Trinity Biotech Plc Stock Price, News & Analysis

Trinity Biotech (NASDAQ:TRIB) has secured World Health Organization (WHO) approval for offshoring and outsourcing the upstream manufacturing of its flagship TrinScreen™ HIV rapid test. This strategic move, set to be implemented in Q3 2025, is a crucial part of the company's transformation plan aimed at improving financial performance and achieving sustainable profitability.

The transition from in-house operations to an outsourced model is expected to deliver significant improvements in gross margins, reduce fixed costs, enhance supply chain resilience, and free up working capital. The company will maintain product integrity and regulatory compliance while focusing internal resources on innovation and market expansion.

Trinity Biotech (NASDAQ: TRIB) reported its Q4 and FY 2024 results, highlighting progress in its Comprehensive Transformation Plan. Q4 2024 revenues reached $15.9M, up 18.1% YoY, with Point-of-Care revenues surging 158% to $5.5M. However, the company posted a net loss of $17M for Q4, wider than the $5.5M loss in Q4 2023. For FY 2024, total revenues were $61.6M, an 8.3% increase from 2023, driven by strong Point-of-Care growth (+91.8%). The company secured WHO approval for offshore manufacturing of HIV tests and is consolidating operations across facilities. Trinity also amended its credit agreement with Perceptive Advisors, gaining $4.5M in additional liquidity and extending loan maturity to July 2026. Q1 2025 revenue is expected to temporarily decline to $7-8M due to manufacturing transitions, but management anticipates recovery by late Q2 to Q3 2025.

Trinity Biotech (TRIB) has received two non-compliance notices from Nasdaq regarding listing requirements. The first notice concerns the company's failure to maintain a minimum bid price of $1.00 per share for its American depositary shares (ADSs). The second notice relates to not meeting the minimum market value of publicly held shares (MVPHS) requirement of $15,000,000.

The company has until September 10, 2025 to regain compliance with both requirements. For the bid price requirement, TRIB must maintain a closing bid price above $1.00 for at least 10 consecutive business days. For the MVPHS requirement, the company must exceed $15,000,000 for a minimum of 10 consecutive business days.

If Trinity fails to meet these requirements, it may be eligible for additional grace periods or could seek transfer to the Nasdaq Capital Market. The notices do not immediately affect TRIB's listing status, and shares continue trading on the Nasdaq Global Select Market.

Trinity Biotech (Nasdaq: TRIB) has appointed Barclays Capital Inc. as its exclusive financial advisor to support its strategic realignment, focusing primarily on Continuous Glucose Monitoring (CGM) technology development. This appointment marks a significant step in the company's transformation plan.

The company's decision follows substantial progress in developing its differentiated CGM technology, which promises to be more affordable, user-focused, and sustainable. CEO John Gillard highlighted strong pre-pivotal clinical trial data and market interest as key factors driving this strategic direction.

The transformation plan aims to achieve near-term profitability improvements while optimizing the company's portfolio to support CGM-related growth. Barclays will actively assess how Trinity Biotech's existing businesses can align with this new strategic focus.

Trinity Biotech (TRIB) has secured an additional $4 million in debt financing from Perceptive Advisors to support two key initiatives: the continued development of its continuous glucose monitoring (CGM) technology and the company's transformation plan.

The funding follows previously announced positive results from Trinity's pre-pivotal CGM trial. The company's transformation plan aims to enhance profitability and cash-flow generation across its portfolio of operating businesses. Trinity has already implemented measures to increase operational efficiencies and continues to optimize its business portfolio and capital structure.

Trinity Biotech (TRIB) announced significant improvements in its next-generation continuous glucose monitoring (CGM) system from its latest pre-pivotal trial. The trial, involving 30 diabetic participants over a 15-day period, demonstrated a 35% improvement in Mean Absolute Relative Difference (MARD) and over 50% improvement in Mean Absolute Difference (MAD) during the critical first-day performance compared to the previous Waveform product.

Key achievements include superior signal quality, enhanced post-insertion reliability, and a 25-30% overall improvement in MARD over earlier Waveform CGM sensors. The company's redesigned ergonomic modular CGM system focuses on affordability and sustainability with reusable and rechargeable components.

Trinity Biotech plans regulatory submissions in Europe in 2025 and FDA filing in 2026. Additional pre-pivotal clinical trials on device enhancements are scheduled to begin in Q1 2025. The global CGM market is projected to exceed $20 billion by 2029.

Trinity Biotech (TRIB) has announced significant results from its pre-pivotal trial for its next-generation continuous glucose monitoring (CGM) system. The trial, involving 30 diabetic participants over a 15-day period, demonstrated notable improvements including a 25-30% enhancement in accuracy metrics (MARD) compared to previous Waveform CGM sensors.

The company's innovative CGM features a reusable applicator and rechargeable transmitter, designed to reduce costs significantly compared to current market leaders. The system showed superior signal quality, enhanced post-insertion reliability, and industry-standard low-glucose precision.

Trinity aims to target the global CGM market, projected to exceed $20 billion by 2029. The company plans to file for EU regulatory approval in 2025 and FDA approval in 2026. Currently, the two largest CGM manufacturers serve only 10 million users out of 800 million people living with diabetes worldwide, primarily due to cost barriers.

Trinity Biotech (TRIB) has amended agreements with Perceptive Advisors, securing additional liquidity of approximately $5.5 million through cash and payment-in-kind interest. The company also extended a $5 million deferred payment for the Waveform Technologies biosensor assets to November 2025.

As part of the agreement, Trinity granted Perceptive 1.5 million additional ADS warrants and repriced existing warrants to $0.80 per ADS. The company recently received WHO approval for transferring late-stage manufacturing of TrinScreen HIV and Uni-Gold HIV to a lower-cost offshore manufacturer, advancing its Comprehensive Transformation Plan focused on achieving long-term profitability through operational efficiency.

Trinity Biotech (TRIB) has received early approval from the World Health Organization (WHO) to transfer the manufacturing of TrinScreen HIV and Uni-Gold HIV tests to a lower-cost offshore facility. This approval is a key milestone in the company's Comprehensive Transformation Plan, enabling the later-stage manufacturing processes of both rapid HIV tests at an outsourced provider. The company plans to begin manufacturing at the new location in Q1 2025, a move expected to improve margins and enhance shareholder value.