
|
)
|
0.2
|
%
|
|
Year ended December 31,
|
|||||||
|
2017
US$‘000
|
2016
US$‘000
|
||||||
Loss on discontinued operations
|
(1,609
|
)
|
(62,042
|
)
|
6. |
Overview
|
7. |
Revenues
|
8. |
Operating Loss
|
9. |
Loss for the year
|
10. |
Discontinued operations
|
• |
the discontinuation of our Cardiac point-of-care operation, which resulted in a loss on discontinued operations for the year of US$66.9 million before tax, comprising the write off of assets and closure costs.
|
• |
a non-cash impairment charge of US$43.4 million in the statement of operations relating to the carrying value of goodwill and other intangible assets, property, plant and equipment and prepayments.
|
• |
the decision by management to cull some product lines resulting in inventory provisions of US$4.8 million.
|
|
Year ended December 31, 2016
|
|||||||||||||||
|
Discontinued
Operation US$000 |
Impairment
Charges – continuing operations US$’000 |
Product
Cull - continuing operations US$’000 |
Total
US$‘000 |
||||||||||||
Property, plant & equipment (Item 18, Note 12)
|
4,647
|
4,382
|
—
|
9,029
|
||||||||||||
Goodwill and other intangible assets (Item 18, Note 13)
|
49,433
|
38,240
|
—
|
87,673
|
||||||||||||
Inventory (Item 18, Note 16)
|
2,578
|
—
|
4,786
|
7,364
|
||||||||||||
Prepayments ((Item 18, Note 17)
|
—
|
757
|
—
|
757
|
||||||||||||
Loss for the year including closure costs – discontinued operation (Item 18, Note 10)
|
6,492
|
—
|
—
|
6,492
|
||||||||||||
Write off of foreign currency translation reserve - discontinued operation (Item 18, Note 10)
|
3,779
|
—
|
—
|
3,779
|
||||||||||||
|
||||||||||||||||
Total loss on discontinued operation and impairment charges and inventory provisioning before tax
|
66,929
|
43,379
|
4,786
|
115,094
|
||||||||||||
|
||||||||||||||||
Income tax credit (Item 18, note 9)
|
(4,887
|
)
|
(3,094
|
)
|
(689
|
)
|
(8,670
|
)
|
||||||||
|
||||||||||||||||
Total loss on discontinued operation, impairment charges and product cull after tax
|
62,042
|
40,285
|
4,097
|
106,424
|
|
Year ended December 31,
|
|||||||||||
|
2016
US$’000
|
2015
US$’000
|
% Change
|
|||||||||
Revenues
|
||||||||||||
Clinical Laboratory
|
74,166
|
73,576
|
0.8
|
%
|
||||||||
Point-of-Care
|
16,908
|
18,810
|
(10.1
|
)%
|
||||||||
Laboratory Services
|
8,537
|
7,809
|
9.3
|
%
|
||||||||
|
||||||||||||
Total
|
99,611
|
100,195
|
(0.6
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
2016
US$‘000
|
2015
US$‘000
|
% Change
|
|||||||||
Revenues
|
||||||||||||
Americas
|
61,613
|
62,421
|
(1.3
|
)%
|
||||||||
Asia/Africa
|
25,501
|
22,346
|
14.1
|
%
|
||||||||
Europe
|
12,497
|
15,428
|
(19.0
|
)%
|
||||||||
|
||||||||||||
Total
|
99,611
|
100,195
|
(0.6
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
2016
US$’000
|
2015
US$’000
|
% Change
|
|||||||||
Revenues
|
99,611
|
100,195
|
(0.6
|
)%
|
||||||||
Cost of sales
|
(56,127
|
)
|
(53,683
|
)
|
4.6
|
%
|
||||||
|
||||||||||||
Gross profit
|
43,484
|
46,512
|
(6.5
|
)%
|
||||||||
Other operating income
|
239
|
288
|
(17.0
|
)%
|
||||||||
Research & development
|
(5,040
|
)
|
(5,069
|
)
|
(0.6
|
)%
|
||||||
SG&A expenses
|
(30,366
|
)
|
(28,225
|
)
|
7.6
|
%
|
||||||
Selling, general and administrative expenses - impairment charges and inventory write-off/provision
|
(48,165
|
)
|
—
|
100
|
%
|
|||||||
|
||||||||||||
Operating (loss)/profit on continuing operations
|
(39,848
|
)
|
13,506
|
(395.0
|
)%
|
|
Year ended December 31,
|
|||||||||||
|
2016
US$’000
|
2015
US$’000
|
% Change
|
|||||||||
SG&A (excl. share-based payments and amortisation)
|
26,044
|
24,031
|
8.4
|
%
|
||||||||
Share-based payments
|
1,349
|
1,541
|
(12.5
|
)%
|
||||||||
Amortisation
|
2,973
|
2,653
|
12.1
|
%
|
||||||||
|
||||||||||||
Total
|
30,366
|
28,225
|
7.6
|
%
|
|
Year ended December 31,
|
|||||||||||
|
2016
US$‘000
|
2015
US$‘000
|
% Change
|
|||||||||
Operating (loss)/profit
|
(39,848
|
)
|
13,506
|
(395
|
)%
|
|||||||
Net financing (expense)/income
|
(2,292
|
)
|
9,437
|
(124
|
)%
|
|||||||
(Loss)/Profit before tax
|
(42,140
|
)
|
22,943
|
(284
|
)%
|
|||||||
Income tax credit/(expense)
|
3,557
|
(756
|
)
|
(571
|
)%
|
|||||||
|
||||||||||||
(Loss)/Profit of the year from continuing operations
|
(38,583
|
)
|
22,187
|
(274
|
)%
|
|
Year ended December 31,
|
|||||||
|
2016
US$‘000
|
2015
US$‘000
|
||||||
Loss on discontinued operations
|
(62,042
|
)
|
(391
|
)
|
• |
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.
|
• |
A decrease in trade and other receivables of US$306,000 due to the decrease, year on year, in the debtors days number;
|
• |
An increase in inventory of US$2,
461
,000 due to the strategic build up of certain inventory items during the course of the year; and
|
• |
An increase
in trade and other payables balance of US$
2,017
,000 due to timing of payments.
|
• |
Payments to acquire intangible assets of US$10,229,000 (2016: US$16,548,000), 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$4,839,000 (2016: US$4,215,000) incurred as part of the Group’s investment programme for its manufacturing and distribution activities, and placement of instruments.
|
• |
There were no acquisitions of subsidiaries in 2017 or 2016.
|
|
Payments due by Period
|
|||||||||||||||||||
Contractual Obligations
|
Total
US$’000
|
less than
1 year
US$’000
|
1-3 Years
US$’000
|
4-5 Years
US$’000
|
more than
5 years
US$’000
|
|||||||||||||||
Exchangeable note
|
115,000
|
—
|
—
|
—
|
115,000
|
|||||||||||||||
Exchangeable note interest
|
126,500
|
4,600
|
9,200
|
9,200
|
103,500
|
|||||||||||||||
Operating lease obligations
|
22,139
|
2,693
|
4,356
|
3,430
|
11,660
|
|||||||||||||||
Finance lease obligations
|
938
|
387
|
551
|
—
|
—
|
|||||||||||||||
|
||||||||||||||||||||
Total
|
264,577
|
7,680
|
14,107
|
12,630
|
230,160
|
|
2017
|
2016
|
Total project
costs to December 31, 2017 ¹ |
|||||||||
Product Name
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Premier Instrument for Haemoglobin A1c testing
|
2,601
|
2,810
|
27,444
|
|||||||||
HIV screening rapid test
|
1,514
|
1,085
|
4,230
|
|||||||||
US Striped Lyme
|
1,156
|
1,003
|
3,752
|
|||||||||
Uni-gold test enhancement
|
1,134
|
1,154
|
3,546
|
|||||||||
G-6-PDH test
|
812
|
-
|
812
|
|||||||||
Tri-stat Point-of-Care instrument
|
764
|
678
|
7,941
|
|
Total estimated
cost to complete |
Estimated date
for completion |
||||||
Product Name
|
US$’000
|
|||||||
Premier Instrument for Haemoglobin A1c testing
|
1,900
|
2018
|
||||||
HIV screening rapid test
|
4,600
|
2019
|
||||||
US
Striped
Lyme
|
900
|
2018
|
||||||
Uni-gold test enhancement
|
750
|
2018
|
||||||
G-6-PDH test
|
575
|
2018
|
||||||
Tri-stat Point-of-Care instrument
|
260
|
2018
|
Name
|
Age
|
Title
|
Ronan O’Caoimh
|
62
|
Chairman and Chief Executive Officer
|
Jim Walsh, PhD
|
59
|
Executive Director
|
Kevin Tansley
|
47
|
Executive Director, Chief Financial Officer & Company Secretary
|
Denis R. Burger, PhD
|
74
|
Non Executive Director / Lead Director
|
Peter Coyne
|
58
|
Non Executive Director
|
Clint Severson
|
69
|
Non Executive Director
|
James D. Merselis
|
64
|
Non Executive Director
|
Executive Director
|
Salary/
Benefits
US$’000
|
Performance
related bonus
US$’000
|
Defined
contribution
pension
US$’000
|
Total
2017
US$’000
|
Total
2016
US$’000
|
|||||||||||||||
Ronan O’Caoimh
1
|
639
|
135
|
—
|
774
|
788
|
|||||||||||||||
Jim Walsh
2
|
115
|
—
|
2
|
117
|
240
|
|||||||||||||||
Kevin Tansley
3
|
423
|
88
|
42
|
553
|
559
|
|||||||||||||||
|
1,177
|
223
|
44
|
1,444
|
1,587
|
Non-executive Director
|
Fees
US$’000
|
Total
2017
US$’000
|
Total
2016
US$’000
|
|||||||||
Denis R. Burger
|
100
|
100
|
100
|
|||||||||
Peter Coyne
|
100
|
100
|
100
|
|||||||||
James Merselis
|
100
|
100
|
100
|
|||||||||
Clint Severson
|
100
|
100
|
100
|
|||||||||
|
400
|
400
|
400
|
1 |
Represents
payments
to Ronan O'Caoimh for director fees and
to Darnick Company
in respect of CEO services
.
|
2 |
Includes payments made to Diagnostic Polymers, a company wholly-owned by Jim Walsh and members of his immediate family.
Represents payments to Jim Walsh for director fees and to Diagnostic Polymers in respect of executive services.
|
3 |
Kevin Tansley was appointed to the board in September 2016 as Executive Director. Remuneration also includes remuneration paid to Kevin Tansley in respect of his roles as Chief Financial Officer and Company Secretary.
|
Director/Executive Officer
|
Number of Options
Granted |
Exercise Price of
Options Granted |
Date of Option
Grant* |
||
Ronan O’Caoimh
|
2,244,000 ‘A’ shares
(561,000 ADS)
|
US$1.34 per ‘A’ share
(US$5.35 per ADS)
|
7 September 2017
|
||
Jim Walsh
|
750,000 ‘A’ shares
(187,500 ADS)
|
US$1.34 per ‘A’ share
(US$5.35 per ADS)
|
7 September 2017
|
||
Kevin Tansley
|
864,000 ‘A’ shares
(216,000 ADS)
|
US$1.34 per ‘A’ share
(US$5.35 per ADS)
|
7 September 2017
|
||
Denis Burger
|
662,000 ‘A’ shares
(165,500 ADS)
|
US$1.34 per ‘A’ share
(US$5.35 per ADS)
|
7 September 2017
|
||
Peter Coyne
|
210,000 ‘A’ shares
(52,500 ADS)
|
US$1.34 per ‘A’ share
(US$5.35 per ADS)
|
7 September 2017
|
||
Clint Severson
|
210,000 ‘A’ shares
(52,500 ADS)
|
US$1.34 per ‘A’ share
(US$5.35 per ADS)
|
7 September 2017
|
||
James Merselis
|
210,000 ‘A’ shares
(52,500 ADS)
|
US$1.34 per ‘A’ share
(US$5.35 per ADS)
|
7 September 2017
|
* |
All options issued are subject to a 7 year life from date of grant.
|
Director/Executive Officer
|
Number of Options
Granted
|
Ronan O’Caoimh
|
1,600,000 ‘A’ shares
(400,000 ADS)
|
Jim Walsh
|
660,000 ‘A’ shares
(165,000 ADS)
|
Kevin Tansley
|
1,000,000 ‘A’ shares
(250,000 ADS)
|
Denis Burger
|
120,000 ‘A’ shares
(30,000 ADS)
|
Peter Coyne
|
120,000 ‘A’ shares
(30,000 ADS)
|
Clint Severson
|
100,000 ‘A’ shares
(25,000 ADS)
|
James Merselis
|
120,000 ‘A’ shares
(30,000 ADS)
|
Director/Company Secretary
|
Number of
Options ‘A’ Shares |
Number of
Options ADS Equivalent |
Exercise
Price (Per ‘A’ Share) |
Exercise Price
(Per ADS) |
Expiration Date of
Options |
||||
Ronan O’Caoimh
|
800,000
|
200,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||
800,000
|
200,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||
2,244,000
|
561,000
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||
Denis Burger
|
60,000
|
15,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
||||
662,000
|
165,500
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||
Jim Walsh
|
500,000
|
125,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||
160,000
|
40,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||
750,000
|
187,500
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||
Peter Coyne
|
60,000
|
15,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||
60,000
|
15,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||
210,000
|
52,500
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||
Clint Severson
|
20,000
|
5,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||
60,000
|
15,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||
210,000
|
52,500
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||
James Merselis
|
40,000
|
10,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||
60,000
|
15,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||
210,000
|
52,500
|
US$1.34
|
US$5.35
|
7 September 2024
|
|||||
Kevin Tansley
|
500,000
|
125,000
|
US$2.52
|
US$10.09
|
7 March 2019
|
||||
500,000
|
125,000
|
US$2.43
|
US$9.73
|
24 February 2023
|
|||||
864,000
|
216,000
|
US$1.34
|
US$5.35
|
7 September 2024
|
|
Number of ‘A’
Ordinary Shares
Subject to Option
|
Range of
Exercise Price
per Ordinary Share
|
Range of Exercise Price
per ADS
|
||
Total options outstanding
|
10,977,376
|
US$1.24-US$4.36
|
US$4.95-US$17.44
|
|
Number of ‘A’
Ordinary Shares Beneficially
Owned
|
Number of
ADSs Beneficially Owned |
Percentage
‘A’ Ordinary
Shares (8) |
Percentage
Total
Voting
Power |
||||||||||||
Paradice Investment Management LLC
|
6,557,184
|
1,639,296
|
6.1
|
%
|
6.1
|
%
|
||||||||||
Janus Capital Management LLC
|
5,657,164
|
1,414,291
|
5.3
|
%
|
5.3
|
%
|
||||||||||
Heartland Advisors, Inc.
|
5,384,600
|
1,346,150
|
5.0
|
%
|
5.0
|
%
|
||||||||||
Ronan O’Caoimh
|
7,481,501
|
(1)
|
1,870,375
|
7.0
|
%
|
7.0
|
%
|
|||||||||
Jim Walsh
|
2,803,610
|
(2)
|
700,903
|
2.6
|
%
|
2.6
|
%
|
|||||||||
Denis Burger
|
754,000
|
(3)
|
188,500
|
0.7
|
%
|
0.7
|
%
|
|||||||||
Peter Coyne
|
360,000
|
(4)
|
90,000
|
0.3
|
%
|
0.3
|
%
|
|||||||||
Clint Severson
|
578,000
|
(5)
|
144,500
|
0.5
|
%
|
0.5
|
%
|
|||||||||
James Merselis
|
498,600
|
(6)
|
124,650
|
0.5
|
%
|
0.5
|
%
|
|||||||||
Kevin Tansley
|
2,014,000
|
(7)
|
503,500
|
1.9
|
%
|
1.9
|
%
|
|||||||||
Directors & Co. Secretary as a group (7 persons)
|
14,489,711
|
(1)(2)(3)(4)(5)(6)(7)
|
3,622,428
|
13.5
|
%
|
13.5
|
%
|
(1) |
Includes 3,844,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(2) |
Includes 1,410,000 ‘A’ Ordinary shares issuable upon exercise of options. Note that 1,200,000 ‘A’ Ordinary shares (300,000 ADSs) of Dr Walsh’s shares are held in trust for the benefit of Dr Walsh’s immediate family.
|
(3) |
Includes 722,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(4) |
Includes 330,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(5) |
Includes 290,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(6) |
Includes 310,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(7) |
Includes 1,864,000 ‘A’ Ordinary shares issuable upon exercise of options.
|
(8) |
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
|
|
2013
|
US$25.63
|
US$14.30
|
|
2014
|
US$28.06
|
US$14.00
|
|
2015
|
US$20.24
|
US$10.74
|
|
2016
|
US$13.68
|
US$5.76
|
|
2017
|
US$7.04
|
US$4.50
|
2016
|
High
|
Low
|
|
Quarter ended March 31
|
US$12.02
|
US$9.20
|
|
Quarter ended June 30
|
US$12.17
|
US$10.37
|
|
Quarter ended September 30
|
US$13.68
|
US$10.51
|
|
Quarter ended December 31
|
US$13.15
|
US$5.76
|
2017
|
High
|
Low
|
|
Quarter ended March 31
|
US$7.04
|
US$5.31
|
|
Quarter ended June 30
|
US$6.15
|
US$5.25
|
|
Quarter ended September 30
|
US$6.13
|
US$5.16
|
|
Quarter ended December 31
|
US$5.77
|
US$4.50
|
Month Ended
|
High
|
Low
|
|
March 31, 2017
|
US$6.19
|
US$5.31
|
|
April 30, 2017
|
US$6.15
|
US$5.48
|
|
May 31, 2017
|
US$5.64
|
US$5.25
|
|
June 30, 2017
|
US$6.07
|
US$5.68
|
|
July 31, 2017
|
US$6.13
|
US$5.56
|
|
August 31, 2017
|
US$5.99
|
US$5.16
|
|
September 30, 2017
|
US$5.67
|
US$5.33
|
|
October 31, 2017
|
US$5.52
|
US$4.50
|
|
November 30, 2017
|
US$5.28
|
US$4.82
|
|
December 31, 2017
|
US$5.77
|
US$4.74
|
|
January 31, 2018
|
US$5.63
|
US$5.08
|
|
February 28, 2018
|
US$5.74
|
US$5.37
|
• |
which would have an effect of delaying, deferring or preventing a change in control of the Company and which would operate only with respect to a merger, acquisition or corporate restructuring involving the Company (or any of its subsidiaries); or
|
• |
governing the ownership threshold above which a shareholder ownership must be disclosed; or
|
• |
imposing conditions governing changes in the capital which are more stringent than is required by Irish law.
|
• |
Cash consideration of US$31,652,000;
|
• |
Issuance of share option as at the acquisition date with a fair value of US$1,121,000; and
|
• |
The transfer of 5,566 Trinity Biotech ADSs as at the acquisition date (fair value of US$110,000).
|
• |
An up-front cash payment of US$5.6m;
|
• |
The transfer of 408,000 Trinity Biotech ADSs as at the acquisition date (fair value of US$4.1m); and
|
• |
Contingent cash consideration (net present value) of US$3.2m.
|
• |
an individual resident in the U.S. (or certain other countries with which Ireland has a double taxation treaty) and who is neither resident nor ordinarily resident in Ireland; or
|
• |
a U.S. tax resident corporation not under the control of Irish residents; or
|
• |
a corporation that is not resident in Ireland and which is ultimately controlled by persons resident in the U.S. (or certain other countries with which Ireland has a double taxation treaty), with such person or persons not under the control of persons who are not so resident; or
|
• |
a corporation that is not resident in Ireland and the principal class of whose shares (or its 75% parent’s principal class of shares) is substantially or regularly traded on a recognised stock exchange; or
|
• |
is otherwise entitled to an exemption from DWT.
|
• |
the recipient is the direct beneficial owner of the shares, and
|
• |
the depository bank’s ADS register shows that the direct beneficial owner of the dividends has a U.S. address on the register, and
|
• |
there is an intermediary between the depository bank and the beneficial shareholder and the depository bank receives confirmation from the intermediary that the beneficial shareholder’s address in the intermediary’s records is in the U.S.
|
Service
|
Rate
|
By whom paid
|
||
(1) Issuance of ADSs upon deposit of ordinary shares.
|
Up to $10.00 per 100 ADSs (or portion thereof) issued.
|
Persons depositing ordinary shares or person receiving ADSs.
|
||
(2) Delivery of deposited securities against surrender of ADSs.
|
Up to $10.00 per 100 ADSs (or portion thereof) issued.
|
Persons surrendering ADSs for the purpose of withdrawal of deposited securities or persons to whom deposited securities are delivered.
|
||
(3) Issuance of ADSs in connection with a distribution of shares.
|
Up to $10.00 per 100 ADSs (or portion thereof) issued.
|
Person to whom distribution is made.
|
||
(4) Distribution of cash dividends or other cash distributions, including distribution of cash proceeds following the sale of rights, shares or other property in accordance with the deposit agreement
|
Up to $0.02 per 1 ADS
|
Person to whom distribution is made.
|
||
(5) Transfer of ADSs
|
Up to $1.50 per certificate for ADRs or ADRs transferred
|
Person to whom Receipt is transferred.
|
• |
transfer and registration fees of securities on Trinity Biotech’s securities register to or from the name of the depositary or its agent when ADS holders deposit or withdrawal securities;
|
• |
expenses for cable, telex and fax transmissions and for delivery of securities;
|
• |
expenses incurred for converting foreign currency into U.S. dollars; and
|
• |
taxes and duties upon the transfer of securities (i.e., when ordinary shares are deposited or withdrawn from deposit, other than taxes for which Trinity Biotech is liable).
|
|
Year ended December 31,
2017
|
Year ended December 31,
2016
|
||||||||||||||
|
US$’000
|
%
|
US$’000
|
%
|
||||||||||||
Audit
|
507
|
87
|
%
|
469
|
81
|
%
|
||||||||||
Audit-related
|
-
|
-
|
%
|
37
|
6
|
%
|
||||||||||
Tax
|
73
|
13
|
%
|
77
|
13
|
%
|
||||||||||
|
||||||||||||||||
Total
|
580
|
583
|
|
Year ended December 31
|
|||||||||||||||
|
Notes
|
2017
Total
US$‘000
|
2016
Total
US$‘000
|
2015
Total
US$‘000
|
||||||||||||
Revenues
|
2
|
99,140
|
99,611
|
100,195
|
||||||||||||
Cost of sales
|
(57,250
|
)
|
(56,127
|
)
|
(53,683
|
)
|
||||||||||
|
||||||||||||||||
Gross profit
|
41,890
|
43,484
|
46,512
|
|||||||||||||
Other operating income
|
4
|
100
|
239
|
288
|
||||||||||||
Research and development expenses
|
(5,657
|
)
|
(5,040
|
)
|
(5,069
|
)
|
||||||||||
Selling, general and administrative expenses
|
(32,246
|
)
|
(30,366
|
)
|
(28,225
|
)
|
||||||||||
Impairment
charges and inventory
provisioning
|
6
|
(41,755
|
)
|
(48,165
|
)
|
—
|
||||||||||
|
||||||||||||||||
Operating (loss)/profit
|
(37,668
|
)
|
(39,848
|
)
|
13,506
|
|||||||||||
Financial income
|
2,3
|
3,198
|
3,147
|
13,491
|
||||||||||||
Financial expenses
|
2, 3
|
(5,405
|
)
|
(5,439
|
)
|
(4,054
|
)
|
|||||||||
|
||||||||||||||||
Net financing (expense)/income
|
(2,207
|
)
|
(2,292
|
)
|
9,437
|
|||||||||||
|
||||||||||||||||
(Loss)/Profit before tax
|
5
|
(39,875
|
)
|
(42,140
|
)
|
22,943
|
||||||||||
Total income tax credit/(expense)
|
2, 9
|
1,214
|
3,557
|
(756
|
)
|
|||||||||||
|
||||||||||||||||
(Loss)/Profit for the year
|
2
|
(38,661
|
)
|
(38,583
|
)
|
22,187
|
||||||||||
|
||||||||||||||||
Loss for the year on discontinued operations
|
10
|
(1,609
|
)
|
(62,042
|
)
|
(391
|
)
|
|||||||||
|
||||||||||||||||
(Loss)/Profit for the year (all attributable to equity holders)
|
2
|
(40,270
|
)
|
(100,625
|
)
|
21,796
|
||||||||||
|
||||||||||||||||
Basic (loss)/earnings per ADS (US Dollars) – continuing operations
|
11
|
(1.79
|
)
|
(1.68
|
)
|
0.96
|
||||||||||
Diluted (loss)/earnings per ADS (US Dollars) – continuing operations
|
11
|
(1.79
|
)
|
(1.68
|
)
|
0.48
|
||||||||||
Basic (loss)/earnings per ‘A’ ordinary share (US Dollars) –continuing operations
|
11
|
(0.45
|
)
|
(0.42
|
)
|
0.24
|
||||||||||
Diluted earnings per ‘A’ ordinary share (US Dollars) – continuing operations
|
11
|
(0.45
|
)
|
(0.42
|
)
|
0.12
|
||||||||||
Basic (loss)/earnings per ADS (US Dollars) – group
|
11
|
(1.86
|
)
|
(4.38
|
)
|
0.94
|
||||||||||
Diluted (loss)/earnings per ADS (US Dollars) – group
|
11
|
(1.86
|
)
|
(4.38
|
)
|
0.46
|
||||||||||
Basic (loss)/earnings per ‘A’ ordinary share (US Dollars) – group
|
11
|
(0.47
|
)
|
(1.10
|
)
|
0.24
|
||||||||||
Diluted (loss)/earnings per ‘A’ ordinary share (US Dollars) –group
|
11
|
(0.47
|
)
|
(1.10
|
)
|
0.12
|
|
Year ended December 31
|
|||||||||||||||
|
Notes
|
2017
US$‘000
|
2016
US$‘000
|
2015
US$‘000
|
||||||||||||
(Loss)/Profit for the year
|
2
|
(40,270
|
)
|
(100,625
|
)
|
21,796
|
||||||||||
Other comprehensive income
|
||||||||||||||||
Items that will be reclassified subsequently to profit or loss
|
||||||||||||||||
Foreign exchange translation differences
|
3,086
|
3,122
|
(4,872
|
)
|
||||||||||||
|
||||||||||||||||
Other comprehensive income
|
3,086
|
3,122
|
(4,872
|
)
|
||||||||||||
|
||||||||||||||||
Total Comprehensive (Loss)/Income (all attributable to owners of the parent)
|
(37,184
|
)
|
(97,503
|
)
|
16,924
|
|
At December 31
|
|||||||||||
|
Notes
|
2017
US$‘000
|
2016
US$‘000
|
|||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property, plant and equipment
|
12
|
5,800
|
13,403
|
|||||||||
Goodwill and intangible assets
|
13
|
64,754
|
87,275
|
|||||||||
Deferred tax assets
|
14
|
8,698
|
14,556
|
|||||||||
Derivative financial instruments
|
24
|
360
|
—
|
|||||||||
Other assets
|
15
|
771
|
870
|
|||||||||
|
||||||||||||
Total non-current assets
|
80,383
|
116,104
|
||||||||||
|
||||||||||||
Current assets
|
||||||||||||
Inventories
|
16
|
32,805
|
32,589
|
|||||||||
Trade and other receivables
|
17
|
20,740
|
22,585
|
|||||||||
Income tax receivable
|
1,439
|
1,205
|
||||||||||
Cash and cash equivalents
|
18
|
23,564
|
77,109
|
|||||||||
Short-term investments
|
19
|
34,043
|
—
|
|||||||||
|
||||||||||||
Total current assets
|
112,591
|
133,488
|
||||||||||
|
||||||||||||
TOTAL ASSETS
|
2
|
192,974
|
249,592
|
|||||||||
|
||||||||||||
EQUITY AND LIABILITIES
|
||||||||||||
Equity attributable to the equity holders of the parent
|
||||||||||||
Share capital
|
20
|
1,213
|
1,213
|
|||||||||
Share premium
|
20
|
16,187
|
16,187
|
|||||||||
Treasury shares
|
20
|
(24,783
|
)
|
(17,327
|
)
|
|||||||
Accumulated surplus
|
20
|
75,802
|
110,434
|
|||||||||
Translation reserve
|
20
|
(3,246
|
)
|
(6,332
|
)
|
|||||||
Other reserves
|
20
|
23
|
4,552
|
|||||||||
|
||||||||||||
Total equity
|
65,196
|
108,727
|
||||||||||
|
||||||||||||
Current liabilities
|
||||||||||||
Income tax payable
|
310
|
175
|
||||||||||
Trade and other payables
|
22
|
20,515
|
24,757
|
|||||||||
Provisions
|
23
|
50
|
75
|
|||||||||
Finance lease liabilities
|
25
|
354
|
273
|
|||||||||
|
||||||||||||
Total current liabilities
|
21,229
|
25,280
|
||||||||||
|
||||||||||||
Non-current liabilities
|
||||||||||||
Borrowings
|
24
|
92,955
|
92,232
|
|||||||||
Derivative financial instruments
|
24
|
2,230
|
4,260
|
|||||||||
Finance lease liabilities
|
25
|
532
|
732
|
|||||||||
Deferred tax liabilities
|
14
|
10,832
|
18,361
|
|||||||||
|
||||||||||||
Total non-current liabilities
|
106,549
|
115,585
|
||||||||||
|
||||||||||||
TOTAL LIABILITIES
|
2
|
127,778
|
140,865
|
|||||||||
|
||||||||||||
TOTAL EQUITY AND LIABILITIES
|
192,974
|
249,592
|
|
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, 2015
|
1,192
|
12,422
|
(7,367
|
)
|
(4,582
|
)
|
4,529
|
23
|
190,755
|
196,972
|
||||||||||||||||||||||
Profit for the period
|
—
|
—
|
—
|
—
|
—
|
—
|
21,796
|
21,796
|
||||||||||||||||||||||||
Other comprehensive income
|
—
|
—
|
—
|
(4,872
|
)
|
—
|
—
|
—
|
(4,872
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total comprehensive income
|
—
|
—
|
—
|
(4,872
|
)
|
—
|
—
|
21,796
|
16,924
|
|||||||||||||||||||||||
Share-based payments (Note 21)
|
—
|
—
|
—
|
—
|
—
|
—
|
1,974
|
1,974
|
||||||||||||||||||||||||
Options or warrants exercised
|
17
|
3,110
|
—
|
—
|
—
|
—
|
—
|
3,127
|
||||||||||||||||||||||||
Share issue expenses
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
||||||||||||||||||||||
Dividends
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,099
|
)
|
(5,099
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2015
|
1,209
|
15,526
|
(7,367
|
)
|
(9,454
|
)
|
4,529
|
23
|
209,426
|
213,892
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at January 1, 2016
|
1,209
|
15,526
|
(7,367
|
)
|
(9,454
|
)
|
4,529
|
23
|
209,426
|
213,892
|
||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
—
|
—
|
(100,625
|
)
|
(100,625
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
—
|
—
|
—
|
3,122
|
—
|
—
|
—
|
3,122
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total comprehensive income
|
—
|
—
|
—
|
3,122
|
—
|
—
|
(100,625
|
)
|
(97,503
|
)
|
||||||||||||||||||||||
Share-based payments (Note 21)
|
—
|
—
|
—
|
—
|
—
|
—
|
1,633
|
1,633
|
||||||||||||||||||||||||
Options or warrants exercised
|
4
|
669
|
—
|
—
|
—
|
—
|
—
|
673
|
||||||||||||||||||||||||
Shares purchased
|
—
|
—
|
(9,960
|
)
|
—
|
—
|
—
|
—
|
(9,960
|
)
|
||||||||||||||||||||||
Share issue expenses
|
—
|
(8
|
)
|
—
|
—
|
—
|
—
|
—
|
(8
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2016
|
1,213
|
16,187
|
(17,327
|
)
|
(6,332
|
)
|
4,529
|
23
|
110,434
|
108,727
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at January 1, 2017
|
1,213
|
16,187
|
(17,327
|
)
|
(6,332
|
)
|
4,529
|
23
|
110,434
|
108,727
|
||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
—
|
—
|
(40,270
|
)
|
(40,270
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
—
|
—
|
—
|
3,086
|
—
|
—
|
—
|
3,086
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total comprehensive income/(loss)
|
—
|
—
|
—
|
3,086
|
—
|
—
|
(40,270
|
)
|
(37,184
|
)
|
||||||||||||||||||||||
Transfer of warrant reserve (Note 21)
|
(4,529
|
)
|
4,529
|
—
|
||||||||||||||||||||||||||||
Share-based payments (Note 21)
|
—
|
—
|
—
|
—
|
—
|
—
|
1,109
|
1,109
|
||||||||||||||||||||||||
Shares purchased
|
—
|
—
|
(7,456
|
)
|
—
|
—
|
—
|
—
|
(7,456
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2017
|
1,213
|
16,187
|
(24,783
|
)
|
(3,246
|
)
|
—
|
23
|
75,802
|
65,196
|
|
Year ended December 31,
|
|||||||||||||||
|
Notes
|
2017
US$‘000
|
2016
US$‘000
|
2015
US$‘000
|
||||||||||||
Cash flows from operating activities
|
||||||||||||||||
(Loss) / profit for the year
|
(40,270
|
)
|
(100,625
|
)
|
21,796
|
|||||||||||
Adjustments to reconcile net profit to cash provided by operating activities:
|
||||||||||||||||
Depreciation
|
5
|
1,896
|
3,159
|
2,989
|
||||||||||||
Amortisation
|
5,13
|
3,303
|
2,973
|
2,653
|
||||||||||||
Income tax (credit)/expense
|
(374
|
)
|
(8,630
|
)
|
1,080
|
|||||||||||
Financial income
|
3
|
(3,198
|
)
|
(3,147
|
)
|
(13,491
|
)
|
|||||||||
Financial expense
|
3
|
5,405
|
5,444
|
4,063
|
||||||||||||
Share-based payments
|
21
|
928
|
1,414
|
1,550
|
||||||||||||
Foreign exchange (gains)/losses on operating cash flows
|
307
|
(226
|
)
|
(2,115
|
)
|
|||||||||||
Loss on disposal or retirement of property, plant and equipment
|
5
|
3
|
15
|
15
|
||||||||||||
Movement in inventory provision
|
16
|
2,275
|
(533
|
)
|
852
|
|||||||||||
Impairment of inventory
|
—
|
7,405
|
—
|
|||||||||||||
Impairment of prepayments
|
6, 17
|
1,651
|
757
|
—
|
||||||||||||
Impairment of property, plant and equipment
|
6, 12
|
10,437
|
9,029
|
—
|
||||||||||||
Impairment of intangible assets
|
6, 13
|
29,667
|
87,673
|
—
|
||||||||||||
Provision for closure costs
|
10
|
(1,794
|
)
|
3,431
|
—
|
|||||||||||
Other non-cash items
|
(728
|
)
|
4,087
|
563
|
||||||||||||
|
||||||||||||||||
Operating cash flows before changes in working capital
|
9,508
|
12,226
|
19,955
|
|||||||||||||
Decrease / (increase) in trade and other receivables
|
306
|
682
|
(772
|
)
|
||||||||||||
Increase in inventories
|
(2,461
|
)
|
(3,622
|
)
|
(2,336
|
)
|
||||||||||
Increase / (decrease) in trade and other payables
|
2,017
|
1,270
|
(3,329
|
)
|
||||||||||||
|
||||||||||||||||
Cash generated from operations
|
9,370
|
10,556
|
13,518
|
|||||||||||||
Interest paid
|
(53
|
)
|
(60
|
)
|
(34
|
)
|
||||||||||
Interest received
|
776
|
901
|
135
|
|||||||||||||
Income taxes paid
|
(843
|
)
|
(1,169
|
)
|
(463
|
)
|
||||||||||
|
||||||||||||||||
Net cash generated by operating activities
|
9,250
|
10,228
|
13,156
|
|||||||||||||
|
||||||||||||||||
Cash flows from investing activities
|
||||||||||||||||
Payments to acquire intangible assets
|
(10,229
|
)
|
(16,548
|
)
|
(19,492
|
)
|
||||||||||
Acquisition of property, plant and equipment
|
(4,839
|
)
|
(4,215
|
)
|
(7,094
|
)
|
||||||||||
Licence fees
|
22
|
(1,112
|
)
|
(1,112
|
)
|
(1,112
|
)
|
|||||||||
|
||||||||||||||||
Net cash used in investing activities
|
(16,180
|
)
|
(21,875
|
)
|
(27,698
|
)
|
||||||||||
|
||||||||||||||||
Cash flows from financing activities
|
||||||||||||||||
Proceeds from issue of ordinary share capital
|
|
—
|
857
|
2,943
|
||||||||||||
Share buyback
|
|
(7,799
|
)
|
(9,322
|
)
|
—
|
||||||||||
Expenses paid in connection with share issue and debt financing
|
—
|
(8
|
)
|
(6
|
)
|
|||||||||||
Dividends paid to equity holders of the parent
|
|
—
|
—
|
(5,099
|
)
|
|||||||||||
Proceeds from issuance of exchangeable notes
|
24
|
—
|
—
|
115,000
|
||||||||||||
Fees relating to issuance of exchangeable notes
|
|
—
|
—
|
(4,471
|
)
|
|||||||||||
Interest payment on exchangeable notes
|
29
|
(4,600
|
)
|
(4,600
|
)
|
(2,198
|
)
|
|||||||||
Proceeds from new finance leases
|
51
|
—
|
1,489
|
|||||||||||||
Payment of finance lease liabilities
|
(295
|
)
|
(282
|
)
|
(138
|
)
|
||||||||||
|
||||||||||||||||
Net cash generated by / (used in) financing activities
|
(12,643
|
)
|
(13,355
|
)
|
107,520
|
|||||||||||
|
||||||||||||||||
Increase / (Decrease) in cash and cash equivalents and short term investments
|
(19,573
|
)
|
(25,002
|
)
|
92,978
|
|||||||||||
Effects of exchange rate movements on cash held
|
71
|
158
|
(127
|
)
|
||||||||||||
Cash and cash equivalents and short-term investments at beginning of year
|
77,109
|
101,953
|
9,102
|
|||||||||||||
|
||||||||||||||||
Cash and cash equivalents and short term investments at end of year
|
18,19
|
57,607
|
77,109
|
101,953
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES
|
i) |
General information
|
ii) |
Statement of compliance
|
iii) |
Basis of preparation
|
iv) |
Basis of consolidation
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
v) |
Property, plant and equipment
|
• Leasehold improvements
|
5-15 years
|
|
• Buildings
|
50 years
|
|
• Office equipment and fittings
|
10 years
|
|
• Computer equipment
|
3-5 years
|
|
• Plant and equipment
|
5-15 years
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
vi) |
Goodwill
|
vii) |
Intangibles, including research and development (other than goodwill)
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
• Capitalised development costs
|
15 years
|
|
• Patents and licences
|
6-15 years
|
|
• Other (including acquired customer and supplier lists)
|
6-15 years
|
(a) |
once a diagnostic test becomes established, customers are reluctant to change to new technology until it is fully proven, thus resulting in relatively long product life cycles. There is also reluctance in customers to change to a new product as it can be costly both in terms of the initial changeover cost and as new technology is typically more expensive.
|
(b) |
demand for the diagnostic tests is enduring and robust within a wide geographic base. The diseases that the products diagnose are widely prevalent (HIV, Diabetes and Chlamydia being just three examples) in many countries. There is a general consensus that these diseases will continue to be widely prevalent in the future.
|
(c) |
there are significant barriers to new entrants in this industry. Patents and/or licences are in place for many of our products, though this is not the only barrier to entry. There is a significant cost and time to develop new products, it is necessary to obtain regulatory approval and tests are protected by proprietary know-how, manufacturing techniques and trade secrets.
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
viii) |
Impairment
|
ix) |
Inventories
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
x) |
Trade and other receivables
|
xi) |
Trade and other payables
|
xii) |
Cash and cash equivalents
|
xiii) |
Short-term investments
|
xiv) |
Share-based payments
|
xv) |
Government grants
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
xvi) |
Revenue recognition
|
xvii) |
Employee benefits
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
xviii) |
Foreign currency
|
xix) |
Hedging
|
xx) |
Exchangeable notes and derivative financial instruments
|
1. |
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
|
xxi) |
Segment reporting
|
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
|
xxiv) |
Fair values
|
xxix) |
New IFRS Standards and Interpretations not applied
|
International Financial Reporting Standards (IFRS/IAS)
|
Effective date
|
||
IFRS 9
|
Financial Instruments
|
January 1, 2018 (adopted by the EU with effectivity date of January 1, 2018)
|
|
IFRS 15
|
Revenue from Contracts with Customers
|
January 1, 2018 (adopted by the EU with effectivity date of January 1, 2018)
|
|
IFRS 16
|
Leases
|
January 1, 2019 (not yet adopted by the EU)
|
|
IFRS 2
|
Share-based Payments – Classification and Measurement of Share-based Payment Transactions
|
January 1, 2018 (not yet adopted by the EU)
|
|
IFRIC 22
|
Foreign Currency Transactions and Advance Consideration
|
January 1, 2018 (not yet adopted by the EU)
|
• |
IAS 7 Statement of Cash Flows (Amendment) – Disclosure Initiative
|
• |
IAS 12 Income Taxes (Amendment) – Recognition of Deferred Tax Assets for Unrealised Losses
|
2. |
SEGMENT INFORMATION
|
i) |
The distribution of revenue by geographical area based on location of assets was as follows:
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
ii) |
The distribution of revenue by customers’ geographical area was as follows:
|
Revenue
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Americas
|
59,539
|
61,613
|
62,421
|
|||||||||
Asia / Africa
|
27,131
|
25,501
|
22,346
|
|||||||||
Europe (including Ireland) *
|
12,470
|
12,497
|
15,428
|
|||||||||
|
||||||||||||
|
99,140
|
99,611
|
100,195
|
* |
Revenue from customers in Ireland is not disclosed separately due to the immateriality of these revenues.
|
iii) |
The distribution of revenue by major product group was as follows:
|
Revenue
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Clinical laboratory
|
73,366
|
74,166
|
73,576
|
|||||||||
Point-of-Care
|
16,774
|
16,908
|
18,810
|
|||||||||
Laboratory services
|
9,000
|
8,537
|
7,809
|
|||||||||
|
||||||||||||
|
99,140
|
99,611
|
100,195
|
iv) |
The distribution of segment results by geographical area was as follows:
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result before impairment
|
3,744
|
1,125
|
(44
|
)
|
4,825
|
|||||||||||
Impairment
|
(9,194
|
)
|
(32,561
|
)
|
—
|
(41,755
|
)
|
|||||||||
|
||||||||||||||||
Result after impairment
|
(5,450
|
)
|
(31,436
|
)
|
(44
|
)
|
(36,930
|
)
|
||||||||
Unallocated expenses *
|
(738
|
)
|
||||||||||||||
|
||||||||||||||||
Operating loss
|
(37,668
|
)
|
||||||||||||||
Net financing expense (Note 3)
|
(2,207
|
)
|
||||||||||||||
|
||||||||||||||||
Loss before tax
|
(39,875
|
)
|
||||||||||||||
Income tax credit (Note 9)
|
1,214
|
|||||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
(38,661
|
)
|
||||||||||||||
Loss for the year on discontinued operations (Note 10)
|
(1,609
|
)
|
||||||||||||||
|
||||||||||||||||
Loss for the year
|
(40,270
|
)
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2016
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result before exceptional expenses
|
4,564
|
4,270
|
384
|
9,218
|
||||||||||||
Impairment
|
(22,989
|
)
|
(20,390
|
)
|
—
|
(43,379
|
)
|
|||||||||
Inventory provision
|
(335
|
)
|
(4,451
|
)
|
—
|
(4,786
|
)
|
|||||||||
|
||||||||||||||||
Result after exceptional expenses
|
(18,760
|
)
|
(20,571
|
)
|
384
|
(38,947
|
)
|
|||||||||
Unallocated expenses *
|
(901
|
)
|
||||||||||||||
|
||||||||||||||||
Operating profit
|
(39,848
|
)
|
||||||||||||||
Net financing expense (Note 3)
|
(2,292
|
)
|
||||||||||||||
|
||||||||||||||||
Loss before tax
|
(42,140
|
)
|
||||||||||||||
Income tax credit (Note 9)
|
3,557
|
|||||||||||||||
|
||||||||||||||||
Loss for the year on continuing operations
|
(38,583
|
)
|
||||||||||||||
Loss for the year on discontinued operations (Note 10)
|
(62,042
|
)
|
||||||||||||||
|
||||||||||||||||
Loss for the year
|
(100,625
|
)
|
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
Year ended December 31, 2015
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Result
|
4,183
|
9,782
|
524
|
14,489
|
||||||||||||
Unallocated expenses *
|
(983
|
)
|
||||||||||||||
|
||||||||||||||||
Operating profit
|
13,506
|
|||||||||||||||
Net financing income (Note 3)
|
9,437
|
|||||||||||||||
|
||||||||||||||||
Profit before tax
|
22,943
|
|||||||||||||||
Income tax expense (Note 9)
|
(756
|
)
|
||||||||||||||
|
||||||||||||||||
Profit for the year on continuing operations
|
22,187
|
|||||||||||||||
Loss for the year on discontinued operations (Note 10)
|
(391
|
)
|
||||||||||||||
|
||||||||||||||||
Profit for the year
|
21,796
|
* |
Unallocated expenses represent head office general and administration costs of the Group which cannot be allocated to the results of any specific geographical area.
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
v) |
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, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Assets and liabilities
|
||||||||||||||||
Segment assets
|
88,714
|
36,513
|
3
|
125,230
|
||||||||||||
Unallocated assets:
|
||||||||||||||||
Income tax assets (current and deferred)
|
10,137
|
|||||||||||||||
Cash and cash equivalents and short-term investments
|
57,607
|
|||||||||||||||
|
||||||||||||||||
Total assets as reported in the Group balance sheet
|
192,974
|
|||||||||||||||
|
||||||||||||||||
Segment liabilities
|
11,486
|
104,901
|
249
|
116,636
|
||||||||||||
Unallocated liabilities:
|
||||||||||||||||
Income tax liabilities (current and deferred)
|
11,142
|
|||||||||||||||
|
||||||||||||||||
Total liabilities as reported in the Group balance sheet
|
127,778
|
|||||||||||||||
|
||||||||||||||||
|
Rest of World
|
|||||||||||||||
|
Americas
|
Ireland
|
Other
|
Total
|
||||||||||||
As at December 31, 2016
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||
Assets and liabilities
|
||||||||||||||||
Segment assets
|
93,589
|
63,062
|
71
|
156,722
|
||||||||||||
Unallocated assets:
|
||||||||||||||||
Income tax assets (current and deferred)
|
15,761
|
|||||||||||||||
Cash and cash equivalents and short-term investments
|
77,109
|
|||||||||||||||
|
||||||||||||||||
Total assets as reported in the Group balance sheet
|
249,592
|
|||||||||||||||
|
||||||||||||||||
Segment liabilities
|
9,746
|
108,049
|
4,534
|
122,329
|
||||||||||||
Unallocated liabilities:
|
||||||||||||||||
Income tax liabilities (current and deferred)
|
18,536
|
|||||||||||||||
|
||||||||||||||||
Total liabilities as reported in the Group balance sheet
|
140,865
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
vi) |
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, 2017
US$‘000
|
December 31, 2016
US$‘000
|
||||||
Rest of World – Ireland
|
15,873
|
41,909
|
||||||
Rest of World – Other
|
—
|
—
|
||||||
Americas
|
55,812
|
59,639
|
||||||
|
||||||||
|
71,685
|
101,548
|
vii) |
The distribution of depreciation and amortisation by geographical area was as follows:
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Depreciation:
|
||||||||||||
Rest of World – Ireland
|
1,186
|
1,072
|
825
|
|||||||||
Rest of World – Other
|
—
|
304
|
151
|
|||||||||
Americas
|
1,238
|
2,197
|
2,081
|
|||||||||
|
||||||||||||
|
2,424
|
3,573
|
3,057
|
|||||||||
|
||||||||||||
Amortisation:
|
||||||||||||
Rest of World – Ireland
|
1,164
|
1,533
|
1,468
|
|||||||||
Americas
|
2,139
|
1,440
|
1,185
|
|||||||||
|
||||||||||||
|
3,303
|
2,973
|
2,653
|
viii) |
The distribution of share-based payment expense by geographical area was as follows:
|
|
December 31, 2017
US$‘000 |
December 31, 2016
US$‘000 |
December 31, 2015
US$‘000 |
|||||||||
Rest of World – Ireland
|
841
|
1,187
|
1,415
|
|||||||||
Rest of World – Other
|
—
|
41
|
13
|
|||||||||
Americas
|
87
|
153
|
122
|
|||||||||
|
||||||||||||
|
928
|
1,381
|
1,550
|
|||||||||
Share based-payments – discontinued operations
|
—
|
33
|
—
|
|||||||||
|
||||||||||||
|
928
|
1,414
|
1,550
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
ix) |
The distribution of interest income and interest expense by geographical area was as follows:
|
Total
|
4
|
13,487
|
4,854
|
(4,854
|
)
|
13,491
|
2. |
SEGMENT INFORMATION (CONTINUED)
|
|
Rest of World
|
|||||||||||||||||||
Interest Expense
Year ended December 31, 2015
|
Americas
US$‘000
|
Ireland
US$‘000
|
Other
US$‘000
|
Eliminations
US$’000
|
Total
US$‘000
|
|||||||||||||||
Interest on deferred consideration and licence fee
|
—
|
138
|
—
|
—
|
138
|
|||||||||||||||
Interest on finance leases
|
—
|
33
|
—
|
—
|
33
|
|||||||||||||||
Cash interest on exchangeable notes
|
—
|
3,348
|
—
|
—
|
3,348
|
|||||||||||||||
Non-cash interest on exchangeable notes
|
—
|
535
|
—
|
—
|
535
|
|||||||||||||||
Inter-segment interest expense
|
4,854
|
—
|
—
|
(4,854
|
)
|
—
|
||||||||||||||
|
||||||||||||||||||||
Total
|
4,854
|
4,054
|
—
|
(4,854
|
)
|
4,054
|
x) |
The distribution of taxation (expense)/credit by geographical area was as follows:
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Rest of World – Ireland
|
192
|
2,038
|
(1,050
|
)
|
||||||||
Rest of World – Other
|
(81
|
)
|
(48
|
)
|
(72
|
)
|
||||||
Americas
|
1,103
|
1,567
|
366
|
|||||||||
|
||||||||||||
|
1,214
|
3,557
|
(756
|
)
|
xi) |
During 2017, 2016 and 2015 there were no customers generating 10% or more of total revenues.
|
xii) |
The distribution of capital expenditure by geographical area was as follows:
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
||||||
Rest of World – Ireland
|
7,602
|
14,431
|
||||||
Rest of World – Other
|
—
|
763
|
||||||
Americas
|
8,080
|
7,591
|
||||||
|
||||||||
|
15,682
|
22,785
|
3. |
FINANCIAL INCOME AND EXPENSES
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Financial income:
|
||||||||||||
Non-cash financial income
|
2,390
|
2,270
|
13,015
|
|||||||||
Interest income
|
808
|
877
|
476
|
|||||||||
|
||||||||||||
|
3,198
|
3,147
|
13,491
|
|||||||||
|
||||||||||||
Financial expense:
|
||||||||||||
Interest on finance leases
|
(42
|
)
|
(55
|
)
|
(33
|
)
|
||||||
Cash interest on exchangeable notes
|
(4,600
|
)
|
(4,600
|
)
|
(3,348
|
)
|
||||||
Non-cash interest on exchangeable notes (Note 24)
|
(723
|
)
|
(718
|
)
|
(535
|
)
|
||||||
Interest on deferred consideration and licence fee
|
(40
|
)
|
(66
|
)
|
(138
|
)
|
||||||
|
||||||||||||
|
(5,405
|
)
|
(5,439
|
)
|
(4,054
|
)
|
||||||
Net Financing (Expense) / Income
|
(2,207
|
)
|
(2,292
|
)
|
9,437
|
4. |
OTHER OPERATING INCOME
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Rental income from premises
|
-
|
135
|
201
|
|||||||||
Other income
|
100
|
104
|
87
|
|||||||||
|
||||||||||||
|
100
|
239
|
288
|
5. |
(LOSS)/PROFIT BEFORE TAX
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Directors’ emoluments (including non- executive directors):
|
||||||||||||
Remuneration
|
1,800
|
1,946
|
1,596
|
|||||||||
Pension
|
44
|
41
|
23
|
|||||||||
Share based payments
|
727
|
1,121
|
1,242
|
|||||||||
Auditor’s remuneration
|
||||||||||||
Audit fees
|
568
|
469
|
492
|
|||||||||
Tax fees
|
73
|
33
|
12
|
|||||||||
Other non audit fees
|
-
|
19
|
8
|
|||||||||
Depreciation*
|
1,896
|
2,856
|
2,839
|
|||||||||
Amortisation
|
3,303
|
2,973
|
2,653
|
|||||||||
Loss on the disposal of property, plant and equipment
|
3
|
15
|
15
|
|||||||||
Net foreign exchange differences**
|
(17
|
)
|
888
|
(1,018
|
)
|
|||||||
Operating lease rentals:
|
||||||||||||
Land and buildings
|
2,846
|
2,811
|
2,828
|
|||||||||
Other equipment
|
163
|
114
|
69
|
* |
Note that US$528,000 (2016: US$414,000) (2015: US$68,000) of depreciation was capitalised to research and development projects during 2017 in line with the Group’s capitalisation policy for Intangible projects.
|
** |
The net foreign exchange differences do not include US$440,000 (2016: US$253,000) which were included in the operating expenses that were stated in Note 10 in respect of the discontinued operations in Fiomi.
|
6. |
IMPAIRMENT CHARGES AND INVENTORY PROVISIONING
|
|
Impairment
charges
US$’000
|
Product
Cull
US$’000
|
Total
US$‘000
|
|||||||||
Selling, general & administration expenses
|
||||||||||||
Impairment of PP&E (note 12)
|
4,382
|
—
|
4,382
|
|||||||||
Impairment of goodwill and other intangible assets (note 13)
|
38,240
|
—
|
38,240
|
|||||||||
Impairment of prepayments (note 17)
|
757
|
—
|
757
|
|||||||||
Product discontinuation (note 16)
|
—
|
4,786
|
4,786
|
|||||||||
|
||||||||||||
Total impairment loss and inventory provisioning costs before tax
|
43,379
|
4,786
|
48,165
|
|||||||||
|
||||||||||||
Income tax impact of impairment loss and inventory provisioning costs
|
(3,094
|
)
|
(689
|
)
|
(3,783
|
)
|
||||||
|
||||||||||||
Total impairment loss and inventory provisioning costs after tax
|
40,285
|
4,097
|
44,382
|
7. |
PERSONNEL EXPENSES
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Wages and salaries
|
26,316
|
25,901
|
24,531
|
|||||||||
Social welfare costs
|
2,424
|
2,542
|
2,418
|
|||||||||
Pension costs
|
459
|
552
|
711
|
|||||||||
Share-based payments
|
928
|
1,414
|
1,550
|
|||||||||
Restructuring costs
|
-
|
1,276
|
—
|
|||||||||
|
||||||||||||
|
30,127
|
31,685
|
29,210
|
|
December 31, 2017
|
December 31, 2016
|
December 31, 2015
|
|||||||||
Research and development
|
60
|
73
|
69
|
|||||||||
Administration and sales
|
162
|
161
|
156
|
|||||||||
Manufacturing and quality
|
334
|
348
|
330
|
|||||||||
|
||||||||||||
|
556
|
582
|
555
|
8. |
PENSION SCHEMES
|
9. |
INCOME TAX (CREDIT)/EXPENSE
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Current tax expense
|
||||||||||||
Irish Corporation tax
|
(51
|
)
|
(240
|
)
|
(251
|
)
|
||||||
Foreign taxes (a)
|
358
|
222
|
472
|
|||||||||
Adjustment in respect of prior years
|
150
|
(271
|
)
|
82
|
||||||||
|
||||||||||||
Total current tax (credit)/expense
|
457
|
(289
|
)
|
303
|
||||||||
|
||||||||||||
Deferred tax expense
(b)
|
||||||||||||
Origination and reversal of temporary differences (see Note 14)
|
(5,969
|
)
|
(2,872
|
)
|
2,411
|
|||||||
Origination and reversal of net operating losses (see Note 14)
|
4,298
|
(396
|
)
|
(1,958
|
)
|
|||||||
|
||||||||||||
Total deferred tax (credit)/expense
|
(1,671
|
)
|
(3,268
|
)
|
453
|
|||||||
|
||||||||||||
Total income tax (credit)/charge on continuing operations in statement of operations
|
(1,214
|
)
|
(3,557
|
)
|
756
|
(a) |
The foreign taxes relate primarily to USA and Canada.
|
(b) |
In 2017, there was a deferred tax credit of US$170,000 (2016: credit of US$1,804,000; 2015: charge of US$1,246,000) recognised in respect of Ireland and a deferred tax credit of US$1,501,000 (2016: US$1,464,000 credit; 2015: US$793,000 credit) recognised in respect of overseas tax jurisdictions.
|
Effective tax rate
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Profit/(Loss) before taxation
|
(39,875
|
)
|
(42,140
|
)
|
22,943
|
|||||||
As a percentage of profit/loss before tax:
|
||||||||||||
Current tax
|
1.14
|
%
|
(0.69
|
)%
|
1.32
|
%
|
||||||
Total (current and deferred)
|
(3.05
|
)%
|
(8.44
|
)%
|
3.30
|
%
|
|
December 31, 2017
|
December 31, 2016
|
December 31, 2015
|
|||||||||
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)
|
12.05
|
%
|
6.22
|
%
|
(1.94
|
)%
|
||||||
Effect of changes in US tax code (b)
|
(1.89
|
)%
|
-
|
-
|
||||||||
Effect of tax rates on overseas earnings
|
(2.09
|
)%
|
(1.39
|
)%
|
(1.34
|
)%
|
||||||
Effect of Irish income taxable at higher tax rate
|
-
|
0.05
|
%
|
0.06
|
%
|
|||||||
Adjustments in respect of prior years
|
0.38
|
%
|
(0.64
|
)%
|
2.53
|
%
|
||||||
R&D tax credits (c)
|
(0.17
|
)%
|
(0.65
|
)%
|
(3.98
|
)%
|
||||||
Other items (d)
|
1.17
|
%
|
0.47
|
%
|
(4.53
|
)%
|
||||||
|
||||||||||||
Effective tax rate
|
(3.05
|
)%
|
(8.44
|
)%
|
3.30
|
%
|
(a) |
The effect of current year net operating losses and temporary differences for which no deferred tax asset was
recognised
is analyzed further in the table below (see also Note 14). No deferred tax asset was
recognised
because there was no reversing deferred tax liability in the same jurisdiction reversing in the same period and no future taxable income in the same jurisdiction.
|
9. |
INCOME TAX EXPENSE (CONTINUED)
|
(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 of US$753,000 arising from the reduction in deferred tax balances due to the tax rate change, partially offset by the effect of mandatory deemed repatriation of certain deferred foreign earnings.
|
(c) |
A lower amount of R&D tax credits has been recorded in 2017 compared to prior years because several of the R&D projects in Ireland are at an advanced stage where they no longer qualify for such a tax credit.
|
(d) |
Other items comprise items not chargeable to tax/expenses not deductible for tax. In 2017, other items mainly comprise the movement in the Loan Note’s embedded derivatives value and the accretion of notional interest on the Loan Note’s host contract, both of which are exempt from deferred taxation recognition under IAS 12,
Income Taxes
.
|
Unrecognised deferred tax assets – continuing operations
|
Effect in
2017
US$’000
|
Percentage
effect in
2017
|
Effect in
2016
US$’000
|
Percentage
effect in
2016
|
||||||||||||
Temporary differences arising in the US
|
68
|
0.17
|
%
|
2
|
0.01
|
%
|
||||||||||
(Decrease)/increase in net operating losses arising in Brazil
|
(714
|
)
|
(1.79
|
)%
|
1,670
|
3.96
|
%
|
|||||||||
Net operating losses arising in Ireland
|
5,452
|
13.67
|
%
|
947
|
2.25
|
%
|
||||||||||
|
||||||||||||||||
|
4,806
|
12.05
|
%
|
2,619
|
6.22
|
%
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Rest of World – Ireland
|
(35,821
|
)
|
(23,787
|
)
|
18,232
|
|||||||
Rest of World – Other
|
4,809
|
5,241
|
5,378
|
|||||||||
Americas
|
(8,863
|
)
|
(23,594
|
)
|
(667
|
)
|
||||||
|
||||||||||||
|
(39,875
|
)
|
(42,140
|
)
|
22,943
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
USA
|
7,737
|
8,896
|
11,026
|
|||||||||
Ireland
|
57,206
|
40,652
|
22,609
|
|||||||||
Brazil
|
4,060
|
6,159
|
1,245
|
|||||||||
|
||||||||||||
|
69,003
|
55,707
|
34,880
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
US – unused tax credits
|
345
|
277
|
275
|
|||||||||
Brazil – unused tax losses
|
1,380
|
2,094
|
423
|
|||||||||
Ireland – unused tax losses
|
8,471
|
3,019
|
724
|
|||||||||
|
||||||||||||
Unrecognised deferred tax asset
|
10,196
|
5,390
|
1,422
|
9 . |
INCOME TAX EXPENSE (CONTINUED)
|
10 . |
LOSS
FOR THE YEAR
ON DISCONTINUED OPERATIONS
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
Revenues
|
—
|
—
|
—
|
|||||||||
Operating expenses
|
—
|
(827
|
)
|
(58
|
)
|
|||||||
|
||||||||||||
Operating loss
|
—
|
(827
|
)
|
(58
|
)
|
|||||||
Interest expenses
|
—
|
(5
|
)
|
(9
|
)
|
|||||||
|
||||||||||||
Loss from discontinued operations before tax
|
—
|
(832
|
)
|
(67
|
)
|
|||||||
Income tax credit/(expense)
|
—
|
186
|
(324
|
)
|
||||||||
|
||||||||||||
Loss for the year
|
—
|
(646
|
)
|
(391
|
)
|
|||||||
Loss on remeasurement of assets and liabilities:
|
||||||||||||
Property, plant and equipment (note 12)
|
—
|
(4,647
|
)
|
—
|
||||||||
Goodwill and intangible assets (note 13)
|
—
|
(49,433
|
)
|
—
|
||||||||
Inventories
|
—
|
(2,578
|
)
|
—
|
||||||||
Closure costs
|
1,794
|
(5,846
|
)
|
—
|
||||||||
Foreign currency translation reserve
|
(3,080
|
)
|
(3,779
|
)
|
—
|
|||||||
Taxation
|
(323
|
)
|
4,887
|
—
|
||||||||
|
||||||||||||
Total loss
|
(1,609
|
)
|
(61,396
|
)
|
—
|
|||||||
Loss for the year from discontinued operations
|
(1,609
|
)
|
(62,042
|
)
|
(391
|
)
|
10. |
LOSS
FOR THE YEAR
ON DISCONTINUED OPERATIONS (CONTINUED)
|
|
December 31,
2017 |
December 31,
2016 |
December 31,
2015 |
|||||||||
Basic (loss)/earnings per ADS (US Dollars) – discontinued operations
|
(0.07
|
)
|
(2.70
|
)
|
(0.02
|
)
|
||||||
Diluted (loss)/earnings per ADS (US Dollars) – discontinued operations
|
(0.07
|
)
|
(2.70
|
)
|
(0.02
|
)
|
||||||
Basic (loss)/earnings per ‘A’ share (US Dollars) – discontinued operations
|
(0.02
|
)
|
(0.68
|
)
|
(0.004
|
)
|
||||||
Diluted (loss)/earnings per ‘A’ share (US Dollars) – discontinued operations
|
(0.02
|
)
|
(0.68
|
)
|
(0.004
|
)
|
|
December 31,
2017 |
December 31,
2016 |
December 31,
2015 |
|||||||||
Cash flows from operating activities
|
(2,847
|
)
|
(1,623
|
)
|
(11,135
|
)
|
||||||
Cash flows from investing activities
|
-
|
(8,989
|
)
|
(10,802
|
)
|
11. |
(LOSS)/EARNINGS PER SHARE
|
|
December 31,
2017 |
December 31,
2016 |
December 31,
2015 |
|||||||||
‘A’ ordinary shares
|
86,486,409
|
91,858,813
|
92,647,091
|
|||||||||
|
||||||||||||
Basic earnings per share denominator
|
86,486,409
|
91,858,813
|
92,647,091
|
|||||||||
|
||||||||||||
Reconciliation to weighted average earnings per share denominator:
|
||||||||||||
Number of ‘A’ ordinary shares at January 1 (Note 20)
|
96,162,410
|
95,840,138
|
94,308,358
|
|||||||||
Weighted average number of shares issued during the year*
|
-
|
120,396
|
974,161
|
|||||||||
Weighted average number of treasury shares
|
(9,676,001
|
)
|
(4,101,721
|
)
|
(2,635,428
|
)
|
||||||
|
||||||||||||
Basic earnings per share denominator
|
86,486,409
|
91,858,813
|
92,647,091
|
|
December 31,
2017
|
December 31,
2016
|
December 31,
2015
|
|||||||||
Basic earnings per share denominator (see above)
|
86,486,409
|
91,858,813
|
92,647,091
|
|||||||||
Issuable on exercise of options and warrants
|
-
|
315,019
|
1,700,733
|
|||||||||
Issuable on conversion of exchangeable notes
|
21,023,770
|
21,023,766
|
15,283,348
|
|||||||||
|
||||||||||||
Diluted earnings per share denominator
|
107,510,179
|
113,197,598
|
109,631,172
|
11. |
(LOSS)/EARNINGS PER SHARE (CONTINUED)
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
December 31, 2015
US$‘000
|
|||||||||
(Loss)/Profit after tax for the year
|
(40,270
|
)
|
(100,625
|
)
|
21,796
|
|||||||
Non-cash financial income
|
(2,390
|
)
|
(2,270
|
)
|
(13,020
|
)
|
||||||
Cash interest expense
|
4,600
|
4,600
|
3,348
|
|||||||||
Non-cash interest on exchangeable notes
|
723
|
718
|
534
|
|||||||||
|
||||||||||||
Adjusted (loss)/profit after tax
|
(37,337
|
)
|
(97,577
|
)
|
12,658
|
|
December 31,
2017
|
December 31,
2016
|
December 31,
2015
|
|||||||||
ADS
|
21,621,602
|
22,964,703
|
23,161,773
|
|||||||||
|
||||||||||||
Basic earnings per share denominator
|
21,621,602
|
22,964,703
|
23,161,773
|
|||||||||
|
||||||||||||
Reconciliation to weighted average earnings per share denominator:
|
||||||||||||
Number of ADS at January 1 (Note 20)
|
24,040,602
|
23,960,035
|
23,577,090
|
|||||||||
Weighted average number of shares issued during the year*
|
-
|
30,098
|
243,540
|
|||||||||
Weighted average number of treasury shares
|
(2,419,000
|
)
|
(1,025,430
|
)
|
(658,857
|
)
|
||||||
|
||||||||||||
Basic earnings per share denominator
|
21,621,602
|
22,964,703
|
23,161,773
|
|
December 31,
2017
|
December 31,
2016
|
December 31,
2015
|
|||||||||
Basic earnings per share denominator (see above)
|
21,621,602
|
22,964,703
|
23,161,773
|
|||||||||
Issuable on exercise of options and warrants
|
-
|
78,755
|
425,183
|
|||||||||
Issuable on conversion of exchangeable notes
|
5,255,942
|
5,255,941
|
3,820,837
|
|||||||||
|
||||||||||||
Diluted earnings per share denominator
|
26,877,544
|
28,299,399
|
27,407,793
|
12. |
PROPERTY, PLANT AND EQUIPMENT
|
|
Freehold land
and buildings
US$‘000
|
Leasehold
improvements
US$‘000
|
Computers,
fixtures and
fittings
US$‘000
|
Plant and
equipment
US$‘000
|
Total
US$‘000
|
|||||||||||||||
Cost
|
||||||||||||||||||||
At January 1, 2016
|
2,581
|
2,899
|
5,873
|
31,720
|
43,073
|
|||||||||||||||
Other additions
|
8
|
143
|
391
|
4,735
|
5,277
|
|||||||||||||||
Disposals or retirements
|
—
|
—
|
(257
|
)
|
(268
|
)
|
(525
|
)
|
||||||||||||
Exchange adjustments
|
14
|
(11
|
)
|
(12
|
)
|
297
|
288
|
|||||||||||||
|
||||||||||||||||||||
At December 31, 2016
|
2,603
|
3,031
|
5,995
|
36,484
|
48,113
|
|||||||||||||||
|
||||||||||||||||||||
At January 1, 2017
|
2,603
|
3,031
|
5,995
|
36,484
|
48,113
|
|||||||||||||||
Other additions
|
—
|
465
|
302
|
4,491
|
5,258
|
|||||||||||||||
Disposals or retirements
|
(9
|
)
|
(488
|
)
|
(404
|
)
|
(3,083
|
)
|
(3,984
|
)
|
||||||||||
Exchange adjustments
|
30
|
(4
|
)
|
1
|
3
|
30
|
||||||||||||||
|
||||||||||||||||||||
At December 31, 2017
|
2,624
|
3,004
|
5,894
|
37,895
|
49,417
|
|||||||||||||||
|
||||||||||||||||||||
Accumulated depreciation and impairment losses
|
||||||||||||||||||||
At January 1, 2016
|
(1,123
|
)
|
(2,527
|
)
|
(4,828
|
)
|
(13,936
|
)
|
(22,414
|
)
|
||||||||||
Charge for the year
|
(82
|
)
|
(144
|
)
|
(367
|
)
|
(2,980
|
)
|
(3,573
|
)
|
||||||||||
Impairment loss
|
—
|
(53
|
)
|
(109
|
)
|
(8,867
|
)
|
(9,029
|
)
|
|||||||||||
Disposals or retirements
|
—
|
—
|
234
|
253
|
487
|
|||||||||||||||
Exchange adjustments
|
(1
|
)
|
8
|
6
|
(194
|
)
|
(181
|
)
|
||||||||||||
|
||||||||||||||||||||
At December 31, 2016
|
(1,206
|
)
|
(2,716
|
)
|
(5,064
|
)
|
(25,724
|
)
|
(34,710
|
)
|
||||||||||
|
||||||||||||||||||||
At January 1, 2017
|
(1,206
|
)
|
(2,716
|
)
|
(5,064
|
)
|
(25,724
|
)
|
(34,710
|
)
|
||||||||||
Charge for the year
|
(82
|
)
|
(165
|
)
|
(263
|
)
|
(1,914
|
)
|
(2,424
|
)
|
||||||||||
Impairment loss
|
—
|
(267
|
)
|
(383
|
)
|
(9,787
|
)
|
(10,437
|
)
|
|||||||||||
Disposals or retirements
|
9
|
488
|
402
|
3,062
|
3,961
|
|||||||||||||||
Exchange adjustments
|
(4
|
)
|
1
|
—
|
(4
|
)
|
(7
|
)
|
||||||||||||
|
||||||||||||||||||||
At December 31, 2017
|
(1,283
|
)
|
(2,659
|
)
|
(5,308
|
)
|
(34,367
|
)
|
(43,617
|
)
|
||||||||||
7
|
||||||||||||||||||||
Carrying amounts
|
||||||||||||||||||||
At December 31, 2017
|
1,341
|
345
|
586
|
3,528
|
5,800
|
|||||||||||||||
|
||||||||||||||||||||
At December 31, 2016
|
1,397
|
315
|
931
|
10,760
|
13,403
|
12. |
PROPERTY, PLANT AND EQUIPMENT (CONTINUED)
|
13. |
GOODWILL AND INTANGIBLE ASSETS
|
|
Goodwill
US$‘000
|
Development
costs
US$‘000
|
Patents and
licences
US$‘000
|
Other
US$‘000
|
Total
US$‘000
|
|||||||||||||||
Cost
|
||||||||||||||||||||
At January 1, 2016
|
82,112
|
109,443
|
9,968
|
33,624
|
235,147
|
|||||||||||||||
Other additions
|
—
|
17,431
|
—
|
77
|
17,508
|
|||||||||||||||
Exchange adjustments
|
(423
|
)
|
(255
|
)
|
(43
|
)
|
—
|
(721
|
)
|
|||||||||||
|
||||||||||||||||||||
At December 31, 2016
|
81,689
|
126,619
|
9,925
|
33,701
|
251,934
|
|||||||||||||||
|
||||||||||||||||||||
At January 1, 2017
|
81,689
|
126,619
|
9,925
|
33,701
|
251,934
|
|||||||||||||||
Other additions
|
—
|
10,402
|
22
|
—
|
10,424
|
|||||||||||||||
Disposals
|
(15
|
)
|
(15
|
)
|
||||||||||||||||
Reclassification
|
—
|
(132
|
)
|
—
|
132
|
—
|
||||||||||||||
Exchange adjustments
|
—
|
29
|
—
|
—
|
(29
|
)
|
||||||||||||||
|
||||||||||||||||||||
At December 31, 2017
|
81,689
|
136,918
|
9,947
|
33,818
|
262,372
|
|||||||||||||||
|
||||||||||||||||||||
Accumulated amortisation and Impairment losses
|
||||||||||||||||||||
At January 1, 2016
|
(29,426
|
)
|
(20,199
|
)
|
(6,280
|
)
|
(17,884
|
)
|
(73,789
|
)
|
||||||||||
Charge for the year
|
—
|
(1,259
|
)
|
(86
|
)
|
(1,628
|
)
|
(2,973
|
)
|
|||||||||||
Impairment losses
|
(26,489
|
)
|
(58,195
|
)
|
(2,948
|
)
|
(41
|
)
|
(87,673
|
)
|
||||||||||
Exchange adjustments
|
—
|
—
|
(224
|
)
|
—
|
(224
|
)
|
|||||||||||||
|
||||||||||||||||||||
At December 31, 2016
|
(55,915
|
)
|
(79,653
|
)
|
(9,538
|
)
|
(19,553
|
)
|
(164,659
|
)
|
||||||||||
|
||||||||||||||||||||
At January 1, 2017
|
(55,915
|
)
|
(79,653
|
)
|
(9,538
|
)
|
(19,553
|
)
|
(164,659
|
)
|
||||||||||
Charge for the year
|
—
|
(1,708
|
)
|
(17
|
)
|
(1,578
|
)
|
(3,303
|
)
|
|||||||||||
Disposals
|
—
|
—
|
—
|
8
|
8
|
|||||||||||||||
Impairment losses
|
(7,876
|
)
|
(20,782
|
)
|
(173
|
)
|
(836
|
)
|
(29,667
|
)
|
||||||||||
Exchange adjustments
|
—
|
3
|
—
|
—
|
3
|
|||||||||||||||
|
||||||||||||||||||||
At December 31, 2017
|
(63,791
|
)
|
(102,140
|
)
|
(9,728
|
)
|
(21,959
|
)
|
(197,618
|
)
|
||||||||||
|
||||||||||||||||||||
Carrying amounts
|
||||||||||||||||||||
At December 31, 2017
|
17,898
|
34,778
|
219
|
11,859
|
64,754
|
|||||||||||||||
|
||||||||||||||||||||
At December 31, 2016
|
25,774
|
46,966
|
387
|
14,148
|
87,275
|
13. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
Product Name
|
2017
US$’000 |
2016
US$’000 |
||||||
Premier Instrument for Haemoglobin A1c testing
1
|
2,601
|
2,810
|
||||||
HIV screening rapid test
|
1,514
|
1,085
|
||||||
US Lyme
|
1,156
|
1,003
|
||||||
Uni-gold test enhancement
|
1,134
|
1,154
|
||||||
G-6-PDH test
|
812
|
-
|
||||||
Tri-stat Point-of-Care instrument
|
764
|
678
|
||||||
Sjogrens monoclonal antibodies
|
376
|
166
|
||||||
HIV screening Africa
|
289
|
650
|
||||||
Autoimmune FDA registrations
|
273
|
341
|
||||||
Uni-Gold antigen improvement
|
258
|
287
|
||||||
Premier Resolution
|
252
|
259
|
||||||
Brain Natriuretic Peptide (BNP) assay
|
-
|
2,904
|
||||||
Troponin I assay and reader
|
-
|
1,932
|
||||||
Cardiac analyser
|
-
|
1,056
|
||||||
Enhanced TPHA/CMV
|
-
|
810
|
||||||
Malaria Point-of-Care test
|
-
|
411
|
||||||
D-Dimer development
|
-
|
332
|
||||||
Other projects with spend less than US$250,000 in 2017
|
973
|
1,553
|
||||||
Total capitalised development costs
|
10,402
|
17,431
|
1 |
The Premier project entails the development of a High Performance Liquid Chromotography (HPLC) instrument for testing
haemoglobin A1c (HbA1c). A number of versions of the instrument are being developed including an Ion Exchange version (Premier Resolution). At December 31, 2017 this project had a total carrying amount of $22,955,000. Amortisation will occur over a 15 year period, commencing on commercialization of each version of the instrument.
|
13. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
(a) |
The Group only develops products within its field of expertise. The R&D team is experienced in developing new products in this field and this experience means that only products which have a high probability of technical success are put forward for consideration as potential new products.
|
(b) |
A technical feasibility study is undertaken in advance of every project. The feasibility study for each project is reviewed by the R&D team leader, and by other senior management depending on the size of the project. The feasibility study occurs in the initial research phase of the project and costs in this phase are not capitalised.
|
(c) |
Nearly all of our new product developments involve the transfer of our existing product know-how to a new application. The Group does not engage in pure research. Every development project is undertaken with the intention of bringing a particular new product to market for which there is a known demand.
|
(d) |
The commercial feasibility of each new product is established prior to commencement of a project by ensuring it is projected to achieve an acceptable income after applying appropriate discount rates.
|
13. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
|
US$’000
|
|||
Goodwill and other intangible assets (see note 13)
|
29,667
|
|||
Property, plant and equipment (see note 12)
|
10,437
|
|||
Prepayments (see note 17)
|
1,651
|
|||
|
||||
Total impairment loss
|
41,755
|
13. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
• |
In the event that there was a variation of 10% in the assumed level of future growth in revenues, which would represent a reasonably likely range of outcomes, there would be an additional impairment loss of US$835,000 at December 31, 2017.
|
• |
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$4,
786
,000 at December 31, 2017.
|
|
Fitzgerald Industries
|
|||||||
|
December 31,
2017 |
December 31,
2016 |
||||||
Carrying amount of goodwill (US$’000)
|
12,592
|
12,592
|
||||||
Discount rate applied (real pre-tax)
|
17.70
|
%
|
13.56
|
%
|
||||
Excess value-in-use over carrying amount (US$’000)
|
8,397
|
17,762
|
||||||
% EBITDA would need to decrease for an impairment to arise
|
30.4
|
%
|
46.8
|
%
|
||||
Long-term growth rate
|
2.0
|
%
|
2.0
|
%
|
13. |
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
|
Intangible Assets with Indefinite Useful lives
(included in other intangibles)
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
||||||
Fitzgerald Industries International CGU
|
||||||||
Fitzgerald trade name
|
970
|
970
|
||||||
RDI trade name
|
560
|
560
|
||||||
Primus Corporation CGU
|
||||||||
Primus trade name
|
670
|
670
|
||||||
Immco Diagnostic CGU
|
||||||||
Immco Diagnostic trade name
|
3,393
|
3,393
|
||||||
Total
|
5,593
|
5,593
|
14. |
DEFERRED TAX ASSETS AND LIABILITIES
|
|
Assets
|
Liabilities
|
Net
|
|||||||||||||||||||||
|
2017
US$’000 |
2016
US$’000 |
2017
US$’000 |
2016
US$’000 |
2017
US$’000 |
2016
US$’000 |
||||||||||||||||||
Property, plant and equipment
|
448
|
—
|
(98
|
)
|
(574
|
)
|
350
|
(574
|
)
|
|||||||||||||||
Intangible assets
|
—
|
—
|
(9,443
|
)
|
(16,430
|
)
|
(9,443
|
)
|
(16,430
|
)
|
||||||||||||||
Inventories
|
1,006
|
897
|
—
|
—
|
1,006
|
897
|
||||||||||||||||||
Provisions
|
3,510
|
5,701
|
—
|
—
|
3,510
|
5,701
|
||||||||||||||||||
Other items
|
2,109
|
2,035
|
(1,291
|
)
|
(1,357
|
)
|
818
|
678
|
||||||||||||||||
Tax value of loss carryforwards recognised
|
1,625
|
5,923
|
—
|
—
|
1,625
|
5,923
|
||||||||||||||||||
|
||||||||||||||||||||||||
Deferred tax assets/(liabilities)
|
8,698
|
14,556
|
(10,832
|
)
|
(18,361
|
)
|
(2,134
|
)
|
(3,805
|
)
|
14. |
DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED)
|
|
December 31,
2017 |
December 31,
2016 |
||||||
|
US$’000
|
US$’000
|
||||||
Capital losses
|
8,293
|
8,293
|
||||||
Net operating losses
|
61,264
|
23,630
|
||||||
US state credit carryforwards
|
345
|
277
|
||||||
|
||||||||
|
69,902
|
32,200
|
Movement in unrecognised deferred tax assets
|
Increase /
(decrease)
US$’000
|
Applicable
tax rate
%
|
Tax
effect
US$’000
|
|||||||||
US state credit carryforwards
|
68
|
n/a
|
68
|
|||||||||
Net operating losses Brazil
|
(2,100
|
)
|
34
|
%
|
(714
|
)
|
||||||
Net operating losses Ireland
|
39,734
|
12.5% -25
|
%
|
5,452
|
||||||||
|
||||||||||||
Total – continuing operations
|
37,702
|
4,806
|
14. |
DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED)
|
|
Balance
January, 1
2017 |
Recognised
in income |
Recognised
in loss on discontinued operations |
Foreign
Exchange movement |
Balance
December 31,
2017 |
|||||||||||||||
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||
Property, plant and equipment
|
(574
|
)
|
924
|
—
|
—
|
350
|
||||||||||||||
Intangible assets
|
(16,430
|
)
|
6,987
|
—
|
—
|
(9,443
|
)
|
|||||||||||||
Inventories
|
897
|
109
|
—
|
—
|
1,006
|
|||||||||||||||
Provisions
|
5,701
|
(2,191
|
)
|
—
|
—
|
3,510
|
||||||||||||||
Other items
|
678
|
140
|
—
|
—
|
818
|
|||||||||||||||
Tax value of loss carryforwards recognised
|
5,923
|
(4,298
|
)
|
—
|
—
|
1,625
|
||||||||||||||
|
||||||||||||||||||||
|
(3,805
|
)
|
1,671
|
—
|
—
|
(2,134
|
)
|
|
Balance
January, 1
2016 |
Recognised
in income |
Recognised
in loss on discontinued operations |
Foreign
Exchange movement |
Balance
December 31,
2016 |
|||||||||||||||
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
|||||||||||||||
Property, plant and equipment
|
(830
|
)
|
256
|
—
|
—
|
(574
|
)
|
|||||||||||||
Intangible assets
|
(22,319
|
)
|
(214
|
)
|
6,036
|
67
|
(16,430
|
)
|
||||||||||||
Inventories
|
1,015
|
(118
|
)
|
—
|
—
|
897
|
||||||||||||||
Provisions
|
2,960
|
2,741
|
—
|
—
|
5,701
|
|||||||||||||||
Other items
|
471
|
207
|
—
|
—
|
678
|
|||||||||||||||
Tax value of loss carryforwards recognised
|
6,676
|
396
|
(1,149
|
)
|
—
|
5,923
|
||||||||||||||
|
||||||||||||||||||||
|
(12,027
|
)
|
3,268
|
4,887
|
67
|
(3,805
|
)
|
15. |
OTHER ASSETS
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
||||||
Finance lease receivables (see Note 17)
|
685
|
788
|
||||||
Other assets
|
86
|
82
|
||||||
|
||||||||
|
771
|
870
|
16. |
INVENTORIES
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
||||||
Raw materials and consumables
|
10,345
|
9,176
|
||||||
Work-in-progress
|
7,236
|
7,288
|
||||||
Finished goods
|
15,224
|
16,125
|
||||||
|
||||||||
|
32,805
|
32,589
|
|
December 31,
2017
US$‘000
|
December 31,
2016
US$‘000
|
December 31,
2015
US$‘000
|
|||||||||
Opening provision at January 1
|
10,017
|
4,822
|
4,636
|
|||||||||
Charged during the year
|
2,561
|
6,390
|
892
|
|||||||||
Utilised during the year
|
(4,749
|
)
|
(1,065
|
)
|
(666
|
)
|
||||||
Released during the year
|
(286
|
)
|
(130
|
)
|
(40
|
)
|
||||||
|
||||||||||||
Closing provision at December 31
|
7,543
|
10,017
|
4,822
|
17. |
TRADE AND OTHER RECEIVABLES
|
|
December 31,
2017
US$‘000
|
December 31,
2016
US$‘000
|
||||||
Trade receivables, net of impairment losses
|
17,242
|
18,340
|
||||||
Prepayments
|
2,998
|
3,634
|
||||||
Value added tax
|
-
|
69
|
||||||
Finance lease receivables
|
500
|
542
|
||||||
|
||||||||
|
20,740
|
22,585
|
17. |
TRADE AND OTHER RECEIVABLES (CONTINUED)
|
|
December 31, 2017
US$‘000
|
|||||||||||
|
Gross
investment
|
Unearned
income
|
Minimum
payments
receivable
|
|||||||||
Less than one year
|
860
|
360
|
500
|
|||||||||
Between one and five years (Note 15)
|
1,204
|
519
|
685
|
|||||||||
|
||||||||||||
|
2,064
|
879
|
1,185
|
|
December 31, 2016
US$‘000
|
|||||||||||
|
Gross
investment
|
Unearned
income
|
Minimum
payments
receivable
|
|||||||||
Less than one year
|
949
|
407
|
542
|
|||||||||
Between one and five years (Note 15)
|
1,388
|
600
|
788
|
|||||||||
|
||||||||||||
|
2,337
|
1,007
|
1,330
|
December 31, 2017
US$‘000
|
||||||||
|
Instruments
|
Total
|
||||||
Less than one year
|
3,959
|
3,959
|
||||||
Between one and five years
|
90
|
90
|
||||||
|
||||||||
|
4,049
|
4,049
|
December 31, 2016
US$‘000
|
||||||||
|
Instruments
|
Total
|
||||||
Less than one year
|
3,671
|
3,671
|
||||||
Between one and five years
|
184
|
184
|
||||||
|
||||||||
|
3,855
|
3,855
|
18. |
CASH AND CASH EQUIVALENTS
|
|
December 31, 2017
US$’000
|
December 31, 2016
US$’000
|
||||||
Cash at bank and in hand
|
9,561
|
9,845
|
||||||
Short-term deposits
|
14,003
|
67,264
|
||||||
|
||||||||
Cash and cash equivalents
|
23,564
|
77,109
|
19. |
SHORT-TERM INVESTMENTS
|
|
December 31, 2017
US$’000
|
December 31, 2016
US$’000
|
||||||
Investments (deposits)
|
34,043
|
-
|
20. |
CAPITAL AND RESERVES
|
|
Class ‘A’
Ordinary shares |
Class ‘A’
Ordinary shares |
||||||
In thousands of shares
|
2017
|
2016
|
||||||
In issue at January 1
|
96,162
|
95,840
|
||||||
Issued for cash
|
-
|
322
|
||||||
|
||||||||
In issue at December 31
|
96,162
|
96,162
|
|
ADS
|
ADS
|
||||||
In thousands of ADSs
|
2017
|
2016
|
||||||
Balance at January 1
|
24,041
|
23,960
|
||||||
Issued for cash
|
-
|
81
|
||||||
|
||||||||
Balance at December 31
|
24,041
|
24,041
|
|
Class ‘A’
Treasury shares |
Class ‘A’
Treasury shares |
||||||
In thousands of shares
|
2017
|
2016
|
||||||
Balance at January 1
|
7,073
|
2,635
|
||||||
Purchased during the year
|
5,375
|
4,438
|
||||||
|
||||||||
Balance at December 31
|
12,448
|
7,073
|
|
ADS
Treasury shares
|
ADS
Treasury shares |
||||||
In thousands of ADSs
|
2017
|
2016
|
||||||
Balance at January 1
|
1,768
|
659
|
||||||
Purchased during the year
|
1,344
|
1,109
|
||||||
|
||||||||
Balance at December 31
|
3,112
|
1,768
|
20. |
CAPITAL AND RESERVES (CONTINUED)
|
(a) |
During 2017, the Group did not issue any shares from the exercise of employee options (2016: 322,272 ‘A’ Ordinary shares were issued from the exercise of employee options for a consideration of US$673,000 settled in cash). During 2016, the Group incurred costs of US$8,000 in connection with the issue of shares. At December 31, 2017, there were no amounts receivable on issuance share capital (2016: US$nil) relating to the exercise of share options.
|
(b) |
During 2017, the Group repurchased 5,374,692 'A' ordinary shares (1,343,673 ADS's) under its share buyback program.
(2016: 4,437,740 'A' ordinary shares or 1,109,435 ADS's).
|
(c) |
There were no dividends paid during 2017 in respect of the 2016 financial year, (nil in respect of the 2015 financial year), (22 cents per ADS in respect of the 2014 financial year). As provided in the Articles of Association of the Company, dividends or other distributions are declared and paid in US Dollars.
|
21. |
SHARE OPTIONS AND SHARE WARRANTS
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
|
Options and
warrants |
Weighted-
average exercise price
US$
|
Range
US$
|
|||||||||
|
‘A’ Ordinary
Shares |
Per ‘A’ Ordinary
Share
|
Per ‘A’ Ordinary
Share |
|||||||||
Outstanding January 1, 2015
|
9,291,652
|
3.20
|
0.66 –4.79
|
|||||||||
Granted
|
976,000
|
3.20
|
2.71 –4.47
|
|||||||||
Exercised
|
(1,602,000
|
)
|
1.95
|
1.07 –4.21
|
||||||||
Forfeited
|
(507,200
|
)
|
3.96
|
2.50 –4.79
|
||||||||
|
||||||||||||
Outstanding at end of year
|
8,158,452
|
3.36
|
0.66 –4.47
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
4,679,323
|
3.03
|
0.66 –4.23
|
|||||||||
|
||||||||||||
Outstanding January 1, 2016
|
8,158,452
|
3.36
|
0.66 –4.47
|
|||||||||
Granted
|
2,160,000
|
2.39
|
1.67 –2.80
|
|||||||||
Exercised
|
(322,272
|
)
|
2.09
|
0.66 –2.65
|
||||||||
Forfeited
|
(165,997
|
)
|
3.39
|
2.52 –3.61
|
||||||||
|
||||||||||||
Outstanding at end of year
|
9,830,183
|
3.19
|
0.66 –4.47
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
5,838,851
|
3.31
|
0.75 –4.23
|
|||||||||
|
||||||||||||
Outstanding January 1, 2017
|
9,830,183
|
3.19
|
0.66 –4.47
|
|||||||||
Granted
|
5,630,000
|
1.31
|
1.24 –1.44
|
|||||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Forfeited
|
(4,732,807
|
)
|
3.86
|
0.75 –4.47
|
||||||||
|
||||||||||||
Outstanding at end of year
|
10,727,376
|
1.92
|
1.24 –4.36
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
3,268,707
|
2.57
|
1.66 –4.36
|
|
Options and
warrants |
Weighted-
average exercise price
US$
|
Range
US$
|
|||||||||
|
‘ADS’ Equivalent
|
Per ‘ADS’
|
Per ‘ADS’
|
|||||||||
Outstanding January 1, 2015
|
2,322,913
|
12.80
|
2.63 –19.15
|
|||||||||
Granted
|
244,000
|
12.80
|
10.84 –17.88
|
|||||||||
Exercised
|
(400,500
|
)
|
7.80
|
4.28 –16.84
|
||||||||
Forfeited
|
(126,800
|
)
|
15.84
|
10.00 –19.16
|
||||||||
|
||||||||||||
Outstanding at end of year
|
2,039,613
|
13.44
|
2.63 –17.88
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
1,169,831
|
12.12
|
2.63 –16.92
|
|||||||||
|
||||||||||||
Outstanding January 1, 2016
|
2,039,613
|
13.44
|
2.63 –17.88
|
|||||||||
Granted
|
540,000
|
9.57
|
6.69 –11.20
|
|||||||||
Exercised
|
(80,568
|
)
|
8.35
|
2.64 –10.61
|
||||||||
Forfeited
|
(41,499
|
)
|
13.58
|
10.08 –14.44
|
||||||||
|
||||||||||||
Outstanding at end of year
|
2,457,546
|
13.43
|
2.64 –17.88
|
|||||||||
|
||||||||||||
Exercisable at end of year
|
1,459,713
|
13.24
|
3.00 –16.92
|
|||||||||
|
||||||||||||
Outstanding January 1, 2017
|
2,457,546
|
12.74
|
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
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
|
Outstanding
|
Exercisable
|
||||||||||||||||||||||
Exercise price range
|
No. of
options ‘A’ ordinary shares |
Weighted–
average exercise price |
Weighted-
average contractual life remaining (years) |
No. of
options ‘A’ ordinary shares |
Weighted–
average exercise price |
Weighted-
average contractual life remaining (years) |
||||||||||||||||||
US$1.00-US$2.05
|
6,075,644
|
1.38
|
6.52
|
215,652
|
1.69
|
2.57
|
||||||||||||||||||
US$2.06- US$2.99
|
4,333,732
|
2.52
|
3.20
|
2,861,061
|
2.53
|
2.20
|
||||||||||||||||||
US$3.00 -US$4.47
|
318,000
|
4.21
|
3.95
|
192,002
|
4.21
|
3.92
|
||||||||||||||||||
|
||||||||||||||||||||||||
|
10,727,376
|
3,268,715
|
|
Outstanding
|
Exercisable
|
||||||||||||||||||||||
Exercise price range
|
No. of
options ‘ADS equivalent’ |
Weighted–
average exercise price |
Weighted-
average contractual life remaining (years) |
No. of
options ‘ADS equivalent’ |
Weighted–
average exercise price |
Weighted-
average contractual life remaining (years) |
||||||||||||||||||
US$4.00-US$8.20
|
1,518,911
|
5.52
|
6.52
|
53,913
|
6.76
|
2.57
|
||||||||||||||||||
US$8.24- US$11.96
|
1,083,433
|
10.08
|
3.20
|
715,265
|
10.12
|
2.20
|
||||||||||||||||||
US$12.00 -US$17.88
|
79,500
|
16.84
|
3.95
|
48,001
|
16.84
|
3.92
|
||||||||||||||||||
|
||||||||||||||||||||||||
|
2,681,844
|
817,179
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
|
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
|
14,000
|
0.80
|
1.70
|
14,000
|
0.80
|
1.70
|
||||||||||||||||||
US$1.00-US$2.05
|
801,652
|
1.63
|
2.71
|
571,652
|
1.59
|
1.01
|
||||||||||||||||||
US$2.06- US$2.99
|
4,776,531
|
2.54
|
4.29
|
2,230,534
|
2.54
|
2.20
|
||||||||||||||||||
US$3.00 -US$4.47
|
4,238,000
|
4.22
|
4.21
|
3,022,665
|
4.21
|
3.89
|
||||||||||||||||||
|
||||||||||||||||||||||||
|
9,830,183
|
5,838,851
|
|
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$2.63-US$3.96
|
3,500
|
3.20
|
1.70
|
3,500
|
3.20
|
1.70
|
||||||||||||||||||
US$4.00-US$8.20
|
200,413
|
6.52
|
2.71
|
142,913
|
6.36
|
1.01
|
||||||||||||||||||
US$8.24- US$11.96
|
1,194,133
|
10.16
|
4.29
|
557,634
|
10.16
|
2.20
|
||||||||||||||||||
US$12.00 -US$17.88
|
1,059,500
|
16.88
|
4.21
|
755,666
|
16.84
|
3.89
|
||||||||||||||||||
|
||||||||||||||||||||||||
|
2,457,546
|
1,459,713
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
|
December 31,
2017
US$‘000
|
December 31,
2016
US$‘000
|
December 31,
2015
US$‘000
|
|||||||||
Share-based payments – cost of sales
|
35
|
32
|
9
|
|||||||||
Share-based payments – selling, general and administrative
|
893
|
1,349
|
1,541
|
|||||||||
|
||||||||||||
Total – continuing operations
|
928
|
1,381
|
1,550
|
|||||||||
Share-based payments – discontinued operations
|
-
|
33
|
—
|
|||||||||
|
||||||||||||
Total
|
928
|
1,414
|
1,550
|
|
Key
management personnel |
Other
employees |
Key
management personnel |
Other
employees |
Key
management personnel |
Other
employees |
|||||
|
2017
|
2017
|
2016
|
2016
|
2015
|
2015
|
|||||
Weighted average fair value at measurement date per ‘A’ share / (per ADS)
|
US$0.43 /
(US$1.72)
|
US$0.44 /
(US$1.76)
|
US$0.58 /
(US$2.32)
|
US$0.57 /
(US$2.28)
|
Nil
|
US$0.68 /
(US$2.72)
|
|||||
Total ‘A’ share options granted / (ADS’s equivalent)
|
5,150,000 /
(1,287,500) |
480,000 /
(120,000)
|
1,700,000 /
(425,000) |
460,000 /
(115,000)
|
Nil
|
976,000 /
(244,000)
|
|||||
Weighted average share price per ‘A’ share / (per ADS)
|
US$1.34 /
(US$5.36) |
US$1.31 /
(US$5.24) |
US$2.43 /
(US$9.72) |
US$2.25 /
(US$9.00) |
Nil
|
US$3.20 /
(US$12.80) |
|||||
Weighted average exercise price per ‘A’ share / (per ADS)
|
US$1.34 /
(US$5.36) |
US$1.31 /
(US$5.24) |
US$2.43 /
(US$9.72) |
US$2.25 /
(US$9.00) |
Nil
|
US$3.20 /
(US$12.80) |
|||||
Weighted average expected volatility
|
40.62%
|
40.48%
|
29.63%
|
36.73%
|
Nil
|
29.27%
|
|||||
Weighted average expected life
|
4.45
|
4.69
|
4.81
|
3.74
|
Nil
|
3.73
|
|||||
Weighted average risk free interest rate
|
1.59%
|
1.91%
|
1.21%
|
1.29%
|
Nil
|
1.46%
|
|||||
Expected dividend yield
|
0.81%
|
0.81%
|
1.14%
|
0.96%
|
Nil
|
1.14%
|
21. |
SHARE OPTIONS AND SHARE WARRANTS (CONTINUED)
|
22. |
TRADE AND OTHER PAYABLES
|
|
December 31, 2017
US$’000
|
December 31, 2016
US$’000
|
||||||
Trade payables
|
8,045
|
9,017
|
||||||
Payroll taxes
|
423
|
489
|
||||||
Employee related social insurance
|
151
|
416
|
||||||
Accrued liabilities
|
11,618
|
10,877
|
||||||
Deferred income
|
278
|
224
|
||||||
Restructuring accrual
|
-
|
3,734
|
||||||
|
||||||||
|
20,515
|
24,757
|
23. |
PROVISIONS
|
|
December 31, 2017
US$’000
|
December 31, 2016
US$’000
|
||||||
Provisions
|
50
|
75
|
24. |
BORROWINGS
|
|
December 31,
2017
US$’000
|
December 31,
2016
US$’000
|
||||||
Non-current assets
|
||||||||
Exchangeable note bond call option
|
360
|
—
|
||||||
|
||||||||
Non-current liabilities
|
||||||||
Exchangeable note equity conversion option
|
440
|
3,970
|
||||||
Exchangeable note bond put option
|
1,790
|
290
|
||||||
|
||||||||
|
2,230
|
4,260
|
||||||
|
||||||||
Total value of embedded derivatives – net liability
|
1,870
|
4,260
|
|
December 31,
2017
US$’000
|
December 31,
2016
US$’000
|
||||||
Balance at 1 January
|
92,232
|
91,514
|
||||||
Accretion interest
|
723
|
718
|
||||||
|
||||||||
|
92,955
|
92,232
|
|
December 31,
2017
US$’000
|
December 31,
2016
US$’000
|
||||||
Exchangeable senior notes
|
92,955
|
92,232
|
||||||
Total value of embedded derivatives – liability
|
2,230
|
4,260
|
||||||
|
||||||||
Total non-current liabilities
|
95,185
|
96,492
|
25. |
FINANCE LEASE LIABILITIES
|
|
December 31, 2017
US$’000
|
December 31, 2016
US$’000
|
||||||
Current liabilities
|
||||||||
Finance lease liabilities
|
354
|
273
|
||||||
|
||||||||
|
354
|
273
|
||||||
|
||||||||
Non-current liabilities
|
532
|
732
|
||||||
|
||||||||
Finance lease liabilities
|
532
|
732
|
Facility
|
Currency
|
Nominal
interest
rate |
Year of
maturity
|
Fair
Value
|
Carrying
Value
|
|||||||||||||
Finance lease liabilities
|
Euro
|
4.54
|
%
|
2020
|
835
|
835
|
||||||||||||
Finance lease liabilities
|
USD
|
5.51
|
%
|
2019
|
51
|
51
|
||||||||||||
|
|
|||||||||||||||||
Total interest-bearing loans and borrowings
|
|
886
|
886
|
25. |
FINANCE LEASE LIABILITIES (CONTINUED)
|
Facility
|
Currency
|
Nominal
interest
rate |
Year of
maturity
|
Fair
Value
|
Carrying
Value
|
|||||||||||||
Finance lease liabilities
|
Euro
|
4.54
|
%
|
2020
|
1,005
|
1,005
|
||||||||||||
|
|
|||||||||||||||||
Total interest-bearing loans and borrowings
|
|
1,005
|
1,005
|
26. |
COMMITMENTS AND CONTINGENCIES
|
(a) |
Capital Commitments
|
(b) |
Leasing Commitments
|
26. |
COMMITMENTS AND CONTINGENCIES (CONTINUED)
|
(c) |
Bank Security
|
(d) |
Group Company Guarantees
|
(e) |
Government Grant Contingencies
|
(f) |
Litigation
|
(g)
|
Licence Agreement Dispute
|
27. |
RELATED PARTY TRANSACTIONS
|
|
December 31, 2017
|
December 31, 2016
|
||||||
|
US$’000
|
US$’000
|
||||||
Short-term employee benefits
|
1,177
|
1,298
|
||||||
Performance related bonus
|
223
|
248
|
||||||
Post-employment benefits
|
44
|
41
|
||||||
Share-based compensation benefits
|
663
|
1,114
|
||||||
|
||||||||
|
2,107
|
2,701
|
27. |
RELATED PARTY TRANSACTIONS (CONTINUED)
|
|
‘A’ Ordinary Shares
|
Share options
|
||||||
At January 1, 2017
|
5,719,706
|
7,655,004
|
||||||
Exercised
|
—
|
—
|
||||||
Granted
|
—
|
5,150,000
|
||||||
Expired
|
—
|
(315,000
|
)
|
|||||
Forfeited
|
—
|
(3,720,000
|
)
|
|||||
|
||||||||
At December 31, 2017
|
5,719,706
|
8,770,004
|
|
‘A’ Ordinary Shares
|
Share options
|
||||||
At January 1, 2016
|
5,695,306
|
6,015,004
|
||||||
Exercised
|
—
|
(60,000
|
)
|
|||||
Granted
|
—
|
1,700,000
|
||||||
Shares purchased during the year
|
24,400
|
—
|
||||||
|
||||||||
At December 31, 2016
|
5,719,706
|
7,655,004
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS
|
As at December 31, 2017
|
Note
|
Effective
interest
rate |
Total
US$’000
|
6 mths or less
US$’000
|
6 –12 mths
US$’000
|
1-2 years
US$’000
|
2-5 years
US$’000
|
> 5 years
US$’000
|
||||||||||||||||||||||||
Cash and cash equivalents
|
18
|
1.4
|
%
|
23,564
|
23,564
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||
Short-term investments
|
19
|
1.4
|
%
|
34,043
|
—
|
34,043
|
—
|
—
|
—
|
|||||||||||||||||||||||
Finance lease receivable
|
17
|
4.0
|
%
|
1,185
|
267
|
233
|
333
|
352
|
—
|
|||||||||||||||||||||||
Licence payments
|
22
|
3.0
|
%
|
(1,112
|
)
|
(1,112
|
)
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Finance lease payable
|
25
|
4.6
|
%
|
(886
|
)
|
(176
|
)
|
(178
|
)
|
(364
|
)
|
(168
|
)
|
—
|
||||||||||||||||||
Exchangeable note
|
24
|
4.8
|
%
|
(92,955
|
)
|
—
|
—
|
—
|
—
|
(92,955
|
)
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total
|
(36,161
|
)
|
22,543
|
34,098
|
(31
|
)
|
184
|
(92,955
|
)
|
|||||||||||||||||||||||
As at December 31, 2016
|
Note
|
Effective
interest rate |
Total
US$’000
|
6 mths or less
US$’000
|
6 –12 mths
US$’000
|
1-2 years
US$’000
|
2-5 years
US$’000
|
> 5 years
US$’000
|
||||||||||||||||||||||||
Cash and cash equivalents
|
18
|
0.8
|
%
|
77,109
|
77,109
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||
Finance lease receivable
|
17
|
4.1
|
%
|
1,330
|
289
|
253
|
392
|
396
|
—
|
|||||||||||||||||||||||
Licence payments
|
22
|
3.0
|
%
|
(2,195
|
)
|
(1,112
|
)
|
(1,083
|
)
|
—
|
—
|
—
|
||||||||||||||||||||
Finance lease payable
|
25
|
4.5
|
%
|
(1,005
|
)
|
(135
|
)
|
(138
|
)
|
(286
|
)
|
(446
|
)
|
—
|
||||||||||||||||||
Exchangeable note
|
24
|
4.8
|
%
|
(92,232
|
)
|
—
|
—
|
—
|
—
|
(92,232
|
)
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Total
|
(16,993
|
)
|
76,151
|
(968
|
)
|
106
|
(50
|
)
|
(92,232
|
)
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
December 31, 2017
US$‘000
|
December 31, 2016
US$‘000
|
||||||
Fixed rate instruments
|
||||||||
Fixed rate financial liabilities (licence fees)
|
(1,112
|
)
|
(2,195
|
)
|
||||
Fixed rate financial liabilities (exchangeable note)
|
(92,955
|
)
|
(92,232
|
)
|
||||
Fixed rate financial liabilities (finance lease payables)
|
(886
|
)
|
(1,005
|
)
|
||||
Financial assets (short-term deposits and short-term investments)
|
48,046
|
67,265
|
||||||
Financial assets (finance lease receivables)
|
1,185
|
1,330
|
||||||
Variable rate instruments
|
||||||||
Financial assets (cash and short-term deposits)
|
9,561
|
9,844
|
||||||
|
||||||||
|
(36,161
|
)
|
(16,993
|
)
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
As at December 31, 2017
US$’000
|
Carrying
amount
US$’000
|
Contractual
cash flows
US$’000
|
6 mths or
less
US$’000
|
6 mths –
12 mths
US$’000
|
1-2 years
US$’000
|
2-5 years
US$’000
|
>5 years
US$’000
|
|||||||||||||||||||||
Financial liabilities
|
||||||||||||||||||||||||||||
Trade & other payables
|
20,515
|
20,515
|
20,515
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Exchangeable notes
|
92,955
|
115,000
|
—
|
—
|
—
|
—
|
115,000
|
|||||||||||||||||||||
Exchangeable note interest
|
1,150
|
126,500
|
2,300
|
2,300
|
4,600
|
13,800
|
103,500
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
114,620
|
262,015
|
22,815
|
2,300
|
4,600
|
13,800
|
218,500
|
As at December 31, 2016
US$’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$’000
|
|||||||||||||||||||||
Financial liabilities
|
||||||||||||||||||||||||||||
Trade & other payables
|
23,607
|
23,607
|
22,524
|
1,083
|
—
|
—
|
—
|
|||||||||||||||||||||
Exchangeable notes
|
92,232
|
115,000
|
—
|
—
|
—
|
—
|
115,000
|
|||||||||||||||||||||
Exchangeable note interest
|
1,150
|
131,100
|
2,300
|
2,300
|
4,600
|
13,800
|
108,100
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
116,989
|
269,707
|
24,824
|
3,383
|
4,600
|
13,800
|
223,100
|
EUR
|
GBP
|
SEK
|
CAD
|
BRL
|
Other
|
|||||||||||||||||||
As at December 31, 2017
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
||||||||||||||||||
Cash
|
235
|
443
|
5
|
2,107
|
443
|
16
|
||||||||||||||||||
Trade and other receivable
|
1,396
|
101
|
298
|
1,958
|
6
|
|||||||||||||||||||
Trade and other payables
|
(1,936
|
)
|
(16
|
)
|
(239
|
)
|
(86
|
)
|
(2,235
|
)
|
—
|
|||||||||||||
|
||||||||||||||||||||||||
Total exposure
|
(305
|
)
|
528
|
(234
|
)
|
2,319
|
166
|
22
|
||||||||||||||||
|
||||||||||||||||||||||||
As at December 31, 2016
|
EUR
|
GBP
|
SEK
|
CAD
|
BRL
|
Other
|
||||||||||||||||||
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
US$‘000
|
|||||||||||||||||||
Cash
|
214
|
520
|
46
|
845
|
371
|
7
|
||||||||||||||||||
Trade and other receivable
|
852
|
157
|
68
|
414
|
1,103
|
—
|
||||||||||||||||||
Trade and other payables
|
(1,983
|
)
|
(29
|
)
|
(4,528
|
)
|
(85
|
)
|
(1,976
|
)
|
—
|
|||||||||||||
|
||||||||||||||||||||||||
Total exposure
|
(917
|
)
|
648
|
(4,414
|
)
|
1,174
|
(502
|
)
|
7
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
Profit or loss
US$’000
|
|||
December 31, 2017
|
||||
Euro
|
2,158
|
|||
December 31, 2016
|
||||
Euro
|
1,093
|
|
Profit or loss
US$’000
|
|||
December 31, 2017
|
||||
Euro
|
(2,637
|
)
|
||
December 31, 2016
|
||||
Euro
|
(1,336
|
)
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
Carrying Value
December 31, 2017
US$’000
|
Carrying Value
December 31, 2016
US$’000
|
||||||
Third party trade receivables (Note 17)
|
17,242
|
18,340
|
||||||
Finance lease income receivable (Note 17)
|
1,185
|
1,330
|
||||||
Cash & cash equivalents (Note 18)
|
23,564
|
77,109
|
||||||
Short-term investments (Note 19)
|
34,043
|
—
|
||||||
|
||||||||
|
76,034
|
96,779
|
|
Carrying Value
December 31, 2017 US$’000 |
Carrying Value
December 31, 2016
US$’000
|
||||||
United States
|
8,682
|
10,201
|
||||||
Euro-zone countries
|
1,789
|
1,645
|
||||||
United Kingdom
|
185
|
252
|
||||||
Other European countries
|
21
|
10
|
||||||
Other regions
|
7,750
|
7,562
|
||||||
|
||||||||
|
18,427
|
19,670
|
|
Carrying Value
December 31, 2017
US$’000
|
Carrying Value
December 31, 2016
US$’000
|
||||||
End-user customers
|
8,200
|
11,882
|
||||||
Distributors
|
10,003
|
7,127
|
||||||
Non-governmental organisations
|
224
|
661
|
||||||
|
||||||||
|
18,427
|
19,670
|
|
Gross
|
Impairment
|
Gross
|
Impairment
|
||||||||||||
|
2017
|
2017
|
2016
|
2016
|
||||||||||||
|
US$’000
|
US$’000
|
US$’000
|
US$’000
|
||||||||||||
Not past due
|
10,770
|
—
|
12,275
|
—
|
||||||||||||
Past due 0-30 days
|
3,190
|
31
|
2,741
|
8
|
||||||||||||
Past due 31-120 days
|
1,906
|
50
|
1,807
|
67
|
||||||||||||
Greater than 120 days
|
4,966
|
3,509
|
4,688
|
3,096
|
||||||||||||
|
||||||||||||||||
|
20,832
|
3,590
|
21,511
|
3,171
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
2017
|
2016
|
2015
|
|||||||||
|
US$’000
|
US$’000
|
US$’000
|
|||||||||
Balance at January 1
|
3,171
|
2,812
|
2,205
|
|||||||||
Charged to costs and expenses
|
662
|
415
|
780
|
|||||||||
Amounts written off during the year
|
(243
|
)
|
(56
|
)
|
(173
|
)
|
||||||
|
||||||||||||
Balance at December 31
|
3,590
|
3,171
|
2,812
|
• |
the aggregate nominal value of the shares authorised to be acquired shall not exceed 10% of the aggregate nominal value of the issued share capital of the Company at the close of business on the date of the passing of the resolution:
|
• |
the minimum price (exclusive of taxes and expenses) which may be paid for a share shall be the nominal value of that share:
|
• |
the maximum price (exclusive of taxes and expenses) which may be paid for a share shall not be more than the average of the closing bid price on NASDAQ in respect of the ten business days immediately preceding the day on which the share is purchased.
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
Level 1
|
Level 2
|
Total
carrying
amount
|
Fair
Value
|
||||||||||||||||
|
Note
|
US$'000
|
US$'000
|
US$'000
|
US$'000
|
|||||||||||||||
December 31, 2017
|
||||||||||||||||||||
Loans and receivables
|
||||||||||||||||||||
Trade receivables
|
17
|
17,242
|
—
|
17,242
|
17,242
|
|||||||||||||||
Cash and cash equivalents
|
18
|
23,564
|
—
|
23,564
|
23,564
|
|||||||||||||||
Short-term investments
|
19
|
34,043
|
—
|
34,043
|
34,043
|
|||||||||||||||
Finance lease receivable
|
15,17
|
1,185
|
—
|
1,185
|
1,185
|
|||||||||||||||
|
||||||||||||||||||||
|
76,034
|
—
|
76,034
|
76,034
|
||||||||||||||||
|
||||||||||||||||||||
Liabilities at amortised cost
|
||||||||||||||||||||
Exchangeable note
|
24
|
—
|
(92,955
|
)
|
(92,955
|
)
|
(92,955
|
)
|
||||||||||||
Finance lease payable
|
25
|
(886
|
)
|
—
|
(886
|
)
|
(886
|
)
|
||||||||||||
Trade and other payables (excluding deferred income)
|
22
|
(20,237
|
)
|
—
|
(20,237
|
)
|
(20,237
|
)
|
||||||||||||
Provisions
|
23
|
(50
|
)
|
—
|
(50
|
)
|
(50
|
)
|
||||||||||||
|
||||||||||||||||||||
|
(21,173
|
)
|
(92,955
|
)
|
(114,128
|
)
|
(114,128
|
)
|
||||||||||||
|
||||||||||||||||||||
Fair value through profit and loss (FVPL)
|
||||||||||||||||||||
Exchangeable note bond call option
|
24
|
—
|
360
|
360
|
360
|
|||||||||||||||
Exchangeable note equity conversion option
|
24
|
—
|
(440
|
)
|
(440
|
)
|
(440
|
)
|
||||||||||||
Exchangeable note bond put option
|
24
|
—
|
(1,790
|
)
|
(1,790
|
)
|
(1,790
|
)
|
||||||||||||
|
||||||||||||||||||||
|
—
|
(1,870
|
)
|
(1,870
|
)
|
(1,870
|
)
|
|||||||||||||
|
||||||||||||||||||||
|
54,861
|
(94,825
|
)
|
(39,964
|
)
|
(39,964
|
)
|
28. |
DERIVATIVES AND FINANCIAL INSTRUMENTS (CONTINUED)
|
|
Note
|
Level 1
US$'000 |
Level 2
US$'000 |
Total
carrying amount US$'000 |
Fair
Value
US$'000
|
|||||||||||||||
December 31, 2016
|
||||||||||||||||||||
Loans and receivables
|
||||||||||||||||||||
Trade receivables
|
17
|
18,340
|
—
|
18,340
|
18,340
|
|||||||||||||||
Cash and cash equivalents
|
18
|
77,109
|
—
|
77,109
|
77,109
|
|||||||||||||||
Finance lease receivable
|
15,17
|
1,330
|
—
|
1,330
|
1,330
|
|||||||||||||||
|
||||||||||||||||||||
|
96,779
|
—
|
96,779
|
96,779
|
||||||||||||||||
|
||||||||||||||||||||
Liabilities at amortised cost
|
||||||||||||||||||||
Exchangeable note
|
24
|
—
|
(92,232
|
)
|
(92,232
|
)
|
(92,232
|
)
|
||||||||||||
Finance lease payable
|
25
|
(1,005
|
)
|
—
|
(1,005
|
)
|
(1,005
|
)
|
||||||||||||
Trade and other payables (excluding deferred income)
|
22
|
(24,533
|
)
|
—
|
(24,533
|
)
|
(24,533
|
)
|
||||||||||||
Provisions
|
23
|
(75
|
)
|
—
|
(75
|
)
|
(75
|
)
|
||||||||||||
|
||||||||||||||||||||
|
(25,613
|
)
|
(92,232
|
)
|
(117,845
|
)
|
(117,845
|
)
|
||||||||||||
|
||||||||||||||||||||
Fair value through profit and loss (FVPL)
|
||||||||||||||||||||
Exchangeable note bond call option
|
24
|
—
|
—
|
—
|
—
|
|||||||||||||||
Exchangeable note equity conversion option
|
24
|
—
|
(3,970
|
)
|
(3,970
|
)
|
(3,970
|
)
|
||||||||||||
Exchangeable note bond put option
|
24
|
—
|
(290
|
)
|
(290
|
)
|
(290
|
)
|
||||||||||||
|
||||||||||||||||||||
|
—
|
(4,260
|
)
|
(4,260
|
)
|
(4,260
|
)
|
|||||||||||||
|
||||||||||||||||||||
|
71,166
|
(96,492
|
)
|
(25,326
|
)
|
(25,326
|
)
|
29. |
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES
|
|
Note
|
Borrowings & derivative financial instruments
US$’000 |
Short-term lease liabilities
US$’000 |
Long-term lease liabilities
US$’000 |
||||||||||||
Balance at 1 January 2017
|
24,25
|
96,492
|
273
|
732
|
||||||||||||
Cash-flows:
|
||||||||||||||||
Interest paid
|
(4,600
|
)
|
—
|
—
|
||||||||||||
Repayment
|
—
|
(295
|
)
|
—
|
||||||||||||
Proceeds
|
—
|
28
|
24
|
|||||||||||||
Non-cash:
|
||||||||||||||||
Interest charged
|
4,600
|
—
|
—
|
|||||||||||||
Exchange adjustment
|
—
|
53
|
71
|
|||||||||||||
Accretion interest
|
723
|
—
|
—
|
|||||||||||||
Fair value
|
(2,030
|
)
|
—
|
—
|
||||||||||||
Reclassification
|
—
|
295
|
(295
|
)
|
||||||||||||
|
||||||||||||||||
Balance at 31 December 2017
|
24,25
|
98,185
|
354
|
532
|
|
Note
|
Borrowings & derivative financial instruments
US$’000 |
Short-term lease liabilities
US$’000 |
Long-term lease liabilities
US$’000 |
||||||||||||
Balance at 1 January 2016
|
102,734
|
271
|
1,042
|
|||||||||||||
Cash-flows:
|
||||||||||||||||
Interest paid
|
(4,600
|
)
|
—
|
—
|
||||||||||||
Repayment
|
—
|
(282
|
)
|
—
|
||||||||||||
Non-cash:
|
||||||||||||||||
Interest charged
|
4,600
|
—
|
—
|
|||||||||||||
Exchange adjustment
|
—
|
(5
|
)
|
(21
|
)
|
|||||||||||
Accretion interest
|
718
|
—
|
—
|
|||||||||||||
Fair value
|
(6,960
|
)
|
—
|
—
|
||||||||||||
Reclassification
|
—
|
289
|
(289
|
)
|
||||||||||||
|
||||||||||||||||
Balance at 31 December 2016
|
24,25
|
96,492
|
273
|
732
|
30. |
POST BALANCE SHEET EVENTS
|
• |
The entity’s operations in future financial years;
|
• |
The results of those operations in future financial years; or
|
• |
The entity’s state of affairs in future financial years.
|
31. |
ACCOUNTING ESTIMATES AND JUDGEMENTS
|
31. |
ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED)
|
• |
Significant underperformance relative to expected historical or projected future operating results;
|
• |
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;
|
• |
Obsolescence of products;
|
• |
Significant decline in our stock price for a sustained period; and
|
• |
Our market capitalisation relative to net book value.
|
31. |
ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED)
|
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 75
th
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
Rua Claudio Soares
Sao Paulo
Brazil
|
Sale of diagnostic test
kits |
Brazil
|
100%
|
|||
Trinity Biotech (UK) Ltd
184 Cambridge Science Park
Cambridge CB4 0GA
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
(Incorporated
March 20, 2015) |
100%
|
33. |
AUTHORISATION FOR ISSUE
|
TRINITY BIOTECH PLC
|
|||
By
|
/s/ RONAN O’CAOIMH
|
||
|
Mr Ronan O’Caoimh
|
||
|
Director/
|
||
|
Chief Executive Officer
|
||
|
Date: April 20, 2018
|
||
By:
|
/s/ KEVIN TANSLEY
|
||
|
Mr Kevin Tansley
|
||
|
Company secretary/
|
||
|
Chief Financial Officer
|
||
|
Date: April 20, 2018
|
Exhibit No.
|
Description of Exhibit
|