Trinity Biotech plc (Nasdaq:TRIB), a leading developer and
manufacturer of diagnostic products for the point-of-care and
clinical laboratory markets, today announced results for the
quarter ended September 30, 2015.
Quarter 3 Results
Total revenues for Q3, 2015 were $25.8m which
compares to $27.2m in Q3, 2014, a decrease of 5.2%. However, when
the impact of foreign exchange movements, due to the strength of
the US dollar against a range of other currencies is removed,
revenues on a like-for-like basis would have been $27.6m this
quarter, thus representing an increase of almost 2% versus the
equivalent quarter in 2014.
Point-of-Care revenues for Q3, 2015 increased
slightly when compared to Q3, 2014. This increase was attributable
to increased rapid syphilis sales offset by slightly lower HIV
revenues.
Clinical Laboratory revenues increased to
$22.1m, which represents an increase of over 2% compared to Q3,
2014. This increase was primarily attributable to increased Premier
reagent and Immco revenues partly offset by lower Premier
instrument and Lyme revenues.
Revenues for Q3, 2015 were as follows:
|
2014Quarter 3 |
2015Quarter 3 |
2015Quarter
3FXadjusted* |
Increase/(decrease) |
|
US$’000 |
US$’000 |
US$’000 |
% |
Point-of-Care |
5,463 |
5,418 |
5,472 |
|
0.2 |
% |
Clinical Laboratory |
21,698 |
20,343 |
22,148 |
|
2.1 |
% |
Total |
27,161 |
25,761 |
27,620 |
|
1.7 |
% |
* Q3, 2015 revenues have been recalculated on a
constant currency basis using the exchange rates prevailing in Q3,
2014
Gross profit for Q3, 2015 amounted to $12.0m
representing a gross margin of 46.5%, which is lower than the 47.9%
achieved in Q3, 2014, though similar to that reported in Q2, 2014.
This decrease is due to the impact of a lower level of higher
margin Lyme revenues and the impact of foreign currency
movements.
Research and Development expenses have increased
to $1.3m from $1.1m when compared to the equivalent quarter last
year. Meanwhile, Selling, General and Administrative (SG&A)
expenses have increased from $7.0m to $7.5m over the same period.
This increase is attributable to higher sales and marketing costs,
largely due to expenditure on Meritas.
Operating profit for the quarter has decreased
from $4.6m to $3.0m, thus reflecting the lower gross margin and
higher indirect costs incurred this quarter.
Financial income for the quarter was $0.2m, an
increase of $0.2m versus Q3, 2014 due to the higher level of funds
on deposit following the issuance of the 30 Year Exchangeable Loan
Notes (“the Loan Notes”) in Q2, 2015. Meanwhile, financial expenses
increased to $1.1m mainly relating to the cash element of interest
associated with these notes. The non-cash elements of the Loan
Notes represented income of $10.5m which is attributable to
revaluation gains on the derivatives embedded in the Loan Notes of
$10.7m, partly offset by non-cash interest charges of
$0.2m.
The following table summarises the impact of the
Exchangeable Loan Notes on the Income Statement for Q3, 2015.
Exchangeable Loan Notes – Income Statement
impact |
Q3 2015US$’000 |
Cash element |
|
Cash based interest charge* |
|
(1,064 |
) |
|
|
Non-cash element |
|
Non-cash interest charge |
|
(208 |
) |
Revaluation gains on embedded derivatives |
|
10,720 |
|
Total non-cash items |
|
10,512 |
|
|
|
Net financing income relating to the Exchangeable Loan
notes |
|
9,448 |
|
* this is included in financial expenses in the
Income Statement – the remaining element ($21,000) arises on
items not related to the exchangeable note.
Profit before tax for the period was $12.6m
though this was largely impacted by non-cash gains related to the
Loan Notes. Excluding the non-cash elements of the Loan Notes, the
profit before tax for the quarter was $2.1m.
The tax charge for Q3, 2015 was $0.3m, largely
in line with the equivalent quarter in 2014.
Profit after tax for the period was $12.3m.
However, excluding the non-cash elements of the Loan Notes, this
would have been $1.8m, which equates to an adjusted EPS of 7.5
cents. Diluted EPS for the quarter amounted to 9.7 cents.
Cash generated from operations during the
quarter was $3.7m, though this was offset by capital expenditure of
$4.3m and interest and tax payments of $0.1m, resulting in a net
cash outflow for the quarter of $0.7m. In addition, the company
made dividend payments amounting to $5.1m with the result that the
cash balance at the end of the quarter was $104.3m.
Earnings before interest, tax, depreciation,
amortisation and share option expense for the quarter was
$4.7m.
Other Recent Developments
Cardiac Update
The following is an update on the three main components of the
Meritas Troponin-I Clinical Program:
- The most substantial component of this clinical program is the
Acute Coronary Syndrome (ACS) Study for the evaluation of subjects
presenting to the Emergency Departments with symptoms suggestive of
ACS. As reported on the Q2 earnings call, enrolment for this study
was completed in late July with the next step being the
adjudication of each result by a panel of Emergency and Cardiology
physicians. Thus far, this adjudication process, which conforms to
the Third Universal Definition of Myocardial Infarction guidance
document, has been more involved and time consuming than initially
expected. Whilst an adjudication of clear positives or negatives
can be performed in a relatively short time frame, some more
complex or borderline cases are taking significantly longer – in
some cases as long as 2 weeks. The adjudication process is now
expected to conclude by the end of November.Based on our review of
the data which has been adjudicated so far, we are pleased to
report that the data is significantly better than observed in our
own CE Marking trial and is closer to the superior results
contained in the independent study carried out at Hennepin County
Emergency Department by Dr. Fred Apple.
- Enrolment for the URL (99th Percentile Upper Reference Limit)
Study, was completed in July and since then the data collected has
been used to determined the URL or “normal level” of Troponin for
inclusion in the FDA submission. We were very pleased to observe
that the results of this study at three US trial sites show
excellent correlation with the URL determinations from our European
CE-marking clinical studies.
- The Precision Study is currently in the process of being
completed at 3 trial sites and will be completed in the coming
weeks.
From a timing perspective, the completion of the
adjudication analysis of the ACS Study will be the final component
to be completed and based on the timelines outlined above, we
expect to submit to the FDA during December 2015.
Dividend
During Q3, following approval at the company’s AGM in June 2015,
an annual dividend payment of 22 US cents per ADR was made, which
resulted in a total payment of $5.1m.
Comments
Commenting on the results, Kevin Tansley, Chief
Financial Officer, said “The profit this quarter was $12.3m.
However, this was impacted by significant non-cash gains related to
the company’s Loan Notes. Consequently, a better way of
assessing the performance this quarter is to look at operating
profit, which decreased from $4.6m to $3m compared to the
equivalent quarter last year. Our gross margins continue to
remain under pressure due to lower Lyme revenues and currency
factors. Meanwhile, indirect costs have increased due increased
sales and marketing costs including continued investment in
Meritas. Also, for the first time, overall profitability has been
adversely impacted by exchange rate movements. Prior to this
quarter, the impact of exchange rate movements had been neutral on
the income statement as each of the currencies in which the company
operates tended to move in tandem with each other versus the US
dollar. However, in Q3 this was no longer the case with the
significant weakening of the Brazilian Real and to a lesser extent
the Canadian Dollar having an adverse impact on overall
profitability.”
Ronan O’Caoimh, CEO of Trinity said “Completion
of our Meritas Troponin trial constitutes an extremely important
milestone for the company. We are confident that cardiologist
adjudication will be completed within the next four weeks and that
will enable FDA submission by the middle of December. Although the
adjudication process is not yet completed, based on the results to
date, we are extremely pleased with the performance of the product
and in particular with its high sensitivity and specificity
levels.”
Litigation Reform Act of 1995. Investors are
cautioned that such forward-looking statements involve risks and
uncertainties including, but not limited to, the results of
research and development efforts, the effect of regulation by the
United States Food and Drug Administration and other agencies, the
impact of competitive products, product development
commercialisation and technological difficulties, and other risks
detailed in the Company's periodic reports filed with the
Securities and Exchange Commission.
Trinity Biotech develops, acquires, manufactures
and markets diagnostic systems, including both reagents and
instrumentation, for the point-of-care and clinical laboratory
segments of the diagnostic market. The products are used to detect
infectious diseases and to quantify the level of Haemoglobin A1c
and other chemistry parameters in serum, plasma and whole blood.
Trinity Biotech sells direct in the United States, Germany, France
and the U.K. and through a network of international distributors
and strategic partners in over 75 countries worldwide. For further
information please see the Company's website:
www.trinitybiotech.com.
|
Trinity Biotech plc |
Consolidated Income Statements |
|
|
|
|
|
(US$000’s except
share data) |
Three
MonthsEndedSeptember
30,2015(unaudited) |
Three
MonthsEndedSeptember
30,2014(unaudited) |
Nine
MonthsEndedSeptember
30,2015(unaudited) |
Nine
MonthsEndedSeptember
30,2014 (unaudited) |
|
|
|
|
|
Revenues |
|
25,761 |
|
|
27,161 |
|
|
75,258 |
|
|
78,191 |
|
|
|
|
|
|
Cost of sales |
|
(13,776 |
) |
|
(14,150 |
) |
|
(39,780 |
) |
|
(40,510 |
) |
|
|
|
|
|
Gross
profit |
|
11,985 |
|
|
13,011 |
|
|
35,478 |
|
|
37,681 |
|
Gross profit % |
|
46.5 |
% |
|
47.9 |
% |
|
47.1 |
% |
|
48.2 |
% |
|
|
|
|
|
Other operating
income |
|
73 |
|
|
91 |
|
|
222 |
|
|
339 |
|
|
|
|
|
|
Research
& development expenses |
|
(1,293 |
) |
|
(1,138 |
) |
|
(3,560 |
) |
|
(3,329 |
) |
Selling, general and
administrative expenses |
|
(7,467 |
) |
|
(6,995 |
) |
|
(20,467 |
) |
|
(19,726 |
) |
Indirect share based
payments |
|
(327 |
) |
|
(326 |
) |
|
(1,357 |
) |
|
(1,223 |
) |
|
|
|
|
|
Operating
profit |
|
2,971 |
|
|
4,643 |
|
|
10,316 |
|
|
13,742 |
|
|
|
|
|
|
Financial income |
|
204 |
|
|
9 |
|
|
299 |
|
|
93 |
|
Financial expenses |
|
(1,085 |
) |
|
(15 |
) |
|
(2,279 |
) |
|
(79 |
) |
Non-cash financial
income |
|
10,512 |
|
|
- |
|
|
11,490 |
|
|
- |
|
Net financing
income / (expense) |
|
9,631 |
|
|
(6 |
) |
|
9,510 |
|
|
14 |
|
|
|
|
|
|
Profit before
tax |
|
12,602 |
|
|
4,637 |
|
|
19,826 |
|
|
13,756 |
|
|
|
|
|
|
Income tax expense |
|
(339 |
) |
|
(276 |
) |
|
(858 |
) |
|
(667 |
) |
Profit for the period |
|
12,263 |
|
|
4,361 |
|
|
18,968 |
|
|
13,089 |
|
|
|
|
|
|
Earnings per ADR (US
cents) |
|
52.9 |
|
|
19.0 |
|
|
82.0 |
|
|
57.7 |
|
|
|
|
|
|
Earnings per ADR excluding
non-cash financial income (US cents) |
|
7.5 |
|
|
19.0 |
|
|
32.3 |
|
|
57.7 |
|
|
|
|
|
|
Diluted earnings per ADR
(US cents) |
|
9.7 |
|
|
18.4 |
|
|
35.7 |
|
|
55.2 |
|
Weighted average
no. of ADRs used in computing basic earnings per ADR |
|
23,202,228 |
|
|
22,907,333 |
|
|
23,128,287 |
|
|
22,693,552 |
|
|
|
|
|
|
Weighted average no. of
ADRs used in computing diluted earnings per ADR |
|
28,766,691 |
|
|
23,674,859 |
|
|
27,059,058 |
|
|
23,719,930 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The above financial statements have been prepared in accordance
with the principles of International Financial Reporting Standards
and the Company’s accounting policies but do not constitute an
interim financial report as defined in IAS 34 (Interim Financial
Reporting).
|
Trinity Biotech plc |
Consolidated Balance Sheets |
|
|
|
|
|
|
September 30,2015US$
‘000(unaudited) |
June 30,2015US$
‘000(unaudited) |
March 31,2015US$
‘000(unaudited) |
Dec 31,2014US$
‘000(audited) |
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Property, plant and
equipment |
|
19,198 |
|
|
19,212 |
|
|
17,760 |
|
|
17,877 |
|
Goodwill and intangible
assets |
|
156,326 |
|
|
152,338 |
|
|
147,568 |
|
|
145,024 |
|
Deferred tax assets |
|
10,370 |
|
|
10,117 |
|
|
9,528 |
|
|
9,798 |
|
Other assets |
|
1,040 |
|
|
1,091 |
|
|
1,249 |
|
|
1,194 |
|
Total non-current
assets |
|
186,934 |
|
|
182,758 |
|
|
176,105 |
|
|
173,893 |
|
|
|
|
|
|
Current
assets |
|
|
|
|
Inventories |
|
36,882 |
|
|
38,193 |
|
|
37,064 |
|
|
33,516 |
|
Trade and other
receivables |
|
27,153 |
|
|
28,344 |
|
|
27,640 |
|
|
25,976 |
|
Income tax receivable |
|
119 |
|
|
212 |
|
|
221 |
|
|
351 |
|
Cash and cash
equivalents |
|
104,289 |
|
|
110,257 |
|
|
5,745 |
|
|
9,102 |
|
Total current
assets |
|
168,443 |
|
|
177,006 |
|
|
70,670 |
|
|
68,945 |
|
|
|
|
|
|
TOTAL
ASSETS |
|
355,377 |
|
|
359,764 |
|
|
246,775 |
|
|
242,838 |
|
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
|
Equity
attributable to the equity holders of the parent |
|
|
|
|
Share capital |
|
1,216 |
|
|
1,216 |
|
|
1,215 |
|
|
1,204 |
|
Share premium |
|
14,560 |
|
|
14,533 |
|
|
14,393 |
|
|
12,422 |
|
Accumulated surplus |
|
198,882 |
|
|
191,368 |
|
|
188,094 |
|
|
183,375 |
|
Other reserves |
|
(3,661 |
) |
|
(2,056 |
) |
|
(2,463 |
) |
|
(29 |
) |
Total
equity |
|
210,997 |
|
|
205,061 |
|
|
201,239 |
|
|
196,972 |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
Income tax payable |
|
951 |
|
|
497 |
|
|
467 |
|
|
785 |
|
Trade and other
payables |
|
18,694 |
|
|
19,756 |
|
|
20,116 |
|
|
21,197 |
|
Provisions |
|
75 |
|
|
75 |
|
|
75 |
|
|
75 |
|
Total current
liabilities |
|
19,720 |
|
|
20,328 |
|
|
20,658 |
|
|
22,057 |
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Exchangeable senior note
payable |
|
99,069 |
|
|
109,124 |
|
|
- |
|
|
- |
|
Other payables |
|
3,569 |
|
|
3,180 |
|
|
3,205 |
|
|
2,370 |
|
Deferred tax
liabilities |
|
22,022 |
|
|
22,071 |
|
|
21,673 |
|
|
21,439 |
|
Total non-current
liabilities |
|
124,660 |
|
|
134,375 |
|
|
24,878 |
|
|
23,809 |
|
|
|
|
|
|
TOTAL
LIABILITIES |
|
144,380 |
|
|
154,703 |
|
|
45,536 |
|
|
45,866 |
|
|
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
|
355,377 |
|
|
359,764 |
|
|
246,775 |
|
|
242,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The above financial statements have been prepared in accordance
with the principles of International Financial Reporting Standards
and the Company’s accounting policies but do not constitute an
interim financial report as defined in IAS 34 (Interim Financial
Reporting).
|
Trinity Biotech plc |
Consolidated Statement of Cash Flows |
|
|
|
|
|
(US$000’s) |
Three
MonthsEndedSeptember
30,2015(unaudited) |
Three
MonthsEndedSeptember
30,2014(unaudited) |
Nine
MonthsEndedSeptember
30,2015(unaudited) |
Nine
MonthsEndedSeptember
30,2014(unaudited) |
|
|
|
|
|
Cash and cash
equivalents at beginning of period |
|
110,257 |
|
|
15,153 |
|
|
9,102 |
|
|
22,317 |
|
|
|
|
|
|
Operating cash flows
before changes in working capital |
|
3,851 |
|
|
6,068 |
|
|
14,279 |
|
|
16,979 |
|
Changes in working
capital |
|
(166 |
) |
|
(538 |
) |
|
(8,504 |
) |
|
(10,108 |
) |
Cash generated from
operations |
|
3,685 |
|
|
5,530 |
|
|
5,775 |
|
|
6,871 |
|
|
|
|
|
|
Net Interest and Income
taxes received/(paid) |
|
(108 |
) |
|
(324 |
) |
|
(440 |
) |
|
290 |
|
|
|
|
|
|
Capital Expenditure &
Financing (net) |
|
(4,290 |
) |
|
(6,380 |
) |
|
(15,623 |
) |
|
(15,499 |
) |
|
|
|
|
|
Free cash flow |
|
(713 |
) |
|
(1,174 |
) |
|
(10,288 |
) |
|
(8,338 |
) |
|
|
|
|
|
30 year Convertible Note
proceeds, net of fees |
|
(156 |
) |
|
- |
|
|
110,574 |
|
|
- |
|
Dividend payment |
|
(5,099 |
) |
|
(5,030 |
) |
|
(5,099 |
) |
|
(5,030 |
) |
|
|
|
|
|
Cash and cash
equivalents at end of period |
|
104,289 |
|
|
8,949 |
|
|
104,289 |
|
|
8,949 |
|
|
|
|
|
|
The above financial statements have been prepared in accordance
with the principles of International Financial Reporting Standards
and the Company’s accounting policies but do not constitute an
interim financial report as defined in IAS 34 (Interim Financial
Reporting).
Contact:
Trinity Biotech plc
Kevin Tansley
353)-1-2769800
E-mail: kevin.tansley@trinitybiotech.com
Lytham Partners LLC
Joe Diaz, Joe Dorame & Robert Blum
602-889-9700
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