SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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 2024
(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-
This Form 6-K is being incorporated by reference into our Registration Statements on Form S-8 (File Nos. 333-182279, 333-195232 and 333-253070) and Registration Statements on Form
F-3 (File Nos. 333-239701, 333-264992 and 333-267160).
On November 15th, 2024, the Company issued a
press release announcing its financial results for the fiscal quarter
ended September 30, 2024. A copy of the press release is filed herewith as Exhibit 99.1.
EXHIBIT INDEX
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.
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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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Louise Tallon
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Chief Financial Officer
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Exhibit 99.1
| Contact: Trinity Biotech plc |
LifeSci Partners, LLC
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| Louise Tallon |
Eric Ribner
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| (353)-1-2769800 |
(1)-646-751-4363 |
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investorrelations@trinitybiotech.com |
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RedChip Companies Inc. |
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Dave Gentry, CEO |
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(1)-407-644-4256
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TRIB@redchip.com |
Trinity Biotech Announces Q3 2024 Financial Results
Q3 2024 total revenue of $15.2 million grew +3% Y/Y based on strong demand and output in the TrinScreen HIV business
Point-of-Care product revenue of $4.3 million grew 60% Y/Y
Reiterates guidance to achieve approximately $20 million of annualized run-rate EBITDASO1 on annualized run-rate
revenues of approximately $75 million by Q2 2025
Reiterates guidance to achieve 2024 sales revenue for TrinScreen HIV of approximately $10 million
DUBLIN, Ireland (November 15, 2024)... Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes
management solutions, including wearable biosensors, today announced the Company’s results for the quarter ended September 30, 2024.
Key Highlights and Developments
Continued Revenue and Profitability Improvements
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Year-over-year revenue growth of 3% and continued disciplined execution on our profitability enhancing initiatives contributed to a decrease in the operating loss (before restructuring and impairment charges) to $2.2 million from $4.5m
in Q3 2023, a 51% improvement.
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1Management continues to make significant progress on the execution of the profitability focused initiatives announced in early 2024 as part of its Comprehensive Transformation
Plan, many of which are now at the final stages of execution and expected to deliver near term profitability improvements:
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Consolidate & Offshore Manufacturing:
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We successfully completed the transfer of our second rapid HIV product manufacturing processes to our offshore manufacturing partner and we have made submissions to the relevant international regulator to permit commercial production of
both rapid HIV tests with our offshore partner. We expect offshore production to begin in Q1 2025.
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We are also beginning the transfer of some more technical aspects of production of both of our rapid HIV tests to our offshore partner. Once in place we expect this to be gross margin-accretive.
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1 Earnings before interest, tax, depreciation, amortization, share based payments from continuing operations– also excludes impairment charges and one-off items.
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We have continued to make significant progress in consolidating our main haemoglobin manufacturing activities currently carried out at our Kansas City plant into two of our other sites. We remain on track to cease our main manufacturing
activities at our Kansas City site by the end of 2024.
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We have informed staff at our autoimmune test manufacturing site in Buffalo, New York, of our intention to consolidate the site’s main manufacturing activities into our Jamestown, New York site. We expect to cease main manufacturing
activities in our Buffalo site by the end of Q1 2025.
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Centralise & Offshore Corporate Services:
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Our new centralised corporate services site is now live across a number of functions, with additional functions expected to be added through the end of 2024.
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Based upon continued strong execution in our Comprehensive Transformation Plan, the Company reiterates its guidance of expecting to achieve approximately $20 million of annualized run-rate EBITDASO1 based on annualised run-rate revenues of approximately $75 million by Q2 2025. This outlook is predicated solely on growth from the existing businesses including haemoglobin testing and HIV, and planned improvements
to operating margins, with no contribution from the recently acquired biosensor and lab-based diagnostic businesses.11
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Diabetes CGM Developments
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We continue to progress the development of our next generation Continuous Glucose Monitoring (“CGM”) solution for diabetes management in line with our previously communicated plan.
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The CGM market is already estimated to be worth over $10 billion a year and projected to grow rapidly.
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Following the successful completion of our first pre-pivotal trial, we are this week starting a second, larger, pre-pivotal trial which will provide extensive data on further developments of the sensor technology which will feed into our
sensor design choices.
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We are confident that the steps we are taking, with our impressive partners, with an emphasis on a great user experience, enhanced data capture & insights, and reduced cost through more reusable components, will lead to a
differentiated product and a higher value proposition.
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We continue to see strong commercial and strategic interest and are actively building and nurturing these relationships.
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Establishing strategic manufacturing & supply chain relationships with large scale premium market players to prepare for efficient & rapid scaling globally.
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Business Development Update
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We recently completed two new lab-based technology acquisitions, which form an additional vertical to our long-term value creation & growth strategy:
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EpiCapture Limited, a company developing a non-invasive test for monitoring the risk of aggressive prostate cancer. Prostate cancer is the most common non-skin cancer among men in the U.S., with about 1 in 8 men diagnosed during their
lifetime, and the cost for diagnosis and treatment is estimated at over approximately $10 billion annually. This acquisition marks Trinity Biotech’s strategic expansion into the oncology diagnostics market.
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Metabolomics Diagnostics Limited, a company that has developed an innovative test, PrePsia, to accurately predict the risk of preeclampsia in pregnant women. Preeclampsia is a frequently occurring maternal health issue, impacting up to 5%
of pregnancies, which can cause serious illness or death in affected mothers and babies.
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We intend to commercialise both tests in our New York State Department of Health-certified Immco diagnostic reference laboratory.
Third Quarter Results (Unaudited)
Total revenue for Q3 2024 was $15.2m compared to $14.7m in Q3 2023, an increase of 3.2% and consisted of the following:
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2024
Quarter 3
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2023
Quarter 3
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Increase/
(decrease)
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US$’000
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US$’000
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%
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Clinical Laboratory
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10,836
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11,981
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(9.6%)
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Point-of-Care
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4,316
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2,696
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60.1%
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Total
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15,152
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14,677
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3.2%
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Our Point-of-Care (‘PoC’) portfolio generated revenue of $4.3m for Q3 2024, compared to $2.7m in Q3 2023, an increase of 60.1%. Sales of our HIV screening test, TrinScreen HIV were $2.4m in the
quarter (Nil in Q3 2023) as we continued to see strong demand following our initial shipments in late 2023.
Our clinical laboratory revenue was $10.8m in Q3 2024, a decrease of $1.2m or 9.6% compared to $12.0m in Q3 2023. There was a strong performance in the quarter from our clinical chemistry portfolio
which grew 79.3% year-over-year. This increase in revenue was offset by a revenue decrease in our haemoglobins business, which was 17.1% lower year-over-year. This occurred due to decreased instrument sales during the period, combined with increased
consumable sales in Q3 2023, which were influenced by the phasing of haemoglobin revenues from certain customers throughout 2023. The decline in instrument sales is in line with expectations as we commercially reposition our instrument offering in
line with our new improved diabetes column system which is now being rolled out.
Gross profit for the quarter was $5.3m and gross margin for Q3 2024 was 35.0%. Gross margin was broadly in line with Q3 2023 when excluding stock obsolescence charges.
We continued to record improved margins in our haemoglobins division in Q3 2024 due to the financial benefits resulting from our previously announced initiatives, namely our revised in-house
manufacturing process of our key diabetes HbA1c consumable. The improved margin performance in haemoglobins was offset by the negative margin impact of the higher TrinScreen HIV revenues which are currently achieving lower-than-average gross margin
returns. The higher TrinScreen revenues will continue to pressure our overall gross margin percentage in the last quarter of 2024 given its lower price point when compared to our other HIV rapid test, Uni-Gold, and because of temporarily reduced
efficiency as we scale up production capacity of this new product. We expect TrinScreen HIV gross margins to improve in early 2025 due to increased operational efficiency and the expected transfer of assembly to a lower cost manufacturing location.
R&D
Research and development expenses in Q3 2024 were $1.0m, a decrease of $0.2m compared to Q3 2023. We capitalized $2.1m (including capitalized borrowing costs of $0.6m as required by IAS 23) for the
quarter in relation to our CGM development as we continued our development activities.
SG&A
Selling, general and administrative (SG&A) expenses were $6.5m in Q3 2024, compared to $7.7m in Q3 2023, a decrease of $1.2m over the comparative period. Key drivers of this lower SG&A
expense include:
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Lower recurring salary costs of $0.7m in Q3 2024 versus the comparative period, driven by ongoing headcount optimisation activities during late 2023 and 2024.
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Our share-based payments accounting charge was $0.5m lower in Q3 2024 compared to Q3 2023, due to headcount changes.
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SG&A – Restructuring costs
As previously announced, the Company has implemented a comprehensive restructuring plan across the business to include the centralization and offshoring of corporate services and consolidation and
relocation of manufacturing operations. The offshoring of corporate services is progressing well and offshoring has already commenced in several areas and will continue to be rolled out through Q4 2024. Additionally, cessation of the main
manufacturing activities in Kansas City remains on schedule and is expected to be completed by December 2024. A charge of $0.3m was recognized in Q3 2024 in relation to the costs associated with these restructuring activities.
Operating loss for the quarter was $2.6m, compared to an operating loss of $4.5m in Q3 2023. The lower loss this quarter was mainly attributable to higher gross margins combined with reduced
overheads in Q3 2024, as a result of cost saving initiatives.
Financial expense costs in Q3 2024 were $3.1m compared to $2.4m in Q3 2023, an increase of $0.7m. The financial expense for the current and comparative period are summarized in the table below.
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Q3 2024
US$000
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Q3 2023
US$000
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Term loan interest
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3,224
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1,942
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Convertible note interest
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292
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276
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Notional interest on lease liabilities for Right-of-use assets
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152
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151
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Fair value movement on prepayment option
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3
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18
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Accretion interest on deferred contingent consideration
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14
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Capitalization of borrowing costs
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(601)
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3,084
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2,387
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Loss after tax on continuing operations
Loss after tax on continuing operations for the quarter was $4.8m compared to $6.7m for the equivalent period last year.
EBITDASO
Loss before interest, tax, depreciation, amortization, share-based payments, impairment and restructuring costs (Adjusted EBITDASO) for continuing operations for Q3 2024 was $1.4m, compared to $3.5m
for the comparative period. This is made up as follows:
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Q3 2024
US$000
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Q3 2023
US$000
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Operating loss
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(2,558)
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(4,500)
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Depreciation
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260
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173
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Amortization
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338
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56
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Restructuring costs
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339
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-
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Adjusted EBITDA on continuing operations
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(1,621)
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(4,271)
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Share-based payments
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250
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738
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Adjusted EBITDASO on continuing operations
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(1,371)
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(3,533)
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The basic and diluted loss per ADS for Q3 2024 was $0.46 compared to $1.55 in Q3 2023.
Liquidity
The Group’s cash balance decreased to $2.8m at the end of Q3 2024 from $5.3m at the end of Q2 2024.
Cash used by operating activities for Q3 2024 was $3.6m (Q3 2023: $4.7m). During Q3 2024 the Company had investing cash outflows of $3.1m (Q3 2023: $0.9m), the largest element of this pertained to
the capitalization of the development costs of our CGM device. Interest payments in the quarter were $2.2m (Q3 2023: $1.9m).
At the Market Program
On July 12, 2024, the Company entered into an At the Market Offering Agreement with Craig-Hallum Capital Group LLC, as sales agent. As of September 30, 2024, the Company had sold 3,344,208 ADSs under
the ATM Program, for aggregate gross proceeds of $7.7 million and aggregate net proceeds of approximately $7.1 million, after deducting commissions and fees.
Use of Non-IFRS Financial 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 payments, depreciation, amortization, restructuring costs and
impairment charges.
Adjusted EBITDA for continuing operations and Adjusted EBITDASO for continuing operations 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 for continuing operations and Adjusted EBITDASO for continuing operations, 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 for continuing operations and Adjusted EBITDASO for continuing operations 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 loss and Adjusted EBITDA for continuing operations and Adjusted EBITDASO for continuing operations 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 characterized 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 release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and of
our recent acquisitions, 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, 2023 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. Our 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 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.
