Trinity Biotech Secures Major Regulatory Approval for Offshored and Outsourced Manufacturing of Its Market Leading Uni-Gold Rapid HIV Test, Further Accelerating Financial Performance Transformation
Trinity Biotech (Nasdaq: TRIB) announced on November 18, 2025 that it received World Health Organization (WHO) approval for offshored and outsourced upstream manufacturing of its Uni-Gold™ HIV rapid test. The approval permits transitioning upstream production from in-house to outsourced offshore partners after ~two years of development. Management said the change is part of a broader transformation to streamline operations and is expected to improve gross margins, EBITDA and cashflow. The company plans to implement the new Uni-Gold™ manufacturing model in the coming months while retaining regulatory compliance and product integrity.
Trinity Biotech (Nasdaq: TRIB) ha annunciato il 18 novembre 2025 di aver ricevuto l'approvazione dell'Organizzazione Mondiale della Sanità (OMS) per la produzione a monte offshore esternalizzata del suo Uni-Gold™ HIV test rapído. L'approvazione consente di trasferire la produzione upstream da interne a partner offshore esternalizzati dopo circa due anni di sviluppo. La direzione ha dichiarato che il cambiamento è parte di una trasformazione più ampia volta a snellire le operazioni e ci si aspetta che migliori margini lordi, EBITDA e flussi di cassa. L'azienda intende implementare il nuovo modello di produzione Uni-Gold™ nei prossimi mesi mantenendo la conformità normativa e l'integrità del prodotto.
Trinity Biotech (Nasdaq: TRIB) anunció el 18 de noviembre de 2025 que recibió la aprobación de la Organización Mundial de la Salud (OMS) para la fabricación upstream externalizada y realizada en el extranjero de su prueba rápida Uni-Gold™ HIV. La aprobación permite trasladar la producción aguas arriba de instalaciones propias a socios offshore externos después de aproximadamente dos años de desarrollo. La dirección dijo que el cambio forma parte de una transformación más amplia para optimizar las operaciones y se espera que mejore márgenes brutos, EBITDA y flujo de caja. La empresa planea implementar el nuevo modelo de fabricación Uni-Gold™ en los próximos meses manteniendo el cumplimiento normativo y la integridad del producto.
Trinity Biotech (나스닥: TRIB)는 2025년 11월 18일에 자사의 Uni-Gold™ HIV 신속 검사의 상류 제조를 해외로 외주화/오프쇼어링하는 승인을 받았다고 발표했다. 이 승인은 약 2년간의 개발 끝에 내부 생산에서 외부의 해외 파트너로 상류 생산을 전환할 수 있도록 한다. 경영진은 이 변화가 운영을 간소화하기 위한 더 광범위한 전환의 일부이며 총마진, EBITDA 및 현금 흐름을 개선할 것으로 기대한다고 말했다. 회사는 규제 준수와 제품 무결성을 유지하면서 향후 몇 개월 내에 새 Uni-Gold™ 제조 모델을 도입할 계획이다.
Trinity Biotech (Nasdaq : TRIB) a annoncé le 18 novembre 2025 avoir obtenu l'approbation de l'Organisation mondiale de la Santé (OMS) pour la fabrication en amont délocalisée et externalisée de son test rapide Uni-Gold™ VIH. Cette approbation permet de passer de la production en interne à des partenaires offshore externes après environ deux ans de développement. La direction a indiqué que ce changement fait partie d'une transformation plus vaste visant à rationaliser les opérations et devrait améliorer les marges brutes, l'EBITDA et les flux de trésorerie. L'entreprise prévoit de mettre en œuvre le nouveau modèle de fabrication Uni-Gold™ dans les mois à venir tout en garantissant la conformité réglementaire et l'intégrité du produit.
Trinity Biotech (Nasdaq: TRIB) gab am 18. November 2025 bekannt, dass es die Genehmigung der Weltgesundheitsorganisation (WHO) für das Offshore- und Outsourcing-Upstream‑Manufacturing seines Uni-Gold™ HIV-Schnelltests erhalten hat. Die Genehmigung ermöglicht die Verlagerung der Upstream-Produktion von interner zu externen Offshore-Partnern nach etwa zwei Jahren Entwicklung. Das Management sagte, dass diese Veränderung Teil einer umfassenderen Transformation sei, um die Abläufe zu straffen, und voraussichtlich die Bruttomargen, EBITDA und Cashflow verbessern werde. Das Unternehmen plant, das neue Uni-Gold™ Herstellungsmodell in den kommenden Monaten umzusetzen, wobei Regeltreue und Produktintegrität gewahrt bleiben.
Trinity Biotech (Nasdaq: TRIB) أعلنت في 18 نوفمبر 2025 أنها تلقّت اعتماد منظمة الصحة العالمية (WHO) لتصنيع السلسلة العلوية خارج الشركة وتعهيدها (upstream) لاختبار HIV السريع Uni-Gold™. يتيح الاعتماد الانتقال من الإنتاج الداخلي إلى شركاء خارجيين في الخارج بعد نحو عامين من التطوير. قالت الإدارة إن هذا التغيير جزء من تحول أوسع يهدف إلى تبسيط العمليات ومن المتوقع أن يحسن الهامش الإجمالي وEBITDA والتدفقات النقدية. تخطط الشركة لتنفيذ نموذج التصنيع الجديد لـ Uni-Gold™ في الأشهر المقبلة مع الحفاظ على الالتزام التنظيمي وسلامة المنتج.
- WHO approval granted for offshored upstream Uni-Gold manufacturing
- Outsourcing expected to improve gross margin and EBITDA
- Implementation planned within the coming months
- Two-year development project completed enabling transition
- Possible pause or disruption in U.S. government HIV test funding
- Dependence on outsourced suppliers creates supplier-concentration risk
- Potential inventory imbalances at distributors could affect sales
Insights
WHO approval enables outsourced upstream manufacturing for Uni-Gold™; company expects margin, EBITDA and cashflow benefits.
Trinity Biotech received World Health Organization approval to offshore and outsource upstream manufacturing of its Uni-Gold™ HIV rapid test, allowing the company to move production from legacy in‑house operations to external manufacturers. The announcement explicitly links this approval to the company’s transformation plan and states the change will occur in the coming months.
The firm states the transition is expected to improve gross margins, EBITDA and cashflow generation while reducing fixed costs and refocusing internal resources on innovation and market expansion. Execution risk remains because the benefits are described as forward‑looking and depend on successful transfer, supplier performance, and regulatory compliance during implementation.
Watch for concrete implementation milestones over the next several months, including announced supplier contracts, completion of transfer activities, and any post‑transfer regulatory confirmations; these items will materially affect the realization and timing of the stated margin and cashflow improvements.
Strategic Offshore Manufacturing Move Expected to Drive Gross Margin Expansion, EBITDA Accretion and Cashflow Generation
DUBLIN, Nov. 18, 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 market leading Uni-Gold™ HIV rapid test, a well-established and cornerstone diagnostic product used in HIV screening programs internationally. This regulatory approval marks a further critical milestone in the Company’s comprehensive transformation plan aimed at driving sustainable profitability.
This major regulatory approval enables Trinity Biotech to transition upstream production of Uni-Gold™ from its legacy in-house operations to a more cost-effective outsourced model, while maintaining the highest levels of product integrity and regulatory compliance.
The initiative is part of a complex, multifaceted project that has been in development for approximately two years. It reflects the ability of Trinity Biotech’s current leadership team to envision and execute high-value, strategic business transformation projects to drive long-term capital value. This transformation capability creates a long-term value creation driver in the business as it focuses on future growth opportunities.
“This achievement underscores our commitment to executing a profitability-focused transformation strategy. By strategically partnering with world-class manufacturing providers, we are ensuring that Trinity Biotech remains competitive, agile, and well-positioned for long-term growth," said John Gillard, President & Chief Executive Officer of Trinity Biotech.
The transition to outsourced offshore upstream manufacturing is expected to deliver substantial improvements in gross margin, EBITDA and cashflow generation. 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 Uni-Gold™ HIV manufacturing model in the coming months.
Key Highlights:
- WHO approval granted for offshored and outsourced upstream manufacturing activities of Uni-Gold™ HIV.
- Supports transformation plan focused on financial turnaround and sustainable growth.
- Expected to improve gross margins, EBITDA and cashflow generation.
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. |
| Micheál Roche (353)-1-2769800 | Dave Gentry, CEO (1)-407-644-4256 (1)-800-RED-CHIP (733-2447) TRIB@redchip.com |
FAQ
What did Trinity Biotech announce on November 18, 2025 about Uni-Gold (TRIB)?
How will the WHO approval affect Trinity Biotech's margins and cashflow for TRIB?
When will Trinity Biotech implement the outsourced Uni-Gold manufacturing for TRIB?
Does the WHO approval allow Trinity Biotech to move all Uni-Gold production offshore for TRIB?
What risks did Trinity Biotech (TRIB) highlight related to the manufacturing transition?
