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Item 1. Business

2025-03-03 compared with 2024-03-01 · 181 added, 176 removed, 449 unchanged (44% of the section changed)

We are a 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 CGM (“Eversense”), including the Eversense E3 continuous glucose monitoring (“CGM”) system version is 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 six months as compared to seven to 14 days for non-implantable CGM systems.

We affixed the CE mark to the original 90-day Eversense CGM system in June 2016, which marked the first certification for the product to be sold within the European Economic Area (being the European Union plus Norway, Iceland, and Liechtenstein) (“EEA”).

Subsequently, we affixed the CE mark to the extended life Eversense XL CGM system in September 2017 to be sold in select markets in Europe and the Middle East.

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.

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 June 2018, the U.S.

Food and Drug Administration (“FDA”), approved the 90-day Eversense CGM system for distribution throughout the United States.

Prior to the commercialization of the current Eversense systems, we sold Eversense system measuring glucose levels for up to 180 days in the United States and prior to that 90 days in both the United States and select European markets.

In September 2017, we affixed the CE mark to the Eversense XL CGM system to be sold in select markets in Europe and the Middle East.

In June 2018, we obtained FDA approval for the 90-day Eversense CGM system for distribution throughout the United States.

In June 2019, we received FDA approval for the non-adjunctive indication (dosing claim) for the 90-day Eversense system.

With this approval and the availability of a new app in December 2019, the Eversense system can now be used as a therapeutic CGM in the United States to replace fingerstick blood glucose measurement to make treatment decisions, including insulin dosing.

In February 2022, the 180-day extended life Eversense E3 CGM system was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States in the second quarter of 2022.

In February 2020, we announced that the FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor.

This sub-set of 30 participants was left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days.

Information gathered from this sub-set and additional development efforts provided us the confidence to start the Pivotal study for the Eversense 365-day System.

The ENHANCE pivotal study for the Eversense 365-day system has completed enrollment, the last patient of the adult cohort completed the study and we completed analysis of the data.

Based on this analysis we determined to advance to the next generation sensor platform as the underlying technology used in the 365-day and future products.

We expect that this data will support an FDA submission to be made in the coming weeks for a new product with a target 365-day duration and once per week calibration.

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.

During 2020, we initiated a new commercialization strategy and collaboration to bring our product to market.

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 our 90-day Eversense CGM system and our 180-day Eversense E3 CGM system worldwide, with certain initial exceptions.

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 CGM systems, including Eversense E3, Eversense 365 and future generation products.

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.

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

Global Commercialization of Eversense E3 CGM System

In February 2022, the FDA approved the Eversense E3 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 E3 system worldwide for people with diabetes.

Ascensia began commercializing Eversense E3 in the U.S.

during the second quarter of 2022.

In June 2022, we affixed the CE mark to the extended life Eversense E3 CGM system, and Ascensia began commercialization in all EEA markets during the third and fourth quarters of 2022.

In October 2023, Ascensia and the Company announced a new direct to consumer U.S.

marketing campaign launched on television in select markets, in addition to social and digital media platforms.

‘The CGM for Real Life’ campaign expanded market awareness of the Eversense E3 system's unique benefits among people with diabetes and healthcare professionals.

‘The CGM for Real Life’ 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 E3 provides a differentiated CGM option, with unparalleled flexibility and long-term use that allows it to seamlessly integrate into real life.

The continued success of the commercial launch of the Eversense E3 product 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 E3 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 six-month and future generation products 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 relative to CGM.

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.

The first Medicare administrative contractor (“MAC)” expansion became effective on February 25, 2024 with the remaining MAC’s expected to become effective in the near future.

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.

Ascensia began commercializing Eversense 365 in the U.S.

in October 2024.

Prior to that, Ascensia commercialized the Eversense E3 CGM system which was approved by the FDA in February 2022.

In June 2022, we affixed the CE mark to the Eversense E3 CGM system, and Ascensia began commercialization in all European Economic Area (“EEA”) markets during the third and fourth quarters of 2022.

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

marketing campaign on social and digital media platforms.

‘The One Year.

One CGM.’ campaign expanded market awareness of the Eversense 365 system's unique benefits among people with diabetes and healthcare professionals.

‘The One Year.

One CGM’ campaign aims to highlight the reality of the diabetes experience, through everyday complexities, successes, and challenges that people with diabetes face.

The campaign demonstrates how Eversense 365 provides a differentiated CGM option, with unparalleled flexibility and long-term use that allows it to seamlessly integrate into real life.

Following the launch of Eversense 365, the Company has experienced higher direct-to-consumer leads compared to pre-launch months, 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 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 the Eversense E3 System by providing additional convenient in-office and at-home sensor insertion options utilizing NPG’s broad network in over 30 states.

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.

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

The disease is caused by the body's inability to produce or effectively utilize the hormone insulin, which prevents the body from adequately

regulating blood glucose levels.

The disease is caused by the body's inability to produce or effectively utilize the hormone insulin, which prevents the body from adequately regulating blood glucose levels.

If diabetes is not managed properly, it can lead to serious health conditions and complications, including heart disease, limb amputations, loss of kidney function, blindness, seizures, coma and even death.

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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 expands 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 updates the payment amounts for the three CPT© Category III codes to account for the longer 6-month sensor.

The Calendar Year 2024 Medicare Physician Fee Schedule continues to include the three CPT© Category III codes.

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.

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.

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.

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Commercial Strategy

Our Eversense CGM systems are primarily sold through Ascensia globally.

Ascensia sells our products directly to strategic fulfillment partners, who provide our Eversense CGM systems to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement.

Sales of the Eversense E3 CGM system and future models are widely dependent on the ability of patients to obtain coverage and adequate reimbursement from third-party

payors or government agencies.

Ascensia is leveraging and targeting regions where we have coverage decisions for patient device use and provider insertion and removal procedure payment.

Addressing reimbursement and access barriers has been a top priority for us and during 2023, we reached approximately 300 million covered lives in the U.S.

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.

Sales of the Eversense 365 and E3 CGM system and future products are widely dependent on the ability of patients to obtain coverage and adequate reimbursement from third-party payors or government agencies.

We prioritize and target regions where we have coverage decisions for patient device use and provider insertion and removal procedure payment.

Addressing reimbursement and access barriers is a top priority for us.

We have reached approximately 300 million covered lives in the U.S.

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

In efforts to address these priorities, Ascensia, in consultation with us, initiated the Patient Assistance and Simple Savings (PASS) program to provide financial assistance for patients adopting Eversense E3.

Additionally, as discussed above, we announced a collaboration with NPG designed to expand U.S.

patient access the Eversense E3 System by providing additional convenient in-office and at-home sensor insertion options utilizing NPG’s broad network in over 30 states.

Our net revenues are derived from sales of the Eversense CGM system which is sold in two separate kits:

the disposable Eversense Sensor Pack which includes the sensor, insertion tool, and adhesive patches, and the durable Eversense Smart Transmitter Pack which includes the transmitter and charger.

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.

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 Company’s 90-day Eversense CGM system and our Eversense 180-day (XL) CGM system worldwide for use in people with diabetes, with the following initial exceptions:

(1) until January 31, 2021, the territory did not include countries covered by our then existing distribution agreement with Roche Diagnostics International AG and Roche Diabetes Care GmbH (collectively “Roche”), which are the Europe, Middle East and Asia, excluding Scandinavia and Israel, and 17 additional countries, including Brazil, Russia, India and China, as well as select markets in the Asia Pacific and Latin American regions;

(2) until September 13, 2021, the territory did not include countries covered by our current distribution agreement with Rubin Medical, which are Sweden, Norway and Denmark;

and (3) until May 31, 2022, the territory did not include Israel.

Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the 90-day Eversense product on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for 90-day Eversense product during the second quarter of 2021.

The distribution rights under the Roche agreement expired January 31, 2021 after Roche provided certain transition and wind-down services.

In February 2022, the extended life Eversense E3 CGM system was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States during the second quarter of 2022.

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

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

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

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

Our Promise pivotal trial in the U.S.

was completed during 2020.

We received a Premarket Approval (“PMA”) supplement, from the FDA for the Eversense E3 system in February 2022 and Ascensia began commercializing Eversense E3 in the United States during the second quarter of 2022.

We affixed the CE mark to Eversense E3 in the EEA in June 2022 and Ascensia began commercializing Eversense in all oversea markets by the end of 2022.

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

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Ninety subjects were enrolled in eight centers across the United States.

Eighty-seven of the ninety enrollees completed the 90-day trial.

The clinical trial population consisted of subjects at least 18 years of age who had a clinically confirmed diagnosis of diabetes.

Subjects who had a history of severe hypoglycemia, defined as hypoglycemia resulting in loss of consciousness or seizure, or diabetic ketoacidosis, in the six months prior to the trial, were excluded from participation in the clinical trial.

Accuracy measurements were taken at 1 day, 30 days, 60 days, and 90 days post-insertion.

These sensor measurements were continued through the earlier of the failure of the sensor or 90 days post-insertion.

The purpose of this clinical trial was to evaluate the accuracy of Eversense measurements, measured by the mean absolute relative difference (“MARD”), when compared with bed-side blood glucose measurements obtained using the YSI glucose analyzer over successive periods of 30 days through 90 days, as well as to assess the safety of Eversense.

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The lower the MARD of a glucose monitoring system, the more accurate the system and, therefore, the more reliable the system's readings.

During the trial, 75 subjects underwent unilateral sensor insertions and 15 subjects underwent bilateral sensor insertions in the clinic and used Eversense’s smart transmitter and mobile app at home for the next 90 days.

Subjects were blinded to the real-time glucose readings and trends during home-use and sensor readings were not used to adjust their treatment.

Clinic visits were scheduled at approximately 30-day intervals in order to obtain lab reference glucose values for comparison with the sensor values and to evaluate hyperglycemic and hypoglycemic challenges in a controlled setting.

In the trial, we observed a MARD of 8.8% for Eversense across the 40-400 mg/dL range when compared to YSI blood reference values during the 90-day continuous wear period.

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Over 180 subjects were enrolled in eight centers across the United States.

We completed enrollment in September 2019 and had our last patient complete their 180-day visit during the first quarter of 2020.

The clinical trial population consists of subjects at least 18 years of age who have had a clinically confirmed diagnosis of diabetes for at least one year.

Subjects with a history of unexplained severe hypoglycemia, defined as hypoglycemia resulting in loss of consciousness or seizure, or diabetic ketoacidosis, in the six months prior to the trial were excluded from participation in the clinical trial.

After screening, sensor(s) were inserted and accuracy measurements were taken at multiple visits during the first 30 days and then every 30 days to 180 days post-insertion or

until sensor failure, if earlier than 180 days post-insertion.

In the trial, we observed performance matching that of the 90-day Eversense system available in the United States, with MARD of 8.5%-9.6%.

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Following the results of the PROMISE trial, on September 30, 2020, a Premarket Approval Application Supplement, or PMA supplement to extend the wearable life of the Eversense CGM System to six months was submitted to the FDA.

As described elsewhere, we received PMA approval from the FDA for the Eversense E3 CGM system in February 2022, Ascensia began commercializing Eversense E3 in the United States during the second quarter of 2022.

On February 26, 2020, we announced that the FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor.

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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.

Over 165 subjects were inserted with Eversense systems in four centers across the United States.

In mid-2023, the data gathered in this trial was used to submit an application to the FDA for the integrated continuous glucose monitoring (“iCGM”) designation.

The iCGM designation will enable our ability to integrate with insulin delivery devices like pens and pumps to create systems that would use Eversense for autonomous control and we expect approval in the first half of 2024.

In 2022, we submitted and received approval for an investigational device exemption (“IDE”) for an extension of the trial to allow for pediatric patients and we began enrolling patients in the first half of 2023.

The trial is a prospective, single-arm, multi-center trial designed to evaluate the accuracy and safety of the Eversense system up to one year using the methods

described above for the 90-day and 180-day systems.

Over 165 adult subjects were inserted with Eversense systems in four centers across the United States.

In mid-2023, the data gathered in this trial were used to submit an application to the FDA for the integrated continuous glucose monitoring (“iCGM”) designation.

In 2022, we submitted and received approval for an IDE for an extension of the trial to allow for pediatric patients and we began enrolling patients in the first half of 2023.

The ENHANCE pivotal study for the Eversense 365-day system has been fully enrolled, the last patient of the adult cohort completed the study, and we completed analysis of the data.

Based on this analysis we determined to advance the next generation sensor platform as the underlying technology used in the 365-day and future products.

We expect that this data will support an FDA submission to be made in the coming weeks for a new product with a target 365-day duration and once per week calibration.

In May 2024 this data supported an FDA 510(k) submission for a new product with a 365-day duration and once per week calibration.

The 510(k) submission was approved by the FDA on September 17, 2024 and our 365-day product was cleared for sale in the United States.

In February 2025, the data supported the 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.

Our Technology

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All of these components work together to provide sensor glucose values, trends and alerts to a user's mobile device within 20 milliseconds.

We have designed this reliable, long-term and implantable CGM system to continually and accurately measure a person's glucose levels for up to six months.

Eversense requires once daily fingerstick calibrations after day 21.

In June 2019, we received FDA approval for the non-adjunctive indication for the 90-day Eversense system.

With this approval, the Eversense system can be used as a therapeutic CGM to replace fingerstick blood glucose measurement for dosing decisions and was launched in December 2019.

We have designed this reliable, long-term and implantable CGM system to continually and accurately measure a person's glucose levels for up to one year.

Eversense 365 requires once weekly fingerstick calibrations after day 13.

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:

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

Longest available sensor duration at up to six months.

Longest available sensor duration at up to one year.

● Convenience:

Our Eversense CGM system supports the patient’s lifestyle;

the smart transmitter is water resistant, rechargeable and 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 up to five people, including 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 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.

● Vibe Alerts:

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These glucose levels are then communicated wirelessly to the smart transmitter.

We have designed the sensor to last up to six months, as compared to other currently available CGM sensors labeled for use for between seven and 14 days.

We have designed the sensor to last up to one year, as compared to other currently available CGM sensors labeled for use for between seven and 14 days.

The sensor consists of an optical system, known as a micro-fluorometer, encased in a rigid, translucent polymer capsule, which is 3.3 mm in diameter and 15 mm in length.

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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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The information from the transmitter is also transmitted for display to the user's mobile device via Bluetooth Low-Energy (“BLE”).

Our transmitter is functional for at least 24 hours following a full charge and can be fully charged in fifteen minutes.

Our transmitter is functional for at least 24 hours following a full charge and can be fully charged in approximately fifteen minutes.

Our mobile app is a software application that runs on both platforms;

iOS mobile devices, including iPhones, iPads and Apple Watches, and Android mobile devices.

The mobile app receives information from the transmitter via

BLE and displays that information discreetly to the user.

The mobile app receives information from the transmitter via BLE and displays that information discreetly to the user.

This user-friendly, intuitive app provides real-time glucose readings, alerts, trends, and graphs.

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We expect these product development initiatives to include system modifications and next generation enhancements that we believe will further increase the convenience and appeal of our products to the diabetes community.

We are focusing our future development efforts on enhancing current product offerings by reducing calibrations towards a once per week calibration.

Our next generation sensor which recently completed pivotal testing is designed to extend the sensor duration even longer at up to 365 days.

We expect the next generation sensor to support our goal of extending the market for long-term implantable CGM to include Type 2 patients not on intensive insulin therapy.

We are also developing 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 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 also developing our “Freedom” product variation which would include Bluetooth in the sensor eliminating the on-body component.

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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 intensively managed patients and their healthcare providers with our commercial partner Ascensia.

We are party to a commercialization agreement with Ascensia, pursuant to which we have granted Ascensia the exclusive right to distribute our prior 90-day Eversense CGM system and our current six-month 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 the 90-day Eversense system on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for the 90-day Eversense system during the second quarter of 2021.

In February 2022, the extended life Eversense E3 CGM system was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States in the second quarter of 2022.

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.

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In 2022, we announced a collaboration with NPG designed to expand U.S.

patient access to the Eversense E3 System by providing additional convenient in-office and at-home sensor insertion options utilizing NPG’s broad network in over 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.

patient access to Eversense by providing additional convenient in-office and at-home sensor insertion options utilizing NPG’s broad network in approximately 30 states.

In October 2024, we acquired the sensor insertion network assets of NPG to begin transitioning nurse practitioners to our Eon Care subsidiaries.

We will continue to expand the inserter network by setting up Eversense procedure capabilities in additional 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.

Our European experience and our feedback in the United States indicates healthcare providers highly value the accuracy and sensor duration of our CGM system and the majority of physicians surveyed considered the insertion process to be fairly simple or feasible.

Our United States and European experience indicate healthcare providers highly value the accuracy and sensor duration of our CGM system and the majority of physicians surveyed considered the insertion process to be fairly simple or feasible.

We intend to continue educating healthcare providers and people with diabetes on the advantages of Eversense compared to SMBG and other currently available CGM systems.

In October 2023, Ascensia and the Company announced a new direct to consumer U.S.

marketing campaign launched on television in select markets, in addition to social and digital media platforms.

‘The CGM for Real Life’ campaign expanded market awareness of the Eversense E3 system's unique benefits among people with diabetes and healthcare professionals.

‘The CGM for Real Life’ 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 E3 provides a differentiated CGM option, with unparalleled flexibility and long-term use that allows it to seamlessly integrate into real life.

In October 2024, Ascensia and the Company launched a new direct to consumer U.S.

marketing campaign on social and digital media platforms.

‘The One Year.

One CGM.’ campaign expanded market awareness of the Eversense 365 system's unique benefits among people with diabetes and healthcare professionals.

‘The One Year.

One CGM’ campaign aims to highlight the reality of the diabetes experience, through everyday complexities, successes, and challenges that people with diabetes face.

The campaign demonstrates how Eversense 365 provides a differentiated 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.

Reimbursement

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commercial third-party payor community in efforts to establish coverage for Eversense.

To date, approximately 300 million people in the United States may have coverage and access to the Eversense E3 product via commercial (for example, UnitedHealthcare) or government (for example, Medicare) payors.

To date, approximately 300 million people in the United States may have coverage and access to Eversense via commercial (for example, UnitedHealthcare) or government (for example, Medicare) payors.

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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Coverage systems in international markets vary significantly by country and, within some countries, by region.

Coverage approvals

must be obtained on a country-by-country, region-by-region or, in some instances, a case-by case basis.

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.

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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.

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.

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As the industry evolves, we anticipate encountering increasing competition from companies that integrate CGM with insulin pumps.

Abbott also received an iCGM indication for their Freestyle Libre 2 and 3 products and we expect all other CGM companies besides Dexcom to pursue an iCGM indication including Medtronic.

Abbott has also received an iCGM indication for its Freestyle Libre 2 and 3 products and we expect all other CGM companies to pursue an iCGM indication including Medtronic.

In addition to CGM providers, we also compete with providers of SMBG systems.

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and Ascensia.

We may also compete with companies who are developing real-time intermittent sensing devices, low cost transcutaneous CGM systems, fully implantable CGM devices and non-invasive CGM system to measure a user's

glucose level.

There are also a number of academic and other institutions involved in various phases of our industry's technology development.

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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.

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”.

Intellectual Property

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Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling our products, which could have a significant adverse impact on our business.

We have two pending U.S.

trademark applications and five pending foreign trademark applications, as well as 12 U.S.

trademark registrations and 129 foreign trademark registrations.

We have 14 U.S.

trademark registrations and 133 foreign trademark registrations, as well as one pending foreign trademark application.

Trade Secrets

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

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.

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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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 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.

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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 cGMP requirements, as set forth in the 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 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.

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.

We believe that our design, manufacturing and quality control procedures are in compliance with the FDA’s regulatory requirements.

We must also comply with post-market surveillance regulations, including medical device reporting, or MDR, requirements which require that we review and report to the FDA any incident in which our products may have caused or contributed to a death or serious injury.

We must also comply with post-market surveillance regulations, including medical device reporting (“MDR”) requirements which require that we review and report to the FDA any incident in which our products may have caused or contributed to a death or serious injury.

We must also report any incident in which our product has malfunctioned if that malfunction would likely cause or contribute to a death or serious injury if it were to recur.

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The Medical Device Regulation and its associated guidance documents and harmonized standards govern, among other things, device design and development, preclinical and clinical or performance testing, premarket conformity assessment, registration and listing, manufacturing, labeling, storage, claims, sales and distribution, export and import and post-market surveillance, vigilance, and market surveillance.

Medical devices must comply with the General Safety and Performance Requirements, or GSPRs, set out in Annex I of the Medical Device Regulation.

Medical devices must comply with the General Safety and Performance Requirements, (“GSPRs”) set out in Annex I of the Medical Device Regulation.

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.

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.

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.

Depending on the relevant conformity assessment procedure, the Notified Body audits and examines the technical documentation and the quality system for the manufacture, design and final inspection of the medical devices.

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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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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:

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.

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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.

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.

Other Regulatory Requirements

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● 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 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.

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.

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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

We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.

We are subject to certain data privacy and security regulation by both the federal government and the states in which we conduct our business.

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and their respective implementing regulations, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information.

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federal and state laws and equivalent third country laws pertaining to healthcare fraud and abuse, including anti-kickback laws and physician self-referral laws.

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

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.

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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.

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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.

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

As a result, 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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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.

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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Civil Monetary Penalties Law

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, or CMPs, assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct.

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:

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Noncompliance can result in significant civil money penalties for each wrongful act, assessment of three times the amount claimed for each item or service and exclusion from the federal healthcare programs.

State Fraud and Abuse Provisions

Many states have also adopted some form of anti-kickback and anti-referral laws and a false claims act, some of which apply regardless of source of payment and do not have the same exceptions as the federal laws.

We believe that we are in conformance to such laws.

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

Physician Payments Sunshine Act

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Similar laws have been enacted or are under consideration in many states and foreign jurisdictions.

State Fraud and Abuse Provisions

Many states have also adopted some form of anti-kickback and anti-referral laws, false claims laws, some of which apply regardless of source of payment and do not have the same exceptions as the federal laws, as well as professional fee-splitting laws.

We believe that we are in conformance with such laws.

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

State Corporate Practice of Medicine Restrictions

Our consolidated financial statements include our subsidiaries and VIEs.

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.

Some states have laws that prohibit business entities from practicing medicine, employing physicians to practice medicine, or exercising control over medical decisions of physicians.

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.

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

If regulatory authorities or other parties in any jurisdiction successfully assert that we are engaged in the unauthorized corporate practice of medicine, we could be required to pay significant fines and restructure our contractual and other arrangements.

In addition, any physician who participates in an arrangement that violates a state’s corporate practice of medicine prohibition may be punished for aiding and abetting a lay entity in the unlawful practice of medicine.

Outside the United States, interactions between medical device companies and health care professionals are also governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct.

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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.

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 significant developments in, and continued legislative activity around, attempts to repeal or repeal and replace the PPACA.

While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the PPACA have been signed into law.

The Tax Cuts and Jobs Act of 2017, or Tax Act, included a provision which repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”.

Additionally, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the PPACA-mandated medical device tax and the “Cadillac” tax on high-cost employer-sponsored health coverage and, effective January 1, 2021, also eliminated the health insurer tax.

On June 17, 2021, the U.S.

Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress.

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

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.

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 Biden administration will impact the PPACA.

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

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

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Brexit and the Regulatory Framework in the United Kingdom

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

Pursuant to the formal withdrawal arrangements agreed between the United Kingdom and the European Union, the United Kingdom, or 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 United Kingdom and the European Union have signed an EU-UK Trade and Cooperation Agreement, or 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 United Kingdom and European Union’s relationship will operate going forwards however there are still many uncertainties.

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.

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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-2024.

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

Foreign Corrupt Practices Act

Foreign Corrupt Practices Act, or FCPA, prohibits U.S.

Foreign Corrupt Practices Act (“FCPA”) prohibits U.S.

corporations and their representatives from offering, promising, authorizing or making corrupt payments, gifts or transfers to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business abroad.

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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 2024.

Throughout the year, we committed to employ initiatives and communications to build close connections between our employees and the company mission, vision, and values.

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.

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

Our values define the behaviors of our existing employees, and the new hires that we welcomed to our organization during 2024:

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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.

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.

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 twice per month to update all employees on progress towards our company objectives, initiatives, what is happening in various departments and to celebrate employee achievements and company milestones.

We also conduct quarterly employee engagement events to recognize the value of our employees and their contributions.

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.

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

Employee Health & Wellbeing

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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 in 2023 added Diversity, Equity, and Inclusion training for all employees to this effort.

We continued the momentum with our wellness program “A Healthier You”, which focuses on three pillars:

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.

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

To further demonstrate our focus on employee wellness, in 2023, we sponsored our first Senseonics Wellness Fair, which included speakers, workshops, and vendors to support our workplace wellness.

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.

Organizational Development

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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 celebrated our revised technical leadership pathway with a formal awards program to recognize and reward our 2023 patent inventors.

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

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

Diversity, Equity, and Inclusion

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.

Inclusion in the Workplace

As stated in our company values, our success thrives on the diversity of backgrounds, knowledge, skills, ideas, and capabilities within our workforce.

We deeply respect each other and trust the diversity we have.

We aspire to create a diverse and inclusive culture that reflects the diversity of the customers we serve and fosters an environment where all employees feel welcomed, respected, and valued.

In 2022, we began a focused diversity, equity, and inclusion, or DEI journey by reviewing demographic data for a baseline and our senior management participated in a customized DEI development program.

In 2023, we trained all employees on the basics of Diversity, Equity, and Inclusion.

With over half of our employees representing diverse ethnicities, we aspire to promote a diverse and inclusive culture that reflects the diversity of the customers we serve and fosters an environment where all employees feel welcomed, respected, and valued.

Total Rewards

We provide competitive compensation and benefits to attract and retain the best people.

We engage nationally recognized compensation and benefits consulting firms to evaluate our total rewards programs and to provide

benchmarking against our peers within the industry.

We engage nationally recognized compensation and benefits consulting firms to evaluate our total rewards programs and to provide benchmarking against our peers within the industry.

We provide our employees with market competitive pay and bonuses.

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

We offer an employee stock purchase program to all employees.

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.

7 unchanged sentences

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.

8 unchanged sentences

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