Financial Position and Performance - The consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) effective for accounting periods beginning January 1, 2024[22]. - The company has incurred substantial debt, which could impair flexibility and access to capital, adversely affecting financial position[39]. - The company has a history of losses from operations and negative cash flows from operating activities, which may continue in the future[39]. - The company expects to require future additional capital to continue as a going concern[39]. - The company incurred net losses of US$31.8 million and US$24.0 million for the years ended December 31, 2024 and 2023, respectively, with negative cash flows from operating activities of US$4.2 million and US$11.6 million[57]. - The company has a history of negative cash flows from operating activities, raising concerns about its ability to continue as a going concern[58]. - As of December 31, 2024, the total indebtedness was approximately US$101.6 million, with a senior secured term loan outstanding amount of US$75.5 million[62]. - The anticipated annual cash interest expense on US$84.9 million variable rate debt at the current rate of approximately 12.75 percent would be approximately US$10.8 million[72]. - The company incurred an increase in indebtedness of US$9.4 million to US$84.9 million between January 2025 and May 2025[71]. - The company expects to need additional capital in the future, and market conditions may hinder access to funding[59]. Business Strategy and Operations - The company’s long-term success depends on the successful development and commercialization of new products, particularly in the biosensor area[39]. - The transformation plan initiated in April 2024 aims to improve financial performance through cost-saving initiatives, including consolidating manufacturing and outsourcing[81]. - The company plans to reduce costs by changing suppliers and negotiating new deals, as well as simplifying internal operations[82]. - The company made several acquisitions in 2024, including biosensor assets from Waveform and Metabolomic Diagnostics, aiming to expand into maternal health and oncology markets[85]. - The company is facing potential civil claims from the DOJ related to approximately US$4.0 million in first-round PPP loans, with possible treble damages up to US$5.5 million if claims are pursued[90]. - The company may need to raise capital through debt or equity offerings to fund operations and obligations[65]. - The company may encounter difficulties in realizing the potential financial or strategic benefits of recent business acquisitions[39]. - The company is monitoring the impact of geopolitical events, such as the Israel-Hamas and Russia-Ukraine wars, on market conditions and financing availability[59]. Regulatory and Compliance Risks - The company is subject to regulatory risks, including potential delays in obtaining FDA approvals, which could negatively impact product commercialization[51]. - The company’s inclusion in national HIV testing algorithms is critical for sales, and legal challenges to these algorithms could adversely affect business[55]. - The company faces significant competition in the diagnostics industry, with major competitors including Abbott, Roche, and Siemens, which could impact market share and revenues[45]. - The company is subject to regular tax reviews and audits, and disagreements with tax authorities could lead to additional tax liabilities, impacting financial condition[138]. - Changes in the U.S. tax code could significantly affect the company's profitability and the valuation of deferred tax assets and liabilities[139]. - The company is subject to ongoing and extensive post-market regulatory requirements, impacting manufacturing, labeling, and marketing[166]. - Regulatory compliance costs are increasing, and failure to maintain necessary approvals could hinder the ability to market products[157]. - The process for obtaining FDA clearance or approval for medical devices is lengthy and costly, with no assurance of timely approval[159]. - The company is subject to increased scrutiny from the U.S. Department of Justice regarding interactions with healthcare providers, which could lead to investigations and additional compliance costs[189]. Market and Economic Conditions - Changes in global economic conditions may have a material adverse impact on the company's results[39]. - Global trade issues and uncertainties may adversely affect the company's costs and competitiveness, impacting financial results[73]. - The ongoing uncertainty regarding international trade and tariffs poses a risk to the company's cost of goods sold and supply chain stability[100]. - Global economic conditions, including the invasion of Ukraine and the Israel-Hamas war, have increased market volatility and uncertainty, potentially impacting demand for products[111]. - The company has seen disruptions to ordering patterns and demand for its rapid HIV tests due to changes in U.S. government funding, with an estimated 15-20% cut in overall U.S. government spending for development-related programs[49]. Research and Development - The company incurred capitalized R&D expenses of US$10.9 million in 2024, significantly higher than US$1.8 million in 2023 and US$4.5 million in 2022, indicating a strong commitment to R&D following the acquisition of biosensor technology[91]. - Future liquidity and capital requirements will depend on the success of research and product development efforts, particularly in biosensor technology[84]. - The company expects to incur significantly higher R&D costs due to the acquisition of biosensor technology, impacting future financial performance[91]. - The company faces challenges in conducting clinical trials, which are necessary for product approvals, and delays or failures in these trials could adversely affect business prospects[144]. Supply Chain and Manufacturing Risks - Significant interruptions in production at principal manufacturing facilities could adversely affect business and operating results[39]. - The company relies on third-party suppliers for critical components, and disruptions in supply chains could adversely affect manufacturing and sales[98]. - The company experienced interruptions in international supply chains in 2024, which may continue to affect production and fulfillment schedules[114]. - The company faces risks related to manufacturing interruptions, including reliance on third-party manufacturers and potential compliance issues[116][117]. Intellectual Property and Competition - The company holds several active patents, but there is no assurance that these patents will provide sufficient protection against competitive threats or that future patent applications will be successful[197]. - Trade secrets and confidential know-how are critical to the company's success, but there is no guarantee that proprietary information will remain protected[200]. - The diagnostic industry faces prevalent litigation over intellectual property rights, which could lead to costly disputes and limit product sales[205]. - As the diagnostics market grows, the company may face increased patent infringement claims from third parties[206]. - Defending against infringement claims could divert significant resources and lead to substantial litigation expenses[207]. Management and Governance - Approximately 9.6% and 12.5% of the voting share capital is owned by affiliates of Perceptive Credit Holdings III, LP and MiCo IVD Holdings, LLC, respectively, which may influence management decisions[42]. - The company is highly dependent on its senior management team and key employees, and the loss of these individuals could adversely affect operations[43]. - Changes in senior management, including the appointment of a new CEO and CFO, could impact operational effectiveness and results[125][126]. - Ownership concentration by MiCo (12.5%) and Perceptive (9.6%) may influence management decisions and deter favorable transactions for other shareholders[213][214]. Cybersecurity and Data Privacy - Cybersecurity risks, including potential data breaches, could disrupt operations and compromise sensitive data, impacting financial condition and reputation[128][129]. - Compliance with evolving data privacy and cybersecurity regulations may result in significant costs and operational changes for the company[133]. Environmental, Social, and Governance (ESG) Considerations - Increasing scrutiny regarding Environmental, Social, and Governance (ESG) policies may impose additional costs and risks, potentially affecting access to capital[143].

DUBLIN, May 15, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors, today announced results for the quarter ended December 31, 2024 and the fiscal year then ended. Key Highlights and Developments Management continues to make significant progress on the execution of the profitability focused initiatives announced in 2024 as part of its Comprehensive Transformation Pl ...

Core Viewpoint - Trinity Biotech plc has received notices from Nasdaq regarding non-compliance with minimum bid price and market value requirements, which could affect its listing status if not addressed within the specified grace periods [1][2][3]. Compliance Issues - The company is not in compliance with Nasdaq Listing Rule 5450(a)(1), which requires a minimum bid price of US $1.00 per share, based on the closing bid price of its American depositary shares (ADSs) for the last 30 consecutive business days [1]. - Additionally, Trinity Biotech does not meet the requirement of Nasdaq Listing Rule 5450(b) for a minimum market value of publicly held shares (MVPHS) of US $15,000,000, also based on the last 30 consecutive business days [1]. Grace Periods - Trinity Biotech has a 180-calendar day period, until September 10, 2025, to regain compliance with the minimum bid price requirement by maintaining a closing bid price of at least US $1.00 for ten consecutive business days [2]. - The same 180-day period applies for regaining compliance with the MVPHS requirement, which must exceed US $15,000,000 for a minimum of 10 consecutive business days [3]. Potential Outcomes - If compliance is not regained within the grace periods, the company may apply for a transfer to The Nasdaq Capital Market if it meets other listing requirements, or face delisting [3]. - The company can appeal any delisting determination to a hearings panel, although there is no guarantee of a successful appeal [3]. Management's Response - Trinity Biotech's management plans to actively monitor the bid price and MVPHS, with intentions to cure the deficiencies within the grace periods [4]. - The company is evaluating various options to regain compliance and maintain its listing status, while its business operations remain unaffected by these notices [4]. Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [7]. - The company develops, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments, and has recently entered the wearable biosensor market through the acquisition of Waveform Technologies Inc. [7].

Core Insights - Trinity Biotech is undergoing a comprehensive transformation plan with a focus on developing its continuous glucose monitoring (CGM) technology, appointing Barclays Capital as its exclusive financial advisor to support this strategic realignment [1][3][4] - The company's board and management have identified CGM technology and related data-driven insights as the primary strategic focus moving forward, highlighting the significant market potential of this technology [2][4] - Successful execution of the transformation plan is expected to enhance near-term profitability and create opportunities for portfolio optimization and CGM-related growth [3][4] Company Overview - Trinity Biotech is a commercial-stage biotechnology company specializing in human diagnostics and diabetes management solutions, including wearable biosensors [6] - The company develops, acquires, manufactures, 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. [6][7] - Trinity Biotech's products are utilized for detecting infectious diseases and quantifying various chemistry parameters in blood samples, with a distribution network spanning over 75 countries [7]

Core Viewpoint - Trinity Biotech plc has secured an additional $4 million in debt financing to support its continuous glucose monitoring technology and transformation plan aimed at increasing profitability and cash flow generation [1][2][3] Group 1: Financing and Development - The company has obtained $4 million in debt financing from Perceptive Advisors, its primary lender [1] - The additional liquidity will aid in the development of Trinity Biotech's continuous glucose monitoring (CGM) technology [2] - The company is focusing its growth efforts on CGM technology, especially following positive results from its recent pre-pivotal trial [2] Group 2: Transformation Plan - Trinity Biotech's comprehensive transformation plan aims to enhance profitability and cash flow across its portfolio of operating businesses [3] - Steps have been taken to increase operational efficiencies to strengthen the company's financial position [3] - The company will continue to optimize its business portfolio and capital structure as part of the transformation plan [3] Group 3: Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors [6] - The company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments [6] - Recently, Trinity Biotech entered the wearable biosensor industry through the acquisition of Waveform Technologies Inc.'s biosensor assets [6]

Core Insights - Trinity Biotech plc has secured an additional $4 million in debt financing from Perceptive Advisors to support its growth initiatives [1][2] - The funding will primarily aid the development of the company's continuous glucose monitoring (CGM) technology and its comprehensive transformation plan aimed at enhancing profitability and cash flow [2][3] Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [6] - The company develops, acquires, manufactures, and markets diagnostic systems for both point-of-care and clinical laboratory segments, with a recent entry into the wearable biosensor market through the acquisition of Waveform Technologies Inc. [6] Financial Strategy - The comprehensive transformation plan is designed to increase operational efficiencies and financial strength across the company's portfolio [3] - The company is actively reviewing and managing the optimization of its business portfolio and capital structure to enhance profitability [3]

Core Insights - Trinity Biotech's patented technology is set to revolutionize the continuous glucose monitoring (CGM) market, which is projected to exceed $20 billion by 2029 [1] - The company has reported significant improvements in the first-day performance of its next-generation CGM system, addressing a critical pain point for users [2][3] Performance Improvements - The latest pre-pivotal trial showed a 35% improvement in Mean Absolute Relative Difference (MARD) and over 50% improvement in Mean Absolute Difference (MAD) compared to the previous Waveform product [2] - The trial involved 30 diabetic participants, primarily with Type 1 diabetes, wearing multiple sensors over a 15-day period, confirming the effectiveness of the redesigned CGM sensor [3] Product Design and Accessibility - The redesigned CGM system focuses on affordability, accuracy, and sustainability, featuring reusable and rechargeable components to reduce costs and environmental impact [4] - This innovation aims to make continuous glucose monitoring more accessible to millions who previously could not afford it [4] Regulatory and Commercialization Plans - Trinity Biotech is on track for regulatory submissions in Europe in 2025 and plans to file with the U.S. FDA in 2026, targeting both diabetes patients and health-conscious consumers [5] - The company plans to initiate further pre-pivotal clinical trials in Q1 2025 to enhance the device [5] Technical Advancements - The new CGM system demonstrates superior signal quality and enhanced reliability post-insertion, significantly improving consistency and reducing variability for users [8] - The accuracy for low blood sugar readings now aligns with industry benchmarks, a critical achievement for hypoglycemia management [8] Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors [10] - The company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments, with a recent entry into the wearable biosensor industry [10]

Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [1] - 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 [7] - Trinity Biotech's products are used to detect infectious diseases and quantify Haemoglobin A1c and other chemistry parameters in serum, plasma, and whole blood [7] - The company sells directly in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide [7] Product Innovation - Trinity Biotech has announced compelling results from its latest pre-pivotal clinical trial for its next-generation continuous glucose monitoring (CGM) system [1] - The redesigned ergonomic modular device features a reusable applicator and a rechargeable wearable transmitter, eliminating costly disposable components [2] - The CGM system is designed to deliver care at a significantly lower cost than current market leaders, addressing affordability as a key barrier to adoption [2] - The company's patented technology features a modular, eco-friendly design and cutting-edge sensor performance, representing a paradigm shift in the CGM market [3] Market Potential - The CGM market is projected to exceed $20 billion by 2029 [3] - The two largest CGM manufacturers currently generate approximately $11 billion in sales annually, serving just 10 million users combined, which is less than 2% of the 800 million people living with diabetes worldwide [3] - Trinity Biotech's innovative approach has the potential to bring CGM technology to millions of individuals who have been priced out of the market [2] Clinical Trial Results - The pre-pivotal clinical trial involved 30 diabetic participants, primarily individuals with Type 1 diabetes, each of whom wore multiple sensors over a 15-day period [4] - The trial evaluated modifications made by Trinity's R&D team to technology acquired from Waveform Technologies, Inc, yielding exceptional results [4] - Significant improvements in signal clarity, enhanced reliability post-insertion, and a 25-30% improvement in the key accuracy metric (mean absolute relative difference, or MARD) were observed [5] - Accuracy for low blood sugar readings is now aligned with industry benchmarks, a critical achievement for hypoglycemia management [5] Regulatory and Commercialization Plans - Trinity Biotech expects to complete further clinical trials on additional device enhancements and remains on track to file for regulatory approval in the European Union in 2025, followed by filing for U.S FDA approval in 2026 [4] - The company aims to deliver a calibration-free CGM system that meets FDA's iCGM standard, enabling seamless integration with insulin pumps [4] - Commercial rollouts are targeting both diabetes patients and the broader market of individuals seeking real-time glucose insights [4]

Core Viewpoint - Trinity Biotech plc has amended agreements with its primary lender, Perceptive Advisors, to enhance liquidity and support its Comprehensive Transformation Plan, focusing on continuous glucose monitoring technology and operational efficiency [1][2][4][5]. Financial Agreements - A deferred payment of $5 million related to the acquisition of Waveform Technologies' biosensor assets has been extended to November 2025, providing greater financial flexibility [2]. - An additional liquidity of approximately $5.5 million has been secured through cash and payment-in-kind interest, strengthening the company's financial position during its transformation [2]. - Trinity Biotech has granted Perceptive Advisors 1.5 million additional warrants to purchase the company's American Depositary Shares (ADS) and repriced existing ADS warrants at $0.80 per ADS [2]. Transformation Plan - The additional liquidity will support the Comprehensive Transformation Plan aimed at achieving long-term profitability through operational efficiency and innovation [4]. - A significant milestone includes the World Health Organization (WHO) approval for transferring late-stage manufacturing of TrinScreen HIV and Uni-Gold HIV to a lower-cost offshore partner, demonstrating the company's strategic execution capabilities [4]. Future Outlook - The company is well-positioned for sustainable growth and market expansion, particularly with its continuous glucose monitoring technology developed from the Waveform Technologies acquisition [7]. - The CEO emphasized the importance of these amendments in creating a stronger financial foundation and supporting critical initiatives, including CGM technology development [5].

Core Insights - Trinity Biotech plc has announced an important update regarding its Comprehensive Transformation Plan, which includes transferring the manufacturing of TrinScreen HIV and Uni-Gold HIV to a lower-cost offshore partner [1][2] - The company received earlier than expected approval from the World Health Organization (WHO) for the later-stage manufacturing process of its rapid HIV tests, marking a significant milestone in its transformation efforts [1][2] Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [4] - 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 [4] - Its products are utilized to detect infectious diseases and quantify various chemistry parameters in blood samples, with a distribution network in over 75 countries [4]