SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 

 
F O R M  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, 2018

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-                 


   
   
Press Release dated October 23, 2018
 
   
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
 
 
Trinity Biotech Announces Results for Q3, 2018
 
DUBLIN, Ireland (October 23, 2018)…. 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, 2018.

Quarter 3 Results

Total revenues for Q3, 2018 were $23.7m, which is broken down as follows:

 
2017
Quarter 3
2018
Quarter 3
 
Change
 
US$’000
US$’000
%
Point-of-Care
4,598
3,005
-34.6%
Clinical Laboratory
21,006
20,707
-1.4%
Total
25,604
23,712
-7.4%
 
Point-of-Care revenues for Q3, 2018 decreased from $4.6m to $3.0m. This was due to lower HIV sales in Africa due to normal fluctuations in ordering patterns in this market. The decrease is accentuated by the fact that Q3, 2017 point-of-care revenues were higher than average for the same reason.

Meanwhile, Clinical Laboratory sales for the quarter were $20.7m compared to $21.0m for the corresponding period last year, thus representing a decrease of 1.4%.  However, excluding the impact of currency movements and primarily the weak Brazilian Real, Q3 Clinical Laboratory revenues would have increased by 0.4%. During the quarter both Premier and autoimmunity revenues continued to increase, though this was offset by lower infectious diseases revenues in the USA, including Lyme revenues.

The gross margin for the quarter was 42.1%, which compares to 43% in Q3, 2017. This decrease is largely due to lower overall revenues, particularly in the case of point-of-care, which are higher margin products. It was also significantly impacted by currency factors, in particular the weakness of the Brazilian Real. Meanwhile, the decrease was partially offset by cost reductions introduced as part of the company’s recent cost saving program.  Whilst the gross margin was lower this quarter, the year-to-date gross margin has increased from 42.5% to 43.0%.

Research and Development expenses decreased from $1.5m in Q3, 2017 to $1.3m in Q3, 2018. Meanwhile, Selling, General and Administrative (SG&A) expenses decreased from $7.8m to $7.1m in Q3, 2018. SG&A costs had already been trending downwards, in the first half of 2018 and this further decrease in Q3, 2018 reflects the impact of the recently announced cost savings program and as well as the gain which arose on the exchangeable notes repurchased during the quarter.

Operating profit for the quarter decreased from $1.5m to $1.2m. This was due to the combined impact of lower revenues and gross margins partially offset by the lower indirect costs incurred during the quarter.



The interest expense, which arises mainly on the Company’s exchangeable notes, reduced by $107,000 to $1,061,000.  This reduction was due to the repurchase of $15m of exchangeable notes during the quarter (see below). Further non-cash income of $0.6m was recognised in this quarter’s income statement, again in relation to the exchangeable notes.  This was due to a non-cash interest charge of $0.2m which was offset by a gain of $0.8m arising on a decrease in the fair value of the derivatives embedded in these notes.

Meanwhile, financial income reduced by $37,000 to $175,000 due to the lower level of cash deposits.

Overall, the Company recorded a profit of $0.9m for the quarter, which equates to earnings per share of 4.3 cents.  However, excluding non-cash items the profit for the quarter was $0.3m or an EPS of 1.3 cents. Fully diluted EPS for the quarter was 5.1 cents compared to 6.3 cents in Q3, 2017.

EBITDA before share option expense for the quarter was $2.8m.

Exchangeable Notes Repurchase

On 1 August 2018, the company repurchased $15.1m of its exchangeable notes in the open market for $12m representing a price of 79.75% of nominal value. This resulted in a net gain of approximately $0.4m in the income statement this quarter relating to this buyback. This comprises a cash gain of $3.1m on the repurchase, partly offset by non-cash items - acceleration of non-cash accretion interest and the write-off of the value of the embedded derivative portion of the repurchased notes.

Following this repurchase, $99.9m of exchangeable notes remain outstanding and the annual cash interest expense on the exchangeable notes has now reduced from $4.6m to $4.0m p.a.

FDA Approvals

Trinity Biotech has received two FDA approvals for HEp-2 Elite and Immulisa RNA Polymerase III, both of which were developed at our Buffalo facility.  These products are an enhancement to our already extensive autoimmunity product and laboratory testing range. Our HEp-2 Elite provides a superior screening method for antinuclear antibodies. Meanwhile, RNA Polymerase III is a highly specific biomarker for the diagnosis of systemic sclerosis.

Comments

Commenting on the results, Kevin Tansley, Chief Financial Officer, said “This quarter we saw a decrease in revenues and gross margins.  Margins were lower due to the decrease in overall revenues given the fixed nature of our cost base and also due to the reduction in higher margin Point-of-Care sales. It was also heavily impacted by a significant fall in the value of the Brazilian Real. However, margins for the year to date are running at a higher level than at this point last year. Also from a positive perspective, indirect costs were $0.7m lower than the comparative quarter. This was due to the combination of our recent cost savings measures and the profit on the repurchase of our exchangeable notes during the quarter.  Our improved margin profile and lower cost base puts us in an enhanced financial position going into 2019.”

Ronan O’Caoimh, CEO said “Whilst our revenues were lower this quarter we are continuing to see revenue growth in our key haemoglobins and autoimmune revenues lines. With the rollout of Premier Resolution and a new version of our haemoglobin point-of-care device Tri-stat, as well as a greater emphasis on autoimmunity product sales, we expect that this revenue growth will accelerate in 2019. Whilst it was obviously disappointing that HIV revenues were weaker this quarter, we are pleased to be able to say that this is due to the unpredictable nature of NGO purchasing rather than any underlying loss of market share.




During the quarter, we repurchased $15.1m of our exchangeable notes for cash consideration of $12m.  In so doing, we were taking advantage of the discount versus nominal values at which the notes have been trading, thus achieving an effective cash saving of $3.1m in the process. It will also result in a reduction in the interest charge on the notes of $0.6m p.a.  Following the transaction the nominal value of our notes now stands at just under $100m.”

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,
2018
(unaudited)
   
Three Months
Ended
September 30,
2017
(unaudited)
   
Nine Months
Ended
September 30,
2018
(unaudited)
   
Nine Months
Ended
September 30,
2017
(unaudited)
 
                         
Revenues
   
23,712
     
25,604
     
72,512
     
74,588
 
                                 
Cost of sales
   
(13,731
)
   
(14,606
)
   
(41,296
)
   
(42,889
)
                                 
Gross profit
   
9,981
     
10,998
     
31,216
     
31,699
 
Gross margin %
   
42.1
%
   
43.0
%
   
43.0
%
   
42.5
%
                                 
Other operating income
   
27
     
25
     
76
     
73
 
                                 
Research & development expenses
   
(1,292
)
   
(1,469
)
   
(3,983
)
   
(4,119
)
Selling, general and administrative expenses
   
(7,113
)
   
(7,761
)
   
(21,412
)
   
(22,341
)
Indirect share based payments
   
(367
)
   
(265
)
   
(1,130
)
   
(644
)
                                 
Operating profit
   
1,236
     
1,528
     
4,767
     
4,668
 
                                 
Financial income
   
175
     
212
     
577
     
584
 
Financial expenses
   
(1,061
)
   
(1,168
)
   
(3,378
)
   
(3,506
)
Net financing expense
   
(886
)
   
(956
)
   
(2,801
)
   
(2,922
)
                                 
Profit before tax & non-cash financial income / (expense)
   
350
     
572
     
1,966
     
1,746
 
                                 
Income tax expense
   
(76
)
   
(56
)
   
(366
)
   
(331
)
                                 
Profit for the period before non-cash financial income / (expense)
   
274
     
516
     
1,600
     
1,415
 
                                 
Non-cash financial income / (expense)    
622
     
(71
)
   
268
     
1,178
 
                               
Profit after tax and once-off items
   
896
     
445
     
1,868
     
2,593
 
                                 
Earnings per ADR (US cents)
   
4.3
     
2.1
     
8.9
     
11.9
 
                                 
Earnings per ADR excluding non-cash financial income/expense (US cents)
   
1.3
     
2.4
     
7.6
     
6.5
 
                                 
Diluted earnings per ADR (US cents)*
   
5.1
     
6.3
     
18.9
     
18.0
 
                                 
Weighted average no. of ADRs used in computing basic earnings per ADR
   
20,901,703
     
21,379,422
     
20,902,386
     
21,773,874
 
                                 
Weighted average no. of ADRs used in computing diluted earnings per ADR
   
26,157,644
     
26,636,857
     
26,158,326
     
27,031,396
 

* Under IAS 33 Earnings per Share, diluted earnings per share cannot be anti-dilutive. In a reporting period where it is anti-dilutive, diluted earnings per ADR should be constrained to equal 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,
2018
US$ ‘000
(unaudited)
   
June 30,
2018
US$ ‘000
(unaudited)
   
March 31,
2018
US$ ‘000
(unaudited)
   
Dec 31,
2017
US$ ‘000
(audited)
 
ASSETS
                       
Non-current assets
                       
Property, plant and equipment
   
10,046
     
7,769
     
7,033
     
5,800
 
Goodwill and intangible assets
   
69,804
     
68,263
     
66,474
     
64,754
 
Deferred tax assets
   
9,342
     
9,047
     
8,968
     
8,698
 
Other assets
   
656
     
701
     
779
     
771
 
Total non-current assets
   
89,848
     
85,780
     
83,254
     
80,023
 
                                 
Current assets
                               
Inventories
   
32,888
     
34,818
     
34,179
     
32,805
 
Trade and other receivables
   
23,380
     
23,138
     
22,118
     
20,740
 
Income tax receivable
   
1,532
     
1,287
     
1,234
     
1,440
 
Cash and cash equivalents
   
35,679
     
49,426
     
53,895
     
57,607
 
Total current assets
   
93,479
     
108,669
     
111,426
     
112,592
 
TOTAL ASSETS
   
183,327
     
194,449
     
194,680
     
192,615
 
                                 
EQUITY AND LIABILITIES
                               
Equity attributable to the equity holders of the parent
                               
Share capital
   
1,224
     
1,224
     
1,224
     
1,224
 
Share premium
   
16,187
     
16,187
     
16,187
     
16,187
 
Accumulated surplus
   
48,325
     
47,430
     
46,837
     
46,157
 
Other reserves
   
2,347
     
1,853
     
1,529
     
1,628
 
Total equity
   
68,083
     
66,694
     
65,777
     
65,196
 
                                 
Current liabilities
                               
Income tax payable
   
135
     
252
     
344
     
310
 
Trade and other payables
   
20,682
     
20,494
     
21,761
     
20,870
 
Provisions
   
50
     
50
     
50
     
50
 
Total current liabilities
   
20,867
     
20,796
     
22,155
     
21,230
 
                                 
Non-current liabilities
                               
Exchangeable senior note payable
   
82,051
     
95,179
     
95,167
     
94,825
 
Other payables
   
498
     
341
     
453
     
532
 
Deferred tax liabilities
   
11,828
     
11,439
     
11,128
     
10,832
 
Total non-current liabilities
   
94,377
     
106,959
     
106,748
     
106,189
 
TOTAL LIABILITIES
   
115,244
     
127,755
     
128,903
     
127,419
 
TOTAL EQUITY AND LIABILITIES
   
183,327
     
194,449
     
194,680
     
192,615
 
 
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,
2018
(unaudited)
   
Three Months
Ended
September 30,
2017
(unaudited)
   
Nine Months
Ended
September 30,
2018
(unaudited)
   
Nine Months
Ended
September 30,
2017
(unaudited)
 
                         
Cash and cash equivalents at beginning of period
   
49,426
     
63,977
     
57,607
     
77,109
 
                                 
Operating cash flows before changes in working capital
   
3,445
     
3,672
     
9,907
     
9,679
 
Changes in working capital
   
(512
)
   
313
     
(4,656
)
   
(2,262
)
Cash generated from operations
   
2,933
     
3,985
     
5,251
     
7,417
 
                                 
Net Interest and Income taxes (paid)/received
   
(125
)
   
86
     
49
     
324
 
                                 
Capital Expenditure & Financing (net)
   
(4,308
)
   
(3,727
)
   
(12,247
)
   
(10,559
)
                                 
Free cash flow
   
(1,500
)
   
344
     
(6,947
)
   
(2,818
)
                                 
Share buyback
   
-
     
(1,543
)
   
(434
)
   
(6,472
)
                                 
Payment of HIV-2 licence fee
   
-
     
-
     
-
     
(1,112
)
                                 
30 year Exchangeable Note interest payment
   
(205
)
   
-
     
(2,505
)
   
(2,300
)
                                 
Once-off items
   
-
     
(249
)
   
-
     
(1,878
)
                                 
Purchase of Exchangeable Notes
   
(12,042
)
   
-
     
(12,042
)
   
-
 
                                 
Cash and cash equivalents at end of period
   
35,679
     
62,529
     
35,679
     
62,529
 
 
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:  23 October 2018