Exhibit
|
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Description
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TRINITY BIOTECH PLC
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Trinity Biotech plc
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|||
(Registrant)
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By:
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/s/ John Gillard
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John Gillard
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Chief Financial Officer
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Contact: | Trinity Biotech plc | Lytham Partners, LLC |
John Gillard | Joe Diaz | |
(353)-1-2769800 | (1)-602-889-9700 |
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E-mail: investorrelations@trinitybiotech.com |
• |
Total revenues for Q3, 2022 were $19.5m. Excluding our Covid focused PCR Viral Transport Media (“VTM”) products, Q3, 2022 revenues of $19.2m were marginally higher by 2% compared to Q3, 2021 and were up 6% compared to Q2, 2022.
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• |
A strong YoY 30% increase in revenues attributable to both our Haemoglobins and Fitzgerald Industries Life Sciences businesses offset the timing impact of atypically concentrated sales of UniGold HIV in Q3 2021. In addition, pricing
changes and capacity optimisation actions in our Autoimmune product business led to a 30%+ increase compared to the same period in 2021.
|
• |
Quarter over quarter revenue momentum was driven by Fitzgerald Industries at 25%, reflecting actions to optimize demand generation throughout the year, strong demand for UniGold HIV with an increase of over 35% and over 20% Autoimmune
product growth.
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• |
We are experiencing particularly strong demand for our Haemoglobins products in AsiaPac and Latin America, with well over 50% YoY revenue growth in AsiaPac and over 40% YoY revenue growth in Latin America. We continue to scale our
commercial coverage in these markets where the increase in diabetes and propensity for haemoglobin variants is at some of its highest rates and our boronate affinity technology has a particular competitive advantage.
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• |
In late August 2022, the Company submitted its 510k submission to the FDA seeking US regulatory approval of its Premier Resolution Haemoglobin Variants instrument and expects to launch the product in the US in Q2, 2023.
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• |
In November 2022, the Company initiated the development of its next generation flagship diabetes HbA1c instrument, the Premier 9210. Expected to launch in Q3, 2023, it is planned to feature an improved, backward compatible reagent column
system that will feature up to 3x the injection capacity and stability, limited calibration, improved user interface and lab system integration. In addition, this system should underpin the lower cost, mid throughput A1c instrument
currently in development.
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• |
Since World Health Organisation approval in February 2022 of our TrinScreen HIV product, the Kenyan Ministry of Health task force recommended it as the first line screening test for Kenya’s new HIV testing algorithm. We expect to
conclude the current pilot program in Kenya by year-end, deliver initial Ministry of Health orders in Q1, 2023 and ramp up to approximately 6 million tests per year.
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• |
The Company is in partnership negotiations with a number of rapid test innovators to leverage its lateral flow biological development and manufacturing capabilities and provide access to its global distribution channels. In addition to
capital efficient growth, this strategy provides early access to intellectual property associated with evolving user interface concepts.
|
• |
Improved design for manufacturing, supply chain enhancements and insourcing actions are underway seeking to significantly optimise margins across the portfolio. In Q3, 2022 we focused on streamlining the portfolio with the elimination
of loss-making legacy products and inventory. We continue to consolidate multi-product flexible production in our Jamestown facility with the transfer of immunofluorescence and urine tube manufacturing from Buffalo, NY and Burlington,
Canada respectively.
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• |
The Company continues to focus on attracting and developing a world class leadership team with the recent appointments of a Chief Technology Officer, Head of Quality and Regulatory Affairs and Global Supply Chain Leader.
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• |
Trinity Biotech was recently featured at the 2022 Piper Sandler Healthcare Conference, where Aris Kekedjian, Chairman and Chief Executive Officer, outlined the Company’s strategic growth playbook. A copy of the presentation is available
at www.trinitybiotech.com.
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2021
Quarter 3
|
2022
Quarter 3
|
(Decrease)
|
|
US$’000
|
US$’000
|
%
|
|
Clinical Laboratory
|
17,891
|
16,966
|
(5.2%)
|
Point-of-Care
|
4,113
|
2,536
|
(38.3%)
|
Total
|
22,004
|
19,502
|
(11.4%)
|
Q3 2022
US$000
|
|
Revenues
|
19,502
|
Cost of sales (including significant excess and obsolescence charges related to inventory of $4,697)
|
17,487
|
Gross profit
|
2,015
|
Gross margin %
|
10.3%
|
Adjusted Gross profit (excluding significant excess and obsolescence charges related to inventory of $4,697)
|
6,712
|
Adjusted Gross margin %
|
34.4%
|
1. |
VTM inventory write down ($3.5m) – as previously disclosed, the situation relating to COVID-19 products was fluid and as such we chose to retain the capability to flex manufacturing volumes should market conditions warrant. As such, we
maintained a significant inventory of critical raw materials to allow a ramping up of COVID focused VTM production to meet peak demand as it was important that we were able to fulfil high volume orders at short notice in order to retain
existing customers and capture new customers at attractive price points. Unlike in prior years, during Q3 or to date in Q4 2022, we have not seen any evidence of current or future significant peaks in demand. This has led management to
revisit our strategy of maintaining significant levels of raw materials inventory to meet demand peaks. We now intend to expedite the sale of the vast majority of this inventory, which given current market conditions, is expected to be at
lower prices. Consequently, the value of inventory has been written down to our estimate of its net realisable value.
|
2. |
Other inventory write down ($0.9m) - we have written down the value of certain excess raw materials and work in progress following a review and an update to our relevant quality assurance policy.
|
3. |
Tri-stat inventory write down ($0.3m) - we undertook a strategic review of our Tri-stat instrument line as part of a broader review of our haemoglobins product portfolio. With annual sales of approximately $0.2m, Tri-stat is the least
significant product in the portfolio. To rationalise and to simplify the haemoglobins product portfolio and to allow us to focus our resources on the higher growth products within that portfolio, management has decided to limit sales of
Tri-stat to certain targeted partnerships. Consequently, management has written down the value of this inventory to reflect the consequent revised outlook.
|
$m
|
|
Operating loss
|
(7.1)
|
Depreciation
|
0.5
|
Amortisation
|
0.3
|
Impairment charges
|
2.3
|
Significant excess and obsolescence charges related to inventory
|
4.7
|
Adjusted EBITDA
|
0.7
|
Share option expense
|
0.1
|
Adjusted EBITDASO
|
0.8
|
(US$000’s except share data)
|
Three Months Ended
September 30, 2022
US$000
(unaudited)
|
Three Months Ended
September 30, 2021
US$000
(unaudited)
|
Nine
Months Ended
September 30, 2022
US$000
(unaudited)
|
Nine
Months Ended
September 30, 2021
US$000
(unaudited)
|
||||||||||||
Revenues
|
19,502
|
22,004
|
56,742
|
73,441
|
||||||||||||
Cost of sales (including Q3, 2022 significant excess and obsolescence charges related to inventory of $4,697; 2021: $Nil)
|
(17,487
|
)
|
(13,104
|
)
|
(40,930
|
)
|
(42,601
|
)
|
||||||||
Gross profit
|
2,015
|
8,900
|
15,812
|
30,840
|
||||||||||||
Gross margin %
|
10.3
|
%
|
40.4
|
%
|
27.9
|
%
|
42.0
|
%
|
||||||||
Other operating income
|
1
|
1,043
|
2
|
3,950
|
||||||||||||
Research & development expenses
|
(1,023
|
)
|
(1,063
|
)
|
(2,972
|
)
|
(3,556
|
)
|
||||||||
Selling, general and administrative expenses
|
(5,791
|
)
|
(6,112
|
)
|
(18,979
|
)
|
(19,102
|
)
|
||||||||
Impairment charges
|
(2,288
|
)
|
0
|
(2,808
|
)
|
(6,068
|
)
|
|||||||||
Operating (Loss)/Profit
|
(7,086
|
)
|
2,768
|
(8,945
|
)
|
6,064
|
||||||||||
Financial income
|
329
|
194
|
329
|
1,213
|
||||||||||||
Financial expenses
|
(2,184
|
)
|
(1,361
|
)
|
(22,488
|
)
|
(4,097
|
)
|
||||||||
Net financial expense
|
(1,855
|
)
|
(1,167
|
)
|
(22,159
|
)
|
(2,884
|
)
|
||||||||
(Loss)/Profit before tax
|
(8,941
|
)
|
1,601
|
(31,104
|
)
|
3,180
|
||||||||||
Income tax (expense)/credit
|
(3
|
)
|
(251
|
)
|
177
|
(1,011
|
)
|
|||||||||
(Loss)/Profit for the period on continuing operations
|
(8,944
|
)
|
1,350
|
(30,927
|
)
|
2,169
|
||||||||||
Loss for the period on discontinued operations
|
(1
|
)
|
(29
|
)
|
(3
|
)
|
(29
|
)
|
||||||||
(Loss)/Profit for the period (all attributable to owners of the parent)
|
(8,945
|
)
|
1,321
|
(30,930
|
)
|
2,140
|
||||||||||
(Loss)/ Earnings per ADS (US cents)
|
(23.5
|
)
|
6.3
|
(95.9
|
)
|
10.2
|
||||||||||
Diluted (loss)/ Earnings per ADS (US cents)
|
(23.5
|
)
|
6.1
|
(95.9
|
)
|
9.6
|
||||||||||
Weighted average no. of ADSs used in computing basic earnings per ADS
|
38,107,571
|
20,901,703
|
32,261,235
|
20,901,703
|
||||||||||||
Weighted average no. of ADSs used in computing diluted earnings per ADS
|
38,107,571
|
21,831,978
|
32,261,235
|
22,262,325
|
September 30,
2022
US$ ‘000
(unaudited)
|
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
|
6,082
|
6,261
|
5,634
|
5,918
|
||||||||||||
Goodwill and intangible assets
|
37,144
|
38,743
|
37,320
|
35,981
|
||||||||||||
Deferred tax assets
|
4,533
|
4,553
|
4,478
|
4,101
|
||||||||||||
Derivative financial asset
|
147
|
140
|
219
|
-
|
||||||||||||
Other assets
|
155
|
207
|
175
|
207
|
||||||||||||
Total non-current assets
|
48,061
|
49,904
|
47,826
|
46,207
|
||||||||||||
Current assets
|
||||||||||||||||
Inventories
|
23,553
|
29,109
|
29,627
|
29,123
|
||||||||||||
Trade and other receivables
|
17,265
|
15,913
|
16,898
|
16,116
|
||||||||||||
Income tax receivable
|
1,762
|
1,762
|
1,734
|
1,539
|
||||||||||||
Cash, cash equivalents and deposits
|
7,254
|
10,453
|
10,012
|
25,910
|
||||||||||||
Total current assets
|
49,834
|
57,237
|
58,271
|
72,688
|
||||||||||||
TOTAL ASSETS
|
97,895
|
107,141
|
106,097
|
118,895
|
||||||||||||
EQUITY AND LIABILITIES
|
||||||||||||||||
Equity attributable to the equity holders of the parent
|
||||||||||||||||
Share capital
|
1,963
|
1,963
|
1,445
|
1,213
|
||||||||||||
Share premium
|
53,297
|
53,297
|
21,874
|
16,187
|
||||||||||||
Treasury shares
|
(24,922
|
)
|
(24,922
|
)
|
(24,922
|
)
|
(24,922
|
)
|
||||||||
Accumulated (deficit)/surplus
|
(17,929
|
)
|
(9,103
|
)
|
481
|
12,559
|
||||||||||
Translation reserve
|
(5,799
|
)
|
(5,439
|
)
|
(5,186
|
)
|
(5,379
|
)
|
||||||||
Other reserves
|
23
|
23
|
23
|
23
|
||||||||||||
Total equity/(deficit)
|
6,633
|
15,819
|
(6,285
|
)
|
(319
|
)
|
||||||||||
Current liabilities
|
||||||||||||||||
Trade and other payables
|
14,447
|
13,600
|
15,637
|
17,107
|
||||||||||||
Income tax payable
|
21
|
21
|
40
|
22
|
||||||||||||
Exchangeable note payable
|
210
|
210
|
210
|
83,312
|
||||||||||||
Provisions
|
50
|
50
|
50
|
50
|
||||||||||||
Total current liabilities
|
14,728
|
13,881
|
15,937
|
100,491
|
||||||||||||
Non-current liabilities
|
||||||||||||||||
Senior secured term loan
|
44,143
|
43,990
|
76,246
|
-
|
||||||||||||
Derivative financial liability
|
1,681
|
2,002
|
1,671
|
-
|
||||||||||||
Convertible note
|
13,557
|
13,372
|
-
|
-
|
||||||||||||
Other payables
|
11,818
|
12,723
|
13,279
|
13,865
|
||||||||||||
Deferred tax liabilities
|
5,335
|
5,354
|
5,249
|
4,858
|
||||||||||||
Total non-current liabilities
|
76,534
|
77,441
|
96,445
|
18,723
|
||||||||||||
TOTAL LIABILITIES
|
91,262
|
91,322
|
112,382
|
119,214
|
||||||||||||
TOTAL EQUITY AND LIABILITIES
|
97,895
|
107,141
|
106,097
|
118,895
|
|
Three
Months
Ended
September 30, 2022
US$000
(unaudited)
|
Three Months Ended
September 30, 2021
US$000
(unaudited)
|
Nine
Months Ended
September 30, 2022
US$000
(unaudited)
|
Nine
Months Ended
September 30, 2021
US$000
(unaudited)
|
||||||||||||
Cash flows from operating activities
|
||||||||||||||||
(Loss)/profit for the period
|
(8,945
|
)
|
1,321
|
(30,930
|
)
|
2,140
|
||||||||||
Adjustments to reconcile net profit/(loss) to cash provided by operating activities:
|
||||||||||||||||
Depreciation
|
478
|
545
|
957
|
1,681
|
||||||||||||
Amortisation
|
266
|
231
|
708
|
689
|
||||||||||||
Income tax expense/(credit)
|
3
|
251
|
(177
|
)
|
1,011
|
|||||||||||
Financial income
|
(329
|
)
|
(194
|
)
|
(329
|
)
|
(1,213
|
)
|
||||||||
Financial expense
|
2,184
|
1,361
|
22,488
|
4,097
|
||||||||||||
Share-based payments
|
119
|
253
|
438
|
946
|
||||||||||||
Foreign exchange gains on operating cash flows
|
164
|
101
|
15
|
34
|
||||||||||||
Impairment charges
|
2,288
|
-
|
2,808
|
6,068
|
||||||||||||
Excess and obsolescence charges related to inventory
|
4,697
|
-
|
4,697
|
-
|
||||||||||||
Other non-cash items
|
(399
|
)
|
(1,487
|
)
|
(96
|
)
|
(4,631
|
)
|
||||||||
|
||||||||||||||||
Operating cash flows before changes in working capital
|
526
|
2,382
|
579
|
10,822
|
||||||||||||
Net movement on working capital
|
153
|
(1,777
|
)
|
(3,328
|
)
|
(3,103
|
)
|
|||||||||
|
||||||||||||||||
Cash generated/(used) from operations
|
679
|
605
|
(2,749
|
)
|
7,719
|
|||||||||||
Interest paid
|
(1
|
)
|
(13
|
)
|
(4
|
)
|
(38
|
)
|
||||||||
Interest received
|
0
|
1
|
2
|
3
|
||||||||||||
Income taxes (paid)/received
|
(2
|
)
|
1,104
|
(1
|
)
|
1,224
|
||||||||||
|
||||||||||||||||
Net cash generated/(used) by operating activities
|
676
|
1,697
|
(2,752
|
)
|
8,908
|
|||||||||||
|
||||||||||||||||
Cash flows from investing activities
|
||||||||||||||||
Payments to acquire intangible assets
|
(1,003
|
)
|
(1,686
|
)
|
(4,214
|
)
|
(4,974
|
)
|
||||||||
Acquisition of property, plant and equipment
|
(321
|
)
|
(273
|
)
|
(626
|
)
|
(1,242
|
)
|
||||||||
|
||||||||||||||||
Net cash used in investing activities
|
(1,324
|
)
|
(1,959
|
)
|
(4,840
|
)
|
(6,216
|
)
|
||||||||
|
||||||||||||||||
Cash flows from financing activities
|
||||||||||||||||
Issue of ordinary share capital including share premium (net of issuance costs)
|
-
|
-
|
25,019
|
-
|
||||||||||||
Net proceeds from new senior secured term loan
|
-
|
-
|
80,014
|
-
|
||||||||||||
Proceeds for convertible note issued
|
-
|
-
|
20,000
|
-
|
||||||||||||
Expenses paid in connection with debt financing
|
-
|
-
|
(2,356
|
)
|
-
|
|||||||||||
Repayment of senior secured term loan
|
-
|
-
|
(34,500
|
)
|
-
|
|||||||||||
Penalty for early settlement of term loan
|
-
|
-
|
(3,450
|
)
|
-
|
|||||||||||
Purchase of exchangeable notes
|
-
|
-
|
(86,730
|
)
|
-
|
|||||||||||
Interest paid on senior secured term loan
|
(1,609
|
)
|
-
|
(5,315
|
)
|
-
|
||||||||||
Interest paid on convertible note
|
(75
|
)
|
-
|
(124
|
)
|
-
|
||||||||||
Proceeds from Paycheck Protection loans
|
-
|
-
|
-
|
1,764
|
||||||||||||
Interest payment on exchangeable notes
|
(4
|
)
|
-
|
(1,293
|
)
|
(1,998
|
)
|
|||||||||
Payment of lease liabilities
|
(684
|
)
|
(726
|
)
|
(2,184
|
)
|
(2,198
|
)
|
||||||||
|
||||||||||||||||
Net cash generated/(used) in financing activities
|
(2,372
|
)
|
(726
|
)
|
(10,919
|
)
|
(2,432
|
)
|
||||||||
|
||||||||||||||||
(Decrease)/increase in cash and cash equivalents and short-term investments
|
(3,020
|
)
|
(988
|
)
|
(18,511
|
)
|
260
|
|||||||||
Effects of exchange rate movements on cash held
|
(179
|
)
|
(154
|
)
|
(145
|
)
|
(112
|
)
|
||||||||
Cash and cash equivalents and short-term investments at beginning of period
|
10,453
|
28,617
|
25,910
|
27,327
|
||||||||||||
|
||||||||||||||||
Cash and cash equivalents and short-term investments at end of period
|
7,254
|
27,475
|
7,254
|
27,475
|