What changed in this filing

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Item 1. Business

2026-03-02 compared with 2025-03-03 · 172 added, 189 removed, 441 unchanged (45% of the section changed)

We are a commercial-stage medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology.

Our implantable continuous glucose monitoring (“CGM”) system (“Eversense”), including Eversense E3 and Eversense 365 CGM systems are designed to continually and accurately measure glucose levels in people with diabetes via an under-the-skin sensor, a removable and rechargeable smart transmitter, and a convenient app for real-time diabetes monitoring and management for a period of up to twelve months in the case of Eversense 365 and six months in the case of Eversense E3, as compared to seven to 14 days for non-implantable CGM systems.

In September 2024, the 365-day extended life Eversense E3 CGM system was approved by the FDA and Ascensia began commercializing Eversense 365 in the fourth quarter of 2024.

We are a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (“CGM”) system to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy.

Our implantable CGM system (“Eversense”), including Eversense E3 and Eversense 365 CGM systems are designed to continually and accurately measure glucose levels in people with diabetes via an under-the-skin sensor, a removable and rechargeable smart transmitter, and a convenient app for real-time diabetes monitoring and management for a period of up to twelve months in the case of Eversense 365 and six months in the case of Eversense E3, as compared to seven to 15 days for non-implantable CGM systems.

In September 2024, the 365-day extended life Eversense E3 CGM system was approved by the FDA and, through Ascensia Diabetes Care Holdings AG (“Ascensia”), we began commercializing Eversense 365 in the fourth quarter of 2024.

In January 2026, we took over full commercial responsibility for Eversense 365 in the United States and began marketing and distributing the product with our own sales force.

In June 2022, we affixed the CE Mark to the Eversense E3 CGM system and Ascensia began commercialization in select markets in Europe during the third quarter 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.

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.

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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 now be used as a therapeutic CGM in the United States to replace fingerstick blood glucose measurement to make treatment decisions, including insulin dosing.

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.

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.

Our future generation products in development are 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 and our “Freedom” product variation which would include Bluetooth in the sensor eliminating the on-body component.

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

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.

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.

While Ascensia is responsible for sales, marketing, market access, patient and provider onboarding and first level customer support, we remain responsible for product development and manufacturing, including regulatory submissions, approvals, conformity assessment and requests for CE Certificates of Conformity and registrations and second level customer support.

Significant Recent Developments

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.

Significant Business Developments

Global Commercialization of Eversense CGM Systems

In September 2024, the FDA approved the Eversense 365 CGM system for marketing and sale in the U.S.

As described in this report, Ascensia has the exclusive right to distribute the Company’s Eversense system worldwide for people with diabetes.

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.

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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.

In connection with the launch of Eversense 365, Ascensia and the Company initiated a new direct to consumer U.S.

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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, higher patient shipments in December 2024 compared to any previous month in company history, an increase in the number of new prescribers and prescriptions, and an increase in new patients.

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 twiist TM automated insulin delivery (or “AID”) campaign, and other focused marketing strategies.

Transfer of Eversense Commercial Operations

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,

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.

Asset Purchase closed on January 1, 2026 (the “U.S.

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.

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.

The continued success of the commercial launch of the Eversense globally will continue to depend on several factors such as:

(1) growing the installed base of users, (2) 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, (3) increasing awareness and adoption of Eversense by healthcare providers, including high volume CGM prescribers, through expanded targeted marketing efforts, (4) educating patients and prescribers regarding the product and its benefits relative to legacy products, (5) 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, (6) timely establishing and maintaining favorable payor coverage for the product, including transitioning commercial payors from six month to one year coverage, (7) more effective tender participation outside the U.S.

and (8) Ascensia’s continued organizational development of its sales and marketing capabilities related to CGM.

In July 2024, we began first-in-human testing for the Gemini system.

The next-generation Gemini product utilizes a fully implantable self-powering system that includes a flash glucose monitor with no on-body component for people with type 2 diabetes and traditional CGM with an on-body component for people with type 1 diabetes.

The Gemini product is built on the 365-day sensor platform and the clinical and regulatory work will be focused on demonstrating the battery integration and functionality rather than the sensor life.

Data gathered from this first-in-human testing will be utilized for an investigational device exemption (“IDE”) submission anticipated in the second half of 2025.

In April 2024 and July 2024, Eon Care Services, LLC and Eon Management Services, LLC, were formed as wholly owned subsidiaries of Senseonics, Incorporated.

In November 2024, Eon Management Services, LLC entered into the Administrative Agreement with several professional corporations (“Eon Care PCs”), which are consolidated as variable interest entities (“VIEs”).

The wholly owned entities and Eon Care PCs (collectively, “Eon Care”) were established to support patient access to the Eversense system by providing convenient Eversense insertion and training

The Company expects established CPT codes associated with Eversense insertions to support this initiative in the future.

In November 2022, we announced a collaboration with the Nurse Practitioner Group (“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.

Under the agreement between Senseonics and NPG, NPG providers will be certified to perform Eversense procedures in the specified geographies and will offer its services for patients who have been prescribed Eversense.

During 2023, we expanded the inserter network by setting up Eversense procedure capabilities in additional select geographic areas.

In October 2024, we acquired the sensor insertion network assets of NPG to begin transitioning nurse practitioners to our Eon Care subsidiaries in order to further expand patient access and convenience.

(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.

Diabetes is a chronic, life-threatening disease for which there is no known cure.

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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 grow to 783 million by 2045, driven primarily by growth in type 2 diabetes and due to various reasons, including changes in dietary trends, an aging population and increased prevalence of the disease in younger people.

The number of people with diabetes worldwide is estimated to reach 853 million by

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.

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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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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.

Historically, the FDA and other foreign regulatory authorities required that CGMs be labeled and marketed as "adjunctive" to test-strip measurements, with instructions that patients confirm CGM measurements with test-strip measurements using blood obtained from fingersticks prior to self-medicating.

However, given the broader clinical indications for the use of CGM systems, including real-time alerts and multi-device integration, the FDA issued the first “non-adjunctive” label in 2016.

In June 2019, an updated Eversense CGM system received a non-adjunctive label from the FDA and can now be used as a replacement to fingerstick glucose testing for treatment decisions.

This non-adjunctive indication also enabled our pathway to access patients on Medicare.

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 and 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 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.

CMS provided G-codes to enable immediate access to Eversense 365 for all eligible Medicare beneficiaries.

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.

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 and Medtronic.

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.

Commercial Strategy

We primarily sell directly to our network of distributors, 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 arrangements with our network of healthcare professionals.

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.

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through positive insurance payor coverage decisions including UnitedHealthcare, the largest healthcare insurance company in the U.S.

In efforts to address these priorities, Ascensia, in consultation with us, initiated the Patient Assistance and Simple Savings (“PASS”) program to provide financial assistance for patients adopting Eversense.

Additionally, as discussed above, we recently announced the acquisition of the insertion network assets of NPG 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 in approximately 30 states.

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

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.

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.

Collaboration and Commercialization Agreement with Ascensia Diabetes Care Holdings AG

On August 9, 2020, we entered into a Commercialization Agreement with Ascensia pursuant to which we have granted Ascensia the exclusive right to distribute the Eversense CGM system worldwide for use in people with diabetes.

Ascensia receives a portion of net revenue at specified tiered percentages ranging from the mid-teens to the mid-forties based on levels of global net revenues.

Ascensia is obligated to achieve specified minimum annual revenue targets and meet specified levels of sales and marketing spend.

Ascensia purchases Eversense products from us at prices which have been negotiated based on parameters set forth in the commercialization agreement.

We are responsible for product development and manufacturing, including regulatory submissions, approvals, certifications and registrations and second level customer support, and Ascensia is responsible for sales, marketing, market access, patient and provider onboarding and level one customer support.

We established a joint alliance committee and joint marketing committee, each with equal representation from each party, in order to collaborate.

Clinical Development and Regulatory Pathway

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 issue of a CE Certificate of Conformity allowing us to commercialize our products.

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.

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

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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.

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.

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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 Eversense 365-day product CE Mark submission in compliance with the EU Medical Device Regulation (MDR) and, upon approval, would enable the commercialization of Eversense 365 in European Union (EU) member countries.

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.

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.

Our Technology

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Eversense 365 requires once weekly fingerstick calibrations after day 13.

In June 2019, we received FDA approval for the non-adjunctive indication for the Eversense system.

With this approval, the Eversense system can be used as a therapeutic CGM to replace fingerstick blood glucose measurement for dosing decisions.

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

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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 friends, family, and health care providers, and tracking of meals and workouts for further diabetes treatment management.

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.

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

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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.

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.

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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 performing feasibility studies with 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 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 oxygen, and the company may consider opportunities for the development or out-licensing of such applications.

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.

Sales and Marketing

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 with our commercial partner Ascensia.

As described above, we are party to a commercialization agreement with Ascensia, pursuant to which we have granted Ascensia the exclusive right to distribute our Eversense CGM system worldwide for use in people with diabetes,

with certain exceptions.

Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for Eversense on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities during the second quarter of 2021.

As a result of our strategic partnership, Ascensia is responsible for sales, marketing, market access, patient and provider onboarding and level one customer support.

We have established a joint alliance committee and joint marketing committee, each with equal representation from each party, in order to collaborate.

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.

Building strong adoption with an implantable device requires a strong network of healthcare providers trained on the Eversense sensor placement procedure.

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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 by setting up Eversense procedure capabilities in additional select geographic areas.

We will continue to expand the inserter network through EON Care select geographic areas.

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.

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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 in October 2024, the Company has experienced higher direct-to-consumer leads compared to pre-launch months, higher patient shipments in December 2024 compared to any previous month in company history, an increase in the number of new prescribers and prescriptions, and an increase in new patients.

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 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 twiist TM AID campaign, and other focused marketing strategies.

Reimbursement

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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 more recently by Medicare for patients who require the use of insulin to manage their diabetes.

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.

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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.

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.

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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 and Ascensia has continued similar programs for this purpose.

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.

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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 resides with our third-party distributors in the respective markets.

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.

Manufacturing and Quality Assurance

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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, international regulatory requirements.

international regulatory requirements.

We believe the manufacturers we currently utilize have sufficient capacity to meet our requirements.

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Most of the raw materials we use in our manufacturing operations are available from more than one source.

However, we obtain certain raw material components are obtained principally from one supplier.

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.

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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.

Dexcom’s CGM system was the first CGM system to be approved by the FDA for marketing as a non-adjunctive device, and Abbott’s Freestyle Libre was also approved for non-adjunctive use.

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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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 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.

These competitors also compete with us in recruiting

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.

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 and the timing of Ascensia’s purchases in accordance with minimum purchase requirements under our distribution agreement.

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.

For additional information, refer to “Part I.

Risk Factors” in this Annual Report on Form 10-K, including the risk factor entitled “Our product revenue is subject to seasonal variation”.

Risk Factors” in this Annual Report, including the risk factor entitled “Our product revenue is subject to seasonal variation”.

Intellectual Property

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We also rely on trade secrets, technical know-how and continuing innovation to develop and maintain our competitive position.

assignment of invention agreements upon the commencement of their employment or engagement as the case may be.

We seek to protect such intellectual property and proprietary information by generally requiring our employees, consultants, contractors, scientific collaborators and other advisors to execute non-disclosure and assignment of invention agreements upon the commencement of their employment or engagement as the case may be.

Our agreements with our employees prohibit them from providing us with any intellectual property or proprietary information of third parties.

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In the United States, the Federal Food, Drug and Cosmetic Act (“FDCA”), and the implementing regulations of the FDA govern product design and development, preclinical and clinical testing, premarket clearance or approval, product manufacturing, import and export, product labeling, product storage, recalls and field safety corrective actions, advertising and promotion, product sales and distribution, and post-market clinical surveillance.

Our business is subject to federal, state, local, and foreign regulations and standards, such as ISO 13485, ISO 14971, FDA's Quality System Regulation (“QSR”) contained in 21 CFR Part 820, Directive 90/385/EEC concerning active implantable medical devices and, Regulation 2017/745 on Medical Devices, as amended.

Our business is subject to federal, state, local, and foreign regulations and standards, such as ISO 13485, ISO 14971, FDA's Quality Management System Regulation (“QMSR”) contained in 21 CFR Part 820, Directive 90/385/EEC concerning active implantable medical devices and, Regulation 2017/745 on Medical Devices, as amended.

Regulation by the FDA

The FDA classifies medical devices into one of three classes according to the degree of risk the FDA determines to be associated with a device and the level of regulatory control deemed necessary to ensure the device’s safety and effectiveness.

The Eversense System is a Class III device and subject to pre-market approval (“PMA”) application under section 515 of the FDCA in order to obtain a marketing approval.

A PMA application must be supported by valid scientific evidence that typically includes extensive technical, preclinical, clinical, manufacturing and labeling data, to demonstrate to the FDA's satisfaction the safety and efficacy of the device.

A PMA application also must include a complete description of the device and its components, a detailed description of the methods, facilities and controls used to manufacture the device, and proposed labeling.

After a PMA application is submitted and found to be sufficiently complete, the FDA begins an in-depth review of the submitted information.

New PMA applications or PMA supplements may be required for modifications to the manufacturing process, labeling, device specifications, materials or design of a device that has been approved through the PMA process.

PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the approved PMA application and may or may not require as extensive technical or clinical data or the convening of an advisory panel.

The Eversense System is a Class II device and subject to 510(k) approval under section 515 of the FDCA in order to obtain a marketing approval.

A 510(k) application must be supported by valid scientific evidence that typically includes extensive technical, preclinical, clinical, manufacturing and labeling data, to demonstrate to the

FDA's satisfaction the safety and efficacy of the device.

A 510(k) application also must include a complete description of the device and its components, a detailed description of the methods, facilities and controls used to manufacture the device, and proposed labeling.

After a 510(k) application is submitted and found to be sufficiently complete, the FDA begins an in-depth review of the submitted information.

New 510(k) applications or 510(k) supplements may be required for modifications to the manufacturing process, labeling, device specifications, materials or design of a device that has been approved through the 510(k) process.

510(k) supplements often require submission of the same type of information as an initial 510(k) application, except that the supplement is limited to information needed to support any changes from the device covered by the approved 510(k) application and may or may not require as extensive technical or clinical data or the convening of an advisory panel.

Any devices we manufacture and distribute pursuant to clearance or approval by the FDA are subject to pervasive and continuing regulation by the FDA and certain state agencies.

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As a medical device manufacturer, all of our manufacturing facilities are subject to inspection on a routine basis by the FDA.

We are required to adhere to applicable regulations setting forth detailed Current Good Manufacturing Practice (“cGMP”) requirements, as set forth in the Quality System Regulation, or QSR, which require, manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process.

We are required to adhere to applicable regulations setting forth detailed Current Good Manufacturing Practice (“cGMP”) requirements, as set forth in the QMSR, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process.

Noncompliance with these standards can result in, among other things, fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of production, refusal of the government to grant 510(k) clearance or PMA approval of devices, withdrawal of marketing approvals and criminal prosecutions.

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Compliance with these requirements is a prerequisite to be able to affix the CE Mark to devices, without which they cannot be marketed or sold in the EEA.

To demonstrate compliance with the GSPRs provided in the Medical Device Regulation and obtain the right to affix the CE mark, medical devices manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.

To demonstrate compliance with the GSPRs provided in the Medical Device Regulation and obtain the right to affix the CE Mark, medical devices

manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.

Apart from low risk medical devices (Class I with no measuring function and which are not sterile), in relation to which the manufacturer may issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the GSPRs, a conformity assessment procedure requires the intervention of a Notified Body, which is an organization designated by a Competent Authority of an EEA country to conduct conformity assessments.

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The conduct of clinical studies in the EEA is governed by detailed regulatory obligations.

These may include the requirement of prior authorization by the Competent Authorities of the country in which the study takes place and the requirement to obtain a positive opinion from a

competent Ethics Committee.

These may include the requirement of prior authorization by the Competent Authorities of the country in which the study takes place and the requirement to obtain a positive opinion from a competent Ethics Committee.

This process can be expensive and time-consuming.

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Manufacturers of medical devices may only benefit from the above extended transitional provisions deadlines if the following conditions are fulfilled:

(i) the devices continue to comply with the requirements of the MDD or AIMD, (ii) there are no significant changes in the design and intended purpose, (iii) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, (iv) the manufacturer implements a quality management system by May 26, 2024 which complies with the requirements of the Medical Devices Regulation, (v) by May 26, 2024 an application is lodged with a Notified Body for conduct of the conformity assessment of the devices covered by the CE Certificate of Conformity, or the devices intended to substitute for such devices, in accordance with the Medical Device Regulation and a related written agreement is signed with the Notified Body by September 26, 2024, and (vi) from May 26, 2021, compliance with the Medical Device Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices is ensured in place of the corresponding requirements in the MDD or AIMD.

In addition, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD from May 25, 2017, which were valid on May 26, 2021 and have not been withdrawn since but which expired before March 20, 2023, will only continue to be valid in accordance with the extended transitional deadlines above if either (i) the manufacturer signed a written agreement with a Notified Body for the conformity assessment of the device covered by the expired CE Certificate of Conformity, or the device intended to substitute that device, in accordance with the Medical Device Regulation before the date of expiry of the CE Certificate of Conformity, or (ii) a competent authority of an EU Member State has granted a derogation from the application conformity assessment procedure in accordance with Article 59(1) or Article 97(1) of the Medical Device Regulation.

Class III custom-made implantable medical devices may be placed on the market until May 26, 2026 without a CE Certificate of Conformity issued by Notified Body, provided that (i) by May 26, 2024, an application is lodged with a Notified Body for the conformity assessment of the devices, in accordance with the Medical Device Regulation and a related written agreement is signed with the Notified Body by September 26, 2024.

The advertising and promotion of medical devices in the EU is subject to the national laws of the individual EU Member States that implemented the MDD, the AIMD and that apply the Medical Device Regulation, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual EU Member States governing the advertising and promotion of medical devices.

EU Member States’ national legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public.

In addition, voluntary EU and national industry Codes of Conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.

Accordingly, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD from May 25, 2017, and which remained valid on May 26, 2021 and have not since been withdrawn will, with certain exceptions, remain valid until December 31, 2027 for Class III and Class IIb implantable medical devices and until 31 December 2028 for other Class IIb, Class IIa and Class I devices with a measuring function or which are sterile.

Class I medical devices, for which the conformity assessment procedure in accordance with the MDD or the AIMD did not require the involvement of a Notified Body but will require the involvement of a Notified Body in accordance with the Medical Device Regulation and for which an EU Declaration of Conformity was issued in accordance with the MDD or the AIMD prior to May 26, 2021, can continue to be placed on the EEA market until December 31, 2028.

Manufacturers of medical devices may only benefit from the above extended

transitional provisions deadlines if the following conditions are fulfilled:

(i) the devices continue to comply with the requirements of the MDD or AIMD, (ii) there are no significant changes in the design and intended purpose, (iii) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, (iv) the manufacturer implemented a quality management system by May 26, 2024 which complies with the requirements of the Medical Devices Regulation, (v) by May 26, 2024 an application was lodged with a Notified Body for conduct of the conformity assessment of the devices covered by the CE Certificate of Conformity, or the devices intended to substitute for such devices, in accordance with the Medical Device Regulation and a related written agreement was signed with the Notified Body by September 26, 2024, and (vi) from May 26, 2021, compliance with the Medical Device Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices is ensured in place of the corresponding requirements in the MDD or AIMD.

an EU Member State has granted a derogation from the application conformity assessment procedure in accordance with Article 59(1) or Article 97(1) of the Medical Device Regulation.

Class III custom-made implantable medical devices may be placed on the market until May 26, 2026 without a CE Certificate of Conformity issued by a Notified Body, provided that (i) by May 26, 2024, an application was lodged with a Notified Body for the conformity assessment of the devices, in accordance with the Medical Device Regulation and a related written agreement was signed with the Notified Body by September 26, 2024.

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These include, but are not limited to:

● establishment registration and device listing;

● QSR, which requires manufacturers, including third party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;

● MDR regulations, which require that manufacturers report to the FDA, competent authorities of the EEA countries and Notified Bodies, and foreign regulatory authorities, when applicable, if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur;

● establishment registration, device listing and other registration requirements;

● QMSR and Quality Management System requirements, which require manufacturers, including third party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;

● MDR regulations, which require that manufacturers report to the FDA, and foreign regulatory authorities, when applicable, if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur and comparable foreign post-market surveillance and vigilance requirements;

● voluntary and mandatory device recalls addressing problems when a device is defective and could be a risk to health;

● corrections and removals reporting regulations, which require that manufacturers report to the FDA, competent authorities of the EEA countries and Notified Bodies, and foreign regulatory authorities, when applicable, field

corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health.

● corrections and removals reporting regulations, which require that manufacturers report to the FDA, and foreign regulatory authorities, when applicable, field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health, and comparable foreign requirements.

Also, the FDA requires us to conduct Post Approval Studies (post-market surveillance studies) and establish and maintain a system for tracking our products through the chain of distribution to the patient level.

We may be subject to similar requirements abroad.

The FDA and applicable regulatory authorities enforce regulatory requirements by conducting periodic, unannounced inspections and market surveillance.

Inspections may include the manufacturing facilities of our subcontractors.

Moreover, the FDA, competent authorities of the EEA countries and Notified Bodies, and foreign regulatory authorities, when applicable, strictly regulates marketing, labeling, advertising and promotion of medical products.

Medical products may be promoted only for the approved indications and in accordance with the provisions of the approved label, although physicians, in the practice of medicine, may prescribe approved medical products for unapproved indications.

Moreover, the FDA, competent authorities of the EEA countries, and foreign regulatory authorities, when applicable, strictly regulate marketing, labeling, advertising and promotion of medical devices.

Medical devices may be promoted only for the approved or CE Marked indications and in accordance with the provisions of the approved or certified label, although physicians, in the practice of medicine, may prescribe approved medical devices for unapproved indications.

Companies may also share truthful and not misleading information that is otherwise consistent with the labeling.

The FDA, competent authorities of the EEA countries and Notified Bodies, and foreign regulatory authorities, when applicable, and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

The FDA, competent authorities of the EEA countries, and foreign regulatory authorities, when applicable, and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

In the United States, failure to comply with applicable regulatory requirements can result in enforcement actions by the FDA and other regulatory agencies.

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If a Notified Body suspects or discovers any non-compliance, this may also result in Notified Bodies revoking, suspending or varying a CE Certificate of Conformity that they have issued for a device or the manufacturer’s quality system.

Our contract manufacturers, specification developers and some suppliers of components or device accessories, also are required to manufacture our products in compliance with current good manufacturing practice requirements set forth in the QSR.

The QSR requires a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and it includes extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling of components or services, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping.

The FDA evaluates compliance with the QSR through periodic unannounced inspections that may include the manufacturing facilities of our subcontractors.

The QMSR requires a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and it includes extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling of components or services, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping.

The FDA evaluates compliance with the QMSR through periodic unannounced inspections that may include the manufacturing facilities of our subcontractors.

If the FDA believes that any of our contract manufacturers or regulated suppliers are not in compliance with these requirements, it can shut down such manufacturing operations, require recall of our products, refuse to approve new marketing applications, institute legal proceedings to detain or seize products, enjoin future violations or assess civil and criminal penalties against us or our officers or other employees.

Similar quality management requirements and related risks apply abroad.

Health Insurance Portability and Accountability Act of 1996 and Other Foreign and State Laws and Regulations Affecting the Transmission, Security and Privacy of Personal Information

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In the EEA, the General Data Protection Regulation (2016/679) (“EU GDPR”) and in the United Kingdom (“UK”), the United Kingdom’s GDPR (“UK GDPR”) (together the “GDPR”), applies to personal data about identified or identifiable data subjects processed by automated means and data contained in, or intended to be part of, non-automated filing systems (traditional paper files) as well as transfer of such data to a country outside of the EEA or UK.

Under the EU GDPR companies may face temporary of definitive bans on data processing and other corrective actions, fines of up to €20 million or up to 4% of the annual global turnover, whichever is greater;

Under the EU GDPR companies may face temporary or definitive bans on data processing and other corrective actions, fines of up to €20 million or up to 4% of the annual global turnover, whichever is greater;

or private litigation related to processing of personal data brought by classes of data subject or consumer protection organizations authorized at law to represent their interests.

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Our relationships with healthcare providers and other third parties are subject to scrutiny under these laws.

Violations of these laws are punishable by significant criminal, civil, and administrative sanctions, including, in some instances, imprisonment and exclusion from participation in federal and state healthcare programs, including the Medicare, Medicaid and Veterans Administration health programs, or similar comparable foreign programs.

Violations of these laws are punishable by significant criminal, civil, and administrative sanctions, including, in some instances, monetary penalties, payment denials, imprisonment, exclusion from participation in federal and state healthcare programs, including the Medicare, Medicaid and Veterans Administration health programs, or similar comparable foreign programs, as well as integrity oversight and reporting obligations to resolve allegations of non-compliance.

Federal Anti-Kickback and Self-Referral Laws

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Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a review of all its relevant facts and circumstances.

Several courts

have interpreted the statute's intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of (or purchases, or recommendations related to) federal healthcare covered business, the federal Anti-Kickback Statute has been implicated and potentially violated.

Several courts have interpreted the statute's intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of (or purchases, or recommendations related to) federal healthcare covered business, the federal Anti-Kickback Statute has been implicated and potentially violated.

The penalties for violating the federal Anti-Kickback Statute include imprisonment for up to ten years, criminal fines of up to $100,000 per violation, possible exclusion from federal healthcare programs such as Medicare and Medicaid and other penalties, including significant civil monetary penalties and integrity oversight and reporting obligations to resolve allegations of non-compliance.

Many states have adopted prohibitions similar to the federal Anti-Kickback Statute, some of which do not have the same exceptions or safe harbors and apply to the referral of patients for healthcare services reimbursed by any source, not only by the Medicare and Medicaid programs.

Further, the federal Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively “PPACA”).

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In addition, the PPACA codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

Many states have adopted prohibitions similar to the federal Anti-Kickback Statute, some of which do not have the same exceptions or safe harbors

and apply to the referral of patients for healthcare services reimbursed by any source, not only by the Medicare and Medicaid programs.

Federal law also includes a provision commonly known as the "Stark Law," which prohibits a physician from referring Medicare or Medicaid patients to an entity providing "designated health services," including a company that furnishes durable medical equipment, in which the physician has an ownership or investment interest or with which the physician has entered into a compensation arrangement.

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Nevertheless, a determination of liability under such laws could result in fines and penalties and restrictions on our ability to operate in these jurisdictions.

Additionally, as some of these laws are still evolving, we lack definitive guidance as to the application of certain key aspects of these laws as they relate to our arrangements with providers with respect to patient training.

As a result, our provider and training arrangements may ultimately be found to be not in compliance with applicable federal law.

Additionally, as some of these laws are still evolving, we lack definitive guidance as to the application of certain key aspects of these laws as they relate to our operations and activities, including our arrangements with providers with respect to patient training.

As a result, our operations and activities, including our provider and training arrangements, may ultimately be found to be not in compliance with applicable federal law.

Federal False Claims Act & HIPAA

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Penalties include significant civil monetary penalties for each false claim, plus three times the amount of damages that the federal government sustained because of the act of that person.

Qui tam actions have increased significantly in recent years, causing greater numbers of healthcare companies to have to defend a false claim action, pay fines, be excluded from Medicare, Medicaid or other federal or state healthcare programs, or be subject to integrity oversight and reporting obligations to resolve allegations of non-compliance, as a result of an investigation arising out of such action.

There are other federal anti-fraud laws that that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a

material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Qui tam actions have continued to increase significantly in recent years, causing greater numbers of healthcare companies to have to defend a false claim action, pay fines, be excluded from Medicare, Medicaid or other federal or state healthcare programs, or be subject to integrity oversight and reporting obligations to resolve allegations of non-compliance, as a result of an investigation arising out of such action.

There are other federal anti-fraud laws that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Additionally, HIPAA established two federal crimes for healthcare fraud and false statements relating to healthcare matters.

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In addition to the federal Anti-Kickback Statute and the civil and criminal false claims laws, including the federal False Claims Act, the federal government has the authority to seek civil monetary penalties (“CMPs”) assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct.

For example, the Civil Monetary Penalties Law authorizes the imposition of substantial CMPs against an entity that engages in activities including, but not limited to:

For example, the Civil Monetary Penalties Law authorizes the imposition of substantial CMPs against an entity that engages in

activities including, but not limited to:

(1) knowingly presenting or causing to be presented, a claim for services not provided as claimed or which is otherwise false or fraudulent in any way;

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State Corporate Practice of Medicine Restrictions

Our consolidated financial statements include our subsidiaries and VIEs.

Our consolidated financial statements include our subsidiaries and variable interest entities.

Through the administrative agreements with the Eon Care PCs, our medical affiliates, we have exclusive authority over all non-medical decisions related to their ongoing business operations.

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These laws are generally referred to as corporate practice of medicine laws.

These state laws and regulations and agency and court decisions that enumerate the specific corporate practice rules vary considerably from state to state and are enforced

by both the courts and regulatory authorities, each with broad discretion.

These state laws and regulations and agency and court decisions that enumerate the specific corporate practice rules vary considerably from state to state and are enforced by both the courts and regulatory authorities, each with broad discretion.

In these states, a violation of the corporate practice of medicine prohibition constitutes the unlawful practice of medicine.

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Such new laws may result in decreased reimbursement for medical devices, which may further exacerbate industry-wide pressure to reduce the prices charged for medical devices.

For example, in March 2010, the PPACA, was enacted, which substantially changes the way healthcare is financed by both governmental and private insurers, encourages improvements in the quality of healthcare items and services and significantly impacts the medical device industry.

For example, in March 2010, the PPACA, was enacted, which substantially changes the way healthcare is financed by both governmental and private

insurers, encourages improvements in the quality of healthcare items and services and significantly impacts the medical device industry.

In the years since its enactment, there have been judicial and Congressional challenges and amendments to certain aspects of the PPACA.

For example, on August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in PPACA marketplaces through plan year 2025.

The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.

For example, on July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, which narrowed access to PPACA marketplace exchange enrollment and declined to extend the PPACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.

The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.

Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired PPACA subsidies.

It is possible that the PPACA will be subject to judicial or Congressional challenges in the future.

It is unclear how such challenges and the healthcare reform measures of the second Trump administration will impact the PPACA.

It is unclear how such challenges and the healthcare reform measures of the current administration will impact the PPACA.

In addition, other legislative changes have been proposed and adopted since the PPACA was enacted.

In August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, starting in 2013 and, due to subsequent legislative amendments, will remain in effect until 2032 unless additional congressional action is taken.

Additionally, in January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

It is uncertain whether and how future legislation could affect prospects for our product candidates or what actions federal, state, or private payors for healthcare treatment and services may take in response to any such healthcare reform proposals or legislation.

Brexit and the Regulatory Framework in the United Kingdom

In August 2011, the Budget Control Act of 2011 was signed into law, which, among other things, included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, starting in 2013 and, due to subsequent legislative amendments, will remain in effect until 2032 unless additional congressional action is taken.

It is uncertain whether and how future legislation could affect our current and future operations or what actions federal, state, or private payors for healthcare treatment and services may take in response to any such healthcare reform proposals or legislation.

Regulatory Framework in the United Kingdom

Following the result of a referendum in 2016, the UK left the European Union on January 31, 2020, commonly referred to as Brexit.

Pursuant to the formal withdrawal arrangements agreed between the UK and the European Union, the UK was subject to a transition period until December 31, 2020, or the Transition Period, during which European Union rules continued to apply.

The UK and the European Union have signed an EU-UK Trade and Cooperation Agreement (“TCA”), which became provisionally applicable on January 1, 2021 and entered into force on May 1, 2021.

This agreement provides details on how some aspects of the UK and European Union’s relationship will operate going forwards however there are still many uncertainties.

The TCA primarily focuses on ensuring free trade between the European Union and the UK in relation to goods.

The TCA does not, however, specifically address medical devices.

Among the changes that will now occur are that Great Britain (England, Scotland and Wales) will be treated as a "third country," a country that is not a member of the European Union and whose citizens do not enjoy the European Union right to free movement.

Northern Ireland will continue to follow many aspects of the European Union regulatory rules, particularly in relation to trade in goods, including the Medical Device Regulation.

On May 26, 2021, the Medical Device Regulation entered into application in the EU.

However, the Medical Device Regulation is not applicable in the UK.

In the UK, medical devices are governed by the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which retains a regulatory framework similar to the framework set out by the MDD.

In light of the fact that the CE Marking process is set out in EU law, which no longer applies in the UK, the UK has devised a new route to market culminating in a UKCA Mark to replace the CE Mark.

Northern Ireland will, however, continue to be covered by the regulations governing CE Marks.

The UK Government has established transitional provision to recognize the acceptance of CE marked medical devices on the Great Britain market.

Accordingly, Class III and Class IIb implantable medical devices which have been CE marked in accordance with the MDD or AIMD and for which a CE Certificate of Conformity has been delivered by a Notified Body in accordance with the MDD or AIMD, can be placed on the Great Britain market until the sooner of the expiry of the related CE Certificate of Conformity or June 30, 2028.

However, in light of the extended transitional provisions of the Medical Device Regulation, related CE Certificates of Conformity will expire, at the latest, on December 31, 2027.

Other Class IIb, Class IIa and Class I devices with a measuring function which have been CE marked in accordance with the MDD or AIMD and for which a CE Certificate of Conformity has been delivered by a Notified Body in accordance with the MDD or AIMD, can be placed on the Great Britain market until the sooner of the expiry of the related CE Certificate of Conformity or June 30, 2028.

However, the Medical Device Regulation is not applicable in Great Britain (England, Scotland, and Wales).

In Great Britain, medical devices are governed by the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which currently retains a regulatory framework similar to the framework set out by the MDD.

The UK has devised a new route to market culminating in a UKCA Mark to replace the CE Mark.

Northern Ireland will, however, continue to be covered by the EU regulations governing CE Marks (and comply with the Medical Device Regulation).

The UK Government has established transitional provisions to recognize the acceptance of CE Marked medical devices on the Great Britain market.

Current legislations provides that medical devices which have been CE Marked in accordance with the MDD or AIMD, and for which a CE Certificate of Conformity has been delivered by a Notified Body in accordance with the MDD or AIMD, can be placed on the Great Britain market until the sooner of the expiry of the certificate or June 30, 2028.

Medical devices which have been CE Marked in accordance with the Medical Device Regulation may be placed on the Great Britain market until June 30, 2030.

The UK government plans on introducing new legislation governing medical devices with an aim for core aspects of the future regime for medical devices to apply from July 1, 2025.

New legislation is also anticipated to bring into force strengthened post-market surveillance requirements ahead of the wider future regulatory regime.

These post-market surveillance requirements are expected to apply from mid-2025, following a six-month implementation period.

However, the government has indicated that it intends to launch a consultation (that was penciled in for late 2025 but has not yet commenced) on proposals to indefinitely recognize CE Marked medical devices.

The UK government has introduced new legislation governing medical devices, with the first regulations strengthening post-market surveillance having come into force on June 16, 2025.

Further updated regulations are scheduled to follow in the course of 2026.

Foreign Corrupt Practices Act

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As of December 31, 2025, we had 130 full-time employees, of whom over half hold Ph.D., M.D., master’s degree, or other post graduate degrees, and all of whom are in the United States.

Most employees are in Operations and Research and Development positions aligned with our corporate focus of designing, developing and manufacturing glucose monitoring products.

In 2025, most employees were in Operations and Research and Development positions aligned with our corporate focus of designing, developing and manufacturing glucose monitoring products.

Effective January 2, 2026, in connection with the transition of commercialization and marketing activities back to the Company from Ascensia, we significantly expanded our workforce by hiring more than 150 employees, primarily within commercial sales, marketing, and related support functions.

As a result, the composition of our employee base has begun to shift toward a greater proportion of commercial and customer-facing roles.

None of our employees are represented by a labor union or covered by a collective bargaining agreement.

We consider our relationship with our employees to be good.

We consider our relationship with our employees to be good and believe our culture emphasizes innovation, accountability, collaboration, and a shared commitment to improving outcomes for people living with diabetes.

Employee engagement is always important to us, and improving our employee engagement with a remote, in-person and hybrid workforce remained a strategic imperative for us in 2025.

We are committed to maintaining a flexible working environment for our employees, however, this requires an intentional focus to build communications and connections in the workplace.

We are committed to maintaining a flexible working environment for our employees because it is important to them, however this requires an intentional focus to build communications and connections in a diverse work place settings.

Throughout the year, we employed initiatives and communications to attach our employees to our company mission, vision, and values.

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● Get It Done represents working with a sense of urgency to go above and beyond to get the job done right through quality, compliance, and timeliness.

We utilize a human resource software which collects weekly employee feedback on work experience, culture, communications, interaction with their managers and other topics enabling us to react and address real time feedback.

We continue to utilize a human resource software which collects weekly employee feedback on work experience, culture, communications, interaction with their managers and other topics enabling us to react and address real time feedback.

This software is an excellent tool to help monitor our culture at the organizational level, as well as the individual manager level.

This feedback allows us to evaluate our initiatives and the reactions of our employees to successes and challenges in the organization.

We leverage this platform to distribute surveys on specific topics, which demonstrates our commitment to hearing the voice of our employees and creating an inclusive environment.

We use this platform to distribute surveys on specific topics, which demonstrates our commitment to hearing the voice of our employees and creating an inclusive environment.

This software also provides opportunities for peer-to-peer recognition and valuable insights for managers to better lead their teams.

We also conduct

company calls at least once month to update all employees on progress towards our company objectives, initiatives, what is happening in various departments, customer feedback and to celebrate employee achievements and company milestones.

We also conduct regular company calls to update all employees on progress towards our company objectives, initiatives, what is happening in various departments, customer feedback and to celebrate employee achievements and company milestones and personal employee milestones.

In addition, we conduct regular employee engagement events to recognize the value of our employees and their contributions.

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We operate in modern, efficient, and safe facilities, and have minimal accident and injury rates.

In 2022, we launched a platform to improve harassment training efforts, and we continued this training in 2024.

We also expanded our wellness program “A Healthier You” in 2024.

This program focuses on three pillars:

financial, physical, and workplace wellness.

Each pillar is supported by specific tools and resources to educate and reinforce the importance of wellness.

This program includes a stipend to further support healthy behaviors and to demonstrate our commitment to employee well-being.

In 2024, we created a Wellness Committee to engage interested employees and help deliver the initiatives.

We created special interest groups, such as healthy eating and fitness activities, plus we delivered a weekly newsletter to emphasize the importance of regular healthy habits and to increase mental health awareness.

In 2025, we expanded our wellness program “A Healthier You” to deliver a consistent cadence of weekly wellness tips, lunch and learns focused on wellness, and employee recognition to demonstrate our commitment to employee well-being.

This program also includes a stipend to further support healthy behaviors.

Organizational Development

We are committed to attracting, developing, and retaining employees by promoting an environment to continuously develop and learn.

As part of our performance management process, all levels of employees are formally required to meet with their managers at least quarterly to receive feedback on their established objectives, identify opportunities for skill development, discuss opportunities to support their career goals, and reflect on how their behaviors demonstrate our corporate values.

As part of our performance management process, all levels of employees are formally required to meet with their managers at semi-annually to receive feedback on their established objectives, identify opportunities for skill development, discuss opportunities to support their career goals, and reflect on how their behaviors demonstrate our corporate values.

Managers are strongly encouraged to have routine 1:1 meetings with their employees in between formal performance management meetings.

The executive team meets routinely to discuss key initiatives for strategic, operational, and organizational planning.

Many of these meetings were focused on organizational development including reviewing demographic data and employment engagement data to better understand our employee profiles and address their specific needs.

We continued to celebrate our revised technical leadership pathway with an awards program to recognize and reward our 2024 patent inventors.

Many of these meetings were focused on organizational development including high-potential and high-performer talent discussions and employment engagement data to better understand our employee profiles and address their specific needs.

We continued to celebrate our revised technical leadership pathway with an awards program to recognize and reward employees who were recently named as patent inventors.

We continue to encourage professional certification and continuing education by reimbursement for professional certification classes, testing, maintenance, and tuition reimbursement of up to $5,250 annually.

During 2024, we enhanced our focus on the development of and investment in our key leaders within the organization by offering a Manager Training Program for our managers and director level employees.

We regularly engage in development conversations with our managers and directors regularly to reinforce best practices and ensure effective performance management.

During 2025, we enhanced our focus on the development of and investment in our Senior Directors, which represent the key leaders within the organization by connecting regularly to capture feedback and discuss organizational strengths and challenges.

We regularly engage in development conversations with our managers and directors to reinforce best practices and ensure effective performance management

Inclusion in the Workplace

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We provide our employees with market competitive pay and bonuses.

In 2021, we implemented a year-end market adjustment review process to ensure we maintain our competitive pay and pay equity between active employees and new hires and to align to the highly competitive labor market.

We complete a year-end market adjustment review process to ensure we maintain our competitive pay and pay equity between active employees and new hires and to align with the highly competitive labor market.

As a result of this review process, we evaluate any market adjustments required to stay on track with the everchanging labor market and align with individual employee performance.

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All employees are issued stock options and/or restricted stock units under our broad-based stock incentive programs.

offer an employee stock purchase program to all employees.

We offer an employee stock purchase program to all employees.

Finally, we offer comprehensive benefits to all eligible employees, including health insurance, paid time off, a retirement plan with company match, health savings accounts, flexible spending accounts, life and disability coverage, voluntary accident, and critical illness.

Corporate Information

We were originally incorporated as ASN Technologies, Inc.

in Nevada on June 26, 2014.

In 2015, we acquired Senseonics, Incorporated, a medical technology company focused on the design, development and commercialization of glucose monitoring systems to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy.

From its inception in 1996 until 2010, Senseonics, Incorporated devoted substantially all of its resources to researching various sensor technologies and platforms.

Beginning in 2010, the company narrowed its focus to designing, developing and refining a commercially viable glucose monitoring system.

In connection with the acquisition of Senseonics, Incorporated, we reincorporated in Delaware and changed our name to Senseonics Holdings, Inc.

Upon the closing of the acquisition, Senseonics, Incorporated merged with a wholly owned subsidiary of ours formed solely for that purpose and became our wholly owned subsidiary.

Eon Care Services, LLC and Eon Management Services, LLC are wholly owned subsidiaries of Senseonics, Incorporated formed in April 2024 and July 2024, respectively.

Our principal executive offices are located at 20451 Seneca Meadows Parkway, Germantown, Maryland 20876-7005 and our telephone number is (301) 515-7260.

Our common stock is listed on the NYSE American under the symbol “SENS.”

Our common stock is listed on the Nasdaq Global Select Market under the symbol “SENS.”

Available Information

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In addition to the information contained in this Annual Report, information about us can be found on our website.

Information contained in, or accessible through, our website is not a part of this Annual Report on Form 10-K, and the inclusion of our website address in this prospectus is only as an inactive textual reference.

Information contained in, or accessible through, our website is not a part of this Annual Report on Form 10-K, and the inclusion of our website address in this Annual Report is only as an inactive textual reference.

Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are available free of charge through our website as soon as reasonably practicable after they are electronically filed with or furnished to the Securities and Exchange Commission, or SEC.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business