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Senseonics Signs Memorandum of Understanding with Ascensia Diabetes Care to Take Over Commercialization and Distribution of Eversense 365
GlobenewswireĀ· 2025-09-03 21:17
Core Viewpoint - Senseonics Holdings, Inc. is transitioning the commercialization and distribution of its Eversense 365 continuous glucose monitoring system from Ascensia Diabetes Care to itself, aiming for improved growth and operational efficiency [1][2][3]. Group 1: Transition Details - The transition will take effect on January 1, 2026, with Senseonics assuming global sales, marketing, and commercialization responsibilities [2]. - Brian Hansen, currently President of CGM at Ascensia, will join Senseonics as Chief Commercial Officer on the same date [2]. - The companies are collaborating to finalize the documentation for this transition [2]. Group 2: Strategic Rationale - The decision to bring Eversense commercialization in-house is driven by the need for strategic investment and dedicated commercial efforts to respond to market demands [3]. - Senseonics believes that unifying the Eversense business will accelerate growth and realize its full potential more effectively than under the current structure [3]. Group 3: Financial Implications - Senseonics has expanded its non-dilutive debt facility with Hercules Capital to $100 million to fund its commercial organization [1]. - The company anticipates immediate revenue improvement and gross margin expansion to 50% in 2026, with a target of over 70% gross margins at scale [4]. - For the full year 2025, Senseonics expects global net revenue to be approximately $34-38 million, with a projected doubling of its global patient base [5][6]. Group 4: Conference Call - A conference call is scheduled for September 4, 2025, at 8:00 A.M. Eastern Time to discuss the commercial transition [1][7].
Trinity Biotech Achieves Breakthrough Clinical Trial Results for Redesigned CGM Sensor
GlobenewswireĀ· 2025-08-12 12:45
Core Insights - Trinity Biotech has achieved a significant technical breakthrough with its next-generation continuous glucose monitoring (CGM) technology, CGM+, eliminating the need for finger-stick calibration and enhancing the commercial pathway for its biosensor platform [1][2][3] Company Developments - The redesigned needle-free glucose sensor provides accurate readings over a 15-day wear period without finger-stick calibration, reducing disposable components and lowering care costs compared to existing market products [1][3][6] - The successful technical de-risking of the glucose sensor increases confidence in the product's performance and regulatory pathway, aligning it with market leaders while offering a differentiated product architecture [2][6] Market Potential - The global CGM market is projected to grow from approximately $13 billion in 2025 to about $28 billion by 2030, driven by rising diabetes prevalence and demand for real-time health data [4] - Trinity Biotech's innovative CGM+ platform aims to expand access to glucose monitoring technology for millions who are currently priced out of existing systems, emphasizing affordability, reusability, and sustainability [4][6] Product Features - The CGM+ wearable biosensor is designed to integrate glucose monitoring with cardiovascular, temperature, and activity data in a single modular device, enhancing user convenience and reliability [7][6]
Abbott(ABT) - 2025 Q2 - Earnings Call Transcript
2025-07-17 14:02
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]
Senseonics Holdings, Inc. Schedules Second Quarter 2025 Earnings Release and Conference Call for August 6, 2025 at 4:30 P.M. Eastern Time
GlobenewswireĀ· 2025-07-16 20:05
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]
Abbott Sees Upside on Diagnostics Growth, FreeStyle Libre Expansion
ZACKSĀ· 2025-07-02 15:06
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]
Abbott's LibreĀ® Technology is First Continuous Glucose Monitor Associated with Reduced Hospitalizations for Heart Complications in People with Diabetes
PrnewswireĀ· 2025-05-15 13:05
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].
Senseonics Holdings, Inc. Schedules First Quarter 2025 Earnings Release and Conference Call for May 8, 2025 at 4:30 P.M. Eastern Time
GlobenewswireĀ· 2025-04-29 20:05
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].
Sequel Med Tech and Senseonics Integrate Technologies to Create First Automated Insulin Delivery (AID) System with One-Year Continuous Glucose Monitor (CGM)
GlobenewswireĀ· 2025-04-29 11:30
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]
EPD Growth in Emerging Market Supports Abbott Stock Amid Macro Woes
ZACKSĀ· 2025-04-24 16:40
Core Insights - Abbott's diversified business portfolio is positioned to drive momentum in 2025 despite foreign exchange challenges [1] - The stock currently holds a Zacks Rank 3 (Hold) [1] Factors Driving Abbott Shares - Abbott's Established Pharmaceuticals Division (EPD) saw an 8% organic sales increase in Q1 2025, leveraging its presence in emerging markets [2] - The company has secured rights to 15 biosimilar products and recently agreed to commercialize four additional biosimilars across various regions, enhancing its position in the branded generic pharmaceutical market [2] Diagnostics Business Expansion - Abbott's Diagnostics business accounted for 20% of total revenues in Q1 2025, with a 6.5% growth in Core Laboratory Diagnostics (excluding China) [3] Diabetes Care Growth - The FreeStyle Libre continuous glucose monitoring system has achieved global leadership, with sales in Diabetes Care growing 21.6% to over $1.7 billion in Q1 2025 [4][5] Stock Performance - Year-to-date, Abbott shares have gained 17.7%, outperforming the industry's 1.7% improvement, driven by expansion in high-growth areas and new product launches [6] Concerns for Abbott - Foreign exchange impacts were unfavorable, contributing to a 2.8% decline in sales year-over-year in Q1 2025 [7] - Rising raw material and freight costs, along with a challenging macroeconomic environment, may affect Abbott's business in the coming months [8] - Selling, general, and administrative expenses increased by 3.4% in Q1 2025 [9]
DXCM Inks Deal With Nanowear to Boost CGM Application Beyond Diabetes
ZACKSĀ· 2025-03-31 14:31
Core Insights - DexCom has entered a licensing and data partnership with Nanowear to utilize glucose data from its G7 Continuous Glucose Monitoring Systems alongside Nanowear's cardiovascular biomarkers for investigational purposes [1][2] Group 1: Partnership and Integration - The collaboration enhances DexCom's leadership in CGM integration and aligns with its vision to expand CGM applications beyond diabetes management, emphasizing the potential for continuous metabolic health monitoring [2] - The integration of DexCom G7 CGM data into Nanowear's SimpleSense platform creates a self-administered cardiometabolic assessment tool, offering real-time diagnostic insights by synchronizing glucose data with cardiovascular biomarkers [3] Group 2: Market Demand and Health Insights - Cardiometabolic health issues, such as obesity and hypertension, are significant contributors to morbidity in the U.S., with only 6.8% of Americans having optimal cardiometabolic health, highlighting the need for innovative solutions [4] - The partnership allows DexCom to provide insights into the cardiometabolic effects of new therapeutics, catering to pharmaceutical and biotech sectors seeking novel assessment solutions [4] Group 3: Innovation in Clinical Research - The ability to conduct home-based, self-administered assessments represents a shift in clinical research, allowing for continuous monitoring that traditional assessments lack [5] - By integrating with Nanowear's AI-driven diagnostic tools, DexCom aids pharmaceutical and biotechnology companies in evaluating drug safety and efficacy with greater detail [5] Group 4: Competitive Landscape - DexCom faces competition from Abbott's FreeStyle Libre CGM device, which offers automatic glucose readings every minute and a longer wear time of 15 days compared to DexCom's 10-day wear time for G7 [9][10] - Recent FDA warnings regarding manufacturing practices may delay DexCom's approval for a 15-day G7 sensor, increasing competitive pressure from FreeStyle Libre [10]