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]

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]

Core Insights - Senseonics Holdings, Inc. reported a fourth quarter 2025 revenue of $14.3 million, marking a 72% increase year-over-year, and a full year revenue of $35.3 million, up 57% from 2024 [1][4][10]. Financial Performance - Fourth quarter 2025 gross profit was $7.7 million, an increase from $4.0 million in the same quarter of 2024, attributed to favorable margins on the Eversense 365 product sales and lower fixed manufacturing costs [5][11]. - Research and development expenses decreased to $8.8 million in Q4 2025 from $9.4 million in Q4 2024, primarily due to the completion of clinical trials for Eversense 365 [6][12]. - Selling, general and administrative expenses rose significantly to $19.8 million in Q4 2025 from $8.9 million in Q4 2024, driven by increased marketing and sales commission expenses [7][13]. - The net loss for Q4 2025 was $20.8 million, compared to a net loss of $15.5 million in Q4 2024, reflecting higher expenses related to commercialization efforts [9][14]. Strategic Developments - The company received CE Mark approval for the Eversense 365 in the European Union, allowing for commercialization in Europe [1][7]. - Senseonics launched the twiist Automated Insulin Delivery (AID) System integrated with the Eversense 365 CGM system in the U.S. [7]. - The company plans to expand Eversense 365 compatibility with AID systems and complete the Gemini pivotal trial in 2026, which is a key milestone for its innovation pipeline [3][15]. Market Position and Growth - Senseonics achieved a 103% growth in new patients in the U.S. in 2025 compared to 2024, largely due to effective direct-to-consumer marketing [7]. - The number of active prescribers increased by over 80% from 2024 to 2025, indicating strong growth in the healthcare provider channel [7]. Future Outlook - For 2026, Senseonics expects global net revenue to be approximately $58-$62 million, representing a year-over-year growth of 65% to 76% as the company transitions commercialization from Ascensia and enhances its sales and marketing infrastructure [15].

Company Overview - Senseonics has launched the full U.S. availability of its Eversense 365 Continuous Glucose Monitoring (CGM) system, integrated with Sequel Med Tech's twiist Automated Insulin Delivery (AID) system for type 1 diabetes patients [1][7] - The Eversense 365 CGM system offers a wear time of up to 365 days, significantly longer than the maximum of 15 days for other approved CGM devices from competitors like DexCom and Abbott [2][7] Financial Performance - Senseonics reported total revenues of $21 million, which is considerably lower than competitors DexCom and Abbott, who recorded $5.6 billion and $3.4 billion in sales related to CGM devices, respectively, in the first nine months of 2025 [4] - The company expects total revenues for 2026 to be in the range of $58-$62 million, representing an increase of 65% to 76% over 2025 revenue [12] Market Dynamics - The total CGM devices market size was valued at $13.66 billion in 2024 and is projected to grow at a CAGR of 15.4%, reaching $49.87 billion by 2033, driven by the rising prevalence of diabetes and technological advancements [10] - The integration of Eversense 365 with the twiist AID system is expected to enhance customer adoption and drive sales growth in 2026 [4][8] Recent Developments - Senseonics received CE Mark approval for the Eversense 365 CGM system and plans to launch it in Germany, Italy, Spain, and Sweden in the coming months [11] - The company reported a 71% year-over-year increase in total revenues for the fourth quarter of 2025, with new patients in the U.S. increasing by 103% from the previous year [12]

Financial Data and Key Metrics Changes - The company closed 2025 with total revenues of $784 million in Q4, representing a 29% increase in constant currency and a 31.2% increase at reported rates [7][26] - Full year revenues surpassed $2.7 billion, more than doubling the revenue base over the last three years, with approximately 30% year-over-year constant currency growth [7][26] - Adjusted EPS for Q4 was $1.55, a 35% increase from $1.15 in the prior year, while full year adjusted EPS was $4.97, up 53% from $3.24 [33] Business Line Data and Key Metrics Changes - U.S. revenues for Omnipod grew 28% in Q4 and 27.2% for the full year, driven by demand across Type 1 and Type 2 customers [27] - International Omnipod revenue grew 50.7% on a reported basis and 41.7% on a constant currency basis for Q4, with full year growth at 44.1% reported and 39.3% constant currency [28] - The company achieved record new customer starts across both U.S. and international markets, with over 85% of new starts in the U.S. coming from multiple daily injections [27][8] Market Data and Key Metrics Changes - The U.S. Type 1 market is valued at over $9 billion, with AID penetration at just 40%, indicating significant growth potential [9] - The Type 2 market exceeds $12 billion, with AID penetration below 5%, presenting a substantial opportunity for expansion [11] - The company has established a prescriber base of over 30,000 healthcare professionals in the U.S., up approximately 28% year-over-year [9] Company Strategy and Development Direction - The company aims to maintain its leadership position in the AID market while expanding its customer base, particularly in Type 2 diabetes [8][10] - A fully closed loop offering is planned for launch in 2028, which is expected to enhance accessibility for Type 2 diabetes patients [12][21] - Continued investment in R&D is prioritized, with plans to increase spending significantly to support innovation and market expansion [30][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to sustain top-tier growth and margin expansion, supported by a strong financial position and recurring revenue model [16][71] - The company anticipates total Omnipod revenue growth of 21%-23% and total company revenue growth of 20%-22% for 2026, reflecting continued market leadership [36][37] - Management highlighted the importance of educating healthcare providers on the clinical performance of Omnipod to drive further adoption [55][68] Other Important Information - The company ended 2025 with $760 million in cash and $500 million available under its credit facility, delivering over $375 million in free cash flow for the year [34] - The company has expanded its global footprint with launches in nine new countries and plans to enter Spain by late 2026 [14][37] Q&A Session Summary Question: Insights on underappreciated aspects of Insulet - Management highlighted four key areas: technology leadership, growing commercial prowess, manufacturing at scale, and financial strength [45][49] Question: Trends in new patient starts in the U.S. and internationally - The company reported record new customer starts in both markets, primarily driven by patients transitioning from multiple daily injections [53][54] Question: Reconciling script trends with reported revenue - Management advised that total pods are the best reflection of future revenue outlook, with script data being a secondary option [61] Question: Sustaining growth amid competition - Management emphasized barriers to entry for competitors, including manufacturing at scale and the need for strong clinical performance [68][70]

Financial Data and Key Metrics Changes - The company closed 2025 with total revenues of $784 million in Q4, representing a 29% increase in constant currency and a 31.2% increase at reported rates [7][26] - Full year revenues surpassed $2.7 billion, more than doubling the revenue base over the last three years, with approximately 30% year-over-year constant currency growth [7][26] - Adjusted EPS for Q4 was $1.55, a 35% increase from $1.15 in the prior year, while full year adjusted EPS was $4.97, up 53% from $3.24 [33] Business Line Data and Key Metrics Changes - U.S. revenues for Omnipod grew 28% in Q4 and 27.2% for the full year, driven by demand for Omnipod 5 across Type 1 and Type 2 customers [27] - International Omnipod revenue grew 50.7% on a reported basis and 41.7% on a constant currency basis for Q4, with full year growth at 44.1% reported and 39.3% constant currency [28] - Record new customer starts were achieved across both U.S. and international markets, with over 85% of new customer starts in the U.S. coming from multiple daily injections (MDI) [27][8] Market Data and Key Metrics Changes - The U.S. Type 1 market is valued at over $9 billion, with AID penetration at just 40%, indicating significant growth potential [9] - The Type 2 market exceeds $12 billion, with AID penetration below 5%, presenting a substantial opportunity for growth [11] - The company has expanded its prescriber base to over 30,000 healthcare professionals in the U.S., a 28% increase year-over-year [9] Company Strategy and Development Direction - The company aims to maintain its leadership position in the automated insulin delivery (AID) market, focusing on expanding penetration in both Type 1 and Type 2 diabetes segments [8][9] - Plans include launching a fully closed loop system for Type 2 diabetes by 2028, which is expected to significantly increase market access [12][21] - Continued investment in R&D is prioritized, with a commitment to deliver innovative enhancements and maintain competitive advantages [19][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to sustain top-tier growth and value creation for shareholders, supported by a strong financial position and operational excellence [16][24] - The company anticipates total Omnipod revenue growth of 21%-23% and total company revenue growth of 20%-22% for 2026, reflecting continued market-leading growth [35][36] - Management acknowledged potential challenges in growth deceleration due to anniversarying the first full year of the U.S. launch of Omnipod for Type 2 and annualizing international launches [36] Other Important Information - The company ended 2025 with $760 million in cash and $500 million available under its credit facility, delivering over $375 million in free cash flow for the year [34] - The company has a strong commitment to reducing barriers to access for patients, with broad market access available in approximately 48,000 U.S. pharmacies [13] Q&A Session All Questions and Answers Question: What is the most underappreciated part of the Insulet story from an investor perspective? - Management highlighted four key areas: technology leadership, growing commercial prowess, manufacturing at scale, and financial strength [45][49] Question: How are you thinking about sustaining new patient growth in the U.S. and internationally? - Management noted balanced growth from both U.S. and international markets, with a primary source of volume coming from patients transitioning from MDI [53][54] Question: Can you help reconcile script trends to reported revenue? - Management advised that total pods are the best reflection of future revenue outlook, with total scripts as a secondary option [60] Question: How do you feel about sustaining 20% growth in light of new competition? - Management emphasized barriers to entry in the market, including manufacturing at scale and the need for continued innovation [66][70]

The Pod has an IP28 rating for up to 25 feet for 60 minutes. The PDM and Controller are not waterproof. Safe Harbor Statement This presentation contains forward-looking statements regarding, among other things, future operating and financial performance, product success and efficacy, the outcome of studies and trials, and the approval of products by regulatory bodies. These forward-looking statements are based on management's current beliefs, assumptions, and estimates and are not intended to be a guarantee ...

Financial Data and Key Metrics Changes - For Q4 2025, the company reported worldwide revenue of $1.26 billion, a 13% increase from $1.11 billion in Q4 2024, with organic growth at 12% [17] - U.S. revenue reached $892 million in Q4 2025, up 11% from $803 million in Q4 2024 [17] - International revenue grew 18% to $368 million in Q4 2025, with organic growth at 15% [18] - Gross profit for Q4 was $799.8 million, representing 63.5% of revenue, an increase from 59.4% in Q4 2024 [19] - Operating income was $331.5 million, or 26.3% of revenue, compared to $209.5 million, or 18.8% of revenue, in Q4 2024 [20] - Adjusted EBITDA for Q4 was $422.2 million, or 33.5% of revenue, up from $300.1 million, or 27.0% of revenue, in Q4 2024 [20] - The company closed the quarter with approximately $2 billion in cash and cash equivalents, indicating strong financial flexibility [21] Business Line Data and Key Metrics Changes - The rollout of the Dexcom G7 15-day system has received positive feedback, enhancing customer experience and potentially increasing market share [8][9] - The company is focusing on improving customer experience through new digital support systems and AI integration [9][10] - The early access launch of Dexcom Smart Basal aims to improve outcomes for Type 2 diabetes management [10] Market Data and Key Metrics Changes - International markets, particularly Germany, the UK, and France, showed strong growth, with France being one of the fastest-growing markets due to Type 2 access expansion [18] - The company plans to expand its CGM product portfolio in international markets in 2026, targeting new segments [14] Company Strategy and Development Direction - The company aims to be the premier glucose sensing solution, focusing on sensor accuracy, reliability, and connectivity [7][8] - Strategic priorities include enhancing customer experience, expanding international market share, and driving growth through product innovation [12][14] - The company is preparing for an Investor Day in May 2026 to provide further outlook details [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in metabolic health and the impact of CGM technology on patient outcomes [28] - The company anticipates total revenue for 2026 to be between $5.16 billion and $5.25 billion, reflecting growth of 11%-13% [22] - Management highlighted the importance of maintaining strong category growth and expanding CGM access globally [23] Other Important Information - The company has successfully managed supply chain challenges, leading to improved gross margins and reduced sensor deployment issues [15] - The launch of the new patch technology is expected to enhance customer experience across the product portfolio [11] Q&A Session Summary Question: Discussion on glucose journey and market potential - Management believes the company is in the early stages of addressing metabolic health and sees significant growth opportunities, especially with potential Medicare coverage for Type 2 non-insulin users [26][28] Question: CMS proposal for Type 2 non-insulin coverage - Management is optimistic about upcoming CMS coverage decisions and expects to see positive outcomes from ongoing clinical trials [32][35] Question: Impact of the 15-day product on margins and market expansion - The 15-day product is expected to contribute to margins over time, with significant opportunities for international market expansion [38][41] Question: Operating expenses and investment in manufacturing - The increase in operating expenses is primarily due to investments in the new Ireland manufacturing facility, which will enhance production capabilities [46][48] Question: Utilization rates among different user segments - Utilization rates remain stable across various user segments, with high engagement expected to drive further growth [52][54] Question: Revenue outlook and new patient dynamics - Management provided insights into the factors influencing revenue growth, emphasizing the importance of patient retention and utilization [60][62] Question: Strengthening U.S. sensor uptake trends - Improved sensor deployment and the launch of new products have positively impacted sell-through trends, contributing to stable user retention [68][70] Question: Pricing dynamics with potential Medicare unlock - Management discussed the stable pricing environment and the impact of competitive bidding processes on future pricing strategies [75][78] Question: International growth strategy and competition - The company aims to close the revenue gap with competitors by expanding its product portfolio and increasing market penetration in international markets [82][84]

Financial Data and Key Metrics Changes - For Q4 2025, the company reported worldwide revenue of $1.26 billion, a 13% increase from $1.11 billion in Q4 2024, with organic growth at 12% [17] - U.S. revenue reached $892 million in Q4 2025, up 11% from $803 million in Q4 2024 [17] - International revenue grew 18% to $368 million in Q4 2025, with organic growth at 15% [18] - Gross profit for Q4 was $799.8 million, representing 63.5% of revenue, an increase from 59.4% in Q4 2024 [19] - Operating income was $331.5 million, or 26.3% of revenue, compared to $209.5 million, or 18.8% of revenue in Q4 2024 [20] - Adjusted EBITDA for Q4 was $422.2 million, or 33.5% of revenue, up from $300.1 million, or 27.0% of revenue in Q4 2024 [20] - The company closed the quarter with approximately $2 billion in cash and cash equivalents, indicating strong financial flexibility [21] Business Line Data and Key Metrics Changes - The rollout of the Dexcom G7 15-Day system has received positive feedback, enhancing customer experience and potentially increasing market share [8][9] - The company is focusing on expanding its product portfolio, including the introduction of Stelo and a new CGM system in international markets by 2026 [14] Market Data and Key Metrics Changes - The international business showed particular strength in Germany, the United Kingdom, and France, with France being one of the fastest-growing markets due to Type 2 access expansion [18] - The company anticipates that international market opportunities could surpass the U.S. market in the future [14] Company Strategy and Development Direction - The company aims to be the premier glucose sensing solution, focusing on improving sensor accuracy, reliability, and connectivity [8] - A strategic priority is to enhance customer experience across all stakeholders, including prescribers and caregivers, through new digital support systems and AI integration [9] - The company plans to expand its international market share by increasing awareness and access to CGM technology globally [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in metabolic health management, particularly with upcoming Medicare coverage for Type 2 non-insulin users, which could provide access to approximately 12 million people [28] - The company expects total revenue for 2026 to be in the range of $5.16 billion to $5.25 billion, reflecting growth of 11%-13% [22] - Management highlighted the importance of maintaining gross margin improvements and operational efficiencies while investing in new product launches and manufacturing capabilities [23] Other Important Information - The company has surpassed $1 billion in free cash flow for the first time in 2025, indicating strong cash generation capabilities [22] - An Investor Day is planned for May 2026 to provide further details on the company's outlook [16] Q&A Session Summary Question: Discussion on the glucose journey and potential coverage - Management believes the company is in the early stages of addressing metabolic health issues, with significant growth opportunities as coverage expands for Type 2 non-insulin users [26][28] Question: CMS proposal for Type 2 non-insulin coverage - Management is optimistic about upcoming CMS coverage decisions and expects to see results from a randomized control trial in mid-2026 [32][35] Question: Impact of the 15-Day product on margins and new markets - The 15-Day product is expected to contribute to margins over time, with significant opportunities for international expansion [38][41] Question: Operating expenses and investment in manufacturing - The increase in operating expenses is primarily due to investments in the new Ireland manufacturing facility, which will enhance future production capabilities [46][49] Question: Utilization rates among different user segments - Utilization rates remain stable across various user segments, with high rates observed in Type 1 and Type 2 insulin users [52][54] Question: 2026 revenue outlook and new patient dynamics - Revenue growth will depend on patient retention, utilization, and pricing, with expectations for continued strong performance in new patient additions [60][62] Question: International growth strategy and competition - The company aims to close the revenue gap with competitors by expanding coverage and product offerings in international markets [82][84]