Trinity Biotech plc Announces WHO Approval for Manufacturing Transfer of HIV Tests as Part of Comprehensive Transformation Plan

Trinity Biotech updates on its transformation plan, announcing WHO approval for offshore HIV test manufacturing, enhancing growth potential.

Quiver AI Summary

Trinity Biotech plc, a biotechnology company focusing on human diagnostics and diabetes management, has announced a significant update to its Comprehensive Transformation Plan, which includes transferring the manufacturing of its TrinScreen HIV and Uni-Gold HIV tests to a cost-effective offshore partner. The company received early approval from the World Health Organization to commence later-stage manufacturing with this provider, marking a major milestone in their transformation efforts. CEO John Gillard expressed optimism about the impact of this transition on future growth and profitability, with production expected to begin in the first quarter of 2025. Trinity Biotech also emphasized the importance of this development in strengthening its operations and enhancing shareholder value. The release includes forward-looking statements regarding various risks and uncertainties that may affect the company's future performance.

Potential Positives

• Approval from the World Health Organization (WHO) for later-stage manufacturing of TrinScreen HIV and Uni-Gold HIV is a significant achievement, allowing for operational advancements.
• The transfer to a lower-cost offshore manufacturing partner is expected to improve profit margins and drive future growth for Trinity Biotech.
• The announcement signifies an important milestone in the company’s Comprehensive Transformation Plan, highlighting effective collaboration with global regulatory authorities.
• The anticipated start of manufacturing in Q1 2025 underlines the company's strategic focus on enhancing shareholder value.

Potential Negatives

• Transferring manufacturing to a lower-cost offshore partner may raise concerns about product quality and supply chain reliability.
• The press release contains multiple cautionary statements about risks and uncertainties, highlighting potential vulnerabilities related to profitability and market acceptance.
• The company’s future growth relies heavily on several forward-looking statements, which may not materialize as expected, reflecting potential instability in its operations and financial outlook.

FAQ

What is Trinity Biotech's Comprehensive Transformation Plan?

Trinity Biotech's Comprehensive Transformation Plan includes transferring manufacturing of HIV tests to a lower-cost offshore partner to improve margins and growth.

When will manufacturing start at the new facility?

Manufacturing of TrinScreen HIV and Uni-Gold HIV at the new offshore facility is expected to begin in the first quarter of 2025.

What recent approval did Trinity Biotech receive?

The World Health Organization (WHO) granted early approval for the later-stage manufacturing of TrinScreen HIV and Uni-Gold HIV at the new facility.

How will this manufacturing transfer impact Trinity Biotech?

This transfer aims to enhance future growth, improve margins, and create shareholder value for Trinity Biotech as part of its transformation strategy.

What markets does Trinity Biotech serve?

Trinity Biotech serves the human diagnostics and diabetes management markets, selling products directly in the U.S. and through international distributors in over 75 countries.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$TRIB Hedge Fund Activity

We have seen 7 institutional investors add shares of $TRIB stock to their portfolio, and 10 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

• STONEHILL CAPITAL MANAGEMENT LLC removed 248,399 shares (-100.0%) from their portfolio in Q2 2024
• HRT FINANCIAL LP added 34,030 shares (+inf%) to their portfolio in Q3 2024
• ACADIAN ASSET MANAGEMENT LLC removed 30,271 shares (-42.0%) from their portfolio in Q3 2024
• HUNTER ASSOCIATES INVESTMENT MANAGEMENT LLC added 26,100 shares (+7.8%) to their portfolio in Q3 2024
• RENAISSANCE TECHNOLOGIES LLC removed 15,300 shares (-5.8%) from their portfolio in Q3 2024
• SUSQUEHANNA INTERNATIONAL GROUP, LLP removed 13,572 shares (-100.0%) from their portfolio in Q2 2024
• UBS GROUP AG removed 5,178 shares (-100.0%) from their portfolio in Q2 2024

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

Full Release

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

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.