Press Releases June 16, 2026 09:10 AM

Trinity Biotech Awarded Significant Orders for Over 2 Million TrinScreen HIV Tests And Reports Q1 2026 Financial Results

Trinity Biotech receives major orders for TrinScreen HIV tests and reports strong Q1 2026 financials, reinforcing growth outlook.

By Caleb Monroe
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Trinity Biotech announced significant purchase orders exceeding 2 million units of its rapid HIV test, TrinScreen HIV, supporting its 2026 revenue and profit targets. The company reported Q1 2026 revenues up 43% year-on-year with improved gross margins due to operational restructuring. The commercial scale-up of outsourced UniGold HIV production is underway, expected to enhance profitability further. Trinity Biotech continues development of diabetes management and innovation pipelines, underpinning future growth ambitions.

Trinity Biotech Awarded Significant Orders for Over 2 Million TrinScreen HIV Tests And Reports Q1 2026 Financial Results
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Key Points

  • Received purchase orders for over 2 million TrinScreen HIV rapid test units, reinforcing demand in global health markets affected by prior aid funding disruptions.
  • Q1 2026 revenues increased 43% to $10.8 million with gross margin improvement from 25.2% to 35.4%, driven by cost-effective outsourced manufacturing under a Comprehensive Transformation Plan.
  • Advancement in commercial scale-up of outsourced UniGold HIV test manufacturing expected in Q3 2026, aiming to improve EBITDA and cash flow generation.

– Orders reinforce strong demand outlook in global health markets and supports 2026 revenue and profitability targets 

– Company publishes Q1 2026 financial results with revenue in line with prior guidance & substantial year-on-year gross margin percentage improvements             

DUBLIN, June 16, 2026 (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 that it has received additional purchase orders for over 2 million units of its flagship rapid HIV test, TrinScreen™ HIV. These orders are scheduled for fulfillment in Q3 2026 and are expected to make a meaningful contribution to the Company’s 2026 revenue and profitability objectives.

These orders provide further evidence of renewed, broad-based demand for rapid HIV diagnostics across global health markets, following disruptions in 2025 due to changes affecting international aid funding structures.

TrinScreen™ HIV is a WHO prequalified point of care diagnostic test designed for use in high-volume community screening programs in countries with high HIV prevalence, offering reliable results and ease of use in diverse clinical settings. These orders will be manufactured under the new offshored and outsourced manufacturing process, a key deliverable in the Company’s Comprehensive Transformation Plan, which provides for efficient and cost-effective scalability.

John Gillard, CEO of Trinity Biotech, commented:

Recent outbreaks of Ebola and Hantavirus serve as an important reminder of the ongoing public health risks posed by infectious diseases. Against this backdrop, these additional orders for TrinScreen HIV represent a further welcome indication of renewed focus on HIV disease management.

In addition, the Company continues to execute the commercial scale-up of outsourced upstream UniGold HIV™ production, following regulatory approvals received earlier this year. This is a final core component in the Comprehensive Transformation Plan and upon scale-up completion is expected to deliver substantial improvements in gross margin, EBITDA and cashflow generation. The Company expects the commercial scale-up of this outsourced manufacturing model for UniGold HIV™ to be substantially in place during Q3 2026.

Alongside execution of the final stages of the Comprehensive Transformation Plan, the Company continues to advance its development pipeline, including CGM+ and other key innovation programmes, which underpin its long‑term growth ambitions.

Q1 2026 Results

  • Revenues for Q1 2026 increased by 43% to $10.8m, compared to Q1 2025 revenue of $7.6m, primarily due to:
    • Rapid HIV sales of $3.7m in Q1 2026, including TrinScreen™ HIV sales of $2.3m compared to $0.4m in Q1 2025
    • an increase in haemoglobin product sales, rising to $3.3m compared to $2.3m in Q1 2025
  • Gross margin increased from 25.2% to 35.4% supported by changes to the Company’s operating structure under its Comprehensive Transformation Plan. Gross profit for Q1 2026 was $3.8m compared to $1.9m in Q1 2025.
  • Net Loss of $4.4m (Q1 2025: net loss of $8.8m).
  • Adjusted EBITDAi of negative $1.1m for Q1 2026 compared to negative $4.0m for Q1 2025.
  • The Company has issued a full presentation of its Q1 2026 results which can be viewed on the Company’s website www.trinitybiotech.com/investor-relations/financial-reports.

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, 2025 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 plcRedChip Companies Inc. Paul MurphyDave Gentry, CEO (353)-1-2769800(1)-407-644-4256  (1)-800-RED-CHIP (733-2447)  [email protected]   

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i Earnings before interest, tax, depreciation, amortisation, and share-based compensation charges – also excludes impairment charges, restructuring costs and non-recurring corporate finance and transaction-related costs.


Risks

  • Potential disruptions or pauses in U.S. government funding for HIV tests could materially impact sales and revenues.
  • Inventory imbalances or excess inventory at distributors may affect order fulfillment and revenue recognition.
  • Risks associated with outsourced and offshored manufacturing processes, including quality control and supply chain reliability, may impact product delivery and margins.

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