Clinical data confirms elimination of requirement for finger-stick calibration, de-risking pathway to commercialization for the company’s next-generation CGM+ biosensor platformDUBLIN, Aug. 12, 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 compelling positive clinical trial results demonstrating a major technical breakthrough and de-risking th ...

Financial Data and Key Metrics Changes - The company achieved high single-digit sales growth, with adjusted earnings per share of $1.26, reflecting an 11% increase year-over-year and exceeding consensus estimates [8][18] - Adjusted gross margin increased by 100 basis points to 57% of sales, while adjusted operating margin also rose by 100 basis points to 22.9% of sales [19][20] - Sales growth excluding COVID testing was 7.5% in Q2 and 8% in the first half of the year [8][18] Business Line Data and Key Metrics Changes - Nutrition sales increased by 3.5%, driven by a 6.5% growth in adult nutrition [9] - Diagnostics sales declined by 1.5%, primarily due to a decrease in COVID testing sales and volume-based procurement in China, with a projected headwind of approximately $700 million for the full year [10] - Established Pharmaceuticals Division (EPD) saw nearly 8% sales growth, particularly in key markets like India and China [11] - Medical devices sales grew by 12%, with notable growth in diabetes care and heart failure segments [12][16] Market Data and Key Metrics Changes - Core Lab Diagnostics grew by 8% excluding China, indicating strong underlying demand globally [10][32] - The U.S. market for diabetes care saw a 19.5% increase in continuous glucose monitors [12] - The company reported strong performance in international markets, particularly in Latin America and Asia, which are expected to drive future growth [11] Company Strategy and Development Direction - The company is focused on sustainable growth with targets of high single-digit growth, healthy margin expansion, and double-digit EPS growth [15][20] - There is a commitment to expanding the biosimilars portfolio and launching new products across various segments, including diabetes and electrophysiology [11][28] - The company is exploring M&A opportunities selectively, aiming for strategic fits that generate attractive returns [79] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from COVID testing declines and challenges in the China market but remains optimistic about achieving high single-digit growth despite these challenges [26][28] - The company expects to see recovery in certain markets and product lines, with a positive outlook for 2026 as headwinds dissipate [29][32] - Management emphasized the importance of innovation and product launches in driving future growth [11][90] Other Important Information - The company is making significant investments in R&D and expanding its product portfolio, particularly in structural heart and electrophysiology [90][101] - The dual analyte sensor is expected to be a significant innovation in the continuous glucose monitoring market, with ongoing clinical trials [112] Q&A Session Summary Question: Context for 2025 performance and headwinds - Management discussed the impact of COVID testing declines and challenges in the China market, estimating over $1 billion in headwinds but still forecasting high single-digit growth [24][26] Question: Potential for growth acceleration into 2026 - Management indicated that there is a scenario for growth acceleration as headwinds fade and new product launches gain traction [35][36] Question: Trends in diabetes and electrophysiology products - Management reported strong growth in diabetes care, particularly with the Libre product, and positive trends in electrophysiology with the Volt catheter [42][48] Question: Competitive bidding for CGM and potential impacts - Management noted that competitive bidding for CGM is expected to take time to implement and will primarily affect DMEs rather than manufacturers [57] Question: Update on CRM product conversion and growth expectations - Management highlighted a significant increase in the uptake of the Avera leadless pacemaker and expects continued growth in the CRM market [64][66] Question: M&A opportunities and strategic focus - Management expressed a strong interest in M&A opportunities that align with strategic goals and profitability, while also focusing on organic growth [79][80]

Company Overview - Senseonics Holdings, Inc. is a medical technology company focused on developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems for diabetes management [3] - The company's CGM systems, Eversense 365 and Eversense E3, feature a small sensor that is implanted under the skin and communicates with a smart transmitter worn externally, sending glucose data to a mobile app every 5 minutes [3] Financial Results Announcement - Senseonics plans to release its second quarter 2025 financial results after market close on August 6, 2025 [1] - A conference call to review the company's performance for the second quarter 2025 will take place at 4:30 p.m. (Eastern Time) on the same day, with a webcast available on the company's website [2]

Core Insights - Abbott's diversified business portfolio is well-positioned for continued momentum into 2025, currently holding a Zacks Rank 2 (Buy) [1] Factors Driving ABT Shares - Abbott's Established Pharmaceuticals Division (EPD) is leveraging its strong presence in emerging markets, achieving an 8% organic sales growth in Q1 2025. The company is focusing on biosimilars, securing rights to 15 products across key therapeutic areas, and has recently agreed to commercialize four additional biosimilars in Asia, Latin America, the Middle East, and Africa [2] - The Diagnostics business, accounting for 20% of total revenues in Q1 2025, is experiencing increased global demand for routine diagnostics, with Core Laboratory Diagnostics (excluding China) growing 6.5% [3] - The Diabetes Care segment is benefiting from the success of the FreeStyle Libre continuous glucose monitoring system, which has achieved global leadership in its category. In Q1 2025, CGM sales exceeded $1.7 billion, reflecting a 21.6% year-over-year growth [4][5] Recent Performance - Year-to-date, Abbott's shares have increased by 21.7%, outperforming the industry average of 8.2%. The company's expansion in high-growth areas and new product launches are expected to sustain this upward trend [6] Concerns for Abbott - Foreign exchange fluctuations pose a significant challenge, with a 2.8% unfavorable impact on sales in Q1 2025 due to a strong euro and other developed market currencies [7] - The ongoing complex geopolitical situation is leading to higher-than-anticipated expenses for raw materials and freight, which may affect Abbott's business in the coming months. The deteriorating global economic environment is also reducing demand for several MedTech products, impacting sales and increasing costs [8] Other Key Picks - Other top-ranked stocks in the medical space include Phibro Animal Health (PAHC), Hims & Hers Health (HIMS), and Cencora (COR), with varying degrees of performance and earnings estimates [11][12][13][14]

Core Insights - Abbott's FreeStyle Libre continuous glucose monitoring (CGM) technology significantly reduces the risk of hospitalization for heart complications in individuals with diabetes, marking a breakthrough in diabetes management [1][4][5]. Group 1: Study Findings - The REFLECT studies indicate that CGM technology is linked to an 80% reduction in cardiovascular disease-related hospitalizations for Type 1 diabetes patients without prior cardiovascular issues, and a 49% reduction for those with a history of cardiovascular disease [4][5]. - For Type 2 diabetes patients on insulin, similar reductions in heart-related hospitalizations were observed when using Libre technology [1][5]. - The studies utilized data from the Swedish National Diabetes Register, covering approximately 90% of diabetes patients in Sweden, and assessed various cardiovascular complications [6]. Group 2: Health Impact - Diabetes affects around 589 million people globally, with individuals having Type 1 and Type 2 diabetes being 2-4 times more likely to develop heart disease compared to non-diabetics [3][4]. - The findings suggest that the use of Libre technology could lead to lower healthcare costs due to reduced hospital admissions related to heart complications [3]. Group 3: Company Overview - Abbott has been a pioneer in diabetes care with its FreeStyle Libre technology, which is currently used by over 7 million people in more than 60 countries [7]. - The company aims to empower individuals with diabetes to manage their health proactively through real-time glucose monitoring [4][7].

Core Viewpoint - Senseonics Holdings, Inc. is set to release its first quarter 2025 financial results on May 8, 2025, after market close, indicating ongoing developments in its financial performance and product offerings [1]. Group 1: Financial Results Announcement - The company will announce its first quarter 2025 financial results after market close on May 8, 2025 [1]. - A conference call to discuss the financial performance will take place at 4:30 p.m. (Eastern Time) on the same day, which will also be available via webcast [2]. Group 2: Company Overview - Senseonics is a medical technology company focused on developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems for diabetes management [3]. - The company's CGM systems, Eversense 365 and Eversense E3, feature a small sensor that is implanted under the skin and communicates with a smart transmitter, sending glucose data to a mobile app every 5 minutes [3].

Core Insights - Sequel Med Tech and Senseonics have announced a commercial development agreement to integrate the twiist Automated Insulin Delivery (AID) System with Senseonics' Eversense 365 CGM system, making it the first AID system compatible with a one-year CGM [2][3][5] - The integration aims to enhance diabetes management for individuals with type 1 diabetes by providing more tools for glucose control, convenience, and personalization [3][5] - The twiist AID System is designed to automatically adjust insulin delivery based on real-time sensor readings, offering flexibility in diabetes management [6][8] Company Overview - Sequel Med Tech is focused on developing innovative insulin delivery technologies and aims to simplify disease management through advanced systems [8] - Senseonics specializes in long-term implantable glucose monitoring systems, with the Eversense 365 being the only implantable CGM that offers continuous monitoring for up to one year [9][11] - The collaboration between Sequel and Senseonics represents a significant advancement in diabetes care, providing users with a comprehensive solution that combines advanced pump, algorithm, and sensor technologies [4][5] Product Details - The twiist AID System is FDA-cleared for individuals aged six and up with type 1 diabetes, allowing for precise insulin delivery tailored to individual needs [6] - Eversense 365 received FDA clearance as an integrated continuous glucose monitoring system, enabling its use within automated insulin delivery systems [5][10] - The integration of twiist and Eversense 365 is expected to be commercially available in Q3 2025, enhancing the options available for diabetes management [5][6]

Core Insights - Senseonics Holdings, Inc. received FDA approval for the Eversense 365 Continuous Glucose Monitoring (CGM) system and launched it in partnership with Ascensia Diabetes Care, marking a significant advancement in diabetes care [1][3] - The patient base for Eversense increased by 56% in 2024 compared to 2023, reaching approximately 6,000 global patients [1][6] - The company reported total revenue of $8.3 million for Q4 2024, a slight increase from $8.0 million in Q4 2023, with U.S. revenue remaining stable at $6.2 million [4] Financial Performance - Fourth quarter 2024 gross profit was $4.0 million, up from $1.1 million in Q4 2023, primarily due to improved margins on the Eversense 365 product [5] - For the full year 2024, total revenue was $22.5 million, slightly up from $22.4 million in 2023, with U.S. revenue increasing to $15.3 million from $14.1 million [9] - The net loss for Q4 2024 was $15.5 million, a reduction from a net loss of $17.2 million in Q4 2023, attributed to improved gross profit margins [8] Operational Highlights - The Eversense 365 system was launched in the U.S. in 2024, and early performance indicators showed positive results, including record new patient shipments of approximately 600 in December [6] - The company exceeded 2,400 annual U.S. prescribers for Eversense in 2024, with 81% of patients switching from competitive CGMs [6] - Senseonics initiated a collaboration with Mercy Health to study the use of Eversense and remote patient monitoring [6] Future Outlook - For 2025, Senseonics expects global net revenue to be approximately $34-38 million, anticipating a doubling of the global patient base [15] - The company plans to enhance gross margins throughout 2025, projecting margins between 25-30% for the year [15] - Cash utilization in 2025 is expected to be between $50-$60 million as the company continues to roll out Eversense 365 [15]