SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE
ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of April, 2015
TRINITY
BIOTECH PLC
(Name of Registrant)
IDA Business
Park
Bray, Co. Wicklow
Ireland
(Address of
Principal Executive Office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(7): ¨
Indicate by check mark whether by furnishing
the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No
x
If Yes is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b): 82-
Press Release dated April 30, 2015
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Contact: |
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Trinity Biotech plc |
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Lytham Partners LLC |
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Kevin Tansley |
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Joe Diaz, Joe Dorame & Robert Blum |
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(353)-1-2769800 |
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602-889-9700 |
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E-mail: kevin.tansley@trinitybiotech.com |
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Trinity Biotech Announces Quarter 1 Results EPS 17.4 cents
Dividend of 22 cents
DUBLIN, Ireland
(April 30, 2015)
. 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 March 31, 2015.
Quarter 1 Results
Total revenues for Q1,
2015 were $25.2m, an increase of $0.2m when compared with Q1, 2014. However, revenues this quarter were particularly impacted by foreign exchange movements due to the strengthening of the US dollar against a range of currencies. Excluding this
currency effect, revenues would have increased to $26.4m, representing an increase of 6%.
Point-Of-Care revenues for Q1, 2015 increased by 2% (or 4.4% on
a constant currency basis) when compared to Q1, 2014. This increase is due to the impact of the initial sales of the newly CLIA waived Syphilis rapid test.
Clinical Laboratory revenues increased from $20.5m to $20.7m, which represents an increase of approximately 1% compared to Q1, 2014. However, on a constant
currency basis Q1, 2015 revenues were $21.7m an increase of 6%. The principal factors contributing to this increase were the continued growth in Premier revenues due to higher reagent pull-through, in addition to higher autoimmune revenues
from Immco.
Revenues for Q1, 2015 by key product area were as follows:
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2014
Quarter 1 |
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2015
Quarter 1 |
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2015
Quarter 1
FX adjusted* |
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Increase/
(decrease) |
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US$000 |
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US$000 |
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US$000 |
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% |
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Point-of-Care |
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4,506 |
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4,585 |
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4,702 |
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4.4 |
% |
Clinical Laboratory |
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20,519 |
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20,655 |
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21,742 |
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6.0 |
% |
Total |
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25,025 |
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25,240 |
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26,444 |
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5.7 |
% |
* |
quarter 1, 2015 revenues have been recalculated on a constant currency basis using the exchange rates prevailing in Q1, 2014 |
Whilst exchange rate movements have adversely impacted revenues this quarter, they have had a favourable impact
on the companys cost base. The company has an effective natural currency hedge between revenues and costs, thus the exchange rate movements this quarter had no impact on the companys overall profit. In summary, the extent to which
revenues and gross profit have been adversely impacted by the stronger dollar was offset by lower foreign currency denominated SG&A expenses.
The
gross profit for Q1, 2015 amounted to $12.1m, which equates to a gross margin of 47.9%. This represents a slight reduction from 48.6% in Q1, 2014, which is partly explained by the impact of the abovementioned currency movements.
Research and Development expenses were consistent with Q1, 2014 at $1.0m, whilst Selling, General and Administrative (SG&A) expenses also remained largely
in line with Q1, 2014 at $6.3m. The latter includes the favourable impact of the stronger dollar, offset by increased sales and marketing costs, mainly relating to Meritas.
Operating profit for the quarter was $4.3m, compared to $4.5m in Q1, 2014. Operating margin for the quarter was 17.2%. Profit before tax for the quarter was
$4.3m, whilst profit after tax was $4.0m. Meanwhile, EPS for Q1, 2015 was 17.4 cents. However, this quarter we incurred over $0.6m of SG&A costs related to Meritas, against which we have no matching revenues. Excluding such costs would have
resulted in after tax profits of approximately $4.6m or over 20 cents per ADR.
EBITDA and before share option expense for the quarter increased from
$6.0m to $6.2m an increase of over 3%.
The tax charge for the quarter was $0.3m which represents an effective tax rate of 7%. This highly
competitive rate has been driven by the low rate of corporation tax in Ireland and the availability of R&D tax credits in both Ireland and North America.
Other Developments
Cardiac Update
In February 2015, the company announced that, after a brief cessation, it had recommenced US clinical trials on its Troponin I point-of-care product. The
clinical trial is running at 12, geographically diverse, trial sites across the USA and is currently recruiting just under 70 patients per week. Furthermore, the actual rate of myocardial infarctions is tracking slightly higher than expected.
Consequently, the project remains on course to have data collection, subsequent adjudication and statistical analysis all completed during the month of July with FDA submission planned for August, 2015. The product continues to demonstrate the
excellent clinical performance demonstrated in our European CE marking trials and in the independent clinical evaluation carried out at Hennepin County Medical Center, Minneapolis and published at AACC in July, 2014. Furthermore, European
evaluations are well underway along with product registrations in a number of countries including both China and Brazil.
In relation to Meritas BNP, the
company expects USA clinical trials to be completed in September, 2015 with FDA submission following immediately thereafter. Finally, data from an independent clinical evaluation of the Meritas BNP product, carried out by Dr. Apple at Hennepin
County, has been accepted for publication at the AACC meeting in Atlanta on July 26, 2015. This data indicates excellent clinical performance characteristics for Meritas BNP.
Appointment of new Chief Scientific Officer
Trinity Biotech is pleased to announce the appointment of Eric Brouwer, PhD, as Chief Scientific Officer (CSO), and Vice President Cardiac. Previously, Dr
Brouwer led product development at Abbott Point-of-Care. He brings extensive leadership experience in creating, developing and launching FDA approved products for the point-of-care in vitro diagnostics market. At Abbott, he was a member of the
Scientific Governing Board and was the recipient of the Abbott Chairmans Award (2007) for the FDA 510(k) waiver clearance of a point-of-care Basic Metabolic test panel. As CSO and VP Cardiac, Dr Brouwer will lead product development in
our Cardiac Marker and Infectious Diseases Point-of-Care businesses.
Dr Jim Walsh, who previously held the positions of both Business Development
Director and CSO, will now focus on business development with an emphasis on the identification and execution of suitable acquisition targets.
Fundraising and Shelf Registration
The company
raised $115m in April from the issuance of 4% exchangeable senior notes repayable in 2045. However, due to the inclusion of a series of put and call options, earlier redemption is possible. The initial offering of $100m included a 30-day option to
purchase an additional $15m of the notes, an option that was fully exercised. The net proceeds from the offering for Trinity amounted to $110.5m after deducting the associated costs of the transaction. The Companys intention is that these
proceeds will be used for future acquisitions.
On April 22, the company filed a $200m shelf registration with the SEC. This in no way represents an
intention to issue equity at this time, but rather reflects the implementation of a new policy to maintain a live shelf registration at all times.
Annual Dividend
The company is proposing a
dividend of 22 cents per ADR (5.5 cents per A ordinary share), which is consistent with the dividend paid in 2014. The payment of this dividend is subject to shareholder approval, which will be sought at the companys forthcoming
AGM to be held on June 5, 2015. Subject to this approval being granted, the record date will be June 9, 2015 and payment will follow approximately 3 weeks later.
Comments
Commenting on the results, Kevin Tansley, Chief
Financial Officer, said Revenues increased by $0.2m to $25.2m this quarter. However, taking into account exchange rate movements this represents an increase of nearly 6% on a constant currency basis. This growth was largely attributable to our
very successful Premier offering and higher Immco autoimmune sales. Profit for the period amounted to $4m which represent an EPS of 17.4 cents whilst EBITDA and before share option expense increased to $6.2m.
Ronan OCaoimh, CEO, stated that During quarter 1, the business performed well, effectively achieving growth of 6%, with Premier and Immco both
performing strongly. We are also very excited with the rapid syphilis market opportunity in the USA. Whilst sales to date have been modest, we are delighted with the enormous level of interest the product has generated, with virtually every state
and major city health department in the USA having expressed an interest in using the test. This augurs very well for the future of this product, though given the nature of government spending, it will take some time before we achieve a significant
level of sales.
We are also delighted with the progress in our Troponin I clinical trials. The product continues to demonstrate
excellent clinical performance and we expect to submit the trial data to the FDA in August of this year. In addition, the registration process is well underway in a number of other countries, such as China and Brazil, both of which represent very
significant market opportunities for Trinity.
In April, the company completed a significant fundraising in the form of 30 year 4% exchangeable senior
notes, which yielded $110.5m, net of expenses. The company intends to use these funds to make strategic acquisitions. The company has a history of identifying and effectively integrating high quality acquisitions. We will focus on acquisitions which
will be earnings enhancing and cash flow positive, have distinct operational synergies with our existing business, whilst at the same time demonstrating strong growth potential.
Today we are also proposing an annual dividend of 22 cents per ADR. This is consistent with the dividend declared in 2014.
Finally, I would like to welcome Dr. Eric Brouwer to the company in the role of Chief Scientific Officer and VP Cardiac. Eric has a vast amount of
experience, particularly in the area of developing and launching cardiac products and will be a most valuable addition to our team and I have no doubt that he will make a very significant contribution to the launch of our new Meritas range of
products.
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 Companys 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 Companys website: www.trinitybiotech.com
Trinity Biotech plc
Consolidated Income Statements
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(US$000s except share data) |
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Three Months
Ended
March 31, 2015
(unaudited) |
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Three Months
Ended
March 31, 2014
(unaudited) |
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Revenues |
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25,240 |
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25,025 |
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Cost of sales |
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(13,140 |
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(12,864 |
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Gross profit |
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12,100 |
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12,161 |
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Gross profit % |
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47.9 |
% |
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48.6 |
% |
Other operating income |
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78 |
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149 |
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Research & development expenses |
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(998 |
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(1,037 |
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Selling, general and administrative expenses |
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(6,287 |
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(6,314 |
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Indirect share based payments |
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(558 |
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(455 |
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Operating profit |
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4,335 |
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4,504 |
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Financial income |
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1 |
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43 |
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Financial expenses |
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(24 |
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(20 |
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Net financing (expense)/income |
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(23 |
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23 |
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Profit before tax |
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4,312 |
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4,527 |
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Income tax expense |
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(304 |
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(114 |
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Profit for the period |
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4,008 |
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4,413 |
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Earnings per ADR (US cents) |
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17.4 |
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19.6 |
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Diluted earnings per ADR (US cents) |
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17.0 |
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18.2 |
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Weighted average no. of ADRs used in computing basic earnings per ADR |
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22,985,234 |
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22,465,202 |
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Weighted average no. of ADRs used in computing diluted earnings per ADR |
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23,604,244 |
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24,209,680 |
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The above financial statements have been prepared in accordance with the principles of International Financial Reporting
Standards and the Companys accounting policies but do not constitute an interim financial report as defined in IAS 34 (Interim Financial Reporting).
Trinity Biotech plc
Consolidated Balance Sheets
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March 31,
2015 US$ 000
(unaudited) |
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Dec 31,
2014 US$ 000
(unaudited) |
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ASSETS |
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Non-current assets |
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Property, plant and equipment |
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17,760 |
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17,877 |
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Goodwill and intangible assets |
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147,568 |
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145,024 |
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Deferred tax assets |
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9,528 |
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9,798 |
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Other assets |
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1,249 |
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1,194 |
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Total non-current assets |
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176,105 |
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173,893 |
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Current assets |
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Inventories |
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37,064 |
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33,516 |
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Trade and other receivables |
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27,640 |
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25,976 |
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Income tax receivable |
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221 |
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351 |
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Cash and cash equivalents |
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5,745 |
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9,102 |
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Total current assets |
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70,670 |
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68,945 |
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TOTAL ASSETS |
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246,775 |
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242,838 |
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EQUITY AND LIABILITIES |
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Equity attributable to the equity holders of the parent |
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Share capital |
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1,215 |
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1,204 |
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Share premium |
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14,393 |
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12,422 |
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Accumulated surplus |
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188,094 |
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183,375 |
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Other reserves |
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(2,463 |
) |
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(29 |
) |
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Total equity |
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201,239 |
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196,972 |
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Current liabilities |
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Income tax payable |
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467 |
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|
785 |
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Trade and other payables |
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20,116 |
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21,197 |
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Provisions |
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75 |
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75 |
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Total current liabilities |
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20,658 |
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22,057 |
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Non-current liabilities |
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Other payables |
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3,205 |
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2,370 |
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Deferred tax liabilities |
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21,673 |
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21,439 |
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Total non-current liabilities |
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24,878 |
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23,809 |
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TOTAL LIABILITIES |
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45,536 |
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45,866 |
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TOTAL EQUITY AND LIABILITIES |
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246,775 |
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242,838 |
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The above financial statements have been prepared in accordance with the principles of International Financial Reporting
Standards and the Companys 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
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(US$000s) |
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Three Months
Ended
March 31, 2015
(unaudited) |
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Three Months
Ended
March 31, 2014
(unaudited) |
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Cash and cash equivalents at beginning of period |
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9,102 |
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22,317 |
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Operating cash flows before changes in working capital |
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6,298 |
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4,993 |
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Changes in working capital |
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(4,322 |
) |
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(4,212 |
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Cash generated from operations |
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1,976 |
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|
781 |
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Net Interest and Income taxes (paid)/received |
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(108 |
) |
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2 |
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Capital Expenditure & Financing (net) |
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(4,113 |
) |
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(5,042 |
) |
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Free cash flow |
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(2,245 |
) |
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|
(4,259 |
) |
Payment of HIV-2 licence fee |
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(1,112 |
) |
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Deferred consideration paid |
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|
|
|
|
(1,050 |
) |
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Cash and cash equivalents at end of period |
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|
5,745 |
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|
|
17,008 |
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The above financial statements have been prepared in accordance with the principles of International Financial Reporting
Standards and the Companys accounting policies but do not constitute an interim financial report as defined in IAS 34 (Interim Financial Reporting).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
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TRINITY BIOTECH PLC |
(Registrant) |
|
|
By: |
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/s/ Kevin Tansley |
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Kevin Tansley |
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Chief Financial Officer |
Date: April 30, 2015.
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