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TRIB Trinity Biotech

Filed: 17 Nov 20, 12:19pm


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 Profit9.1
Depreciation0.4
Amortisation0.3
Share Option Expense0.2
EBITDASO10.0

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