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].

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 fourth quarter and full year 2024 financial results after market close on March 3, 2025 [1] - A conference call to discuss the financial performance will be held at 4:30 p.m. (Eastern Time) on the same day, with a webcast available on the company's website [2]

Core Viewpoint - Senseonics Holdings, Inc. has filed for CE Mark registration for its Eversense® 365 continuous glucose monitoring (CGM) system, aiming to expand its market presence in the European Union after a successful launch in the United States [1][3][4]. Group 1: Product Overview - Eversense 365 is the world's first and only CGM system designed to last for one year, having received FDA approval in September 2024 and launched in the U.S. in October 2024 [2]. - The Eversense 365 system is an integrated CGM (iCGM) that can work with compatible medical devices, including insulin pumps, as part of an automated insulin delivery (AID) system [6]. Group 2: Market Expansion - The CE Mark submission is in compliance with EU Medical Device Regulation (MDR) and, upon approval, will allow commercialization in EU member countries through Ascensia Diabetes Care, Senseonics' commercial partner [3]. - The initial distribution plans for Eversense 365 in Europe include Germany, Italy, Spain, Poland, Switzerland, and Sweden [3]. Group 3: Impact and Feedback - Feedback from the U.S. launch has been positive, with significant encouragement from endocrinologists, general practitioners, and patients, indicating a tangible impact on the lives of many diabetes patients [5]. - The company aims to provide a 'once a year' solution for glucose control to millions of people living with diabetes in the EU [4]. Group 4: Product Features - Eversense 365 offers several advantages over traditional short-term CGMs, including a longer lifespan, reduced waste, trusted alerts with high accuracy, maximum comfort with gentle adhesives, and consistent reliability with only one calibration required per week [8].

Financial Performance - The Company reported a preliminary unaudited revenue of approximately $8.3 million for Q4 2024 and approximately $22.5 million for the full year ended December 31, 2024[11]. - The unaudited balance of cash, cash equivalents, and restricted cash as of December 31, 2024, is expected to be approximately $74.9 million[11]. - Total unaudited operating expenses and associated cash utilization for Q4 2024 and the full year 2024 were consistent with the Company's previously provided guidance[11]. - The financial information presented is preliminary and has not been reviewed or audited by the Company's independent registered public accounting firm[9]. - The Company anticipates that actual audited financial results may differ from the preliminary financial information provided[9]. Patient Growth - The Company's patient base increased by 56% in 2024 compared to 2023, reaching approximately 6,000 global patients[7]. Corporate Actions - The Company announced the cancellation of the Special Meeting of Stockholders originally scheduled for January 10, 2025, regarding a proposed reverse stock split[6]. Forward-Looking Statements - Forward-looking statements regarding future expectations and plans are subject to various important factors that may cause actual results to differ materially[8]. Company Classification - The Company is classified as an emerging growth company under the Securities Act of 1933[3]. Press Release - The press release detailing these updates was issued on January 8, 2025[4].

GERMANTOWN, Md., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE: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 operational, financial and other business updates. Recent Highlights & Accomplishments Generated preliminary unaudited fourth quarter revenue of approximately $8.3 million, and preliminary unaudited full year 2024 total revenue of appro ...

Senseonics Holdings (SENS) came out with a quarterly loss of $0.04 per share versus the Zacks Consensus Estimate of a loss of $0.03. This compares to loss of $0.04 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -33.33%. A quarter ago, it was expected that this medical technology company would post a loss of $0.03 per share when it actually produced a loss of $0.03, delivering no surprise.Over the last four quarters, the compa ...