Trinity Biotech confirmed that the World Health Organization has approved its plan to offshore and outsource the upstream manufacturing of its Uni‑Gold HIV rapid test, a staple in global screening programs. The approval removes a key regulatory hurdle and allows the company to shift production from its own facilities to an overseas partner, a move that is expected to cut fixed manufacturing costs and improve operational flexibility.
The company’s financials underscore the importance of this milestone. In Q4 2024, Trinity reported $15.9 million in revenue, a 18.1% year‑over‑year increase, but a net loss of $17.0 million, reflecting the high cost base of its domestic manufacturing. Gross margin fell to 30.8% from 34.0% in the prior year, and the company’s full‑year 2024 loss widened to $31.8 million. In Q1 2025, revenue dropped to $7.6 million as the company paused domestic production to transition to the new offshore facility, with guidance for Q2 2025 revenue of $11–12 million. The WHO approval is a critical step toward the company’s “Comprehensive Transformation Plan,” which aims to lift gross margins, boost EBITDA, and return to cash‑flow positive operations.
Operationally, the new offshore partner will take over the upstream manufacturing of the Uni‑Gold test, with production slated to ramp up in the first quarter of 2025. The partnership is expected to reduce fixed manufacturing costs by an estimated 15–20% and increase scale, allowing Trinity to reallocate capital and personnel to its high‑margin diagnostics pipeline, including a next‑generation continuous glucose monitor and emerging oncology and preeclampsia tests.
Strategically, the move positions Trinity to meet rising global demand for HIV testing while freeing resources for growth areas. By streamlining its manufacturing footprint, the company can accelerate development and commercialization of its CGM platform, which targets a $13 billion global market, and expand its oncology and preeclampsia test offerings. The cost savings and margin expansion from the offshore shift are projected to support the company’s goal of achieving adjusted EBITDA‑positive operations by Q2 2025 and cash‑flow positivity by Q3 2025.
John Gillard, President and CEO, said the approval “underscores our commitment to executing a profitability‑focused transformation strategy.” He added that the milestone demonstrates Trinity’s ability to scale manufacturing capacity while maintaining product quality and regulatory compliance.
No market reaction data were reported in the fact‑check sources, and the company has not issued any guidance beyond the operational timeline and cost‑saving expectations.
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