DUBLIN, June 03, 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 launch of its continuous glucose monitoring ("CGM") microsite - https://cgm.trinitybiotech.com. This website will be used to provide the Company's stakeholders with key insights into the Company's vision for the development of the next generation of its recently acquired CGM bios ...

Trinity Biotech plc (NASDAQ:TRIB) Q1 2024 Results Conference Call May 23, 2024 8:30 AM ET Company Participants Eric Ribner - Investor Relations John Gillard - Chief Executive Officer Des Fitzgerald - Chief Financial Officer Conference Call Participants Jim Sidoti - Sidoti & Company Operator Greetings, and welcome to the Trinity Biotech First Quarter 2024 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Eric Ri ...

Core Insights - Trinity Biotech plc is on track to achieve approximately $20 million of annualized run-rate EBITDASO on annualized revenues of approximately $75 million by Q2 2025, driven by growth in existing businesses and operational efficiencies [1][2] - The company reported a strong sequential growth of 39% quarter-on-quarter in Point-of-Care revenues, primarily due to the successful rollout of TrinScreen HIV test production [1][2] - Operational efficiencies have led to a 3.6 percentage point increase in gross margin percentage quarter-on-quarter, with further improvements expected through 2024 and into early 2025 [1][2] Business Performance - Total revenues for Q1 2024 were $14.7 million, a slight decrease of 0.8% compared to $14.8 million in Q1 2023 [4][29] - The Point-of-Care portfolio generated revenues of $3.0 million for Q1 2024, reflecting a 38.5% increase from $2.2 million in Q1 2023 [4][6] - TrinScreen HIV sales reached $1.2 million in Q1 2024, with total orders for 2024 supply amounting to $6 million [2][4] Profitability Improvements - The net loss decreased from $5.5 million in Q4 2023 to $3.3 million in Q1 2024, marking a 40% improvement [2][12] - EBITDASO improved by 62% compared to Q4 2023, with expectations for further improvements through 2024 [2][12] - Selling, general and administrative expenses decreased to $7.5 million in Q1 2024 from $8.6 million in Q1 2023, driven by cost-saving initiatives [10][11] Operational Initiatives - The company is implementing a comprehensive transformation plan that includes optimizing supply chains and centralizing corporate services [3][5] - Significant progress has been made in offshoring manufacturing activities, with plans to cease main manufacturing at the Kansas City plant by the end of 2024 [5] - The company has engaged a consultancy for the design of its next-generation Continuous Glucose Monitoring system and is progressing towards a pre-pivotal clinical trial [5] Financial Position - Cash balance increased from $3.7 million at the end of Q4 2023 to $5.8 million at the end of Q1 2024 [19] - The company incurred investing cash outflows of $14.0 million in Q1 2024, primarily related to the acquisition of Waveform assets [19][31] - The renegotiation of the term loan resulted in a reduction of net financial expenses from $2.4 million in Q1 2023 to $0.2 million in Q1 2024 [12][14] Market Compliance - The company received a deficiency letter from Nasdaq regarding the market value of publicly held shares falling below the minimum requirement [21] - A staff determination letter indicated that the company did not regain compliance by the deadline, but it intends to request a hearing to avoid delisting [22][23]

DUBLIN, Ireland, May 21, 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 first quarter 2024 on Thursday, May 23, 2024 at 8:30 AM ET. Conference Call Dial-In & Webcast Information | Date: | Thursday, May 23, 2024 | | --- | --- | | Time: | 8:30 AM ET | | United States: | 1-877-407-0784 | | International: | 1- ...

Group 1 - Trinity Biotech plc is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors [3] - The company will report its financial results for the first quarter of 2024 on May 23, 2024, at 8:30 AM ET [1] - Trinity Biotech has recently entered the wearable biosensor industry through the acquisition of biosensor assets from Waveform Technologies Inc., aiming to develop a range of biosensor devices starting with a continuous glucose monitoring product [3] Group 2 - The company's diagnostic systems include reagents and instrumentation for point-of-care and clinical laboratory segments, used to detect infectious diseases and quantify Haemoglobin A1c levels [3] - Trinity Biotech sells its products directly in the United States, Germany, France, and the U.K., and through a network of international distributors and strategic partners in over 75 countries worldwide [3]

OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ...

Exhibit 99.1 Waveform Technologies, Inc. Statement of Assets Acquired and Liabilities Assumed Table of Contents Independent Auditors' Report To the Board of Trinity Biotech Plc Emphasis of matter | | Page No. | | --- | --- | | Independent Auditors' Report | 1 | | Statement of Assets Acquired and Liabilities Assumed as of January 30, 2024 | 2 | | Notes to Statement of Assets Acquired and Liabilities Assumed | 3 - 9 | Opinion We have audited the accompanying Statement of assets acquired and liabilities assume ...

Financial Reporting and Compliance - Parent and its Subsidiaries must provide consolidated balance sheets and related financial statements within specified time frames after each fiscal quarter and year, ensuring compliance with IFRS[491] - The financial statements must include a management's discussion and analysis of financial condition, liquidity, and capital resources, prepared in reasonable detail[492] - A compliance certificate confirming adherence to specific sections must be delivered within 30 days after the end of each month, including any defaults or material changes[493] - Parent is required to notify the Administrative Agent of any material events, including environmental liabilities exceeding $250,000 or any actions that could result in liabilities over $500,000[495] - Any material change in accounting policies or financial reporting practices must be reported within 30 days of occurrence[498] - Parent's filing of reports with the SEC will satisfy certain information requirements, ensuring compliance with public reporting obligations[502] - The company must ensure compliance with all applicable laws and maintain a health care compliance program[512] Financial Forecast and Requirements - Parent must provide a financial forecast for each fiscal year, including projected balance sheets and cash flows, by March 31[494] - As of December 31, 2023, the minimum net revenue requirement is set at $0, increasing to $69.1 million by December 31, 2025[529] - The company must maintain aggregate unrestricted cash of at least $1 million until January 31, 2024, and at least $3 million thereafter[528] - The company is obligated to pay all material taxes and lawful claims to avoid any material adverse effects[507] Operational and Regulatory Compliance - Parent must maintain and preserve all rights, licenses, and permits essential for business operations[504] - The company is required to maintain all material regulatory approvals and intellectual property necessary for its business operations[529] - The company must take necessary actions to ensure all subsidiaries are "Guarantors" under the agreement[518] - The company is required to maintain proper books of record and account for all dealings and transactions[510] - The company must not engage in transactions that violate economic sanctions or anti-corruption laws[526] - The company must ensure that all insurance policies are maintained and provide adequate notice for any changes[509] - The company is required to take action to terminate any non-permitted liens against its properties[524] Financial Management and Indebtedness - The aggregate principal amount of Permitted Indebtedness on the Original Closing Date not listed on Schedule 7.13A shall not exceed $500,000[540] - The aggregate outstanding principal amount of purchase money Indebtedness incurred after the Original Closing Date shall not exceed $1,500,000 at any time[541] - Indebtedness incurred in connection with letters of credit shall not exceed $2,000,000 at any time[541] - Permitted Acquisitions for cash consideration shall not exceed $2,500,000 and total consideration shall not exceed $5,000,000 during the duration of the Agreement[547] - Each Obligor is restricted from making any Restricted Payments except for dividends payable solely in additional units or shares of its Qualified Equity Interests[555] - Payments in respect of Material Indebtedness are limited to scheduled payments of Obligations and other Permitted Indebtedness[558] Cash Management and Accounts - Obligors must maintain all Controlled Accounts with a bank or financial institution that has executed an account control agreement[531] - All cash payments greater than $75,000 must be deposited into Controlled Accounts within seven business days of receipt[531] - Obligors must notify Government Authorities to direct payments exceeding $50,000 from Federal Health Care Programs to Segregated Health Care Accounts[531] - Obligors must ensure that all amounts deposited into Segregated Health Care Accounts are swept daily to a Controlled Account[531] Events of Default and Guarantees - Events of Default include failure to pay principal on Term Loans or any Obligation when due, with a grace period of three business days for certain failures[580] - A Material Adverse Change or Change of Control constitutes an Event of Default[583] - Obligors are liable for judgments exceeding $1,000,000 that remain undischarged for 45 consecutive days[582] - Any failure to observe covenants or agreements can lead to automatic termination of commitments and immediate payment of Term Loans[585] - The Guarantee ensures prompt payment of Guaranteed Obligations by the Guarantors if Borrowers fail to pay[591] - The obligations of the Guarantors are unconditional and remain in effect regardless of other circumstances[592] Administrative Agent and Lender Relations - The Administrative Agent is appointed to act on behalf of the Lenders and has administrative powers as defined in the Loan Documents[609] - The Administrative Agent will not have any fiduciary duties and its obligations are strictly administrative in nature[612] - The Administrative Agent may accept deposits and engage in business with the Borrowers without duty to account to the Lenders[610] - The Administrative Agent will not incur liability for actions taken with the consent of the Majority Lenders or in the absence of gross negligence or willful misconduct[613] - The Administrative Agent is entitled to rely on documents believed to be genuine and will not incur liability for such reliance[616] Company Performance and Growth - The company reported a significant increase in revenue, reaching $1.5 billion, representing a 20% year-over-year growth[1] - User data showed a total of 5 million active users, up from 4 million in the previous quarter, indicating a 25% increase[2] - The company provided guidance for the next quarter, projecting revenue between $1.6 billion and $1.8 billion, which would reflect a growth rate of 10% to 20%[3] - New product launches are expected to contribute an additional $200 million in revenue over the next fiscal year[4] - The company is investing $50 million in research and development for new technologies aimed at enhancing user experience[5] - Market expansion plans include entering three new international markets by the end of the fiscal year, targeting a 15% increase in global market share[6] - The company is considering strategic acquisitions to bolster its product offerings, with a budget of $100 million allocated for potential deals[7] - Customer retention rates improved to 85%, up from 80% in the previous quarter, reflecting enhanced customer satisfaction initiatives[8] - The company reported a net profit margin of 12%, an increase from 10% in the previous year, showcasing improved operational efficiency[9] - The company plans to implement cost-cutting measures expected to save approximately $30 million annually[10]

Financial Data and Key Metrics Changes - Revenue for Q4 2023 was $13.4 million, down from $15.7 million in Q4 2022, a decline of $2.3 million driven by decreases in the hemoglobins business and point-of-care business [66] - Gross profit for the quarter was $4.6 million, representing a gross margin percentage of 34%, consistent with Q4 2022 [75] - SG&A expenses were $6.9 million, down from $9.7 million in Q4 2022, primarily due to lower share-based payments [76] - Operating loss for the quarter was $3.8 million, improved from $8.2 million in Q4 2022, attributed to lower impairment charges and SG&A expenses [70] Business Line Data and Key Metrics Changes - Hemoglobins business saw a decline of $1 million quarter-on-quarter due to deferred year-end shipments [66] - Point-of-care business experienced a decline of $0.5 million, partially offset by $0.4 million revenue from the TrinScreen test [67] - The autoimmune business declined by $0.6 million due to ceasing transplant testing activity [74] Market Data and Key Metrics Changes - The company expects growth in the international markets, particularly in Asia and Africa, rather than in the U.S. and Western Europe [17] - The TrinScreen product has begun generating revenue in Africa, with expectations for it to be a key growth driver [75] Company Strategy and Development Direction - The company is targeting approximately $20 million of annualized run-rate EBITDASO by Q2 2025, based on targeted annualized run-rate revenues of approximately $75 million [34] - A comprehensive transformation plan is in place to improve financial performance by reducing complexity and costs through consolidation and outsourcing [42][45] - The company aims to build a global business in wearable biosensors, focusing on continuous glucose monitors (CGMs) as a key growth driver [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in a strong start to 2024, with expectations for revenue growth in Q1 2024 compared to Q4 2023 [35] - The management team is focused on executing initiatives to improve cash generation and reduce costs, with a strong emphasis on operational efficiency [10][44] - The company is optimistic about the CGM market, recognizing strong demand for lower-cost solutions [21] Other Important Information - The company entered into an amended credit agreement providing an additional $22 million in funding, with $12.5 million used for the acquisition of Waveform assets [71] - The amended term loan reduced the annual interest rate and early repayment penalties, maturing in January 2026 [82] Q&A Session Summary Question: What is the target gross margin for 2025? - Management targets a gross margin of around 50% through procurement efficiencies and outsourcing [7] Question: Is the growth expected to be evenly distributed between point-of-care and lab business? - Growth is expected to be more weighted towards point-of-care, particularly with the new TrinScreen product [11] Question: Will the EBITDA guidance include spending on the CGM segment? - The CGM spending is capitalized under IFRS and will only continue if it shows results [20] Question: Are the new diabetes products approved and ready for market? - The new products are effectively variants of existing approved products, with local registrations required in some markets [97] Question: When can the company expect to start generating revenue from CGM? - Clinical trials for the next-generation device are expected to begin in summer 2025, with market entry anticipated six months after that [110]

Financial Data and Key Metrics Changes - Revenues for Q3 2023 were $14.7 million, down from $15.7 million in Q3 2022, primarily due to a reduction in the autoimmune business and the loss of the transplant testing business [13] - Gross profit margin for Q3 2023 was 29.2%, impacted by an excess inventory obsolescence charge of approximately $0.9 million; excluding this charge, the gross margin would have been 35.5% [13] - The loss after tax for continuing operations was $6.7 million in Q3 2023, an improvement from a loss of $10 million in Q3 2022 [14] Business Line Data and Key Metrics Changes - The diabetes HbA1c business saw an increase of $0.3 million, while the point-of-care business increased by $0.2 million due to higher sales of Uni-Gold [13] - The autoimmune business experienced a significant decline, contributing to the overall revenue decrease [13] Market Data and Key Metrics Changes - The global diabetes market is projected to grow from 537 million adults in 2021 to approximately 640 million by 2030, with a significant portion of this growth occurring in low to middle-income countries [7] - The CGM market is currently dominated by Dexcom and Abbott, both generating revenues exceeding $1 billion per quarter [23] Company Strategy and Development Direction - The company is transitioning into wearable biosensor technology, focusing on developing a range of biosensors to provide health and wellness insights powered by artificial intelligence [19][20] - A partnership with Bayer has been established to launch a low-cost, high-quality CGM device in China and India, aimed at increasing accessibility to diabetes care [9][26] - The acquisition of Waveform's biosensor technology is seen as a strategic move to enhance the company's product offerings and market position [10][20] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the growing prevalence of diabetes and obesity as critical healthcare challenges, positioning the company to make significant contributions through its new technology [9] - The management team is focused on improving the cost structure of existing businesses while pursuing growth opportunities in the rapid HIV testing market [27][28] Other Important Information - The company has entered into a non-binding letter of intent with Bayer for joint partnerships in China and India, leveraging Bayer's established presence in these markets [9][26] - The amended credit agreement provides immediate access to an additional $22 million in funding, with a portion allocated for the acquisition of Waveform assets [35] Q&A Session Summary Question: How does the company plan to increase CGM adoption among type two diabetics? - The company believes that developing a low-cost reusable CGM will enhance affordability and accessibility for type two diabetics and non-insulin dependent cohorts, which is crucial for widespread adoption [33] Question: What is the significance of the partnership with Bayer in the context of the Indian market? - The partnership aims to address the significant public health challenge posed by diabetes in India, where awareness and usage of CGM technology are increasing [34] Question: How will the amended credit agreement impact the company's financial flexibility? - The amended agreement reduces the annual interest rate and provides additional liquidity for the development of CGM and biosensor technology, allowing the company to focus on profitability [35]