Core Viewpoint - Trinity Biotech plc has received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement for its American Depositary Shares (ADSs), which must be at least $1.00 per share for 30 consecutive business days [1][2]. Company Compliance Status - The notice does not immediately affect the trading status of the Company's ADSs, which will continue to be listed on the Nasdaq Global Select Market under the symbol "TRIB" [2]. - The Company has a 180-calendar day period, until August 10, 2026, to regain compliance with the minimum bid price requirement [2]. - To regain compliance, the closing bid price of the Company's ADSs must meet or exceed $1.00 for at least ten consecutive business days during this grace period [2]. Management's Response - The Company's management is actively monitoring the bid price of its ADSs and intends to cure the deficiency within the grace period [3]. - Various options are being evaluated by management to regain compliance and maintain the continued listing of the ADSs [3]. Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [5]. - The Company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments, and has recently entered the wearable biosensor industry through the acquisition of Waveform Technologies Inc. [5]. - Products include systems to detect infectious diseases and quantify Haemoglobin A1c levels, with sales occurring directly in the U.S. and through international distributors in over 75 countries [6].

Core Insights - Trinity Biotech has received full regulatory approval for upstream manufacturing of its Uni-Gold™ HIV rapid test, marking a significant milestone in its transformation plan [1][2][5] Group 1: Regulatory Approvals - The recent approval from the in-country healthcare product regulatory authority is the final major regulatory milestone needed to implement the new offshore and outsourced manufacturing model for Uni-Gold™ HIV [2][5] - This approval follows the WHO authorization received in November 2025, which laid the groundwork for the current in-country manufacturing clearance [2][3] Group 2: Strategic Transition - The transition to an offshore and outsourced manufacturing model is expected to enhance cost efficiency and scalability for the production of Uni-Gold™ HIV [2][3][5] - This strategic move aims to expand gross margins, improve working capital efficiency, and support future demand growth for Uni-Gold™ HIV [6] Group 3: Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [8] - The company develops and markets diagnostic systems for point-of-care and clinical laboratory segments, with a recent expansion into the wearable biosensor industry through the acquisition of Waveform Technologies Inc. [8]

Core Insights - Trinity Biotech has achieved the prestigious Gold Classification from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for its Premier Hb9210™ HbA1c Analyser, marking it as the only HbA1c system worldwide to earn this certification for 2026 [1][2][4] Company Developments - The Premier Hb9210™ Buffer A Plus column system enhances usability, minimizes operator interaction, and reduces operating costs while maintaining high patient care standards [3] - Trinity Biotech's cumulative investment in diabetes care technologies has approached approximately $100 million, highlighting its commitment to innovation in diabetes management [7] - The company is actively participating in the World Health Expo from February 10-12, 2026, to discuss advancements in diabetes care and its position in the $2 billion HbA1c testing market [5][6] Market Context - The global market for laboratory HbA1c testing is valued at over $2 billion annually and is projected to exceed $3.5 billion by 2030, driven by the rising incidence of diabetes [5] - The IFCC's certification process evaluates over 200 HbA1c analytical systems, with Gold status representing the highest level of performance, underscoring the significance of Trinity Biotech's achievement [4]

Financial Performance - Revenue for Q3 2025 was $14.3 million, compared to $15.2 million in Q3 2024[7] - Like-for-like revenue (excluding discontinued product lines) was $14.2 million in Q3 2025, compared to $14.6 million in Q3 2024[4, 7] - Gross profit increased to $6.5 million in Q3 2025 from $5.3 million in Q3 2024, with gross margin improving to 45.2% from 35.0%[7] - The company achieved positive Adjusted EBITDA of $0.5 million for the quarter, compared to negative $1.4 million in Q3 2024[4] - Net loss was $5.1 million in Q3 2025, compared to $4.8 million in Q3 2024[4] - Basic and diluted loss per ADS was $0.28 in Q3 2025, compared to $0.46 in Q3 2024[4] Key Revenue Drivers - TrinScreen HIV sales were $1.0 million in Q3 2025, compared to $2.4 million in Q3 2024, reflecting the resumption of manufacture[7] - UniGold HIV sales showed strong performance with sales of $2.6 million in Q3 2025, compared to $1.6 million in Q3 2024[7] - Haemoglobin revenue increased to $5.7 million in Q3 2025 from $5.1 million in Q3 2024[7] Expenses and Liquidity - R&D expense was $0.8 million in Q3 2025, compared to $1.0 million in Q3 2024[10] - SG&A expense decreased to $6.2 million in Q3 2025 from $6.5 million in Q3 2024[10] - Cash balance at the end of Q3 2025 was $1.3 million, compared to $2.8 million in Q3 2024[10]

Financial Performance - Revenue for Q2 2025 was $10.8 million, a decrease compared to $15.8 million in Q2 2024[4, 7] - Like-for-like revenue (excluding sub-scale lower-margin third-party product lines) was $10.7 million in Q2 2025, versus $15.0 million in Q2 2024[7] - Gross profit was $4.6 million in Q2 2025, down from $5.7 million in Q2 2024[7] - Gross margin improved to 42.6% in Q2 2025, compared to 36.2% in Q2 2024[7] - Net loss was $6.0 million in Q2 2025, an improvement from $6.8 million in Q2 2024[4] - Basic and diluted loss per ADS was $0.32 in Q2 2025, compared to $0.71 in Q2 2024[4] - Adjusted EBITDA was negative $2.1 million in Q2 2025, compared to negative $1.4 million in Q2 2024[4] Expenses and Liquidity - R&D expense was $0.6 million in Q2 2025, compared to $0.9 million in Q2 2024, with $1.7 million capitalized[10] - SG&A expense was $7.0 million in Q2 2025, up from $6.4 million in Q2 2024, driven by foreign exchange loss and corporate finance activities[10] - Restructuring costs were $0.7 million in Q2 2025, compared to $1.9 million in Q2 2024[10] - Cash balance at the end of Q2 2025 was $1.5 million, down from $5.3 million in Q2 2024[10]

Core Insights - Trinity Biotech has received regulatory approval to initiate offshore and outsourced manufacturing of its TrinScreen™ HIV rapid test, marking a significant step in its transformation strategy [1][2][3] - The transition to an outsourced production model is expected to drive gross margin expansion, free up working capital, and reduce fixed costs, thereby supporting the company's broader profitability and growth objectives [1][4] Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [5] - The company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments, and has recently entered the wearable biosensor industry [5]

Core Insights - Trinity Biotech has reached a critical profitability inflection point and expects to be Adjusted EBITDA positive and cash flow positive starting Q3 2025 [1][5][10] - The company has undergone significant operational restructuring to reduce costs and improve efficiency, laying the groundwork for sustainable profitability [5][10] - Trinity Biotech is focusing on growth opportunities, including the international rollout of new products and the development of innovative diagnostic solutions [5][12] Financial Performance - For Q1 2025, Trinity Biotech reported revenue of $7.6 million, with a gross profit of $1.9 million and an operating loss of $6.5 million [10] - The company anticipates a significant increase in revenue for Q2 2025, projecting a range of approximately $11 million to $12 million due to ramped-up manufacturing and normalized demand for rapid HIV tests [10] - The company expects further revenue growth in Q3 2025, driven by the resumption of manufacturing and supply of its flagship rapid HIV test, TrinScreen HIV [10] Strategic Developments - The company is advancing its next-generation continuous glucose monitoring (CGM) solution, which is seen as a major growth opportunity in the $13 billion global CGM market [5] - Trinity Biotech is also progressing towards commercialization of key medium-term growth drivers, including a preeclampsia screening test and a prostate cancer test [5] - The company has completed a pre-pivotal trial on its upgraded sensor technology for the CGM solution and plans to unveil key aspects of this innovative design soon [5]

Core Insights - Trinity Biotech has received WHO approval for offshored and outsourced upstream manufacturing of its TrinScreen™ HIV rapid test, a significant step in its transformation plan aimed at improving financial performance and achieving sustainable profitability [1][6]. Group 1: Manufacturing Transition - The approval allows Trinity Biotech to shift production from in-house operations to a more cost-effective and scalable outsourced model, ensuring product integrity and regulatory compliance [2]. - The transition is expected to unlock significant cost efficiencies, enhance operational agility and scalability, and improve gross margins and working capital [3][6]. Group 2: Strategic Objectives - This move is part of a broader strategic initiative to streamline operations, reduce fixed costs, and focus on innovation and market expansion [3]. - The new manufacturing model for TrinScreen™ HIV is set to be implemented in Q3 2025, marking a critical phase in the company's transformation journey [4]. Group 3: Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [8]. - The company develops and markets diagnostic systems for point-of-care and clinical laboratory segments, with a presence in over 75 countries worldwide [8].