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 December 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).
EXPLANATORY NOTE
On December 18, 2024, the Company issued a press release
announcing its receipt of early approval from the World Health Organization to transfer the manufacturing of both its TrinScreen HIV and
Uni-Gold HIV to a lower-cost offshore manufacturing partner.
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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/s/ Louise Tallon
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Louise Tallon
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Chief Financial Officer
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Date: December 18, 2024
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 Receives Early Approval from the World Health
Organization to Begin Offshore Manufacturing of TrinScreen HIV
& Uni-Gold HIV
DUBLIN, Ireland (December 18, 2024)... Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology
company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced an important update on its Comprehensive Transformation Plan, which includes the transfer of manufacturing of both TrinScreen HIV
and Uni-Gold HIV to a lower-cost offshore manufacturing partner. Trinity Biotech has received earlier than expected approval from the World Health Organization (WHO) to permit the later-stage manufacturing process of TrinScreen HIV and Uni-Gold HIV
at its outsourced provider. This approval was a key prerequisite in the manufacturing transfer the Company has been working towards as part of its Comprehensive Transformation Plan.
“We are pleased to have received the earlier than expected regulatory approval from the WHO to begin the later-stage
manufacturing processes of both of our rapid HIV tests, TrinScreen HIV and Uni-Gold HIV, at our offshore manufacturing facility,” said John Gillard, CEO of Trinity Biotech. “This achievement represents a significant
milestone for Trinity Biotech in our previously announced Comprehensive Transformation Plan and demonstrates the strong execution of our team in collaborating with global regulatory authorities. We expect to begin manufacturing our rapid HIV tests
at the new location in Q1, 2025, which will benefit our future growth, improve our margins and create shareholder value. I would like to thank all the Trinity Biotech employees who have pushed hard to attain this goal in an expedited manner.”
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.
