SENS 10-K & 10-Q changes, risk factors and insider trading

Since our inception, we have incurred significant net losses and expect to incur additional losses in the near future. We incurred total net loss of $(78.669.1) million and $(60.478.6) million for the years ended December 31, 2024,2025, and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $947.9$1.0 million.billion. To date, we have financed our operations primarily through sales of our equity securities and debt financings. We have devoted substantially all of our resources to the research and development of our products, including conducting clinical trials, and the commercial launch of Eversense in the United States, select markets in Europe, the Middle East, and Africa (EMEA).

To implement our business strategy we need to, among other things, successful transition commercial responsibility for Eversense back to the Company from Ascensia, gain regulatory approval or certification in other regions where we intend to sell our products, expand our commercial launch in the United States and Europe, and develop future generations of Eversense. We have never been profitable from operations and do not expect to be profitable for at least the next several years. We expect to make significant investments in product development as we pursue these objectives. The extent of our future operating losses and the timing of profitability are highly uncertain, and we expect to continue incurring expenses and operating losses over the next several years. Any additional operating losses may have an adverse effect on our stockholders' equity, and we cannot assure you that we will ever be able to achieve profitability. Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our development efforts, obtain regulatory approvals or certificates, diversify our product offerings or continue our operations.

Due to our limited operating history as a commercial-stage company, we may not have the institutional knowledge or experience to be able to effectively address these and other risks that may face our business. In addition, we may not be able to develop insights into trends that could emerge and negatively affect our business and may fail to respond effectively to those trends.trends As a result of these or other risks, we may not be able to execute key components of our business strategy, and our business, financial condition and operating results may suffer.

If we are unable to successfully expand our commercialization of Eversense in the United States and Europe through our Commercialization Agreement with Ascensia, our business will be harmed.

We have limited commercialization experience in both the United States and Europe. We have invested substantially all of our efforts and financial resources to the development and commercialization of Eversense. Our ability to generate revenue from our products will depend heavily on successful commercialization of products in the United States and Europe, which is entirely dependent on our collaboration with Ascensia,Europe and on continuing development of future generations of our Eversense system. The success of any products that we develop will depend on several factors, including:

Both before and after a product is commercially released, we will have ongoing responsibilities under U.S. and EU regulations. We will also be subject to periodic inspections by the FDA, the Notifiednotified Bodiesbodies in the EEA and comparable foreign authorities to determine compliance with regulatory requirements, such as the QSR,QMSR of the FDA, medical device reporting regulations, vigilance in reporting of adverse events and regulations regarding notification, corrections, and recalls. These inspections can result in observations or reports, warning letters or other similar notices or forms of enforcement action. If the FDA, or any comparable foreign regulatory authority concludes that we are not in compliance with applicable laws or regulations, or that any of our products are ineffective or pose an unreasonable health risk, such authority could ban these products, suspend, vary or cancel our marketing authorizations or CE Certificates of Conformity, impose "“stop-sale"” and "“stop-import"” orders, refuse to issue export certificates, detain or seize adulterated or misbranded products, order a recall, repair, replacement, correction or refund of such products, or require us to notify health providers and others that the products present unreasonable risks of substantial harm to the public health. Discovery of previously unknown problems with our product'sproduct’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. The FDA, competent authorities of EEA countries and comparable foreign regulatory authorities may also impose operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices, assess civil or criminal penalties against our officers, employees or us, or recommend criminal prosecution of our company. Adverse regulatory action may restrict us from effectively marketing and selling our products. In addition, negative publicity and product liability claims resulting from any adverse regulatory action could have a material adverse effect on our business, financial condition, and operating results.

Our current business strategy is highly dependent on the successful commercialization of Eversense by Ascensia and achieving and maintaining market acceptance. 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. 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.

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. Patients who receive treatment for their medical conditions and their healthcare providers generally rely on third party payors to reimburse all or part of the costs associated with their medical treatment, including healthcare providers' services. As a result, access to coverage and adequate reimbursement for Eversense by third-party payors is essential to the acceptance of our products by people with diabetes. Similarly, healthcare providers may choose not to order a product unless third-party payors cover and reimburse a substantial portion of the product. Coverage determinations and reimbursement levels of both our products and the healthcare provider's performance of the insertion and removal procedures are critical to the commercial success of our product, and if we or our commercial partners are not able to secure positive coverage determinations and reimbursement levels for our products or the insertion and removal procedures, our business would be materially adversely affected.

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. AscensiaWe intendsintend to continue developing customer loyalty programs to help with retention aimed at patients, their caregivers and healthcare providers, which include patient ambassadors, training specific to Eversense, ongoing support by sales and clinical employees and 24/7 technical support and customer service. If demand for our products fluctuates as a result of the introduction of competitive products, changes in reimbursement policies, manufacturing problems, perceived safety issues with our or our competitors' products, the failure to secure regulatory clearance or approvals, certifications or for other reasons, our ability to attract and retain customers could be harmed. The failure to retain a high percentage of our customers would negatively impact our business, financial condition and operating results.

We intend to continue to increase our operating expenses in connection with the commercialization of Eversense with our collaboration partner Ascensia,Eversense, our ongoing research and development activities including the development of next generation products and the clinical trials for those products, and the commensurate development of our management and administrative functions. We will need to generate significant sales to achieve profitability, and we might not be able to do so. Even if we do generate significant sales, we might not be able to achieve, sustain or increase profitability on a quarterly or annual basis in the future. If our sales grow more slowly than we expect,expect or if our operating expenses otherwise exceed our expectations, our financial performance and operating results will be adversely affected.

We have limited operating history as a commercial-stage company and we anticipate that there will be meaningful variability in our operating results among years and quarters, as well as within each year and quarter. Our operating results, and the variability of these operating results, will be affected by numerous factors, including:

As a result of our lack of operating history as a commercial-stage company and Ascensia’s lack of experience selling CGM systems, and Eversense in particular, and due to the complexities of the industry and regulatory framework in which we operate, it will be difficult for us to forecast demand for our future products and to forecast our sales with any degree of certainty. For example, many of the products we will seek to develop and introduce in the future will require regulatory approval, certification or clearance and import licenses before we can sell such products and given that the timing of such approvals, certification, clearances or licenses may be uncertain, it will be difficult for us to predict sales projections for these products with any degree of certainty before such approvals, certifications, clearances or licenses are obtained. In addition, we will be increasing our operating expenses as we expand our business. Accordingly, we may experience substantial variability in our operating results from year to year and quarter to quarter. If our quarterly or annual operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any quarterly or annual fluctuations in our operating results may, in turn, cause the price of our common stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.

Our product revenues have historically been lower in the first quarter of the year as compared to the fourth quarter of the preceding year. We believe this arises primarily due to the annual reset of health insurance plan deductibles that occur at the beginning of the insurance plan year and the utilization of patient assistance programs to offset those costs and our distributors reductions of inventory of our products in the first quarter. The seasonal variance is has also historically been impacted by the timing of Ascensia’s purchases in accordance with minimum purchase requirements under our distribution agreement. As a result, our distributors typically end the calendar year with higher levels of inventory than at the end of the first quarter of the following year. As a result, our net sales are typically lower in the first quarter of the year than would otherwise have been the case as a result of the reduction of product inventory at our distributors. Many health insurance plans and government insurance programs reset annual limits on deductibles and out-of-pocket costs at the beginning of each calendar year and require participants to pay for a large portion of medical products and services until such deductibles and annual out-of-pocket cost limits are met. As a result of these factors, patients may delay medical expenses or find cheaper alternatives until such deductibles and annual out-of-pocket cost limits are met. 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.

In September 2023, we entered into a loan agreement (the “Loan and Security Agreement”) with several institutions (collectively, the “Lenders"”) and Hercules Capital, Inc. (“Hercules”), as administrative agent. On September 3, 2025, the Company amended the Loan and Security Agreement (the “Amended Loan and Security Agreement”). The Amended Loan and Security Agreement contains customary terms and covenants, including financial covenants, such as operating within an approved budget and achieving minimum revenue and liquidity targets, and negative covenants, such as limitations on indebtedness, liens, mergers, asset transfers, certain investing activities and other matters customarily restricted in such agreements. Most of these restrictions are subject to certain minimum thresholds and exceptions. The Amended Loan and Security Agreement also contains customary events of default, after which borrowings under the Loanterm and Security Agreementloan 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.

Despite our current consolidated debt levels, subject to certain conditions and limitations in the indentures related to the 2025 Notes and the Loan and Security Agreement, we may be able to incur substantial additional debt in the future, some of which may be secured debt. We may not be subject to any restrictions on incurrence of additional indebtedness under the terms of any future indebtedness. If new debt is added to our current debt levels, the related risks that we and they now face could intensify.

The accompanying financial statements have been prepared assuming the Company will continue as a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our management concluded that our recurring losses from operations, existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, and minimum cash and satisfaction of performance milestones to comply with debt covenants under its Loan and Security Agreement raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements. As of December 31, 2024,2025 the Company had unrestricted cash, cash equivalents and marketable securities of $74.6$94.0 million consisting of cash and investments in highly liquid U.S. money market funds. On October 28, 2024, we raised additional proceeds of approximately $14.8 million before expenses incurred by the Company in a registered direct offering of the Company’s common stock and concurrent private placement of warrants to purchase shares of the Company’s common stock. We do not expect our existing cash and cash equivalents will be sufficient to fund our operations, including the expanded operations that will be required to resume commercialization of Eversense, through the next twelve months and we will need to seek additional capital to fund our operations, working capital needs, capital expenditures and other strategic initiatives beyond that time. There can be no assurance that we will be successful in raising additional capital or that any needed financing will be available in the future at terms acceptable to us. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements are issued and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, and substantial doubt exists about our ability to continue as a going concern. If we are unable to generate to secure additional capital on acceptable terms or at all, we may be required to significantly reduce or cease our operations, pursue strategic alternatives, or consider other actions which could result in thea loss to investors of their investment in our securities.

We are highly dependent on the management, research and development, clinical,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. Although we have employment agreements with our executive officers, each of them may terminate their employment with us at any time and will continue to be able to do so. We do not maintain "“key person"” insurance for any of our executives or employees.

Recruiting and retaining qualified scientific andscientific, clinical personnel and, as we progress the development of our product pipeline toward scaling up for commercialization, manufacturing and sales and marketing personnel,personnel will also beare critical to our success. In addition, as we have begun to transition responsibility for the commercialization of our products, we will also be required to recruit and retain a qualified sales force and supporting functions. The loss of the services of our executive officers or other key employeesemployees, or the inability to add required staff, could impede the achievement of our research, development and commercialization objectives or the expansion of activities to support Eversense, and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous medical device companies for similar personnel, many of which have greater financial and other resources dedicated to attracting and retaining personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.

We maywill need to expand our developmentsales and regulatory capabilities and our marketing and distributionpotentially other capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

As of December 31, 2024,2025, we had 117137 full-time employees. As ourwe resume responsibility for the commercialization progresses,of our products, we mayexpect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of sales and marketing and commercial operations. In connection with that effort, effective January 2, 2026, we expanded our workforce by hiring more than 150 employees, primarily within commercial sales, marketing, and related support functions. We also may experience growth in the number of employees in the areas of research, product development, clinical sciences, regulatory affairs, supply chain, andlogistics, marketing.clinical/insertion services, or additional commercial activities. To manage our future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

We are exposed to the risk that our employees, independent contractors, consultants, manufacturers and distributors may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless or negligent conduct or disclosure of unauthorized activities to us that violates FDA regulations, including those laws requiring the reporting of true, complete and accurate information to the FDA, manufacturing standards, federal and state healthcare laws and regulations, and laws that require the true, complete and accurate reporting of financial information or data. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct by these parties could also involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. Our exposure to these risks will increase as we significantly increase our work force and resume responsibility for the commercialization of our products. We have adopted a code of business conduct and ethics, but it is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. 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.

The medical device industry in general, and the glucose testing sector of this industry in particular, are characterized by the existence of a large number of patents and frequent litigation based on assertions of patent infringement. We are aware of numerous patents issued to third parties that may relate to the technology used in our business, including the design and manufacture of CGM sensors and CGM systems, as well as methods for continuous glucose monitoring. Each of these patents contains multiple claims, any one of which may be independently asserted against us. The owners of these patents may assert that the manufacture, use, sale or offer for sale of our CGM sensors or CGM systems infringes one or more claims of their patents. For example, as noted in Item 3: Legal Proceedings, in May 2024, wethe wereCompany servedreceived withnotice and accepted service of a civil complaint bythat Cellspinhad Soft, Inc., a non-practicing entity,been filed against us in the United States District Court for the Eastern District of Texas,Texas and styled Cellspin Soft, Inc. vs. Senseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG Case No. 2:24-cv 263. The case was filed by a non-practicing entity alleging thatpatent weinfringement infringeof onthree certainpatents. patents owned by it and seeking unspecified damages. We note that theThe validity of all three patents-in-suitof these patents currently is currently being challenged in Inter Partes Review proceedings at the U.S. Patent and Trademark Office,Office whereby another party, TikTok Inc., (the “TikTok IPR”) and on September 30, 2024, the Patent Trial and Appeal Board instituted a review whichwith respect to each of the Companyasserted hasclaims joined.in these three patents. 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 complaintproceedings in the Eastern District of Texas pending resolution of the Inter Partes Review.Reviews. WeOn 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. 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. 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 furtherall reviewingstayed pending the allegations,outcome andof intendthe sua sponte Director’s review. The timing of this review remains uncertain. Were the 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. Should any asserted claim in the three patents survive the invalidity challenge in the Inter Partes Review proceedings, the Company intends to vigorously defend this matter, however, the outcome of any litigation, such as this, is inherently unpredictable.lawsuit.

We and our third-party suppliers are required to comply with the FDA's QSR,QMSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products. The FDA audits compliance with the QSRQMSR through periodic announced and unannounced inspections of manufacturing and other facilities. The FDA may impose inspections or audits at any time. If we or our suppliers have significant non-compliance issues or if any corrective action plan that we or our suppliers propose in response to observed deficiencies is not sufficient, the FDA could take enforcement action against us. We are subject to equivalent limitations and penalties in foreign countries. Any of the foregoing actions could impair 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. 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 federal, state or foreign regulatory review to which we may become subject, regardless of the outcome, would be costly and time-consuming. In addition, if our affiliated physicians are found to have violated these laws, they could also be subject to significant fines and other sanctions through professional licensure proceedings.

For example, to enforce compliance with the federal laws, the U.S. 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. 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. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.

In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), imposes specific requirements relating to the privacy, security, and transmission of individually identifiable protected health information.

Numerous U.S. states have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data. As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making. The exercise of these rights may impact our business and ability to provide our products and services. Certain states also impose stricter requirements for processing certain personal data, including sensitive information, such as conducting data privacy impact assessments. These state laws allow for statutory fines for noncompliance. The California Consumer Privacy Act of 2018 (“CCPA”) and other comprehensive U.S. state privacy laws exempt some data processed in the context of clinical trials, but these developments may further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties with whom we work. Similar laws are being considered in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future.

The collection and use of personal health data in the EEA and the UK is governed by the EU and UK GDPR (collectively, GDPR). The GDPR applies to the processing of personal data by any company established in the EEA or UK and to companies established outside the EEA to the extent they process personal data in connection with the offering of goods or services to data subjects in the EEA or the monitoring of the behavior of data subjects in the EEA or UK. Under the GDPR, companies may face temporary or definitive bans on data processing and other corrective actions; fines of up to 20 million Euros under the EU GDPR / 17.5 million pounds sterling under the UK GDPR, or 4% of annual global revenue, whichever is greater; or private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests. The GDPR enhances data protection obligations for data controllers of personal data, including stringent requirements relating to the consent of data subjects, expanded disclosures about how personal data is used, requirements to conduct privacy impact assessments for “high risk” processing, limitations on retention of personal data, mandatory data breach notification and “privacy by design” requirements, and creates direct obligations on service providers acting as processors. The Swiss Federal Act on Data Protection, or the FADP, also applies to the collection and processing of personal data, including health-related information, by companies located in Switzerland, or in certain circumstances, by companies located outside of Switzerland. The GDPR also imposes strict rules on the transfer of personal data outside of the EEA and UK to countries that do not ensure an adequate level of protection, like the United States. In the ordinary course of business, we transfer personal data from the EEA and UK or other jurisdictions to the United States or other countries. Europe and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer of personal data to other countries. In particular, the EEA and the UK have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it generally believes are inadequate. 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. 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,Framework). theseThese 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. If there is no lawful manner for us to transfer personal data from the EEA or UK or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions at significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business. Additionally, companies that transfer personal data out of the EEA and UK to other jurisdictions, particularly to the United States, are subject to increased scrutiny from regulators, individual litigants, and activist groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers out of Europe for allegedly violating the GDPR’s cross-border data transfer limitations. Other jurisdictions have adopted and may adopt stringent data localization and cross-border data transfer laws.

In addition to data privacy and security laws, we are contractually subject to certain industry standards adopted by industry groups and, we are, and may become subject in the future, to additional such obligations. We are also bound by contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful. 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. Regulations in the United States are increasingly scrutinizing these statements, and if these policies or statements are found to be deficient, lacking in transparency, deceptive, unfair, misleading, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences.

We are a medical technology company focused on the design, development and manufacturingcommercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Our implantable CGM (“Eversense”),systems, including the Eversense E3 system (“Eversense E3”) and the Eversense 365 CGMsystem systems(“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 1415 days for non-implantable CGM systems. 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. In February 2022, the 180-day Eversense E3E3, a 180 day CGM systemsystem, 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 markMark to the extended life Eversense E3 CGM system and Ascensia began commercialization in select markets in Europe during the third quarter of 2022. In September 2024, theEversense 365, a 365-day extended life Eversense E3 CGM systemsystem, was approved by the FDA and Ascensia began commercializing Eversense 365 in the United States in the fourth quarter of 2024. In January 2026, we took over full commercial responsibility for Eversense 365 in the United States and began marketing and distributing the product with our own sales force.

We primarily sell directly to our network of distributors,distributors and strategic fulfillment partners, who provide the Eversense system to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement. In addition, we sell our product through a consignment model through arrangements with our network of healthcare professionals. Sales of the Eversense system are widely dependent on the ability of patients to obtain coverage and adequate reimbursement from third-party payors or government agencies. We leverage and target regions where we have coverage decisions for patient device use and provider insertion and removal procedure payment. We have reached approximately 300 million covered lives in the United States through positive insurance payor coverage decisions. 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. 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,Systems, as a medical benefit, rather than as part of the Durable Medical Equipment channel that includes other CGMs. In December 2021, CMS released its Calendar Year 2022 Medicare Physician Fee Schedule that updated globalbundled 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 February 2024, we announced that Medicare coverage was expanded for Eversense E3 to include all people with diabetes using insulin and non-insulin users who have a history of problematic hypoglycemia providing access to millions of Medicare patients. All of the Medicare administrative contractors (“MAC”) expansions became effective in 2024. In April 2025, CMS providedupdated G-codesthe payment amounts in the Physician Fee Schedule to enableaccount immediatefor accessthe tolonger duration Eversense 365 for all eligible Medicare beneficiaries. We have been working with payors to transition their policies to Eversense 365 and have confirmed immediate coverage policy transition from select payors.

We are in the early commercialization stages of the Eversense brand and are focused on driving awareness of our CGM system amongst people with diabetes and their healthcare providers. In both the United States and our overseas markets, we have entered into strategic partnerships and distribution agreements that allow third party collaborators with direct sales forces and established distribution systems to market and promote SenseonicsSenseonics’ CGM systems, including 90-day Eversense,various Eversense XL, Eversense E3, Eversense 365Systems and future generation products.products, Our future generation products in development areincluding our “Gemini” product variation to allow for a 2-in-1 glucose monitoring system combining the functionality of CGM and Flashflash Glucoseglucose Monitoring,monitoring, in an implantable sensor with battery that may be utilized with a smart transmitter to get continuous glucose readings and alerts, or be utilized through a swipe over the sensor with a smart phone to get on-demand glucose reading without a smart transmitter and our “Freedom” product variation which would include Bluetooth in the sensor eliminating the on-body component.

In 2016, we completed our PRECISE II pivotal clinical trial in the United States. 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. 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. 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. OnIn June 21, 2018, we received PMA approval from the FDA for the Eversense 90 system. 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. 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 inon September 30, 2019, we completed enrollment of the PROMISE trial. In the trial, we observed performance matching that of the then current Eversense 90-day product90 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. Following the results of the PROMISE trial, on September 30, 2020, a PMA supplement application to extend the wearable life of the Eversense CGM System90 to six months was submitted to the FDA. In February 2022, the extended life Eversense E3 CGM system was approved by the FDA.

On February 26, 2020, we announced that the FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor. This sub-set of 30 participants werewas left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days. Information gathered from this sub-set and additional development efforts provided us with the confidence to start the Pivotal study for the Eversense 365 System.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 had previously obtained this indication for Eversense 90 in the United States in 2019. 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 system90 and our 180-day Eversense E3 CGM system worldwide, with the followingcertain 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.exceptions. Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the 90-dayEversense Eversense90 product on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for the 90-day Eversense product90 during the second quarter of 2021.

In February 2022, we received approval from the FDA for the Eversense E3 CGM System.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%. 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 the Eversense E3 system using the SBA technology. 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 November 2022, we submitted and in the first quarter of 2023 we received approval of an investigational device enrollmentexemption (“IDE”) for the enrollment of a pediatric cohort in the ENHANCE study. In 2023 the data gathered in the ENHANCE study supported the iCGM submission and in April 20242024, 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. 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. The 510(k) submission was approved by the FDA on September 17, 2024 and ourEversense 365-day365 product was cleared for sale in the United States. 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, LLCLLC, (collectively “Eon Care PCs”), which were formed as wholly owned subsidiaries of Senseonics, Incorporated. 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 systemsystems by providing convenient Eversense insertion and training services. TheWe Companyfully expectscompleted the transition of our network of inserters from the Nurse Practitioner Group to Eon Care in the second quarter of 2025, and we experienced an increase in the number of insertions through Eon Care during the second and third quarters. Once we build out and establish the Eon Care network, we expect established CPT codes associated with Eversense insertions to enable a self-sustaining economic model for this initiative in the future.

In July 2024, we began first-in-human testing for the Gemini system.product. The next-generation Gemini product utilizes a fully implantable self-powering system that includes a flash glucose monitor with no on-body component for people with type 2 diabetes and traditional CGM with an on-body component for people with type 1 diabetes. The Gemini product is built on the 365-day sensor platform and the clinical and regulatory work will be focused on demonstrating the battery integration and functionality rather than the sensor life. Data gathered from this first-in-human testing will bewas utilized for an IDE submission anticipatedthat was approved by the FDA in December 2025 which allowed us to begin enrolling patients in the secondGemini halfpivotal of 2025.study.

In September 2017, we affixed the CE markMark for Eversense XL,XL which permits the product to be sold freely in any part of the European Economic Area (“EEA”). TheEEA. Eversense XL is indicated for a sensor life of up to 180 days. Eversense XL began commercialization in the EEAEurope in the fourth quarter of 2017. All such commercialization and marketing activities remain subject to applicable government approvals.

In June 2022, we affixed the CE markMark for theto Eversense E3 CGM system,E3, and Ascensia began commercialization in certain European markets during the second half of 2022.

In February 2025, we submitted an application for the conformity assessment of Eversense 365 CGM system to our notifiedNotified bodyBody for CE Mark approval.certification. The submission was prepared in compliance with the EU medical device regulationregulation. (“MDR”)In and,January upon approval, would enable2026, the commercializationCompany ofobtained CE Mark approval for Eversense 365 inand European Union member countries. Following CE Mark approval, we planexpects to launch Eversense 365 within ourthe globalEuropean commercialTerritories partner, Ascensia, inby the second half of 2025.2026.

We generate aA 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 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. Our contract with Ascensia contains performance obligations, mostly for the supply of goods, and are typically satisfied upon transfer of control of the product and does not include the right to return unless there is a product issue, in which case we may provide replacement product. Product conformity guarantees do not create additional performance obligations and are accounted for as warranty obligations in accordance with guarantee and loss contingency accounting guidance.

Our total net revenue increased to $22.5$35.3 million for the twelve months ended December 31, 2024,2025, compared to $22.4$22.5 million for the year ended December 31, 2023,2024, an increase of $0.1$12.8 million. 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 increased for U.S. sales of the 365-day productproduct, indriven by a higher number of patients reaching their annual deductibles and the USfirst patients receiving re-insertions after obtainingtheir FDAinitial approvalyear in September 2024. Higher sales withinon the United365-day States of $1.2 million was largely offset by $1.1 million in lower sales outside of the United States primarily due to reduced inventory levels.product.

Our cost of sales were $19.5 million for the twelve months ended December 31, 2025 compared to $21.9 million for the twelve months ended December 31, 20242024, compareda decrease of $2.4 million. Our gross profit increased to $19.3$15.8 million for the twelve months ended December 31, 2023,2025, an increase of $2.6 million. Our gross profit decreasedcompared to $0.5 million for the twelve months ended December 31, 2024, compared to $3.1 million for the twelve months ended December 31, 2023.2024. Gross profit as a percentage of revenue, or gross margin, was 2.4%44.7% and 13.8%2.4% for the twelve months ended December 31, 20242025 and December 31, 2023,2024, respectively. The reductionimprovement in gross margin was primarilypartially drivendue byto $4.8 million in one-time charges incurred in the prior year as the result of the transition from Eversense E3 to Eversense 365,365. partiallyThe offsetadditional byimprovement manufacturingin coststhe previouslygross expensedmargin is due to researchseveral andfactors, developmentincluding expenses.favorable Priormargins to receiving FDA approval foron the 365-day product insales, Septemberlower 2024, costs associated withfixed manufacturing 365-daycosts, one-time impacts such as VAT recoveries of $0.7 million and the benefit of previously expensed inventory in the aggregate amount of $2.1$0.6 millionmillion. wereThese expensedimprovements asare researchslightly andoffset developmentby expense.an Ifincrease wein wererevenue share to haveAscensia includedunder thesethe costs previously expensed as a componentterms of costs of sales, our costs of sales would have been $23.5 million, resulting in a gross loss of $1.1 million. We expect cost of sales related to the EversenseCommercialization 365 will continue to reflect a lower average cost per unit over approximately the next quarter as the previous expensed inventory is fully exhausted.Agreement.

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, compared to $29.9 million for the twelve months ended December 31, 2023, an increase of $4.3$18.3 million. The increase was primarily duedriven by an $11.3 million increase in selling and marketing expenses related to direct-to-consumer marketing campaigns, a $2.4$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 $1.4$3.2 million increase in legalother expenses,selling, general & administrative costs partially driven by costs related to the transition of commercial and adistribution $0.7rights millionto increaseEversense infrom third-party consulting fees. These increases were partially offset by a $0.4 million reduction in insurance costs and other sales and marketing expenses.Ascensia.

Since our inception, we have incurred significant net losses and expect to incur additional losses in the near future. We incurred total net loss of $(78.669.1) million and $(60.478.6) million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $947.9$1.0 million.billion. To date, wethe haveCompany financedhas ourfunded its operations primarilyprincipally through salesthe issuance of ourpreferred equitystock, securitiescommon stock, warrants, convertible notes, and debt financings.debt. As of December 31, 2024,2025, the Company had unrestricted cash, cash equivalents, and cashmarketable equivalentssecurities of $74.6$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 athe registered2024 directRegistered offeringDirect 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, the entry into a term loan facility and the issuance of shares of common stock pursuant to an at the market offering program. These transactions are described in greater detail below.programs. We have also taken measures to manage our operating expenses, including through a company restructuring in 2024.

On September 8, 2023, wethe Company entered into a loan agreement (the “Loan and Security Agreement”) with severalHercules institutionsCapital, Inc. and its managed fund (collectively, the “Lenders") and Hercules Capital, Inc. (“Hercules”) in its capacity as administrative agent and collateral agent for itself and the Lenders,, pursuant to which the Lenders agreedhave 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 Septemberthe 8,Effective 2023Date and (ii) two$10.0 additionalmillion, trancheswhich ofwas termfunded loanson January 2, 2024 upon meeting certain terms in conditions under the amountsloan ofagreement, up to $10.0 millionand (the “Tranche 2 Loan”) and iii) $15.0 million which has not been drawn. On September 3, 2025, the Company amended the Loan and Security Agreement (the “Amended Loan and Security Agreement”) with the Lenders and Hercules. The Amended Loan and Security Agreement increased the total loan commitment under the facility from $50.0 million to $100.0 million (collectively, the “2025 Term Loans”). In the Amended Loan and Security Agreement, the undrawn loans increased from $15.0 million to $65.0 million divided into three tranches of up to $10.0 million (“2025 Tranche 2 Loan”), up to $20.0 million (“2025 Tranche 3 Loan”) and up to $35.0 million (“2025 Tranche 4 Loan”), respectively, which will become available to usSenseonics upon ourSenseonics’ satisfaction of certain terms and conditions set forth in the Amended Loan and Security Agreement. In December 2023, we met the terms and conditions to draw on Tranche 2 Loan and the loan was funded on January 2, 2024 in an amount of $10.0 million. The loans under the Amended Loan and Security Agreement mature on September 1,3, 2027.2029.

On March 13, 2023, we issued and sold to PHC a Purchase Warrantwarrant to purchase 15,425,750771,288 shares of common stock for $15.0 million.million (the “Purchase Warrant”). The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001$0.02 per share (the “Purchase Warrant Share.Shares”). 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,Notes”), including all accrued and unpaid interest thereon, for a warrant (the “PHC Exchange Warrant”) to purchase up to 68,525,3113,426,266 shares of common stock.stock (the “PHC Exchange Warrant Shares”). The PHC Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001$0.02 per PHC Exchange Warrant 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 832,36241,619 shares of common stock at an initial exercise price of $0.6007$12.01 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,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. All other terms of the warrants, including the expiration date and number of shares issuable upon exercise, remain unchanged.

On January 2, 2024, we issued the Tranche 2 Warrants to acquire an aggregate of 347,88717,395 shares at an initial exercise price of $0.5749$11.50 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,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. All other terms of the warrants, including the expiration date and number of shares issuable upon exercise, remain unchanged.

On October 24, 2024, in connection with the registered2024 directRegistered offeringDirect described above,Offering, the Company issued to the investors in the offering the PP Warrants to purchase an aggregate of 45,714,2862,285,714 shares of common stock at an exercise price of $0.35$7.00 per share. The PP Warrants arewere non-exercisable for the first six months after issuance and expire on April 29, 2030.

On September 8, 2023, wethe Company entered into the Loan and Security Agreement with the Lenders and Hercules, pursuant to which the Lenders agreed to make available to usthe Company the Term Loan Facility, consisting of (i) an initial Tranche 1 Loan, which was previously funded on the Effective Date in thean 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 loans under the Loan and Security Agreement mature on September 1, 2027. In December 2023, we met the terms and conditions to draw on Tranche 2 Loan and the loan was funded on January 2, 2024 in an amount of $10.0 million, and (iii) Tranche 3 Loan, which has not been drawn. On September 3, 2025, the Company entered into the Amended Loan and Security Agreement, increasing the total loan commitment under the facility from $50.0 million to $100.0 million. Under the Amended Loan and Security Agreement, the undrawn loans increased from $15.0 million to $65.0 million divided into three tranches of up to $10.0 million, up to $20.0 million, and up to $35.0 million, respectively, which will become available to Senseonics upon Senseonics’ satisfaction of certain terms and conditions set forth in the Amended Loan and Security Agreement. The loans under the Amended Loan and Security Agreement mature on September 3, 2029.

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. 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. 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. 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. In June 2022, we affixed the CE Mark to the extended life Eversense E3 system and Ascensia began commercialization in select markets in EuropeItaly, Germany, Spain and Sweden (the “European Territories”) during the third quarter of 2022. In September 2024, Eversense 365, a 365-day extended life CGM system, was approved by the FDA and Ascensia began commercializing Eversense 365 in the United States in the fourth quarter of 2024. In January 2026, we took over full commercial responsibility for Eversense 365 in the United States and began marketing and distributing the product with our own sales force. In January 2026, we also obtained CE Mark approval for Eversense 365 and are currently in the process of launching Eversense 365 in Italy, Germany, Spain and Sweden (the “European Territories”).Territories.

On September 3, 2025 the Company and Ascensia signed a memorandum of understanding (“MOU”) related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company. On December 31, 2025, the parties entered into the Master Asset Purchase Agreement formalizing this transfertransfer, closed these transations in the U.S. on January 1, 2026, and subsequently entered into A&R Commercialization Agreement, which terminated Ascensia’s right to market Eversense products in the U.S. and rendered Ascensia’s right to market Eversense products in Italy, Germany, Spain and Sweden (the “European Territories”) non-exclusive. Pursuant to the A&R Commercialization Agreement, effective January 1, 2026, we are entitled to 100% of the revenues derived from the sale of Eversense products in the European Territories. As contemplated by the Master Asset Purchase Agreement, on March 12, 2026 we entered into local asset purchase agreements to facilitate the transition of Ascensia’s commercialization activities in the European TerritoriesTerritories. The Company and weAscensia expectalso entered into a Transition Services Agreement, under which the closingsCompany paid Ascensia for certain support and administrative services in Europe during 2026. The European transactions closed in early June 2026. Ascensia continues to provide certain transition support services, particularly related to Italy and Germany to facilitate an orderly transition of thesethe transactionscommercialization toactivities occurin onthose ormarkets beforefollowing Junethe 30, 2026, subject to customary regulatory and operational conditions.closings.

WeIn primarilythe United States, we sell directly to our network of distributors and strategic fulfillment partners, who provide the Eversense system to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement. In addition, we sell our product through a consignment model through arrangements with our network of healthcare professionals. In Europe, we sell primarily to hospital networks under tender agreements and through distributors, who resell the Eversense systems to hospitals. Sales of the Eversense system are widely dependent on the ability of patients to obtain coverage and adequate reimbursement from third-party payors or government agencies. We leverage and target regions where we have coverage decisions for patient device use and provider insertion and removal procedure payment. We have reached approximately 300 million covered lives in the United States through positive insurance payor coverage decisions. 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. 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 Systems, as a medical benefit, rather than as part of the Durable Medical Equipment channel that includes other CGMs. 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. 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. In April 2025, CMS updated the payment amounts in the Physician Fee Schedule to account for the longer duration Eversense 365 for all eligible Medicare beneficiaries. The Physician Fee Schedule was updated with similar pricing for 2026. We have been working with payors that previously supported Eversense to transition their policies to Eversense 365 and the majority of these eligible payors have now completed that transition.

We continue to expand commercialization of the Eversense brand and are focused on driving awareness of our CGM system among people with diabetes and their healthcare providers. Effective January 1, 2026, U.S. commercialization activities were returned to theus. CompanyIn March 2026, we executed separate European local asset purchase agreements for Italy, Germany, Spain, and Sweden, and in Europe,the second quarter assumed primary commercialization responsibilities in Spain and Sweden and initiated the transitions in Italy and Germany. Ascensia continues to sellsupport some commercialization activities in Italy and marketGermany, thewhich Eversenseare producttargeted to supportsubstantially the orderly transition of the business to Senseonics anticipatedconclude in the secondthird quarter of 2026. In both the United States and our overseas markets we will commercialize the products with direct sales forces and distribution systems that market and promote our various Eversense Systems and future generation products, including our Gemini and Freedom product variations. The Gemini product will 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 phonesmartphone to get an on-demand glucose reading without a smart transmitter. Our Freedom product variation is being designed to include Bluetooth in the sensor, eliminating the on-body component.

The A&R Commercialization Agreement rendered Ascensia’s right to market Eversense products in the European Territories non-exclusive. Ascensia agreed to continue to sell and market the Eversense product in Europethe European Territories to support the orderly transition of the business pending the closing of the European Asset Purchases and to allow Senseonics to transfer its local tender contracts. These rights and obligations apply from January 1, 2026 until the later of (i) January 1, 2027, (ii) the transfer of all local tender contracts, or (iii) the wind down of certain other commercial activities. Pursuant to the A&R Commercialization Agreement, effective January 1, 2026, the Company is entitled to 100% of the revenues derived from the sale of Eversense products in the European Territories. Senseonics will pay for certain transition services, and certain other costs, to maintain and achieve the orderly transition of the commercial operations in the European Territories. The Company and Ascensia executed separate local asset purchase agreements in the European Territories on March 12, 2026, in connection with the European Asset Purchases. The closings of the European Asset Purchases occurred in early June 2026. In Italy and Germany, Ascensia continues to provide certain transition support services to facilitate the orderly transition of commercial operations in those markets.

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. Effective January 1, 2026, in connection with the transition of U.S. commercialization activities to the Company, we began generating a greater portion of our product revenue through direct sales to strategic fulfillment partners and through our consignment network in the United States,States. whileIn addition, following the closings of the European Asset Purchases in early June 2026, revenues are now derived from the sale of Eversense products in the European Territories directly, with Ascensia continuescontinuing to provide certain transition support commercializationservices activitiesin outsideItaly theand United StatesGermany during a defined transition period.

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. Following the closings of the European Asset Purchases, our contract with Ascensia is winding down. Our contract with Ascensia contains performance obligations, mostly for the supply of goods, and are typically satisfied upon transfer of control of the product and does not include the right to return unless there is a product issue, in which case we may provide replacement product. Product conformity guarantees do not create additional performance obligations and are accounted for as warranty obligations in accordance with guarantee and loss contingency accounting guidance.

The consideration we expect to receive includes estimates of variable consideration for which reserves are established that is primarily the result of variable consideration such as patient assistance program rebates, prompt-pay discounts, tier-volume price discounts andand, forprior to January 1, 2026, revenue share in connection with the Commercialization Agreement, revenue share.Agreement. Variable consideration, such as rebates and prompt-pay incentives, are treated as a reduction in revenue and variable considerations, such as revenue share, is treated as an addition in revenue when the product sale is recognized. The amount of variable consideration that is included in the transaction price may be constrained and is included in revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period, when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of significant management judgment. Depending on the variable consideration, we develop estimates for the expected value based on the terms of the agreements, historical data, geographic mix, reimbursement rates, and market conditions. Variances in the consideration recognized is partially mitigated by minimum price provisions for certain purchases under the contract.

A significant portion of the Company’s revenue has historically been derived from one customer, Ascensia. For the three months ended MarchJune 31,30, 2026 and 2025, sales to Ascensia accounted for 20%12.5% and 71%52.0% of total revenue, respectively. For the six months ended June 30, 2026 and 2025, sales to Ascensia accounted for 15.5% and 61.0% of total revenue, respectively.

A portion of the Company’s revenue is earned under consignment arrangements with healthcare providers. For the three months ended MarchJune 31,30, 2026 and 2025, sales under consignment arrangements accounted for 37.3%57.7% and 19.6%40.9% of total revenue, respectively. For the six months ended June 30, 2026 and 2025, sales under consignment arrangements accounted for 47.2% and 32.5% of total revenue, respectively. During 2025, Ascensia earned commissioncommissions on sales made through these consignment arrangements for the support provided by their sales reps and commercial organization. Revenues for these corresponding periods represent sales of sensors, transmitters and miscellaneous Eversense System components.

On September 3, 2025 the Company and Ascensia signed a memorandum of understanding related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company, including the proposed termination, orderly unwinding of, and smooth transition of the commercial relationship between the Company and Ascensia. On December 31, 2025, the parties entered into the Master Asset Purchase Agreement and the A&R Commercialization Agreement, pursuant to which commercial activities in the United States transitioned back to the Company effective January 1, 2026 and the commercialization rights in certainthe European Territories were modified to be non-exclusive. In connection with the Master Asset Purchase Agreement, the Company and Ascensia executed local asset purchase agreements in the European Territories on March 12, 2026, the closings of which occurred in early June 2026. The parties continue to cooperate through the transition period and Ascensia continues to provide transition services in Italy and Germany to ensure continuity of supply, customer support, and patient access. Following the execution of the A&R Commercialization Agreement, the Company will no longer recognize revenue associated with U.S. product sales to Ascensia under the distribution arrangement. As a result,result of these transition activities, our revenues and results of operations will not be directly comparable to our historical revenues and results of operations for periods in which the Commercialization Agreement was in place.

The following table sets forth net revenue derived from our two primary geographical markets, the United States and outside of the United States, based on the geographic location to which we deliver the product, for the three and six months ended MarchJune 31,30, 2026 and 2025:

Results of Operations for the Three Months Ended MarchJune 31,30, 2026 and 2025

Our total revenue increased to $11.7$14.5 million for the three months ended MarchJune 31,30, 2026, compared to $6.3$6.6 million for the three months ended MarchJune 31,30, 2025, an increase of $5.4$7.9 million. 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 increase in total revenue was further driven by the elimination of Ascensia revenue share amounts following the termination of Ascensia'sAscensia’s commercialization rights in the United States and the transition of commercialization activities in the European Territories to a non-exclusive arrangement.

Our cost of sales remainedincreased consistentto at $4.8$5.9 million for the three months ended MarchJune 31,30, 2026 and the three months ended March 31, 2025. Our gross profit increasedcompared to $6.9$3.5 million for the three months ended MarchJune 31,30, 2026,2025, comparedan increase of $2.4 million. Our gross profit increased to $1.5$8.6 million for the three months ended MarchJune 31,30, 2026, compared to $3.1 million for the three months ended June 30, 2025. Gross profit as a percentage of revenue, or gross margin, was 59.3%59.1% and 24.1%46.9% for the three months ended MarchJune 31,30, 2026, and MarchJune 31,30, 2025, respectively. The improvement in gross margin is largely driven by favorable margins on the 365-day product sales, higher consignment network sales with ASPprice favorability, the elimination of the Ascensia revenue share and consistent fixed manufacturing costs. In addition, we recognized a one-time benefit of $0.5 million related to a change in estimate of previously accrued E3 product shutdown costs.

Research and development expenses were $8.6$11.6 million for the three months ended MarchJune 31,30, 2026, compared to $7.3$7.7 million for the three months ended MarchJune 31,30, 2025, an increase of $1.3$3.9 million. This increase was primarily driven by the ramp up of our Gemini pivotal study drivingwhich effortsadds an implantable battery to power the sensor, as well as higher salary, contract fabrication, and consulting costs in support of additional product development projects to progress our freedom product to eliminate the on-body transmitter component and additional product development projects.component.

Selling, general and administrative expenses were $30.2$32.9 million for the three months ended MarchJune 31,30, 2026, compared to $7.7$9.7 million for the three months ended MarchJune 31,30, 2025, representing an increase of $22.5$23.2 million. The increase consisted of $18.0an $11.0 million higherincrease in salary and related costs, largely driven by a large increase in headcount due to the transition of commercialization of Eversense back to the Company, an increase of $8.9 million in selling and marketing costscosts, and a $3.3 million increase in general and administrative expenses, all of which were largely driven by re-assuming commercialization activities resulting in a large increase in our headcount and increased marketing spend largely consisting of direct-to-consumer marketing initiatives. Our total general and administrative costs increased by $4.5 million driven by newly assumed operational responsibilities related to the commercial integration, as well as legal, IT and consulting costs associated with the establishment of business operations to support the transition of European commercialization activities to the Company.integration.

Total other income (expense),expense, net was $(0.5$0.7) million for the three months ended MarchJune 31,30, 2026, compared to other expense, net of ($0.8$0.2) million for three months ended MarchJune 31,30, 2025, aan decreaseincrease in other income (expense), net of $0.3$0.5 million. The change was primarily due to a $0.2$0.5 million decreaseincrease in interest expense driven by increased borrowings under the Company's amended debt facility with Hercules and a $0.1 million increase in miscellaneous gains recorded in other expense, offset by a $0.1 million increase in interest income.

From its founding in 1996 until 2010, the Company has devoted substantially all of its resources to researching various sensor technologies and platforms. Beginning in 2010, the Company narrowed its focus to developing and refining a commercially viable glucose monitoring system. The Company has incurred substantial losses and cumulative negative cash flows from operations since its inception in October 1996 and expects to incur additional losses in the near future. We incurred total net loss of $(69.1) million and $(78.6) million for the years ended December 31, 2025 and 2024, respectively. For the threesix months ended MarchJune 31,30, 2026, the Company had a net loss of $(32.369.0) million, and an accumulated deficit of $(1.01.1) billion. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, warrants, convertible notes, and debt. As of MarchJune 31,30, 2026, the Company had unrestricted cash, cash equivalents, and marketable securities of $64.3$142.7 million.

In August 2025, we entered into an at-the-market sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”), under which we may offer and sell, from time to time, at our sole discretion, shares of 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. 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 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 6, 2025. During the twelve months ended December 31, 2025, we received approximately $2.4 million proceeds from the sale of 334,330 shares under the Sales Agreement, after deducting sales commissions and offering expenses. During the threesix months ended MarchJune 31,30, 2026, the Company received approximately $3.5$6.2 million in proceeds from the sale of 478,067892,380 shares under the Sales Agreement, after deducting sales commissions and offering expenses. As of MarchJune 31,30, 2026, an aggregate of $93.8$90.8 million remained available for issuance under the Sales Agreement.

On April 30, 2026, we entered into an underwriting agreement with TD Cowen and Barclays Capital Inc., as representatives of the several underwriters named therein, for the sale of 8,000,000 shares of Common Stock and 8,000,000 pre-funded warrants, each representing the right to purchase one share of Common Stock at an exercise price of $.001$0.001 per share (the “May 2026 Pre-Funded Warrants”), at a price to the public of $5.00 per share (or $4.999 per May Pre-Funded Warrant) (the “May 2026 Offering”). The May 2026 Offering closed on May 4, 2026, and the underwriters exercised in full their option to purchase 2,400,000 additional shares of Common Stock. In the aggregate, we sold 10,400,000 shares of Common Stock and 8,000,000 May 2026 Pre-Funded Warrants in the May 2026 Offering, generating aggregate gross proceeds of approximately $92.0 million, before deducting underwriting discounts and commissions and offering expenses payable by us. The net proceeds to Senseonics were approximately $86.0 million, after deducting underwriting discounts and commissions and estimated offering expenses. The securities were offered and sold pursuant to an effective shelf registration statement on Form S-3 (File No. 333-289306).

On September 8, 2023, the Company entered into the Loan and Security Agreement with the Lenders and Hercules. The Company and Hercules have amended this agreement on two occasions, most recently on May 1, 2026 (as amended, the “Amended Loan and Security Agreement”). Under the Amended Loan and Security Agreement, the Lenders have agreed to make available to the Company the Term Loan Facility, providing for an aggregate of up to $140.0 million of loans. To date, Hercules and the Lenders have extended term loans to the Company in the aggregate amount of $55.0 million. The Amended Loan and Security Agreement provides for additional potential borrowings in the aggregate amount of up to $85 million, which may be extended in three tranches of up to $10.0 million, up to $15.0 million, and up to $60.0 million, respectively, which will become available to the Company upon the Company’s satisfaction of certain terms and conditions set forth in the Amended Loan and Security Agreement and, in the case of the $60 million tranche, the Lenders’ investment committee approval. The loans under the Amended Loan and Security Agreement mature on September 3, 2029. The Company received proceeds from the Tranche 2 Loan and an additional $10.0 million tranche (the “2026 Tranche 3A Loan”) upon the closing of the Second Amendment to the Loan and Security Agreement (the “Second Amendment”) on May 6, 2026.

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,development and regulatory approvals, and post-approval requirements.approvals. Successful completion of the transfer of commercial operations relating to Eversense from Ascensia back to the Company may provide opportunities to have greater influence on revenue generation and market adoption of Eversense. These activities, including our ongoing focus to grow coveredEversense lives through positive insurance payor policy decisions,awareness, initiatives to support patient access, and continued development of Eversense 365, will require significant uses of working capital through 2026 and beyond. As of March 31, 2026, the Company had unrestricted cash, cash equivalents and marketable securities of $64.3 million.

Net cash used in operating activities was $32.0$62.1 million for the threesix months ended MarchJune 31,30, 2026, and consisted of a net loss of $32.3$69.0 million and a net change in operating assets and liabilities of $2.7$1.0 million (mostprimarily notablydriven by increases in accounts receivable of $3.0 million, inventory of $1.3 million, and accrued expenses and other liabilities of $3.0 million), partially offset by a $2.3$5.8 million increase of stock-based compensation, and a $0.7$1.1 million increase related to depreciation/amortization expense, and other$1.0 non-cashmillion items.for the allowance for credit losses.

Net cash used in operating activities was $16.1$25.3 million for the threesix months ended MarchJune 31,30, 2025, and consisted of a net loss of $14.3$28.8 million and a net change in operating assets and liabilities of $4.8$3.0 million (most notably decreases in accrued expenses and other liabilities of $5.7 million and accounts payable of $0.9 million, net of decreases in accounts receivable of $1.7 million and prepaid expenses and other current assets of $1.0$2.5 million), partially offset by $1.8$4.7 million of stock-based compensation and $1.1$1.8 million related to depreciation/amortization and other non-cash items.

Net cash provided by (used in) investing activities

Net cash used in investing activities was $25.3$45.3 million for the threesix months ended MarchJune 31,30, 2025,2026, and consisted of $24.9$98.4 million in purchases of marketable securitiessecurities, $0.3 million in capital expenditures, and $0.4$1.3 million for cash paid in connection with the asset acquisition, partially offset by $54.7 million in proceeds from the sale of capitalmarketable expenditures.securities.

Net cash provided by financing activities was $3.4$112.0 million for the threesix months ended MarchJune 31,30, 2026, and primarily consisted of $3.5$93.5 million in proceeds from the issuance of common stock and $0.1prefunded warrants and $19.8 million ofin proceedsborrowings fromunder the exercise of stock options, RSUs,Loan and ESPPSecurity issuances,Agreement, partially offset by $0.2$1.3 million ofin taxes paid related to net share settlement of equity awards.

Net cash provided by financing activities was $6.1$77.2 million for the threesix months ended MarchJune 31,30, 2025, and primarily consisted of $26.5$72.3 million in net proceeds from the issuancePublic Offering and Private Placement, $26.5 million in net proceeds from issuances of common stock netunder the Equity Distribution Agreement, offset by $20.4 million used to repay the remaining outstanding 2025 Notes.Notes and $1.2 million from taxes paid related to net share settlement of equity awards.