03/02/2026 | Press release | Distributed by Public on 03/02/2026 15:38
Management's Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes in Part II, Item 8 of this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the "Risk Factors" section of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Unless otherwise indicated, all information in this Annual Report on Form 10-K gives effect to a 1-for-20 reverse stock split of our common stock that became effective on October 17, 2025 (the "Reverse Stock Split"), and all references to historical share and per share amounts give effect to the Reverse Stock Split.
Overview
We are a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. 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.
On September 3, 2025 the Company and Ascensia signed a memorandum of understanding ("MOU") related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company. On December 31, 2025, the parties entered into a master asset purchase agreement (the "Master Asset Purchase Agreement") formalizing this transfer and subsequently entered into an Amended and Restated Collaboration and Commercialization Agreement (the "A&R Commercialization Agreement"), which terminated Ascensia's right to market Eversense products in the U.S. and rendered Ascensia's right to market Eversense products in Italy, Germany, Spain and Sweden(the "European Territories") non-exclusive. Pursuant to the A&R Commercialization Agreement, effective January 1, 2026, we are entitled to 100% of the revenues derived from the sale of Eversense products in the European Territories. We expect to enter into a series of asset purchase agreements to acquire certain additional assets related to Ascensia's commercial Eversense activities in the European Territories on or before March 31, 2026.
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. All of the Medicare administrative contractors expansions became effective in 2024. In April 2025, CMS updated the payment amounts in the Physician Fee Schedule to account for the longer duration Eversense 365 for all eligible Medicare beneficiaries. We have been working with payors to transition their policies to Eversense 365 and have confirmed immediate coverage policy transition from select payors.
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 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 Senseonics' various Eversense Systems and future generation products, including our Gemini product variation to allow for a 2-in-1 glucose monitoring system combining the functionality of CGM and flash glucose monitoring, in an implantable sensor with battery that may be utilized with a smart transmitter to get continuous glucose readings and alerts, or be utilized through a swipe over the sensor with a smart phone to get on-demand glucose reading without a smart transmitter and our Freedom product variation which would include Bluetooth in the sensor eliminating the on-body component.
United States Development and Commercialization of Eversense
In 2016, we completed our PRECISE II pivotal clinical trial in the United States. 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 Collaboration 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, (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 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 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.
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 expects to launch Eversense 365 in the European Territories by the second half of 2026.
The A&R Commercialization Agreement rendered Ascensia's right to market Eversense products in the European Territories non-exclusive. 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 Purchasesand 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. In connection with the transfer of commercial operations relating to Eversense from Ascensia back to the Company, the Company reassessed its remaining performance obligations under its arrangement with Ascensia and adjusted the related contract assets and contract liabilities in accordance with ASC 606 based on the satisfaction (or non-satisfaction) of performance obligations as of the termination date.
Critical Accounting Estimates
The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States.
The preparation of our consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities and equity and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. These estimates, particularly estimates relating to accounting for variable consideration related to revenue, inventory obsolescence and embedded derivatives, have a material impact on our financial statements and are discussed in detail throughout our analysis of the results of operations discussed below. We did not make any material changes to these assumptions for the year ended December 31, 2025. We do not expect any material changes to the underlying assumptions during the year ending December 31, 2026.
We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets, liabilities and equity that are not readily apparent from other sources. Actual results and outcomes could differ from these estimates and assumptions.
Revenue
A significant portion of our product revenue has historically been generated from sales of the Eversense system and related components and supplies to Ascensia, through the Commercialization Agreement, who then resells the products to health care providers and patients.
Revenue from product sales to Ascensia is recognized at a point in time when Ascensia obtains control of our product based upon the delivery terms as defined in the contract at an amount that reflects the consideration which we expect to receive in exchange for the product. 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.
Inventory Obsolescence
Inventory is valued at the lower of cost or net realizable value. Cost is determined using the standard cost method that approximates first in, first out. We record an adjustment to reduce the value of inventory for items that are potentially obsolete, where the standard costs require adjustment to the net realizable value, and are in excess of future demand taking into consideration current sales orders, timing of new product launches, market conditions, and remaining shelf life. Our sensor manufacturing process can span several months, involves various contract manufacturers and includes raw components with long lead times, often resulting in significant work-in-progress inventory. However, expiry does not commence until the chemistry is applied to the sensor. We are able to isolate pre-chemistry sensor inventory in progress from post-chemistry sensor inventory and finished goods to assess against demand forecasts and customer dating requirements for potential excess or obsolete inventory. Our estimates are based on information known at the time and include factors such as anticipated future usage and sales, potential for external unfavorable conditions such as import holds or quality issues, and planned product upgrades.
However, if actual product conditions differ from our assumptions, additional inventory adjustments that would increase cost of sales could be required.
Results of Operations
Comparison of the Years Ended December 31, 2025 and 2024
The following table sets forth our results of operations for the years ended December 31, 2025 and 2024.
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2025 |
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2024 |
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Period Change |
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(in thousands) |
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(in thousands) |
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Revenue, net |
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$ |
17,084 |
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$ |
3,973 |
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$ |
13,111 |
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Revenue, net - related parties |
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18,173 |
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18,499 |
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(326) |
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Total revenue |
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35,257 |
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|
22,472 |
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|
12,785 |
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Cost of sales |
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19,494 |
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21,939 |
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(2,445) |
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Gross profit |
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15,763 |
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533 |
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15,230 |
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Expenses: |
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Research and development expenses |
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31,592 |
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41,144 |
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(9,552) |
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Selling, general and administrative expenses |
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52,508 |
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34,231 |
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18,277 |
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Operating loss |
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(68,337) |
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(74,842) |
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6,505 |
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Other income (expense), net: |
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Interest income |
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4,198 |
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4,502 |
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(304) |
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Interest expense |
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(4,951) |
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(8,437) |
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3,486 |
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Gain on change in fair value of derivatives |
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- |
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102 |
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(102) |
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Other (expense) income |
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(23) |
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59 |
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(82) |
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Total other expense, net |
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(776) |
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(3,774) |
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2,998 |
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Net Loss |
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$ |
(69,113) |
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$ |
(78,616) |
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$ |
9,503 |
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Components of Results of Operations
Total revenue
Our total net revenue increased to $35.3 million for the twelve months ended December 31, 2025, compared to $22.5 million for the year ended December 31, 2024, an increase of $12.8 million. 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, shipments to Ascensia increased for U.S. sales of the 365-day product, driven by a higher number of patients reaching their annual deductibles and the first patients receiving re-insertions after their initial year on the 365-day product.
Cost of sales and gross profit
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, 2024, a decrease of $2.4 million. Our gross profit increased to $15.8 million for the twelve months ended December 31, 2025, compared to $0.5 million for the twelve months ended December 31, 2024. Gross profit as a percentage of revenue, or gross margin, was 44.7% and 2.4% for the twelve months ended December 31, 2025 and December 31, 2024, respectively. The improvement in gross margin was partially due to $4.8 million in one-time charges incurred in the prior year as the result of the transition from Eversense E3 to Eversense 365. The additional improvement in the gross margin is due to several factors, including favorable margins on the 365-day product sales, lower fixed manufacturing costs, one-time impacts such as VAT recoveries of $0.7 million and the benefit of previously expensed inventory in the amount of $0.6 million. These improvements are slightly offset by an increase in revenue share to Ascensia under the terms of the Commercialization Agreement.
Research and development expenses
Research and development expenses were $31.6 million for the twelve months ended December 31, 2025, compared to $41.1 million for the twelve months ended December 31, 2024, a decrease of $9.5 million. The decrease was primarily driven by a $6.3 million decrease in clinical study and outsourced development costs, a $2.2 million decrease in personnel costs, and a $1.2 million decrease in consulting costs. These reductions are primarily driven by the completion of the Eversense 365 system clinical trials and development efforts as well as a reduction in headcount, and were offset by a $0.2 million increase in other research and development expenses.
Selling, general and administrative expenses
Selling, general and administrative expenses were $52.5 million for the twelve months ended December 31, 2025, compared to $34.2 million for the twelve months ended December 31, 2024, an increase of $18.3 million. The increase was primarily driven by an $11.3 million increase in selling and marketing expenses related to direct-to-consumer marketing campaigns, a $2.7 million increase in sales commission expenses to Ascensia as we increased consignment sales, a $1.1 million increase in personnel costs, and a $3.2 million increase in other selling, general & administrative costs partially driven by costs related to the transition of commercial and distribution rights to Eversense from Ascensia.
Total other (expense) income, net
Total other expense, net was $(0.8) million for the twelve months ended December 31, 2025, compared to other expense, net of $(3.8) million for the twelve months ended December 31, 2024, a decrease of $3.0 million. The change was primarily due to lower interest expense of $3.5 million (primarily due to repayment of the 2025 Notes), partially offset by a decrease in other income of $0.5 million (primarily the result of lower returns on marketable securities investments).
Liquidity and Capital Resources
Since our inception, we have incurred significant net losses and expect to incur additional losses in the near future. We incurred total net loss of $(69.1) million and $(78.6) million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $1.0 billion. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, warrants, convertible notes, and debt. As of December 31, 2025, the Company had unrestricted cash, cash equivalents, and marketable securities of $94.0 million.
In the past two years, we have taken a number of measures to strengthen our financial position, including the closing of the Amended Loan and Security Agreement, repayment of our 2023 Notes, the sale of common stock in the 2024 Registered Direct Offering (as defined below) and related issuance of warrants, the issuance of a pre-funded warrant to PHC for cash in a private placement, the exchange of our PHC Notes for a newly issued pre-funded warrant, the exchange of a portion of our 2025 Notes for cash and common stock in a series of private exchanges and the repayment of the remaining 2025 Notes, and the issuance of shares of common stock pursuant to at the market offering programs. We have also taken measures to manage our operating expenses, including through a company restructuring in 2024.
On September 8, 2023, the Company entered into the "Loan and Security Agreement with Hercules Capital, Inc. and its managed fund (collectively, the "Lenders"), pursuant to which the Lenders have to make available to Senseonics up to $50.0 million in senior secured term loans (the "Term Loan Facility"), consisting of (i) an initial term loan of $25.0 million (the "Tranche 1 Loan"), which was funded on the Effective Date and (ii) $10.0 million, which was funded on January 2, 2024 upon meeting certain terms in conditions under the loan agreement, and (the "Tranche 2 Loan") and iii) $15.0 million which has not been drawn. 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 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.
In August 2025, the Company entered into an at-the-market sales agreement (the "Sales Agreement") with TD Securities (USA) LLC ("TD Cowen"), under which the Company could offer and sell, from time to time, at its sole discretion, shares of its common stock having an aggregate offering price of up to $100.0 million through TD Cowen as its sales agent in an "at the market" offering. TD Cowen will receive commissions up to 3.0% of the gross proceeds of any common stock sold through TD Cowen under the Sales Agreement. The shares were offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on August 6, 2025. During the twelve months ended December 31, 2025, the Company received approximately $2.4 million proceeds from the sale of 334,330 shares under the Sales Agreement, after deducting sales commissions and offering expenses.
On May 15, 2025, the Company entered into an underwriting agreement (the "Underwriting Agreement") with several underwriters for the sale of 5,000,000 shares of its common stock (the "Public Offering"), at a public offering price of $10.00 per share (the "Public Offering Price"). Under the terms of the Underwriting Agreement, the Companyalso granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock at the Public Offering Price, which the underwriters exercised in full. The Company received aggregate gross proceeds from the Public Offering of $57.5 million. The Company also entered into a securities purchase agreement with Abbott Laboratories ("Abbott") pursuant to which the Company agreed to issue and sell 2,026,963 shares of its common stock substantially concurrently with the Public Offering, at the Public Offering Price, to Abbott for an aggregate purchase price of approximately $20.3 million in a private placement (the "Private Placement"). The Public Offering and Private Placement closed on May 19, 2025 and May 20, 2025, respectively, and the Company received net proceeds of approximately $52.1 million and $20.1 million, respectively, after deducting underwriting discount, commissions, and offering expenses.
In August 2023, the Company entered into an Equity Distribution Agreement (the "Equity Distribution Agreement") with Goldman Sachs & Co. LLC ("GS"), under which the Company could offer and sell, from time to time, at its sole discretion, shares of its common stock having an aggregate offering price of up to $106.6 million through GS as its sales agent in an "at the market" offering. GS received commissions up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares were offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on August 10, 2023. On October 24, 2024, the Company amended the Equity Distribution Agreement with GS to reduce the maximum amount of shares issuable thereunder to $55.0 million. On May 15, 2025, in connection with the Public Offering and Private Placement, the Equity Distribution Agreement was terminated. At the time of termination of the Equity Distribution Agreement on May 15, 2025, the Company had received approximately $30.8 million in net proceeds from the sale of 2,006,528 shares under the Equity Distribution Agreement, after deducting sales commissions and offering expenses.
On October 24, 2024, the Company completed a registered direct securities offering (the "2024 Registered Direct Offering") to certain institutional investors in which we issued and sold 2,285,714 shares of common stock at $7.00 per share and simultaneously issued the PP Warrants to these investors in a private placement to purchase an aggregate of 2,285,714 shares of common stock at an exercise price of $7.00 per share. The PP Warrants were non-exercisable for the first six months after issuance and expire on April 29, 2030. The offering closed on October 28, 2024, and the Company received proceeds of approximately $14.8 million after payment of fees to the placement agent, but before payment of any additional expenses incurred by the Company in connection with the transaction.
On August 10, 2023, we entered into separate, privately negotiated exchange agreements (the "Exchange Agreements") with a limited number of holders (the "Noteholders") of our outstanding 5.25% Convertible Senior Notes due 2025 (the "2025 Notes"). Under the terms of the Exchange Agreements, the holders of the 2025 Notes agreed to exchange up to $30.8 million in aggregate principal amount of the 2025 Notes (the "Exchanged Notes") for a combination of $7.5 million of cash and newly issued shares of common stock. The number of shares issued was
determined based upon the volume-weighted average price per share of the common stock during a 15-day averaging period. Based on the volume-weighted average price per share of the common stock during the averaging period, we issued a total of 35.1 million shares of common stock in the exchanges. Following the exchange, the remaining balance of the 2025 Notes was $20.4 million. On January 15, 2025, the Company repaid the outstanding principal and accrued interest in full.
Warrants
In connection with certain of our historical financing transactions, we have issued warrants to investors and providers of debt financing, as described below.
On June 30, 2016, we entered into a loan agreement with Oxford Finance and Silicon Valley Bank (collectively, the "Lenders") and issued to the Lenders 10-year stock purchase warrants to purchase an aggregate of 5,830, 3,152 and 4,033 shares of common stock at an exercise price of $77.20, $47.60 and $37.20 per share, respectively ("Oxford/SVB Warrants"). The Oxford/SVB Warrants expire on June 30, 2026, November 22, 2026 and March 29, 2027, respectively.
On March 13, 2023, we issued and sold to PHC a warrant to purchase 771,288 shares of common stock for $15.0 million (the "Purchase Warrant"). The Purchase Warrant is a "pre-funded" warrant with a nominal exercise price of $0.02 per share (the "Purchase Warrant 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"), including all accrued and unpaid interest thereon, for a warrant (the "PHC Exchange Warrant") to purchase up to 3,426,266 shares of common stock (the "PHC Exchange Warrant Shares"). The PHC Exchange Warrant is a "pre-funded" warrant with a nominal exercise price of $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 41,619 shares of common stock at an initial exercise price of $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, 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 17,395 shares at an initial exercise price of $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, 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 2024 Registered Direct Offering, the Company issued to the investors in the offering the PP Warrants to purchase an aggregate of 2,285,714 shares of common stock at an exercise price of $7.00 per share. The PP Warrants were non-exercisable for the first six months after issuance and expire on April 29, 2030.
Indebtedness
Amended Loan and Security Agreement
On September 8, 2023, the Company entered into the Loan and Security Agreement with the Lenders and Hercules, pursuant to which the Lenders agreed to make available to the Company the Term Loan Facility, consisting of (i) an initial Tranche 1 Loan, which was previously funded on the Effective Date in an amount of $25.0 million and (ii) the Tranche 2 Loan, which was funded on January 2, 2024 in an amount of $10.0 million, and (iii) Tranche 3 Loan, which has not been drawn. On 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.
Convertible Notes
The 2025 Notes were repaid in full on January 15, 2025. See Note 13 in the accompanying notes to our consolidated financial statements included elsewhere in this Annual Report for further discussion of the 2025 Notes.
Funding Requirements and Outlook
Our ability to grow revenues and achieve profitability depends on the successful commercialization and adoption of our Eversense System by diabetes patients and healthcare providers, along with future product development, regulatory approvals, and post-approval requirements. 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 in the United States, will require significant uses of working capital through 2025 and beyond. As of December 31, 2025, the Company had unrestricted cash, cash equivalents and marketable securities of $94.0 million.
In accordance with the FASB Accounting Standards Codification Topic 205-40, Presentation of Financial Statements-Going Concern, management is required to assess the Company's ability to continue as a going concern through twelve months after issuance of the financial statements. Based on the Company's current operating plan including expected capital investments required to assume commercialization and distribution responsibilities, existing unrestricted cash, cash equivalents and marketable securities, minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under its Amended Loan and Security Agreement, the Company has determined that it may not meet its debt covenants as early as the third quarter of 2026. Further, the Company will require additional liquidity to continue its operations over the next twelve months. Therefore, the Company has concluded that substantial doubt exists regarding its ability to continue as a going concern for the one-year period following the date these consolidated financial statements are issued. As part of our liquidity strategy, the Company will continue to monitor our capital structure and market conditions, and the Company may finance our cash needs through public or private debt and equity financings and other sources which may include collaborations, strategic alliances, and licensing arrangements with third parties. There is no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms, if at all, and could be forced to delay, reduce, or eliminate some or all of its research, clinical trials, product development or future commercialization efforts, which could materially adversely affect its business prospects or its ability to continue as a going concern.
Cash Flows
The following is a summary of cash flows for each of the periods set forth below (in thousands):
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Year Ended |
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December 31, |
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2025 |
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2024 |
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Net cash used in operating activities |
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$ |
(59,129) |
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$ |
(60,465) |
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Net cash (used in) provided by investing activities |
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(53,422) |
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32,838 |
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Net cash provided by financing activities |
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78,188 |
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26,830 |
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Net decrease in cash and cash equivalents |
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$ |
(34,363) |
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$ |
(797) |
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Net cash used in operating activities
Net cash used in operating activities was $59.1 million for the year ended December 31, 2025, and consisted of a net loss of $69.1 million, a $3.3 million net change in operating assets and liabilities, partially offset by $10.2 million of stock-based compensation, and $3.1 million related to depreciation/amortization and other non-cash items.
Net cash used in operating activities was $60.5 million for the year ended December 31, 2024, and consisted of a net loss of $78.6 million, partially offset by a $0.9 million net change in operating assets and liabilities, $9.2 million of stock-based compensation, $3.9 million in non-cash inventory costs primarily due to transition to the 365-day product, and $4.1 million related to depreciation/amortization and other non-cash items.
Net cash (used in) provided by investing activities
Net cash used in investing activities was $53.4 million for the year ended December 31, 2025, and consisted of $100.7 million from the purchase of marketable securities and $1.1 million of capital expenditures partially offset by $48.4 million from the sales and maturity of marketable securities.
Net cash provided by investing activities was $32.8 million for the year ended December 31, 2024, and consisted of $93.1 million from the sale and maturity of marketable securities, partially offset by $58.1 million from the purchase of marketable securities and $2.2 million of capital expenditures.
Net cash provided by financing activities
Net cash provided by financing activities was $78.2 million for the year ended December 31, 2025, and primarily consisted of $72.3 million in net proceeds from the Public Offering and Private Placement, $28.5 million in net proceeds related to the issuance of common stock pursuant to our at the market offering and the exercise of stock options, offset by $20.4 million used to repay the remaining outstanding 2025 Notes, $1.7 million of taxes paid related to net share settlement of equity awards and $0.4 million used to repay the debt modification costs.
Net cash provided by financing activities was $26.8 million for the year ended December 31, 2024, and primarily consisted of an aggregate of $4.0 million in proceeds related to the issuance of common stock pursuant to our at the market offering and the exercise of stock options, $14.5 million in proceeds from a registered direct offering, and $10.0 million in net proceeds from borrowings pursuant to the Loan and Security Agreement, partially offset by $1.7 million of taxes paid related to net share settlement of equity awards.