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What changed in Senseonics Holdings, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Senseonics Holdings, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+493 added−458 removedSource: 10-K (2026-03-02) vs 10-K (2025-03-03)

Top changes in Senseonics Holdings, Inc.'s 2025 10-K

493 paragraphs added · 458 removed · 340 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

112 edited+37 added−43 removed129 unchanged
Biggest changeFollowing 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.
Biggest changeIn 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) 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. ​ Background ​ Diabetes is a chronic, life-threatening disease for which there is no known cure.
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.
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 and strategic fulfillment partners, who provide the Eversense system to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement.
Over 180 subjects were enrolled in eight centers across the United States. ​ In the trial, we observed performance matching that of the 90-day Eversense system available in the United States, with MARD of 8.5%-9.6%. This result was achieved with reduced calibration, down to one per day, while also doubling the sensor life to 180 days.
Over 180 subjects were enrolled in eight centers across the United States. ​ 8 In the trial, we observed performance matching that of the 90-day Eversense system available in the United States, with MARD of 8.5%-9.6%. This result was achieved with reduced calibration, down to one per day, while also doubling the sensor life to 180 days.
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.
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.
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; 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.
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.
Manufacturers of medical devices may only benefit from the above extended 17 ​ 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.
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. ​ 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 17 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. ​ 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.
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; (2) knowingly giving or causing to be given false or misleading information reasonably expected to influence the decision to discharge a patient; (3) offering or giving remuneration to any beneficiary of a federal health care program likely to influence the receipt of reimbursable items or services; (4) arranging for reimbursable services with an entity which is excluded from participation from a federal health care program; (5) knowingly or willfully soliciting or receiving remuneration for a referral of a federal health care program beneficiary; or (6) using a payment intended for a federal health care program beneficiary for another use.
For example, the Civil Monetary Penalties Law authorizes the imposition of substantial CMPs against an entity that engages in 21 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; (2) knowingly giving or causing to be given false or misleading information reasonably expected to influence the decision to discharge a patient; (3) offering or giving remuneration to any beneficiary of a federal health care program likely to influence the receipt of reimbursable items or services; (4) arranging for reimbursable services with an entity which is excluded from participation from a federal health care program; (5) knowingly or willfully soliciting or receiving remuneration for a referral of a federal health care program beneficiary; or (6) using a payment intended for a federal health care program beneficiary for another use.
In addition, many state laws govern the privacy and security of health information in certain circumstances, many of which differ from HIPAA and each other in significant ways and may not have the same effect. ​ 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.
In addition, many state laws govern the privacy and security of health information in certain circumstances, many of which differ from HIPAA and each other in significant ways and may not have the same effect. 19 ​ 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.
Several courts 20 ​ 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.
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.
Activities that violate the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight, and debarment from government contracts. ​ UK Bribery Act and other anti-corruption laws ​ The UK Bribery Act 2010 and other applicable foreign anti-corruption laws that apply in countries where we do business, generally prohibit us and our employees and intermediaries from authorizing, promising, offering, or providing, directly or indirectly, improper or prohibited payments, or anything else of value, to government officials or other persons to obtain or retain business or gain some other business advantage.
Activities that violate the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight, and debarment from government contracts. 23 ​ UK Bribery Act and other anti-corruption laws ​ The UK Bribery Act 2010 and other applicable foreign anti-corruption laws that apply in countries where we do business, generally prohibit us and our employees and intermediaries from authorizing, promising, offering, or providing, directly or indirectly, improper or prohibited payments, or anything else of value, to government officials or other persons to obtain or retain business or gain some other business advantage.
In addition, because patent applications can take many years to issue, there may be patent applications that are currently pending and unknown to us, which may later result in issued patents that third parties could assert against us and materially and adversely affect our business. ​ Any adverse determination in litigations, post grant trial proceedings, including interference proceedings, at the Patent Office relating to intellectual property to which we are or may become a party could subject us to significant liabilities to third parties or require us to seek licenses from third parties, and result in the cancellation and/or invalidation of our intellectual property.
In addition, because patent applications can take many years to issue, there may be patent applications that are currently pending and unknown to us, which may later result in issued patents that third parties could assert against us and materially and adversely affect our business. ​ 14 Any adverse determination in litigations, post grant trial proceedings, including interference proceedings, at the Patent Office relating to intellectual property to which we are or may become a party could subject us to significant liabilities to third parties or require us to seek licenses from third parties, and result in the cancellation and/or invalidation of our intellectual property.
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. ​ 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.
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.
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. ​ 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.
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.
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. ​ ​ Seasonality ​ We anticipate that the revenue generated from our product sales will vary from quarter to quarter as we continue to commercialize Eversense.
These competitors also compete with us in recruiting 13 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. ​ ​ Seasonality ​ We anticipate that the revenue generated from our product sales will vary from quarter to quarter as we continue to commercialize Eversense.
We believe that our design, manufacturing and quality control procedures are in compliance with the FDA’s regulatory requirements. 15 ​ ​ 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 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 (“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.
Failure to comply with the UK’s Bribery Act, and other anti-corruption laws and trade control laws could subject us to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses. ​ ​ 24 ​ ​ ​ Environmental Health and Safety Regulations ​ We are also subject to various environmental health and safety rules and regulations both within the U.S. and internationally relating to pollution or protection of human health and the environment.
Failure to comply with the UK’s Bribery Act, and other anti-corruption laws and trade control laws could subject us to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses. ​ Environmental Health and Safety Regulations ​ We are also subject to various environmental health and safety rules and regulations both within the U.S. and internationally relating to pollution or protection of human health and the environment.
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.
We have designed the sensor to last up to one year, as compared to other currently available CGM sensors labeled for use for between seven and 15 days. ​ 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.
We disagree with this 11 ​ 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.
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.
We believe that, if necessary, alternative sources of supply would be available in a relatively short period of time and on commercially reasonable terms. Most of the raw materials we use in our manufacturing operations are available from more than one source. However, we obtain certain raw material components are obtained principally from one supplier.
We believe that, if necessary, alternative sources of supply would be available in a relatively short period of time and on commercially reasonable terms. Most of the raw materials we use in our manufacturing operations are available from more than one source. However, certain raw material components are obtained principally from one supplier.
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 regularly engage in development conversations with our managers and directors to reinforce best practices and ensure effective performance management ​ Inclusion in the Workplace ​ 25 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.
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 8 ​ 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.
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.
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 12 ​ systems across the United States and EEA.
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.
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 14 ​ 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.
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- 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.
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 22 ​ by both the courts and regulatory authorities, each with broad discretion.
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.
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 9 ​ fluorescence via a near field communication (“NFC”) interface to the transmitter.
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.
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 16 ​ competent Ethics Committee. This process can be expensive and time-consuming.
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.
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 22 insurers, encourages improvements in the quality of healthcare items and services and significantly impacts the medical device industry.
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 16 manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.
The mobile app also allows for cloud-based storage. ​ ​ Future Product Development ​ We intend to continue to expand our line of product offerings to benefit people with diabetes and healthcare providers.
The mobile app also allows for cloud-based storage. ​ ​ 10 Future Product Development ​ We intend to continue to expand our line of product offerings to benefit people with diabetes and healthcare providers.
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.
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 QMSR.
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.
The campaign demonstrates how Eversense 365 provides a differentiated 11 CGM option, with unparalleled flexibility and long-term use that allows it to seamlessly integrate into real life.
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 21 ​ 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.
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.
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.
All employees are issued stock options and/or restricted stock units under our broad-based stock incentive programs. We 26 ​ offer an employee stock purchase program to all employees.
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.
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. ​ 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.
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.
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. We approach the U.S. commercial third-party payor community in efforts to establish coverage for Eversense.
CGM as a class of products has been broadly accepted by commercial third-party payors, such as health insurers and health maintenance organizations, and by Medicare for patients who require the use of insulin to manage their diabetes. We approach the U.S. commercial third-party payor community in efforts to establish coverage for Eversense.
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 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.
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 ​ The federal False Claims Act provides, in part, that the federal government may bring a lawsuit against any person whom it believes has knowingly presented, or caused to be presented, a false or fraudulent request for payment from the federal government, or who has made a false statement or used a false record to get a claim approved.
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 ​ The federal False Claims Act provides, in part, that the federal government may bring a lawsuit against any person whom it believes has knowingly presented, or caused to be presented, a false or fraudulent request for payment from the federal government, or who has made a false statement or used a false record to get a claim approved.
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.
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 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. ​ In the United States, failure to comply with applicable regulatory requirements can result in enforcement actions by the FDA and other regulatory agencies.
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. ​ 18 In the United States, failure to comply with applicable regulatory requirements can result in enforcement actions by the FDA and other regulatory agencies.
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.
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.
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.
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.
If patents are issued on our pending patent applications, the resulting patents are projected to expire on dates ranging from 2033 to 2044, subject to any patent term extensions or adjustments that may be available for such patents. ​ Our patents and patent applications cover certain aspects of our core sensor technologies and our product concepts for CGM systems.
If patents are issued on our pending patent applications, the resulting patents are projected to expire on dates ranging from 2037 to 2043, subject to any patent term extensions or adjustments that may be available for such patents. ​ Our patents and patent applications cover certain aspects of our core sensor technologies and our product concepts for CGM systems.
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.
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; ● voluntary and mandatory device recalls addressing problems when a device is defective and could be a risk to health; and ● 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 18 ​ 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.
These include, but are not limited to: ​ ● 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; and ● 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 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.
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 variable interest entities.
As of December 31, 2024, we had 117 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.
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. 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.
We rely on a combination of patents, trademarks, copyrights, trade secrets as well as nondisclosure and assignment of invention agreements, material transfer agreements, confidentiality agreements and other measures to protect our intellectual property and other proprietary rights. 13 ​ ​ Patents ​ As of December 31, 2024, we held a total of approximately 482 issued patents and pending patent applications that relate to our CGM system.
We rely on a combination of patents, trademarks, copyrights, trade secrets as well as nondisclosure and assignment of invention agreements, material transfer agreements, confidentiality agreements and other measures to protect our intellectual property and other proprietary rights. ​ Patents ​ As of December 31, 2025, we held a total of approximately 504 issued patents and pending patent applications that relate to our CGM system.
The FDA evaluates compliance with the QSR through periodic unannounced inspections that may include the manufacturing facilities of our subcontractors.
The FDA evaluates compliance with the QMSR through periodic unannounced inspections that may include the manufacturing facilities of our subcontractors.
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.
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.
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.
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 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 15 FDA's satisfaction the safety and efficacy of the device.
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 ​ Protection of our intellectual property is a strategic priority for our business.
Risk Factors” in this Annual Report, including the risk factor entitled “Our product revenue is subject to seasonal variation”. ​ ​ Intellectual Property ​ Protection of our intellectual property is a strategic priority for our business.
We believe that, as we increase our demand in the future, our per unit costs will decrease materially. ​ We have received certification from BSI, our Notified Body to the International Standards Organization (“ISO”) for our quality system. This ISO 13485:2016 certification includes design control requirements.
We believe the manufacturers we currently utilize have sufficient capacity to meet our requirements. We believe that, as we increase our demand in the future, our per unit costs will decrease materially. ​ We have received certification from BSI, our Notified Body to the International Standards Organization (“ISO”) for our quality system. This ISO 13485:2016 certification includes design control requirements.
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. ​ Federal Anti-Kickback and Self-Referral Laws ​ The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, to induce either the referral of an individual, or the furnishing, recommending, or arranging of a good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid or other federal healthcare 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 ​ The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, to induce either the referral of an individual, or the furnishing, recommending, or arranging of a good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid or other federal healthcare programs.
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.
As described in this Annual Report, Ascensia had the exclusive right to distribute the Company’s Eversense system worldwide for people with diabetes prior to December 31, 2025. Ascensia began commercializing Eversense 365 in the U.S. in October 2024. Prior to that, Ascensia commercialized the Eversense E3 CGM system which was approved by the FDA in February 2022.
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: ​ ● Duration: Longest available sensor duration at up to one year. ● Convenience: Our Eversense CGM system supports the patient’s lifestyle; the smart transmitter can be removed and replaced without disturbing the sensor, strong but gentle-on-skin adhesive patches, wireless communication to patient’s mobile device or Apple Watch ®, including readings every five minutes whether the patient has their mobile device or not, remote monitoring that can be shared friends, family, and health care providers, and tracking of meals and workouts for further diabetes treatment management. ● Accuracy: Exceptional accuracy particularly in the low glucose range throughout the sensor life. ● Vibe Alerts: Added safety of an on-body vibration alert when low or high glucose threshold is reached, or importantly before low or high threshold is reached, even when the mobile device is not nearby. ● Continuous Support: Patient and healthcare provider hotline support 24/7. ​ ​ Sensor ​ The sensor is approved and CE marked to be inserted under the skin, in the upper arm, and measures the glucose in the interstitial fluid.
Eversense 365 requires once weekly fingerstick calibrations after day 13. ​ We believe our implantable CGM system offers the following advantages to support the management of diabetes: 9 ​ ● Duration: Longest available sensor duration at up to one year. ● Convenience: Our Eversense CGM system supports the patient’s lifestyle; the smart transmitter can be removed and replaced without disturbing the sensor, strong but gentle-on-skin adhesive patches, wireless communication to patient’s mobile device or Apple Watch ®, including readings every five minutes whether the patient has their mobile device or not, remote monitoring that can be shared with friends, family, and health care providers, and tracking of meals and workouts for further diabetes treatment management. ● Accuracy: Exceptional accuracy particularly in the low glucose range throughout the sensor life. ● Vibe Alerts: Added safety of an on-body vibration alert when low or high glucose threshold is reached, or importantly before low or high threshold is reached, even when the mobile device is not nearby. ● Continuous Support: Patient and healthcare provider hotline support 24/7. ​ ​ Sensor ​ The sensor is approved and CE Marked to be inserted under the skin, in the upper arm, and measures the glucose in the interstitial fluid.
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. Companies may also share truthful and not misleading information that is otherwise consistent with the labeling.
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.
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 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.
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.
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.
Our common stock is listed on the NYSE American under the symbol “SENS.” ​ ​ Available Information ​ Our website address is www.senseonics.com. In addition to the information contained in this Annual Report, information about us can be found on our website.
Our common stock is listed on the Nasdaq Global Select Market under the symbol “SENS.” ​ ​ Available Information ​ Our website address is www.senseonics.com. In addition to the information contained in this Annual Report, information about us can be found on our website.
According to the 2021 International Diabetes Federation Atlas, an estimated 537 million people worldwide had diabetes as of the date of the report.
According to the 2025 International Diabetes Federation Atlas, an estimated 589 million people worldwide had diabetes as of the date of the report.
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.
In efforts to address these priorities, we initiated the Patient Assistance and Simple Savings (“PASS”) program to provide financial assistance for patients adopting Eversense.
All of these components work together to provide sensor glucose values, trends and alerts to a user's mobile device within 20 milliseconds. We have designed this reliable, long-term and implantable CGM system to continually and accurately measure a person's glucose levels for up to one year. Eversense 365 requires once weekly fingerstick calibrations after day 13.
All of these components work together to provide sensor glucose values, trends and alerts to a user's mobile device within 20 milliseconds. We have designed this reliable, long-term and implantable CGM system to continually and accurately measure a person's glucose levels for up to one year.
Our values define the behaviors of our existing employees, and the new hires that we welcomed to our organization during 2024: ​ ● Customer Inspired emphasizes how we put the customer first while we use our talents, passion, empathy, and hard work to build technology solutions for the unmet needs of our customers. ​ ● Game-Changing Innovation affects everything we do from how we think, design, and manufacture advanced technology that makes a difference. ​ ● Learn Fast highlights our respect for the process of discovery and supports intelligent risk-taking knowing that all outcomes are learning opportunities to iterate and improve. ​ ● Thrive Together reflects the deep respect and trust in the diversity of our backgrounds, knowledge, skills, ideas and capabilities and our belief in each other and our partners to drive success. ​ ● 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.
Our values define the behaviors of our existing employees, and the new hires that we welcomed to our organization during 2025: ​ ● Customer Inspired emphasizes how we put the customer first while we use our talents, passion, empathy, and hard work to build technology solutions for the unmet needs of our customers. 24 ​ ● Game-Changing Innovation affects everything we do from how we think, design, and manufacture advanced technology that makes a difference. ● Learn Fast highlights our respect for the process of discovery and supports intelligent risk-taking knowing that all outcomes are learning opportunities to iterate and improve. ● Thrive Together reflects the deep respect and trust in the diversity of our backgrounds, knowledge, skills, ideas and capabilities and our belief in each other and our partners to drive success. ● 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.
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.
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.
People with type 1 diabetes must administer insulin, either by injection or insulin pump, to survive. People with type 2 diabetes may require diet and nutrition management, exercise, oral medications or the administration of insulin to regulate blood glucose levels.
People with type 1 diabetes must administer insulin, either by injection or insulin pump, to survive. People with type 2 diabetes may require diet and nutrition management, exercise, oral medications or the administration of insulin to regulate blood glucose levels. Type 2 diabetes is the most common type of diabetes and accounts for over 90% of all diabetes worldwide.
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 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.
Our intellectual property portfolio includes 111 issued United States patents, 194 patents issued in countries outside the United States and 177 pending patent applications worldwide. Our patents expire between 2025 and 2043, subject to any patent term extensions or adjustments that may be available for such patents.
Our intellectual property portfolio includes 122 issued United States patents, 251 patents issued in countries outside the United States and 131 pending patent applications worldwide. Our patents expire between 2026 and 2049, subject to any patent term extensions or adjustments that may be available for such patents.
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.
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.
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 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.
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. 4 ​ ​ 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.
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 4 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.
We believe that we have structured our provider arrangements to comply with current fraud and abuse law requirements. ​ 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.
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 operations and activities, including our arrangements with providers with respect to patient training.
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.
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 foreign regulatory authorities, when applicable, strictly regulate marketing, labeling, advertising and promotion of medical devices.
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.
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.
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.
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 current administration will impact the PPACA. ​ In addition, other legislative changes have been proposed and adopted since the PPACA was enacted.
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. We believe the manufacturers we currently utilize have sufficient capacity to meet our requirements.
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, 12 international regulatory requirements.
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 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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAny such issuance could result in substantial dilution to our existing stockholders and cause the trading price of our common stock to decline. ​ PHC may have the ability exert substantial influence over us in a manner adverse to your interests. ​ Subject to maintaining specified ownership thresholds, PHC continues to hold the right to designate up to two individuals to serve on our board of directors as outlined in their Investor Rights Agreement. ​ As a result, PHC may be able to significantly influence our decisions, including the election and removal of directors, any merger, consolidation, sale of all or substantially all of our assets, or other significant corporate transactions.
Biggest changeAdditionally, although PHC’s designee to the Company’s board of directors resigned from our board in connection with the execution of the Master Asset Purchase Agreement on December 31, 2025, PHC continues to have the right to designate one individual to serve on our board of directors as outlined in their Investor Rights Agreement and that right will continue as long as PHC beneficially owns in excess of 5% of our outstanding common stock. ​ As a result, PHC may be able to significantly influence our decisions, including the election and removal of directors, any merger, consolidation, sale of all or substantially all of our assets, or other significant corporate transactions.
Compliance or the actual or perceived failure to comply with such obligations could increase the costs to our products, limit their use or adoption, and otherwise negatively affect our operating results and business . ● Holders of debt instruments may exert substantial influence over us and may exercise their control in a manner adverse to the interests of our common stockholders. ​ Risks Relating to our Business and our Industry ​ We have incurred significant operating losses since inception and cannot assure you that we will ever achieve or sustain profitability . ​ Since our inception, we have incurred significant net losses and expect to incur additional losses in the near future.
Compliance or the actual or perceived failure to comply with such obligations could increase the costs of our products, limit their use or adoption, and otherwise negatively affect our operating results and business. ● Holders of debt instruments may exert substantial influence over us and may exercise their control in a manner adverse to the interests of our common stockholders. ​ Risks Relating to our Business and our Industry ​ We have incurred significant operating losses since inception and cannot assure you that we will ever achieve or sustain profitability . ​ Since our inception, we have incurred significant net losses and expect to incur additional losses in the near future.
For example, in September 2019 we voluntarily initiated a recall of Eversense sensors that had not yet been implanted, due to premature loss of function due to inadequate hydration of the sensor’s glucose-sensing surface.
For example, in September 2019 we voluntarily initiated a recall of Eversense sensors that had not yet been implanted, due to premature loss of function due to inadequate hydration of the sensor’s glucose-sensing surface.
Preparing for and complying with these obligations requires us to devote significant resources, which has in the past and may in the future necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf. ​ If we or our parties on which we rely fail to comply or are alleged to have failed to comply with applicable data privacy obligations, we could face significant consequences, including but not limited to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims) and mass arbitration demands; additional reporting requirements and/or oversight; bans on processing personal data; orders to destroy or not use personal data and imprisonment of company officials.
Preparing for and complying with these obligations requires us to devote significant resources, which has in the past and may in the future necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf. ​ If we or the parties on which we rely fail to comply or are alleged to have failed to comply with applicable data privacy obligations, we could face significant consequences, including but not limited to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims) and mass arbitration demands; additional reporting requirements and/or oversight; bans on processing personal data; orders to destroy or not use personal data and imprisonment of company officials.
Our potential inability to integrate any acquired products or technologies effectively may adversely affect our business, operating results and financial condition. ​ Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises such as pandemics, political crises, geopolitical events, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance. ​ The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including, among other things, severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates and uncertainty about economic stability, due to reasons including, among other things, political changes and trends such as protectionism, economic nationalism resulting in government actions impacting international trade agreements or imposing trade restrictions such as tariffs and retaliatory counter measures. ​ 41 ​ A widespread public health crisis such as a pandemic could result in significant disruption of global financial markets, reducing our ability to access capital, which could negatively affect our liquidity.
Our potential inability to integrate any acquired products or technologies effectively may adversely affect our business, operating results and financial condition. ​ Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises such as pandemics, political crises, geopolitical events, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance. ​ The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including, among other things, severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates and uncertainty about economic stability, due to reasons including, among other things, political changes and trends such as protectionism, economic nationalism resulting in government actions impacting international trade agreements or imposing trade restrictions such as tariffs and retaliatory counter measures. ​ A widespread public health crisis such as a pandemic could result in significant disruption of global financial markets, reducing our ability to access capital, which could negatively affect our liquidity.
Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations. ​ Any associated claims, inquiries, or investigations or other government actions could lead to unfavorable outcomes that have a material impact on our business including through significant penalties or fines, monetary judgments or settlements including criminal and civil liability for us and our officers and directors, increased compliance 57 ​ costs, delays or impediments in the development of new products, inability to process personal data or to operate in certain jurisdictions; negative publicity, increased operating costs, diversion of management time and attention, or other remedies that harm our business, including orders that we modify or cease existing business practices. ​ Moreover, governments and regulators in certain jurisdictions, including Europe, are increasingly seeking to regulate the use, transfer and other processing of non-personal information (for example, under the European Union’s Data Act).
Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations. ​ Any associated claims, inquiries, or investigations or other government actions could lead to unfavorable outcomes that have a material impact on our business including through significant penalties or fines, monetary judgments or settlements including criminal and civil liability for us and our officers and directors, increased compliance costs, delays or impediments in the development of new products, inability to process personal data or to operate in certain jurisdictions; negative publicity, increased operating costs, diversion of management time and attention, or other remedies that harm our business, including orders that we modify or cease existing business practices. ​ Moreover, governments and regulators in certain jurisdictions, including Europe, are increasingly seeking to regulate the use, transfer and other processing of non-personal information (for example, under the European Union’s Data Act).
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 that may be necessary for, our programs. ​ If we are unable to effectively compete with our competitors, we may fail to meet our strategic objectives, and our business, financial condition and operating results could be harmed. ​ Competitive products or other technological innovations for the monitoring, treatment or prevention of diabetes may render our products less competitive or obsolete. ​ Our ability to achieve our strategic objectives will depend, among other things, on our ability to develop and commercialize products for the monitoring and management of diabetes that offer distinct features, have a longer duration than available alternatives, are easy-to-use, receive adequate coverage and reimbursement from third-party payors, include essential safety features and are more appealing than available alternatives.
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 that may be necessary for, our programs. ​ If we are unable to effectively compete with our competitors, we may fail to meet our strategic objectives, and our business, financial condition and operating results could be harmed. ​ Competitive products or other technological innovations for the monitoring, treatment or prevention of diabetes may render our products less competitive or obsolete. ​ Our ability to achieve our strategic objectives will depend, among other things, on our ability to develop and commercialize products for the monitoring and management of diabetes that offer distinct features, have a longer 37 duration than available alternatives, are easy-to-use, receive adequate coverage and reimbursement from third-party payors, include essential safety features and are more appealing than available alternatives.
There are also a number of academic and other institutions involved in various phases of our industry’s technology development. ​ Many of these competitors enjoy several advantages over us, including: ​ ● greater financial and human resources for sales and marketing, and product development; ● established relationships with healthcare providers and third-party payors; ● established reputation and name recognition among healthcare providers and other key opinion leaders in the diabetes industry; ● in some cases, an established base of long-time customers; ● products supported by long-term clinical data; ● larger and more established sales, marketing and distribution networks; ● greater ability to cross-sell products or provide incentives to healthcare providers to use their products; and ● more experience in conducting research and development, manufacturing, clinical trials, and obtaining regulatory approval or clearance and certification. ​ 37 ​ In addition, mergers and acquisitions in the diabetes industry may result in even more resources being concentrated among a smaller number of our competitors.
There are also a number of academic and other institutions involved in various phases of our industry’s technology development. ​ Many of these competitors enjoy several advantages over us, including: ​ ● greater financial and human resources for sales and marketing, and product development; ● established relationships with healthcare providers and third-party payors; ● established reputation and name recognition among healthcare providers and other key opinion leaders in the diabetes industry; ● in some cases, an established base of long-time customers; ● products supported by long-term clinical data; ● larger and more established sales, marketing and distribution networks; ● greater ability to cross-sell products or provide incentives to healthcare providers to use their products; and ● more experience in conducting research and development, manufacturing, clinical trials, and obtaining regulatory approval or clearance and certification. ​ In addition, mergers and acquisitions in the diabetes industry may result in even more resources being concentrated among a smaller number of our competitors.
Even if we are able to successfully develop future versions of Eversense when anticipated, these products may not produce sales in excess of the costs of development, and they may be quickly rendered obsolete by the changing preferences of people with diabetes or the introduction by our competitors of products embodying new technologies or features. ​ Failure to secure or retain coverage or adequate reimbursement for Eversense or future versions of Eversense systems, including the related insertion and removal procedures, by third-party payors, and an inability of patients to be able to access the product, could adversely affect our business, financial condition and operating results. ​ We plan to derive nearly all of our revenue from sales of Eversense in the United States and Europe and expect to do so for the next several years.
Even if we are able to successfully develop future versions of Eversense when anticipated, these products may not produce sales in excess of the costs of development, and they may be quickly rendered obsolete by the changing preferences of people with diabetes or the introduction by our competitors of products embodying new technologies or features. ​ Failure to secure or retain coverage or adequate reimbursement for Eversense or future versions of Eversense systems, including the related insertion and removal procedures, by third-party payors, and an inability of patients to be able to access the product, could adversely affect our business, financial condition and operating results. ​ We derive nearly all of our revenue from sales of Eversense in the United States and Europe and expect to do so for the next several years.
In addition, because patent applications can take many years to issue, there may be patent applications that are currently pending and unknown to us, which may later result in issued patents that third parties could assert against us and harm our business. ​ In preparation for commercializing our Eversense products, we are performing an analysis, the purpose of which is to review and assess publicly available information to determine whether third parties hold any valid patent rights that a well-informed court would more likely than not find that we would infringe by commercializing our products, understanding that there are risks and uncertainties associated with any litigation and no predictions or 49 ​ assurances can be made regarding the outcome of any such litigation.
In addition, because patent applications can take many years to issue, there may be patent applications that are currently pending and unknown to us, which may later result in issued patents that third parties could assert against us and harm our business. ​ In preparation for commercializing our Eversense products, we are performing an analysis, the purpose of which is to review and assess publicly available information to determine whether third parties hold any valid patent rights that a well-informed court would more likely than not find that we would infringe by commercializing our products, understanding that there are risks and uncertainties associated with any litigation and no predictions or assurances can be made regarding the outcome of any such litigation.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, including, without limitation, damages, fines, disgorgement of profits, individual imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, and the curtailment or restructuring of our operations. ​ We may incur product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses. ​ Our business exposes us to potential product liability claims that are inherent in the design, manufacture, testing and sale of medical devices.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, including, without limitation, damages, fines, disgorgement of profits, individual imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, and the curtailment or restructuring of our operations. ​ ​ ​ ​ 48 We may incur product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses. ​ Our business exposes us to potential product liability claims that are inherent in the design, manufacture, testing and sale of medical devices.
You should review and consider carefully the risks and uncertainties described in the “Risk Factors” section of this Annual Report on Form 10-K, which includes a more complete discussion of the risks 27 ​ summarized below as well as a discussion of other risks related to our business and an investment in our common stock, as well as our other public filings with the Securities and Exchange Commission, or SEC. ​ Any of the following risks could have a material adverse effect on our business, financial condition, results of operations and prospects and cause the trading price of our common stock to decline: ​ ● We have incurred significant operating losses since inception and cannot assure you that we will ever achieve or sustain profitability.
You should review and consider carefully the risks and uncertainties described in the “Risk Factors” section of this Annual Report on Form 10-K, which includes a more complete discussion of the risks summarized below as well as a discussion of other risks related to our business and an investment in our common stock, as well as our other public filings with the Securities and Exchange Commission, or SEC. ​ Any of the following risks could have a material adverse effect on our business, financial condition, results of operations and prospects and cause the trading price of our common stock to decline: ​ ● We have incurred significant operating losses since inception and cannot assure you that we will ever achieve or sustain profitability.
The success of Eversense or future versions of Eversense will depend on numerous factors, including our ability, and the ability of our commercial partners, to: ​ ● identify the product features that people with diabetes, their caregivers and healthcare providers are seeking in a CGM system and successfully incorporate those features into our products; ● develop and introduce future generations of Eversense in a timely manner; ● offer products at a price that is competitive with other products then available; ● adequately protect our intellectual property and avoid infringing upon the intellectual property rights of third parties; ● demonstrate the accuracy and safety of Eversense or future versions of Eversense; ● obtain coverage and adequate reimbursement for Eversense or future versions of Eversense and the related insertion and removal procedures; and 34 ​ ● obtain the necessary regulatory approvals or certifications for Eversense and future versions of Eversense.
The success of Eversense or future versions of Eversense will depend on numerous factors, including our ability, and the ability of our commercial partners, to: ​ ● identify the product features that people with diabetes, their caregivers and healthcare providers are seeking in a CGM system and successfully incorporate those features into our products; ● develop and introduce future generations of Eversense in a timely manner; ● offer products at a price that is competitive with other products then available; ● adequately protect our intellectual property and avoid infringing upon the intellectual property rights of third parties; ● demonstrate the accuracy and safety of Eversense or future versions of Eversense; ● obtain coverage and adequate reimbursement for Eversense or future versions of Eversense and the related insertion and removal procedures; and ● obtain the necessary regulatory approvals or certifications for Eversense and future versions of Eversense.
Accordingly, healthcare providers may not recommend Eversense unless and until there is sufficient evidence to convince them to alter the treatment methods they typically recommend, such as receiving recommendations from prominent healthcare providers or other key opinion leaders in the diabetes treatment community. ​ If we are not successful in educating people with diabetes of the benefits of Eversense, or if we are unable to achieve the support of caregivers and healthcare providers or widespread market acceptance for Eversense, then our sales 32 ​ potential, strategic objectives and profitability could be negatively impacted, which would adversely affect our business, financial condition and operating results. ​ We contract with third parties for the manufacture of Eversense.
Accordingly, healthcare providers may not recommend Eversense unless and until there is sufficient evidence to convince them to alter the treatment methods they typically recommend, such as receiving recommendations from prominent healthcare providers or other key opinion leaders in the diabetes treatment community. ​ If we are not successful in educating people with diabetes of the benefits of Eversense, or if we are unable to achieve the support of caregivers and healthcare providers or widespread market acceptance for Eversense, then our sales potential, strategic objectives and profitability could be negatively impacted, which would adversely affect our business, financial condition and operating results. ​ We contract with third parties for the manufacture of Eversense.
Moreover, clinical data is often susceptible to varying interpretations and analyses, and many companies that have believed their products performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval or certification. ​ If we are unable to successfully complete clinical trials of Eversense or other testing, if the results of these trials or tests are not favorable or if there are safety concerns, we may: ​ ● not obtain marketing approval or certification for such modifications; ● be delayed in obtaining marketing approval or certification for such modifications; ● be subject to additional post-marketing testing requirements; or ● have Eversense removed from the market after obtaining marketing approval. 45 ​ ​ Our development costs will also increase if we experience delays in testing, marketing approvals, or certification.
Moreover, clinical data is often susceptible to varying interpretations and analyses, and many companies that have believed their products performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval or certification. ​ If we are unable to successfully complete clinical trials of Eversense or other testing, if the results of these trials or tests are not favorable or if there are safety concerns, we may: ​ ● not obtain marketing approval or certification for such modifications; ● be delayed in obtaining marketing approval or certification for such modifications; ● be subject to additional post-marketing testing requirements; or ● have Eversense removed from the market after obtaining marketing approval. ​ Our development costs will also increase if we experience delays in testing, marketing approvals, or certification.
You may not receive a gain on your investment when you sell shares and you may lose the entire amount of the investment. ​ 63 ​ Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result. ​ There are provisions in our certificate of incorporation and bylaws that may make it difficult for a third party to acquire, or attempt to acquire, control of our company, even if a change of control was considered favorable by some or all of our stockholders.
You may not receive a gain on your investment when you sell shares and you may lose the entire amount of the investment. ​ Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result. ​ There are provisions in our certificate of incorporation and bylaws that may make it difficult for a third party to acquire, or attempt to acquire, control of our company, even if a change of control was considered favorable by some or all of our stockholders.
Our operating results may be adversely impacted if we are unable to obtain successful appeals or favorable coverage decisions by insurance providers, or if there are not effective patient access programs in place. ​ ​ ​ ​ 36 ​ If important assumptions we have made about what people with intensively managed diabetes are seeking in a CGM system are inaccurate, our business and operating results may be adversely affected. ​ Our business strategy was developed based on a number of important assumptions about the diabetes industry in general, and the diabetes market for CGM in particular, any one or more of which may prove to be inaccurate.
Our operating results may be adversely impacted if we are unable to obtain successful appeals or favorable coverage decisions by insurance providers, or if there are not effective patient access programs in place. ​ If important assumptions we have made about what people with intensively managed diabetes are seeking in a CGM system are inaccurate, our business and operating results may be adversely affected. ​ Our business strategy was developed based on a number of important assumptions about the diabetes industry in general, and the diabetes market for CGM in particular, any one or more of which may prove to be inaccurate.
Market acceptance and adoption of Eversense depends on educating people with diabetes, as well as their caregivers and healthcare providers, as to the distinct features, ease-of-use, positive lifestyle impact, and other perceived benefits of Eversense as compared to competitive products. ​ Achieving and maintaining market acceptance of Eversense could be negatively impacted by many factors, including: ​ ● the failure of Eversense to achieve wide acceptance among people with diabetes, their caregivers, healthcare providers, third-party payors and key opinion leaders in the diabetes treatment community; ● lack of evidence supporting the accuracy, duration, safety, ease-of-use or other perceived benefits of Eversense over competitive products or other currently available diabetes management therapies; ● perceived risks associated with the use of Eversense or similar products or technologies generally; ● the introduction of competitive products and the rate of acceptance of those products as compared to Eversense; ● adverse results of clinical trials relating to Eversense or similar competitive products; ● loss of regulatory approval or CE Certificates of Conformity for Eversense, adverse publicity or other adverse events including any product liability lawsuits; and ● any limitations in the ability of Ascensia to effectively communicate and promote product benefits. ​ In addition, Eversense may be perceived by people with diabetes, their caregivers or healthcare providers to be more complicated or less effective than traditional monitoring methodologies, including SMBG or CGM systems which may require less calibration, and people may be unwilling to change their current regimens. ​ Moreover, healthcare providers tend to be slow to change their medical treatment practices because of perceived liability risks arising from the use of new products and the uncertainty of third-party payor reimbursement.
Market acceptance and adoption of Eversense depends on educating people with diabetes, as well as their caregivers and healthcare providers, as to the distinct features, ease-of-use, positive lifestyle impact, and other perceived benefits of Eversense as compared to competitive products. ​ Achieving and maintaining market acceptance of Eversense could be negatively impacted by many factors, including: ​ ● the failure of Eversense to achieve wide acceptance among people with diabetes, their caregivers, healthcare providers, third-party payors and key opinion leaders in the diabetes treatment community; ● lack of evidence supporting the accuracy, duration, safety, ease-of-use or other perceived benefits of Eversense over competitive products or other currently available diabetes management therapies; ● perceived risks associated with the use of Eversense or similar products or technologies generally; ● the introduction of competitive products and the rate of acceptance of those products as compared to Eversense; ● adverse results of clinical trials relating to Eversense or similar competitive products; ● loss of regulatory approval or CE Certificates of Conformity for Eversense, adverse publicity or other adverse events including any product liability lawsuits; and ● any limitations in our ability to effectively communicate and promote product benefits. ​ In addition, Eversense may be perceived by people with diabetes, their caregivers or healthcare providers to be more complicated or less effective than traditional monitoring methodologies, including SMBG or CGM systems which may require less calibration, and people may be unwilling to change their current regimens. ​ Moreover, healthcare providers tend to be slow to change their medical treatment practices because of perceived liability risks arising from the use of new products and the uncertainty of third-party payor reimbursement.
If the actual number of people with diabetes who would benefit from Eversense and the size and future growth in the market for Eversense is smaller than we have estimated, it may impair our projected sales growth and have an adverse impact on our business. ​ ​ 38 ​ Our ability to maintain and grow our revenue will depend on establishing a customer base and retaining a high percentage of our customer base. ​ A key to maintaining and growing our revenue will be establishing a customer base and retaining a high percentage of our customers due to the potentially significant revenue generated from ongoing purchases of disposable sensors.
If the actual number of people with diabetes who would benefit from Eversense and the size and future growth in the market for Eversense is smaller than we have estimated, it may impair our projected sales growth and have an adverse impact on our business. ​ Our ability to maintain and grow our revenue will depend on establishing a customer base and retaining a high percentage of our customer base. ​ A key to maintaining and growing our revenue will be establishing a customer base and retaining a high percentage of our customers due to the potentially significant revenue generated from ongoing purchases of disposable sensors.
The occurrence of any of these events may harm our business, financial condition and operating results. ​ 48 ​ Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. ​ Periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and applications will be due to be paid to the United States Patent and Trademark Office (“USPTO”) the European Patent Office (“EPO”), and other foreign patent agencies over the lifetime of our owned patents and applications.
The occurrence of any of these events may harm our business, financial condition and operating results. ​ Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. ​ Periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and applications will be due to be paid to the United States Patent and Trademark Office (“USPTO”) the European Patent Office (“EPO”), and other foreign patent agencies over the lifetime of our owned patents and applications.
Failure of any of our suppliers to deliver components at the level our business requires could disrupt the manufacturing of our products and limit our ability to meet our sales commitments, which could harm our reputation and adversely affect our business. ​ We may also have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or other foreign regulatory authorities, and the failure of our suppliers to comply with strictly enforced regulatory requirements could expose us to regulatory action including warning letters, product recalls, and termination of distribution, product seizures or civil penalties.
Failure of any of our suppliers to deliver components at the level our business requires could disrupt the manufacturing of our products and limit our ability to meet our sales commitments, which could harm our reputation and adversely affect our business. ​ 33 We may also have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or other foreign regulatory authorities, and the failure of our suppliers to comply with strictly enforced regulatory requirements could expose us to regulatory action including warning letters, product recalls, and termination of distribution, product seizures or civil penalties.
Risks associated with the manufacturing of our products, loss of key suppliers or disruption to their facilities could reduce our gross margins and negatively affect our operating results. ● We operate in a regulated industry and our business, operations and the business and operations of our third-party manufacturers are subject to various foreign, U.S. federal, state and local laws and regulations, including those promulgated by the FDA and equivalent foreign regulatory authorities, among others.
Risks associated with the manufacturing of our products, loss of key suppliers or disruption to their facilities could reduce our gross margins and negatively affect our operating results. 27 ● We operate in a regulated industry and our business, operations and the business and operations of our third-party manufacturers are subject to various foreign, U.S. federal, state and local laws and regulations, including those promulgated by the FDA and equivalent foreign regulatory authorities, among others.
Security incidents and attendant consequences may prevent or cause customers to stop using our products, deter new customers from using our products, and negatively impact our ability to grow and operate our business. ​ Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.
Security incidents and attendant consequences 61 may prevent or cause customers to stop using our products, deter new customers from using our products, and negatively impact our ability to grow and operate our business. ​ Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.
The changes to the regulatory system implemented in the EU by the Medical Device Regulation include stricter requirements for clinical evidence and pre-market assessment of safety and performance, new classifications to 60 ​ indicate risk levels, requirements for third party testing by Notified Bodies, tightened and streamlined quality management system assessment procedures and additional requirements for the quality management system, additional requirements for traceability of products and transparency as well as a refined responsibility of economic operators.
The changes to the regulatory system implemented in the EU by the Medical Device Regulation include stricter requirements for clinical evidence and pre-market assessment of safety and performance, new classifications to indicate risk levels, requirements for third party testing by Notified Bodies, tightened and streamlined quality management system assessment procedures and additional requirements for the quality management system, additional requirements for traceability of products and transparency as well as a refined responsibility of economic operators.
These agencies review our design and manufacturing practices, labeling, record keeping, manufacturers’ required reports of adverse experiences and other information to identify potential problems with marketed medical devices. We are subject to unannounced device inspections by Notified Bodies, as well as other regulatory authorities overseeing the implementation and adherence of applicable regulations. These inspections may include our suppliers’ facilities.
These agencies review 63 our design and manufacturing practices, labeling, record keeping, manufacturers’ required reports of adverse experiences and other information to identify potential problems with marketed medical devices. We are subject to unannounced device inspections by Notified Bodies, as well as other regulatory authorities overseeing the implementation and adherence of applicable regulations. These inspections may include our suppliers’ facilities.
These actions could disrupt the employee base, our ability to attract and retain qualified personnel, or cause other operational and administrative inefficiencies. 46 ​ Our employees, independent contractors, consultants, manufacturers and distributors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements. ​ We are exposed to the risk that our employees, independent contractors, consultants, manufacturers and distributors may engage in fraudulent conduct or other illegal activity.
These actions could disrupt the employee base, our ability to attract and retain qualified personnel, or cause other operational and administrative inefficiencies. ​ Our employees, independent contractors, consultants, manufacturers and distributors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements. ​ We are exposed to the risk that our employees, independent contractors, consultants, manufacturers and distributors may engage in fraudulent conduct or other illegal activity.
The process of obtaining regulatory approvals or certifications to market a medical device can be costly and time-consuming, and we may not be able to obtain these approvals or certifications on a timely basis, or at all for our products. ​ If the FDA requires us to go through a more rigorous examination for future products or modifications to existing products than we had expected, our product introductions or modifications could be delayed or canceled, which could cause our sales to decline or to not increase in line with our expectations. ​ The FDA or comparable foreign regulatory authorities and Notified Bodies can delay, limit or deny approval or certification of a device for many reasons, including: ​ ● we may not be able to demonstrate that our products are safe and effective for their intended users; ● the data from our clinical trials may be insufficient to support approval or certification; and ● the manufacturing process or facilities we use may not meet applicable requirements. ​ In addition, the FDA or comparable foreign regulatory authorities may change approval or certification policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval or certification of our product modifications under development. ​ Any delay in, or failure to receive or maintain, approval or certifications for our products could prevent us from generating revenue from these products or achieving profitability. ​ If we or our third-party suppliers fail to comply with the FDA's or other foreign regulatory authorities’ good manufacturing practice regulations, this could impair our ability to market our products in a cost-effective and timely manner. ​ 52 ​ We and our third-party suppliers are required to comply with the FDA's QSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products.
The process of obtaining regulatory approvals or certifications to market a medical device can be costly and time-consuming, and we may not be able to obtain these approvals or certifications on a timely basis, or at all for our products. ​ If the FDA requires us to go through a more rigorous examination for future products or modifications to existing products than we had expected, our product introductions or modifications could be delayed or canceled, which could cause our sales to decline or to not increase in line with our expectations. ​ The FDA or comparable foreign regulatory authorities and Notified Bodies can delay, limit or deny approval or certification of a device for many reasons, including: ​ ● we may not be able to demonstrate that our products are safe and effective for their intended users; ● the data from our clinical trials may be insufficient to support approval or certification; and ● the manufacturing process or facilities we use may not meet applicable requirements. ​ In addition, the FDA or comparable foreign regulatory authorities may change approval or certification policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay approval or certification of our product modifications under development. ​ Any delay in, or failure to receive or maintain, approval or certifications for our products could prevent us from generating revenue from these products or achieving profitability. ​ If we or our third-party suppliers fail to comply with the FDA's or other foreign regulatory authorities’ good manufacturing practice regulations, this could impair our ability to market our products in a cost-effective and timely manner. ​ We and our third-party suppliers are required to comply with the FDA's QMSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products.
Obtaining variation of existing CE Certificates of Conformity or a new Certificate can be a time-consuming process, and delays in obtaining required future clearances or approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth. ​ Medical device development involves a lengthy and expensive process, with an uncertain outcome.
Obtaining variation of existing CE Certificates of Conformity or a new Certificate can be a time-consuming process, and delays in obtaining required future clearances or approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth. 46 Medical device development involves a lengthy and expensive process, with an uncertain outcome.
Departments of Justice, Commerce, State and Treasury and other federal agencies and authorities have a broad range of civil and 53 ​ criminal penalties they may seek to impose against corporations and individuals for violations of economic sanctions laws, export control laws, the Foreign Corrupt Practices Act (“FCPA”) and other federal statutes and regulations, including those established by the Office of Foreign Assets Control (“OFAC”).
Departments of Justice, Commerce, State and Treasury and other federal agencies and authorities have a broad range of civil and criminal penalties they may seek to impose against corporations and individuals for violations of economic sanctions laws, export control laws, the Foreign Corrupt Practices Act (“FCPA”) and other federal statutes and regulations, including those established by the Office of Foreign Assets Control (“OFAC”).
Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework, these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer 56 ​ personal data to the United States.
Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework). These mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States.
Although we intend to train our marketing and direct sales force to not promote our 59 ​ products for uses outside of their cleared uses and our policy will be to refrain from statements that could be considered off-label promotion of our products, the FDA competent authorities of the EEA countries, or another regulatory agency could disagree and conclude that we have engaged in off-label promotion.
Although we intend to train our marketing and direct sales force to not promote our products for uses outside of their cleared uses and our policy will be to refrain from statements that could be considered off-label promotion of our products, the FDA competent authorities of the EEA countries, or another regulatory agency could disagree and conclude that we have engaged in off-label promotion.
If we do not achieve one or more of these approvals, or certifications in a timely manner or at all, we could experience significant delays or an inability to fully commercialize Eversense and achieve profitability. ​ Both before and after a product is commercially released, we will have ongoing responsibilities under U.S. and EU regulations.
If we do not achieve one or more of these approvals, or certifications in a timely manner or at all, we could experience significant delays or an inability to fully commercialize Eversense and achieve profitability. ​ ​ 30 Both before and after a product is commercially released, we will have ongoing responsibilities under U.S. and EU regulations.
We note that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. ​ These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage lawsuits against us and our directors, officers and other employees.
We note that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. ​ These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage lawsuits against 67 us and our directors, officers and other employees.
Moreover, we have not previously performed an exhaustive review of this type, and we cannot be certain that it will not result in our locating patent rights relating to our products of which we were not previously aware. ​ In the future, we could receive communications from various industry participants alleging our infringement of their intellectual property rights.
Moreover, we have not previously performed an exhaustive review of this type, and we cannot be certain that it will not result in our locating patent rights relating to our products of which we were not previously aware. ​ 51 In the future, we could receive communications from various industry participants alleging our infringement of their intellectual property rights.
In addition, 35 ​ those third-party payors that cover CGM products may and have included limitations as to the patient conditions and characteristics eligible for coverage and may adopt different coverage and reimbursement policies for our products, which could also diminish payments for Eversense. It is possible that some third-party payors will not offer any coverage for our products.
In addition, those third-party payors that cover CGM products may and have included limitations as to the patient conditions and characteristics eligible for coverage and may adopt different coverage and reimbursement policies for our products, which could also diminish payments for Eversense. It is possible that some third-party payors will not offer any coverage for our products.
Our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments in competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make and sell our products.
Our competitors in both the United States and 50 abroad, many of which have substantially greater resources and have made substantial investments in competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make and sell our products.
In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised. ​ 58 ​ While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective.
In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised. ​ While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective.
Additionally, our suppliers may encounter problems that limit their ability to supply components or manufacture products for us, 33 ​ including financial difficulties, damage to their manufacturing equipment or facilities, or product discontinuations. As a result, there is a risk that certain components could be discontinued and no longer available to us.
Additionally, our suppliers may encounter problems that limit their ability to supply components or manufacture products for us, including financial difficulties, damage to their manufacturing equipment or facilities, or product discontinuations. As a result, there is a risk that certain components could be discontinued and no longer available to us.
For example, we have one pending foreign application for the "Eversense Now" trademark relating to our mobile application. We cannot assure you that our trademark applications will be approved in a timely manner or at all. Third parties also may oppose our trademark applications, or otherwise challenge our use of the trademarks.
For example, we have one pending foreign application for the "Eversense Now" trademark relating to our mobile application. We cannot assure you that our 49 trademark applications will be approved in a timely manner or at all. Third parties also may oppose our trademark applications, or otherwise challenge our use of the trademarks.
Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations. We publish privacy policies, whitepapers and other statements concerning data privacy and security.
Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations. We publish privacy policies, and other statements concerning data privacy and security.
Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK or other jurisdictions to the United States in compliance with law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S.
Although there are currently various 58 mechanisms that may be used to transfer personal data from the EEA and UK or other jurisdictions to the United States in compliance with law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S.
In order to sell Eversense to people with diabetes, we and Ascensia must educate them, their caregivers and healthcare providers that Eversense is an attractive alternative to competitive products for the monitoring of glucose levels, including SMBG, as well as other competitive CGM systems and alternatives to CGM methodologies.
In order to sell Eversense to people with diabetes, we must educate them, their caregivers and healthcare providers that Eversense is an attractive alternative to competitive products for the monitoring of glucose levels, including SMBG, as well as other competitive CGM systems and alternatives to CGM methodologies.
We may 39 ​ also be subject to increased warranty and liability claims for damages related to errors or defects in Eversense or future versions of Eversense. A material liability claim or other occurrence that harms our reputation or decreases market acceptance of Eversense could harm our business and operating results.
We may also be subject to increased warranty and liability claims for damages related to errors or defects in Eversense or future versions of Eversense. A material liability claim or other occurrence that harms our reputation or decreases market acceptance of Eversense could harm our business and operating results.
Department of Justice has recently increased its scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing with investigations can be time and resource consuming and can divert management's attention from our core business.
Department of Justice has increased its scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing with investigations can be time and resource consuming and can divert management's attention from our core business.
Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business. ​ We are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security.
Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business. ​ ​ ​ 57 We are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects. ​ 50 ​ We are subject to the patent laws of countries other than the United States, which may not offer the same level of patent protection and whose rules could seriously affect how we draft, file, prosecute and maintain patents, trademarks and patent and trademark applications. ​ Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties (for example, the patent owner has failed to "work" the invention in that country, or the third party has patented improvements).
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects. ​ We are subject to the patent laws of countries other than the United States, which may not offer the same level of patent protection and whose rules could seriously affect how we draft, file, prosecute and maintain patents, trademarks and patent and trademark applications. ​ 52 Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties (for example, the patent owner has failed to "work" the invention in that country, or the third party has patented improvements).
If any of the following events actually occur or risks actually materialize, it could have a material adverse effect on our business, operating results and financial condition and cause the trading price of our common stock to decline. ​ Summary of Risks Affecting Our Business ​ Our business is subject to numerous risks.
If any of the following events actually occur or risks actually materialize, it could have a material adverse effect on our business, operating results and financial condition and cause the trading price of our common stock to decline. ​ 26 Summary of Risks Affecting Our Business ​ Our business is subject to numerous risks.
If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited. ​ Although it will be subject to restrictions on trading, a portion of the equity of our management team will not contain other contractual transfer restrictions.
If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited. 47 ​ Although it will be subject to restrictions on trading, a portion of the equity of our management team will not contain other contractual transfer restrictions.
Given this heterogeneity, we will have to work closely with certified clinics to keep abreast of which process to follow and what to expect. This will be disruptive to some clinics and could delay product uptake until the process of payment becomes more homogenous and well defined for clinics to follow.
Given this heterogeneity, we will have to work closely with certified clinics to keep abreast of which process to follow 35 and what to expect. This will be disruptive to some clinics and could delay product uptake until the process of payment becomes more homogenous and well defined for clinics to follow.
The Loan and Security Agreement also contains customary events of default, after which borrowings under the Loan and Security Agreement will be due and payable immediately, including defaults related to payment compliance, material inaccuracy of representations and warranties, covenant compliance, material adverse changes, bankruptcy and insolvency proceedings, cross defaults to certain other agreements, judgments against the Company, change of control or delisting events, termination of any guaranty, governmental approvals, and lien priority. ​ As a result, we are limited in the manner in which we conduct our business and we may be unable to engage in favorable business activities, repurchase shares of our common stock or finance future operations or capital needs. ​ ​ ​ 43 ​ Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt. ​ Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control.
The Amended Loan and Security Agreement also contains customary events of default, after which borrowings under the term loan will be due and payable immediately, including defaults related to payment compliance, material inaccuracy of representations and warranties, covenant compliance, material adverse changes, bankruptcy and insolvency proceedings, cross defaults to certain other agreements, judgments against the Company, change of control or delisting events, termination of any guaranty, governmental approvals, and lien priority. ​ As a result, we are limited in the manner in which we conduct our business and we may be unable to engage in favorable business activities, repurchase shares of our common stock or finance future operations or capital needs. ​ Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt. ​ Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control.
Our business strategy depends on our third-party manufacturers' ability to manufacture Eversense in sufficient quantities and on a timely basis so as to meet consumer demand, while adhering to product quality standards, complying with regulatory requirements and managing manufacturing costs.
Our business strategy depends on our third-party manufacturers' ability to manufacture Eversense in sufficient quantities and on a timely basis so as to meet consumer demand, while adhering to product quality standards, complying 32 with regulatory requirements and managing manufacturing costs.
While we do not believe that, as a general matter, such a claim would have merit, the possibility of an adverse result to the manufacturer cannot be dismissed, and in any event, we could incur significant defense costs.
While we do not believe that, as a general matter, such a claim would have merit, the possibility of an adverse result to the manufacturer cannot be dismissed, and in any event, we could incur significant 62 defense costs.
The failure to retain a high percentage of our customers would negatively impact our business, financial condition and operating results. ​ Various factors outside our direct control may adversely affect manufacturing, sterilization and distribution of our products. ​ The manufacture, sterilization and distribution of our products is challenging.
The failure to retain a high percentage of our customers would negatively impact our business, financial condition and operating results. ​ ​ ​ ​ 38 Various factors outside our direct control may adversely affect manufacturing, sterilization and distribution of our products. ​ The manufacture, sterilization and distribution of our products is challenging.
Additionally, if we settle an investigation with law enforcement or other regulatory agencies, we may be forced to agree to additional onerous 55 ​ compliance and reporting requirements as part of a consent decree or corporate integrity agreement.
Additionally, if we settle an investigation with law enforcement or other regulatory agencies, we may be forced to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement.
Discovery of previously unknown problems with our product's design or manufacture may result in restrictions on the use of Eversense, restrictions placed on us or our suppliers, or withdrawal or variation of an existing regulatory clearance 31 ​ or CE Certificate of Conformity for Eversense.
Discovery of previously unknown problems with our product’s design or manufacture may result in restrictions on the use of Eversense, restrictions placed on us or our suppliers, or withdrawal or variation of an existing regulatory clearance or CE Certificate of Conformity for Eversense.
These licensors may determine not to pursue litigation against other companies or may pursue such litigation less aggressively than we would. Further, entering into such license agreements could impose various diligence, commercialization, royalty or other obligations on us.
These licensors may 40 determine not to pursue litigation against other companies or may pursue such litigation less aggressively than we would. Further, entering into such license agreements could impose various diligence, commercialization, royalty or other obligations on us.
These governmental authorities enforce laws and regulations that are meant to assure product safety and effectiveness, including the regulation of, among other things: ​ ● product design and development; 51 ​ ● preclinical studies and clinical trials; ● product safety; ● establishment registration and product listing; ● labeling and storage; ● marketing, manufacturing, sales and distribution; ● pre-market clearance, certification or approval; ● servicing and post-market surveillance; ● advertising and promotion; and ● recalls and field safety corrective actions. ​ The regulations to which we are subject are complex and have tended to become more stringent over time.
These governmental authorities enforce laws and regulations that are meant to assure product safety and effectiveness, including the regulation of, among other things: ​ ● product design and development; ● preclinical studies and clinical trials; ● product safety; ● establishment registration and product listing; ● labeling and storage; 53 ● marketing, manufacturing, sales and distribution; ● pre-market clearance, certification or approval; ● servicing and post-market surveillance; ● advertising and promotion; and ● recalls and field safety corrective actions. ​ The regulations to which we are subject are complex and have tended to become more stringent over time.
Subject to compliance with applicable rules and regulations, we may issue our shares of common stock, including securities convertible into common stock, in connection with a financing, acquisition, investment, our equity incentive plans or otherwise.
Subject to compliance with applicable rules and regulations, we may issue our shares of common stock, including securities convertible into common stock, in connection with a financing, acquisition, investment, our equity incentive 65 plans or otherwise.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including significant civil, criminal, and administrative penalties, damages, fines, disgorgement of profits, imprisonment, exclusion from governmental health care programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including significant civil, criminal, and administrative penalties, damages, fines, disgorgement of profits, imprisonment, exclusion from governmental health care programs, such as Medicare and Medicaid, payment denials, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.
Any delays in our anticipated product launches may significantly impede our ability to successfully compete in our markets. In particular, such delays could cause customers to delay or forego purchases of our products, or to purchase our competitors' products.
Any delays in our anticipated product launches may significantly impede our ability to successfully 34 compete in our markets. In particular, such delays could cause customers to delay or forego purchases of our products, or to purchase our competitors' products.
Governments have passed and are likely to pass additional laws regulating generative AI. Our use of this technology could result in additional compliance costs, regulatory investigations and actions, and lawsuits.
Governments have passed and are likely to pass additional laws and regulations regulating generative AI. Our use of this technology could result in additional compliance costs, regulatory investigations and actions, and lawsuits.
The government may assert 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 false claims statutes; ● HIPAA, and its implementing regulations, which created federal criminal and civil statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● HIPAA, as amended by HITECH, and their implementing regulations, which also imposes obligations on “covered entities,” including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective “business associates” that create, receive, maintain or transmit individually identifiable health 54 ​ information for or on behalf of a covered entity and their subcontractors, regarding the privacy, security and transmission of such individually identifiable health information; ● federal "sunshine" requirements imposed by the PPACA, on device manufacturers regarding the annual reporting to CMS, of any "transfer of value" made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners, and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members.
The government may assert 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 false claims statutes; ● HIPAA, and its implementing regulations, which created federal criminal and civil statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● HIPAA, as amended by HITECH, and their implementing regulations, which also imposes obligations on “covered entities,” including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective “business associates” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity and their subcontractors, regarding the privacy, security and transmission of such individually identifiable health information; ● federal "sunshine" requirements, under the Physician Payments Sunshine Act, imposed by the PPACA, on device manufacturers regarding the annual reporting to CMS, of any "transfer of value" made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), other healthcare 56 professionals (such as physician assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members.
As a result, the attributes we incorporated into the Eversense system may not be reflective of what is desired by the various constituents in the diabetes market.
As a result, the attributes we incorporated into the Eversense system may not be reflective of what is desired by the various constituents 36 in the diabetes market.
If any conflicts arise with any future collaborators, they may act in their self-interest, which may be adverse to our best interest, and they may 40 ​ breach their obligations to us.
If any conflicts arise with any future collaborators, they may act in their self-interest, which may be adverse to our best interest, and they may breach their obligations to us.
Significant clinical trial delays also could allow our competitors to bring innovative products to market before we do and impair our ability to successfully commercialize our products. ​ Risks Related to Employee Matters and Managing our Growth ​ Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel. ​ We are highly dependent on the management, research and development, clinical, financial and business development expertise of Tim Goodnow, our Chief Executive Officer, Rick Sullivan, our Chief Financial Officer, Mukul Jain, our Chief Operating Officer, and Ken Horton, our General Counsel and Corporate Development Advisor, as well as the other members of our scientific and clinical teams.
Significant clinical trial delays also could allow our competitors to bring innovative products to market before we do and impair our ability to successfully commercialize our products. ​ Risks Related to Employee Matters and Managing our Growth ​ Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel. ​ We are highly dependent on the management, research and development, commercial, financial and business development expertise of Tim Goodnow, our Chief Executive Officer, Rick Sullivan, our Chief Financial Officer, Mukul Jain, our Chief Operating Officer, Brian Hansen, Chief Commercial Officer and Ken Horton, our General Counsel and Corporate Development Advisor, as well as the other members of our scientific and clinical teams.
In addition, the U.K. Bribery Act of 2010 (“Bribery Act”) prohibits both domestic and international bribery, as well as bribery across both private and public sectors.
In addition, the U.K. Bribery Act of 2010 (“Bribery Act”) prohibits both domestic and international bribery, as well as bribery across both private and public 55 sectors.
Also, if there should be widespread off-label use of our system by patients, and resulting adverse medical events, the FDA, competent authorities of the EEA countries or other foreign regulatory bodies might require us to implement additional measures to reduce off-label use, which could be costly or reduce adoption of Eversense. ​ Legislative or regulatory healthcare reforms may make it more difficult and costly for us to obtain regulatory clearance, certification or approval of our products. ​ Recent political, economic and regulatory influences are subjecting the healthcare industry to fundamental changes.
Also, if there should be widespread off-label use of our system by patients, and resulting adverse medical events, the FDA, competent authorities of the EEA countries or other foreign regulatory bodies might require us to implement additional measures to reduce off-label use, which could be costly or reduce adoption of Eversense. ​ Legislative or regulatory healthcare reforms may make it more difficult and costly for us to obtain regulatory clearance, certification or approval of our products or otherwise impact our profitability. ​ Recent political, economic and regulatory influences are subjecting the healthcare industry to fundamental changes.
Accordingly, you may have to sell some or all of your shares of our common stock in order to generate cash flow from your investment.
Accordingly, you may have to sell some or all of your shares of our common stock in order to generate 66 cash flow from your investment.
For example, the PPACA was enacted in March 2010. The PPACA 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 industries. ​ There have been executive, judicial and Congressional challenges and amendments to certain aspects of the PPACA.
For example, the PPACA was enacted in March 2010. The PPACA substantially changed 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 industries. ​ There have been executive, judicial and Congressional challenges and amendments to certain aspects of the PPACA.
We will also be subject to periodic inspections by the FDA, the Notified Bodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QSR, of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls.
We will also be subject to periodic inspections by the FDA, the notified bodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QMSR of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls.
Failure to comply 28 ​ with applicable laws and regulations should harm our business and we may incur significant expenditures related to compliance efforts. ● Failure or perceived failure to comply with existing or future laws, regulations, contracts, self-regulatory schemes, standards, and other obligations related to data privacy and security (including security incidents) could harm our business.
Failure to comply with applicable laws and regulations could harm our business and we may incur significant expenditures related to compliance efforts. ● Failure or perceived failure to comply with existing or future laws, regulations, contracts, self-regulatory schemes, standards, and other obligations related to data privacy and security (including security incidents) could harm our business.
If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal control over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by the NYSE American, the SEC or other regulatory authorities.
If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal control over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.
We have no material weaknesses in our internal control over financial reporting at December 31, 2024. While we have established certain procedures and controls over our financial reporting processes, we cannot assure you that these efforts will prevent future material weaknesses or restatements of our financial statements.
We have no material weaknesses in our internal control over financial reporting at December 31, 2025. While we have established certain procedures and controls over our financial reporting processes, we cannot assure you that these efforts will prevent future material weaknesses or restatements of our financial statements.
To date, we have not experienced significant losses or lack of access to cash in our operating accounts or our invested cash or cash equivalents; however, we can provide no assurances that access to our operating cash or invested cash and cash equivalents will not be impacted by adverse conditions in the financial markets. ​ Item 1B.
To date, we have not experienced significant losses or lack of access to cash in our operating accounts or our invested cash or cash equivalents; however, we can provide no assurances that access to our operating cash or invested cash and cash equivalents will not be impacted by adverse conditions in the financial markets. ​
Any reduction in the demand for Eversense as a result of the foregoing factors or otherwise, can adversely affect our business, operating results and financial condition. ​ Covenants under the Loan and Security Agreement may result in the acceleration of outstanding indebtedness and limit the manner in which we operate. ​ In September 2023, we entered into a loan agreement (the “Loan and Security Agreement”) with several institutions (collectively, the “Lenders") and Hercules Capital, Inc.
Any reduction in the demand for Eversense as a result of the foregoing factors or otherwise, can adversely affect our business, operating results and financial condition. ​ ​ ​ ​ 44 Covenants under the Loan and Security Agreement may result in the acceleration of outstanding indebtedness and limit the manner in which we operate. ​ In September 2023, we entered into a loan agreement (the “Loan and Security Agreement”) with several institutions (collectively, the “Lenders”) and Hercules Capital, Inc.
If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities and reputational harm.
If we 39 cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities and reputational harm.
Any of these challenges could impact our reputation, business, financial condition and operating results. ​ Our activities, including our research, sales and marketing, and patient reimbursement support activities, and relationships with Eon Care PCs, may be subject to scrutiny under these laws.
Any of these challenges could impact our reputation, business, financial condition and operating results. ​ Our activities, including our research, sales and marketing, training programs, and patient reimbursement support activities, and relationships with Eon Care PCs, may be subject to scrutiny under these laws.
Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.
Additionally, these obligations may be subject to differing applications 59 and interpretations, which may be inconsistent or conflict among jurisdictions.
Our success depends on our ability to continue to develop, commercialize and gain market acceptance for our products. ​ Our current business strategy is highly dependent on the successful commercialization of Eversense by Ascensia and achieving and maintaining market acceptance.
Our success depends on our ability to continue to develop, commercialize and gain market acceptance for our products. ​ Our current business strategy is highly dependent on the successful commercialization of Eversense and achieving and maintaining market acceptance.
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 (EEA).
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 (“EEA”).

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeRisk Factors in this Annual Report on Form 10-K, including the risk factor entitled “If our information technology systems or those third parties with whom we work, for our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.” ​ Governance ​ Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function.
Biggest changeRisk Factors in this Annual Report, including the risk factor entitled “ If our information technology systems or those third parties with whom we work, for our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences. ” ​ Governance ​ Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function.
Cybersecurity ​ Risk management and strategy ​ We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical computer networks, third party hosted services, 66 ​ communications systems, hardware and software, and our critical data, including intellectual property, and confidential information that is proprietary, strategic or competitive in nature (collectively, “Information Systems and Data”). ​ Our information security function is led by our head of IT and supported by our executive team (specifically, our CEO, COO, and CFO), our engineering department, and third-party service providers, and helps identify, assess and manage the Company’s cybersecurity threats and risks.
Cybersecurity ​ Risk management and strategy ​ We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical computer networks, third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property, and confidential information that is proprietary, strategic or competitive in nature (collectively, “Information Systems and Data”). ​ Our information security function is led by our head of IT and supported by our executive team (specifically, our CEO, COO, and CFO), our engineering department, and third-party service providers, and helps identify, assess and manage the Company’s cybersecurity threats and risks.
The board of directors’ audit committee is responsible for overseeing the Company’s cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats. ​ Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including our executive team and head of IT who has over twenty-five years of IT management experience. ​ Management is responsible for hiring appropriate personnel and the head of IT is responsible for communicating key priorities to relevant personnel.
The board of directors’ audit committee is responsible for overseeing the Company’s cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats. ​ 70 Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including our executive team and head of IT who has over twenty-five years of IT management experience. ​ Management is responsible for hiring appropriate personnel and the head of IT is responsible for communicating key priorities to relevant personnel.
The executive team works with the head of IT to help prepare for 67 ​ cybersecurity incidents, approve cybersecurity processes, and review security assessments and other security-related reports. ​ Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including the executive team, legal and others.
The executive team works with the head of IT to help prepare for cybersecurity incidents, approve cybersecurity processes, and review security assessments and other security-related reports. ​ Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including the executive team, legal and others.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe case was filed by a non-practicing entity alleging patent infringement of three patents. The validity of all three of these patents currently is being challenged in Inter Partes Review proceedings at the U.S.
Biggest changeSenseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG Case No. 2:24-cv 263. The case was filed by a non-practicing entity alleging patent infringement of three patents. The validity of all three of these patents currently is being challenged in Inter Partes Review proceedings at the U.S.
Should any asserted claim in the three patents survive the invalidity challenge in the Inter Partes Review proceedings, the Company intends to vigorously defend the lawsuit. ​ 68 ​ Except as described above, we are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results or financial condition. ​ Item 4.
Should any asserted claim in the three patents survive the invalidity challenge in the Inter Partes Review proceedings, the Company intends to vigorously defend the lawsuit. ​ Except as described above, we are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results or financial condition. ​ Item 4.
Patent and Trademark Office by another party, and on September 30, 2024, the Patent Trial and Appeal Board instituted a review with respect to each of the asserted claims in these three patents.
Patent and Trademark Office by another party, TikTok Inc., (the “TikTok IPR”) and on September 30, 2024, the Patent Trial and Appeal Board instituted a review with respect to each of the asserted claims in these three patents.
Together with LifeScan and Ascensia, on October 30, 2024, we filed a joint motion to join the Inter Partes Review as well as similar Inter Partes Review challenges to these patents. On February 5, 2025, the court issued an order staying the proceedings in the Eastern District of Texas pending resolution of the Inter Partes Review.
Together with LifeScan, Inc. and Ascensia, on October 30, 2024, we filed a joint motion to join the TikTok IPR as well as our own independent, similar Inter Partes Review petitions challenging these patents. On February 5, 2025, the court issued an order staying the proceedings in the Eastern District of Texas pending resolution of the Inter Partes Reviews.
Legal proceedings, including litigation, government investigations and enforcement actions could result in material costs, occupy significant management resources and entail civil and criminal penalties. ​ In February 2021, the Company received notice and accepted service of a civil complaint that had been filed in the Western District of Texas and styled Carew ex rel. United States v. Senseonics, Inc., No.
Legal proceedings, including litigation, government investigations and enforcement actions could result in material costs, occupy significant management resources and entail civil and criminal penalties. ​ In May 2024, the Company received notice and accepted service of a civil complaint that had been filed in the Eastern District of Texas and styled Cellspin Soft, Inc. vs.
Removed
SA20CA0657DAE. The complaint was filed by a relator under seal in May 2020 pursuant to the qui tam provisions in the federal False Claims Act. Prior to the unsealing of the complaint, the government declined to intervene in the case. The case, therefore, is being pursued only by the relator and his counsel.
Added
On June 5, 2025, prior to the imminent TikTok IPR final hearings, the Acting Director of the U.S. Patent and Trademark Office ordered a sua sponte review by the Acting Director of whether the TikTok IPR could proceed based on certain novel issues relating to TikTok’s Chinese ownership status. On January 23, 2026, the Director of the U.S.
Removed
The complaint alleges the Company’s marketing practices with physicians for its product, Eversense CGM system, violated the False Claims Act, 31 U.S.C. § 3729 and the Texas Medicaid Fraud Prevention Law, Tex. Hum Res. Code § 36.002. The court granted the Company’s motion to dismiss the complaint on March 31, 2022 but permitted the plaintiff to file an amended complaint.
Added
Patent and Trademark Office issued and order stating that, in view of a recent order by the Patent Trial and Appeal Board and TikTok Inc.’s announced joint venture (and the referenced ownership attributes thereof), the parties were authorized to file an additional brief addressing whether the evidence Cellspin Soft, Inc. submitted is sufficient to put TikTok Inc.’s real party in interest identification into dispute, and what effect, if any, the announced joint venture has on the TikTok IPR proceedings.
Removed
The court dismissed the amended complaint and entered judgment in favor of Senseonics Holdings, Inc. on March 30, 2023. The relator filed a notice of appeal to the United States Court of Appeals for the Fifth Circuit on April 28, 2023. The appeal was fully briefed and the case was argued before the Fifth Circuit on February 6, 2024.
Added
TikTok, Inc. and Cellspin Soft, Inc. filed additional briefs on February 2, 2026. To date, no decision has been rendered on by the Director whether the TikTok IPR can proceed. The Inter Partes Review proceedings are all stayed pending the outcome of the sua sponte Director’s review. The timing of this review remains uncertain.
Removed
On February 28, 2024 the Fifth Circuit issued a Per Curiam order affirming the District Court’s decision that Carew failed to state a claim.
Added
Were the 71 TikTok IPR terminated, it is our belief that our independent Inter Partes Review should continue because the issues raised in the challenge to the TikTok IPR are not relevant to our filings.
Removed
This order affirms the District Court’s dismissal of plaintiff’s lawsuit. ​ In May 2024, the Company received notice and accepted service of a civil complaint that had been filed in the Eastern District of Texas and styled Cellspin Soft, Inc. vs. Senseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG Case No. 2:24-cv 263.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Registrant’s Common Equit y, Related Stockholder Matters and Issuer Purchases of Equity Securities ​ Market Information for Common Stock ​ Our common stock is listed on the NYSE American under the symbol “SENS.” ​ Dividend Policy ​ We have never declared or paid any dividends on our common stock.
Biggest changeItem 5. Market for Registrant’s Common Equit y, Related Stockholder Matters and Issuer Purchases of Equity Securities ​ Market Information for Common Stock ​ Our common stock is listed on the Nasdaq Global Select Market under the symbol “SENS.” ​ Dividend Policy ​ We have never declared or paid any dividends on our common stock.
Our ability to pay dividends on shares of our common stock is further limited by restrictions on our ability to pay dividends or make distributions under the terms of the agreements governing our indebtedness and may be limited by future similar agreements. ​ Stockholders ​ As of February 24, 2025, we had approximately 156 active holders of record of our common stock.
Our ability to pay dividends on shares of our common stock is further limited by restrictions on our ability to pay dividends or make distributions under the terms of the agreements governing our indebtedness and may be limited by future similar agreements. ​ Stockholders ​ As of February 20, 2026, we had approximately 98 active holders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThere is no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms, if at all, and could be forced to delay, reduce, or eliminate some or all of its research, clinical trials, product development or future commercialization efforts, which could materially adversely affect its business prospects or its ability to continue as a going concern. ​ ​ 79 ​ Cash Flows ​ The following is a summary of cash flows for each of the periods set forth below (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2024 ​ 2023 ​ Net cash used in operating activities $ (60,465) $ (70,163) Net cash provided by investing activities ​ 32,838 ​ 89,713 ​ Net cash provided by financing activities ​ 26,830 ​ 20,366 ​ Net (decrease) increase in cash and cash equivalents ​ $ (797) ​ $ 39,916 ​ ​ Net cash used in operating activities ​ Net cash used in operating activities was $60.5 million for the year ended December 31, 2024, and consisted of a net loss of $78.6 million, partially offset by a $0.9 million net change in operating assets and liabilities, $9.2 million of stock-based compensation, $3.9 million in non-cash inventory costs primarily due to transition to the 365-day product, and $4.1 million related to depreciation/amortization and other non-cash items. ​ Net cash used in operating activities was $70.2 million for the year ended December 31, 2023, and consisted of a net loss of $60.4 million, a $14.1 million exchange-related gain, a $6.6 million gain in the fair value of derivatives on convertible notes, and a $4.0 million net change in operating assets and liabilities, partially offset by $8.7 million of stock-based compensation, and $6.3 million related to depreciation/amortization and other non-cash items. ​ Net cash provided by investing activities ​ Net cash provided by investing activities was $32.8 million for the year ended December 31, 2024, and consisted of $93.1 million from the sale and maturity of marketable securities, partially offset by $58.1 million from the purchase of marketable securities and $2.2 million of capital expenditures for laboratory equipment and leasehold improvements. ​ Net cash provided by investing activities was $89.7 million for the year ended December 31, 2023, and consisted of $158.6 million from the sale and maturity of marketable securities, partially offset by $68.5 million from the purchase of marketable securities and $0.4 million of capital expenditures for laboratory equipment and leasehold improvements. ​ Net cash provided by financing activities ​ Net cash provided by financing activities was $26.8 million for the year ended December 31, 2024, and primarily consisted of an aggregate of $4.0 million in proceeds related to the issuance of common stock pursuant to our at the market offering and the exercise of stock options, $14.5 million in proceeds from a registered direct offering, and $10.0 million in net proceeds from borrowings pursuant to the Loan and Security Agreement, partially offset by $1.7 million taxes paid related to net share settlement of equity awards. ​ Net cash provided by financing activities was $20.4 million for the year ended December 31, 2023, and primarily consisted of an aggregate of $7.4 million in proceeds related to the issuance of common stock pursuant to our at the market offering and the exercise of stock options, $14.7 million in proceeds from the issuance of the PHC Purchase Warrant, and $24.4 million in net proceeds from borrowings pursuant to the Loan and Security Agreement, partially offset by $15.7 million and $7.5 million in repayment and exchange of the 2023 Notes and 2025 Notes, respectively, $2.7 million taxes paid related to net share settlement of equity awards, and $0.4 million in debt issuance costs. ​ ​ 80 ​
Biggest changeThere is no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms, if at all, and could be forced to delay, reduce, or eliminate some or all of its research, clinical trials, product development or future commercialization efforts, which could materially adversely affect its business prospects or its ability to continue as a going concern. ​ 83 Cash Flows ​ The following is a summary of cash flows for each of the periods set forth below (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2025 ​ 2024 ​ Net cash used in operating activities ​ ​ ​ $ (59,129) ​ ​ ​ $ (60,465) Net cash (used in) provided by investing activities ​ (53,422) ​ 32,838 ​ Net cash provided by financing activities ​ 78,188 ​ 26,830 ​ Net decrease in cash and cash equivalents ​ $ (34,363) ​ $ (797) ​ ​ Net cash used in operating activities ​ Net cash used in operating activities was $59.1 million for the year ended December 31, 2025, and consisted of a net loss of $69.1 million, a $3.3 million net change in operating assets and liabilities, partially offset by $10.2 million of stock-based compensation, and $3.1 million related to depreciation/amortization and other non-cash items. ​ Net cash used in operating activities was $60.5 million for the year ended December 31, 2024, and consisted of a net loss of $78.6 million, partially offset by a $0.9 million net change in operating assets and liabilities, $9.2 million of stock-based compensation, $3.9 million in non-cash inventory costs primarily due to transition to the 365-day product, and $4.1 million related to depreciation/amortization and other non-cash items. ​ Net cash (used in) provided by investing activities ​ Net cash used in investing activities was $53.4 million for the year ended December 31, 2025, and consisted of $100.7 million from the purchase of marketable securities and $1.1 million of capital expenditures partially offset by $48.4 million from the sales and maturity of marketable securities. ​ Net cash provided by investing activities was $32.8 million for the year ended December 31, 2024, and consisted of $93.1 million from the sale and maturity of marketable securities, partially offset by $58.1 million from the purchase of marketable securities and $2.2 million of capital expenditures. ​ Net cash provided by financing activities ​ Net cash provided by financing activities was $78.2 million for the year ended December 31, 2025, and primarily consisted of $72.3 million in net proceeds from the Public Offering and Private Placement, $28.5 million in net proceeds related to the issuance of common stock pursuant to our at the market offering and the exercise of stock options, offset by $20.4 million used to repay the remaining outstanding 2025 Notes, $1.7 million of taxes paid related to net share settlement of equity awards and $0.4 million used to repay the debt modification costs. ​ Net cash provided by financing activities was $26.8 million for the year ended December 31, 2024, and primarily consisted of an aggregate of $4.0 million in proceeds related to the issuance of common stock pursuant to our at the market offering and the exercise of stock options, $14.5 million in proceeds from a registered direct offering, and $10.0 million in net proceeds from borrowings pursuant to the Loan and Security Agreement, partially offset by $1.7 million of taxes paid related to net share settlement of equity awards. ​ ​
In the trial, we observed a mean absolute relative difference (“MARD”) of 8.5% utilizing two calibration points for Eversense across the 40-400 mg/dL range when compared to YSI blood reference values during the 90-day continuous wear period.
In the trial, we observed a mean absolute relative difference (“MARD”), of 8.5% utilizing two calibration points for Eversense 90 across the 40-400 mg/dL range when compared to YSI blood reference values during the 90-day continuous wear period.
In July 2018, we began distributing the 90-day Eversense system directly in the United States through our own direct sales and marketing organization.
In July 2018, we began distributing the 90-day Eversense 90 system directly in the United States through our own direct sales and marketing organization.
Based on the analysis of the ENHANCE Pivotal study data, the decision was made to advance to the next generation sensor platform as the underlying technology used in the 365-day and future products. In May 2024, this data supported an FDA 510(k) submission for a new product with a 365-day duration and once per week calibration.
Based on the analysis of the ENHANCE Pivotal study data, the decision was made to advance to the next generation sensor platform as the underlying technology used in the 365-day and future products. In May 2024, this data supported an FDA 510(k) submission for a new product with a 365-day duration and once per week 75 calibration.
In February 2024, we announced that Medicare coverage was expanded for Eversense E3 to include all people with diabetes using insulin and non-insulin users who have a history of problematic hypoglycemia providing access to millions of Medicare patients. All of the Medicare administrative contractors (“MAC”) expansions became effective in 2024.
In 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 expansions became effective in 2024.
In 2023 the data gathered in the ENHANCE study supported the iCGM submission and in April 2024 Eversense was authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future.
In 2023 the data gathered in the ENHANCE study supported the iCGM submission and in April 2024, Eversense 365 was authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future.
In the trial, we observed performance matching that of the then current Eversense 90-day product available in the United States, with a MARD of 8.5%. This result was achieved with reduced calibration, down to one per day, while also doubling the sensor life to six months.
In the trial, we observed performance matching that of the then current Eversense 90 available in the United States, with a MARD of 8.5%. This result was achieved with reduced calibration, down to one per day, while also doubling the sensor life to six months.
In March 2022, we extended the ongoing ENHANCE clinical study to evaluate the safety and accuracy of the Eversense 365 System for a period of up to one year in the United States. In September 2022, we completed enrollment of the ENHANCE study and the last patient of the adult cohort completed the study in the third quarter of 2023.
In March 2022, we extended the ongoing ENHANCE clinical study to evaluate the safety and accuracy of Eversense 365 for a period of up to one year in the United States. In September 2022, we completed enrollment of the ENHANCE study and the last patient of the adult cohort completed the study in the third quarter of 2023.
On August 3, 2020, the Center for Medicare and Medicaid Services (“CMS”) released its Calendar Year 2021 Medicare Physician Fee Schedule Proposed Rule that announces proposed policy changes for Medicare payments, including the proposed establishment of national payment amounts for the three CPT© Category III codes describing the insertion (CPT 0446T), removal (0447T), and removal and insertion (0048T) of an implantable interstitial glucose sensor, which describes our Eversense CGM systems, as a medical benefit, rather than as part of the Durable Medical Equipment channel that includes other CGMs.
On August 3, 2020, the Center for Medicare and Medicaid Services (“CMS”) released its Calendar Year 2021 Medicare Physician Fee Schedule Proposed Rule that announces proposed policy changes for Medicare payments, including the proposed establishment of 73 national payment amounts for the three CPT© Category III codes describing the insertion (CPT 0446T), removal (0447T), and removal and insertion (0048T) of an implantable interstitial glucose sensor, which describes our Eversense Systems, as a medical benefit, rather than as part of the Durable Medical Equipment channel that includes other CGMs.
Based on the data from this trial, in October 2016 we submitted a pre-market approval (“PMA”) application to the FDA to market Eversense in the United States for 90-day use. On June 21, 2018, we received PMA approval from the FDA for the Eversense system.
Based on the data from this trial, in October 2016 we submitted a pre-market approval (“PMA”) application to the FDA to market Eversense 90 in the United States for 90-day use. In June 2018, we received PMA approval from the FDA for the Eversense 90 system.
The number of shares issued was determined based upon the volume-weighted average price per share of the common stock during a 15-day averaging period. Based on the volume-weighted average price per share of the common stock during the averaging period, we issued a total of 35.1 million shares of common stock in the exchanges.
The number of shares issued was 81 determined based upon the volume-weighted average price per share of the common stock during a 15-day averaging period. Based on the volume-weighted average price per share of the common stock during the averaging period, we issued a total of 35.1 million shares of common stock in the exchanges.
Information gathered from this sub-set and additional development efforts provided us the confidence to start the Pivotal study for the Eversense 365 System. ​ In April 2020, we announced that we received an extension to our CE Certificate of Conformity in the EEA such that the Eversense XL is no longer contraindicated for MRI, which means the sensor does not need to be removed from under the skin during MRI scanning.
Information gathered from this sub-set and additional development efforts provided us with the confidence to start the Pivotal study for Eversense 365. ​ In April 2020, we announced that we received an extension to our CE Certificate of Conformity in the EEA such that the Eversense XL is no longer contraindicated for MRI, which means the sensor does not need to be removed from under the skin during MRI scanning.
We do not expect any material changes to the underlying assumptions during the year ending December 31, 2025. ​ We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets, liabilities and equity that are not readily apparent from other sources.
We do not expect any material changes to the underlying assumptions during the year ending December 31, 2026. ​ We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets, liabilities and equity that are not readily apparent from other sources.
In November 2022, we submitted and in the first quarter of 2023 we received approval of an investigational device enrollment (“IDE”) for the enrollment of a pediatric cohort in the ENHANCE study.
In November 2022, we submitted and in the first quarter of 2023 we received approval of an investigational device exemption (“IDE”) for the enrollment of a pediatric cohort in the ENHANCE study.
These estimates, particularly estimates relating to accounting for variable consideration related to revenue, inventory obsolescence and embedded derivatives, have a material impact on our financial statements and are discussed in detail throughout our analysis of the results of operations discussed below. We did not make any material changes to these assumptions for the year ended December 31, 2024.
These estimates, particularly estimates relating to accounting for variable consideration related to revenue, inventory obsolescence and embedded derivatives, have a material impact on our financial statements and are discussed in detail throughout our analysis of the results of operations discussed below. We did not make any material changes to these assumptions for the year ended December 31, 2025.
In December 2021, CMS released its Calendar Year 2022 Medicare Physician Fee Schedule that updated global payments for the device cost and procedure fees. In November 2022, CMS released its Calendar Year 2023 Medicare Physician Fee Schedule Proposed Rule that updates the payment amounts for the three CPT© III codes to account for the longer 6-month sensor.
In December 2021, CMS released its Calendar Year 2022 Medicare Physician Fee Schedule that updated bundled payments for the device cost and procedure fees. In November 2022, CMS released its Calendar Year 2023 Medicare Physician Fee Schedule Proposed Rule that updates the payment amounts for the three CPT© III codes to account for the longer 6-month sensor.
We have received Category III CPT codes for the insertion and removal of the Eversense sensor. ​ In December 2018, we initiated the PROMISE pivotal clinical trial to evaluate the safety and accuracy of Eversense for a period of up to six months in the United States and in September 30, 2019, we completed enrollment of the PROMISE trial.
We have received Category III CPT codes for the insertion and removal of the Eversense 90 sensor. ​ In December 2018, we initiated the PROMISE pivotal clinical trial to evaluate the safety and accuracy of Eversense 90 for a period of up to six months in the United States and on September 30, 2019, we completed enrollment of the PROMISE trial.
In November 2024, Eon Management Services, LLC entered into the Administrative Agreement with the Eon Care PCs, which are consolidated as 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 services.
In November 2024, Eon Management Services, LLC entered into the Administrative Agreement with the Eon Care PCs, which are consolidated as VIEs. The wholly owned entities and Eon Care PCs (collectively, “Eon Care”) were established to support patient access to the Eversense systems by providing convenient Eversense insertion and training services.
Variances in the consideration recognized is partially mitigated by minimum price provisions for certain purchases under the contract. ​ ​ ​ ​ 73 ​ Inventory Obsolescence ​ Inventory is valued at the lower of cost or net realizable value. Cost is determined using the standard cost method that approximates first in, first out.
Variances in the consideration recognized is partially mitigated by minimum price provisions for certain purchases under the contract. ​ ​ ​ ​ 77 Inventory Obsolescence ​ Inventory is valued at the lower of cost or net realizable value. Cost is determined using the standard cost method that approximates first in, first out.
In June 2023, we received positive payor coverage decision from UnitedHealthcare, the largest healthcare insurance company in the United States that effective July 1, 2023, Eversense E3 CGM system would be covered.
In June 2023, we received positive payor coverage decision from UnitedHealthcare, the largest healthcare insurance company in the United States that effective July 1, 2023, Eversense E3 would be covered.
We had previously obtained this indication for Eversense in the United States in 2019.
We had previously obtained this indication for Eversense 90 in the United States in 2019.
Actual results and outcomes could differ from these estimates and assumptions. ​ Revenue ​ We generate a significant portion of product revenue from sales of the Eversense system and related components and supplies to Ascensia, through the Commercialization Agreement, who then resells the products to health care providers and patients. ​ Revenue from product sales to Ascensia is recognized at a point in time when the Ascensia obtains control of our product based upon the delivery terms as defined in the contract at an amount that reflects the consideration which we expect to receive in exchange for the product.
Actual results and outcomes could differ from these estimates and assumptions. ​ Revenue ​ A significant portion of our product revenue has historically been generated from sales of the Eversense system and related components and supplies to Ascensia, through the Commercialization Agreement, who then resells the products to health care providers and patients. ​ Revenue from product sales to Ascensia is recognized at a point in time when Ascensia obtains control of our product based upon the delivery terms as defined in the contract at an amount that reflects the consideration which we expect to receive in exchange for the product.
This trial, which was fully enrolled with 90 subjects, was conducted at eight sites in the United States. In the trial, we measured the accuracy of Eversense measurements through 90 days after insertion. We also assessed safety through 90 days after insertion or through sensor removal.
This trial, which was fully enrolled with 90 subjects, was conducted at eight sites in the United States. In the trial, we measured the accuracy of the Eversense 90 system (“Eversense 90”) measurements through 90 days after insertion. We also assessed safety through 90 days after insertion or through sensor removal.
This sub-set of 30 participants were left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days.
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.
The Eversense XL is indicated for a sensor life of up to 180 days. Eversense XL began commercialization in the EEA in the fourth quarter of 2017.
Eversense XL is indicated for a sensor life of up to 180 days. Eversense XL began commercialization in Europe in the fourth quarter of 2017.
Ascensia began commercializing Eversense E3 in the United States during the second quarter of 2022. 71 ​ ​ The ENHANCE clinical study was initiated as a pivotal study with the purpose of gathering additional clinical data to support an integrated continuous glucose monitoring (iCGM) submission for the Eversense E3 system using the SBA technology.
Ascensia began commercializing Eversense E3 in the United States during the second quarter of 2022. ​ The ENHANCE clinical study was initiated as a pivotal study with the purpose of gathering additional clinical data to support an integrated continuous glucose monitoring (“iCGM”) submission for Eversense E3 using the SBA technology.
The PP Warrants are non-exercisable for the first six months after issuance and expire on April 29, 2030.
The PP Warrants were non-exercisable for the first six months after issuance and expire on April 29, 2030.
Following the results of the PROMISE trial, on September 30, 2020, a PMA supplement application to extend the wearable life of the Eversense CGM System to six months was submitted to the FDA.
Following the results of the PROMISE trial, on September 30, 2020, a PMA supplement application to extend the wearable life of Eversense 90 to six months was submitted to the FDA.
The PHC Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per PHC Exchange Warrant Share.
The PHC Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $0.02 per PHC Exchange Warrant Share.
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.
The 510(k) submission was approved by the FDA on September 17, 2024 and Eversense 365 product was cleared for sale in the United States.
See Note 13 in the accompanying notes to our consolidated financial statements included elsewhere in this Annual Report for further discussion of the 2025 Notes. ​ Funding Requirements and Outlook ​ Our ability to generate revenue and achieve profitability depends on the successful commercialization and adoption of our Eversense CGM systems by diabetes patients and healthcare providers, along with future product development, regulatory approvals, certifications and post-approval requirements.
See Note 13 in the accompanying notes to our consolidated financial statements included elsewhere in this Annual Report for further discussion of the 2025 Notes. ​ Funding Requirements and Outlook ​ Our ability to grow revenues and achieve profitability depends on the successful commercialization and adoption of our Eversense System by diabetes patients and healthcare providers, along with future product development, regulatory approvals, and post-approval requirements.
GS will receive a commission up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares will be offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on August 10, 2023.
GS received commissions up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares were offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on August 10, 2023.
Our implantable CGM (“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 six months in the case of Eversense E3 and up to twelve months in the case of Eversense 365, as compared to seven to 14 days for non-implantable CGM systems.
Our implantable CGM systems, including the Eversense E3 system (“Eversense E3”) and the Eversense 365 system (“Eversense 365” and, together with Eversense E3, “Eversense” or the “Eversense 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 six months in the case of Eversense E3 and up to twelve months in the case of Eversense 365, as compared to seven to 15 days for non-implantable CGM systems.
These activities, including our ongoing focus to grow covered lives through positive insurance payor policy decisions and continued development of Eversense 365-day product in the United States, will require significant uses of working capital through 2025 and beyond.
These activities, including our ongoing focus to grow covered lives through positive insurance payor policy decisions, initiatives to support patient access, and continued development of Eversense 365 in the United States, will require significant uses of working capital through 2025 and beyond.
As of December 31, 2024, the Company had unrestricted cash and cash equivalents of $74.6 million. ​ In accordance with the FASB Accounting Standards Codification Topic 205-40, Presentation of Financial Statements - Going Concern, management is required to assess the Company’s ability to continue as a going concern through twelve months after issuance of the financial statements.
As of December 31, 2025, the Company had unrestricted cash, cash equivalents and marketable securities of $94.0 million. ​ In accordance with the FASB Accounting Standards Codification Topic 205-40, Presentation of Financial Statements-Going Concern, management is required to assess the Company’s ability to continue as a going concern through twelve months after issuance of the financial statements.
All or any part of the Exchange Warrant is exercisable by PHC at any time and from time to time. ​ On September 8, 2023, we entered into the Loan and Security Agreement with several lenders and issued the Tranche 1 Warrants to acquire an aggregate of 832,362 shares of common stock at an exercise price of $0.6007 per share.
All or any part of the PHC Exchange Warrant is exercisable by PHC at any time and from time to time. ​ On September 8, 2023, we entered into the Loan and Security Agreement with several lenders and issued the Tranche 1 Warrants to acquire an aggregate of 41,619 shares of common stock at an initial exercise price of $12.01 per share.
All or any part of the Purchase Warrant is exercisable by PHC at any time and from time to time. ​ In March 2023, we entered into an exchange agreement with PHC, pursuant to which PHC exchanged $35.0 million aggregate principal amount of the PHC Notes, including all accrued and unpaid interest thereon, for a warrant (the “PHC Exchange Warrant”) to purchase up to 68,525,311 shares of common stock.
All or any part of the Purchase Warrant is exercisable by PHC at any time and from time to time. ​ In March 2023, we entered into an exchange agreement with PHC, pursuant to which PHC exchanged $35.0 million aggregate principal amount of convertible notes due October 31, 2024 (the “PHC Notes”), including all accrued and unpaid interest thereon, for a warrant (the “PHC Exchange Warrant”) to purchase up to 3,426,266 shares of common stock (the “PHC Exchange Warrant Shares”).
The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per Purchase Warrant Share.
The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $0.02 per share (the “Purchase Warrant Shares”).
As of December 31, 2024, the Company had unrestricted cash and cash equivalents of $74.6 million. ​ In the past two years, we have taken a number of measures to strengthen our financial position, including the repayment of our 2023 Notes, the sale of common stock in a registered direct offering and related issuance of warrants, the issuance of a pre-funded warrant to PHC for cash in a private placement, the exchange of our PHC Notes for a newly issued pre-funded warrant, the exchange of a portion of our 2025 Notes for cash and common stock in a series of private exchanges and the repayment of the remaining 2025 Notes, the entry into a term loan facility and the issuance of shares of common stock pursuant to an at the market offering program.
As of December 31, 2025, the Company had unrestricted cash, cash equivalents, and marketable securities of $94.0 million. ​ In the past two years, we have taken a number of measures to strengthen our financial position, including the closing of the Amended Loan and Security Agreement, repayment of our 2023 Notes, the sale of common stock in the 2024 Registered Direct Offering (as defined below) and related issuance of warrants, the issuance of a pre-funded warrant to PHC for cash in a private placement, the exchange of our PHC Notes for a newly issued pre-funded warrant, the exchange of a portion of our 2025 Notes for cash and common stock in a series of private exchanges and the repayment of the remaining 2025 Notes, and the issuance of shares of common stock pursuant to at the market offering programs.
Our gross profit decreased to $0.5 million for the twelve months ended December 31, 2024, compared to $3.1 million for the twelve months ended December 31, 2023. Gross profit as a percentage of revenue, or gross margin, was 2.4% and 13.8% for the twelve months ended December 31, 2024 and December 31, 2023, respectively.
Our gross profit increased to $15.8 million for the twelve months ended December 31, 2025, compared to $0.5 million for the twelve months ended December 31, 2024. Gross profit as a percentage of revenue, or gross margin, was 44.7% and 2.4% for the twelve months ended December 31, 2025 and December 31, 2024, respectively.
LLC (“GS”), under which we could offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $106.6 million through GS as our sales agent in an “at the market” offering, which represented the remaining capacity under our then-existing at the market program with Jefferies LLC, as described below.
LLC (“GS”), under which the Company could offer and sell, from time to time, at its sole discretion, shares of its common stock having an aggregate offering price of up to $106.6 million through GS as its sales agent in an “at the market” offering.
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. ​ ​ 70 ​ United States Development and Commercialization of Eversense ​ In 2016, we completed our PRECISE II pivotal clinical trial in the United States.
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. ​ United States Development and Commercialization of Eversense ​ In 2016, we completed our PRECISE II pivotal clinical trial in the United States.
The PP Warrants are non-exercisable for the first six months after issuance and expire on April 29, 2030. ​ Indebtedness ​ Loan and Security Agreement ​ On September 8, 2023, we entered into the Loan and Security Agreement with the Lenders and Hercules, pursuant to which the Lenders agreed to make available to us the Term Loan Facility, consisting of (i) an initial Tranche 1 Loan, which was funded in the amount of $25.0 million on the Effective Date and (ii) the Tranche 2 Loan and Tranche 3 Loan, respectively, which would become available to the Company upon our satisfaction of certain terms and conditions set forth in the Loan and Security Agreement.
The PP Warrants were non-exercisable for the first six months after issuance and expire on April 29, 2030. ​ ​ ​ ​ ​ ​ ​ 82 ​ ​ Indebtedness ​ Amended Loan and Security Agreement ​ On September 8, 2023, the Company entered into the Loan and Security Agreement with the Lenders and Hercules, pursuant to which the Lenders agreed to make available to the Company the Term Loan Facility, consisting of (i) an initial Tranche 1 Loan, which was previously funded on the Effective Date in an amount of $25.0 million and (ii) the Tranche 2 Loan, which was funded on January 2, 2024 in an amount of $10.0 million, and (iii) Tranche 3 Loan, which has not been drawn.
On October 24, 2024, the Company amended the Equity Distribution Agreement with GS to reduce the maximum amount of shares issuable thereunder to $55.0 million.
On October 24, 2024, the Company amended the Equity Distribution Agreement with GS to reduce the maximum amount of shares issuable thereunder to $55.0 million. On May 15, 2025, in connection with the Public Offering and Private Placement, the Equity Distribution Agreement was terminated.
In February 2022, the 180-day 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 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 February 2022, Eversense E3, a 180 day CGM system, was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States in the second quarter of 2022.
You should review the “Risk Factors” section of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. ​ Overview ​ 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 69 ​ management technology.
You should review the “Risk Factors” section of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. 72 ​ Unless otherwise indicated, all information in this Annual Report on Form 10-K gives effect to a 1-for-20 reverse stock split of our common stock that became effective on October 17, 2025 (the “Reverse Stock Split”), and all references to historical share and per share amounts give effect to the Reverse Stock Split. ​ ​ Overview ​ We are a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology.
Ascensia began commercializing Eversense 365 in the United States during the fourth quarter of 2024. ​ In April 2024 and July 2024, Eon Care Services, LLC and Eon Management Services, LLC were formed as wholly owned subsidiaries of Senseonics, Incorporated.
Ascensia began commercializing Eversense 365 in the United States during the fourth quarter of 2024. ​ In an effort to accelerate commercialization efforts and address challenges to Eversense adoption, in April 2024 and July 2024, we established new legal entities, Eon Care Services, LLC and Eon Management Services, LLC, (collectively “Eon Care PCs”), which were formed as wholly owned subsidiaries of Senseonics, Incorporated.
Data gathered from this first-in-human testing will be utilized for an IDE submission anticipated in the second half of 2025. ​ European Commercialization of Eversense ​ In September 2017, we affixed the CE mark for Eversense XL, which permits the product to be sold freely in any part of the European Economic Area (“EEA”).
Data gathered from this first-in-human testing was utilized for an IDE submission that was approved by the FDA in December 2025 which allowed us to begin enrolling patients in the Gemini pivotal study. ​ European Commercialization of Eversense ​ In September 2017, we affixed the CE Mark for Eversense XL which permits the product to be sold freely in any part of the EEA.
The Tranche 1 Warrants may be exercised through the earlier of (i) September 8, 2030 and (ii) the consummation of certain acquisition transactions involving the company, as set forth in the warrant agreement. ​ On January 2, 2024, we issued the Tranche 2 Warrants to acquire an aggregate of 347,887 shares at an exercise price of $0.5749 per share.
The Tranche 1 Warrants may be exercised through the earlier of (i) September 8, 2030 and (ii) the consummation of certain acquisition transactions involving the Company, as set forth in the warrant agreement. On September 3, 2025, the Company and the lenders entered into an amendment to reduce the exercise price to $9.09 per share.
Following CE Mark approval, we plan to launch Eversense 365 with our global commercial partner, Ascensia, in the second half of 2025. ​ Critical Accounting Estimates ​ The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. ​ The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities and equity and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.
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. ​ Critical Accounting Estimates ​ The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. ​ The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities and equity and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.
In the first quarter of 2025, Energy Capital converted its Series B Preferred Stock in full into 30,372,058 shares of common stock. ​ Warrants ​ In connection with certain of our historical financing transactions, we have issued warrants to investors and providers of debt financing, as described below. ​ On June 30, 2016, we entered into a loan agreement with Oxford Finance and Silicon Valley Bank (collectively, the “Lenders”) and issued to the Lenders 10-year stock purchase warrants to purchase an aggregate of 116,581, 63,025 and 80,645 shares of common stock at an exercise price of $3.86, $2.38 and $1.86 per share, respectively (“Oxford/SVB Warrants”).
On January 15, 2025, the Company repaid the outstanding principal and accrued interest in full. ​ Warrants ​ In connection with certain of our historical financing transactions, we have issued warrants to investors and providers of debt financing, as described below. ​ ​ On June 30, 2016, we entered into a loan agreement with Oxford Finance and Silicon Valley Bank (collectively, the “Lenders”) and issued to the Lenders 10-year stock purchase warrants to purchase an aggregate of 5,830, 3,152 and 4,033 shares of common stock at an exercise price of $77.20, $47.60 and $37.20 per share, respectively (“Oxford/SVB Warrants”).
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 United States in the fourth quarter of 2024. ​ 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. ​ 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.
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. ​ ​ 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. ​ 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.
This increase was primarily driven by sales growth in the US largely due to growth in the consignment program and 365-day product demand. In the fourth quarter, we had higher shipments to Ascensia for sales of the 365-day product in the US after obtaining FDA approval in September 2024.
This increase was primarily driven by sales growth in the US largely due to growth in the consignment program and 365-day product demand.
The reduction in gross margin was primarily driven by $4.8 million in one-time charges as the result of the transition from Eversense E3 to Eversense 365, partially offset by manufacturing costs previously expensed to research and development expenses.
The improvement in gross margin was partially due to $4.8 million in one-time charges incurred in the prior year as the result of the transition from Eversense E3 to Eversense 365.
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 the 90-day Eversense product during the second quarter of 2021. ​ In February 2022, we received approval from the FDA for the Eversense E3 CGM System.
Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the Eversense 90 product on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for Eversense 90 during the second quarter of 2021. ​ On September 3, 2025, the Company and Ascensia signed the 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.
With this approval, the Eversense system can be used as a therapeutic CGM to replace fingerstick blood glucose measurement for treatment decisions, including insulin dosing. ​ 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.
In February 2022, the extended life Eversense E3 was approved by the FDA. ​ 74 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.
The approval for our third-generation sensor, with proprietary sacrificial boronic acid (“SBA”) technology doubles the sensor life to six months with MARD of 8.5%.
Following the U.S. Closing, Ascensia has no further rights to revenues from the sale of Eversense products in the U.S. ​ In February 2022, we received approval from the FDA for Eversense E3. The approval for our third-generation sensor, with proprietary sacrificial boronic acid (“SBA”) technology doubles the sensor life to six months with MARD of 8.5%.
The distribution rights under the agreement expired January 31, 2021. ​ In June 2022, we affixed the CE mark for the Eversense E3 CGM system, and Ascensia began commercialization in certain European markets during the second half of 2022. ​ 72 ​ In February 2025, we submitted the Eversense 365 CGM system to our notified body for CE Mark approval.
All such commercialization and marketing activities remain subject to applicable government approvals. ​ In June 2022, we affixed the CE Mark to Eversense E3, and Ascensia began commercialization in European markets during the second half of 2022. ​ In February 2025, we submitted an application for the conformity assessment of Eversense 365 to our Notified Body for certification.
The offering closed on October 28, 2024, and the Company received proceeds of approximately $14.8 million after payment of fees to the placement agent, but before payment of any additional expenses incurred by the Company in connection with the transaction. ​ On September 8, 2023, we entered into a loan agreement (the “Loan and Security Agreement”) with several institutions (collectively, the “Lenders") and Hercules Capital, Inc.
The offering closed on October 28, 2024, and the Company received proceeds of approximately $14.8 million after payment of fees to the placement agent, but before payment of any additional expenses incurred by the Company in connection with the transaction. ​ On August 10, 2023, we entered into separate, privately negotiated exchange agreements (the “Exchange Agreements”) with a limited number of holders (the “Noteholders”) of our outstanding 5.25% Convertible Senior Notes due 2025 (the “2025 Notes”).
The Tranche 2 Warrants may be exercised through the earlier of (i) January 2, 2031 and (ii) the consummation of certain acquisition transactions involving the company, as set forth in the warrant agreement. ​ 78 ​ On October 24, 2024, in connection with the registered direct offering described above, the Company issued to the investors in the offering the PP Warrants to purchase an aggregate of 45,714,286 shares of common stock at an exercise price of $0.35 per share.
The Tranche 2 Warrants may be exercised through the earlier of (i) January 2, 2031 and (ii) the consummation of certain acquisition transactions involving the Company, as set forth in the warrant agreement. On September 3, 2025, the Company and the lenders entered into an amendment to reduce the exercise price to $9.09 per share.
We incurred total net loss of $(78.6) million and $(60.4) million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $947.9 million. To date, we have financed our operations primarily through sales of our equity securities and debt financings.
We incurred total net loss of $(69.1) million and $(78.6) million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $1.0 billion. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, warrants, convertible notes, and debt.
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 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.
The 510(k) submission was approved by the FDA on September 17, 2024 and Eversense 365 was cleared for sale in the United States. ​ 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.
These decreases were partially offset by a $2.7 million reduction in interest expense primarily driven by the exchanges of the PHC Notes for a pre-funded warrant and the exchange of a portion of the 2025 Notes for cash and equity in 2023. ​ Liquidity and Capital Resources ​ Since our inception, we have incurred significant net losses and expect to incur additional losses in the near future.
The change was primarily due to lower interest expense of $3.5 million (primarily due to repayment of the 2025 Notes), partially offset by a decrease in other income of $0.5 million (primarily the result of lower returns on marketable securities investments). ​ Liquidity and Capital Resources ​ Since our inception, we have incurred significant net losses and expect to incur additional losses in the near future.
For the year ended December 31, 2024, the Company received approximately $4.3 million in net proceeds from the sale of 11,918,121 shares under the Equity Distribution Agreement. ​ In November 2021, we entered into an Open Market Sale Agreement (the “2021 Sales Agreement”) with Jefferies LLC (“Jefferies”) under which we could offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million through Jefferies as our sales agent in an “at the market” offering.
The loans under the Amended Loan and Security Agreement mature on September 3, 2029. ​ In August 2025, the Company entered into an at-the-market sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”), under which the Company could offer and sell, from time to time, at its sole discretion, shares of its common stock having an aggregate offering price of up to $100.0 million through TD Cowen as its sales agent in an “at the market” offering.
We have also taken measures to manage our operating expenses, including through a company restructuring in 2024. ​ On October 24, 2024, the Company completed a registered direct securities offering to certain institutional investors in which we issued and sold 45,714,286 shares of common stock at $0.35 per share and simultaneously issued warrants (“PP Warrants”) to these investors in a private placement to purchase an aggregate of 45,714,286 shares of common stock at an exercise price of $0.35 per share.
At the time of termination of the Equity Distribution Agreement on May 15, 2025, the Company had received approximately $30.8 million in net proceeds from the sale of 2,006,528 shares under the Equity Distribution Agreement, after deducting sales commissions and offering expenses. ​ On October 24, 2024, the Company completed a registered direct securities offering (the “2024 Registered Direct Offering”) to certain institutional investors in which we issued and sold 2,285,714 shares of common stock at $7.00 per share and simultaneously issued the PP Warrants to these investors in a private placement to purchase an aggregate of 2,285,714 shares of common stock at an exercise price of $7.00 per share.
These increases were partially offset by a $0.4 million reduction in insurance costs and other sales and marketing expenses. ​ Total other (expense) income, net ​ Total other expense, net was $(3.8) million for the twelve months ended December 31, 2024, compared to other income, net of $15.2 million for the twelve months ended December 31, 2023, a decrease in other income of $19.0 million.
The increase was primarily driven by an $11.3 million increase in selling and marketing expenses related to direct-to-consumer marketing campaigns, a $2.7 million increase in sales commission expenses to Ascensia as we increased consignment sales, a $1.1 million increase in personnel costs, and a $3.2 million increase in other selling, general & administrative costs partially driven by costs related to the transition of commercial and distribution rights to Eversense from Ascensia. ​ Total other (expense) income, net ​ Total other expense, net was $(0.8) million for the twelve months ended December 31, 2025, compared to other expense, net of $(3.8) million for the twelve months ended December 31, 2024, a decrease of $3.0 million.
Based on the Company's current operating plan, existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under its Loan and Security Agreement, the Company has determined that substantial doubt exists regarding its ability to continue as a going concern for the one-year period following the date these condensed consolidated financial statements are issued.
Based on the Company’s current operating plan including expected capital investments required to assume commercialization and distribution responsibilities, existing unrestricted cash, cash equivalents and marketable securities, minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under its Amended Loan and Security Agreement, the Company has determined that it may not meet its debt covenants as early as the third quarter of 2026.
(“Hercules”) in its capacity as administrative agent 76 ​ and collateral agent for itself and the Lenders, pursuant to which the Lenders agreed to make available up to $50.0 million in senior secured term loans (the “Term Loan Facility”), consisting of (i) an initial term loan of $25.0 million (the “Tranche 1 Loan”), which was funded on September 8, 2023 and (ii) two additional tranches of term loans in the amounts of up to $10.0 million (the “Tranche 2 Loan”) and $15.0 million (the “Tranche 3 Loan”), respectively, which will become available to us upon our satisfaction of certain terms and conditions set forth in the Loan and Security Agreement.
We have also taken measures to manage our operating expenses, including through a company restructuring in 2024. ​ On September 8, 2023, the Company entered into the “Loan and Security Agreement with Hercules Capital, Inc. and its managed fund (collectively, the “Lenders”), pursuant to which the Lenders have to make available to Senseonics up to $50.0 million in senior secured term loans (the “Term Loan Facility”), consisting of (i) an initial term loan of $25.0 million (the “Tranche 1 Loan”), which was funded on the Effective Date and (ii) $10.0 million, which was funded on January 2, 2024 upon meeting certain terms in conditions under the loan agreement, and (the “Tranche 2 Loan”) and iii) $15.0 million which has not been drawn.
The Oxford/SVB warrants expire on June 30, 2026, November 22, 2026 and March 29, 2027, respectively. ​ On April 24, 2020, we entered into a loan agreement with Highbridge and issued the lender warrants to purchase an aggregate of 4,500,000 shares of the Company’s common stock with an exercise price of $0.66 per share (“Highbridge Warrants”).
The Oxford/SVB Warrants expire on June 30, 2026, November 22, 2026 and March 29, 2027, respectively. ​ On March 13, 2023, we issued and sold to PHC a warrant to purchase 771,288 shares of common stock for $15.0 million (the “Purchase Warrant”).
These decreases were partially offset by a $3.2 million increase in personnel costs to support our development projects, $1.8 million in 365-day product manufacturing costs incurred prior to FDA approval, a $0.8 million increase in contract fabrication costs and a $0.2 million increase in facilities costs. ​ Selling, general and administrative expenses ​ Selling, general and administrative expenses were $34.2 million for the twelve months ended December 31, 2024, compared to $29.9 million for the twelve months ended December 31, 2023, an increase of $4.3 million.
These reductions are primarily driven by the completion of the Eversense 365 system clinical trials and development efforts as well as a reduction in headcount, and were offset by a $0.2 million increase in other research and development expenses. ​ Selling, general and administrative expenses ​ Selling, general and administrative expenses were $52.5 million for the twelve months ended December 31, 2025, compared to $34.2 million for the twelve months ended December 31, 2024, an increase of $18.3 million.
The loans under the Loan and Security Agreement mature on September 1, 2027.
The loans under the Amended Loan and Security Agreement mature on September 3, 2029. ​ Convertible Notes ​ The 2025 Notes were repaid in full on January 15, 2025.
This MRI approval is a first for the CGM category, as all other sensors are required to be removed during an MRI scan. ​ On August 9, 2020, we entered into a collaboration and commercialization agreement with Ascensia (the “Commercialization Agreement”) 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 the following initial exceptions: (i) until January 31, 2021, the territory did not include territories covered by our then existing distribution agreement with Roche Diagnostics International AG and Roche Diabetes Care GmbH, 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; (ii) 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 (iii) until May 31, 2022, the territory did not include Israel.
This MRI approval is a first for the CGM category, as all other sensors are required to be removed during an MRI scan. ​ On August 9, 2020, we entered into the Commercialization Agreement pursuant to which we granted Ascensia the exclusive right to distribute Eversense 90 and Eversense E3 worldwide, with certain initial exceptions.
We engage a third-party valuation specialist to perform the valuation using the binomial option pricing model. ​ 74 ​ Results of Operations ​ Comparison of the Years Ended December 31, 2024 and 2023 ​ The following table sets forth our results of operations for the years ended December 31, 2024 and 2023. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2024 ​ 2023 ​ Period Change ​ ​ (in thousands) ​ ​ (in thousands) Revenue, net $ 3,973 $ 1,655 $ 2,318 ​ Revenue, net - related parties ​ ​ 18,499 ​ ​ 20,735 ​ ​ (2,236) ​ Total revenue ​ ​ 22,472 ​ ​ 22,390 ​ ​ 82 ​ Cost of sales ​ ​ 21,939 ​ ​ 19,299 ​ ​ 2,640 ​ Gross profit ​ ​ 533 ​ ​ 3,091 ​ ​ (2,558) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Research and development expenses ​ 41,144 ​ 48,752 ​ (7,608) ​ Selling, general and administrative expenses ​ 34,231 ​ 29,942 ​ 4,289 ​ Operating loss ​ (74,842) ​ (75,603) ​ 761 ​ Other income (expense), net: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Interest income ​ ​ 4,502 ​ ​ 5,362 ​ ​ (860) ​ Exchange related gain, net ​ ​ — ​ ​ 14,109 ​ ​ (14,109) ​ Interest expense ​ (8,437) ​ (11,110) ​ 2,673 ​ Gain on change in fair value of derivatives ​ ​ 102 ​ ​ 6,648 ​ ​ (6,546) ​ Other income ​ 59 ​ 202 ​ (143) ​ Total other (expense) income, net ​ (3,774) ​ 15,211 ​ (18,985) ​ Net Loss ​ $ (78,616) ​ $ (60,392) ​ $ (18,224) ​ ​ ​ Components of Results of Operations ​ Total revenue ​ Our total net revenue increased to $22.5 million for the twelve months ended December 31, 2024, compared to $22.4 million for the year ended December 31, 2023, an increase of $0.1 million.
Our estimates are based on information known at the time and include factors such as anticipated future usage and sales, potential for external unfavorable conditions such as import holds or quality issues, and planned product upgrades. ​ However, if actual product conditions differ from our assumptions, additional inventory adjustments that would increase cost of sales could be required. ​ 78 Results of Operations ​ Comparison of the Years Ended December 31, 2025 and 2024 ​ The following table sets forth our results of operations for the years ended December 31, 2025 and 2024. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ 2024 ​ Period Change ​ ​ (in thousands) ​ ​ (in thousands) Revenue, net ​ ​ ​ $ 17,084 ​ ​ ​ $ 3,973 ​ ​ ​ $ 13,111 ​ Revenue, net - related parties ​ ​ 18,173 ​ ​ 18,499 ​ ​ (326) ​ Total revenue ​ ​ 35,257 ​ ​ 22,472 ​ ​ 12,785 ​ Cost of sales ​ ​ 19,494 ​ ​ 21,939 ​ ​ (2,445) ​ Gross profit ​ ​ 15,763 ​ ​ 533 ​ ​ 15,230 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Research and development expenses ​ 31,592 ​ 41,144 ​ (9,552) ​ Selling, general and administrative expenses ​ 52,508 ​ 34,231 ​ 18,277 ​ Operating loss ​ (68,337) ​ (74,842) ​ 6,505 ​ Other income (expense), net: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Interest income ​ ​ 4,198 ​ ​ 4,502 ​ ​ (304) ​ Interest expense ​ (4,951) ​ (8,437) ​ 3,486 ​ Gain on change in fair value of derivatives ​ ​ — ​ ​ 102 ​ ​ (102) ​ Other (expense) income ​ (23) ​ 59 ​ (82) ​ Total other expense, net ​ (776) ​ (3,774) ​ 2,998 ​ Net Loss ​ $ (69,113) ​ $ (78,616) ​ $ 9,503 ​ ​ ​ Components of Results of Operations ​ Total revenue ​ Our total net revenue increased to $35.3 million for the twelve months ended December 31, 2025, compared to $22.5 million for the year ended December 31, 2024, an increase of $12.8 million .
Following the exchange, the remaining balance of the 2025 Notes was $20.4 million. On January 15, 2025, the Company repaid the outstanding principal and accrued interest in full. ​ In August 2023, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Goldman Sachs & Co.
The Public Offering and Private Placement closed on May 19, 2025 and May 20, 2025, respectively, and the Company received net proceeds of approximately $52.1 million and $20.1 million, respectively, after deducting underwriting discount, commissions, and offering expenses. ​ In August 2023, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Goldman Sachs & Co.
The increase was primarily due to a $2.4 million increase in personnel costs, a $1.4 million increase in legal expenses, and a $0.7 million increase in third-party consulting fees.
The decrease was primarily driven by a $6.3 million decrease in clinical study and outsourced development costs, a $2.2 million decrease in personnel costs, and a $1.2 million decrease in consulting costs.
The submission was prepared in compliance with the EU medical device regulation (“MDR”) and, upon approval, would enable the commercialization of Eversense 365 in European Union member countries.
The submission was prepared in compliance with the EU medical device regulation. 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. ​ The A&R Commercialization Agreement rendered Ascensia’s right to market Eversense products in the European Territories non-exclusive.
Jefferies received commissions up to 3.0% of the gross proceeds of any common stock sold through Jefferies under the 2021 Sales Agreement.
TD Cowen will receive commissions up to 3.0% of the gross proceeds of any common stock sold through TD Cowen under the Sales Agreement. The shares were offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on August 6, 2025.
Removed
CMS provided G-codes to enable immediate access to Eversense 365 for all eligible Medicare beneficiaries.
Added
As described in more detail below, in August 2020, we entered into a collaboration and commercialization agreement (“Existing Commercialization Agreement”), with Ascensia Diabetes Care Holdings AG (“Ascensia”) pursuant to which we granted Ascensia the exclusive right to distribute Eversense worldwide, with certain initial exceptions.
Removed
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 90-day Eversense, Eversense XL, Eversense E3, Eversense 365 and future generation products.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Removed
Item 7A. Quantitative and Qualitative Disclosures About Market Risk ​ Interest Rate Risk ​ The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates.
Added
Item 7A. Quantitative and Qualitative Disclosures About Market Risk ​ We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Accordingly, pursuant to Item 305(e) of Regulation S-K, we are not required to provide the disclosures under this Item 7A. ​ 84 ​ ​
Removed
As of December 31, 2024, we had cash and cash equivalents of $74.9 million and at December 31, 2023 we had cash, cash equivalents and marketable securities of $109.5 million. We generally hold our cash in interest-bearing money market accounts or short-term investments that meet our policy for cash equivalents.
Removed
Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates.
Removed
Due to the short-term maturities of our cash equivalents and the low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents. The Company’s Loan and Security Agreement is affected by variations in the U.S. prime rate of interest.
Removed
As of December 31, 2024, we had $35.0 million outstanding under the agreement. A 2% change in the prime rate would result in additional annual interest of approximately $0.4 million based on the outstanding balance at December 31, 2024.
Removed
We do not currently engage in hedging transactions to manage our exposure to interest rate risk. ​ ​ Foreign Currency Risk ​ The majority of our international sales are denominated in Euros. Therefore, our U.S. dollar value of sales is impacted by exchange rates versus the Euro.
Removed
Currency fluctuations or a strengthening U.S. dollar can decrease our revenue from these Euro-denominated international sales.
Removed
To date, foreign currency transaction gains and losses and exchange rate fluctuations have not been material to our consolidated financial statements, and we do not believe that the effect of a hypothetical 10% change in foreign currency exchange rates applicable to our business would have had a material impact on our operating results or financial condition.
Removed
We do not currently engage in any hedging transactions to manage our exposure to foreign currency exchange rate risk. ​ 81 ​ ​ ​

Other SENS 10-K year-over-year comparisons