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 October, 2016

 

 

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  ☒            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  ☒

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 October 25, 2016

 

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 3 Financial Results

DUBLIN, Ireland (October 25, 2016)…. 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, 2016.

Quarter 3 Results

Total revenues for Q3, 2016 were $26.1m which compares to $25.8m in Q3, 2015, an increase of 1.4%.

Point-of-Care revenues for Q3, 2016 decreased from $5.4m to $4.9m when compared to Q3, 2015, a decline of 9.5%. This is within the normal quarterly fluctuation range of HIV sales in Africa.

Clinical Laboratory revenues increased to $21.2m, which represents an increase of 4.3% compared to Q3, 2015. This increase was primarily attributable to increased Premier and autoimmune revenues.

Unlike in previous quarters, the impact of foreign exchange on revenues was not significant when compared to the equivalent quarter last year. When calculated, its impact was to reduce this quarter’s revenues by less than 0.5% with the weakness in Sterling being the biggest single factor.

Revenues for Q3, 2016 were as follows:

 

     2015
Quarter 3
     2016
Quarter 3
     Increase/
(decrease)
 
     US$’000      US$’000      %  

Point-of-Care

     5,418         4,903         (9.5 %) 

Clinical Laboratory

     20,343         21,224         4.3
  

 

 

    

 

 

    

 

 

 

Total

     25,761         26,127         1.4 % 
  

 

 

    

 

 

    

 

 

 

Gross profit for Q3, 2016 amounted to $11.7m representing a gross margin of 44.7%, which is lower than the 46.5% achieved in Q3, 2015. This decrease is largely due to lower sales of higher margin point-of-care products and the knock-on impact of past currency movements – primarily the impact of the stronger dollar on distributor pricing.

Research and Development expenses have remained in line with the equivalent quarter last year at $1.3m. Meanwhile, Selling, General and Administrative (SG&A) expenses have remained at $7.5m for the quarter.

Operating profit for the quarter was $2.7m, which is lower than the $3.0m achieved in Q3, 2015, and this is attributable to the impact of higher revenues and lower indirect costs being more than offset by the lower gross margin.


The net financing expense for the quarter was $3.1m versus income of $9.6m in the equivalent quarter of 2015. This financing income/expense can be broken down into its component parts as follows:

 

Net financing income /(expense)

   Q3 2016      Q3 2015  
     US$’000      US$’000  

Financial income

     212         204   
  

 

 

    

 

 

 

Financial expense – Exchangeable note

     (1,150      (1,064

Other financial expenses

     (29      (21
  

 

 

    

 

 

 

Financial expense (cash)

     (1,179      (1,085
  

 

 

    

 

 

 

Non-cash financial income / (expense)

     (1,940      10,720   

Non-cash financial expense – accretion interest

     (180      (208
  

 

 

    

 

 

 

Non-cash financial income / (expense)

     (2,120      10,512   
  

 

 

    

 

 

 

Net financial income / (expense)

     (3,087      9,631   
  

 

 

    

 

 

 

Financial income increased to $212,000 from $204,000 in the equivalent quarter last year. This was primarily due to improved interest rates.

Financial expenses primarily consist of the cash interest payable on the company’s Exchangeable Notes, which amounts to $1.15m per quarter.

Non-cash financial income represents adjustments required to the fair value of the derivatives embedded in the exchangeable notes along with an amount to accrete the fair value of the debt liability back to its nominal value ($115 million) over the term of the debt using an effective interest rate methodology. For Q3, 2016, the fair value adjustment to the value of the embedded derivatives was a charge to the income statement of $1.9m.

The loss before tax for the period was $0.4m, though this was largely impacted by non-cash charges related to the Exchangeable Notes. Excluding these non-cash items, the profit before tax for the quarter was $1.8m.

The tax charge for Q3, 2016 was $0.1m, an effective tax rate of 8.5% on the profit for the quarter excluding non-cash charges.

The loss after tax for the period was $0.5m. However, excluding the non-cash elements of the Exchangeable Notes, this would have been a profit of $1.6m, which equates to an adjusted EPS of 7.0 cents. This compares to $1.8m and an adjusted EPS of 7.5 cents in Q3, 2015. Diluted EPS for the quarter amounted to 9.7 cents, which is consistent with the equivalent quarter in 2015.

The above results do not reflect the impact of the decisions to withdraw the Meritas Troponin submission from the FDA and to close the company’s facility in Uppsala, Sweden as both of these events occurred after the quarter end. It is expected that the company will record an impairment charge of in excess of $50m in relation to the costs incurred on the Meritas project as well as a provision for closure costs associated with the Swedish facility. Both of these will be reflected in the company’s Q4 income statement.


Cash generated from operations during the quarter was $5.6m, though this was offset by capital expenditure of $5.6m and interest and tax payments of $0.2m, resulting in a net cash outflow for the quarter of under $0.2m. This resulted in a cash balance at the end of the quarter of $84.8m.

Earnings before interest, tax, depreciation, amortisation and share option expense for the quarter was $4.6m.

Meritas – withdrawal of FDA submission

On October 4, 2016 Trinity Biotech announced that it was withdrawing its 510(k) premarket notification submission for the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer. This followed a meeting with the FDA, where they asked Trinity to consider withdrawing its submission due to their concerns about clinical performance. These concerns focussed on the analyzer’s operating temperature range and the inconsistency of the test’s performance with the most recently cleared laboratory Troponin test.

Given these concerns, the company decided to withdraw the submission and to cease development of its Troponin product for the U.S. market. It was felt that, even after carrying out additional development work on the product, which would be both lengthy and likely to cost an additional $20-30m, there was insufficient certainty that its performance could ever match a recently approved laboratory Troponin test. As a consequence of this, the company also decided not to submit its Meritas BNP test for heart failure to the FDA, as this was being developed as a sister product for Troponin.

The Meritas platform has many potential applications in the point-of-care arena, and thus the company has embarked on an internal review process to determine the best future opportunity for this technically excellent platform. This process is expected to take between 9 and 12 months. In conjunction with this, the Company will close its facility in Uppsala, Sweden and transfer the technology to its headquarters in Bray, Ireland.

In its Q4 income statement, the company expects to recognise an impairment charge in excess of $50m reflecting the costs incurred on the Meritas platform to date plus an additional provision for closure costs in relation to the Swedish facility.

Comments

Commenting on the results, Kevin Tansley, Chief Financial Officer, said “Operating profit this quarter was $2.7m, which whilst lower than the equivalent quarter last year, did represent an improvement compared to our more recent quarters. This was driven by improved top line performance. Whilst our gross margin remains under pressure, mainly due to product mix and carry over currency factors, higher revenues combined with control over indirect costs has resulted in an operating margin of over 10%. Meanwhile, our diluted EPS for the quarter remained consistent at 9.7 cents per ADR.”

Ronan O’Caoimh, CEO of Trinity said “The last few weeks have been difficult for the company. We had invested considerable time and effort in developing our Troponin test on the Meritas platform and it was extremely frustrating that, even with its clear performance advantages over its competitors, FDA approval was not forthcoming. Following this we have taken decisive action. We are closing our facility in Sweden, resulting in 40 redundancies and transferring the technology to our Bray facility. Once all closure costs have been incurred, this will result in a reduction in expenditure on the platform from $9m p.a. to $1.5m p.a. thus returning the company to a near break-even cash flow position. We also believe that the excellent technical performance of Meritas still makes this a valuable platform. In the months ahead we will look closely at a wide range of alternatives with a view to maximising this value. This will include looking at alternative menus and/or collaborations with third parties.


In the meantime, we will focus on expanding our core business which has a number of growth drivers. In particular, we will continue to place large numbers of Premier instruments in an ever increasing number of countries, thus building market share. We will also increase our penetration of the haemoglobin variant market with our newly launched Premier Resolution instrument. We will continue to grow our autoimmune business, building on our growth of product sales and reference laboratory services. We are also determined to expand our HIV franchise in Africa. Having already conquered the confirmatory market, we will now look to enter the higher volume screening market.

Whilst we will continue to look for highly synergistic and earnings accretive acquisitions, I believe that at our current share price, buying back our own shares represents the best deployment of capital at this juncture. This, coupled with the growth opportunities inherent in our existing business, will enhance our earnings capacity and drive shareholder value”.

Forward-looking statements in this release are made pursuant to the “safe harbor” provision of the Private Securities 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

September 30,

2016

(unaudited)

   

Three Months

Ended

September 30,

2015

(unaudited)

   

Nine Months

Ended

September 30,

2016

(unaudited)

   

Nine Months

Ended

September 30,

2015

(unaudited)

 

Revenues

     26,127        25,761        75,931        75,258   

Cost of sales

     (14,460     (13,776     (42,316     (39,780
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     11,667        11,985        33,615        35,478   

Gross profit %

     44.7     46.5     44.3     47.1

Other operating income

     70        73        211        222   

Research & development expenses

     (1,296     (1,293     (3,711     (3,560

Selling, general and administrative expenses

     (7,487     (7,467     (22,245     (20,467

Indirect share based payments

     (236     (327     (971     (1,357
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating profit

     2,718        2,971        6,899        10,316   

Financial income

     212        204        657        299   

Financial expenses

     (1,179     (1,085     (3,545     (2,279

Non-cash financial income / (expense)

     (2,120     10,512        (3,308     11,490   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net financing income / (expense)

     (3,087     9,631        (6,196     9,510   
  

 

 

   

 

 

   

 

 

   

 

 

 

Profit / (loss) before tax

     (369     12,602        703        19,826   

Income tax expense

     (148     (339     (462     (858
  

 

 

   

 

 

   

 

 

   

 

 

 

Profit / (loss) for the period

     (517     12,263        241        18,968   
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings per ADR (US cents)

     (2.3     52.9        1.0        82.0   

Earnings per ADR excluding non-cash financial income (US cents)

     7.0        7.5        15.4        32.3   

Diluted earnings per ADR (US cents)

     9.7     9.7        24.6     35.7   

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

     22,797,208        23,202,228        23,032,885        23,128,287   

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

     28,379,444        28,766,691        28,452,580        27,059,058   

 

* Under IAS 33 Earnings per Share, diluted earnings per share cannot be anti-dilutive. Therefore, diluted earnings per ADR in accordance with IFRS would be 1.0 cents for the year to date, and a loss of 2.3 cents for the quarter (i.e. equal to basic earnings per ADR).

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,

2016

US$ ‘000

(unaudited)

   

June 30,

2016

US$ ‘000

(unaudited)

   

March 31,

2016

US$ ‘000

(unaudited)

   

Dec 31,

2015

US$ ‘000

(audited)

 

ASSETS

        

Non-current assets

        

Property, plant and equipment

     21,495        21,760        21,460        20,659   

Goodwill and intangible assets

     173,240        169,049        165,157        161,324   

Deferred tax assets

     13,531        13,312        13,096        12,792   

Other assets

     849        932        860        954   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total non-current assets

     209,115        205,053        200,573        195,729   
  

 

 

   

 

 

   

 

 

   

 

 

 

Current assets

        

Inventories

     39,989        39,253        35,709        35,125   

Trade and other receivables

     25,802        27,832        26,260        25,602   

Income tax receivable

     811        712        664        550   

Cash and cash equivalents

     84,751        84,920        96,829        101,953   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total current assets

     151,353        152,717        159,462        163,230   
  

 

 

   

 

 

   

 

 

   

 

 

 

TOTAL ASSETS

     360,468        357,770        360,035        358,959   
  

 

 

   

 

 

   

 

 

   

 

 

 

EQUITY AND LIABILITIES

        

Equity attributable to the equity holders of the parent

        

Share capital

     1,222        1,221        1,220        1,220   

Share premium

     15,801        15,575        15,521        15,526   

Accumulated surplus

     197,379        197,588        199,453        201,951   

Other reserves

     (4,002     (3,721     (3,723     (4,809
  

 

 

   

 

 

   

 

 

   

 

 

 

Total equity

     210,400        210,663        212,471        213,888   
  

 

 

   

 

 

   

 

 

   

 

 

 

Current liabilities

        

Income tax payable

     772        657        1,026        1,163   

Trade and other payables

     19,976        19,384        19,195        18,874   

Provisions

     75        75        75        75   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total current liabilities

     20,823        20,116        20,296        20,112   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-current liabilities

        

Exchangeable senior note payable

     101,351        99,232        100,073        98,044   

Other payables

     1,939        1,986        2,057        2,096   

Deferred tax liabilities

     25,955        25,773        25,138        24,819   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total non-current liabilities

     129,245        126,991        127,268        124,959   
  

 

 

   

 

 

   

 

 

   

 

 

 

TOTAL LIABILITIES

     150,068        147,107        147,564        145,071   
  

 

 

   

 

 

   

 

 

   

 

 

 

TOTAL EQUITY AND LIABILITIES

     360,468        357,770        360,035        358,959   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

September 30,

2016

(unaudited)

   

Three Months

Ended

September 30,

2015

(unaudited)

   

Nine Months

Ended

September 30,

2016

(unaudited)

   

Nine Months

Ended

September 30,

2015

(unaudited)

 

Cash and cash equivalents at beginning of period

     84,920        110,257        101,953        9,102   

Operating cash flows before changes in working capital

     5,164        3,851        12,950        14,279   

Changes in working capital

     393        (166     (3,469     (8,504
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash generated from operations

     5,557        3,685        9,481        5,775   

Net Interest and Income taxes paid

     (171     (108     (263     (440

Capital Expenditure & Financing (net)

     (5,555     (4,290     (16,982     (15,623
  

 

 

   

 

 

   

 

 

   

 

 

 

Free cash flow

     (169     (713     (7,764     (10,288

Share buyback

     —          —          (6,026     —     

Payment of HIV-2 licence fee

     —          —          (1,112     —     

30 year Convertible Note interest payment

     —          —          (2,300     —     

30 year Convertible Note proceeds, net of fees

     —          (156     —          110,574   

Dividend payment

     —          (5,099     —          (5,099
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at end of period

     84,751        104,289        84,751        104,289   
  

 

 

   

 

 

   

 

 

   

 

 

 

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: October 25, 2016.