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 - 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]

Exhibit 99.1 Contact:Trinity Biotech plc John Gillard (353)-1-2769800 Lytham Partners, LLC Joe Diaz (1)-602-889-9700 E-mail: investorrelations@trinitybiotech.com Trinity Biotech Announces Q2 2023 Financial Results DUBLIN, Ireland (October 3, 2023)... Trinity Biotech plc (Nasdaq: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced the Company's results for the quarter ended June 30, 2023. Summary Highlights: Revenue: Haemog ...

Trinity Biotech plc (NASDAQ:TRIB) Q2 2023 Earnings Call Transcript October 3, 2023 11:00 AM ET Company Participants Joe Diaz - Lytham Partners, Investor Relations Aris Kekedjian - Chief Executive Officer John Gillard - Chief Financial Officer Conference Call Participants Jim Sidoti - Sidoti & Company Operator Good day, and welcome to Trinity Biotech Announces Second Quarter Financial Results. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an o ...

Exhibit 99.1 Trinity Biotech plc Annual Report 2022 This report has been prepared in accordance with the Irish Companies Act 2014 TABLE OF CONTENTS | | Page | | --- | --- | | Corporate Information | 1 | | Market, Industry and Other Data | 2 | | Cautionary Statement Regarding Forward-Looking Statements | 2 | | Board of Directors & Executive Officers | 3 | | Business Overview | 4 | | Directors' Report | 7 | | Statement of Directors' Responsibilities in respect of the annual report and the financial statements ...

[Trinity Biotech Q1 2023 Financial Results](index=1&type=section&id=Trinity%20Biotech%20Q1%202023%20Financial%20Results) [Summary Highlights](index=1&type=section&id=Summary%20Highlights) The company reported Q1 2023 core revenue growth of 2% to $14.0 million while divesting its Fitzgerald division to reduce debt and focus on core franchises [Revenue and Margin](index=1&type=section&id=Revenue%20and%20Margin) Revenue and Margin Metrics | Metric | Value | Note | | :--- | :--- | :--- | | Total Revenue Q1 2023 | $17.2 million | Includes discontinued operations | | Core Revenue Q1 2023 | $14.0 million | Excludes VTM & Fitzgerald; +2.0% YoY | | Gross Margin (ex-Fitzgerald) | Broadly flat YoY | ~4-point improvement vs Q4 2022 | - Revenue growth was driven by strong performance in **Autoimmune (+35% YoY)**, **Clinical Chemistry (+15% YoY)**, and **diabetes HbA1c consumables (+10% YoY)**[5](index=5&type=chunk) - US Autoimmune product revenues **increased over 80% YoY**, and diabetes consumable deliveries in Brazil **rose by approximately 45% YoY**[5](index=5&type=chunk) [Haemoglobins Business](index=1&type=section&id=Haemoglobins) - The company is working with the FDA to gain 510(k) clearance for its **Premier Resolution Haemoglobin Variants instrument**, with a US market introduction expected in **H2 2023**[5](index=5&type=chunk) - Development of the next-generation **Premier 9210 diabetes instrument** is on track for a **2024 rollout**, aiming to expand market, reduce service costs, and increase operating margins[5](index=5&type=chunk) - The company is focusing on expanding its footprint in **China and Brazil** for its Haemoglobins product lines to enhance cost competitiveness and market access[5](index=5&type=chunk) [TrinScreen HIV](index=2&type=section&id=TrinScreen%20HIV) - TrinScreen HIV has been established as the **standard screening test in Kenya** following the adoption of a new HIV rapid testing algorithm by the Kenyan Ministry of Health[12](index=12&type=chunk) - Significant orders are expected in **H2 2023** upon the resolution of legal challenges to the new algorithm[12](index=12&type=chunk) - The Kenyan HIV screening program represents a major market, with an estimated **7 to 9 million screening tests** performed annually[12](index=12&type=chunk) [Portfolio Transformation & Capital Structure](index=2&type=section&id=Portfolio%20Transformation%20%26%20Capital%20Structure) - In April 2023, the company completed the sale of its Fitzgerald Industries division, generating approximately **$30 million in proceeds**[12](index=12&type=chunk) - Approximately **$10 million of the proceeds were used to reduce debt**, as part of a strategy to focus on core Haemoglobins and HIV franchises[12](index=12&type=chunk) - A flexible **$20 million term-facility** was secured in February to enable opportunistic M&A transactions in disruptive diagnostic adjacencies[12](index=12&type=chunk) [Structural & Operational Initiatives](index=2&type=section&id=Structural%20%26%20Operational%20Initiatives) - The company has multiple initiatives underway to **significantly reduce the cost of goods sold** in its core Haemoglobins and HIV franchises[8](index=8&type=chunk) - These initiatives include instrument and consumable design updates, supply chain optimization, and exploring **outsourced/localized manufacturing** to drive higher operating margins[8](index=8&type=chunk) [Financial Performance Analysis (Continuing Operations)](index=2&type=section&id=Financial%20Performance%20Analysis%20(Continuing%20Operations)) Continuing operations revenue fell 5.4% to $14.8 million due to lower COVID-19 product sales, widening the operating loss to $3.9 million [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Revenue by Segment | Revenue Segment | Q1 2023 (US$'000) | Q1 2022 (US$'000) | Change (%) | | :--- | :--- | :--- | :--- | | Clinical Laboratory | 12,669 | 13,511 | (6.2)% | | Point-of-Care | 2,160 | 2,164 | (0.2)% | | **Total** | **14,829** | **15,675** | **(5.4)%** | - The decrease in Clinical Laboratory revenue was mainly due to a **$1.2 million reduction in sales of PCR VTM products** as COVID-19 testing programs scaled down[11](index=11&type=chunk) - The decline was partly offset by strong year-over-year growth in **autoimmune products (over 35%)** and **clinical chemistry products (over 15%)**[13](index=13&type=chunk) [Profitability Analysis](index=3&type=section&id=Profitability%20Analysis) Key Profitability Metrics | Profitability Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Gross Profit | $5.6 million | $6.0 million | | Gross Margin | 37.6% | 38.2% | | Operating Loss | ($3.9 million) | ($1.2 million) | | Loss from Continuing Ops | ($6.3 million) | ($13.1 million) | | Basic Loss per ADS | ($0.15) | ($0.50) | - The Q1 2023 gross margin of **37.6%** represents an improvement over the Q4 2022 like-for-like margin of 33.4%, reflecting benefits from price increases and cost optimization[15](index=15&type=chunk) - The increased operating loss was mainly due to lower revenues and higher indirect costs, particularly a **non-cash share-based payments charge**[19](index=19&type=chunk) [Expense Analysis](index=3&type=section&id=Expense%20Analysis) - R&D expenses declined slightly to **$0.9 million** in Q1 2023 from $1.0 million in Q1 2022[16](index=16&type=chunk) - SG&A expenses increased by $2.4 million to **$8.6 million** in Q1 2023, compared to $6.2 million in Q1 2022[16](index=16&type=chunk) - Key drivers of the SG&A increase included a **$1.2 million higher non-cash share-based payments charge** and increased salary and travel costs[17](index=17&type=chunk) [Financial Income and Expenses](index=4&type=section&id=Financial%20Income%20and%20Expenses) Financial Item Breakdown | Financial Item | Q1 2023 (US$'m) | Q1 2022 (US$'m) | | :--- | :--- | :--- | | Financial Expenses | 2.6 | 12.2 | | Loss on disposal of Exchangeable Notes | – | 9.7 | | Term loan interest | 2.1 | 2.0 | - The significant decrease in financial expenses YoY is due to a **one-off $9.7 million loss** on the disposal of Exchangeable Notes recorded in Q1 2022[22](index=22&type=chunk) [Non-IFRS Financial Measures](index=5&type=section&id=Non-IFRS%20Financial%20Measures) The company uses non-IFRS measures like Adjusted EBITDASO to clarify core operational performance, reporting a loss of $2.0 million for Q1 2023 - The company presents non-IFRS measures, Adjusted EBITDA and Adjusted EBITDASO, to provide a more complete understanding of underlying operational results by excluding items like share-based payments, depreciation, and amortization[28](index=28&type=chunk)[29](index=29&type=chunk) Reconciliation to Adjusted EBITDASO (Q1 2023) | Reconciliation to Adjusted EBITDASO (Q1 2023) | Amount (US$'m) | | :--- | :--- | | Operating loss | (3.9) | | Depreciation | 0.3 | | Amortisation | 0.3 | | **Adjusted EBITDA for continuing operations** | **(3.3)** | | Share option expense | 1.4 | | **Adjusted EBITDASO for continuing operations** | **(2.0)** | [Liquidity and Capital Resources](index=6&type=section&id=Liquidity%20and%20Capital%20Resources) The cash balance ended Q1 2023 at $4.2 million, with post-quarter proceeds from a major asset sale expected to significantly improve liquidity - The Group's cash balance decreased from $6.6 million at the end of Q4 2022 to **$4.2 million at the end of Q1 2023**[30](index=30&type=chunk) - Cash used by operations for Q1 2023 was **$2.7 million**[30](index=30&type=chunk) - Net proceeds of **$4.9 million** were received from a drawdown under the senior secured term loan facility in February 2023[30](index=30&type=chunk) - The disposal of Fitzgerald Industries post-quarter-end for **~$30 million** provides capital for growth, transformation, and potential debt reduction[30](index=30&type=chunk) [Consolidated Financial Statements (Unaudited)](index=8&type=section&id=Consolidated%20Financial%20Statements%20(Unaudited)) Unaudited statements for Q1 2023 show a total loss of $5.8 million, with total assets of $91.2 million and total liabilities of $97.8 million [Consolidated Income Statements](index=8&type=section&id=Consolidated%20Income%20Statements) Income Statement Summary | (US$000's) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Revenues | 14,829 | 15,675 | | Gross profit | 5,573 | 5,982 | | Operating Loss | (3,919) | (1,216) | | Loss for the period on continuing operations | (6,305) | (13,070) | | Loss for the period (total) | (5,809) | (12,279) | | Loss per ADS (US cents) | (15.2) | (50.0) | [Consolidated Balance Sheets](index=9&type=section&id=Consolidated%20Balance%20Sheets) Balance Sheet Summary | (US$ '000) | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **ASSETS** | | | | Total non-current assets | 32,895 | 45,436 | | Total current assets | 58,262 | 46,668 | | **TOTAL ASSETS** | **91,157** | **92,104** | | **EQUITY AND LIABILITIES** | | | | Total deficit | (6,618) | (2,176) | | Total current liabilities | 16,150 | 17,339 | | Total non-current liabilities | 81,625 | 76,941 | | **TOTAL LIABILITIES** | **97,775** | **94,280** | | **TOTAL EQUITY AND LIABILITIES** | **91,157** | **92,104** | [Consolidated Statement of Cash Flows](index=11&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) Cash Flow Summary | (US$000's) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | (2,718) | (1,493) | | Net cash used in investing activities | (1,329) | (1,715) | | Net cash provided by/(used in) financing activities | 1,608 | (12,872) | | **Decrease in cash and cash equivalents** | **(2,439)** | **(16,080)** | | Cash and cash equivalents at end of period | 4,153 | 10,012 |

Financial Position and Debt - As of December 31, 2022, the company had total indebtedness of approximately $73.8 million, including a senior secured term loan of $46.8 million due in January 2026[45]. - The company closed the sale of its Fitzgerald Industries life sciences supply business for cash proceeds of approximately $30 million, using about $11 million to repay senior secured debt[46]. - The company expects to require additional capital in the future to fund operations and obligations[48]. - The Company entered into a Credit Agreement for a US$81,250,000 senior secured term loan, with a nominal outstanding amount of US$46,750,000 as of December 31, 2022, after an early partial settlement of US$34,500,000 in 2022[51]. - In February 2023, the Company amended the Credit Agreement, increasing the Term Loan by US$5,000,000 and providing a US$20,000,000 facility for potential acquisitions[51]. - The amended Credit Agreement requires maintaining unrestricted cash of at least US$5,000,000 and achieving specified minimum total revenue requirements starting from the fiscal quarter ended June 30, 2023[52]. - The Company’s variable rate debt increased to US$51.8 million in February 2023, with an anticipated annual cash interest expense of US$6.7 million at a current rate of 16 percent[57]. - The company has incurred substantial debt, which could impair its flexibility and access to capital[45]. Operational Risks and Challenges - The company may face liquidity challenges if it fails to meet minimum total revenue requirements set forth in its Term Loan credit agreement[47]. - The company is highly dependent on its senior management team and key employees, and the loss of these individuals could adversely affect operations[37]. - The diagnostics industry is highly competitive, with significant competition from established players and new entrants, which could impact the company's market position[42]. - The company may face challenges in developing and commercializing new products, which are critical for long-term success[41]. - The company is dependent on third-party suppliers for critical components, and disruptions in the supply chain could adversely affect operations and product availability[67]. - Future growth in the U.S. is contingent upon obtaining FDA clearance for new products, with similar dependencies for international markets[63][64]. - The company faces potential adverse effects from reductions in government funding for public health agencies that purchase its products[60]. - Significant interruptions in production at principal manufacturing facilities could adversely affect business and operating results, with reliance on a small number of third-party manufacturers posing additional risks[85]. - The company may face challenges in attracting and retaining qualified personnel, which could adversely affect manufacturing and sales capabilities[84]. - Future recalls of products could harm the company's reputation and financial results, with the FDA requiring certain classifications of recalls to be reported within 10 working days[77]. Regulatory and Compliance Issues - The company is exposed to risks related to regulatory compliance, which could result in fines or penalties affecting its operations[40]. - The company is subject to fluctuations in currency exchange rates, which could impact sales and operations[37]. - The company is subject to strict governmental controls on product development, marketing, and distribution, which can be lengthy and expensive[124]. - Non-compliance with regulatory requirements could lead to product recalls, fines, and operational restrictions, adversely affecting profitability[136]. - The company received a Warning Letter from the FDA in August 2020, but subsequent remediation actions led to a close-out letter in December 2022, indicating compliance[134]. - The FDA's enforcement discretion regarding laboratory developed tests (LDTs) may change, potentially leading to substantial costs and delays for the company[119]. - The process for obtaining FDA premarket clearance or approval can be lengthy and costly, with the 510(k) process taking 3 to 12 months and the PMA process taking 1 to 3 years or longer[126]. - The company is subject to the Clinical Laboratory Improvement Amendments (CLIA) and state regulations, which require compliance to avoid significant fines and loss of licenses[154][156]. - The company may face civil and criminal penalties if regulators disagree with its compliance efforts, which could harm its reputation and business operations[138]. - Changes in FDA regulations regarding LDTs could adversely affect customers using the company's Life Science instruments, impacting revenue[130]. Intellectual Property and Legal Risks - The company may face costly disputes over product infringement claims, which could divert resources and affect sales[176]. - The outcome of intellectual property litigation is unpredictable, and adverse results could invalidate patents, harming the company's business[178]. - The company may face challenges in enforcing its intellectual property rights, particularly in jurisdictions with weaker protections[180]. - Non-compliance with patent maintenance requirements could result in the loss of patent rights, adversely affecting the company's competitive position[171]. - The company currently holds active patents with remaining lives ranging from 5 to 12 years, but faces challenges in protecting its intellectual property[167]. - The initiation of legal claims may lead to counterclaims that could challenge the validity of the company's patents[179]. - The company has not yet developed a comprehensive compliance program, which increases the risk of legal challenges and penalties[161]. Market and Economic Conditions - Economic uncertainty, particularly due to the invasion of Ukraine, may impact demand for products and the ability to manage commercial relationships[81]. - The company faces potential penalties and sanctions for non-compliance with federal and state healthcare laws, which could adversely affect its business operations[157]. - Legislative changes, such as the elimination of the "individual mandate" under the Affordable Care Act, may further impact the company's financial condition[153]. - The ongoing geopolitical uncertainty and inflation may lead to greater volatility in currency exchange rates globally[99]. Product Development and Innovation - The company has expanded its product base through internal development and acquisitions, with a focus on medical diagnostic products for various diseases[204]. - The Premier Resolution, a next-generation Haemoglobinopathy Analyzer, was launched in Europe and the Middle East after successful field trials, with a 510(k) clearance submitted to the FDA in 2022[222]. - Trinity Biotech's principal product, Uni-Gold™ HIV, is a leading confirmatory HIV test in the African market, contributing significantly to global HIV detection efforts[211]. - The new HIV screening test, TrinScreen HIV, received World Health Organization approval in February 2022 and targets a screening market valued at approximately $150 million annually[213]. - The Premier Hb9210, used for monitoring diabetes, was launched in Europe and obtained FDA approval in late 2011, showcasing the company's commitment to innovative diagnostic solutions[220]. Shareholder and Market Considerations - The market price of the company's ADSs fluctuated from a high of $1.18 to a low of $0.87 during Q1 2023, indicating high volatility[187]. - If all vested and currently exercisable options were exercised, the company would issue 17,101,339 additional 'A' Ordinary Shares, diluting existing shareholders' ownership by approximately 15%[192]. - The company expects to require additional capital in the future, which may involve private and public equity offerings, debt financing, or asset sales, potentially diluting existing shareholders' interests[189]. - The company may be classified as a passive foreign investment company (PFIC), which could subject U.S. investors to adverse tax rules[186]. - Future sales of ADSs could reduce their market price, impacting investor value[190]. - Trinity Biotech's ADSs are listed on the NASDAQ Capital Market under the symbol "TRIB," and compliance with listing standards is crucial to avoid delisting[198].

[Summary Highlights](index=1&type=section&id=Summary%20Highlights) Trinity Biotech's 2022 performance focused on core haemoglobins growth and strategic expansion, alongside cost optimization, despite overall revenue decline from reduced COVID-19 VTM sales Fiscal Year and Q4 2022 Revenue | Period | Total Revenue ($ million) | Revenue (Ex-VTM) ($ million) | YoY Change (Ex-VTM) (%) | | :--- | :--- | :--- | :--- | | Fiscal Year 2022 | $74.8 | $71.5 | -1.0 | | Q4 2022 | $18.0 | Not specified | -0.4 | - The core haemoglobins business was a key focus in 2022, with the main diabetes product line experiencing **27% overall revenue growth** and a **60% increase in instrument placements** compared to 2021[5](index=5&type=chunk) - The company plans to launch its **TrinScreen HIV screening test** in Kenya in Q2 2023, targeting a market with an estimated **7 to 9 million annual tests**[5](index=5&type=chunk) - A **strategic portfolio review** is underway to exit or optimize non-core products, focusing on Diabetes/Haemoglobins, Point of Care & Digital Health, and Personalized Therapeutic Drug Monitoring[10](index=10&type=chunk) - Structural and operational initiatives include achieving a **40% operating gross margin run rate** (excluding one-offs), **reducing headcount by approximately 10%** since Q4 2021, and targeting a **15% cost reduction** for the Premier 9210 instrument[10](index=10&type=chunk) [Fourth Quarter 2022 Financial Results](index=3&type=section&id=Fourth%20Quarter%20Results) Trinity Biotech's Q4 2022 saw total revenue decline by 7.6% to $18.0 million, driven by reduced COVID-19 VTM sales, resulting in an operating loss of $7.8 million due to increased SG&A and impairment charges Q4 2022 Revenue Breakdown (US$ thousand) | Category | Q4 2022 (US$ thousand) | Q4 2021 (US$ thousand) | Change (%) | | :--- | :--- | :--- | :--- | | Clinical Laboratory | 15,361 | 17,146 | (10.4%) | | Point-of-Care | 2,675 | 2,379 | 12.4% | | **Total** | **18,036** | **19,525** | **(7.6%)** | - The decrease in Clinical Laboratory revenue was mainly due to a **$1.4 million reduction** in PCR VTM product sales as COVID-19 testing programs scaled down[11](index=11&type=chunk) - **SG&A expenses increased by $4.6 million to $10.2 million**, driven by a $1.2 million non-cash share-based payment charge, a $0.9 million unfavorable variance in foreign exchange on leases, and $1.0 million in non-recurring legal/professional fees for M&A activities[17](index=17&type=chunk)[20](index=20&type=chunk) - The company recognized a **$3.0 million impairment charge**, primarily from writing down the value of two internally developed COVID-19 tests to zero due to unsuccessful commercialization and uncertain regulatory pathways[18](index=18&type=chunk)[19](index=19&type=chunk) Q4 2022 Adjusted EBITDASO Calculation ($ million) | Item | Amount ($ million) | | :--- | :--- | | Operating loss | (7.8) | | Depreciation | 0.4 | | Amortisation | 0.2 | | Impairment charges | 3.0 | | **Adjusted EBITDA** | **(4.2)** | | Share option expense | 1.3 | | **Adjusted EBITDASO** | **(2.9)** | - The company's cash balance **decreased by $0.7 million** during the quarter, ending at **$6.6 million** as of December 31, 2022[27](index=27&type=chunk) [Fiscal Year 2022 Financial Results](index=7&type=section&id=Fiscal%20Year%202022%20Results) Trinity Biotech's FY 2022 revenues declined 19.6% to $74.8 million, primarily due to reduced COVID-19 VTM sales, leading to a $16.8 million operating loss and a $41.0 million net loss, significantly impacted by financial expenses Fiscal Year 2022 Revenue Breakdown (US$ thousand) | Category | FY 2022 (US$ thousand) | FY 2021 (US$ thousand) | Change (%) | | :--- | :--- | :--- | :--- | | Clinical Laboratory | 65,566 | 82,628 | (20.6%) | | Point-of-Care | 9,213 | 10,337 | (10.9%) | | **Total** | **74,779** | **92,965** | **(19.6%)** | - The main diabetes products achieved year-on-year revenue growth of **26.6%**, with particularly strong demand in Asia Pacific and Latin America[31](index=31&type=chunk) - **Gross margin for FY 2022 was 29.5%**, significantly impacted by a **$4.7 million excess inventory and obsolescence charge**, primarily a **$3.5 million write-down of VTM inventory**[33](index=33&type=chunk) - **Operating loss for FY 2022 was $16.8 million**, a sharp decline from an **operating profit of $6.6 million** in 2021, due to lower revenues, reduced gross margin, and higher indirect costs[41](index=41&type=chunk) - **Financial expenses increased to $24.7 million from $7.1 million** in 2021, mainly due to a **$9.7 million loss** on the disposal of Exchangeable Notes and a **$3.5 million penalty** for early debt settlement[43](index=43&type=chunk)[44](index=44&type=chunk) FY 2022 Adjusted EBITDASO Calculation ($ million) | Item | Amount ($ million) | | :--- | :--- | | Operating loss | (16.8) | | Depreciation | 1.4 | | Amortisation | 0.9 | | Impairment charges | 5.8 | | Significant inventory charges | 4.7 | | **Adjusted EBITDA** | **(4.0)** | | Share option expense | 1.8 | | **Adjusted EBITDASO** | **(2.2)** | [Consolidated Financial Statements](index=13&type=section&id=Consolidated%20Financial%20Statements) Trinity Biotech's consolidated financial statements for FY 2022 show a net loss of $41.0 million, an equity deficit of $2.2 million, and a $19.2 million decrease in cash, reflecting significant operational and financial challenges Key Income Statement Data (FY 2022 vs FY 2021, US$ thousand) | Metric | FY 2022 (US$ thousand) | FY 2021 (US$ thousand) | | :--- | :--- | :--- | | Revenues | 74,779 | 92,965 | | Gross Profit | 22,048 | 38,077 | | Operating (Loss)/Profit | (16,752) | 6,625 | | Net (Loss)/Profit | (41,009) | 875 | | (Loss)/Earnings per ADS | (121.6)¢ | 4.2¢ | Key Balance Sheet Data (As of Dec 31, 2022 vs Dec 31, 2021, US$ thousand) | Metric | Dec 31, 2022 (US$ thousand) | Dec 31, 2021 (US$ thousand) | | :--- | :--- | :--- | | Total Assets | 92,104 | 118,895 | | Cash & Equivalents | 6,578 | 25,910 | | Total Liabilities | 94,280 | 119,214 | | Total Equity | (2,176) | (319) | Key Cash Flow Data (FY 2022 vs FY 2021, US$ thousand) | Metric | FY 2022 (US$ thousand) | FY 2021 (US$ thousand) | | :--- | :--- | :--- | | Net Cash from Operating Activities | (921) | 13,238 | | Net Cash used in Investing Activities | (5,977) | (8,691) | | Net Cash used in Financing Activities | (12,322) | (6,019) | | **Decrease in Cash** | **(19,220)** | **(1,472)** |

Trinity Biotech plc (NASDAQ:TRIB) Q4 2022 Earnings Conference Call March 23, 2023 10:00 AM ET Company Participants Joe Diaz - Lytham Partners, Investor Relations Aris Kekedjian - Chief Executive Officer John Gillard - Chief Financial Officer Conference Call Participants Jim Sidoti - Sidoti & Company Paul Nouri - Noble Equity Operator Good morning and welcome to the Trinity Biotech Fourth Quarter 2022 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] Aft ...

[Q3 2022 Financial Results](index=1&type=section&id=Q3%202022%20Financial%20Results) [Summary Highlights](index=1&type=section&id=Summary%20Highlights) Trinity Biotech reported Q3 2022 revenues of $19.5M, with non-COVID revenues up 2% YoY, driven by strong Haemoglobins and Fitzgerald Life Sciences growth, and advanced its product pipeline Q3 2022 Revenue Highlights | Metric | Value | Comparison | | :--- | :--- | :--- | | Total Revenues Q3 2022 | $19.5M | - | | Non-VTM Revenues Q3 2022 | $19.2M | +2% YoY, +6% QoQ | - Strong YoY revenue growth was driven by a **30% increase** in both Haemoglobins and Fitzgerald Industries Life Sciences businesses, and a **30%+ increase** in the Autoimmune product business[3](index=3&type=chunk) - The Haemoglobins business saw particularly strong demand in AsiaPac (**over 50% YoY growth**) and Latin America (**over 40% YoY growth**)[3](index=3&type=chunk) - Key product pipeline developments include the **FDA 510k submission** for the **Premier Resolution instrument** (expected US launch Q2 2023) and the initiation of development for the **Premier 9210 HbA1c instrument** (expected launch Q3 2023)[3](index=3&type=chunk) [Third Quarter Financial Performance](index=2&type=section&id=Third%20Quarter%20Financial%20Performance) Q3 2022 saw revenue decline to $19.5M due to reduced COVID VTM sales, leading to a 10.3% gross margin, $7.1M operating loss, and $8.9M net loss, impacted by inventory write-downs and impairment charges [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Total Q3 2022 revenue decreased **11.4% YoY to $19.5M**, driven by declines in Point-of-Care and Clinical Laboratory, though Clinical Laboratory (ex-VTM) grew **13.4%** due to Haemoglobins and Fitzgerald Industries Q3 2022 Revenue by Segment (US$ thousands) | Revenue Segment | Q3 2022 (US$'000) | Q3 2021 (US$'000) | Change (%) | | :--- | :--- | :--- | :--- | | Clinical Laboratory | 16,966 | 17,891 | (5.2%) | | Point-of-Care | 2,536 | 4,113 | (38.3%) | | **Total** | **19,502** | **22,004** | **(11.4%)** | - Excluding COVID-related VTM products, Clinical Laboratory revenues increased by nearly **$2.0 million**, or **13.4%**, compared to Q3 2021[5](index=5&type=chunk) - Growth drivers in the Clinical Laboratory segment included a **$1.4M (30.3%) increase** in Haemoglobins revenues and a **$0.9M (30.2%) increase** in Fitzgerald Industries revenues compared to Q3 2021[6](index=6&type=chunk)[8](index=8&type=chunk) - Point-of-Care revenues decreased YoY due to an unusually high volume of HIV tests sold in Africa in Q3 2021; however, Q3 2022 revenues of **$2.5M** represented a **38% increase** compared to Q2 2022[9](index=9&type=chunk) [Profitability Analysis](index=3&type=section&id=Profitability%20Analysis) Gross margin fell to **10.3%** from **40.4%** YoY, primarily due to a **$4.7M** inventory write-down, resulting in a **$7.1M** operating loss and **$2.3M** impairment charge on intangible assets Q3 2022 Gross Profit and Margin (US$ thousands) | Metric | Q3 2022 (US$'000) | | :--- | :--- | | Gross Profit | 2,015 | | Gross Margin % | 10.3% | | Significant Inventory Charges | 4,697 | | **Adjusted Gross Profit** | **6,712** | | **Adjusted Gross Margin %** | **34.4%** | - The company recorded a **$4.7M inventory write-down**, comprising **$3.5M for VTM**, **$0.9M for other excess raw materials**, and **$0.3M for the Tri-stat instrument line**[10](index=10&type=chunk)[11](index=11&type=chunk) - An **impairment charge of $2.3M** was recorded for two internally developed intangible assets: the **autoimmune smart reader** and the **Tri-stat instrument**, whose recoverable amounts were determined to be zero[14](index=14&type=chunk)[15](index=15&type=chunk) - The **operating loss of $7.1M** compares to an **operating profit of $2.8M** in Q3 2021; the **net loss for the quarter was $8.9M**, compared to a **profit of $1.3M** in the prior-year period[16](index=16&type=chunk)[19](index=19&type=chunk) [Earnings Per Share (EPS)](index=6&type=section&id=Earnings%20Per%20Share%20(EPS)) Q3 2022 saw a basic loss per ADS of **23.5 cents**, a reversal from a **6.3 cents** profit in Q3 2021 Q3 Earnings Per American Depositary Share (US cents) | Earnings Per ADS (US cents) | Q3 2022 | Q3 2021 | | :--- | :--- | :--- | | Basic (Loss)/Profit per ADS | (23.5) | 6.3 | | Diluted (Loss)/Profit per ADS | (23.5) | 6.1 | [Non-IFRS Financial Measures](index=5&type=section&id=Non-IFRS%20Financial%20Measures) Trinity Biotech reported Q3 2022 Adjusted EBITDASO of **$0.8M**, derived from an operating loss of **$7.1M** adjusted for non-cash items like impairment charges and inventory write-downs Q3 2022 Reconciliation to Adjusted EBITDASO (US$ millions) | Reconciliation to Adjusted EBITDASO | Value ($m) | | :--- | :--- | | Operating loss | (7.1) | | Depreciation | 0.5 | | Amortisation | 0.3 | | Impairment charges | 2.3 | | Significant inventory charges | 4.7 | | Share option expense | 0.1 | | **Adjusted EBITDASO** | **0.8** | - The company presents non-IFRS measures like **Adjusted Gross Profit**, **Adjusted Gross Margin**, **Adjusted EBITDA**, and **Adjusted EBITDASO** to help investors perform additional financial analysis and to evaluate and manage operations internally[22](index=22&type=chunk) [Liquidity and Cash Flow](index=6&type=section&id=Liquidity%20and%20Cash%20Flow) The company's cash balance decreased by **$3.2M** to **$7.3M** in Q3 2022, with **$0.7M** cash from operations offset by **$1.3M** capital expenditures and **$1.7M** interest payments - The Group's cash balance fell from **$10.5 million** at the end of Q2 2022 to **$7.3 million** at the end of Q3 2022[23](index=23&type=chunk) Q3 2022 Key Cash Flow Items (US$ millions) | Key Cash Flow Items (Q3 2022) | Value (US$m) | | :--- | :--- | | Cash generated from operations | 0.7 | | Capital expenditure outflows | (1.3) | | Interest payments | (1.7) | | Payments for property leases | (0.7) | [Business Outlook and Strategic Initiatives](index=1&type=section&id=Business%20Outlook%20and%20Strategic%20Initiatives) Trinity Biotech is pursuing product innovation, market expansion, and margin improvement through new instrument launches, commercial footprint growth, strategic partnerships, and operational streamlining - The company's **TrinScreen HIV product** was recommended as the **first-line screening test in Kenya**, with initial orders expected in Q1 2023, ramping up to approximately **6 million tests per year**[7](index=7&type=chunk) - Trinity is in **partnership negotiations** to leverage its **lateral flow manufacturing capabilities** and gain access to new intellectual property[7](index=7&type=chunk) - Margin optimization efforts include **eliminating loss-making legacy products**, **consolidating manufacturing** into its Jamestown facility, and **reducing production headcount** at two facilities[7](index=7&type=chunk)[11](index=11&type=chunk) - The leadership team has been strengthened with recent appointments of a **Chief Technology Officer**, **Head of Quality and Regulatory Affairs**, and **Global Supply Chain Leader**[7](index=7&type=chunk) [Consolidated Financial Statements](index=7&type=section&id=Consolidated%20Financial%20Statements) The unaudited consolidated financial statements for Q3 2022 show a net loss of **$8.9M**, total assets of **$97.9M**, total equity of **$6.6M**, and a net cash usage of **$3.2M** [Consolidated Income Statements](index=7&type=section&id=Consolidated%20Income%20Statements) Q3 2022 revenues were **$19.5M**, with gross profit of **$2.0M**, leading to a net loss of **$8.9M** after operating expenses and a **$2.3M** impairment charge Consolidated Income Statement (US$ thousands) | (US$000's) | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Revenues | 19,502 | 22,004 | | Gross profit | 2,015 | 8,900 | | Operating (Loss)/Profit | (7,086) | 2,768 | | (Loss)/Profit for the period | (8,945) | 1,321 | [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) As of Sep 30, 2022, total assets were **$97.9M**, with **$7.3M** cash and **$23.6M** inventories, total liabilities **$91.3M**, and total equity **$6.6M** Consolidated Balance Sheet (US$ thousands) | (US$ '000) | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **ASSETS** | | | | Total non-current assets | 48,061 | 46,207 | | Total current assets | 49,834 | 72,688 | | **TOTAL ASSETS** | **97,895** | **118,895** | | **EQUITY AND LIABILITIES** | | | | Total equity/(deficit) | 6,633 | (319) | | Total liabilities | 91,262 | 119,214 | | **TOTAL EQUITY AND LIABILITIES** | **97,895** | **118,895** | [Consolidated Statement of Cash Flows](index=9&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) Q3 2022 saw **$0.7M** cash from operations, **$1.3M** used in investing, and **$2.4M** used in financing, leading to a **$3.0M** net decrease in cash Consolidated Statement of Cash Flows (US$ thousands) | (US$000) | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash generated by operating activities | 676 | 1,697 | | Net cash used in investing activities | (1,324) | (1,959) | | Net cash (used) in financing activities | (2,372) | (726) | | **(Decrease) in cash and cash equivalents** | **(3,020)** | **(988)** |