Core Insights - Trinity Biotech plc has announced an important update regarding its Comprehensive Transformation Plan, specifically the transfer of manufacturing for 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 at the outsourced facility, which is a key milestone in the transformation plan [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] Manufacturing and Regulatory Update - The approval from WHO allows Trinity Biotech to begin manufacturing its rapid HIV tests at the new offshore facility in Q1 2025, which is expected to enhance future growth and improve margins [2] - The transfer of manufacturing is part of the company's strategy to create shareholder value and demonstrates effective collaboration with global regulatory authorities [2]

Revenue Performance - Q3 2024 total revenue reached $15.2 million, representing a 3.2% increase year-over-year, driven by strong demand in the TrinScreen HIV business[4] - Point-of-Care product revenue grew 60.1% year-over-year to $4.3 million, while clinical laboratory revenue decreased by 9.6% to $10.8 million[19] - Revenue for the three months ended September 30, 2024, was $15,152,000, a 3.2% increase from $14,677,000 in the same period of 2023[36] Profitability and Loss - Operating loss improved to $2.6 million in Q3 2024, down from $4.5 million in Q3 2023, marking a 42.2% reduction[26] - Loss after tax on continuing operations for Q3 2024 was $4.8 million, compared to $6.7 million for the same period last year[27] - The company reported a basic loss per ADS of $(0.46) for the three months ended September 30, 2024, an improvement from $(0.88) in the same period of 2023[36] - The company reported a loss for the period of $(4,759) million, an improvement from $(6,721) million in the prior year[40] Cash Flow and Financial Position - Cash balance decreased to $2.8 million at the end of Q3 2024 from $5.3 million at the end of Q2 2024, with cash used in operating activities of $3.6 million[29] - Cash outflow from operating activities before income taxes was $(3,640) million, a decrease from $(5,067) million year-over-year[40] - Net cash outflow from operating activities totaled $(3,624) million, compared to $(4,664) million in the previous period[40] - Cash and cash equivalents decreased to $2,840,000 as of September 30, 2024, from $5,317,000 as of June 30, 2024[38] - Cash and cash equivalents at the end of the period stood at $2,840 million, consistent with the previous period[40] Research and Development - Research and development expenses for Q3 2024 were $1.0 million, with $2.1 million capitalized for Continuous Glucose Monitoring (CGM) development[23] - Research and development expenses for the three months ended September 30, 2024, were $1,010,000, down from $1,169,000 in the same period of 2023[36] Strategic Initiatives - The company completed two new lab-based technology acquisitions, expanding into oncology diagnostics and maternal health[17][18] - The company has initiated the offshoring of corporate services and is on track to cease main manufacturing activities in Kansas City by December 2024[25] - The company has entered the wearable biosensor industry with the acquisition of Waveform Technologies Inc., focusing on developing continuous glucose monitoring products[34] Future Outlook - The company expects to achieve approximately $20 million of annualized run-rate EBITDASO based on revenues of approximately $75 million by Q2 2025[12] - The company aims to achieve profitable operations in the future, despite ongoing risks and uncertainties related to market acceptance and product development[33]

Financial Data and Key Metrics - Q3 2024 revenue was $15.2 million, a 3% year-on-year increase, driven by TrinScreen HIV revenues [9][37] - Operating loss before restructuring and impairment charges decreased to $2.2 million from $4.5 million in Q3 2023, a 51% improvement [10] - Gross profit for Q3 2024 was $5.3 million, with a gross margin of 35%, consistent with Q3 2023 excluding stock obsolescence costs [39] - Adjusted EBITDASO for Q3 2024 was a loss of $1.4 million, compared to a loss of $3.5 million in Q3 2023 [44] - Net loss post-tax and interest for Q3 2024 was $4.8 million, compared to $6.7 million in Q3 2023 [43] Business Line Performance - TrinScreen HIV revenues were lower in Q3 compared to Q2 due to ordering patterns, but full-year 2024 guidance remains at $10 million [9][37] - Hemoglobin A1C testing revenues were lower in Q3 2024 compared to Q3 2023 due to uneven ordering patterns in 2023 [10] - Point-of-care revenue increased by 60% year-on-year to $4.3 million, driven by TrinScreen product sales [37] - Clinical laboratory revenues decreased by 9% year-on-year to $10.8 million, with a strong performance in clinical chemistry offset by a 70% decline in hemoglobin business revenues [38] Market Performance - The continuous glucose monitor (CGM) market is valued at over $10 billion annually and is projected to grow rapidly [6] - The company is targeting the CGM market with a next-generation solution designed to reduce cost per day and waste, leveraging reusable components [13][16] - The prostate cancer market in the US is significant, with an estimated annual cost of over $100 billion for diagnosis and treatment [21] - The preeclampsia market impacts up to 5% of pregnancies in the US, with significant health risks for mothers and babies [23] Strategic Direction and Industry Competition - The company is focusing on long-term growth through its CGM solution and recent acquisitions in prostate cancer and preeclampsia diagnostics [6][7][19] - The FDA's new rules on lab-developed tests (LDTs) provide a competitive advantage for the company, as its Immco lab is New York State Department of Health certified [19] - The company is leveraging its New York State lab to attract innovative technologies and products, aiming to address large-scale clinical issues [20] - Strategic manufacturing and supply chain relationships are being established to prepare for global scaling upon product launch [18] Management Commentary on Operating Environment and Future Outlook - The company expects a near-term step change in profitability performance as many profitability initiatives are set to be completed by the end of 2024 or early 2025 [11] - The company is on track to achieve approximately $20 million of annualized run rate EBITDASO and $75 million of annualized run rate revenues by Q2 2025 [33] - The company has regained compliance with NASDAQ listing requirements, removing an overhang on its stock [34] Other Important Information - The company has completed the transfer of its second rapid HIV product manufacturing process to an offshore partner, with commercial production expected to begin in Q1 2025 [27] - The company is consolidating manufacturing activities, including the closure of its Kansas City plant by the end of 2024 and the Buffalo site by Q1 2025 [29] - The company has made a 12.5% strategic investment in Novus Diagnostics, which is developing a rapid 15-minute sepsis test [25] Q&A Session Summary Question: TrinScreen sales expectations for Q4 2024 - The company expects approximately $3 million in TrinScreen sales for Q4 2024, consistent with historical ordering patterns [48] Question: Premier Instruments sales outlook - Premier Instruments sales are expected to stabilize, with a focus on the new column proposition, which offers better value and lower costs [49][50][51] Question: Timeline for cost reduction initiatives - The first phase of cost reduction initiatives is expected to be completed by the end of Q1 2025, with significant profitability and cash flow benefits anticipated [52][53] Question: Commercialization timeline for prostate cancer and preeclampsia tests - The preeclampsia test is expected to generate revenue in the second half of 2025, while the prostate cancer test is expected to generate revenue in 2026 [55][57] Question: Key drivers for achieving Q2 2025 financial goals - The biggest contributors to achieving the Q2 2025 financial goals are the consolidation of manufacturing facilities and offshoring of less complex operations [59] Question: TrinScreen revenue sources for 2025 - TrinScreen revenues for 2025 are expected to come from a mix of new tenders and existing evaluations, with the company prepared to scale up production as needed [61][62] Question: Remaining capacity on the ATM - There is less than $1 million remaining on the current ATM filing [63]

Q3 2024 total revenue of $15.2 million grew +3% Y/Y based on strong demand and output in the TrinScreen HIV business Point-of-Care product revenue of $4.3 million grew 60% Y/Y Reiterates guidance to achieve approximately $20 million of annualized run-rate EBITDASO1 on annualized run-rate revenues of approximately $75 million by Q2 2025 Reiterates guidance to achieve 2024 sales revenue for TrinScreen HIV of approximately $10 million DUBLIN, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRI ...

DUBLIN, Ireland, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) (the “Company”), a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors, will report financial results for the third quarter 2024 on Friday, November 15, 2024 and host a conference call at 10:00 AM ET. Conference Call Dial-In & Webcast Information Date:Friday, November 15, 2024Time:10:00 AM ETUnited States:1-877-407-0784International:1-201-689- ...

DUBLIN, Oct. 25, 2024 (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 a strategic investment in Novus Diagnostics, a company pioneering a rapid sepsis testing platform. This investment will accelerate the development and commercialization of Novus’ groundbreaking point-of-care diagnostic solutions, including its 15-minute bloodstream infection test. ...

DUBLIN, Oct. 25, 2024 (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 the acquisition of EpiCapture Limited, a company developing a non-invasive test for monitoring the risk of aggressive prostate cancer. This acquisition marks Trinity Biotech’s strategic expansion into the oncology diagnostics market. Prostate cancer is the most common non-skin canc ...

Trinity Biotech plc (TRIB) has completed its first pre-pivotal clinical trial in Europe for its next-generation continuous glucose monitor (CGM). This trial assessed the effectiveness of significant technology enhancements since acquiring the CGM from Waveform Technologies in January 2024. The results confirm the progress in improving performance, usability and cost-efficiency, positioning Trinity Biotech for further advancements. CGMs are wearable devices that track real-time glucose levels using biosensor ...

DUBLIN, Oct. 07, 2024 (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 the successful completion of its first pre-pivotal clinical trial in Europe for its next-generation continuous glucose monitor (CGM) technology. The study assessed the analytical performance of CGM technology enhancements implemented by Trinity Biotech since acquiring the technolog ...

F - 21 The Group has entered into various arrangements with JRJ Investments ("JRJ"), a partnership owned by Mr O'Caoimh and Dr Walsh, directors of Trinity Biotech, and directly with Mr O'Caoimh, to provide premises at IDA Business Park, Bray, County Wicklow, Ireland. Commencing in December 2003, the Group entered into an agreement with JRJ for a 25-year lease for offices that were then adjacent to its then premises at IDA Business Park, Bray, Co. Wicklow, Ireland. At the Market Offering Agreement TRINITY BI ...