Senseonics Holdings, Inc.: Form 10-Q for the period ended Mar 31, 2026

Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “plan,” “project,” “expect,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks, uncertainties, and assumptions, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those described below and elsewhere in this Quarterly Report on Form 10-Q, and in our Annual Report on Form 10-K, particularly in Part I – Item 1A, “Risk Factors,” and our other filings with the Securities and Exchange Commission. Statements made herein are as of the date of the filing of this Quarterly Report on Form 10-Q with the Securities and Exchange Commission and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and related notes for the year ended December 31, 2025, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 2, 2026. Unless otherwise indicated or the context otherwise requires, all references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section to the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to Senseonics Holdings, Inc. and its consolidated subsidiaries and affiliated entities, as appropriate, including its consolidated VIEs.

Unless otherwise indicated, all information in this Quarterly Report on Form 10-Q gives effect to a 1-for-20 reverse stock split of our common stock that became effective on October 17, 2025 (the “Reverse Stock Split”), and all references to historical share and per share amounts give effect to the Reverse Stock Split.

Overview

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

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 transfer 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 Territories and we expect the closings of these transactions to occur on or before June 30, 2026, subject to customary regulatory and operational conditions.

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

We primarily sell directly to our network of distributors and strategic fulfillment partners, who provide the Eversense system to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement. 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 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.

In February 2020, we announced that the FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor. This sub-set of 30 participants was left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days. Information gathered from this sub-set and additional development efforts provided us the confidence to start the ENHANCE pivotal study of Eversense 365. The ENHANCE pivotal study of Eversense 365 completed enrollment, the last patient of the adult cohort completed the study, and we completed our analysis of the data. Based on this analysis, we determined to advance to the next generation sensor platform as the underlying technology used in the 365-day and future products. 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 Eversense 365 was cleared for sale in the United States.

We continue to expand commercialization of the Eversense brand and are focused on driving awareness of our CGM system amongst people with diabetes and their healthcare providers. Effective January 1, 2026, U.S.

commercialization activities were returned to the Company and in Europe, Ascensia continues to sell and market the Eversense product to support the orderly transition of the business to Senseonics anticipated in the second 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 phone to get 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.

United States Development and Commercialization of Eversense

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. In June 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 on September 30, 2019, we completed enrollment of the PROMISE trial. In the trial, we observed performance matching that of the then current Eversense 90 available in the United States, with a MARD of 8.5%. This result was achieved with reduced calibration, down to one per day, while also doubling the sensor life to six months. Following the results of the PROMISE trial, on September 30, 2020, a PMA supplement application to extend the wearable life of Eversense 90 to six months was submitted to the FDA. In February 2022, the extended life Eversense E3 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 was left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days. Information gathered from this sub-set and additional development efforts provided us with the confidence to start the Pivotal study for Eversense 365.

In April 2020, we announced that we received an extension to our CE Certificate of Conformity in the EEA such that the Eversense XL is no longer contraindicated for MRI, which means the sensor does not need to be removed from under the skin during MRI scanning. We 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 the Commercialization Agreement pursuant to which we granted Ascensia the exclusive right to distribute Eversense 90 and Eversense E3 worldwide, with certain initial exceptions. Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the Eversense 90 product on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for Eversense 90 during the second quarter of 2021.

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

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

In connection with the execution of the Master Asset Purchase Agreement, the Company and Ascensia also entered into the A&R Commercialization Agreement on December 31, 2025, which amended and restated the Existing Commercialization Agreement. The A&R Commercialization Agreement terminated Ascensia’s right to market Eversense products in the U.S. Following the U.S. Closing, Ascensia has no further rights to revenues from the sale of Eversense products in the U.S.

In February 2022, we received approval from the FDA for Eversense E3. The approval for our third-generation sensor, with proprietary sacrificial boronic acid (“SBA”) technology doubles the sensor life to six months with MARD of 8.5%. Ascensia began commercializing Eversense E3 in the United States during the second quarter of 2022.

The ENHANCE clinical study was initiated as a pivotal study with the purpose of gathering additional clinical data to support an integrated continuous glucose monitoring (“iCGM”) submission for Eversense E3 using the SBA technology. In March 2022, we extended the ongoing ENHANCE clinical study to evaluate the safety and accuracy of Eversense 365 for a period of up to one year in the United States. In September 2022, we completed enrollment of the ENHANCE study and the last patient of the adult cohort completed the study in the third quarter of 2023. In November 2022, we submitted and in the first quarter of 2023 we received approval of an investigational device exemption (“IDE”) for the enrollment of a pediatric cohort in the ENHANCE study. In 2023 the data gathered in the ENHANCE study supported the iCGM submission and in April 2024, Eversense 365 was authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future. 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 Eversense 365 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, LLC, which were formed as wholly owned subsidiaries of Senseonics, Incorporated. In November 2024, Eon Management Services, LLC entered into management services agreements (the “Administrative Agreement”) for an initial fixed term of 10 years with the Eon Care PCs, which were created to support patient access to the Eversense Systems by contracting nurse practitioners and other healthcare professionals to perform Eversense insertion procedures and other clinical activities. On April 1, 2026, Eon Management Services, LLC entered into an additional management services agreement with an additional professional corporation with an initial fixed term of 10 years. The Eon Care PCs are consolidated as VIEs.

The wholly owned entities and Eon Care PCs (collectively, “Eon Care”) were established to support patient access to the Eversense systems by providing convenient Eversense insertion and training services. We fully completed 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 since then. 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.

We have also sought to complement commercialization efforts by establishing a consignment program, whereby we sell the Eversense system and related components and supplies through a network of healthcare professionals, and supporting certain commercial programs such as direct to consumer (“DTC”) spending, certain key account activities, and market access support. We are determined to increase investment in supporting DTC spending, which we believe correlates with higher awareness and adoption of Eversense. Although the rate of Eversense adoption and lead generation has increased following these initiatives, as well as the regulatory approval of Eversense 365, we continue to work on ways to accelerate commercialization and adoption of our product.

In July 2024, we began first-in-human testing for the Gemini 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 was utilized for an IDE submission that was approved by the FDA in December 2025 which allowed us to begin enrolling patients in the Gemini pivotal study.

European Commercialization of Eversense

In September 2017, we affixed the CE Mark for Eversense XL which permits the product to be sold freely in any part of the EEA. Eversense XL is indicated for a sensor life of up to 180 days. Eversense XL began commercialization in Europe in the fourth quarter of 2017. All such commercialization and marketing activities remain subject to applicable government approvals.

In June 2022, we affixed the CE Mark to Eversense E3, and Ascensia began commercialization in European markets during the second half of 2022.

In February 2025, we submitted an application for the conformity assessment of Eversense 365 to our Notified Body for certification. The submission was prepared in compliance with the EU medical device regulation. In January 2026, the Company obtained CE Mark approval for Eversense 365 and are currently in the process of launching Eversense 365 in the European Territories.

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 Europe to support the orderly transition of the business pending the closing of the European Asset Purchases and to allow Senseonics to transfer its local tender contracts. These rights and obligations apply from January 1, 2026 until the later of (i) January 1, 2027, (ii) the transfer of all local tender contracts, or (iii) the wind down of certain other commercial activities. 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.

Financial Overview

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, while Ascensia continues to support commercialization activities outside the United States 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. 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 and for the Commercialization Agreement, revenue share. 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.

Under the consignment model, small quantities of inventory are held at healthcare provider locations to ensure availability when a patient is identified. No revenue is recognized upon delivery of our products to the healthcare provider locations, as we retain the ability to control the inventory. Rather, revenue is recognized when the product is consumed by a patient.

Contract assets consist of unbilled receivables from customers and are recorded at net realizable value and relate to the timing of billings and revenue share variable consideration from the Commercialization Agreement.

Concentration of Revenue and Customers

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

A portion of the Company’s revenue is earned under consignment arrangements with healthcare providers. For the three months ended March 31, 2026 and 2025, sales under consignment arrangements accounted for 37.3% and 19.6% of total revenue, respectively. During 2025, Ascensia earned commission 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.

Termination and Modification of Commercialization Arrangements

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 certain European Territories were modified to be non-exclusive. The parties continue to cooperate through the transition period 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, 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.

Revenue by Geographic Region

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 months ended March 31, 2026 and 2025:

(Dollars in thousands)

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

(in thousands)

(in thousands)

Total revenue

Our total revenue increased to $11.7 million for the three months ended March 31, 2026, compared to $6.3 million for the three months ended March 31, 2025, an increase of $5.4 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's commercialization rights in the United States and the transition of commercialization activities in the European Territories to a non-exclusive arrangement.

Cost of sales and gross profit

Our cost of sales remained consistent at $4.8 million for the three months ended March 31, 2026 and the three months ended March 31, 2025. Our gross profit increased to $6.9 million for the three months ended March 31, 2026, compared to $1.5 million for the three months ended March 31, 2025. Gross profit as a percentage of revenue, or gross margin, was 59.3% and 24.1% for the three months ended March 31, 2026, and March 31, 2025, respectively. The improvement in gross margin is largely driven by favorable margins on the 365-day product sales, higher consignment network sales with ASP 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

Research and development expenses were $8.6 million for the three months ended March 31, 2026, compared to $7.3 million for the three months ended March 31, 2025, an increase of $1.3 million. This increase was primarily driven by the ramp up of our Gemini pivotal study driving efforts to eliminate the on-body transmitter component and additional product development projects.

Selling, general and administrative expenses

Selling, general and administrative expenses were $30.2 million for the three months ended March 31, 2026, compared to $7.7 million for the three months ended March 31, 2025, representing an increase of $22.5 million. The increase consisted of $18.0 million higher selling and marketing costs 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.

Total other income (expense), net

Total other income (expense), net was $(0.5) million for the three months ended March 31, 2026, compared to other expense, net of ($0.8) million for three months ended March 31, 2025, a decrease in other income (expense), net of $0.3 million. The change was primarily due to a $0.2 million decrease in interest expense offset by a $0.1 million increase in interest income.

Liquidity and Capital Resources

Sources of Liquidity

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 three months ended March 31, 2026, the Company had a net loss of $(32.3) million, and an accumulated deficit of $(1.0) billion. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, warrants, convertible notes, and debt. As of March 31, 2026, the Company had unrestricted cash, cash equivalents, and marketable securities of $64.3 million.

In the recent years, we have taken a number of measures to strengthen our financial position, including but not limited to the following actions:

Equity Offerings

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 three months ended March 31, 2026, the Company received approximately $3.5 million proceeds from the sale of 478,067 shares under the Sales Agreement, after deducting sales commissions and offering expenses. As of March 31, 2026, an aggregate of $93.8 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 shares of Common Stock and pre-funded warrants, each representing the right to purchase one share of Common Stock at an exercise price of $.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).

Indebtedness

Amended Loan and Security Agreement

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 “Tranche 3A Loan”) upon the closing of the Second Amendment to the Loan and Security Agreement (the “Second Amendment”) on May 6, 2026.

Convertible Notes

The 2025 Notes were repaid in full on January 15, 2025. See Note 12 in the accompanying notes to our consolidated financial statements included elsewhere in this 10-Q for further discussion of the 2025 Notes.

Funding Requirements and Outlook

Our ability to grow revenues and achieve profitability depends on the successful commercialization and adoption of our Eversense System by diabetes patients and healthcare providers, along with future product development, regulatory approvals, and post-approval requirements. 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 covered lives through positive insurance payor policy decisions, 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.

In accordance with the FASB Accounting Standards Codification Topic 205-40, Presentation of Financial Statements- Going Concern, management is required to assess the Company’s ability to continue as a going concern through twelve months after issuance of the financial statements. Management previously disclosed conditions and events that raised substantial doubt about our ability to continue as a going concern. In addition, given the Company’s historical reliance upon debt and equity financing, management will continue to evaluate our funding needs against operating performance and strategic initiatives.

As of the first quarter of 2026, based on current operating plans, the subsequent receipt of financing proceeds (as further described under “Sources of Liquidity”), its existing unrestricted cash, cash equivalents, and marketable securities management now believes that the Company has sufficient resources to meet the Company’s anticipated operating needs for the next twelve months from the issuance of the financial statements. Accordingly, management has concluded that the substantial doubt that was raised in the past about the Company’s ability to continue as a going concern has been alleviated.

Cash Flows

The following is a summary of cash flows for each of the periods set forth below (in thousands).

Net cash used in operating activities

Net cash used in operating activities was $32.0 million for the three months ended March 31, 2026, and consisted of a net loss of $32.3 million and a net change in operating assets and liabilities of $2.7 million (most notably 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 million increase of stock-based compensation, and a $0.7 million increase related to depreciation/amortization and other non-cash items.

Net cash used in operating activities was $16.1 million for the three months ended March 31, 2025, and consisted of a net loss of $14.3 million and a net change in operating assets and liabilities of $4.8 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 million), partially offset by $1.8 million of stock-based compensation and $1.1 million related to depreciation/amortization and other non-cash items.

Net cash provided by (used in) investing activities

Net cash provided by investing activities was $18.0 million for the three months ended March 31, 2026, and consisted of $23.3 million in proceeds from the sale of marketable securities, partially offset by $4.0 million in purchases of marketable securities and $1.1 million related to the acquisition of U.S. commercialization assets from Ascensia.

Net cash used in investing activities was $25.3 million for the three months ended March 31, 2025, and consisted of $24.9 million in purchases of marketable securities and $0.4 million of capital expenditures.

Net cash provided by financing activities

Net cash provided by financing activities was $3.4 million for the three months ended March 31, 2026, and primarily consisted of $3.5 million in proceeds from the issuance of common stock and $0.1 million of proceeds from the exercise of stock options, RSUs, and ESPP issuances, partially offset by $0.2 million of taxes paid related to net share settlement of equity awards.

Net cash provided by financing activities was $6.1 million for the three months ended March 31, 2025, and primarily consisted of $26.5 million in proceeds from the issuance of common stock net offset by $20.4 million used to repay the remaining outstanding 2025 Notes.

Under SEC rules and regulations, because we are considered to be a “smaller reporting company”, we are not required to provide the information required by this item in this Quarterly Report on Form 10-Q.

Evaluation of Disclosure Controls and Procedures

Our management, with the assistance of our chief executive officer, who is our principal executive officer, and our chief financial officer, who is our principal financial officer, has reviewed and evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of March 31, 2026. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed by us in the periodic reports filed with the SEC is accumulated and communicated to our management, including our principal executive, financial and accounting officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving such control objectives. Based on the evaluation of our disclosure controls and procedures as of March 31, 2026, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. Except as set forth below, there have been no material changes from our risk factors described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 2, 2026, except for the following:

Risks Relating to our Business and our Industry

The consummation of the European Asset Purchases is subject to conditions that may not be satisfied, and delays or failures in completing the European Closings could adversely affect our business, financial condition and results of operations.

On March 12, 2026, we entered into the Local Purchase Agreements with Ascensia, pursuant to which we agreed to acquire certain commercial assets and assume certain related liabilities in Italy, Germany, Spain and Sweden. The closing of each of the European Asset Purchases is subject to the satisfaction or waiver of customary closing conditions, including the obtaining of certain regulatory clearances, consents or non-objection with respect to the transfer of tender contracts and the completion of certain required labor and employment processes. There can be no assurance that these conditions will be satisfied or waived in a timely manner, or at all. Potential delays in consummating the European Closings could result in increased execution costs, diversion of management attention and resources, and prolonged reliance on Ascensia for transition services under the Transition Services Agreement, which could increase our operating expenses. In addition, the assumption of direct commercial responsibility for Eversense in the European Territories involves significant operational risks, including potential disruptions in relationships with employees, patients, prescribers, distributors or regulatory authorities. We will be required to establish or expand local operations, hire or retain qualified personnel, and comply with local regulatory requirements in each of the European Territories. If we are unable to successfully complete the European Asset Purchases or effectively manage the transition of commercial operations, our ability to generate revenue in the European Territories could be materially adversely affected, and we may incur significant costs that could harm our financial condition and results of operations.

Risks Related to our Financial Results and Need for Financing

Future borrowings under the Second Amendment to our Amended Loan and Security Agreement with Hercules Capital, Inc. are subject to conditions that may not be satisfied, and we may not have access to the full amount of the facility.

On May 1, 2026, we entered into the Second Amendment to our Amended Loan and Security Agreement with Hercules (the “Second Amendment”), which increased the total loan potential borrowings under the agreement from $100.0 million to $140.0 million. As of the date of this report, we have drawn an aggregate of $55 million of borrowings under the Hercules facility. However, future borrowings under the agreement are subject to the satisfaction of certain terms and conditions and, with respect to the final $60.0 million, the approval of Hercules’s investment committee. There can be no assurance that such conditions to funding will be satisfied. If we are unable to access the full amount of the facility, we may not have sufficient liquidity to fund our operations and may need to seek additional financing on terms that may be less favorable, or we may not be able to obtain additional financing at all.

Our increased indebtedness under the amended Hercules facility may adversely affect our financial condition, and we may not be able to maintain compliance with the financial covenants contained therein.

As a result of the Second Amendment, we have the potential to incur significantly greater indebtedness under the amended Hercules facility. Increased indebtedness could, among other things, increase our vulnerability to general adverse economic and industry conditions, limit our flexibility in planning for or reacting to changes in our business and the industry in which we operate, and place us at a competitive disadvantage compared to our competitors that have less debt. In addition, we will be required to comply with financial and other covenants in the amended facility and our ability to comply with these covenants will depend on our future operating performance, which is subject to prevailing economic conditions and other factors, many of which are beyond our control. If we fail to comply with these covenants, we could be in default under the facility, which could result in the acceleration of all outstanding indebtedness thereunder and materially adversely affect our financial condition and ability to continue as a going concern.