Trinity Biotech Secures Key Regulatory Approval for Offshored and Outsourced Manufacturing of Its Flagship Rapid HIV Test, Accelerating Strategic & Financial Performance Transformation
Trinity Biotech (NASDAQ:TRIB) has secured World Health Organization (WHO) approval for offshoring and outsourcing the upstream manufacturing of its flagship TrinScreen™ HIV rapid test. This strategic move, set to be implemented in Q3 2025, is a crucial part of the company's transformation plan aimed at improving financial performance and achieving sustainable profitability.
The transition from in-house operations to an outsourced model is expected to deliver significant improvements in gross margins, reduce fixed costs, enhance supply chain resilience, and free up working capital. The company will maintain product integrity and regulatory compliance while focusing internal resources on innovation and market expansion.
Trinity Biotech (NASDAQ:TRIB) ha ottenuto l'approvazione dall'Organizzazione Mondiale della Sanità (OMS) per esternalizzare e delocalizzare la produzione a monte del suo prodotto di punta, il test rapido HIV TrinScreen™. Questa decisione strategica, che sarà attuata nel terzo trimestre del 2025, rappresenta un elemento fondamentale del piano di trasformazione dell'azienda volto a migliorare le prestazioni finanziarie e a raggiungere una redditività sostenibile.
Il passaggio da una gestione interna a un modello esternalizzato porterà significativi miglioramenti nei margini lordi, una riduzione dei costi fissi, un aumento della resilienza della catena di approvvigionamento e una liberazione di capitale circolante. L'azienda garantirà l'integrità del prodotto e la conformità regolatoria, concentrando al contempo le risorse interne su innovazione ed espansione del mercato.
Trinity Biotech (NASDAQ:TRIB) ha obtenido la aprobación de la Organización Mundial de la Salud (OMS) para externalizar y deslocalizar la fabricación inicial de su principal producto, el test rápido de VIH TrinScreen™. Esta medida estratégica, que se implementará en el tercer trimestre de 2025, es una parte clave del plan de transformación de la compañía para mejorar el rendimiento financiero y alcanzar una rentabilidad sostenible.
La transición de operaciones internas a un modelo externalizado se espera que genere mejoras significativas en los márgenes brutos, reduzca los costos fijos, mejore la resiliencia de la cadena de suministro y libere capital de trabajo. La empresa mantendrá la integridad del producto y el cumplimiento regulatorio mientras enfoca sus recursos internos en la innovación y la expansión del mercado.
트리니티 바이오텍(NASDAQ:TRIB)은 세계보건기구(WHO)로부터 주력 제품인 TrinScreen™ HIV 신속 검사의 상류 제조 공정 해외 이전 및 외주에 대한 승인을 받았습니다. 이 전략적 조치는 2025년 3분기에 시행될 예정이며, 회사의 재무 성과 개선과 지속 가능한 수익성 달성을 목표로 하는 전환 계획의 핵심 부분입니다.
내부 운영에서 외주 모델로의 전환은 총이익률 개선, 고정비 절감, 공급망 회복력 강화, 운전자본 확보에 큰 도움이 될 것으로 기대됩니다. 회사는 제품의 완전성과 규제 준수를 유지하면서 내부 자원을 혁신과 시장 확장에 집중할 예정입니다.
Trinity Biotech (NASDAQ:TRIB) a obtenu l'approbation de l'Organisation mondiale de la santé (OMS) pour externaliser et délocaliser la fabrication en amont de son test rapide VIH phare, le TrinScreen™. Cette démarche stratégique, qui sera mise en œuvre au troisième trimestre 2025, constitue une étape clé du plan de transformation de l'entreprise visant à améliorer ses performances financières et à atteindre une rentabilité durable.
Le passage d'une production interne à un modèle externalisé devrait permettre des améliorations significatives des marges brutes, une réduction des coûts fixes, un renforcement de la résilience de la chaîne d'approvisionnement et une libération de fonds de roulement. L'entreprise garantira l'intégrité du produit et la conformité réglementaire tout en concentrant ses ressources internes sur l'innovation et le développement du marché.
Trinity Biotech (NASDAQ:TRIB) hat die Genehmigung der Weltgesundheitsorganisation (WHO) erhalten, die vorgelagerte Herstellung seines Flaggschiffprodukts, des TrinScreen™ HIV-Schnelltests, auszulagern und ins Ausland zu verlagern. Dieser strategische Schritt, der im dritten Quartal 2025 umgesetzt werden soll, ist ein wesentlicher Bestandteil des Transformationsplans des Unternehmens zur Verbesserung der finanziellen Leistung und zur Erreichung nachhaltiger Rentabilität.
Der Übergang von internen Abläufen zu einem ausgelagerten Modell wird voraussichtlich erhebliche Verbesserungen der Bruttomargen, eine Reduzierung der Fixkosten, eine höhere Widerstandsfähigkeit der Lieferkette sowie die Freisetzung von Betriebskapital bringen. Das Unternehmen wird die Produktintegrität und regulatorische Compliance aufrechterhalten und interne Ressourcen auf Innovation und Markterweiterung konzentrieren.
- WHO approval secured for outsourced manufacturing of flagship HIV test
- Expected improvement in gross margins through cost-effective production
- Reduction in fixed costs through outsourced manufacturing model
- Enhanced supply chain resilience and scalability
- Improved working capital efficiency
- Transition risks during Q3 2025 implementation phase
- Potential dependency on third-party manufacturers
- Possible short-term operational disruptions during manufacturing transfer
Insights
WHO approval for offshored manufacturing of TrinScreen HIV test positions Trinity for improved margins and reduced costs, advancing financial turnaround.
Trinity Biotech has achieved a significant operational milestone with WHO approval for offshored and outsourced upstream manufacturing of its TrinScreen™ HIV rapid test. This regulatory clearance represents more than just a manufacturing change – it's a fundamental shift in the company's operating model that addresses multiple financial challenges simultaneously.
The transition to outsourced manufacturing delivers three distinct financial advantages: margin expansion through lower production costs, working capital improvements by reducing inventory investment requirements, and enhanced scalability that better aligns production costs with demand. For a diagnostic company like Trinity, manufacturing represents one of the largest fixed cost components, and this shift converts substantial fixed costs to variable expenses – a critical element for financial turnaround.
The timing of implementation in Q3 2025 suggests investors will begin seeing financial improvements in late 2025, with full impact likely reflected in 2026 financial statements. This transformation addresses a core challenge for diagnostic manufacturers – maintaining regulatory compliance while improving cost structures. The WHO approval validates that Trinity has successfully navigated this balance, maintaining product integrity while restructuring operations.
This approval reflects broader industry trends where diagnostic manufacturers are increasingly outsourcing production to specialized contract manufacturers that offer economies of scale not achievable in-house. Trinity's focus on TrinScreen™, described as a "cornerstone diagnostic product," indicates they're prioritizing their highest-volume offerings first in this transformation – a methodical approach that targets maximum financial impact while minimizing operational disruption.
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, June 24, 2025 (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 it has received World Health Organization (WHO) approval for the offshored and outsourced upstream manufacturing activities of its high-volume TrinScreen™ HIV rapid test, a cornerstone diagnostic product used in HIV screening programs. This regulatory approval marks a critical milestone in the Company’s comprehensive transformation plan aimed at restoring financial performance and driving sustainable profitability.
This key regulatory approval 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.
“This approval is a major step forward in our transformation journey,” said John Gillard, President & Chief Executive Officer of Trinity Biotech. “By offshoring and outsourcing the further upstream manufacturing activities of one of our principal products, we are unlocking significant cost efficiencies, improving operational agility & scalability, and positioning the Company for long-term financial health.”
The transition to outsourced offshore upstream manufacturing is expected to deliver substantial improvements in gross margin and working capital, while also enhancing supply chain resilience and scalability. The move is part of a broader strategic initiative to streamline operations, reduce fixed costs, and focus internal resources on innovation and market expansion.
Trinity Biotech will implement this next phase of this new TrinScreen™ HIV manufacturing model in Q3 2025.
Key Highlights:
- WHO approval granted for offshored and outsourced upstream manufacturing activities of TrinScreen HIV.
- Supports transformation plan focused on financial turnaround and sustainable growth.
- Expected to improve gross margins, reduce fixed costs, and enhance supply chain agility.
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.
| Contact: | Trinity Biotech plc | RedChip Companies Inc. |
| Micheal Roche | Dave Gentry, CEO | |
| (353)-1-2769800 | (1)-407-644-4256 | |
| (1)-800-RED-CHIP (733-2447) | ||
| TRIB@redchip.com | ||
FAQ
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