Trinity Biotech Announces Fourth Quarter and Fiscal Year 2023 Financial Results & Business Updates
DUBLIN, Ireland, April 04, 2024 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors, today announced results for the quarter ended December 31, 2023 and fiscal year 2023 and key business updates.
Business Updates
Comprehensive Transformation Plan
At the Emerging Growth Investor Conference on March 7, 2024, our new management team announced a comprehensive transformation plan to deliver a step change in the financial performance of our existing business.
Our transformation plan for the existing business has several key components that we believe are rapidly achievable, in most cases by mid-2025:
- 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.
- 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.
- 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:
- 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.
Financial Guidance
The Company is targeting approximately
Biosensor Technology Acquisition and Progress Updates
In January 2024, the Company announced the acquisition of the biosensor assets of Waveform Technologies Inc. (“Waveform”) for
Since the acquisition, we have been building out our new biosensor team to augment the Waveform team members we hired, and have made a number of senior appointments across a number of areas including programme management, R&D, regulatory & quality and operations. These new team members come from leading medical device and diabetes management companies such as Phillips, Johnson & Johnson and Lifescan.
Our team is progressing our plans across a number of areas including:
- 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.
We will keep investors appraised on progress in this business as we advance our plans forward.
Execution On Key Initiatives
- Optimization of our existing Diabetes business:
- 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.
- 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.
- We remain on track to deliver approximately
$4 million of annualised recurring cost savings from this and our ongoing Diabetes business supply chain optimisation initiatives, based on expected production volumes, and we believe that these changes will allow us to deliver an increasingly cost competitive Diabetes HbA1c solution, putting us in a stronger position to grow market share over time.
- TrinScreen HIV update:
- Earlier this week we received a purchase order for an additional 2 million TrinScreen HIV tests for the Kenya market and expect to deliver these in Q2, 2024.
- Additionally, in Q1, 2024 we successfully scaled manufacturing of our new rapid HIV screening test, TrinScreen HIV and have manufactured all 2.5 million tests from the initial Kenya purchase order.
- The ability to deliver such a significant increase in production capacity was an important demonstration to our stakeholders of our execution capabilities and our commitment to the new HIV testing algorithm adopted by the Kenyan Ministry of Health that established TrinScreen HIV as the screening test under World Health Organisation guidelines.
- The Kenyan HIV screening programme is one of the largest in Africa, with up to an estimated 10 million screening tests annually.
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1 Earnings before interest, tax, depreciation, amortisation, share based payments – also excludes impairment charges and one-off items
Fourth Quarter Results
The results of the Fitzgerald Industries life sciences supply business, which was sold as of April 27, 2023, have been reported separately as discontinued operations in the Consolidated Income Statements for all periods presented. The assets and liabilities attributable to Fitzgerald Industries have been removed from our Consolidated Balance Sheet as of December 31, 2023.
Total revenues for Q4, 2023 were
2023 Quarter 4 | 2022 Quarter 4 | Decrease | |
US$’000 | US$’000 | % | |
Clinical laboratory | 11,279 | 13,050 | |
Point-of-Care | 2,149 | 2,675 | |
Total | 13,428 | 15,725 | 14.6% |
Clinical laboratory revenues for the quarter were
Autoimmune lab services and product revenue in Q4, 2023 were
Point-of-Care revenues for Q4, 2023 decreased from
Gross Profit
In Q4, 2023, gross profit was
Other operating income
Other operating income decreased from
R&D and SG&A
Research and development expenses were
Selling, general and administrative expenses (“SG&A”) were
Impairment Charges
The Company recognised an impairment charge of
Operating Loss
Operating loss decreased from
Financial income and expenses
Financial income for Q4, 2023 was
Financial expenses in Q4, 2023 were
Other Items
The loss after tax for continuing operations for the quarter was
Loss before interest, tax, depreciation, amortisation, share based payments credit and impairment charges for Q4, 2023 (Adjusted EBITDASO) was
US$’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) |
Liquidity
The Group’s cash balance decreased from
In January 2024, the Company entered into an amended credit agreement (the “Amended Term Loan”) with its existing main lender, Perceptive Advisors. Under the Amended Term Loan, an additional
Fiscal Year 2023 Results
Total revenues for continuing operations for fiscal year 2023 were
Full Year 2023 | Full Year 2022 | Decrease | |
US$’000 | US$’000 | % | |
Clinical laboratory | 47,741 | 53,308 | |
Point-of-Care | 9,091 | 9,213 | |
Total | 56,832 | 62,521 | 9.1% |
Clinical laboratory product revenues decreased by
Point-of-Care revenues for the year 2023 were broadly flat (-
Gross profit for the year ended December 31, 2023 amounted to
Other operating income decreased from
R&D and SG&A
Research and development expenses increased from
Selling, General and Administrative (“SG&A”) expenses increased by
Impairment Charges
Impairment charges increased from
Operating Loss
Operating loss for the year ended December 31, 2023 was
Financial expenses
Financial expenses in the year ended December 31, 2023 were
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 |
Note: table above contains rounded numbers
The year-on-year decrease is mainly due to two material expenses incurred in 2022, which were a loss of
Interest on the senior secured term loan, comprising cash and non-cash interest, decreased from
Other Items
Financial income for the year ended December 31, 2023 was
The loss before tax for continuing operations for the year ended December 31, 2023 was
Profit for the period from discontinued operations totalled
Loss before interest, tax, depreciation, amortisation, share based payments and impairment charges for 2023 (Adjusted EBITDASO) was
$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) |
Non-GAAP Measures
The attached summary unaudited financial statements were prepared in accordance with International Financial Reporting Standards (IFRS). To supplement the consolidated financial statements presented in accordance with IFRS, the Company presents non-IFRS presentations of, Adjusted EBITDA and Adjusted EBITDASO. The adjustments to the Company's IFRS results are made with the intent of providing both management and investors a more complete understanding of the Company's underlying operational results, trends, and performance. Non-IFRS financial measures mainly exclude, if and when applicable, the effect of share-based compensation, significant excess and obsolescence charges related to inventory, depreciation, amortization and impairment charges.
Adjusted EBITDA and Adjusted EBITDASO are presented to evaluate the Company's financial and operating results on a consistent basis from period to period. The Company also believes that these measures, when viewed in combination with the Company's financial results prepared in accordance with IFRS, provides useful information to investors to evaluate ongoing operating results and trends. Adjusted EBITDA and adjusted EBITDASO, however, should not be considered as an alternative to operating income or net income for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA and adjusted EBITDASO are not measures of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. Reconciliation between the Company's operating profit/(loss) and Adjusted EBITDA and Adjusted EBITDASO are presented.
Forward-Looking Statements
This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe-harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterised by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this presentation may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on our purchase of the assets of Waveform, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2022 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.
About Trinity Biotech
Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company 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 and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. 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 | 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 |
*As of February 23, 2024, Trinity Biotech changed the ratio of its American Depositary Shares (“ADS”) from one (1) ADS representing four (4) ‘A’ ordinary shares to one (1) ADS representing twenty (20) ‘A’ ordinary shares. The above loss per ADS calculations reflects this change.
Trinity Biotech plc Consolidated Balance Sheets | |||
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 |
Trinity Biotech plc Consolidated Statements of Cash Flows | ||||
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 |
