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 Viewpoint - Senseonics Holdings (SENS) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Senseonics indicates an expected earnings of -$0.10 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 16.7% [9]. - Over the past three months, the Zacks Consensus Estimate for Senseonics has increased by 17%, showcasing a trend of rising earnings estimates [9]. Zacks Rating System - The Zacks rating system is based solely on a company's changing earnings picture, which is tracked through EPS estimates from sell-side analysts [2]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) to Zacks Rank 5 (Strong Sell), and has a strong historical performance, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [8]. Market Implications - The upgrade to Zacks Rank 2 positions Senseonics in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11]. - Rising earnings estimates and the corresponding rating upgrade imply an improvement in Senseonics' underlying business, which could lead to increased buying pressure and a higher stock price [6][4].

Financial Data and Key Metrics Changes - In Q4 2024, net revenue was $8.3 million, an increase from $8 million in the prior year period [27] - For the full year 2024, total revenue was $22.5 million compared to $22.4 million in 2023, with US revenue at $15.3 million and revenue outside the US at $7.2 million [35] - Net loss for Q4 2024 was $15.5 million, a decrease from $17.2 million in Q4 2023, primarily due to improved gross profit margins [34] - Full year net loss was $78.6 million, compared to $60.4 million in 2023, with the increase attributed to reduced gains from note exchanges and derivative fair value changes [39] Business Line Data and Key Metrics Changes - The Eversense 365 product launch has seen a 56% increase in the patient base to approximately 6,000 global patients in 2024 [23] - The number of annual US Eversense prescribers increased by 73% to over 2,400 [24] - Approximately 81% of the patient base switched from other continuous glucose monitors (CGMs) [25] Market Data and Key Metrics Changes - US revenue for Q4 2024 was $6.2 million, while revenue outside the US was $2.1 million [27] - The company anticipates launching Eversense 365 in Europe in the second half of 2025, following CE Mark approval [12] Company Strategy and Development Direction - The company is focused on expanding its product pipeline, including the Gemini and Freedom systems, which will enhance patient experience [13][14] - Partnerships with health systems like Mercy Health are aimed at increasing access to Eversense for patient populations [16] - The company plans to commercialize Eversense 365 in Europe and continue building on the technology platform [47] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in 2025, highlighting the successful initial launch of Eversense 365 as a significant catalyst [46] - The CGM market is viewed as an exciting space in medical devices, with a large opportunity to simplify diabetes management [48] - The company expects full year 2025 global net revenue to be approximately $34 million to $38 million, with a focus on transitioning US patients to Eversense 365 [42] Other Important Information - The company has simplified its capital structure, repaying $20.4 million in convertible notes and converting preferred stock into common stock [40][41] - Cash, restricted cash, and cash equivalents totaled $74.9 million as of December 31, 2024 [39] Q&A Session Summary Question: What should we expect when taking Eversense 365 OUS? - Management anticipates a more gradual inventory stocking in Europe compared to the US [53] Question: What are the early signs of 365-day insertions in the Mercy system? - There is excitement around the 365 product, with a focus on expanding to primary care for Type 2 patients [55] Question: Clarification on prescriber numbers? - The 2,400 prescribers represent an annual number, while over 1,000 was since launch [62] Question: Revenue growth expectations from international versus US? - Most growth is expected from the US, with significant increases anticipated from the European launch in the second half of the year [64] Question: Update on Medicare reimbursement efforts? - Reimbursement is available for Medicare patients, with ongoing work on pricing expected to resolve in the next quarter [74] Question: OpEx cadence throughout the year? - SG&A expenses are expected to be linear across quarters, with slight increases due to sales commissions from the consignment program [81]

Financial Data and Key Metrics Changes - In Q4 2024, net revenue was $8.3 million, an increase from $8 million in the prior year period [27] - For the full year 2024, total revenue was $22.5 million compared to $22.4 million in 2023, with US revenue at $15.3 million and revenue outside the US at $7.2 million [35] - Net loss for Q4 2024 was $15.5 million, a decrease from $17.2 million in Q4 2023, primarily due to improved gross profit margins [34] - Full year net loss was $78.6 million, compared to $60.4 million in 2023, with the increase attributed to reduced gains from note exchanges and changes in derivative fair value [39] Business Line Data and Key Metrics Changes - The patient base increased by 56% to approximately 6,000 global patients in 2024, exceeding the target growth of 50% [23] - The number of annual US Eversense prescribers increased by 73% to over 2,400 [24] - Approximately 81% of the patient base switched from other continuous glucose monitors (CGMs) [24] Market Data and Key Metrics Changes - US revenue for Q4 2024 was $6.2 million, while revenue outside the US was $2.1 million [27] - The company anticipates launching Eversense 365 in Europe in the second half of 2025, following the CE Mark approval [12] Company Strategy and Development Direction - The company plans to commercialize Eversense 365 in Europe and continue developing the Gemini and Freedom systems [47] - Focus on expanding relationships with health systems and accountable care organizations to increase access to Eversense [16] - The company is working on transitioning US reimbursement from Eversense E3 to Eversense 365, particularly for the Medicare segment [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in 2025, highlighting the successful initial launch of Eversense 365 as a significant catalyst [46] - The CGM market is viewed as an exciting space with a large opportunity for growth [48] - The company expects full year 2025 global net revenue to be approximately $34 million to $38 million, with a focus on transitioning US patients to Eversense 365 [42] Other Important Information - Gross profit for Q4 2024 was $4 million, an increase from $1.1 million in the prior year period, driven by increased margins on the 365-day product [32] - Research and development expenses for 2024 decreased by $7.6 million from 2023, primarily due to the completion of 365-day product trials [38] - The company received gross proceeds of approximately $27 million from the sale of common stock, extending its cash runway into mid-2026 [41] Q&A Session Summary Question: What should we expect when taking Eversense 365 OUS? - Management anticipates a more gradual inventory stocking in Europe compared to the US [53] Question: What are the observations from the Mercy system regarding 365-day insertions? - There is excitement around the 365 product, with a focus on expanding to primary care physicians to reach more Type 2 patients [55] Question: Clarification on the number of prescribers in the US? - The 2,400 prescribers represent an annual number, while the previous figure was since launch [62] Question: How much revenue growth is expected from international versus the US? - Most growth is expected to come from the US, with significant increases anticipated upon the launch of the 365-day product in Europe [64] Question: Update on reimbursement efforts, especially at Medicare? - Reimbursement is available for Medicare patients, with ongoing work on pricing expected to be resolved in the next quarter [74] Question: Details on the cadence of operating expenses throughout the year? - SG&A expenses are expected to be linear across quarters, with slight increases due to sales commissions from the consignment program [81]

Company Performance - Senseonics Holdings reported a quarterly loss of $0.02 per share, better than the Zacks Consensus Estimate of a loss of $0.03, and an improvement from a loss of $0.03 per share a year ago, representing an earnings surprise of 33.33% [1] - The company posted revenues of $8.3 million for the quarter ended December 2024, in line with the Zacks Consensus Estimate, and an increase from $8 million in the same quarter last year [2] - Over the last four quarters, Senseonics has surpassed consensus revenue estimates three times [2] Stock Performance - Senseonics shares have increased approximately 62.4% since the beginning of the year, significantly outperforming the S&P 500's gain of 1.2% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.03 on revenues of $8.36 million, and for the current fiscal year, it is -$0.12 on revenues of $35.86 million [7] Industry Outlook - The Medical Info Systems industry, to which Senseonics belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Senseonics' stock performance [5][6]

Product Development and Approval - The Eversense 365 CGM system received FDA approval in September 2024 and began commercialization in the U.S. in October 2024[22] - Eversense 365 offers a unique 365-day sensor life, significantly longer than the 7 to 14 days of non-implantable CGM systems[22] - The FDA approved the Eversense 365-day product for sale in the U.S. on September 17, 2024, following a 510(k) submission[49] - A PMA supplement was submitted to the FDA to extend the Eversense CGM system's wearable life to six months following the PROMISE trial results[46] - The ENHANCE trial began enrollment in March 2022 to evaluate the accuracy and safety of the Eversense system for up to one year[48] - The company is focusing on future product development, including enhancements to incorporate a power source and Bluetooth technology in the sensor[58] - The Gemini product, currently in first-in-human testing, aims to combine CGM and Flash Glucose Monitoring functionalities in a single implantable sensor[25] Market Performance and Sales - The company experienced a record increase in patient shipments in December 2024, surpassing any previous month in company history[23] - A new direct-to-consumer marketing campaign launched in October 2024 increased patient shipments and new prescribers[65] - The company anticipates increasing competition from companies integrating CGM with insulin pumps, as both Dexcom and Abbott have received iCGM indications for their products[75] - The company expects a substantial majority of future revenue to come from the Commercialization Agreement with Ascensia, which has limited experience in marketing continuous glucose monitoring (CGM) systems[173] - The success of the company's products is highly dependent on Ascensia's ability to effectively market and sell Eversense, which is a new product for them globally[183] Regulatory Compliance and Challenges - The Eversense system is classified as a Class III medical device and requires pre-market approval (PMA) from the FDA, which includes extensive technical, preclinical, and clinical data[92] - The company is subject to extensive regulation by the FDA and other international regulatory bodies, which govern all aspects of its operations from product development to marketing[91] - The Medical Device Regulation (MDR) came into effect on May 26, 2021, replacing previous directives and establishing new compliance requirements for medical devices[99] - Manufacturers must implement a quality management system compliant with the MDR by May 26, 2024, to benefit from extended transitional provisions[107] - Non-compliance with regulatory requirements can lead to severe consequences, including product recalls, fines, and legal actions[118] Financial Performance and Risks - The company incurred a total net loss of $(78.6) million and $(60.4) million for the years ended December 31, 2024, and 2023, respectively, with an accumulated deficit of $947.9 million as of December 31, 2024[171] - Revenue from product sales is expected to vary quarterly due to factors such as annual insurance deductible limits and inventory reductions by distributors, with generally lower revenues in Q1 compared to Q4[80] - The company anticipates ongoing operating losses and uncertainty regarding profitability for the foreseeable future[172] - The company faces significant risks related to competition and technological advancements in diabetes monitoring and treatment, which could impact market potential for Eversense[171] Intellectual Property and Manufacturing - The company currently holds approximately 482 issued patents and pending patent applications related to its CGM system, with patents expiring between 2025 and 2043[84] - The company relies on a combination of patents, trademarks, and trade secrets to protect its intellectual property, with 14 U.S. trademark registrations and 133 foreign trademark registrations[88] - The company outsources manufacturing to contract manufacturers in North America and Europe, believing that increased demand will lead to a material decrease in per unit costs[70] - The company maintains sufficient inventory to mitigate supply interruptions from key raw material suppliers, although reliance on single suppliers for certain components poses risks[72] Employee Engagement and Culture - As of December 31, 2024, the company had 117 full-time employees, with over half holding advanced degrees, primarily in Operations and Research and Development[151] - The company launched a wellness program "A Healthier You" in 2024, focusing on financial, physical, and workplace wellness, supported by specific tools and resources[156] - The company offers a tuition reimbursement of up to $5,250 annually to support professional certification and continuing education[157] - Over half of the company's employees represent diverse ethnicities, promoting a diverse and inclusive culture[158] Market Competition - The CGM market is competitive, with major competitors including Dexcom, Medtronic, and Abbott, all of which have received FDA approval for their products[73] - The effectiveness of patient access programs is uncertain, potentially leading to increased product utilization without corresponding recognized revenue[211] - Market acceptance of Eversense may be hindered by perceptions of complexity compared to traditional monitoring methods, such as SMBG and CGM systems[190] - Variability in reimbursement policies among private insurance companies may affect coverage and payment rates for Eversense[206] Regulatory and Legal Environment - The company is subject to various data privacy and security regulations, including HIPAA and HITECH, which impose specific requirements on the handling of protected health information[119] - The federal Anti-Kickback Statute prohibits remuneration to induce referrals for services covered by federal healthcare programs, with penalties including imprisonment for up to ten years and fines up to $100,000 per violation[124] - The Stark Law prohibits physicians from referring Medicare or Medicaid patients to entities in which they have a financial interest, with violations leading to civil penalties and exclusion from federal programs[125] - Legislative changes, such as the Inflation Reduction Act of 2022, may impact reimbursement rates and the overall financial landscape for medical devices[139]

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]

Core Insights - Senseonics and Ascensia Diabetes Care have integrated SweetSpot software with the Eversense 365 Continuous Glucose Monitoring (CGM) System, enhancing patient care in endocrinology practices [1][2][3] - SweetSpot provides a centralized platform for diabetes device data management, offering clinical support services and monthly CGM data reviews to improve glycemic control [2][7] - Eversense 365 is the only implantable CGM available, providing one year of continuous glucose monitoring with minimal interruptions, thus improving patient quality of life [3][9] Company Overview - Senseonics Holdings, Inc. focuses on developing long-term implantable glucose monitoring products, with Eversense 365 being a key offering that communicates glucose data to a mobile app every five minutes [9] - Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation, is dedicated to empowering individuals with diabetes through innovative solutions and is the exclusive global distributor of Eversense CGM systems [10][12] - SweetSpot partners with endocrinology practices to enhance diabetes management through virtual CGM monitoring and automated capture of reimbursable care events, optimizing both clinical and operational efficiency [2][7] Market Impact - The integration of SweetSpot with Eversense 365 allows for personalized support and timely treatment adjustments, which can lead to improved patient outcomes and reduced hospitalizations [4][5] - The collaboration between SweetSpot and Eversense represents a significant advancement in healthcare integration for diabetes management, potentially transforming patient care practices [4][5] - The automated capture of reimbursable care events through SweetSpot can unlock new revenue streams for healthcare practices, making partnerships financially beneficial [2][7]

Core Viewpoint - Senseonics Holdings, Inc. is actively participating in the TD Cowen 45 Annual Health Care Conference, highlighting its focus on long-term implantable continuous glucose monitoring systems for diabetes management [1][2]. Company Overview - Senseonics is a medical technology company dedicated to developing and manufacturing glucose monitoring products aimed at improving the lives of individuals in the diabetes community [3]. - The company's continuous glucose monitoring systems, Eversense® 365 and Eversense® E3, feature a small sensor that is implanted under the skin and communicates with a smart transmitter worn externally [3]. - Glucose data from the sensors are transmitted automatically every 5 minutes to a mobile application on the user's smartphone, enhancing user convenience and monitoring accuracy [3]. Event Details - The TD Cowen 45 Annual Health Care Conference will take place on March 4, 2025, at 3:10 pm ET, featuring a corporate overview and one-on-one meetings [2]. - Interested parties can access a live and recorded webcast of the presentation through the company's Investor Relations section on its website [2].

GERMANTOWN, Md., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced that it plans to release its fourth quarter and full year 2024 financial results after market close on Monday, March 3, 2025. Management will hold a conference call to review the Company’s fourth quarter and full year 2024 per ...