Trinity Biotech plc received World Health Organization approval on November 18 2025 to offshore and outsource the upstream manufacturing of its Uni‑Gold rapid HIV test, a move that removes a long‑standing regulatory hurdle and enables the company to shift production to a cost‑effective overseas partner.
The approval allows Trinity to replace its in‑house manufacturing with a new partner that is expected to reduce fixed costs and improve gross margins. While the company has not disclosed the exact cost savings, it has stated that the transition will lift EBITDA and strengthen cash‑flow generation as part of its broader transformation plan that has been underway since 2024.
This regulatory milestone is a key component of Trinity’s strategy to return to profitability. The company has historically reported negative EBITDA and has been burning cash; the offshore model is projected to bring the company to adjusted EBITDA‑positive and cash‑flow‑positive status from the third quarter of 2025 onward. The approval also positions Trinity to capture a larger share of the high‑volume HIV testing market, which is projected to exceed $5.3 billion by 2030.
CEO John Gillard said the approval “underscores our commitment to executing a profitability‑focused transformation strategy. By partnering with world‑class manufacturing providers, we are ensuring that Trinity Biotech remains competitive, agile, and well‑positioned for long‑term growth.”
The company will report its next earnings on November 21 2025, with analysts estimating a consensus EPS of –$1.48 for that period. The approval is expected to be a significant driver of the company’s financial outlook moving forward.
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