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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]

Core Viewpoint - Trinity Biotech plc has entered into agreements with Perceptive Advisors to enhance its financial flexibility and optimize its capital structure, supporting ongoing and future growth projects [1][2]. Financial Capacity and Operational Flexibility - The transactions strengthen Trinity Biotech's financial capacity and operational flexibility, enabling continued investment in strategic growth priorities and reinforcing its ability to deliver advanced diagnostic and diabetes management solutions [2][3]. - The agreements position Trinity Biotech to advance its long-term growth agenda while supporting a reduction in overall debt levels [2]. Overview of the Transactions - The agreements reflect a positive relationship between Trinity Biotech and Perceptive Advisors, underscoring their support for the Company's strategy and operational momentum [3]. Financial Summary - The Second Amendment to the Credit Agreement extends the maturity to early 2027 and provides increased near-term funding [6]. - New term-loan proceeds of $5 million will strengthen liquidity for key strategic development initiatives, including the continuous glucose monitoring solution, CGM+ [7]. - Up to $60 million in elective equitization capacity under the term-loan may allow for significant debt and cash interest cost reductions [7]. - Equity settlement mechanisms for milestone payments and contingent obligations are designed to reduce cash requirements [7]. Management Commentary - The CEO of Trinity Biotech stated that these developments place the company in a stronger strategic position to accelerate its innovation agenda, particularly in diabetes management and diagnostics [8].

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 a significant order for 9 million units of its TrinScreen HIV screening product, indicating a recovery in the global HIV testing market [1][2][4] - The company achieved positive Adjusted EBITDA in Q3 2025 and anticipates further profitability growth in Q1 and Q2 2026 through its Comprehensive Transformation Plan [1][8][10] TrinScreen HIV Order - The order reflects renewed commitment from global health organizations to support HIV screening, particularly in heavily affected regions [2] - TrinScreen HIV is a WHO-prequalified rapid diagnostic test designed for high-volume screening, providing reliable results in various clinical settings [2] Manufacturing and Supply Chain - Trinity Biotech will produce the tests through a WHO-approved outsourced manufacturing process, allowing for efficient scalability [3] - The company expects to fulfill the order in Q4 2025 and Q1 2026, adjusting its manufacturing and supply chain to meet increased demand [3] Financial Performance - Revenues for Q3 2025 increased by 32% to $14.3 million compared to $10.8 million in Q2 2025, driven by a $2.1 million increase in rapid HIV test sales and a rise in haemoglobin product sales [8] - Gross profit for Q3 2025 was $6.5 million, with an increase in gross margin from 42.6% to 45.2% due to operational changes [8] - Adjusted EBITDA for Q3 2025 was $0.5 million, a significant improvement from negative $2.1 million in Q2 2025 [8] Strategic Positioning - The order is expected to positively impact revenue and profitability, highlighting the company's strategic position in the global infectious disease diagnostics market [4] - The company is focused on immediate growth opportunities and expanding into international markets with new product offerings [7][14] Management Transition - Susan O'Connor has completed her term as interim Chief Financial Officer, with Paul Murphy promoted to the role [10]

Core Insights - Trinity Biotech is advancing its mission to deliver next-generation diabetes management solutions and expand its global market penetration, particularly in the $2 billion+ HbA1c market [1][2] Company Developments - Trinity Biotech has secured regulatory clearances in multiple countries for its next-generation high-capacity HbA1c column system for the Premier Hb9210 analyzer, which is now available in over 10 countries, including the United States [1] - The upgraded column system enhances testing throughput by up to four times compared to the existing system, reduces instrument downtime, and minimizes maintenance requirements, leading to improved operational efficiency [3][7] - The Premier Hb9210 solution is recognized as a gold standard in HbA1c testing, with strong clinical performance confirmed by peer-reviewed studies [3] Market Potential - The global laboratory HbA1c market is currently valued at over $2 billion and is projected to exceed $3.5 billion by 2030, driven by the increasing prevalence of diabetes [2] - The launch of the advanced system in key markets positions Trinity Biotech to capture further growth opportunities in the global diabetes care segment [3] Operational Efficiency - The new column system's operational gains create a more efficient workflow for clinical laboratories, supporting broader adoption of the platform [3] - The latest software update enhances automation of routine tasks, enabling greater productivity and cost savings [7]

Core Insights - Trinity Biotech has received WHO approval for offshored and outsourced upstream manufacturing of its Uni-Gold™ HIV rapid test, marking a significant milestone in its transformation plan aimed at sustainable profitability [1][7] - The transition to an outsourced manufacturing model is expected to enhance gross margins, EBITDA, and cash flow generation, while maintaining product integrity and regulatory compliance [2][5] Company Strategy - The initiative is part of a complex project developed over two years, showcasing the leadership's capability to execute strategic business transformations for long-term capital value [3] - The company aims to streamline operations, reduce fixed costs, and focus on innovation and market expansion through strategic partnerships with world-class manufacturing providers [4][5] Financial Impact - The expected improvements in gross margin, EBITDA, and cash flow generation are central to the company's profitability-focused transformation strategy [5][7]

Core Insights - Trinity Biotech plc has announced a strategic collaboration with a leading bioinformatics company to enhance the analysis of clinical trial data for its EpiCapture test, a PCR-based epigenetic liquid biopsy for monitoring prostate cancer progression [1][3] - The EpiCapture test offers a non-invasive method to detect DNA methylation patterns associated with high-grade prostate cancer, aiming to improve patient care by reducing unnecessary invasive procedures [2][5] - Prostate cancer represents a significant clinical and economic burden, with approximately 1 in 8 men diagnosed in the U.S. and annual costs for diagnosis and treatment exceeding $10 billion [4] Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [9] - The company develops and markets diagnostic systems for point-of-care and clinical laboratory segments, recently entering the wearable biosensor market through the acquisition of Waveform Technologies Inc. [9] - Trinity Biotech's products are utilized to detect infectious diseases and quantify various chemistry parameters in blood samples, with a distribution network spanning over 75 countries [9] Clinical Development - The collaboration aims to support the late-stage development of the EpiCapture test, preparing it for regulatory approval and commercialization [3][7] - A study published in The Journal of Clinical Oncology – Precision Oncology indicated that EpiCapture accurately predicted all high-grade cancers when used with the PSA test, highlighting its potential to enhance clinical decision-making [6]

Core Viewpoint - Trinity Biotech plc is welcoming a proposal from its largest investor, Perceptive Advisors, to convert a portion of its outstanding debt into equity, which is seen as a strategic initiative to strengthen the company's balance sheet and enhance financial flexibility [1][2]. 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, with recent expansion into the wearable biosensor industry through the acquisition of Waveform Technologies Inc. [5]. - Products include diagnostics for infectious diseases and quantification of Haemoglobin A1c and other chemistry parameters in various blood samples [5]. Investor Relations - Perceptive Advisors, a leading life sciences investment firm with approximately $8 billion in assets, has been a supportive partner during Trinity Biotech's transformation [2][7]. - The proposed equitization program aims to align the interests of all stakeholders, including shareholders, and is expected to facilitate discussions that are mutually beneficial [3][2].

Company Overview - Trinity Biotech plc is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [5][6] - The company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments [5][6] Recent Developments - The company announced the appointment of Paul Tivnan as a Non-Executive Director on its Board of Directors [1] - Mr. Tivnan has over 25 years of senior leadership experience in finance, capital markets, and corporate governance across various sectors, including infrastructure and cleantech [2][3] - His previous roles include CFO of Deriva Energy LLC and CFO of Brookfield Renewable Ireland, where he led a successful IPO [2][3] Strategic Goals - The appointment of Mr. Tivnan is aimed at strengthening corporate governance and bringing diverse perspectives to the Board as the company pursues growth opportunities in diagnostics and wearable health technologies [3] - Trinity Biotech is focused on executing its transformation strategy and developing a range of biosensor devices, starting with a continuous glucose monitoring product [6]