Trinity Biotech PLC 6-K, filed Aug 20, 2025
Trinity Biotech PLC (TRIB)
6-K
2025-08-20
For: 2025-08-20
View Original
Added on
April 12, 2026
About this 6-K
Trinity Biotech PLC filed this 6-K on August 20, 2025.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
F O R M 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2025
TRINITY BIOTECH PLC
(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 ☐
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).
EXPLANATORY NOTE
On August 20, 2025, the Company issued a press release announcing it had regulatory approval granted for commencement of Trinity Biotech’s offshored and outsourced manufacturing of its flagship rapid HIV Test,
facilitating strategic and financial performance transformation. A copy of the press release is filed herewith as Exhibit 99.1.
EXHIBIT INDEX
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Exhibit
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Description
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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/ John Gillard
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John Gillard
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Chief Executive Officer
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Date: August 20, 2025
Exhibit 99.1
| Contact: Trinity Biotech plc |
RedChip Companies Inc. |
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Susan O’Connor
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Dave Gentry, CEO |
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(353)-1-2769800
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(1)-407-644-4256 |
| (1)-800-RED-CHIP (733-2447) | |
| TRIB@redchip.com |
Regulatory Approval Granted for Commencement Of Trinity
Biotech’s Offshored and Outsourced Manufacturing of its
Flagship Rapid HIV Test, Facilitating Strategic and Financial
Performance Transformation
Approval Facilitates Immediate Offshored and Outsourced Manufacturing
Strategic Offshore Manufacturing Move Expected to Drive Gross Margin Expansion, Free Up Working Capital, and Enhance Scalability
Transition to Outsourced Production Reduces Fixed Costs and Supports Trinity’s Broader Profitability and Growth Objectives
DUBLIN, Ireland (August 20, 2025) - Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes
management solutions, including wearable biosensors, today announced that the in-country healthcare product regulatory authority has granted the key approval to initiate offshore and outsourced manufacturing of its flagship World Health
Organization (WHO) prequalified TrinScreen™ HIV rapid test.
This key approval now enables Trinity Biotech to transition upstream production from its legacy in-house operations to a more cost-effective and scalable outsourced model, while maintaining the
highest levels of product integrity and regulatory compliance. Trinity Biotech has now begun manufacturing under this new model, marking a critical milestone in the Company’s transformation strategy. The strategic shift is expected to:
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Expand gross margins.
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Free up working capital.
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Reduce fixed costs, supporting broader profitability and growth objectives.
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This latest approval builds on the previously announced WHO approval for the offshored and outsourced upstream manufacturing activities of Trinity Biotech’s high-volume TrinScreen™ HIV rapid test.
“This key regulatory approval is a major step forward in our transformation journey,” said John Gillard, President and Chief Executive Officer of Trinity Biotech. “It builds on our earlier WHO
authorization and allows us to fully operationalize our offshore manufacturing model for TrinScreen™ HIV. This transition unlocks significant cost efficiencies, enhances scalability, and positions the Company for long-term financial health.”
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, the possible pause and/or disruption in
U.S. Government funding for HIV tests produced by Trinity Biotech, 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, 2024 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.