-Trinity Biotech projects it reached Adjusted EBITDA -positive operations during Q2 2025 and expects to be Adjusted EBITDA positive going forward, reflecting continued strong execution on its comprehensive transformation plan.- - The Company now expects to be meaningfully Adjusted EBITDA -positive and cashflow positive from ongoing operating activities, starting Q3 2025 and into the foreseeable future.- DUBLIN, July 01, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial stage biotechn ...

Strategic Offshore Manufacturing Move Expected to Drive Gross Margin Expansion, Free Up Working Capital, and Enhance Scalability Transition to Outsourced Production Reduces Fixed Costs and Supports Trinity’s Broader Profitability and Growth Objectives DUBLIN, June 24, 2025 (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 it has received World Health ...

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]

[Fourth Amended and Restated Credit Agreement and Guaranty](index=1&type=section&id=Fourth%20Amended%20and%20Restated%20Credit%20Agreement%20and%20Guaranty) This agreement amends a prior credit facility to provide a new term loan and modify terms for Trinity Biotech and its lenders [Agreement Overview](index=1&type=section&id=Agreement%20Overview) The agreement provides a new Fourth Amendment Term Loan to Trinity Biotech, amending a prior agreement without constituting a novation of existing debt - The agreement involves **Trinity Biotech, Inc.** and its subsidiaries as Borrowers, with **Perceptive Credit Holdings III, LP** as the Administrative Agent and Lender[2](index=2&type=chunk)[10](index=10&type=chunk) - This agreement amends and restates the Third A&R Credit Agreement dated December 23, 2024, to provide a new **Fourth Amendment Term Loan** and update certain terms[14](index=14&type=chunk)[15](index=15&type=chunk) - The parties intend for this agreement to continue existing obligations, clarifying it is **not a novation** of the prior agreement[16](index=16&type=chunk) [Article I: Definitions](index=8&type=section&id=Article%20I%20Definitions) This article defines the key terms, financial metrics, and legal concepts governing the credit agreement [Certain Defined Terms](index=8&type=section&id=Section%201.01.%20Certain%20Defined%20Terms) This section provides comprehensive definitions for critical terms used throughout the credit agreement - The "Fourth Amendment Term Loan Commitment" is defined as the commitment of a Lender to fund the Fourth Amendment Term Loan, with an aggregate amount of **$4,000,000** as of the restatement date[138](index=138&type=chunk) - The "Stated Maturity Date" is **January 27, 2026**, the fourth anniversary of the original Funding Date (January 27, 2022)[139](index=139&type=chunk)[276](index=276&type=chunk) - An "Event of Default" is defined as any of the events specified in **Section 10.01** of the agreement[115](index=115&type=chunk) - The "Applicable Margin" for interest calculation is **8.75%** per annum when the aggregate principal of Term Loans is $35,000,000 or more, and **6.25%** per annum when it is less[35](index=35&type=chunk) [Accounting Terms and Principles](index=50&type=section&id=Section%201.02.%20Accounting%20Terms%20and%20Principles) This section mandates the use of IFRS for all accounting and outlines a process for handling changes to these standards - All accounting determinations must be made substantially in accordance with **IFRS**[321](index=321&type=chunk) - If a change in IFRS materially alters covenant calculations, the parties must negotiate amendments to maintain the agreement's original intent[321](index=321&type=chunk) [Article 2: The Commitments](index=52&type=section&id=Article%202%20The%20Commitments) This article details the term loan facilities, including the new loan amount, and specifies the permitted use of proceeds [Term Loans](index=52&type=section&id=Section%202.01.%20Term%20Loans) This section details the new **$4,000,000** Fourth Amendment Term Loan and confirms that repaid principal cannot be reborrowed - Lenders agree to provide a **Fourth Amendment Term Loan of $4,000,000** on the Fourth Amendment Restatement Date[138](index=138&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk) - As of January 31, 2025, the aggregate outstanding principal of the Term Loans was **$76,342,637.90**, including capitalized PIK interest[339](index=339&type=chunk) - Principal amounts of any Term Loans that are repaid or prepaid **may not be reborrowed**[340](index=340&type=chunk) [Use of Proceeds](index=54&type=section&id=Section%202.05.%20Use%20of%20Proceeds) This section designates proceeds from the term loans for specific purposes like acquisitions and general corporate use - The proceeds of the Fourth Amendment Term Loan are to be used for **general corporate purposes**[343](index=343&type=chunk) - The proceeds of the Effective Date Term Loan were used to fund the **Effective Date Acquisition**, pay fees and expenses, and for general corporate purposes[343](index=343&type=chunk) [Article 3: Payments of Principal and Interest](index=55&type=section&id=Article%203%20Payments%20of%20Principal%20and%20Interest) This article outlines the repayment schedule, interest calculation methods, and conditions for loan prepayments [Repayment](index=55&type=section&id=Section%203.01.%20Repayment) This section specifies that the entire outstanding principal is due as a single balloon payment on the Maturity Date - No scheduled principal repayments are required before the Maturity Date; the entire outstanding principal balance is due on the **Maturity Date**[346](index=346&type=chunk) [Interest](index=55&type=section&id=Section%203.02.%20Interest) This section details the interest calculation, including provisions for paid-in-kind interest and a default rate - The interest rate on the Term Loans is **Term SOFR plus the Applicable Margin**[347](index=347&type=chunk) - Interest for the periods from September 2024 through March 2025 will be paid as **PIK Interest**, which is capitalized to the principal balance[347](index=347&type=chunk) - Upon an Event of Default, the interest rate increases by **3.00% per annum** (the "Default Rate"), and all interest must be paid in cash[355](index=355&type=chunk) [Prepayments](index=59&type=section&id=Section%203.03.%20Prepayments) This section outlines conditions for optional and mandatory prepayments, both of which may be subject to a prepayment premium Optional Prepayment Premiums | Redemption Date | Prepayment Premium | | :--- | :--- | | After 1st anniversary, on or before 2nd anniversary | 4.5% of principal prepaid | | After 2nd anniversary, on or before 3rd anniversary | 4.0% of principal prepaid | | After 3rd anniversary, before Stated Maturity Date | 3.5% of principal prepaid | - Mandatory prepayments are required for **100% of Net Cash Proceeds** from Casualty Events (above a certain threshold), incurrence of non-permitted Indebtedness, and non-permitted Asset Sales[365](index=365&type=chunk)[366](index=366&type=chunk)[367](index=367&type=chunk) - A mandatory prepayment equal to **75% of Net Partnership Agreement Proceeds** is required from Asset Sales made in connection with Partner Agreements, and this amount is not subject to a Prepayment Premium[369](index=369&type=chunk) - The Prepayment Premium is defined as **liquidated damages**, not a penalty, and is due upon any acceleration of the Term Loans prior to the Stated Maturity Date[370](index=370&type=chunk)[581](index=581&type=chunk) [Article 4: Payments, Etc.](index=61&type=section&id=Article%204%20Payments,%20Etc.) This article specifies the mechanics for all payments, including the application waterfall and lender set-off rights [Payments](index=61&type=section&id=Section%204.01.%20Payments) This section establishes the mechanics and priority waterfall for all payments made by the Obligors - Payments are applied in a specific order of priority: first to costs and expenses, second to interest and fees, third to certain claims, fourth to principal, and finally to any other Obligations[374](index=374&type=chunk) [Set-Off](index=63&type=section&id=Section%204.04.%20Set-Off) This section grants Lenders the right to set-off and apply any deposits they owe to an Obligor against outstanding Obligations upon a default - Upon an Event of Default, Lenders have the right to **set off and apply** any deposits or other debts they owe to any Obligor against the outstanding Obligations[381](index=381&type=chunk) [Article 5: Yield Protection, Etc.](index=63&type=section&id=Article%205%20Yield%20Protection,%20Etc.) This article protects Lenders from increased costs due to changes in law or tax regulations [Additional Costs](index=63&type=section&id=Section%205.01.%20Additional%20Costs) This section requires Borrowers to compensate Lenders for increased costs resulting from changes in law or capital adequacy requirements - If a change in law or regulation increases a Lender's cost or reduces the amount received, the Borrowers must pay **additional amounts to compensate** the Lender[384](index=384&type=chunk) - Changes related to the **Dodd-Frank Act and Basel III** are explicitly defined as changes in law, triggering potential compensation[384](index=384&type=chunk) [Taxes](index=65&type=section&id=Section%205.03.%20Taxes) This section requires Obligors to make payments free of tax deductions and to "gross-up" payments if taxes are withheld - All payments on Obligations must be made without deduction for Taxes; if an Indemnified Tax is withheld, the payment must be **increased** so the Recipient receives the full amount[391](index=391&type=chunk) - Borrowers must **indemnify** each Recipient for the full amount of any Indemnified Taxes and Warrant Indemnified Taxes[394](index=394&type=chunk) - Lenders must provide necessary tax forms (e.g., **W-9, W-8BEN-E**) to the Borrowers to establish exemptions from or reductions in withholding tax[397](index=397&type=chunk)[399](index=399&type=chunk) [Article 6: Conditions Precedent](index=71&type=section&id=Article%206%20Conditions%20Precedent) This article lists the conditions that must be met before Lenders are obligated to fund the new term loan [Conditions to Fourth Amendment Term Loan; Fourth Amendment Restatement Date](index=71&type=section&id=Section%206.01.%20Conditions%20to%20Fourth%20Amendment%20Term%20Loan;%20Fourth%20Amendment%20Restatement%20Date) This section lists the conditions that must be satisfied before the Lenders will fund the Fourth Amendment Term Loan - The funding of the Fourth Amendment Term Loan is **conditional** upon several requirements being met or waived[412](index=412&type=chunk) - Key conditions include: representations and warranties must be true, **no Default or Event of Default** shall have occurred, and all required legal documents must be received[413](index=413&type=chunk)[414](index=414&type=chunk)[415](index=415&type=chunk) [Article 7: Representations and Warranties](index=72&type=section&id=Article%207%20Representations%20and%20Warranties) This article contains the Obligors' binding statements of fact regarding their legal, financial, and operational status [Representations and Warranties](index=72&type=section&id=Representations%20and%20Warranties) The Obligors make binding statements covering their legal status, financial condition, asset ownership, and compliance with laws - The Obligors represent that since December 31, 2020, **no Material Adverse Change** has occurred[426](index=426&type=chunk) - The Obligors affirm they are **Solvent** and will remain so after the transaction[458](index=458&type=chunk) - The Obligors represent compliance with critical regulations, including **Anti-Corruption Laws, Sanctions Laws, and Anti-Terrorism Laws**[481](index=481&type=chunk)[482](index=482&type=chunk)[483](index=483&type=chunk) - The Obligors represent that they hold all necessary **Regulatory Approvals** and are in compliance with FDA Laws and other healthcare regulations[449](index=449&type=chunk)[467](index=467&type=chunk) [Article 8: Affirmative Covenants and Financial Covenants](index=83&type=section&id=Article%208%20Affirmative%20Covenants%20and%20Financial%20Covenants) This article details the ongoing obligations of the Obligors, including financial reporting, operational duties, and specific financial targets [Financial Reporting and Notices](index=83&type=section&id=Financial%20Reporting%20and%20Notices) This section details the Obligors' obligations to provide regular financial statements and prompt notices of material events - The Administrative Borrower must provide **quarterly and annual consolidated financial statements**, along with a management discussion and analysis (MD&A)[486](index=486&type=chunk)[487](index=487&type=chunk) - A **Compliance Certificate** must be delivered with financial reports and monthly, confirming compliance with covenants[487](index=487&type=chunk) - The Administrative Borrower must provide prompt written notice of any **Default or Event of Default** and other material events[490](index=490&type=chunk) [Operational and Corporate Covenants](index=89&type=section&id=Operational%20and%20Corporate%20Covenants) This section outlines the affirmative operational covenants the Obligors must adhere to, including maintaining assets and legal status - Obligors must maintain their legal existence and **preserve all properties material to the business**[497](index=497&type=chunk)[498](index=498&type=chunk) - Obligors must maintain all Deposit Accounts (other than Excluded Accounts) as **Controlled Accounts** subject to an account control agreement[524](index=524&type=chunk) - Parent must maintain sufficient authorized but unissued share capital to satisfy all obligations under the **Warrant Certificates**[500](index=500&type=chunk) - The Parent and each other Irish Obligor must maintain its **center of main interests (COMI) in Ireland**[527](index=527&type=chunk) [Financial Covenants](index=93&type=section&id=Financial%20Covenants) This section establishes the minimum liquidity and net revenue targets that the Obligors must maintain - Commencing April 1, 2025, the Obligors must maintain aggregate **Unrestricted Cash of not less than $3,000,000** at all times[520](index=520&type=chunk) Minimum Net Revenue Covenant (Trailing 12-Months) | Twelve-Month Period Ended | Minimum Net Revenue | | :--- | :--- | | December 31, 2023 | $0 | | March 31, 2024 | $53,100,000 | | June 30, 2024 | $54,300,000 | | September 30, 2024 | $55,700,000 | | December 31, 2024 | $0 | | March 31, 2025 | $60,000,000 | | June 30, 2025 | $64,600,000 | | September 30, 2025 | $67,500,000 | | December 31, 2025 | $69,100,000 | [Article 9: Negative Covenants](index=97&type=section&id=Article%209%20Negative%20Covenants) This article imposes restrictions on the Obligors' ability to incur debt, grant liens, make investments, and engage in major corporate changes [Indebtedness, Liens, and Investments](index=97&type=section&id=Indebtedness,%20Liens,%20and%20Investments) This section restricts the Obligors' ability to incur new debt, grant liens, and make investments, subject to specific permitted exceptions - Obligors are prohibited from incurring new Indebtedness, with exceptions including the Obligations, Permitted Indebtedness, and purchase money debt up to **$1.5M**[533](index=533&type=chunk)[534](index=534&type=chunk) - Obligors cannot create Liens on their property except for **Permitted Liens**, which include Liens securing the Obligations[539](index=539&type=chunk) - Investments are restricted, with exceptions for intercompany investments and investments in Immaterial Foreign Subsidiaries up to an annual cap of **$1M**[546](index=546&type=chunk)[547](index=547&type=chunk) [Fundamental Changes, Asset Sales, and Other Restrictions](index=102&type=section&id=Fundamental%20Changes,%20Asset%20Sales,%20and%20Other%20Restrictions) This section restricts major corporate actions such as mergers, asset sales, and restricted payments like dividends - **Fundamental changes** like mergers, consolidations, and liquidations are prohibited, except for mergers between Obligors[541](index=541&type=chunk) - **Asset Sales** are restricted, with exceptions for certain property up to **$3,000,000 per fiscal year**, provided no Default exists[554](index=554&type=chunk)[555](index=555&type=chunk) - **Restricted Payments**, such as dividends, are generally prohibited, with exceptions for intercompany payments and certain stock repurchases[549](index=549&type=chunk)[551](index=551&type=chunk) - **Transactions with affiliates** are restricted unless they are on arm's-length terms or fall under other specific exceptions[558](index=558&type=chunk) [Article 10: Events of Default](index=111&type=section&id=Article%2010%20Events%20of%20Default) This article defines the events that constitute a default and outlines the remedies available to the Lenders [Events of Default](index=111&type=section&id=Section%2010.01.%20Events%20of%20Default) This section defines the specific triggers for a default, including payment failures, covenant breaches, and bankruptcy - Failure to pay principal when due is an immediate Event of Default; failure to pay interest has a **3-business-day grace period**[574](index=574&type=chunk) - A breach of certain critical covenants (e.g., financial and negative covenants) constitutes an **immediate Event of Default**[574](index=574&type=chunk) - **Bankruptcy or insolvency proceedings** against an Obligor are Events of Default, with voluntary proceedings being immediate[575](index=575&type=chunk) - A **Change of Control** or the occurrence of a **Material Adverse Change** are also defined as Events of Default[577](index=577&type=chunk) [Remedies](index=114&type=section&id=Section%2010.02.%20Remedies) This section outlines the actions Lenders can take upon a default, including accelerating the loan and terminating commitments - Upon most Events of Default, the Majority Lenders may declare all outstanding Term Loans **immediately due and payable** at the Redemption Price[578](index=578&type=chunk) - In the case of a bankruptcy-related Event of Default, the termination of commitments and acceleration of the Term Loans are **automatic**[579](index=579&type=chunk) [Article 11: Guarantee](index=115&type=section&id=Article%2011%20Guarantee) This article establishes an absolute and unconditional guarantee from the Guarantors for all obligations of the Borrowers [Guarantee Provisions](index=115&type=section&id=Guarantee%20Provisions) This section establishes a joint and several guarantee from the Guarantors, which is absolute, unconditional, and continuing - The Guarantors provide a **joint and several guarantee** for the prompt payment in full of all "Guaranteed Obligations"[584](index=584&type=chunk) - The guarantee is **absolute and unconditional**, and Guarantors waive numerous defenses, including diligence, presentment, and notice of default[585](index=585&type=chunk)[588](index=588&type=chunk) - The obligations of each Irish Obligor under the guarantee are limited to the extent they would constitute **unlawful financial assistance** under Irish law[599](index=599&type=chunk) [Article 12: Administrative Agent](index=120&type=section&id=Article%2012%20Administrative%20Agent) This article defines the role, rights, and protections of the Administrative Agent in managing the credit facility [Role and Rights of the Administrative Agent](index=120&type=section&id=Role%20and%20Rights%20of%20the%20Administrative%20Agent) This section defines the Administrative Agent's duties as administrative, not fiduciary, and grants broad exculpatory provisions - Each Lender irrevocably appoints Perceptive to act as the Administrative Agent, whose role is **administrative in nature** and not fiduciary[602](index=602&type=chunk) - The Administrative Agent is protected from liability for any action taken, except in cases of its own **gross negligence or willful misconduct**[606](index=606&type=chunk) - The Agent is authorized to release any Lien or Guarantor if the transaction is permitted or approved by the **Majority Lenders**[616](index=616&type=chunk) [Article 13: Miscellaneous](index=124&type=section&id=Article%2013%20Miscellaneous) This article contains standard legal clauses governing the agreement's interpretation, enforcement, and amendment [Miscellaneous Provisions](index=124&type=section&id=Miscellaneous%20Provisions) This section contains critical legal clauses including governing law, jurisdiction, jury trial waiver, and amendment procedures - The agreement and other Loan Documents are governed by the laws of the **State of New York**[642](index=642&type=chunk) - All parties irrevocably **waive their right to a trial by jury** in any legal proceeding related to the agreement[646](index=646&type=chunk) - Amendments generally require written consent of the Borrowers, the Administrative Agent, and the **Majority Lenders**[625](index=625&type=chunk) - The agreement is confirmed to be an amendment and restatement and **not a novation**, ensuring security interests remain in full force[676](index=676&type=chunk)[678](index=678&type=chunk) [Schedules and Exhibits](index=6&type=section&id=Schedules%20and%20Exhibits) This section contains detailed schedules and forms referenced in the agreement, including commitments and warrant grants [Schedules and Exhibits Overview](index=6&type=section&id=Schedules%20and%20Exhibits%20Overview) The agreement includes numerous schedules providing specific details, including loan commitments and warrant grants Schedule 1: Fourth Amendment Term Loan Commitment | Lender | Fourth Amendment Term Loan Commitment | | :--- | :--- | | Perceptive Credit Holdings III, LP | $4,000,000 | Schedule 1: Warrant Shares Granted to Perceptive Credit Holdings III, LP | Warrant Certificate Type | Number of American Depositary Shares | | :--- | :--- | | Existing Warrant Certificate | 500,000* | | Effective Date Warrant Certificate | 500,000* | | Third Amendment Warrant Certificate | 1,000,000 | - The number of shares for the Existing and Effective Date Warrant Certificates reflects a **revised ADS Ratio** effective February 23, 2024[691](index=691&type=chunk)[692](index=692&type=chunk)

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 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'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]