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 fiscal
year 2014 and the quarter ended December 31, 2014.
Fiscal year 2014 Results
Total revenues for fiscal year 2014 were $104.9m versus $91.2m
in 2013, an increase of 15.0% year on year.
Point-of-care revenues increased from $19.8m in 2013 to $20.0m
in 2014, which represents an increase of 1.4%.
Meanwhile, Clinical Laboratory revenues grew by almost 19%,
mainly due to:
- higher diabetes revenues achieved through a combination of
higher placements of Premier instruments and the increased pull
through of related consumables for the larger installed base;
and
- the underlying growth and full year impact of the Immco and
blood bank screening acquisitions which were made during 2013.
Growth in these areas was partly offset by lower Lyme revenues.
This decrease was attributable to the impact of adverse weather
conditions in Q1, 2014 which impacted the prevalence of Lyme
disease in subsequent months.
Revenues for Q4 and fiscal year 2014 by key product area were as
follows:
|
|
2013 Quarter
4 |
2014 Quarter
4 |
Q4 2014 vs Q4
2013 |
Full Year
2013 |
Full Year
2014 |
Full Year
2014 vs 2013 |
|
US$'000 |
US$'000 |
% |
US$'000 |
US$'000 |
% |
Point-of-Care |
5,088 |
5,451 |
7.1% |
19,754 |
20,036 |
1.4% |
|
|
|
|
|
|
|
Clinical Laboratory |
20,367 |
21,229 |
4.2% |
71,462 |
84,835 |
18.7% |
|
|
|
|
|
|
|
Total |
25,455 |
26,680 |
4.8% |
91,216 |
104,871 |
15.0% |
The other key financial results for 2014 were as follows:
- Operating profit for the year grew by 5.0% from $17.2m to
$18.0m. This represents an operating margin of 17.2%.
- Profit after tax increased from $17.1m to $17.2m.
- EBITDA before share option expense for the year increased from
$22.8m to $23.8m
- EPS for the year was 76 cents versus 78 cents in 2013 whilst
diluted EPS was 73 cents (2013: 73 cents).
The tax charge for the year was 4.7% which compares favourably
to the 7.0% reported in 2013. This low effective rate of tax is due
to the competitive corporation tax rate in Ireland and the
availability of R&D tax credits in a number of
jurisdictions.
The growth in profits was achieved despite the impact of a
number of factors which had an adverse impact on profitability
during the year, including:
- the impact of the operational costs and closure costs
associated with two facilities which were undertaken as part of the
blood banking acquisition. The closure of these facilities and
associated costs occurred in Q3, 2014;
- sales and marketing costs incurred in relation to the company's
new Meritas range for which there were no matching revenues during
the year;
- increased sales of Premier instruments – instrument sales by
their nature have lower margins; and
- lower sales of Lyme products which typically attract stronger
gross margins.
Quarter 4
Results
Total revenues for Q4, 2014 were $26.7m which compares to $25.5m
in Q4, 2013, an increase of 5%. Excluding the impact of exchange
rate movements due to the strengthening dollar, the increase would
have been 6.4%.
Point-of-Care revenues for Q4, 2014 increased by over 7% versus
Q4, 2013. This increase reflects stronger sales of HIV
products in Africa in the quarter.
Clinical Laboratory revenues increased from $20.4m to $21.2m, an
increase of over 4% compared to Q4, 2013, or 6.2% after the
exclusion of exchange rate movements. The main drivers of
this growth were the continued strong performance of Premier and
increased autoimmune sales (Immco) particularly with respect to
Sjögren's disease testing.
Consistent with the previous quarters in 2014, the gross margin
of 47.5% for the quarter was lower than the equivalent quarter in
2013 due to the impact of increased Premier instrument sales and
lower Lyme sales.
Research and Development expenses were just under $1m, which was
broadly consistent with the corresponding period last
year. Selling, General and Administrative (SG&A) expenses
increased, from $6.5m to $7.2m which includes increased Meritas
related expenditure, reflecting the addition of a new dedicated
sales and marketing team.
The impact of the lower gross margin and increased SG&A
expenditure has resulted in a reduction in operating profit from
$4.8m to $4.3m. Meanwhile, profit after tax for the quarter was
$4.1m, which represents an EPS for the quarter of 18 cents. EBITDA
before share option expense for the quarter was $5.8m.
Cardiac Update
Trinity achieved some key milestones during 2014 relating to our
new point-of-care cardiac products on the Meritas platform. CE
marking was obtained for the company's new high sensitivity
Troponin I test in Q1, 2014. The trial data as part of these trials
demonstrated unrivalled performance for a point-of-care Troponin
product. These results were subsequently corroborated by an
independent trial carried out at Hennepin County Medical Centre,
Minneapolis and published at the AACC meeting in July 2014.
FDA clinical trials for the product commenced in Q2, 2014 with
enrolment initially taking place at 5 trial sites throughout the
USA. Due to the impact of a format change in a chemical raw
material used in the product, these clinical trials were
temporarily suspended in October, 2014. After taking remedial
action, the product's performance was restored and the resumption
of trials was announced in February, 2015. Enrolment is now taking
place at 12 sites in the USA with the entire trial process,
consisting of patient sampling, data collection, cardiologist
adjudication and statistical analysis, expected to be completed by
the end of July, 2015 with FDA submission planned for August,
2015.
Significant progress was also made on the second test to be
launched on the Meritas platform, BNP, which determines the risk of
heart failure. CE Marking for this product was obtained in Q3, 2014
with FDA submission to follow in 2015. As with our Troponin I test,
we are extremely confident that this product will obtain FDA
approval based on its strong performance in trials to date.
Premier Update
It was another strong year for our Premier diabetes instrument.
We shipped a record number of instruments and achieved our target
of 460 placements in 2014. Sales were strong in a wide range of
markets including the USA, Europe, China, and South-East
Asia. In addition, we gained access to the Brazilian market
which performed very strongly throughout 2014 with placements in
this single market reaching 121 instruments.
During 2014, Trinity also launched the Premier Resolution
instrument which has been specifically designed for the detection
and identification of haemoglobin variants as opposed to A1c
testing which is currently undertaken by the existing Premier
instrument. Premier Resolution will act as a companion instrument
for the Premier and will provide greater access to the variant
segment of the market.
CLIA waiver for Rapid Syphilis test
In December, 2014 a CLIA waiver was awarded by the FDA in
relation to the Syphilis Health Check test, the first ever waiver
for a rapid screening test for syphilis in the United States.
Importantly, the waiver allows the test to be performed by
untrained healthcare workers in a variety of non-traditional sites
such as emergency rooms, public health department clinics and other
free standing counselling and testing locations.
In recent years the incidence of syphilis in the USA has been
growing at a significant rate. Given that this is the only product
which is capable of reaching the principal patient demographic at
the point-of-care this represents a key growth opportunity for
Trinity. It will also serve as a companion product for our
Uni-Gold rapid HIV test which itself is CLIA waived and services a
similar patient demographic.
Comments
Commenting on the results, Kevin Tansley, Chief Financial
Officer, said, "Overall revenues in 2014 increased by 15% to
$104.9m. This increase was driven by particularly strong
growth for our Premier business and higher Immco revenues.
Meanwhile, operating profit for the year grew to over $18m. Whilst
overall profit after tax increased moderately, this was achieved in
the context of increased expenditure on our new cardiac sales force
and the impact that the combination of higher instrument and lower
Lyme sales had on gross margins."
Ronan O'Caoimh, CEO of Trinity, said, "During the year:
- We achieved CE marking for our high sensitivity Troponin I
product and commenced the clinical trials for FDA approval. Whilst
these trials were temporarily suspended in October 2014, we were
happy to be able to announce the resumption of the trials in
February, 2015 at 12 trial sites with the result that we expect to
be in a position to submit the trial data to the FDA in August of
this year;
- Our Premier instrument had another excellent year with a record
460 instruments being placed during the year. The highlight was the
success achieved by our Brazilian sales force who placed 121
Premier instruments in the 11 months following regulatory approval.
After three short years post-launch we have already placed close to
1,000 Premier instruments worldwide;
- We now have the only rapid syphilis test which is CLIA waived
in the USA, thus allowing point-of-care syphilis testing to be
carried out in the public health market. Given the increasing
incidence of syphilis in the USA and the fact that we have the only
approved test in the market, this is clearly a very significant
growth opportunity for us. This belief has been reinforced by the
across the board interest expressed by state and city public health
departments since the CLIA waiver was awarded in December 2014;
and
- We successfully completed the integration of the Immco and
blood bank screening acquisitions and were particularly pleased
with the success of our new Sjögren's test following its nationwide
launch across the USA."
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.
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|
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Trinity Biotech
plc |
Consolidated Income
Statements |
|
|
|
|
|
(US$000's except share data) |
Three Months |
Three Months |
Year |
Year |
|
Ended |
Ended |
Ended |
Ended |
|
Dec 31, |
Dec 31, |
Dec 31, |
Dec 31, |
|
2014 |
2013 |
2014 |
2013 |
|
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
|
|
|
|
|
Revenues |
26,680 |
25,455 |
104,871 |
91,216 |
|
|
|
|
|
Cost of sales |
(14,014) |
(12,828) |
(54,524) |
(45,996) |
|
|
|
|
|
Gross profit |
12,666 |
12,627 |
50,347 |
45,220 |
Gross profit % |
47.5% |
49.6% |
48.0% |
49.6% |
|
|
|
|
|
Other operating income |
85 |
247 |
424 |
532 |
|
|
|
|
|
Research & development expenses |
(961) |
(1,035) |
(4,290) |
(3,691) |
Selling, general and administrative
expenses |
(7,238) |
(6,481) |
(26,964) |
(22,901) |
Indirect share based payments |
(255) |
(521) |
(1,478) |
(1,978) |
|
|
|
|
|
Operating profit |
4,297 |
4,837 |
18,039 |
17,182 |
|
|
|
|
|
Financial income |
48 |
132 |
96 |
1,300 |
Financial expenses |
(34) |
-- |
(69) |
(75) |
Net financing income |
14 |
132 |
27 |
1,225 |
|
|
|
|
|
Profit before tax |
4,311 |
4,969 |
18,066 |
18,407 |
|
|
|
|
|
Income tax expense |
(187) |
(328) |
(853) |
(1,290) |
|
|
|
|
|
Profit for the period before once-off
charges |
4,124 |
4,641 |
17,213 |
17,117 |
|
|
|
|
|
Once-off charges |
-- |
-- |
-- |
(8,187) |
Tax credit on once-off charges |
-- |
-- |
-- |
716 |
|
|
|
|
|
Profit for the period after once-off
charges |
4,124 |
4,641 |
17,213 |
9,646 |
|
|
|
|
|
Earnings per ADR (US cents) |
18.0 |
20.8 |
75.7 |
44.0 |
|
|
|
|
|
Diluted earnings per ADR (US cents) |
17.6 |
19.2 |
72.6 |
41.2 |
|
|
|
|
|
Earnings per ADR excluding once-off charges
(US cents) |
18.0 |
20.8 |
75.7 |
78.0 |
|
|
|
|
|
Diluted earnings per ADR excluding once-off
charges (US cents) |
17.6 |
19.2 |
72.6 |
73.1 |
|
|
|
|
|
Weighted average no. of ADRs used in
computing basic earnings per ADR |
22,916,417 |
22,261,568 |
22,749,726 |
21,936,647 |
Weighted average no. of ADRs used in
computing diluted earnings per ADR |
23,482,268 |
24,218,493 |
23,717,747 |
23,428,174 |
|
|
|
|
|
|
|
|
Trinity Biotech
plc |
Consolidated Balance
Sheets |
|
|
|
|
|
Dec 31, |
Sept 30, |
Dec 31, |
|
2014 |
2014 |
2013 |
|
US$ '000 |
US$ '000 |
US$ '000 |
|
(unaudited) |
(unaudited) |
(unaudited) |
ASSETS |
|
|
|
Non-current assets |
|
|
|
Property, plant and equipment |
17,877 |
15,782 |
12,991 |
Goodwill and intangible assets |
145,024 |
141,815 |
128,547 |
Deferred tax assets |
9,798 |
10,066 |
7,044 |
Other assets |
1,091 |
1,276 |
1,162 |
Total non-current
assets |
173,790 |
168,939 |
149,744 |
|
|
|
|
Current assets |
|
|
|
Inventories |
33,517 |
33,779 |
29,670 |
Trade and other receivables |
26,080 |
25,190 |
24,268 |
Income tax receivable |
351 |
139 |
487 |
Cash and cash equivalents |
9,102 |
8,949 |
22,317 |
Total current assets |
69,050 |
68,057 |
76,742 |
|
|
|
|
TOTAL ASSETS |
242,840 |
236,996 |
226,486 |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
Equity attributable to the equity
holders of the parent |
|
|
|
Share capital |
1,204 |
1,203 |
1,182 |
Share premium |
12,422 |
12,295 |
8,732 |
Accumulated surplus |
183,375 |
178,960 |
168,772 |
Other reserves |
(26) |
2,321 |
4,325 |
Total equity |
196,975 |
194,779 |
183,011 |
|
|
|
|
Current liabilities |
|
|
|
Income tax payable |
785 |
555 |
770 |
Trade and other payables |
21,196 |
15,151 |
20,131 |
Provisions |
75 |
75 |
75 |
Total current
liabilities |
22,056 |
15,781 |
20,976 |
|
|
|
|
Non-current liabilities |
|
|
|
Other payables |
2,370 |
4,676 |
4,596 |
Deferred tax liabilities |
21,439 |
21,760 |
17,903 |
Total non-current
liabilities |
23,809 |
26,436 |
22,499 |
|
|
|
|
TOTAL LIABILITIES |
45,865 |
42,217 |
43,475 |
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
242,840 |
236,996 |
226,486 |
|
|
|
|
|
|
|
|
|
|
Trinity Biotech
plc |
Consolidated Statement
of Cash Flows |
|
|
|
|
|
(US$000's) |
Three Months |
Three Months |
Year |
Year |
|
Ended |
Ended |
Ended |
Ended |
|
Dec 31, |
Dec 31, |
Dec 31, |
Dec 31, |
|
2014 |
2013 |
2014 |
2013 |
|
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
|
|
|
|
|
Cash and cash equivalents at
beginning of period |
8,949 |
26,806 |
22,317 |
74,947 |
|
|
|
|
|
Operating cash flows before changes in
working capital |
5,048 |
3,877 |
22,027 |
19,764 |
Changes in working capital |
3,596 |
(915) |
(6,512) |
(8,657) |
Cash generated from operations |
8,644 |
2,962 |
15,515 |
11,107 |
|
|
|
|
|
Net Interest and Income taxes
received/(paid) |
(53) |
(74) |
237 |
599 |
|
|
|
|
|
Capital Expenditure & Financing
(net) |
(8,438) |
(5,015) |
(23,937) |
(19,583) |
|
|
|
|
|
Free cash flow |
153 |
(2,127) |
(8,185) |
(7,877) |
|
|
|
|
|
Cash paid to acquire Immco and Blood Bank
Screening Business |
-- |
-- |
-- |
(39,424) |
|
|
|
|
|
Payments for license fees |
-- |
(2,362) |
-- |
(2,362) |
|
|
|
|
|
Net cash acquired on acquisition |
-- |
-- |
-- |
1,406 |
|
|
|
|
|
Dividend payment |
-- |
-- |
(5,030) |
(4,373) |
|
|
|
|
|
Cash and cash equivalents at end of
period |
9,102 |
22,317 |
9,102 |
22,317 |
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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