NASDAQ: SENS

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Prior to the commercialization of the current Eversense systems, we sold Eversense system measuring glucose levels for up to 180 days in the United States and prior to that 90 days in both the United States and select European markets. In September 2017, we affixed the CE Mark to the Eversense XL CGM system to be sold in select markets in Europe and the Middle East. In June 2018, we obtained FDA approval for the 90-day Eversense CGM system for distribution throughout the United States. In June 2019, we received FDA approval for the non-adjunctive indication (dosing claim) for the 90-day Eversense system. With this approval and the availability of a new app in December 2019, the Eversense system can be used as a therapeutic CGM in the United States to replace fingerstick blood glucose measurement to make treatment decisions, including insulin dosing.

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We are in the early commercialization stages of the Eversense brand and are focused on driving awareness of our CGM system amongst people with diabetes and their healthcare providers. In both the United States and our overseas markets, we have entered into strategic partnerships and distribution agreements that allow third party collaborators with direct sales forces and established distribution systems to market and promote Senseonics’ various Eversense systems and future generation products, including our “Gemini” product variation to allow for a 2-in-1 glucose monitoring system combining the functionality of CGM and flash glucose monitoring, in an implantable sensor with battery that may be utilized with a smart transmitter to get continuous glucose readings and alerts, or be utilized through a swipe over

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the sensor with a smart phone to get on-demand glucose reading without a smart transmitter and our “Freedom” product variation which would include Bluetooth in the sensor eliminating the on-body component.

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As described in detail below, in August 2020, we entered into a collaboration and commercialization agreement (“Commercialization Agreement”), with Ascensia pursuant to which we granted Ascensia the exclusive right to distribute Eversense worldwide, with certain initial exceptions. On September 3, 2025, the Company and Ascensia signed a memorandum of understanding (“MOU”) related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company. On December 31, 2025, the parties entered into a master asset purchase agreement (the “Master Asset Purchase Agreement”) formalizing this transfer and subsequently entered into an Amended and Restated Collaboration and Commercialization Agreement (the “A&R Commercialization Agreement”), which terminated Ascensia’s right to market Eversense products in the U.S. and rendered Ascensia’s right to market Eversense products in Italy, Germany, Spain and Sweden (the “European Territories”) non-exclusive. Pursuant to the A&R Commercialization Agreement, effective January 1, 2026, we are entitled to 100% of the revenues derived from the sale of Eversense products in the European Territories. We expect to enter into a series of asset purchase agreements to acquire certain additional assets related to Ascensia’s commercial Eversense activities in the European Territories on or before March 31, 2026.

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Significant Business Developments

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Global Commercialization of Eversense CGM Systems

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In September 2024, the FDA approved the Eversense 365 CGM system for marketing and sale in the U.S. As described in this Annual Report, Ascensia had the exclusive right to distribute the Company’s Eversense system worldwide for people with diabetes prior to December 31, 2025. Ascensia began commercializing Eversense 365 in the U.S. in October 2024. Prior to that, Ascensia commercialized the Eversense E3 CGM system which was approved by the FDA in February 2022. In June 2022, we affixed the CE Mark to the Eversense E3 CGM system, and Ascensia began commercialization in all European Economic Area (“EEA”) markets during the third and fourth quarters of 2022. In January 2026, the Company obtained CE Mark approval for Eversense 365 and expects to launch Eversense 365 in the European Territories by the second half of 2026.

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In connection with the launch of Eversense 365, Ascensia and the Company initiated a new direct to consumer U.S. marketing campaign on social and digital media platforms. ‘The One Year. One CGM.’ campaign expanded market awareness of the Eversense 365 system's unique benefits among people with diabetes and healthcare professionals. ‘The One Year. One CGM’ campaign aims to highlight the reality of the diabetes experience, through everyday complexities, successes, and challenges that people with diabetes face. The campaign demonstrates how Eversense 365 provides a differentiated CGM option, with unparalleled flexibility and long-term use that allows it to seamlessly integrate into real life. Following the launch of Eversense 365, the Company has experienced higher direct-to-consumer leads compared to pre-launch months, continued growth in patient shipments with December 2025 being the largest compared to any previous month in company history, an increase in the number of new prescribers and prescriptions, and an increase in new patients. In 2026 we continue to drive efforts to raise patient and prescriber awareness with targeted programs such as paid social ads, website optimization strategies, the Eversense 365 and twiistTM automated insulin delivery (or “AID”) campaign, and other focused marketing strategies.

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Transfer of Eversense Commercial Operations

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On September 3, 2025 the Company and Ascensia signed a MOU related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company, including the proposed termination, orderly unwinding of, and smooth transition of the commercial relationship between the Company and Ascensia. On December 31, 2025, the Company and Ascensia entered into the Master Asset Purchase Agreement, pursuant to which, among other things, the Company agreed to acquire Ascensia’s right, title and interest in and to certain assets related to the marketing, selling and distribution of Eversense in the United States (such assets, the “U.S. Purchased Assets”). Pursuant to the terms of the Master Asset Purchase Agreement, the Company agreed to assume certain liabilities and obligations associated with the U.S. Purchased Assets (the “U.S. Assumed Liabilities” and together with the U.S. Purchased Assets,

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the “U.S. Asset Purchase”), including, but not limited to, certain liabilities under the contracts transferred to the Company under the Master Asset Purchase Agreement, liabilities arising out of the use or ownership of the transferred assets after the closing, and liabilities and obligations arising from certain employees who were offered employment with Senseonics Inc. pursuant to new employment letter agreements. The U.S. Asset Purchase closed on January 1, 2026 (the “U.S. Closing”).

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Subject to the terms and conditions of the Master Asset Purchase Agreement, as well as the negotiation and execution of local asset purchase agreements which we expect to execute on or before March 31, 2026 (the “Local Purchase Agreements”), the Company and/or its affiliates are in the process of acquiring certain additional assets related to Ascensia’s commercial Eversense activities in the European Territories (such assets, the “European Purchased Assets”) and in connection therewith expect to assume certain liabilities and obligations associated with the European Purchased Assets (the “European Assumed Liabilities” and together with the European Purchased Assets, the “European Asset Purchases”). The European Asset Purchases remain subject to negotiation and the execution of Local Purchase Agreements. The closing of each of the European Asset Purchases will be subject to the terms and conditions set forth in the Master Asset Purchase Agreement and the Local Purchase Agreements, and are expected to close on or before June 30, 2026.

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In connection with the execution of the Master Asset Purchase Agreement, the Company and Ascensia also entered into the A&R Commercialization Agreement on December 31, 2025, which amended and restated that certain Collaboration and Commercialization Agreement, dated August 9, 2020, as amended to date (the “Existing Commercialization Agreement”). The A&R Commercialization Agreement terminated Ascensia’s right to market Eversense products in the U.S. and rendered Ascensia’s right to market Eversense products in the European Territories non-exclusive. Ascensia agreed to continue to sell and market the Eversense product in Europe to support the orderly transition of the business pending the closing of the European Asset Purchases and to allow Senseonics to transfer its local tender contracts. These rights and obligations apply from January 1, 2026 until the later of (i) January 1, 2027, (ii) the transfer of all local tender contracts, or (iii) the wind down of certain other commercial activities. Following the U.S. Closing, Ascensia has no further rights to revenues from the sale of Eversense products in the U.S. Pursuant to the A&R Commercialization Agreement, effective January 1, 2026, the Company is entitled to 100% of the revenues derived from the sale of Eversense products in the European Territories. Senseonics will pay for certain transition services, and certain other costs, to maintain and achieve the orderly transition of the commercial operations in the European Territories. In connection with the transfer of commercial operations relating to Eversense from Ascensia back to the Company, the Company reassessed its remaining performance obligations under its arrangement with Ascensia and adjusted the related contract assets and contract liabilities in accordance with ASC 606 based on the satisfaction (or non-satisfaction) of performance obligations as of the termination date.

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The continued success of the commercial launch of the Eversense globally will continue to depend on several factors such as: (1) the success of the transition of commercial responsibility for Eversense back to the Company (2) growing the installed base of users, (3) increasing patient awareness of Eversense above current levels in order to expand the population of Eversense users, through driving sales and marketing efforts on the Eversense system, (4) increasing awareness and adoption of Eversense by healthcare providers, including high volume CGM prescribers, through expanded targeted marketing efforts, (5) educating patients and prescribers regarding the product and its benefits relative to legacy products, (6) continuing to grow the base of the authorized inserters through geographically targeted efforts so that potential users locating a qualified inserter of Eversense is not an impediment to adoption, (7) timely establishing and maintaining favorable payor coverage for the product, including transitioning commercial payors from six month to one year coverage and (8) more effective tender participation outside the U.S.

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Background

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Diabetes is a chronic, life-threatening disease for which there is no known cure. The disease is caused by the body's inability to produce or effectively utilize the hormone insulin, which prevents the body from adequately regulating blood glucose levels. If diabetes is not managed properly, it can lead to serious health conditions and complications, including heart disease, limb amputations, loss of kidney function, blindness, seizures, coma and even death. According to the 2025 International Diabetes Federation Atlas, an estimated 589 million people worldwide had diabetes as of the date of the report. The number of people with diabetes worldwide is estimated to reach 853 million by

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2050, driven primarily by growth in type 2 diabetes and due to various reasons, including an aging population, changes in dietary trends primarily as the result of increased urbanization, and a higher prevalence of the disease in younger people. Diabetes is typically classified into two primary types. Type 1 diabetes is an autoimmune disorder that usually develops during childhood and is characterized by the inability of the body to produce insulin, resulting from destruction of the insulin producing beta cells of the pancreas.

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Type 2 diabetes is a metabolic disorder that results when the body is unable to produce sufficient amounts of insulin or becomes insulin resistant. People with type 1 diabetes must administer insulin, either by injection or insulin pump, to survive. People with type 2 diabetes may require diet and nutrition management, exercise, oral medications or the administration of insulin to regulate blood glucose levels. Type 2 diabetes is the most common type of diabetes and accounts for over 90% of all diabetes worldwide. We expect the growth in sales of CGM systems to be driven by increased penetration of CGM in both the type 1 and type 2 patient populations.

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In an attempt to maintain blood glucose levels within the normal range, many people with diabetes seek to actively monitor their blood glucose levels. The traditional self-monitoring of blood glucose, (“SMBG”), method of glucose monitoring requires lancing the fingertips, commonly referred to as fingersticks, multiple times per day and night to obtain a blood drop to be applied to a test strip inside a blood glucose meter. This method of monitoring glucose levels is inconvenient and can be painful and, because each measurement represents a single blood glucose value at a single point in time, it provides limited information regarding trends in blood glucose levels. In contrast, CGM systems are generally less painful and involve the insertion of sensors into the body to measure glucose levels in the interstitial fluid throughout the day and night, providing real-time data that shows trends in glucose measurements. As a result, CGMs improve glycemic control and quality of life, particularly in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion or multiple daily insulin injection therapy, and support avoidance of hypoglycemia.

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In November 2019, the Eversense CGM system became the first CGM technology to be reimbursed through the Part B Medical Services benefit for Medicare beneficiaries and expanded access to our product. In November 2022, the Centers for Medicare & Medicaid Services (“CMS”) released its Calendar Year 2023 Medicare Physician Fee Schedule Proposed Rule that updated the payment amounts for the three CPT© Category III codes to account for the longer 6-month sensor. In February 2024, we announced that Medicare coverage was expanded for Eversense E3 to include all people with diabetes using insulin and non-insulin users who have a history of problematic hypoglycemia providing access to millions of Medicare patients. All of the Medicare administrative contractors (“MAC”) expansions became effective in 2024. In April 2025, CMS updated the payment amounts in the Physician Fee Schedule to account for the longer duration Eversense 365 for all eligible Medicare beneficiaries. We have been working with payors to transition their policies to Eversense 365 and have confirmed immediate coverage policy transition from select payors.

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We are headquartered in Germantown, Maryland. The members of our management team have held senior leadership positions at a number of medical technology and biopharmaceutical companies, including Abbott Diabetes Care, Medtronic, and Tandem Diabetes Care. Members of our team have contributed to the development, regulatory approval and commercialization of several glucose monitoring systems and insulin pumps.

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Commercial Strategy

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We primarily sell directly to our network of distributors and strategic fulfillment partners, who provide the Eversense system to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement. In addition, we sell our product through a consignment model through established agreements with our network of healthcare professionals. Sales of the Eversense 365 and E3 CGM system and future products are widely dependent on the ability of patients to obtain coverage and adequate reimbursement from third-party payors or government agencies. We prioritize and target regions where we have coverage decisions for patient device use and provider insertion and removal procedure payment.

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Addressing reimbursement and access barriers is a top priority for us. We have reached approximately 300 million covered lives in the U.S. through positive insurance payor coverage decisions including UnitedHealthcare, the largest healthcare insurance company in the U.S. In efforts to address these priorities, we initiated the Patient Assistance and Simple Savings (“PASS”) program to provide financial assistance for patients adopting Eversense. Additionally, we

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acquired the insertion network assets of NPG establishing our Eon Care Network to continue to expand U.S. patient access to the Eversense System by providing additional convenient in-office and at-home sensor insertion options utilizing the insertor network currently operating in approximately 30 states.

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Our net revenues are derived from sales of the Eversense CGM system which includes the Eversense sensor pack containing the sensor, insertion tool, and adhesive patches, the Eversense smart transmitter pack containing the transmitter and charger and in some cases the procedure revenue associated with insertions and removals.

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Clinical Development and Regulatory Pathway

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Overview

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We conduct pivotal trials, primarily in the United States, to gather the data that supports submission to the FDA as a Premarket Approval (“PMA”) application, PMA supplement or 510(k) submission and to our Notified Body for issuance of a CE Certificate of Conformity allowing us to commercialize our products.

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We are also continuing to conduct a number of post-approval and feasibility studies.

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United States Pivotal Trials

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PRECISE II Trial

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In 2016, we conducted our U.S. 90-day pivotal trial. The trial was a prospective, single-arm, multi-center trial designed to determine the accuracy and safety of the Eversense system. Ninety subjects were enrolled in eight centers across the United States.

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The purpose of this clinical trial was to evaluate the accuracy of Eversense measurements, measured by the mean absolute relative difference (“MARD”), when compared with bed-side blood glucose measurements obtained using the YSI glucose analyzer over successive periods of 30 days through 90 days, as well as to assess the safety of Eversense. YSI in vitro analyzers are bed-side instruments used in hospitals and clinics to accurately measure blood glucose levels and are commonly used as comparators of glucose monitoring systems in clinical trials. MARD is a statistical calculation that measures the average absolute value of the differences, expressed as a percentage, between glucose measurements taken from interstitial fluid based on our CGM system and blood glucose measurements from YSI. The lower the MARD of a glucose monitoring system, the more accurate the system and, therefore, the more reliable the system's readings.

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In the trial, we observed a MARD of 8.8% for Eversense across the 40-400 mg/dL range when compared to YSI blood reference values during the 90-day continuous wear period. We conducted a second study, the PRECISION study, to collect supplementary data early in sensor life with two additional in-clinic visits in the first 30 days after insertion. Study participants were able to see their real-time glucose readings during this study. The accuracy and safety observed in PRECISE II was confirmed in this study. In addition, the data from PRECISE II study was also analyzed using an updated glucose calculation algorithm which improved the MARD to 8.5%. Based on the data from both of these trials, we submitted a PMA application to the FDA to market Eversense in the United States for 90-day use. On June 21, 2018, we received PMA approval from the FDA for the 90-day Eversense system and received Category III CPT codes for the insertion and removal of the Eversense sensor.

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PROMISE Trial

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In December 2018, we began enrollment for the U.S. 180-day pivotal trial. The trial is a prospective, single-arm, multi-center trial designed to evaluate the accuracy and safety of the Eversense system up to six months using the methods described above for the 90-day system. Over 180 subjects were enrolled in eight centers across the United States.

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In the trial, we observed performance matching that of the 90-day Eversense system available in the United States, with MARD of 8.5%-9.6%. This result was achieved with reduced calibration, down to one per day, while also doubling the sensor life to 180 days. Following the results of the PROMISE trial, on September 30, 2020, a Premarket Approval Application Supplement, or PMA supplement to extend the wearable life of the Eversense CGM System to six months was submitted to the FDA.

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On February 26, 2020, we announced that the FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor. This sub-set of 30 participants who all had sensors with the modified chemistry were left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days. Information gathered from this sub-set and continued development efforts provided us the confidence to start the pivotal study for the Eversense 365-day System.

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ENHANCE Trial

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In March 2022, we began enrollment for the U.S. 365-day pivotal trial. The trial is a prospective, single-arm, multi-center trial designed to evaluate the accuracy and safety of the Eversense system up to one year using the methods described above for the 90-day and 180-day systems. Over 165 adult subjects were inserted with Eversense systems in four centers across the United States. In mid-2023, the data gathered in this trial were used to submit an application to the FDA for the integrated continuous glucose monitoring (“iCGM”) designation. The iCGM designation will enable our ability to integrate with insulin delivery devices like pens and pumps to create systems that would use Eversense for autonomous control and we received approval in April 2024. In 2022, we submitted and received approval for an IDE for an extension of the trial to allow for pediatric patients and we began enrolling patients in the first half of 2023. The ENHANCE pivotal study for the Eversense 365-day system has been fully enrolled, the last patient of the adult cohort completed the study, and we completed analysis of the data. Based on this analysis we determined to advance the next generation sensor platform as the underlying technology used in the 365-day and future products. In May 2024 this data supported an FDA 510(k) submission for a new product with a 365-day duration and once per week calibration. The 510(k) submission was approved by the FDA on September 17, 2024 and our 365-day product was cleared for sale in the United States. In February 2025, the data supported the submission of an application for the conformity assessment of the Eversense 365-day product in compliance with the EU Medical Device Regulation, to our Notified Body. The CE Mark was approved on January 29, 2026, permitting the Company to commercialize Eversense 365 in the EEA.

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GEMINI Trial

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In December 2025, we secured Investigational Device Exemption (“IDE”) approval from the FDA to commence a U.S. pivotal clinical trial for our next-generation Gemini sensor, a self-powered, battery-enabled continuous glucose monitoring system. Following IDE approval, we initiated patient enrollment and enrolled the first patients in the GEMINI pivotal trial in December 2025. The GEMINI pivotal trial is designed to evaluate the safety and performance of the Gemini sensor in adult patients with diabetes in the U.S. The study is intended to support future regulatory submissions for the Gemini system. The trial is being conducted at multiple clinical sites, and enrollment is ongoing, with a planned enrollment of 80 patients. We expect to complete the trial in 2026 to support a 510(k) submission to the FDA.

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Our Technology

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Eversense consists of three primary components: a small sensor inserted subcutaneously under the skin by a healthcare provider; an external removable smart transmitter that receives, assesses and relays data from the sensor and provides vibratory alerts; and a mobile app that receives data from the transmitter and provides real-time glucose readings, alerts and other data on the person's mobile device. All of these components work together to provide sensor glucose values, trends and alerts to a user's mobile device within 20 milliseconds. We have designed this reliable, long-term and implantable CGM system to continually and accurately measure a person's glucose levels for up to one year. Eversense 365 requires once weekly fingerstick calibrations after day 13.

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We believe our implantable CGM system offers the following advantages to support the management of diabetes:

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●Duration: Longest available sensor duration at up to one year.

●Convenience: Our Eversense CGM system supports the patient’s lifestyle; the smart transmitter can be removed and replaced without disturbing the sensor, strong but gentle-on-skin adhesive patches, wireless communication to patient’s mobile device or Apple Watch ®, including readings every five minutes whether the patient has their mobile device or not, remote monitoring that can be shared with friends, family, and health care providers, and tracking of meals and workouts for further diabetes treatment management.

●Accuracy: Exceptional accuracy particularly in the low glucose range throughout the sensor life.

●Vibe Alerts: Added safety of an on-body vibration alert when low or high glucose threshold is reached, or importantly before low or high threshold is reached, even when the mobile device is not nearby.

●Continuous Support: Patient and healthcare provider hotline support 24/7.

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Sensor

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The sensor is approved and CE Marked to be inserted under the skin, in the upper arm, and measures the glucose in the interstitial fluid. These glucose levels are then communicated wirelessly to the smart transmitter. We have designed the sensor to last up to one year, as compared to other currently available CGM sensors labeled for use for between seven and 15 days.

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The sensor consists of an optical system, known as a micro-fluorometer, encased in a rigid, translucent polymer capsule, which is 3.3 mm in diameter and 15 mm in length. The capsule is coated with a glucose-indicating hydrogel that is bound to the surface of the capsule through polymerization. This hydrogel is energized, or excited, by a light-emitting diode (“LED”), contained in the optical system of the sensor, causing the hydrogel to fluoresce, or glow. Two photodiodes within the optical system of the sensor measure the degree of fluorescence of the hydrogel, which is proportional to the level of glucose present in the interstitial fluid. The sensor then communicates the amount of fluorescence via a near field communication (“NFC”) interface to the transmitter. NFC is a high frequency wireless communication technology that enables the exchange of data and energy between devices over a short range. The sensor does not have a power source and remains electrically dormant (powered off) between readings every five minutes, and it is remotely and discretely powered, as needed, by an inductive NFC link between the sensor and the transmitter. On power-up, the LED source is energized for approximately five milliseconds to excite the hydrogel.

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Smart Transmitter

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The removable smart transmitter is a rechargeable, external device that is worn over the sensor implantation site using a daily adhesive patch. The transmitter supplies wireless power to the sensor through an inductive NFC link, which activates a measurement sequence every five minutes. The transmitter then receives data from the sensor and calculates glucose concentrations and trends. Based on these calculations and on the user's individual settings for glucose levels, the transmitter determines if an alert condition exists, in which case the transmitter communicates the condition to the user through the mobile app and through on-body vibration. The information from the transmitter is also transmitted for display to the user's mobile device via Bluetooth Low-Energy (“BLE”). Our transmitter is functional for at least 24 hours following a full charge and can be fully charged in approximately fifteen minutes.

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Mobile App

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Our mobile app is a software application that runs on both platforms; iOS mobile devices, including iPhones, iPads and Apple Watches, and Android mobile devices. The mobile app receives information from the transmitter via BLE and displays that information discreetly to the user. This user-friendly, intuitive app provides real-time glucose readings, alerts, trends, and graphs. Within the mobile app, users can set alerts based on, among other things, glucose levels. The mobile app also allows for cloud-based storage.

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Future Product Development

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We intend to continue to expand our line of product offerings to benefit people with diabetes and healthcare providers. We expect these product development initiatives to include system modifications and next generation enhancements that we believe will further increase the convenience and appeal of our products to the diabetes community.

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We are focusing our future development efforts on enhancing current product offerings by incorporating first a power source and then Bluetooth in the sensor to remove the need for an on-body component of our system. We are currently conducting a pivotal study of our Gemini product variation to allow for a 2-in-1 glucose monitoring system combining the functionality of CGM and flash glucose monitoring, in an implantable sensor with battery that may be utilized with a smart transmitter to get continuous glucose readings and alerts, or be utilized through a swipe over the sensor with a smart phone to get on-demand glucose reading without a smart transmitter. We are also developing our Freedom product variation which would include Bluetooth in the sensor eliminating the on-body component. We are seeking to ensure that we meet the growing and unique needs of people with diabetes utilizing our core and proprietary sensor technology. The company’s technology also has potential applications measuring analytes other than glucose, such as keytones and oxygen, and the company may consider incorporating these in future products or opportunities for the development or out-licensing of such applications. We aim to launch the Gemini and Freedom systems by the fourth quarter of 2027 and fourth quarter of 2028, respectively. These target dates will depend on our ability to successfully achieve clinical and regulatory milestones, including obtaining FDA approval, which is uncertain.

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Sales and Marketing

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We are in the early commercialization stages of Eversense and are focused on driving awareness and adoption of our CGM system amongst people with diabetes and their healthcare providers. As described above, the Company is in the process of transferring the global commercial operations relating to Eversense from Ascensia back to the Company.

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Building strong adoption with an implantable device requires a strong network of healthcare providers trained on the Eversense sensor placement procedure. In the first few quarters of our commercial launch, our focus was ensuring the Endocrinology providers obtained the necessary training needed to support their diabetes patients. In 2019, we began our second phase of establishing a large network of Eversense proceduralists with the launch of the Certified Eversense Specialist (“CES”) network. This group of healthcare providers includes specialists who have strong familiarity with conducting in-office procedures such as dermatologists and plastic surgeons. The CES network offers an alternative for healthcare providers who want to prescribe Eversense for their patients but prefer to refer the procedure to a specialist. In 2022, we announced a collaboration with NPG designed to expand U.S. patient access to Eversense by providing additional convenient in-office and at-home sensor insertion options utilizing NPG’s broad network in approximately 30 states. In October 2024, we acquired the sensor insertion network assets of NPG to begin transitioning nurse practitioners to our Eon Care subsidiaries. We will continue to expand the inserter network through EON Care select geographic areas.

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As people with diabetes often consult with their healthcare providers about treatment options, we believe that educating healthcare providers regarding the benefits of Eversense compared to SMBG and other currently available CGM systems is an important step in promoting its use in people with diabetes. Our United States and European experience indicate healthcare providers highly value the accuracy and sensor duration of our CGM system and the majority of physicians surveyed considered the insertion process to be fairly simple or feasible. We intend to continue educating healthcare providers and people with diabetes on the advantages of Eversense compared to SMBG and other currently available CGM systems.

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In October 2024, Ascensia and the Company launched a new direct to consumer U.S. marketing campaign on social and digital media platforms. ‘The One Year. One CGM.’ campaign expanded market awareness of the Eversense 365 system's unique benefits among people with diabetes and healthcare professionals. ‘The One Year. One CGM’ campaign aims to highlight the reality of the diabetes experience, through everyday complexities, successes, and challenges that people with diabetes face. The campaign demonstrates how Eversense 365 provides a differentiated

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CGM option, with unparalleled flexibility and long-term use that allows it to seamlessly integrate into real life. Following the launch of Eversense 365 in October 2024, the Company has experienced higher direct-to-consumer leads compared to pre-launch months, continued growth in patient shipments with December 2025 being the largest in company history, an increase in the number of new prescribers and prescriptions, and an increase in new patients. In 2026 we continue to drive efforts to raise patient and prescriber awareness with targeted programs such as paid social ads, website optimization strategies, the Eversense 365 and twiistTM AID campaign, and other focused marketing strategies.

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Reimbursement

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Coverage in the United States

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In the U.S. market, it is essential to obtain third-party payor coverage policies, coding mechanisms, and adequate payment for medical technology to expand market acceptance and adoption. CGM as a class of products has been broadly accepted by commercial third-party payors, such as health insurers and health maintenance organizations, and by Medicare for patients who require the use of insulin to manage their diabetes. We approach the U.S. commercial third-party payor community in efforts to establish coverage for Eversense. To date, approximately 300 million people in the United States may have coverage and access to Eversense via commercial (for example, UnitedHealthcare) or government (for example, Medicare) payors.

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Some commercial payors have denied coverage deeming Eversense as an “experimental and investigational” technology electing to wait for further clinical evidence, more safety data, or time in market. We disagree with this position as the CGM class has already proven to improve health outcomes and Eversense is another product that fits into the class. Additionally, in 2019 we published several sets of real-world data, which show Eversense provides the same clinical benefits as other CGM systems and has a favorable safety profile. However, until payment for the Eversense sensor placement becomes consistent, some patients will be required to bear the financial cost for the placement of the sensor by their healthcare provider. As a result, some patients and their healthcare provider may choose not to use Eversense on a widespread basis. Patient access programs and patient appeals support have been key initiatives to expanding payor policy and acceptance through case-by-case review and eventual denial overturn. This can be a long process with varying results in each case but is a prudent step to challenge payor positions of non-coverage given the strong evidence that supports CGM and Eversense. Further, coverage policies and third-party payor reimbursement rates may change at any time. Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future.

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Coverage Outside the United States

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In countries outside the United States, coverage for CGM systems is obtained from various sources, including governmental authorities, national healthcare systems, private health insurance plans, and hospital funds. Coverage systems in international markets vary significantly by country and, within some countries, by region. Coverage approvals must be obtained on a country-by-country, region-by-region or, in some instances, a case-by case basis. The responsibility for securing this coverage historically resided with our third-party distributors in the respective markets. We are in the process of acquiring the coverage and payment contracts for Eversense in the European Territories from Ascensia and upon the closing of the Local Purchase Agreements, we expect to be responsible for securing coverage for the related CGM systems going forward.

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Manufacturing and Quality Assurance

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We currently outsource the manufacturing of all components of the Eversense system to contract manufacturers across North America and Europe. We plan to continue with an outsourced manufacturing arrangement for the foreseeable future. Our contract manufacturers are all recognized in their field for their competency to manufacture the respective portions of our system and have quality systems established that meet FDA and, to the extent required,

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international regulatory requirements. We believe the manufacturers we currently utilize have sufficient capacity to meet our requirements. We believe that, as we increase our demand in the future, our per unit costs will decrease materially.

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We have received certification from BSI, our Notified Body to the International Standards Organization (“ISO”) for our quality system. This ISO 13485:2016 certification includes design control requirements. As a medical device manufacturer, the facilities of our sterilization and other critical suppliers are subject to periodic inspection by the FDA and corresponding state and foreign regulatory authorities and Notified Bodies. We believe that our quality systems and those of our suppliers are robust and achieve high product quality.

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Typically, our outside vendors produce the components to our specifications and in many instances to our designs. Our suppliers are audited periodically by our quality department to ensure conformity with the specifications, policies and procedures for our devices. We believe that, if necessary, alternative sources of supply would be available in a relatively short period of time and on commercially reasonable terms. Most of the raw materials we use in our manufacturing operations are available from more than one source. However, certain raw material components are obtained principally from one supplier. In the event one of these suppliers was unable to provide the materials or product, we generally seek to maintain sufficient inventory to supply the market until an alternative source of supply can be implemented. However, in the event of an extended failure of a supplier, it is possible that we could experience an interruption in supply until we established new sources or, in some cases, implemented alternative processes.

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Competition

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The market for CGM systems is developing and competitive, subject to rapid change and significantly affected by new product introductions. We compete with well-capitalized companies, some of which are publicly traded, that manufacture CGM systems including Dexcom, Medtronic and Abbott. Each of these companies has received FDA approval, CE Certificates of Conformity and CE Marked their products, permitting them to market their respective CGM systems across the United States and EEA. Both Dexcom (G6 and G7) and Abbott (Freestyle Libre 2 and 3) systems have factory calibration, and do not require user calibration.

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Dexcom has also received the first FDA iCGM indication allowing its Dexcom G6 and G7 to be interoperable with other diabetes tech devices such as insulin pumps. As the industry evolves, we anticipate encountering increasing competition from companies that integrate CGM with insulin pumps. Abbott has also received an iCGM indication for its Freestyle Libre 2 and 3 products and we expect all other CGM companies to pursue an iCGM indication including Medtronic.

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In addition to CGM providers, we also compete with providers of SMBG systems. Three companies currently account for a substantial share of the worldwide sales of SMBG systems: Roche Diabetes Care, a division of Roche Diagnostics; Abbott; and Ascensia.

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We may also compete with companies who are developing real-time intermittent sensing devices, low cost transcutaneous CGM systems, fully implantable CGM devices and non-invasive CGM system to measure a user's glucose level. There are also a number of academic and other institutions involved in various phases of our industry's technology development.

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Although we face potential competition from many different sources, we believe that our technology, knowledge, experience and scientific resources provide us with competitive advantages. The key competitive factors affecting the success of Eversense are accuracy, duration, convenience, alert functionality, and customer support.

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Many of the companies which we compete with have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, certifications and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or earlier stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting

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and retaining qualified scientific and management personnel and establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our development.

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Seasonality

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We anticipate that the revenue generated from our product sales will vary from quarter to quarter as we continue to commercialize Eversense. This variation is influenced by annual insurance deductible limits and out-of-pocket costs associated with some health insurance plans and government insurance programs providing coverage to Eversense and the utilization of patient assistance programs to offset those costs. This variation is also influenced by our distributor’s reductions of inventory of our products in the first quarter. Specifically, our revenues are generally lower in the first quarter of the year as compared to the fourth quarter of the preceding year.

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For additional information, refer to “Part I.