Core Insights - Senseonics Holdings, Inc. (SENS) presented its first real-world evidence for the Eversense 365 continuous glucose monitoring (CGM) system, demonstrating strong performance over a full year of use [1][4] Company Performance - The Eversense 365 system has shown strong patient adherence with an average transmitter wear time of 93.8% and a Time in Range (TIR) of 66%, indicating effective glycemic control [6][7][8] - The integration of Eversense 365 with automated insulin delivery systems has shown promising early results, with a TIR of 77% in initial users [10] - Senseonics reported a significant increase in total revenues for the third quarter of 2025, rising to $8.1 million from $4.3 million year-over-year, primarily driven by U.S. adoption [12] - The company achieved a gross profit of $3.5 million in the latest quarter, a notable improvement from a gross loss of $4.1 million in the previous year [13] Market Position and Trends - The global blood glucose monitoring devices market is projected to grow from $15.53 billion in 2025 to $30.18 billion by 2033, with a compound annual growth rate (CAGR) of 8.8% from 2026 to 2033, driven by the rising prevalence of diabetes and an aging population [11] - Following the announcement of the real-world evidence, SENS shares increased by 11.8% in a single trading session, although the stock has seen a decline of 27.9% over the past six months [3]

Core Insights - The Eversense 365 Continuous Glucose Monitoring (CGM) system has demonstrated sustained performance and positive real-world impact over a full year, showcasing strong patient adherence and effective glycemic outcomes [1][2][3] Group 1: Product Performance - Eversense 365 achieved an average transmitter wear time of 93.8%, with consistent results across the first and second six-month periods, indicating reliable use of the system [4] - The mean Glucose Management Indicator (GMI) was reported at 7.14%, and the mean Time in Range (TIR) was 66%, reflecting effective glycemic control [4] - Over 75% of users met hypoglycemic targets, highlighting the system's accuracy in low glucose ranges, which is critical for patient safety [5] Group 2: Age Group Analysis - The analysis indicated that Eversense 365 provided positive outcomes across all age groups, with the >65 year-old population achieving a mean GMI of 6.99% and a mean TIR of over 70% [5] - Young adults (aged 18-25) also showed promising results, with a mean GMI of 7.3% and over 90% average wear time, indicating strong adherence [6] Group 3: Market Expansion and Future Prospects - Senseonics plans to launch Eversense 365 in select European markets following its CE mark approval in January 2026, building on its commercial momentum in the US [9] - The company is also analyzing early data from the twiist™ Automated Insulin Delivery (AID) system, which is compatible with Eversense 365, showing encouraging glucose outcomes [7][8]

Core Insights - Senseonics Holdings, Inc. specializes in long-term, implantable continuous glucose monitoring systems for diabetes management, with its flagship product being the Eversense CGM System [1] - The company faces competition from other medical technology and biotechnology firms in the market [1] Financial Performance - Senseonics has a Weighted Average Cost of Capital (WACC) of 8.89% and a Return on Invested Capital (ROIC) of -66.62%, resulting in a ROIC to WACC ratio of -7.50, indicating it is not generating returns above its cost of capital [2][6] - Compared to its peers, Senseonics has a better ROIC to WACC ratio than Bionano Genomics, which has a WACC of 4.27% and a ROIC of -64.06, leading to a ratio of -15.00 [3][6] - Zomedica Corp. has a WACC of 9.37% and a ROIC of -70.67%, resulting in a ROIC to WACC ratio of -7.54, which is slightly worse than Senseonics [4][6] - Castor Maritime Inc. stands out with the highest ROIC to WACC ratio of -0.76 among peers, indicating relatively better capital efficiency despite all companies analyzed generating returns below their cost of capital [5][6]

Core Viewpoint - Senseonics Holdings (SENS) has shown a significant price increase of 14.9% over the past four weeks, with a mean price target of $18.7 indicating a potential upside of 124.5% from the current price of $8.33 [1] Price Targets and Analyst Estimates - The mean estimate consists of five short-term price targets with a standard deviation of $8.07, where the lowest estimate is $9.00 (an 8% increase) and the highest is $31.00 (a 272.2% increase) [2] - A low standard deviation among price targets suggests a strong agreement among analysts regarding the stock's price movement [9] Analyst Sentiment and Earnings Estimates - Analysts have shown increasing optimism about SENS's earnings prospects, as indicated by a positive trend in earnings estimate revisions [11] - The Zacks Consensus Estimate for the current year has increased by 4% over the past month, with one estimate rising and no negative revisions [12] - SENS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - While price targets are often sought after by investors, they can be misleading and should not be the sole basis for investment decisions [3][7][10] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8]

Core Viewpoint - Senseonics Holdings reported a quarterly loss of $0.46 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.43, marking an earnings surprise of -7.80% [1] Financial Performance - The company posted revenues of $14.3 million for the quarter ended December 2025, exceeding the Zacks Consensus Estimate by 0.70% and showing a significant increase from $8.3 million in the same quarter last year [2] - Over the last four quarters, Senseonics has consistently surpassed consensus revenue estimates, achieving this four times [2] Stock Performance - Senseonics shares have increased by approximately 49.8% since the beginning of the year, significantly outperforming the S&P 500, which gained only 0.5% [3] Future Outlook - The company's earnings outlook will be crucial for determining the stock's future price movements, with current consensus EPS estimates at -$0.46 for the next quarter and -$2.26 for the current fiscal year [4][7] - The estimate revisions trend for Senseonics was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical Info Systems industry, to which Senseonics belongs, is currently ranked in the bottom 38% of over 250 Zacks industries, suggesting potential challenges ahead [8]

Financial Data and Key Metrics Changes - In 2025, the company achieved full-year revenue of over $35 million, growing approximately 60% year-over-year from less than $23 million in 2024 [5][27] - Gross margins improved to greater than 50% by the end of 2025, up from around 25% the previous year [5][27] - The net loss for 2025 was $69.1 million, a decrease from a net loss of $78.6 million in 2024 [27][28] Business Line Data and Key Metrics Changes - U.S. revenue for Q4 2025 was $12.1 million, while revenue outside the U.S. was $2.2 million [24] - The number of Eversense users in the U.S. more than doubled from 2024 to 2025, with new patient starts growing 103% [5][20] - The number of providers actively prescribing Eversense grew more than 80% year-over-year [21] Market Data and Key Metrics Changes - The company expects Europe to contribute about 20% of total revenue in 2026 following the launch of Eversense 365 [41] - The company anticipates full-year 2026 global net revenue to be approximately $58 million-$62 million, representing year-over-year growth of 65%-76% [28][29] Company Strategy and Development Direction - The company transitioned all commercial activities from Ascensia Diabetes Care back to Senseonics, enhancing operational efficiency and control [7][8] - The integration with Sequr Med Tech's twiist Automated Insulin Delivery System is a significant milestone, expected to simplify life for patients requiring insulin [10] - The company plans to launch Eversense 365 in several European markets in Q2 2026, with a dedicated sales force [12][106] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for 2026, driven by strategic decisions made in 2025 and the integration of commercial operations [6][32] - The company noted that Q4 is typically the strongest quarter due to insurance deductibles being met, and expects similar trends in 2026 [11][29] - Management highlighted the importance of patient retention and the effectiveness of direct-to-consumer marketing strategies [17][18] Other Important Information - The company raised capital from institutional investors and executed a reverse stock split, beginning trading on Nasdaq [10] - Research and development expenses decreased in 2025 due to the completion of clinical trials for Eversense 365 [25][28] Q&A Session Summary Question: Trends in new patient starts at the beginning of the year - Management noted that new patient growth continues as expected, with January typically being the softest month due to patient resets [37] Question: Contribution of Europe and twiist to revenue guidance - Management indicated that Europe is expected to contribute about 20% of revenue in 2026, with unique economics for each company involved in the twiist integration [39][41] Question: Seamlessness of the commercial transition from Ascensia - Management confirmed that the transition was straightforward in the U.S., with nearly 100% of employees transitioning smoothly [44] Question: Growth of the prescriber base and patient starts - Management expressed optimism about the potential for accelerated growth in the prescriber base and new patient starts, supported by increased awareness and DTC investments [50] Question: Challenges in expanding the EonCare inserter network - Management stated that the expansion is primarily dependent on volume and demand, with no significant barriers to increasing the number of inserters [81] Question: Timeline for the rollout in Europe - Management expects the transition to occur in Q2 2026, with some tenders potentially extending into early fall [105][106]

Financial Data and Key Metrics Changes - In 2025, the company achieved full-year revenue of over $35 million, growing approximately 60% year-over-year from less than $23 million in 2024 [5][24] - Gross margins improved to greater than 50% by the end of 2025, up from around 25% the previous year [5][24] - The net loss for 2025 was $69.1 million, a decrease from a net loss of $78.6 million in 2024 [24] Business Line Data and Key Metrics Changes - U.S. revenue for the fourth quarter of 2025 was $12.1 million, while revenue outside the U.S. was $2.2 million [21] - The number of patients using Eversense in the U.S. doubled, with new patient starts growing by 103% [5][17] - The active prescriber base grew more than 80% year-over-year, reflecting increased awareness and confidence in the Eversense 365 system [17] Market Data and Key Metrics Changes - The company expects Europe to contribute about 20% of total revenue in 2026, driven by the launch of Eversense 365 [40] - The company anticipates full-year 2026 global net revenue to be approximately $58 million-$62 million, representing year-over-year growth of 65%-76% [25] Company Strategy and Development Direction - The company transitioned all commercial activities from Ascensia Diabetes Care back to Senseonics, enhancing control and operational efficiency [7][8] - The integration with Sequel Med Tech's twiist Automated Insulin Delivery System is a significant milestone, expected to simplify life for patients requiring insulin [9] - The company plans to launch Eversense 365 in Germany, Italy, Spain, and Sweden, with a dedicated European sales force [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for 2026, supported by strategic decisions made in 2025 [6][12] - The company noted that the fourth quarter is typically the strongest due to insurance deductibles being met, and expects similar seasonality in 2026 [10][26] - Management highlighted the importance of patient retention and the effectiveness of direct-to-consumer marketing strategies [14][15] Other Important Information - The company raised capital from institutional investors and executed a reverse stock split, beginning trading on Nasdaq [9] - Cash, restricted cash, and cash equivalents totaled $94.3 million as of December 31, 2025 [25] Q&A Session Questions and Answers Question: Trends in new patient starts early in the year - Management noted that new patient growth continues as expected, with encouraging interest in the Sequel product [35] Question: Contribution of Europe and twiist to revenue guidance - Management expects Europe to be about 20% of revenue in 2026, with the twiist product launch contributing positively [40] Question: Seamlessness of the commercial transition from Ascensia - The transition was described as straightforward, with nearly 100% of employees successfully moving to Senseonics [43][44] Question: Growth of the prescriber base and patient base - Management indicated that they expect to double the patient base again in 2026, with potential for acceleration in prescriber growth [49][52] Question: Challenges in expanding the EonCare inserter network - Management stated that there are no significant barriers to expanding the network, but it is dependent on volume to justify additional inserters [80] Question: Expected timeline for the European rollout - The rollout is expected to occur in the second quarter of 2026, with some tenders potentially extending into early fall [104]

Financial Data and Key Metrics Changes - In 2025, the company achieved full-year revenue of over $35 million, growing approximately 60% year-over-year from less than $23 million in 2024 [5][25] - Gross margins improved to greater than 50% by the end of 2025, up from around 25% previously [5][24] - The net loss for 2025 was $69.1 million, a decrease from $78.6 million in 2024, indicating improved financial performance [25][26] Business Line Data and Key Metrics Changes - U.S. revenue for the fourth quarter of 2025 was $12.1 million, while revenue outside the U.S. was $2.2 million [21] - The number of patients using Eversense in the U.S. doubled, with new patient starts growing by 103% [5][18] - The active prescriber base grew more than 80% year-over-year, reflecting increased awareness and confidence in the Eversense 365 system [18] Market Data and Key Metrics Changes - The company expects Europe to contribute about 20% of total revenue in 2026, driven by the launch of Eversense 365 [40] - The company anticipates full-year 2026 global net revenue to be approximately $58 million-$62 million, representing year-over-year growth of 65%-76% [26] Company Strategy and Development Direction - The company transitioned all commercial activities from Ascensia Diabetes Care back to Senseonics, enhancing control and operational efficiency [6][9] - The integration with Sequel Med Tech's twiist Automated Insulin Delivery System is a significant milestone, expected to simplify life for patients requiring insulin [9][17] - The company plans to launch Eversense 365 in Germany, Italy, Spain, and Sweden, with a dedicated European sales force [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for 2026, supported by strategic decisions made in 2025 [12][31] - The company noted that January is typically a soft month due to patient resets, but they are seeing encouraging interest in new patient starts associated with the Sequel product [36] - Management highlighted the importance of direct-to-consumer (DTC) marketing and patient retention as key growth drivers moving forward [14][16] Other Important Information - The company raised capital from institutional investors and strategic partners, executed a reverse stock split, and began trading on Nasdaq [9] - Cash, restricted cash, and cash equivalents totaled $94.3 million as of December 31, 2025 [26] Q&A Session Summary Question: Trends in new patient starts at the beginning of the year - Management noted that new patient growth continues as expected, with January typically being the softest month due to resets, but they are seeing encouraging interest with the Sequel product [36] Question: Contribution of Europe and twiist to revenue guidance - Management indicated that they expect Europe to contribute about 20% of revenue in 2026, with the twiist product launch expected to enhance revenue [40] Question: Seamlessness of the transition from Ascensia - Management confirmed that the transition in the U.S. was straightforward, with nearly 100% of employees transitioning smoothly [43] Question: Growth of the prescriber base and patient starts - Management expressed optimism about the potential for accelerated growth in the prescriber base and new patient starts, supported by increased DTC investments [53] Question: Challenges in expanding the EonCare inserter network - Management stated that the primary factor for expanding the EonCare network is volume, and there are no significant barriers to increasing the number of inserters [80] Question: Long-term investment expectations - Management indicated that while commercial spend will continue to grow with revenue, it will not increase at the same magnitude as in 2026, and R&D expenses are expected to stabilize in the following years [83]

Financial Performance - Total revenue for the year ended December 31, 2025, was $35.257 million, a 56.8% increase from $22.472 million in 2024[511] - Gross profit for 2025 was $15.763 million, compared to $533,000 in 2024, indicating a significant improvement in profitability[511] - The net loss for 2025 was $69.113 million, a decrease from a net loss of $78.616 million in 2024, reflecting better operational performance[511] - Basic net loss per common share improved to $(1.66) in 2025 from $(2.50) in 2024, suggesting better performance on a per-share basis[511] - The net loss for 2025 was $69,113,000, an improvement from a net loss of $78,616,000 in 2024, resulting in a net loss per share of $(1.66) compared to $(2.50) in the previous year[589] Revenue Sources - Revenue from the United States accounted for 79.2% of total revenue in 2025, up from 68.0% in 2024, while revenue from outside the United States was 20.8% in 2025, down from 32.0% in 2024[579] - Sales to Ascensia represented 53% of total revenue in 2025, a decrease from 82% in 2024[581] - Consignment sales accounted for 41% of total revenue in 2025, significantly up from 15% in 2024[582] - Revenue from Ascensia for 2025 was $18.2 million, a slight decrease from $18.5 million in 2024[673] Expenses - Research and development expenses decreased to $31.592 million in 2025 from $41.144 million in 2024, showing a focus on cost management[511] - Selling, general and administrative expenses increased to $52.508 million in 2025 from $34.231 million in 2024, indicating higher operational costs[511] - Advertising expenses of $11.2 million for the year ended December 31, 2025, which were not significant in 2024[566] - Sales and marketing expenses significantly increased to $22,785,000 in 2025 from $7,268,000 in 2024, marking a rise of about 213.5%[686] - General and administrative expenses rose to $29,723,000 in 2025 from $26,963,000 in 2024, an increase of about 10.3%[686] Cash and Liquidity - Cash and cash equivalents decreased to $40.234 million as of December 31, 2025, down from $74.597 million in 2024, raising concerns about liquidity[509] - The company anticipates requiring additional liquidity to continue operations over the next twelve months, indicating potential financial challenges ahead[501] - The company had unrestricted cash, cash equivalents, and marketable securities totaling $94.0 million as of December 31, 2025[527] - The Company had cash, cash equivalents, and restricted cash totaling $40.5 million as of December 31, 2025, down from $74.9 million in 2024[544] - The fair value of cash and cash equivalents, including money market funds, was $33,624,000 as of December 31, 2025, down from $70,613,000 in 2024[681] Assets and Liabilities - Total assets increased to $126.269 million in 2025 from $100.438 million in 2024, reflecting growth in the company's asset base[509] - Total liabilities decreased to $65.223 million in 2025 from $79.337 million in 2024, indicating improved financial health[509] - Total accrued expenses and other current liabilities rose to $20,289,000 in 2025 from $15,506,000 in 2024, with notable increases in sales and marketing services and professional services[600] Financing Activities - The company generated $78.2 million in net cash from financing activities in 2025, compared to $26.8 million in 2024[518] - The Company raised approximately $2.4 million from the sale of 334,330 shares under the Sales Agreement with TD Cowen, after deducting sales commissions and offering expenses[532] - The Public Offering on May 15, 2025, generated gross proceeds of $57.5 million from the sale of 5,000,000 shares at $10.00 per share, with net proceeds of approximately $52.1 million after expenses[533] - The Company received approximately $20.1 million in net proceeds from a Private Placement with Abbott Laboratories for 2,026,963 shares at the Public Offering Price[533] - The Equity Distribution Agreement with Goldman Sachs allowed the Company to sell shares with an aggregate offering price of up to $106.6 million, later amended to $55.0 million, resulting in approximately $30.8 million in net proceeds from the sale of 2,006,528 shares[535] Stock and Equity - A reverse stock split of 1-for-20 was executed on October 17, 2025, reducing the total number of authorized shares from 1.4 billion to 70 million[523] - The Company had 41,265,778 shares of common stock outstanding as of December 31, 2025, compared to 29,767,561 shares as of December 31, 2024[626] - The Company had no shares of preferred stock outstanding as of December 31, 2025, following the conversion of Series B Preferred Stock into common stock[627] - The Company issued $82.0 million in senior convertible notes in July 2019, with an initial conversion rate of 37.88 shares per $1,000 principal amount[618] Inventory and Cost of Goods Sold - Total inventory increased to $6,703,000 in 2025 from $4,421,000 in 2024, with a significant reduction in cost of sales related to obsolete inventory, amounting to $0.7 million in 2025 compared to $4.3 million in 2024[593] - Cost of goods sold decreased to $19,494,000 in 2025 from $21,939,000 in 2024, reflecting a reduction of approximately 11.1%[686] Agreements and Contracts - The Company has a management services agreement for 10 years to support patient access to the Eversense system, involving contracting healthcare professionals[540] - The company executed a Master Asset Purchase Agreement with Ascensia on December 31, 2025, acquiring certain U.S. commercial assets[675] Other Financial Metrics - The accumulated deficit reached $1.0 billion as of December 31, 2025[527] - The credit loss reserve increased to $1.3 million as of December 31, 2025, compared to $0.3 million in 2024[548] - Estimated warranty liabilities increased to $448,000 at the end of 2025, up from $406,000 at the end of 2024, with provisions for warranties during the period totaling $408,000[556] - The Company has gross federal NOL carryforwards of $791.3 million and state NOL carryforwards of $134.9 million as of December 31, 2025[665]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): January 12, 2026 SENSEONICS HOLDINGS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37717 47-1210911 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer FORM 8-K Identification No.) 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 (Addre ...