6-K 1 zk2025167.htm 6-K

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 November, 2020

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 November 17, 2020

Contact:   Trinity Biotech plc          
   Kevin Tansley          
  (353)-1-2769800          
   E-mail: kevin.tansley@trinitybiotech.com

Trinity Biotech Announces Results for Q3, 2020

DUBLIN, Ireland (November 17, 2020)…. 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, 2020.

Quarter 3 Results

Total revenues for Q3, 2020 were $32.0m, which is broken down as follows:

   
2019
Quarter 3
    
2020
Quarter 3
    
Change
  
   
US$’000
    
US$’000
    
%
  
Point-of-Care
    
3,880
      
2,065
      
(46.8
)%
Clinical Laboratory
    
20,714
      
29,949
      
44.6
%
Total
    
24,594
      
32,014
      
30.2
%

Point-of-Care revenues for Q3, 2020 decreased from $3.9m to $2.1m. Whilst $2.1m represents a 63% increase compared to Q2, 2020, HIV revenues continue to be impacted by logistical and testing constraints arising from Covid-19.  The reduction compared with last year also reflects that Q3, 2019 was an unusually high quarter for point-of-care revenues.

Meanwhile, Clinical Laboratory sales for the quarter increased from $20.7m to $29.9m, an increase of 45%. During the quarter, all of the Company’s product lines recovered significantly from Q2, 2020 levels which had reflected the most severe impact of Covid-19.  However, as expected revenues in Q3, 2020 did not return fully to pre-Covid levels mainly due to the temporary deferral of Diabetes instrument purchases and lower testing volumes at our Autoimmunity laboratory in Buffalo. Meanwhile, this was more than offset by strong sales of Covid-19 related products which includes our FDA approved PCR Viral Transport Media product, Covid-19 IgG ELISA antibody test, monoclonal antibodies (through our life science supply business, Fitzgerald) in addition to the boost in demand for the Company’s rapid respiratory products, Strep Pneumoniae and Legionella Urinary Antigen.

The gross margin for the quarter was 52.4%, which compares to 41.0% in Q3, 2019. This increase was largely due to the impact of Covid-19 related sales, fewer instrument placements and lower depreciation.

Research and Development expenses increased slightly from $1.2m in Q3, 2019 to $1.3m in Q3, 2020. Meanwhile, Selling, General and Administrative (SG&A) expenses decreased from $7.3m to $6.3m in Q3, 2020. The decrease in SG&A expenses was due to cost saving measures which were implemented in response to the pandemic, and included reduced travel costs and cancellation of trade shows and other marketing activities.

Operating profit increased from $1.3m to $9.1m for the quarter, representing close to a sevenfold increase compared to the same period last year. This was due to the impact of higher revenues and improved gross margin combined with the reduction in indirect expenses during the quarter.

Financial income for the quarter showed a reduction reflecting the lower level of cash deposits and reduced interest rates. Meanwhile, Financial Expenses amounted to $1.2m, which was in line with Q3, 2019. Of this, $1.0m related to interest payable on the Company’s Exchangeable Notes, with the remaining $0.2m representing notional financing charges arising on leased assets (IFRS 16).  Meanwhile, a non-cash expense of $0.2m was recognised in this quarter’s income statement, in relation to a non-cash interest charge on the Exchangeable Notes.

Overall, the Company recorded a profit of $7.3m for the quarter, which equates to an earnings per share of 35.0 cents.  Fully diluted EPS for the quarter was 32.2 cents compared to 4.3 cents in Q3, 2019.

EBITDA before share option expense (EBITDASO) for the quarter was $10m.

 
$m
Operating Profit
9.1
Depreciation
0.4
Amortisation
0.3
Share Option Expense
0.2
EBITDASO
10.0

Covid-19 Update

ELISA Antibody Test

During the quarter the Company filed its submission to the FDA for an Emergency Use Authorization (EUA) for its Covid-19 IgG ELISA antibody test and is currently awaiting authorisation.  However, as permitted under EUA regulations the Company has already launched this product for sale in the USA pending authorisation being granted.  Meanwhile, the Company expects to obtain a CE Mark for the product during November thus allowing sales to commence in the European Union.

This test determines which individuals within the population have been exposed to the SARS-CoV-2 virus (Covid-19) and demonstrates impressive performance with specificity in excess of 98% and sensitivity in excess of 95%, in samples of 14 days or more from symptom onset.

The product is being manufactured at our ELISA production facility in Jamestown, New York and is capable of being run on a wide range of instrumentation platforms allowing access to virtually every testing laboratory in the world.

Rapid Antibody Test

The Company is continuing to develop a rapid Point-of-Care Covid-19 test to detect antibodies to the virus that can be run in 12 minutes using one drop of blood procured by finger prick. Development of this product is expected to be completed by the middle of Q1, 2021 at which point it is intended to avail of the FDA’s EUA pathway in order allow its sale in the USA.  As in the case of the ELISA antibody test this will be followed by seeking a CE mark for the product in order to provide access to EU markets.

Viral Transport Media

Sales of the Company’s Viral Transport Media product, Flextrans, which is used in the Covid-19 sample collection process for PCR molecular testing, remains very strong.  Demand for this product is expected to continue for the remainder of 2020 and into 2021 as PCR testing volumes remain significant. Consequently, the Company has scaled up the manufacturing of this product at a number of its facilities.

Cost Saving Measures

As demand for the Company’s products is now returning towards pre-Covid levels, the vast majority of the Company’s employees have returned to work following extensive furloughing during Q2, 2020 and all plants are now operating normally. In the light of the continuation of the pandemic, the Company is keeping in place a range of cost-cutting measures designed to minimize discretionary expenditure.  Meanwhile, the Company has commenced the process of seeking forgiveness for the $4.5m of loans received under the U.S. government’s Paycheck Protection Program.  This process is expected to take a number of weeks and be finalized in late 2020 or early 2021.  Whilst the Company expects that the loans will be forgiven in full, this has not yet been recognized in the financial statements pending completion of the forgiveness process.

Appointment of Chief Financial Officer

The Company is pleased to announce the appointment of John Gillard as Chief Financial Officer of the Company.  John qualified as a Chartered Accountant with PWC and has since gained a wealth of financial experience across a number of industry sectors including senior positions in Alphabet Inc./Google, SSE Plc and ION Investment Group.

Kevin Tansley will remain with the Company until the end of the year in order to allow for an effective transition.

Comments

Commenting on the results, Kevin Tansley, Chief Financial Officer, said “Very strong revenues and higher gross margins combined to deliver a sevenfold increase in operating profit this quarter. Whilst sales of Covid related products were the principal driving force behind this increase, we are also seeing the impact of the closure of our Carlsbad facility as well as the benefit of lower indirect costs due to cost control measures.  Meanwhile EBITDASO also increased strongly to $10m for the quarter. This resulted in an increase of $4.3m in our cash balances though cash inflows were partly impacted by adverse working capital movements associated with the step change in our revenues.”

Ronan O’Caoimh, CEO said “Revenues were very strong this quarter, particularly our Clinical Laboratory revenues which grew by 45%.  This was driven by strong demand for our Covid-19 related products which includes our Viral Transport Media product, ELISA antibody test, monoclonal antibodies sold by Fitzgerald as well as our rapid respiratory products, demand for which have increased during the pandemic.

In addition to the strong growth in Covid related products, our remaining business rebounded strongly from Q2, 2020 levels which had been severely impacted by the first wave of the pandemic. However, during Q3, 2020 we still experienced the continuation of some these adverse impacts particularly in relation to fewer Diabetes instrument sales and lower levels of Autoimmunity testing.  In addition, whilst HIV testing in Africa continues to be affected by the pandemic, the decrease in HIV revenues this quarter was more attributable to the particularly strong sales in Q3, 2019.

We expect that Q4, 2020 revenues will show a further return towards pre-Covid levels combined with continued strong demand for Covid related products, demand for which is anticipated to continue well into 2021 and potentially beyond.”

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,
2020
(unaudited)
    
Three Months Ended
September 30,
2019
(unaudited)
    
Nine Months
Ended
September 30,
2020
(unaudited)
    
Nine Months
Ended
September 30,
2019
(unaudited)
  
                         
Revenues
    
32,014
      
24,594
      
69,215
      
69,117
  
                                 
Cost of sales
    
(15,238
)
    
(14,523
)
    
(36,292
)
    
(40,270
)
                                 
Gross profit
    
16,776
      
10,071
      
32,923
      
28,847
  
Gross margin %
    
52.4
%
    
41.0
%
    
47.6
%
    
41.7
%
                                 
Other operating income
    
3
      
21
      
20
      
67
  
                                 
Research & development expenses
    
(1,265
)
    
(1,233
)
    
(3,796
)
    
(3,994
)
Selling, general and administrative expenses
    
(6,273
)
    
(7,274
)
    
(17,364
)
    
(20,455
)
Indirect share based payments
    
(156
)
    
(252
)
    
(504
)
    
(609
)
                                 
Operating profit
    
9,085
      
1,333
      
11,279
      
3,856
  
                                 
Financial income
    
3
      
104
      
37
      
376
  
Financial expenses
    
(1,215
)
    
(1,226
)
    
(3,668
)
    
(3,703
)
Net financing expense
    
(1,212
)
    
(1,122
)
    
(3,631
)
    
(3,327
)
                                 
Profit before tax & non-cash financial income / (expense)
    
7,873
      
211
      
7,648
      
529
  
                                 
Income tax expense
    
(387
)
    
(114
)
    
(549
)
    
(5,875
)
Profit/(Loss) for the period before non-cash financial income / (expense)
    
7,486

   
97
   
7,099
   
(5,346)
                                 
 Non-cash financial (expense)/income    
(161
 )
   
(72
 )
   
(1,038
 )
   
(245
 )
 Once-off items – plant closure costs     -
       -       (2425
)
      -  
                                 
Profit/(Loss) after tax and once-off items
    
7,325
      
25
      
3,636
      
(5,591
)
                                 
Earnings/(Loss) per ADR (US cents)
    
35.0
      
0.1
      
17.4
      
(26.8
)
Earnings/(Loss) per ADR excluding once-off charges & non-cash financial items (US cents)
    
35.8
      
0.5
      
34.0
      
(25.6
)
                                 
Diluted earnings per ADR (US cents)*
    
32.2
      
4.3
      
39.0
      
(9.2
)
                                 
Weighted average no. of ADRs used in computing basic earnings per ADR
    
20,901,703
      
20,901,703
      
20,901,703
      
20,901,703
  
                                 
Weighted average no. of ADRs used in computing diluted earnings per ADR
    
26,321,307
      
25,467,517
      
25,894,218
      
25,467,517
  

* 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. Diluted EPS is calculated excluding once-off charges & non-cash financial items.

 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,
2020
US$ ‘000
(unaudited)
    
June 30,
2020
US$ ‘000
(unaudited)
    
Mar 31,
2020
US$ ‘000
(unaudited)
    
Dec 31,
2019
US$ ‘000
(unaudited)
  
ASSETS
                        
Non-current assets
                        
Property, plant and equipment
    
9,462
      
9,297
      
9,210
      
9,290
  
Goodwill and intangible assets
    
47,876
      
46,751
      
45,498
      
43,654
  
Deferred tax assets
    
5,981
      
6,613
      
6,465
      
6,252
  
Other assets
    
387
      
378
      
485
      
485
  
Total non-current assets
    
63,706
      
63,039
      
61,658
      
59,681
  
                                 
Current assets
                                
Inventories
    
29,607
      
31,473
      
32,671
      
32,021
  
Trade and other receivables
    
21,658
      
17,048
      
19,982
      
20,987
  
Income tax receivable
    
1,194
      
1,598
      
1,572
      
1,982
  
Cash and cash equivalents
    
19,910
      
15,570
      
13,244
      
16,400
  
Total current assets
    
72,369
      
65,689
      
67,469
      
71,390
  
                                 
TOTAL ASSETS
    
136,075
      
128,728
      
129,127
      
131,071
  
                                 
EQUITY AND LIABILITIES
                                
Equity attributable to the equity holders of the parent
                                
Share capital
    
1,213
      
1,224
      
1,224
      
1,224
  
Share premium
    
16,187
      
16,187
      
16,187
      
16,187
  
Accumulated surplus
    
15,665
      
8,194
      
9,431
      
11,514
  
Other reserves
    
(25,994
)
    
(26,317
)
    
(26,074
)
    
(24,212
)
Total equity
    
7,071
      
(712
)
    
768
      
4,713
  
                                 
Current liabilities
                                
Income tax payable
    
765
      
373
      
374
      
48
  
Trade and other payables
    
22,281
      
22,327
      
21,639
      
19,351
  
Provisions
    
50
      
50
      
50
      
50
  
Total current liabilities
    
23,096
      
22,750
      
22,063
      
19,449
  
                                 
Non-current liabilities
                                
Exchangeable senior note payable
    
83,063
      
82,902
      
82,185
      
82,025
  
Other payables
    
16,786
      
16,531
      
17,039
      
17,745
  
Deferred tax liabilities
    
6,059
      
7,257
      
7,072
      
7,139
  
Total non-current liabilities
    
105,908
      
106,690
      
106,296
      
106,909
  
                                 
TOTAL LIABILITIES
    
129,004
      
129,440
      
128,359
      
126,358
  
                                 
TOTAL EQUITY AND LIABILITIES
    
136,075
      
128,728
      
129,127
      
131,071
  

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,
2020
(unaudited)
    
Three Months
Ended
September 30,
2019
(unaudited)
    
Nine Months
Ended
September 30,
2020
(unaudited)
    
Nine Months
Ended
September 30,
2019
(unaudited)
  
                         
Cash and cash equivalents at beginning of period
    
15,570
      
24,990
      
16,400
      
30,277
  
                                 
Operating cash flows before changes in working capital
    
9,722
      
3,184
      
13,501
      
9,495
  
Changes in working capital
    
(2,551
)
    
1,631
      
(2,476
)
    
(475
)
Cash generated from operations
    
7,171
      
4,815
      
11,025
      
9,020
  
                                 
Net Interest and Income taxes (paid)/received
    
(141
)
    
(181
)
    
256
      
34
  
                                 
Capital Expenditure & Financing (net)
    
(1,900
)
    
(3,776
)
    
(6,820
)
    
(9,970
)
                                 
Payments for leases (IFRS 16)
    
(790
)
    
(758
)
    
(2,361
)
    
(2,273
)
                                 
Free cash flow
    
4,340
      
100
      
2,100
      
(3,189
)
                                 
Payment of HIV/2 License Fee
    
-
      
-
      
(1,112
)
    
-
  
                                 
30 year Exchangeable Note interest payment
    
-
      
-
      
(1,998
)
    
(1,998
)
                                 
Proceeds received under Paycheck Protection Program
    
-
      
-
      
4,520
      
-
  
                                 
Cash and cash equivalents at end of period
    
19,910
      
25,090
      
19,910
      
25,090
  

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:  17 November 2020