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, 2019

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 16, 2019

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 Results for Q3, 2019

DUBLIN, Ireland (October 16, 2019)…. 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, 2019.

Quarter 3 Results

Total revenues for Q3, 2019 were $24.6m, which is broken down as follows:

   
2018
Quarter 3
    
2019
Quarter 3
    
Change
  
   
US$’000
    
US$’000
    
%
  
Point-of-Care
    
3,005
      
3,880
      
29.1
%
Clinical Laboratory
    
20,707
      
20,714
      
(0.0
)%
Total
    
23,712
      
24,594
      
3.7
%

Point-of-Care revenues for Q3, 2019 increased from $3.0m to $3.9m. This was due to higher HIV sales in Africa, partially offset by a reduction in U.S. HIV revenues.

Meanwhile, Clinical Laboratory sales for the quarter were $20.7m which is flat compared to the same period last year.  However, excluding the impact of currency movements, due to the strength of the U.S. dollar versus a basket of currencies in which the company invoices, Q3 Clinical Laboratory revenues would have increased by over 1%. 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 41.0%, which compares to 42.1% in Q3, 2018. This decrease was due to the impact of the higher number of instruments sold during the quarter, in addition to the strengthening of the US dollar, in particular against the Brazilian Real.

Research and Development expenses decreased from $1.3m in Q3, 2018 to $1.2m in Q3, 2019. Meanwhile, Selling, General and Administrative (SG&A) expenses increased from $7.1m to $7.3m in Q3, 2019. The increase in SG&A expenses was due to higher sales and marketing expenditure, particularly in relation to trade shows and other marketing activities plus higher professional fees associated with the settlement of the Company’s recent tax audit.

Operating profit increased by $0.1m for the quarter to $1.3m when compared to the same period last year. This was due to the impact of higher revenues being offset by a lower gross margin, whilst total indirect expenses remained flat during the quarter.

The cash based interest expense increased by $0.2m to $1.2m this quarter. Of this $1.0m was related to interest due on the Company’s Exchangeable Notes with the remaining $0.2m being financing charges arising on leased assets following the introduction of the new accounting standard for leases, IFRS 16 earlier this year.  Meanwhile, non-cash income of $0.1m 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 $0.1m arising on a decrease in the fair value of the derivatives embedded in these notes.

Financial income for the quarter saw a reduction of less than $0.1m due to the lower level of cash deposits.

Overall, the Company recorded a profit of $25,000 for the quarter, which equates to a profit per share of 0.1 cents.  Fully diluted EPS for the quarter was 4.3 cents compared to 5.1 cents in Q3, 2018.

EBITDA before share option expense (EBITDASO) for the quarter was $3.1m.

   

$m

Operating Profit
    
1.3
  
Depreciation
    
0.8
  
Amortisation
    
0.7
  
Share Option Expense
    
0.3
  
EBITDASO
    
3.1
  

Comments

Commenting on the results, Kevin Tansley, Chief Financial Officer, said “Operating profit this quarter, at $1.3m was $0.1m higher than the equivalent period last year. Whilst revenues were 4% higher, this was largely offset by the impact of a lower gross margin. Overall indirect costs for the quarter were flat quarter on quarter with an increase in SG&A expenses being offset by lower R&D and share option expense. Meanwhile our cash balance for the quarter increased by $0.1m to $25.1m. ”

Ronan O’Caoimh, CEO said “As anticipated revenues were stronger this quarter, being 4% higher than the equivalent period last year and over 9% higher than quarter 2 of this year.  Point-of-care revenues were higher due to increased sales of HIV products in Africa. Meanwhile, Autoimmune and Diabetes revenues also grew, with the latter being driven by particularly strong instrument placements during the quarter.  Further revenue growth will be derived from our entry into to the HIV screening market with our TrinSreen product, which we expect to submit to the WHO in January next, with approval to follow during 2020.  Given the quality of this product and our knowledge and experience of the African HIV market, we are ideally positioned to take a meaningful share of this substantial market.”

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,
2019
(unaudited)
    
Three Months Ended
September 30,
2018
(unaudited)
    
Nine Months
Ended
September 30,
2019
(unaudited)
    
Nine Months
Ended
September 30,
2018
(unaudited)
  
                         
Revenues
    
24,594
      
23,712
      
69,117
      
72,512
  
                                 
Cost of sales
    
(14,523
)
    
(13,731
)
    
(40,270
)
    
(41,296
)
                                 
Gross profit
    
10,071
      
9,981
      
28,847
      
31,216
  
Gross margin %
    
41.0
%
    
42.1
%
    
41.7
%
    
43.0
%
                                 
Other operating income
    
21
      
27
      
67
      
76
  
                                 
Research & development expenses
    
(1,233
)
    
(1,292
)
    
(3,994
)
    
(3,983
)
Selling, general and administrative expenses
    
(7,274
)
    
(7,113
)
    
(20,455
)
    
(21,412
)
Indirect share based payments
    
(252
)
    
(367
)
    
(609
)
    
(1,130
)
                                 
Operating profit
    
1,333
      
1,236
      
3,856
      
4,767
  
                                 
Financial income
    
104
      
175
      
376
      
577
  
Financial expenses
    
(1,226
)
    
(1,061
)
    
(3,703
)
    
(3,378
)
Net financing expense
    
(1,122
)
    
(886
)
    
(3,327
)
    
(2,801
)
                                 
Profit before tax & non-cash financial income / (expense)
    
211
      
350
      
529
      
1,966
  
                                 
Income tax expense
    
(114
)
    
(76
)
    
(5,875
)
    
(366
)
                                 
Profit/(Loss) for the period before non-cash financial income / (expense)     97
       274
      
(5,346
)
    
1,600
  
                                 
Non-cash financial (expense)/income
    
(72
)
    
622
      
(245
)
    
268
  
                                 
Profit/(Loss) after tax and once-off items
    
25
      
896
      
(5,591
)
    
1,868
  
                                 
Earnings per ADR (US cents)
    
0.1
      
4.3
      
(26.8
)
    
8.9
  
                                 
Earnings per ADR excluding non-cash financial income/expense (US cents)
    
0.5
      
1.3
      
(25.6
)
    
7.6
  
                                 
Diluted earnings per ADR (US cents)*
    
4.3
      
5.1
      
(9.2
)
    
18.9
  
                                 
Weighted average no. of ADRs used in computing basic earnings per ADR
    
20,901,703
      
20,901,703
      
20,901,703
      
20,902,386
  
                                 
Weighted average no. of ADRs used in computing diluted earnings per ADR
    
25,467,517
      
26,157,644
      
25,467,517
      
26,158,326
  

* 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,
2019
US$ ‘000
(unaudited)
    
June 30,
2019
US$ ‘000
(unaudited)
    
Mar 31,
2019
US$ ‘000
(unaudited)
    
Dec 31,
2018
US$ ‘000
(unaudited)
  
ASSETS
                        
Non-current assets
                        
Property, plant and equipment
    
26,306
      
26,293
      
26,586
      
5,362
  
Goodwill and intangible assets
    
57,948
      
56,079
      
54,377
      
52,951
  
Deferred tax assets
    
7,339
      
6,744
      
5,996
      
5,703
  
Other assets
    
555
      
591
      
535
      
558
  
Total non-current assets
    
92,148
      
89,707
      
87,494
      
64,574
  
                                 
Current assets
                                
Inventories
    
29,960
      
31,487
      
30,942
      
30,359
  
Trade and other receivables
    
24,811
      
24,333
      
23,568
      
24,441
  
Income tax receivable
    
1,243
      
1,187
      
1,209
      
1,584
  
Cash and cash equivalents
    
25,090
      
24,990
      
29,433
      
30,277
  
Total current assets
    
81,104
      
81,997
      
85,152
      
86,661
  
                                 
TOTAL ASSETS
    
173,252
      
171,704
      
172,646
      
151,235
  
                                 
EQUITY AND LIABILITIES
                                
Equity attributable to the equity holders of the parent
                                
Share capital
    
1,213
      
1,213
      
1,213
      
1,213
  
Share premium
    
16,187
      
16,187
      
16,187
      
16,187
  
Accumulated surplus
    
50,462
      
50,151
      
55,341
      
55,342
  
Other reserves
    
(28,930
)
    
(28,479
)
    
(28,573
)
    
(28,688
)
Total equity
    
38,932
      
39,072
      
44,168
      
44,054
  
                                 
Current liabilities
                                
Income tax payable
    
5,717
      
5,885
      
125
      
210
  
Trade and other payables
    
20,135
      
18,472
      
19,639
      
17,344
  
Provisions
    
50
      
50
      
50
      
50
  
Total current liabilities
    
25,902
      
24,407
      
19,814
      
17,604
  
                                 
Non-current liabilities
                                
Exchangeable senior note payable
    
81,865
      
81,793
      
81,942
      
81,620
  
Other payables
    
17,803
      
18,351
      
18,994
      
526
  
Deferred tax liabilities
    
8,750
      
8,081
      
7,728
      
7,431
  
Total non-current liabilities
    
108,418
      
108,225
      
108,664
      
89,577
  
                                 
TOTAL LIABILITIES
    
134,320
      
132,632
      
128,478
      
107,181
  
                                 
TOTAL EQUITY AND LIABILITIES
    
173,252
      
171,704
      
172,646
      
151,235
  

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,
2019
(unaudited)
    
Three Months
Ended
September 30,
2018
(unaudited)
    
Nine Months
Ended
September 30,
2019
(unaudited)
    
Nine Months
Ended
September 30,
2018
(unaudited)
  
                         
Cash and cash equivalents at beginning of period
    
24,990
      
49,426
      
30,277
      
57,607
  
                                 
Operating cash flows before changes in working capital
    
3,184
      
3,445
      
9,495
      
9,907
  
Changes in working capital
    
1,631
      
(512
)
    
(475
)
    
(4,656
)
Cash generated from operations
    
4,815
      
2,933
      
9,020
      
5,251
  
                                 
Net Interest and Income taxes (paid)/received
    
(181
)
    
(125
)
    
34
      
49
  
                                 
Capital Expenditure & Financing (net)
    
(3,776
)
    
(4,308
)
    
(9,970
)
    
(12,247
)
                                 
Payments for leases (IFRS 16)
    
(758
)
    
-
      
(2,273
)
    
-
  
                                 
Free cash flow
    
100
      
(1,500
)
    
(3,189
)
    
(6,947
)
                                 
Share buyback
    
-
      
-
      
-
      
(434
)
                                 
30 year Exchangeable Note interest payment
    
-
      
(205
)
    
(1,998
)
    
(2,505
)
                                 
Purchase of Exchangeable Notes
    
-
      
(12,042
)
    
-
      
(12,042
)
                                 
Cash and cash equivalents at end of period
    
25,090
      
35,679
      
25,090
      
35,679
  

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:  16 October 2019