Contact:
|
Trinity Biotech plc
|
Lytham Partners, LLC
|
|
John Gillard
|
Joe Diaz
|
|
(353)-1-2769800
|
(1)-602-889-9700
E-mail: investorrelations@trinitybiotech.com
|
• |
Total revenues for Q2 2022 were $18.5m.
|
• |
Excluding our Covid focused PCR Viral Transport Media (“VTM”) products, Q2 2022 revenues of $18.0m were broadly flat compared to Q2 2021 and were up 7% compared to Q1
2022. A strong YoY increase in revenues in our diabetes A1c product line revenues of over 25% offset a decline in legacy infectious disease product demand in Asia due to continuing COVID-19 lockdowns.
|
• |
Preliminary estimates for Q3 2022 indicate expected revenues of between $19m to $20m. Q3 Global Health HIV orders for Africa, which are often difficult to predict,
increased compared to Q2 2022 and we expect our HIV point of care (“PoC”) revenue to grow over 30% on a QoQ basis. Fitzgerald continues to perform well with a 25% QoQ revenue growth profile expected.
|
• |
In May 2022, the Company announced the closing of a $45.2m investment from MiCo Ltd (“MiCo”). The investment consists of an equity investment of $25.2m acquired for
$2.25 per ADS and a seven-year, unsecured junior convertible note of $20.0m with an interest rate of 1.5% and mandatory conversion price of $3.24.
|
• |
As part of its ongoing balance sheet restructuring, the Company made a partial early repayment of its term loan with the Perceptive group in May 2022. To date, this
partial repayment has saved the Company cash interest expense of $2.3m.
|
• |
In late August 2022 the Company submitted its 510k submission to the FDA seeking US regulatory approval of its Premier Resolution Haemoglobin Variants instrument.
Subject to FDA approval, commercial sales are expected to begin by Q2 2023.
|
• |
The Company is finalising the development of a lower cost, mid throughput A1c instrument that leverages the core consumables technology from our existing Premier 9210
instrument, targeting developing markets. We are also working on the launch of a clinical laboratory reader/processor range to complement our autoimmune products for a 2023 launch.
|
• |
Since World Health Organisation approval in February 2022 of our TrinScreen HIV product, the relevant Kenyan Ministry of Health task force recommended TrinScreen as
the first line screening test for Kenya’s new HIV testing algorithm.
|
• |
Platform optimisation actions to date have resulted in a more efficient workforce. Our average headcount in the six months ended June 30, 2022 was approximately 410
compared to over 500 in the six months ended June 30, 2021 and we expect total headcount to be under 400 by the end of 2022. Trinity Biotech continues to focus on improving gross margin, earnings, and cash contribution from existing
operations through focusing on operational efficiency.
|
• |
The Company is undertaking a portfolio wide capital and talent allocation review emphasising maximizing return on capital and cash contribution.
|
• |
Supply chain and commercial actions are underway to significantly optimise margins in our haemoglobins operation, including insourcing key elements of our consumable
column manufacturing. We are also expanding manufacturing capacity at our Jamestown facility to address demand growth for our autoimmune products while also offsetting excess production capacity from the expected run off in demand for our
legacy infectious disease products.
|
• |
We have launched a strategic review of expansion opportunities in the Point of Care and decentralised testing markets to take advantage of rapidly evolving patient
expectations and technology, new non-traditional market entrants and payor focus on controlling healthcare costs. We are actively exploring acquisition and partnership strategies in these areas aimed at accessing channel distribution,
product innovation and user experience expertise and intend to make a substantial investment toward this effort over the next 18 months in our Buffalo, NY lab which is well positioned to serve the decentralised testing market because,
unlike many other US labs, it is certified to process samples from all 50 US states.
|
• |
The Company continues to focus on attracting and incentivising a world class leadership team with the recent appointment of Aris Kekedjian as CEO and Chairman, and by
making further experienced hires to drive excellence in supply chain, regulatory compliance, business intelligence, corporate development and technology.
|
• |
Trinity Biotech will be a presenter at the 2022 Piper Sandler Healthcare Conference on Thursday, December 1, 2022. Aris Kekedjian, Chairman and Chief Executive
Officer, and John Gillard, Chief Financial Officer, will represent the Company and will also host a number of 1-on-1 meetings with investors.
|
2021
Quarter 2
|
2022
Quarter 2
|
(Decrease)
|
|
US$’000
|
US$’000
|
%
|
|
Clinical Laboratory
|
23,885
|
16,624
|
(30.4)%
|
Point-of-Care
|
1,958
|
1,840
|
(6.0)%
|
Total
|
25,843
|
18,464
|
(28.6)%
|
US$m
|
Q2 2022
|
Q2 2021
|
Penalty for early partial settlement of term loan
|
3.5
|
-
|
Term loan accretion interest
|
2.1
|
-
|
Term loan cash interest
|
1.9
|
-
|
Fair value movement for derivative balances related to term loan
|
0.4
|
-
|
Accretion interest on IFRS 16 leases
|
0.2
|
0.2
|
Convertible Note interest
|
0.2
|
-
|
Exchangeable Notes interest
|
0.0
|
1.2
|
Total financial expense
|
8.3
|
1.4
|
$m
|
|
Operating loss
|
(1.4)
|
Impairment charge
|
0.5
|
Depreciation
|
0.1
|
Amortisation
|
0.2
|
Adjusted EBITDA
|
(0.6)
|
Share option expense
|
0.1
|
Adjusted EBITDASO
|
(0.5)
|
• |
Since Trinity Biotech received World Health Organisation approval in February 2022 for our new HIV screening product, TrinScreen HIV, we have submitted the product
for inclusion on the HIV screening programme of the national HIV rapid algorithm in Kenya. In addition, the pre-submission process has been started in several other African countries.
|
• |
Trinity Biotech chose Kenya as the first country to submit TrinScreen HIV for inclusion in the national HIV algorithm given its large market size, estimated at 5 to 6
million tests per year, and its prestigious and leadership role as an innovator in HIV management in Africa.
|
• |
In Kenya, a technical taskforce appointed by the Ministry of Health to undertake a review of Kenya’s HIV testing algorithm recommended TrinScreen HIV as the first
line HIV screening test for Kenya’s new HIV testing algorithm 2022.
|
• |
That Kenya has recommended TrinScreen HIV as the HIV screening test is a significant vote of confidence in TrinScreen HIV and our Africa Team.
|
• |
The use of the new HIV algorithm has been delayed due to (1) the change of government in Kenya following the election in August 2022 and (2) legal objections by
competitors regarding the overall HIV algorithm evaluation process.
|
• |
The new government is now in place and we understand they are motivated to scale up the HIV rapid testing programme to pre-COVID-19 levels.
|
• |
We understand the implementation of the new HIV testing algorithm will begin before the end of the year and expect the first order to arrive shortly.
|
• |
Target countries for TrinScreen HIV for active evaluation in 2023 have a combined estimated market size of 30 million tests annually.
|
• |
In late August 2022, the Company submitted its 510k submission to the FDA for US regulatory approval of its Premier Resolution Haemoglobin Variants instrument.
|
• |
This product has already been launched in Europe under the CE mark but requires FDA approval in order to be sold in the US and certain other key markets globally.
|
• |
The Company expects to receive 510k approval for the Premier Resolution by Q2 2023 and this should drive further revenue and earnings growth in our Haemoglobins
business.
|
(US$000’s except share data)
|
Three Months Ended
June 30, 2022
(unaudited)
|
Three Months Ended
June 30, 2021
(unaudited)
|
Six Months Ended
June 30, 2022
(unaudited)
|
Six Months Ended
June 30, 2021
(unaudited)
|
||||||||||||
Revenues
|
18,464
|
25,843
|
37,240
|
51,437
|
||||||||||||
Cost of sales
|
(11,937
|
)
|
(14,816
|
)
|
(23,443
|
)
|
(29,497
|
)
|
||||||||
Gross profit
|
6,527
|
11,027
|
13,797
|
21,940
|
||||||||||||
Gross margin %
|
35.3
|
%
|
42.7
|
%
|
37.0
|
%
|
42.7
|
%
|
||||||||
Other operating income
|
1
|
2,906
|
1
|
2,907
|
||||||||||||
Research & development expenses
|
(984
|
)
|
(1,056
|
)
|
(1,949
|
)
|
(2,493
|
)
|
||||||||
Selling, general and administrative expenses
|
(6,459
|
)
|
(6,591
|
)
|
(13,190
|
)
|
(12,990
|
)
|
||||||||
Impairment charges
|
(519
|
)
|
(6,068
|
)
|
(519
|
)
|
(6,068
|
)
|
||||||||
Operating (Loss)/Profit
|
(1,434
|
)
|
218
|
(1,860
|
)
|
3,296
|
||||||||||
Financial income
|
0
|
1,018
|
0
|
1,019
|
||||||||||||
Financial expenses
|
(8,300
|
)
|
(1,364
|
)
|
(20,303
|
)
|
(2,736
|
)
|
||||||||
Net financing expense
|
(8,300
|
)
|
(346
|
)
|
(20,303
|
)
|
(1,717
|
)
|
||||||||
(Loss)/Profit before tax
|
(9,734
|
)
|
(128
|
)
|
(22,163
|
)
|
1,579
|
|||||||||
Income tax credit/(expense)
|
29
|
(655
|
)
|
180
|
(760
|
)
|
||||||||||
Profit/(Loss) for the period on continuing operations
|
(9,705
|
)
|
(783
|
)
|
(21,983
|
)
|
819
|
|||||||||
Profit/(Loss) for the period on discontinued operations
|
(1
|
)
|
-
|
(2
|
)
|
-
|
||||||||||
Profit/(Loss) for the period (all attributable to owners of the parent)
|
(9,706
|
)
|
(783
|
)
|
(21,985
|
)
|
819
|
|||||||||
(Loss)/ Earnings per ADS (US cents)
|
(28.6
|
)
|
(3.7
|
)
|
(75.1
|
)
|
3.9
|
|||||||||
Diluted (loss)/ earnings per ADS (US cents)
|
(28.6
|
)
|
(3.7
|
)
|
(75.1
|
)
|
3.9
|
|||||||||
Weighted average no. of ADSs used in computing basic and diluted earnings per ADS
|
33,952,095
|
20,901,703
|
29,289,617
|
20,901,703
|
June 30,
2022
US$ ‘000
(unaudited)
|
March 31,
2022
US$ ‘000
(unaudited)
|
December 31,
2021
US$ ‘000
|
||||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property, plant and equipment
|
6,261
|
5,634
|
5,918
|
|||||||||
Goodwill and intangible assets
|
38,743
|
37,320
|
35,981
|
|||||||||
Deferred tax assets
|
4,553
|
4,478
|
4,101
|
|||||||||
Derivative financial asset
|
140
|
219
|
-
|
|||||||||
Other assets
|
207
|
175
|
207
|
|||||||||
Total non-current assets
|
49,904
|
47,826
|
46,207
|
|||||||||
Current assets
|
||||||||||||
Inventories
|
29,109
|
29,627
|
29,123
|
|||||||||
Trade and other receivables
|
15,913
|
16,898
|
16,116
|
|||||||||
Income tax receivable
|
1,762
|
1,734
|
1,539
|
|||||||||
Cash, cash equivalents and deposits
|
10,453
|
10,012
|
25,910
|
|||||||||
Total current assets
|
57,237
|
58,271
|
72,688
|
|||||||||
TOTAL ASSETS
|
107,141
|
106,097
|
118,895
|
|||||||||
EQUITY AND LIABILITIES
|
||||||||||||
Equity attributable to the equity holders of the parent
|
||||||||||||
Share capital
|
1,963
|
1,445
|
1,213
|
|||||||||
Share premium
|
53,297
|
21,874
|
16,187
|
|||||||||
Treasury shares
|
(24,922
|
)
|
(24,922
|
)
|
(24,922
|
)
|
||||||
Accumulated surplus/(deficit)
|
(9,103
|
)
|
481
|
12,559
|
||||||||
Translation reserve
|
(5,439
|
)
|
(5,186
|
)
|
(5,379
|
)
|
||||||
Other reserves
|
23
|
23
|
23
|
|||||||||
Total equity/(deficit)
|
15,819
|
(6,285
|
)
|
(319
|
)
|
|||||||
Current liabilities
|
||||||||||||
Income tax payable
|
21
|
40
|
22
|
|||||||||
Trade and other payables
|
13,600
|
15,637
|
17,107
|
|||||||||
Exchangeable senior note payable
|
210
|
210
|
83,312
|
|||||||||
Provisions
|
50
|
50
|
50
|
|||||||||
Total current liabilities
|
13,881
|
15,937
|
100,491
|
|||||||||
Non-current liabilities
|
||||||||||||
Senior secured term loan
|
43,990
|
76,246
|
-
|
|||||||||
Derivative financial liability
|
2,002
|
1,671
|
-
|
|||||||||
Convertible Note
|
13,372
|
-
|
-
|
|||||||||
Other payables
|
12,723
|
13,279
|
13,865
|
|||||||||
Deferred tax liabilities
|
5,354
|
5,249
|
4,858
|
|||||||||
Total non-current liabilities
|
77,441
|
96,445
|
18,723
|
|||||||||
TOTAL LIABILITIES
|
91,322
|
112,382
|
119,214
|
|||||||||
TOTAL EQUITY AND LIABILITIES
|
107,141
|
106,097
|
118,895
|
|
Three
Months
Ended
June 30, 2022
(unaudited)
|
Three Months Ended
June 30, 2021
(unaudited)
|
Six
Months Ended
June 30, 2022
(unaudited)
|
Six Months Ended
June 30, 2021
(unaudited)
|
||||||||||||
Cash flows from operating activities
|
||||||||||||||||
Profit/(loss) for the period
|
(9,706
|
)
|
(783
|
)
|
(21,985
|
)
|
819
|
|||||||||
Adjustments to reconcile net profit/(loss) to cash provided by
operating activities:
|
||||||||||||||||
Depreciation
|
47
|
577
|
479
|
1,136
|
||||||||||||
Amortisation
|
214
|
240
|
442
|
458
|
||||||||||||
Income tax (credit)/expense
|
(29
|
)
|
655
|
(180
|
)
|
760
|
||||||||||
Financial income
|
-
|
(1,018
|
)
|
-
|
(1,019
|
)
|
||||||||||
Financial expense
|
8,300
|
1,364
|
20,303
|
2,736
|
||||||||||||
Share-based payments
|
122
|
312
|
319
|
693
|
||||||||||||
Foreign exchange gains on operating cash flows
|
(191
|
)
|
(276
|
)
|
(149
|
)
|
(67
|
)
|
||||||||
Impairment charge
|
519
|
6,068
|
519
|
6,068
|
||||||||||||
Other non-cash items
|
995
|
(2,774
|
)
|
305
|
(3,144
|
)
|
||||||||||
Net movement on working capital
|
(2,217
|
)
|
(3,155
|
)
|
(3,481
|
)
|
(1,326
|
)
|
||||||||
|
||||||||||||||||
Cash (used)/generated from operations
|
(1,946
|
)
|
1,210
|
(3,428
|
)
|
7,114
|
||||||||||
Interest paid
|
(1
|
)
|
(21
|
)
|
(3
|
)
|
(25
|
)
|
||||||||
Interest received
|
2
|
1
|
2
|
2
|
||||||||||||
Income taxes received/(paid)
|
13
|
(72
|
)
|
1
|
120
|
|||||||||||
|
||||||||||||||||
Net cash (used)/generated by operating activities
|
(1,932
|
)
|
1,118
|
(3,428
|
)
|
7,211
|
||||||||||
|
||||||||||||||||
Cash flows from investing activities
|
||||||||||||||||
Payments to acquire intangible assets
|
(1,658
|
)
|
(1,742
|
)
|
(3,211
|
)
|
(3,288
|
)
|
||||||||
Acquisition of property, plant and equipment
|
(143
|
)
|
(389
|
)
|
(305
|
)
|
(969
|
)
|
||||||||
Net cash used in investing activities
|
(1,801
|
)
|
(2,131
|
)
|
(3,516
|
)
|
(4,257
|
)
|
||||||||
|
||||||||||||||||
Cash flows from financing activities
|
||||||||||||||||
Issue of ordinary share capital including share premium (net of issuance costs)
|
25,019
|
-
|
25,019
|
-
|
||||||||||||
Net proceeds from new senior secured term loan
|
-
|
-
|
80,014
|
-
|
||||||||||||
Proceeds for convertible note issued
|
20,000
|
-
|
20,000
|
|||||||||||||
Expenses paid in connection with debt financing
|
(40
|
)
|
-
|
(2,356
|
)
|
-
|
||||||||||
Repayment of senior secured term loan
|
(34,500
|
)
|
-
|
(34,500
|
)
|
-
|
||||||||||
Penalty for early settlement of term loan
|
(3,450
|
)
|
-
|
(3,450
|
)
|
-
|
||||||||||
Purchase of exchangeable notes
|
-
|
-
|
(86,730
|
)
|
-
|
|||||||||||
Interest paid on senior secured term loan
|
(1,920
|
)
|
-
|
(3,706
|
)
|
-
|
||||||||||
Interest paid on convertible note
|
(49
|
)
|
-
|
(49
|
)
|
-
|
||||||||||
Proceeds from Paycheck Protection loans
|
-
|
-
|
-
|
1,764
|
||||||||||||
Interest payment on exchangeable notes
|
(4
|
)
|
(1,998
|
)
|
(1,289
|
)
|
(1,998
|
)
|
||||||||
Payment of lease liabilities
|
(729
|
)
|
(743
|
)
|
(1,500
|
)
|
(1,472
|
)
|
||||||||
|
||||||||||||||||
Net cash generated/(used) in financing activities
|
4,327
|
(2,741
|
)
|
(8,547
|
)
|
(1,706
|
)
|
|||||||||
|
||||||||||||||||
Increase/(decrease) in cash and cash equivalents and short-term investments
|
594
|
(3,754
|
)
|
(15,491
|
)
|
1,248
|
||||||||||
Effects of exchange rate movements on cash held
|
(153
|
)
|
95
|
34
|
43
|
|||||||||||
Cash and cash equivalents and short-term investments at beginning of period
|
10,012
|
32,277
|
25,910
|
27,327
|
||||||||||||
|
||||||||||||||||
Cash and cash equivalents and short-term investments at end of period
|
10,453
|
28,618
|
10,453
|
28,618
|