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Senseonics Holdings, Inc. to Participate in the Stifel 2025 Healthcare Conference
Globenewswire· 2025-11-10 13:05
Core Insights - Senseonics Holdings, Inc. is set to participate in the Stifel 2025 Healthcare Conference, indicating its active engagement in the healthcare investment community [1][2]. Company Overview - Senseonics is a medical technology company that specializes in developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems aimed at improving the lives of individuals with diabetes [3]. - The company's CGM systems, Eversense® 365 and Eversense® E3, feature a small sensor that is fully implanted under the skin and communicates with a smart transmitter worn externally, providing glucose data to a mobile app every 5 minutes [3]. Event Details - The Stifel 2025 Healthcare Conference will take place on November 12, 2025, at 4:40 pm ET, featuring a fireside chat format and one-on-one meetings [2]. - Interested parties can access a live and recorded webcast of the presentation through the company's website [2].
Senseonics(SENS) - 2025 Q3 - Earnings Call Transcript
2025-11-05 22:30
Financial Data and Key Metrics Changes - In Q3 2025, net revenue grew by 90% to $8.1 million compared to $4.3 million in the prior year period, driven by Eversense 365 US revenue of $6.4 million and $1.7 million from outside the US [17][20][24] - Gross profit was $3.5 million, an increase of $7.5 million from the prior year, primarily due to improved margins on 365-day product sales [18][19] - Net loss decreased to $19.5 million, or $0.43 loss per share, compared to a net loss of $24 million, or $0.77 loss per share in Q3 2024 [20] Business Line Data and Key Metrics Changes - Revenue growth was driven by a 160% increase in new patient shipments year-over-year, with new insertions increasing nearly 150% year-over-year [5][6] - Approximately 60% of new patients in Q3 originated from direct-to-consumer (DTC) advertising, with 40% from healthcare provider (HCP) referrals [6][8] - The number of providers actively prescribing Eversense grew by more than 55% year-over-year, with 75 new trained inserters added, representing a 140% increase from the same time last year [8][9] Market Data and Key Metrics Changes - The installed base of Eversense grew over 150% year-over-year and nearly 40% sequentially, reflecting accelerating adoption among patients and providers [6][8] - The DTC campaign led to a 300% increase in patient leads year-over-year and an 85% increase sequentially [5][6] - The company anticipates that the transition from Ascensia will allow it to recognize 100% of revenues, which is expected to positively impact future revenue growth [18][20] Company Strategy and Development Direction - The company executed a memorandum of understanding with Ascensia Diabetes Care to reassume control of Eversense commercialization, allowing for greater control over strategy and investments [4][10] - The company plans to continue investing in DTC marketing, primarily through social media, to drive demand and awareness [6][8] - Future product development includes the anticipated CE Mark approval for Eversense 365 in Europe, expected before the end of 2025, and the launch planned for the first half of 2026 [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, citing significant new patient additions and top-line growth due to expanding awareness and adoption of Eversense 365 [25][26] - The company expects full-year 2025 global net revenue to be approximately $35 million, with a strong Q4 anticipated due to new patient starts and reorders from first US 365 patients [20][22] - Management highlighted margin improvements, projecting gross profit margins to grow to roughly 50% in 2026 and approximately 70% at scale [14][23] Other Important Information - The company is focused on expanding access to its unique system and advancing technology to simplify glucose testing for people with diabetes [14][25] - The transition to resume control of Eversense commercialization is progressing well, with nearly all employees from Ascensia's US CGM business electing to join Senseonics [11][12] Q&A Session Summary Question: Follow-up on growth opportunities in DTC - Management noted a significant increase in switchers from existing CGM systems, with 90% of new patients coming from this group, primarily from Dexcom and Libre [30][31] Question: Integration with Twist insulin delivery system - The first patients are expected to start in early Q1 2026, with a ramp-up anticipated later in the year [32][34] Question: Update on inserter network evolution and reimbursement - The EonCare model is expanding, with a focus on primary care and Medicare patients, and the company is seeing growth in providers interested in institutionalizing the insertion process [38][40] Question: Update on private payers and bundled payment reimbursement - Management expects continued transitions among private payers, with significant progress made in the first half of the year [42][44] Question: Details on DTC marketing spend and its effectiveness - Increased DTC spending has shown a direct correlation with patient acquisition, though there is a need for education and conversion [62][63] Question: Revenue guidance and inventory dynamics for 2026 - The company anticipates some inventory dynamics affecting revenue recognition in 2026, but remains on track for patient growth [55][66]
DexCom, Inc. (DXCM): A Bear Case Theory
Yahoo Finance· 2025-10-23 00:02
Core Viewpoint - The investigation by Hunterbrook Media highlights significant safety, operational, and financial concerns regarding DexCom, Inc.'s G7 continuous glucose monitor, indicating a decline in the company's reputation and potential risks to patient health [2][5]. Financial Performance - DexCom's share price was $65.41 as of October 15th, with trailing and forward P/E ratios of 46.79 and 25.64 respectively [1]. - Financial indicators suggest deteriorating fundamentals, including a surge in days sales outstanding and a doubling of work-in-process inventory, raising concerns about revenue recognition practices [4]. Product Issues - The G7 sensor's performance has been compromised due to a secret alteration of a key component, leading to underperformance in accuracy metrics and resulting in the FDA classifying the device as "adulterated" [2][3]. - Users have reported serious inaccuracies, leading to hospitalizations and fatalities, including a case linked to a device failure [2][3]. Corporate Culture and Management - Former employees have criticized the corporate culture for prioritizing profit margins over safety, with inadequate technical oversight and rushed design decisions to compete with Abbott's Freestyle Libre 3 [3]. - There are indications of systemic issues within the company, evidenced by executive departures, insider sales, and repeated product recalls [4]. Competitive Landscape - DexCom faces increasing competition from Abbott's superior devices and potential changes in Medicare policies, which could threaten its market share [4]. - The company's own initiatives, such as the Stelo device, are also experiencing accuracy problems and legal challenges [4].
Senseonics Holdings, Inc. Schedules Third Quarter 2025 Earnings Release and Conference Call for November 5, 2025 at 4:30 P.M. Eastern Time
Globenewswire· 2025-10-22 20:05
Core Insights - Senseonics Holdings, Inc. is set to release its third quarter 2025 financial results on November 5, 2025, after market close [1] - A conference call to discuss the financial performance will take place at 4:30 p.m. Eastern Time on the same day, with a webcast available for investors [2] Company Overview - Senseonics is a medical technology company specializing in long-term implantable continuous glucose monitoring systems aimed at improving the lives of individuals with diabetes [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]
American Diversified Holdings Corporation Receives $5,000,000 (Five Million) Financing Commitment from an Institutional Investment Fund
Newsfile· 2025-10-16 13:00
Investment Commitment - A prominent institutional investment fund has committed to providing up to $5,000,000 in financing to American Diversified Holdings Corporation (ADHC) [1][2] Use of Funds - The investment proceeds are designated for the research and development of the GlucoGuard project and for general corporate purposes, as well as to support collaboration with DexCom, a Continuous Glucose Monitoring (CGM) development partner [2] FDA Interaction - ADHC has engaged with its Medical Advisory Board and the FDA, leading to a request for a two-prong sleep study to address safety and efficacy concerns regarding the GlucoGuard device [3] FDA Review - The major components of the Breakthrough Device Application Designation have received positive feedback from the FDA regarding the unmet need and GlucoGuard's potential to assist patients [4] Company Mission - The investment is expected to enhance ADHC's valuation and support its mission to help Type 1 Diabetics manage hypoglycemic events, thereby improving patients' lives [5]
Senseonics Signs Memorandum of Understanding with Ascensia Diabetes Care to Take Over Commercialization and Distribution of Eversense 365
Globenewswire· 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
Globenewswire· 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
Globenewswire· 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
ZACKS· 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]