Exhibit
|
|
Description
|
|
|
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TRINITY BIOTECH PLC
|
|||
Trinity Biotech plc
|
|||
(Registrant)
|
|||
By:
|
/s/ Des Fitzgerald
|
||
Des Fitzgerald
|
|||
Interim Chief Financial Officer
|
Contact:
|
Trinity Biotech plc
Des Fitzgerald
(353)-1-2769800
|
LifeSci Partners, LLC
Eric Ribner
(1)-646-751-4363
E-mail: investorrelations@trinitybiotech.com
|
|
• |
We are reducing complexity and cost by consolidating our main manufacturing operations into a considerably smaller number of sites and also moving to an outsourced model for a significant amount of our less complex manufacturing
activities.
|
|
o |
As part of this initiative, we are today announcing that we intend to cease manufacturing at our Kansas City manufacturing plant which currently serves our Haemoglobin business. We expect to have fully executed this change by the end of
2024 and expect this will deliver significant annualised savings.
|
|
• |
We are also significantly reducing the cost of goods of many of our products by changing suppliers and negotiating new deals with existing suppliers.
|
|
o |
This is an area we have already successfully executed on a number of cost saving initiatives, which we expect will deliver multi-million-dollar annualised savings.
|
|
• |
We are simplifying our internal operations, and optimising our business support function locations:
|
|
o |
Today we are announcing an initiative to move significant aspects of our business support functions to a lower cost and centralised location. We plan to complete this activity by Q4, 2024 and it is expected to deliver significant
reductions to our existing SG&A costs, plus provide an efficient scalable business support platform to facilitate efficient growth in our wearable biosensor business.
|
|
• |
Planning and executing sensor design improvements based on the existing CGM product design, with the assistance of external technical & design consultants.
|
|
• |
Initiating enhanced data analysis on Waveform’s large existing data bank of clinical trial results.
|
|
• |
Progressing discussions and agreements with potential commercial partners for the launch of CGM products.
|
|
• |
Establishing a scientific and user advisory group for CGM to support our product development efforts and ensuring that user needs continue to be at the forefront of our efforts.
|
|
• |
Optimization of our existing Diabetes business:
|
|
o |
Launch of the Improved Column System: Our programme to develop an improved, backward compatible Diabetes HbA1c column system is now completed. The results of this development programme have exceeded expectations, with our new column
system now delivering up to 4 times the number of injections compared to the existing product. As planned, we are now executing on the commercial launch of these new products.
|
|
o |
In-house manufacturing process: Our revised in-house manufacturing process of our key Diabetes HbA1c consumable began in Q4, 2023 as planned, and in Q1, 2024 we ceased to order any further product from our outsourced supplier.
|
|
o |
We remain on track to deliver approximately $4 million of annualised recurring cost savings from this and our ongoing Diabetes business supply chain optimisation initiatives, based on expected production volumes, and we believe that these
changes will allow us to deliver an increasingly cost competitive Diabetes HbA1c solution, putting us in a stronger position to grow market share over time.
|
|
• |
TrinScreen HIV update:
|
|
o |
Earlier this week we received a purchase order for an additional 2 million TrinScreen HIV tests for the Kenya market and expect to deliver these in Q2, 2024.
|
|
o |
Additionally, in Q1, 2024 we successfully scaled manufacturing of our new rapid HIV screening test, TrinScreen HIV and have manufactured all 2.5 million tests from the initial Kenya purchase order.
|
|
o |
The ability to deliver such a significant increase in production capacity was an important demonstration to our stakeholders of our execution capabilities and our commitment to the new HIV testing algorithm adopted by the Kenyan Ministry
of Health that established TrinScreen HIV as the screening test under World Health Organisation guidelines.
|
|
o |
The Kenyan HIV screening programme is one of the largest in Africa, with up to an estimated 10 million screening tests annually.
|
2023
Quarter 4
|
2022
Quarter 4
|
Decrease
|
|
US$’000
|
US$’000
|
%
|
|
Clinical laboratory
|
11,279
|
13,050
|
13.6%
|
Point-of-Care
|
2,149
|
2,675
|
19.7%
|
Total
|
13,428
|
15,725
|
14.6%
|
US$’M
|
|
Operating loss
|
(3.8)
|
Depreciation & Amortisation
|
0.5
|
Impairment charges
|
0.3
|
Adjusted EBITDA
|
(3.0)
|
Credit for share based payments
|
(1.0)
|
Adjusted EBITDASO
|
(4.0)
|
Full Year
2023
|
Full Year
2022
|
Decrease
|
|
US$’000
|
US$’000
|
%
|
|
Clinical laboratory
|
47,741
|
53,308
|
10.4%
|
Point-of-Care
|
9,091
|
9,213
|
1.3%
|
Total
|
56,832
|
62,521
|
9.1%
|
Full Year 2023
|
Full Year 2022
|
|
US$’M
|
US$’M
|
|
Interest on senior secured term loan
|
8.4
|
9.8
|
Interest on convertible note
|
1.1
|
0.7
|
Penalty for early partial settlement of term loan
|
0.9
|
3.5
|
Lease interest
|
0.6
|
0.7
|
Loss on disposal of exchangeable notes
|
0.0
|
9.7
|
Interest on exchangeable notes
|
0.0
|
0.4
|
Other non-cash financial expense
|
0.0
|
0.1
|
Total
|
11.1
|
24.7
|
$m
|
|
Operating loss
|
(27.0)
|
Depreciation & Amortisation
|
1.7
|
Impairment charges
|
11.1
|
Adjusted EBITDA
|
(14.2)
|
Share option expense
|
2.1
|
Adjusted EBITDASO
|
(12.1)
|
(US$000’s except share data)
|
Three Months Ended
December 31, 2023
(unaudited)
|
Three Months Ended
December 31, 2022
(unaudited)
|
Twelve Months Ended
December 31, 2023
(unaudited)
|
Twelve Months Ended
December 31, 2022
|
||||||||||||
Revenues
|
13,428
|
15,725
|
56,832
|
62,521
|
||||||||||||
Cost of sales
|
(8,861
|
)
|
(10,350
|
)
|
(37,382
|
)
|
(45,253
|
)
|
||||||||
Gross profit
|
4,567
|
5,375
|
19,450
|
17,268
|
||||||||||||
Gross margin %
|
34.0
|
%
|
34.2
|
%
|
34.2
|
%
|
27.6
|
%
|
||||||||
Other operating income
|
-
|
341
|
141
|
343
|
||||||||||||
Research & development expenses
|
(1,117
|
)
|
(1,166
|
)
|
(4,379
|
)
|
(4,138
|
)
|
||||||||
Selling, general and administrative expenses
|
(6,939
|
)
|
(9,675
|
)
|
(31,152
|
)
|
(26,983
|
)
|
||||||||
Impairment charges
|
(290
|
)
|
(3,032
|
)
|
(11,105
|
)
|
(5,839
|
)
|
||||||||
Operating Loss
|
(3,779
|
)
|
(8,157
|
)
|
(27,045
|
)
|
(19,349
|
)
|
||||||||
Financial income
|
611
|
112
|
1,171
|
303
|
||||||||||||
Financial expenses
|
(2,337
|
)
|
(2,384
|
)
|
(11,053
|
)
|
(24,734
|
)
|
||||||||
Net financing expense
|
(1,726
|
)
|
(2,272
|
)
|
(9,882
|
)
|
(24,431
|
)
|
||||||||
Loss before tax
|
(5,505
|
)
|
(10,429
|
)
|
(36,927
|
)
|
(43,780
|
)
|
||||||||
Income tax credit
|
3
|
13
|
59
|
194
|
||||||||||||
Loss for the period on continuing operations
|
(5,502
|
)
|
(10,416
|
)
|
(36,868
|
)
|
(43,586
|
)
|
||||||||
Profit for the period on discontinued operations
|
-
|
336
|
12,850
|
2,577
|
||||||||||||
Loss for the period (all attributable to owners of the parent)
|
(5,502
|
)
|
(10,080
|
)
|
(24,018
|
)
|
(41,009
|
)
|
||||||||
Loss per ADS (US cents)
|
(71.8
|
)
|
(132.3
|
)
|
(313.8
|
)
|
(607.8
|
)
|
||||||||
Diluted loss per ADS (US cents)
|
(71.8
|
)
|
(132.3
|
)
|
(313.8
|
)
|
(607.8
|
)
|
||||||||
Weighted average no. of ADSs used in computing basic earnings per ADS*
|
7,665,514
|
7,621,514
|
7,654,970
|
6,746,966
|
||||||||||||
Weighted average no. of ADSs used in computing diluted earnings per ADS*
|
7,665,514
|
7,621,514
|
7,654,970
|
6,746,966
|
December 31,
2023
US$ ‘000
(unaudited)
|
September 30,
2023
US$ ‘000
(unaudited)
|
December 31,
2022
US$ ‘000
|
||||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property, plant and equipment
|
1,892
|
1,804
|
5,682
|
|||||||||
Goodwill and intangible assets
|
16,270
|
16,164
|
35,269
|
|||||||||
Deferred tax assets
|
1,975
|
1,507
|
4,218
|
|||||||||
Derivative financial asset
|
178
|
196
|
128
|
|||||||||
Other assets
|
79
|
98
|
139
|
|||||||||
Total non-current assets
|
20,394
|
19,769
|
45,436
|
|||||||||
Current assets
|
||||||||||||
Inventories
|
19,933
|
20,880
|
22,503
|
|||||||||
Trade and other receivables
|
13,901
|
15,095
|
15,753
|
|||||||||
Income tax receivable
|
1,516
|
1,592
|
1,834
|
|||||||||
Cash, cash equivalents and deposits
|
3,691
|
6,261
|
6,578
|
|||||||||
Total current assets
|
39,041
|
43,828
|
46,668
|
|||||||||
TOTAL ASSETS
|
59,435
|
63,597
|
92,104
|
|||||||||
EQUITY AND LIABILITIES
|
||||||||||||
Equity attributable to the equity holders of the parent
|
||||||||||||
Share capital
|
1,972
|
1,972
|
1,963
|
|||||||||
Share premium
|
46,619
|
46,619
|
46,458
|
|||||||||
Treasury shares
|
(24,922
|
)
|
(24,922
|
)
|
(24,922
|
)
|
||||||
Accumulated deficit
|
(48,644
|
)
|
(42,135
|
)
|
(26,695
|
)
|
||||||
Translation reserve
|
(5,706
|
)
|
(5,753
|
)
|
(5,775
|
)
|
||||||
Equity component of convertible note
|
6,709
|
6,709
|
6,709
|
|||||||||
Other reserves
|
23
|
23
|
86
|
|||||||||
Total deficit
|
(23,949
|
)
|
(17,487
|
)
|
(2,176
|
)
|
||||||
Current liabilities
|
||||||||||||
Income tax payable
|
279
|
252
|
28
|
|||||||||
Trade and other payables
|
14,496
|
12,226
|
17,051
|
|||||||||
Exchangeable senior note payable
|
210
|
210
|
210
|
|||||||||
Provisions
|
50
|
50
|
50
|
|||||||||
Total current liabilities
|
15,035
|
12,738
|
17,339
|
|||||||||
Non-current liabilities
|
||||||||||||
Senior secured term loan
|
40,109
|
39,947
|
44,301
|
|||||||||
Derivative financial liability
|
526
|
1,138
|
1,569
|
|||||||||
Convertible note
|
14,542
|
14,337
|
13,746
|
|||||||||
Other payables
|
10,872
|
10,921
|
12,267
|
|||||||||
Deferred tax liabilities
|
2,300
|
2,003
|
5,058
|
|||||||||
Total non-current liabilities
|
68,349
|
68,346
|
76,941
|
|||||||||
TOTAL LIABILITIES
|
83,384
|
81,084
|
94,280
|
|||||||||
TOTAL EQUITY AND LIABILITIES
|
59,435
|
63,597
|
92,104
|
|
Three
Months
Ended
December 31, 2023
US$ ‘000
(unaudited)
|
Three Months Ended
December 31, 2022
US$ ‘000
(unaudited)
|
Twelve Months Ended
December 31, 2023
US$ ‘000
(unaudited)
|
Twelve Months Ended
December 31, 2022
US$ ‘000
|
||||||||||||
Cash flows from operating activities
|
||||||||||||||||
Loss for the period
|
(5,502
|
)
|
(10,080
|
)
|
(24,018
|
)
|
(41,009
|
)
|
||||||||
Adjustments to reconcile loss to cash generated by/(used in) operating activities:
|
||||||||||||||||
Depreciation
|
2
|
453
|
831
|
1,410
|
||||||||||||
Amortisation
|
460
|
215
|
946
|
923
|
||||||||||||
Income tax credit
|
(3
|
)
|
(16
|
)
|
(59
|
)
|
(192
|
)
|
||||||||
Financial income
|
(611
|
)
|
(112
|
)
|
(1,171
|
)
|
(303
|
)
|
||||||||
Financial expense
|
2,337
|
2,395
|
11,053
|
24,744
|
||||||||||||
Share-based payments
|
(1,009
|
)
|
1,318
|
2,069
|
1,756
|
|||||||||||
Foreign exchange gains on operating cash flows
|
385
|
(91
|
)
|
238
|
(76
|
)
|
||||||||||
Impairment charge
|
290
|
3,032
|
11,105
|
5,839
|
||||||||||||
Gain on sale of business
|
-
|
-
|
(12,718
|
)
|
-
|
|||||||||||
Other non-cash items
|
2,602
|
3,061
|
2,548
|
7,662
|
||||||||||||
|
||||||||||||||||
Operating cash inflows/(outflows) before changes in working capital
|
(1,049
|
)
|
175
|
(9,176
|
)
|
754
|
||||||||||
Net movement on working capital
|
1,359
|
2,112
|
(2,693
|
)
|
(1,662
|
)
|
||||||||||
|
||||||||||||||||
Cash generated by/(used in) operations
|
310
|
2,287
|
(11,869
|
)
|
(908
|
)
|
||||||||||
Interest received
|
-
|
-
|
-
|
2
|
||||||||||||
Income taxes (paid)/received
|
(65
|
)
|
(12
|
)
|
312
|
(15
|
)
|
|||||||||
|
||||||||||||||||
Net cash generated by/(used in) operating activities
|
245
|
2,275
|
(11,557
|
)
|
(921
|
)
|
||||||||||
|
||||||||||||||||
Cash flows from investing activities
|
||||||||||||||||
Payments to acquire intangible assets
|
(641
|
)
|
(663
|
)
|
(1,901
|
)
|
(4,876
|
)
|
||||||||
Acquisition of property, plant and equipment
|
(250
|
)
|
(475
|
)
|
(803
|
)
|
(1,101
|
)
|
||||||||
Payments to acquire financial asset
|
-
|
-
|
(700
|
)
|
-
|
|||||||||||
Proceeds from sale of business (net of transaction costs)
|
-
|
-
|
28,160
|
-
|
||||||||||||
|
||||||||||||||||
Net cash generated by/(used in) investing activities
|
(891
|
)
|
(1,138
|
)
|
24,756
|
(5,977
|
)
|
|||||||||
|
||||||||||||||||
Cash flows from financing activities
|
||||||||||||||||
Issue of ordinary share capital including share premium (net of issuance costs)
|
-
|
(130
|
)
|
-
|
25,336
|
|||||||||||
Proceeds from shares to be issued
|
63
|
-
|
63
|
|||||||||||||
Net proceeds from new senior secured term loan
|
-
|
-
|
5,000
|
80,015
|
||||||||||||
Proceeds for convertible note issued
|
-
|
-
|
-
|
20,000
|
||||||||||||
Expenses paid in connection with debt financing
|
-
|
-
|
(147
|
)
|
(2,356
|
)
|
||||||||||
Purchase of exchangeable notes
|
-
|
-
|
-
|
(86,730
|
)
|
|||||||||||
Repayment of senior secured term loan
|
-
|
-
|
(10,050
|
)
|
(34,500
|
)
|
||||||||||
Penalty for early settlement of term loan
|
-
|
-
|
(905
|
)
|
(3,450
|
)
|
||||||||||
Repayment of other loan
|
-
|
(23
|
)
|
-
|
(23
|
)
|
||||||||||
Interest paid on senior secured term loan
|
(1,129
|
)
|
(1,103
|
)
|
(7,314
|
)
|
(6,424
|
)
|
||||||||
Interest paid on convertible note
|
(75
|
)
|
(75
|
)
|
(300
|
)
|
(199
|
)
|
||||||||
Interest paid on exchangeable notes
|
(4
|
)
|
-
|
(8
|
)
|
(1,293
|
)
|
|||||||||
Payment of lease liabilities
|
(558
|
)
|
(577
|
)
|
(2,318
|
)
|
(2,761
|
)
|
||||||||
|
||||||||||||||||
Net cash used in financing activities
|
(1,766
|
)
|
(1,845
|
)
|
(16,042
|
)
|
(12,322
|
)
|
||||||||
|
||||||||||||||||
Decrease in cash and cash equivalents
|
(2,412
|
)
|
(708
|
)
|
(2,843
|
)
|
(19,220
|
)
|
||||||||
Effects of exchange rate movements on cash held
|
(158
|
)
|
32
|
(44
|
)
|
(112
|
)
|
|||||||||
Cash and cash equivalents at beginning of period
|
6,261
|
7,254
|
6,578
|
25,910
|
||||||||||||
|
||||||||||||||||
Cash and cash equivalents at end of period
|
3,691
|
6,578
|
3,691
|
6,578
|