Core Viewpoint - Sequel Med Tech's twiist Automated Insulin Delivery System has been commercially launched in the U.S. for type 1 diabetes patients, marking a significant shift towards automated, algorithm-driven closed-loop treatment systems in the diabetes device market [2] Group 1: Product Launch and Features - The twiist system received FDA approval in 2024 and is now available through pharmacies with a flexible payment model: the first month is free, followed by a maximum monthly fee of $50 [2][18] - The system automatically adjusts insulin delivery based on real-time blood glucose levels, providing features like infusion blockage alerts [6] - The twiist system can be paired with Abbott's FreeStyle Libre 3 Plus sensor, a leading continuous glucose monitoring product [6] Group 2: Industry Trends - The diabetes device market has traditionally consisted of blood glucose monitoring devices and insulin delivery devices, but advancements in algorithms and sensor technology are leading to their convergence [10] - Automated insulin delivery systems, often referred to as "artificial pancreas" systems, are becoming the core of industry competition, with products that closely mimic the body's natural insulin regulation [11] - The collaboration between continuous glucose monitoring (CGM) devices and insulin pumps is increasingly important for effective diabetes management [12] Group 3: New Business Models - Sequel's product launch introduces a subscription-like payment model, contrasting with traditional insulin pumps that can cost thousands of dollars [14] - This new model aims to lower the entry barrier for patients, thereby expanding the user base for automated insulin delivery systems [15] - Subscription payment models are becoming more common in the U.S. medical device market, particularly in chronic disease management [16] Group 4: Implications for the Chinese Market - Sequel's product path highlights significant changes in the diabetes device industry, including the integration of CGM and insulin pumps into cohesive systems [20] - Some Chinese companies are also exploring similar integration strategies to create comprehensive diabetes management platforms [23] - The effectiveness of automated insulin delivery systems is increasingly dependent on control algorithms that adjust insulin doses based on real-time data [25] Group 5: Competitive Landscape - The diabetes device industry is undergoing structural changes, shifting from competition among individual devices to competition among complete treatment ecosystems [32] - Companies need to possess capabilities across various areas, including sensor technology, infusion devices, algorithm platforms, and data management [34] - Sequel's launch of the twiist system exemplifies this trend, indicating that future competition will focus on comprehensive treatment solutions rather than isolated devices [34]

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]