FORM 6-K

 

 

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 July, 2014

 

 

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-        

 

 

 


LOGO

Press Release dated July 29, 2014

 

Contact:    Trinity Biotech plc    Lytham Partners LLC
   Kevin Tansley    Joe Diaz, Joe Dorame & Robert Blum
   (353)-1-2769800    602-889-9700
   E-mail: kevin.tansley@trinitybiotech.com   

Trinity Biotech Announces Quarter 2 Financial Results

25% Increase in Operating Profits

DUBLIN, Ireland (July 29, 2014)…. 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 June 30, 2014.

Quarter 2 Results

Total revenues for Q2, 2014 were $26.0m compared to $21.3m in Q2, 2013, which represents an increase of 22%.

Point-of-Care revenues for Q2, 2014 were $4.6m and broadly in line with the comparative quarter last year. Clinical Laboratory revenues increased from $16.7m to $21.4m, which represents an increase of 27.9% compared to Q2, 2013. This growth was achieved through a combination of acquisition revenues and higher diabetes revenues as partially offset by slightly lower Lyme and Fitzgerald sales.

Revenues for Q2, 2014 by key product area were as follows:

 

     2013
Quarter 2
     2014
Quarter 2
     Increase  
     US$’000      US$’000      %  

Point-of-Care

     4,586         4,615         0.6

Clinical Laboratory

     16,726         21,390         27.9

Total

     21,312         26,005         22.0

Gross profit for Q2, 2014 amounted to $12.5m representing a gross margin of 48.1%, which is slightly lower than the 49.0% achieved in Q2, 2013. This decrease is primarily attributable to the impact of lower margins on Premier instrument sales, but also due to additional costs associated with running two manufacturing facilities in the UK. Production of blood banking products at these facilities ceased at the end of June and was transferred to other company facilities in the USA and Ireland.

Research and Development expenses have increased from $0.9m to $1.2m when compared to the equivalent quarter last year. Meanwhile, Selling, General and Administrative (SG&A) expenses have increased over the same period from $5.5m to $6.4m. In both cases, the increase was primarily due to the impact of the Immco and blood bank screening acquisitions, both of which were undertaken in the second half of 2013.

Operating profit has increased from $3.7m to $4.6m for the quarter, which equates to an increase of 25% and represents an operating margin of 17.7%.


Financial income was broadly offset by financial expenses resulting in a negligible net expense for the quarter. This compares to net financial income of approximately $0.4m earned in Q2, 2013. This is due to lower funds being placed on deposit following the utilisation of funds for the Immco and blood banking acquisitions and lower prevailing deposit interest rates.

The tax charge for Q2, 2014 was $0.3m which equates to an effective tax rate of approximately 6%.

Profit before tax increased from $4.1m to over $4.6m which represents an increase of approximately 12%. Meanwhile, profit after tax increased from $3.8m to $4.3m, an increase of 13%. EPS for the quarter was 19.0 cents which compares to 17.7 cents for the equivalent period last year.

Earnings before interest, tax, depreciation, amortisation and share option expense for the quarter was $6.0m. This compares to $5.1m for Q2, 2013.

Recent Developments

Cardiac Update

In quarter 1, 2014 the company obtained CE marking for the Meritas Troponin I test, our new high sensitivity Troponin product. The product is currently undergoing clinical evaluation in all major European markets in advance of commercial rollout. Meanwhile, for the purpose of FDA approval, the Meritas Troponin I test is undergoing clinical evaluation at multiple trial sites across the USA. To date, six US trial sites have been enrolling patients for the Acute Coronary Syndrome (ACS) study and over the coming weeks we intend to increase the number of trial sites to 10. We are currently recruiting ACS patients at a rate of approximately 40 per week. With the additional trial sites coming on line, we envisage that enrolment rates will reach 80 to 100 patients per week. At this level of recruitment, sufficient ACS data is expected to be available by mid-Q4 2014, with clinical adjudication to follow immediately thereafter and submission to the FDA targeted for the end of 2014. Meanwhile, enrolment for our Normals (99th percentile) study is progressing according to plan at three trial sites and is expected to be completed well in advance of the ACS trial.

Furthermore, Dr. Fred Apple (Medical Director at Hennepin County Medical Center, Minneapolis and Key Opinion Leader in cardiology) presented the results of an independent clinical evaluation he has carried out on the Meritas Troponin I product at this week’s AACC annual meeting in Chicago. His results indicate that the Meritas product has a diagnostic accuracy far in advance of any of the existing point-of-care Troponin tests and indeed in many cases is as good as, if not better than, some of the central laboratory Troponin products currently available on the US market. Dr Apple concludes that this study validates the Meritas Troponin I test as an appropriate tool for both ruling in and ruling out myocardial infarction in the emergency room setting. Moreover, this study was constructed in a fashion that mirrors the ACS trial required by the FDA. The results of Dr. Apple’s independent trial, in addition to the results of the trials carried out for CE marking, provide us with a high degree of confidence that the Meritas Troponin product has the necessary performance characteristics to meet and indeed exceed the FDA’s new stringent performance specifications for Troponin testing.

During the quarter, significant progress has been made in completing the development of our Meritas BNP product for detection of heart failure. The clinical trials necessary to obtain CE marking are virtually complete and we expect to submit for CE clearance during the month of August. This will be immediately followed by the commencement of US clinical trials, with FDA submission expected before the end of 2014. Meanwhile, development of our Meritas D-dimer product, a test for Pulmonary Embolism and DVT (deep vein thrombosis) is progressing very well and according to schedule.


Premier Update

Sales of our diabetes instrument, Premier, continue to perform strongly. During the quarter, 106 instruments were sold or placed with customers. This compares with 80 instruments for the equivalent period last year. This brings the total sales or placements of instruments for the first half of 2014 to 207. On this basis, we are in line to achieve our target of 460 for the year as a whole.

During the quarter, we also formally launched our new Premier Resolution instrument. This version of the instrument has been specifically designed for the detection and identification of haemoglobin variants as opposed to A1c (diabetes) testing which is currently undertaken by the existing Premier instrument. Prior to this Trinity had only limited presence in the variant market, being largely concentrated in the high throughput end of the US market with the Ultra instrument. Going forward Premier Resolution, which will act as a companion instrument for the Premier, will provide greater access to this segment of the market. Following its launch the first instruments have already been placed in the United Kingdom.

Immco Update

The Immco acquisition has been performing well and has now been fully integrated into the Trinity group. We are particularly pleased with the opportunity that Sjö™ , Immco’s test for the early detection for Sjögren’s syndrome, represents. Towards the end of the quarter, in conjunction with our partner, Nicox, this test was rolled out nationally in the USA. Prior to this, it has only been available in a number of selected US markets – where initial indicators had demonstrated that the product was well received and for which there was strong demand. Since then, we have extended Nicox’s rights to this product to cover all healthcare practitioners in North America – previously it had been limited to the ophthalmic segment of the market.

Sjögren’s syndrome is a very prevalent though widely under-diagnosed debilitating condition of which dry eye is one of the primary symptoms. Immco’s Sjö™ test is the only approved test for Sjögren’s syndrome in the USA.

Dividend

Shareholder approval for payment of a dividend of 22 US cents per ADR, was granted at the company’s AGM, which was held on 6 June, 2014. This represents an increase of 10% compared with 20 US cents per ADR paid in 2013. Payment of the dividend was made in July 2014.

Comments

Commenting on the results, Kevin Tansley, Chief Financial Officer, said “This quarter we achieved impressive profitability growth with operating profit growing by 25% and profit after tax rising by almost 13%. This was achieved notwithstanding increased marketing costs for our new cardiac product range and increased placements of Premier instruments which tend to have lower margins. In addition, this quarter’s results were impacted by running duplicate facilities in the United Kingdom for our blood bank screening business. Production at these facilities has now ceased and they will be fully vacated by the end of this month resulting in cost savings from quarter 3 onwards.”


Ronan O’Caoimh, CEO, stated “The clinical trials for our new Troponin I test on the Meritas platform are now well underway. To date these trials have been progressing more slowly than we would have wanted. This has been solely attributable to slower than expected recruitment of patients for the trials due to the nature of the testing protocol that we are required to adhere to. In order to avoid any delay in submitting the results to the FDA, we have increased the number of trial sites from the six existing sites to 10 sites in total. Recruitment at the new sites will commence imminently. Meanwhile, we were very pleased with the performance of the test in Dr. Apple’s Troponin trial results, which were published yesterday at the AACC annual meeting in Chicago. These results, we believe, demonstrated the unparalleled specificity and sensitivity of the product in the point-of-care environment, thus reinforcing its capability as both a rule in and rule out test.

Meanwhile, our BNP test on the same platform is nearing the completion of its CE marking trials. The results of these trials have been showing excellent performance and consequently we expect to announce European regulatory approval in the coming weeks. Once this has been achieved we will immediately commence our FDA trials. By their nature these trials will be more straight forward than the Troponin trials and thus we expect to be in a position to submit this product to the FDA for approval by the end of 2014.

I am also pleased to report that our Immco product line continues to perform very well. In particular, we believe the company’s Sjö™ test for the early detection of Sjögren’s syndrome represents a significant growth opportunity for the company. The product has already been well received in a number of test markets in the USA. Consequently, in conjunction with our partner, Nicox, it has now been rolled out nationally in the USA where we believe it will gain significant traction.”

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 Months

Ended

June 30,

2014

(unaudited)

   

Three Months

Ended

June 30,

2013

(unaudited)

   

Six Months

Ended

June 30,

2014

(unaudited)

   

Six Months

Ended

June 30,

2013

(unaudited)

 

Revenues

     26,005        21,312        51,030        41,640   

Cost of sales

     (13,496     (10,865     (26,360     (21,026
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     12,509        10,447        24,670        20,614   

Gross profit %

     48.1     49.0     48.3     49.5

Other operating income

     98        85        248        195   

Research & development expenses

     (1,155     (924     (2,192     (1,779

Selling, general and administrative expenses

     (6,417     (5,502     (12,730     (10,535

Indirect share based payments

     (442     (440     (897     (938
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating profit

     4,593        3,666        9,099        7,557   

Financial income

     42        466        84        943   

Financial expenses

     (44     (26     (64     (52
  

 

 

   

 

 

   

 

 

   

 

 

 

Net financing income / (expense)

     (2     440        20        891   
  

 

 

   

 

 

   

 

 

   

 

 

 

Profit before tax

     4,591        4,106        9,119        8,448   

Income tax expense

     (276     (278     (391     (452
  

 

 

   

 

 

   

 

 

   

 

 

 

Profit for the period

     4,315        3,828        8,728        7,996   
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings per ADR (US cents)

     19.0        17.7        38.6        36.8   

Diluted earnings per ADR (US cents)

     18.2        16.9        36.8        34.9   

Weighted average no. of ADRs used in computing basic earnings per ADR

     22,703,261        21,665,259        22,584,889        21,732,983   

Weighted average no. of ADRs used in computing diluted earnings per ADR

     23,686,336        22,711,752        23,720,056        22,935,565   

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

 

    

June 30,

2014

US$ ‘000

(unaudited)

    

March 31,

2014

US$ ‘000

(unaudited)

    

Dec 31,

2013

US$ ‘000

(audited)

 

ASSETS

        

Non-current assets

        

Property, plant and equipment

     14,784         13,841         12,991   

Goodwill and intangible assets

     137,848         133,881         128,547   

Deferred tax assets

     9,082         7,570         7,044   

Other assets

     1,222         1,131         1,162   
  

 

 

    

 

 

    

 

 

 

Total non-current assets

     162,936         156,423         149,744   
  

 

 

    

 

 

    

 

 

 

Current assets

        

Inventories

     33,109         30,864         29,670   

Trade and other receivables

     27,163         24,130         24,268   

Income tax receivable

     88         493         487   

Cash and cash equivalents

     15,153         17,008         22,317   
  

 

 

    

 

 

    

 

 

 

Total current assets

     75,513         72,495         76,742   
  

 

 

    

 

 

    

 

 

 

TOTAL ASSETS

     238,449         228,918         226,486   
  

 

 

    

 

 

    

 

 

 

EQUITY AND LIABILITIES

        

Equity attributable to the equity holders of the parent

        

Share capital

     1,202         1,187         1,170   

Share premium

     12,097         9,731         8,842   

Accumulated surplus

     179,137         174,023         168,670   

Other reserves

     3,672         4,073         4,329   
  

 

 

    

 

 

    

 

 

 

Total equity

     196,108         189,014         183,011   
  

 

 

    

 

 

    

 

 

 

Current liabilities

        

Income tax payable

     1,036         998         770   

Trade and other payables

     16,106         15,679         20,131   

Provisions

     75         75         75   
  

 

 

    

 

 

    

 

 

 

Total current liabilities

     17,217         16,752         20,976   
  

 

 

    

 

 

    

 

 

 

Non-current liabilities

        

Other payables

     4,665         4,634         4,596   

Deferred tax liabilities

     20,459         18,518         17,903   
  

 

 

    

 

 

    

 

 

 

Total non-current liabilities

     25,124         23,152         22,499   
  

 

 

    

 

 

    

 

 

 

TOTAL LIABILITIES

     42,341         39,904         43,475   
  

 

 

    

 

 

    

 

 

 

TOTAL EQUITY AND LIABILITIES

     238,449         228,918         226,486   
  

 

 

    

 

 

    

 

 

 

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 Months

Ended

June 30,

2014

(unaudited)

   

Three Months

Ended

June 30,

2013

(unaudited)

   

Six Months

Ended

June 30,

2014

(unaudited)

   

Six Months

Ended

June 30,

2013

(unaudited)

 

Cash and cash equivalents at beginning of period

     17,008        73,095        22,317        74,947   

Operating cash flows before changes in working capital

     5,919        4,887        10,911        10,064   

Changes in working capital

     (4,309     (2,793     (9,571     (5,344
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash generated from operations

     1,610        2,094        1,340        4,720   

Net Interest and Income taxes received

     611        367        614        799   

Capital Expenditure & Financing (net)

     (4,076     (5,019     (9,118     (9,929
  

 

 

   

 

 

   

 

 

   

 

 

 

Free cash flow

     (1,855     (2,558     (7,164     (4,410

Dividend payment

     —          (4,373     —          (4,373
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at end of period

     15,153        66,164        15,153        66,164   
  

 

 

   

 

 

   

 

 

   

 

 

 

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).


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.

 

TRINITY BIOTECH PLC

            (Registrant)

By:  

 /s/ Kevin Tansley

  Kevin Tansley
  Chief Financial Officer

Date: July 29, 2014.