Trinity Biotech Receives Early Approval from the World Health Organization to Begin Offshore Manufacturing of TrinScreen HIV & Uni-Gold HIV

Rhea-AI Summary

Trinity Biotech (TRIB) has received early approval from the World Health Organization (WHO) to transfer the manufacturing of TrinScreen HIV and Uni-Gold HIV tests to a lower-cost offshore facility. This approval is a key milestone in the company's Comprehensive Transformation Plan, enabling the later-stage manufacturing processes of both rapid HIV tests at an outsourced provider. The company plans to begin manufacturing at the new location in Q1 2025, a move expected to improve margins and enhance shareholder value.

Positive

• Early WHO approval received ahead of schedule
• Manufacturing costs expected to decrease through offshore production
• Margin improvements anticipated from Q1 2025
• Implementation of Comprehensive Transformation Plan proceeding successfully

Negative

• Manufacturing transition costs and risks during Q1 2025 transfer

Insights

Financial Analyst

This WHO approval for offshore manufacturing is a significant cost optimization milestone for Trinity Biotech. Moving production of TrinScreen HIV and Uni-Gold HIV tests to a lower-cost facility should substantially improve profit margins. For a small-cap company with a $24M market capitalization, this manufacturing transition represents a important step toward improved operational efficiency and profitability. The Q1 2025 implementation timeline provides a clear catalyst for potential margin expansion. Given Trinity's focus on cost reduction through its Comprehensive Transformation Plan, this earlier-than-expected approval could accelerate the company's path to enhanced financial performance. The HIV testing market remains stable, making this cost-side improvement particularly valuable for long-term sustainability.

Medical Research Analyst

The WHO's approval for offshore manufacturing of both TrinScreen HIV and Uni-Gold HIV tests demonstrates confidence in Trinity Biotech's quality control processes and manufacturing capabilities. These rapid HIV tests are critical diagnostic tools in global health programs, particularly in resource- settings. The maintenance of manufacturing standards while achieving cost efficiencies is important for expanding access to HIV testing. The company's ability to secure early regulatory approval suggests robust documentation and compliance processes. This manufacturing transition, while primarily a cost-saving measure, should not impact product quality or reliability, which is essential for maintaining market position in the competitive HIV diagnostics sector.

DUBLIN, Ireland, Dec. 18, 2024 (GLOBE NEWSWIRE) -- 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.

Contact:	Trinity Biotech plc Louise Tallon (353)-1-2769800
	LifeSci Partners, LLC Eric Ribner (1)-646-751-4363 investorrelations@trinitybiotech.com
	RedChip Companies Inc. Dave Gentry, CEO (1)-407-644-4256 TRIB@redchip.com

FAQ

When will Trinity Biotech (TRIB) begin offshore manufacturing of HIV tests?

Trinity Biotech plans to begin manufacturing TrinScreen HIV and Uni-Gold HIV tests at the new offshore location in Q1 2025.

What regulatory approval did Trinity Biotech (TRIB) receive for HIV test manufacturing?

Trinity Biotech received early approval from the World Health Organization (WHO) to conduct later-stage manufacturing processes of TrinScreen HIV and Uni-Gold HIV at an offshore facility.

How will offshore manufacturing affect Trinity Biotech's (TRIB) financial performance?

The offshore manufacturing is expected to benefit future growth, improve margins, and create shareholder value through lower production costs.

What HIV tests are included in Trinity Biotech's (TRIB) manufacturing transfer?

The manufacturing transfer includes both TrinScreen HIV and Uni-Gold HIV rapid tests.

What is the significance of WHO's early approval for Trinity Biotech (TRIB)?

The early WHO approval is a key milestone in Trinity Biotech's Comprehensive Transformation Plan, enabling the company to proceed with its manufacturing transfer ahead of schedule.