Senseonics Holdings, Inc.

Previous wording

We are a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Our implantable CGM 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. In February 2022, Eversense E3, a 180 day CGM system, was approved by the FDA and Ascensia Diabetes Care Holdings AG (“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.

Current wording

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. In February 2022, Eversense E3, a 180 day CGM system, was approved by the FDA and Ascensia Diabetes Care Holdings AG (“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.

Previous wording

We primarily sell directly to our network of distributors and strategic fulfillment partners, who provide the Eversense Systems to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement. In addition, we sell our product on consignment through established agreements with our network of healthcare professionals. Sales of the Eversense Systems 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

Current wording

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

Previous wording

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.

Current wording

reimbursement. In addition, we sell our product on consignment through established agreements with our network of healthcare professionals. Sales of the Eversense Systems 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.

Previous wording

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 CGM 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.

Current wording

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.

Previous wording

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 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.

Current wording

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

Previous wording

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.

Current wording

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.

Previous wording

On August 9, 2020, we entered into a commercialization and collaboration agreement with Ascensia (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.

Current wording

On August 9, 2020, we entered into a commercialization and collaboration agreement with Ascensia (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 a memorandum of understanding (“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 (the “Proposed Transition”), which is contemplated to involve the termination of the existing Commercialization Agreement, with commercial activities expected to transition back to the Company beginning January 1, 2026 pursuant to definitive agreements we are currently negotiating with Ascensia and transition planning being undertaken by the two companies.

Previous wording

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.

Current wording

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

Previous wording

In an effort to accelerate Ascensia’s 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

Current wording

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.

Previous wording

We have also sought to complement Ascensia’s 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. We expect this investment to continue into the third and fourth quarters. 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 closely with Ascensia to accelerate commercialization and adoption of our product. We regularly engage in discussions with Ascensia regarding the market opportunity for Eversense, the degree of our respective spending on commercialization, and the potential impact of greater commercial support on product uptake. We continue to assess with Ascensia ways in which we can modify our plans and arrangements and expand or introduce new commercial activities to accelerate commercialization and product adoption.

Current wording

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. We expect this investment to continue into the third and fourth quarters. 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.

Previous wording

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 will be utilized for an IDE submission anticipated in the second half of 2025.

Current wording

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 will be utilized for an IDE submission anticipated by the end of 2025.

Previous wording

In June 2022, we affixed the CE mark to Eversense E3, and Ascensia began commercialization in European markets during the second half of 2022. We plan to submit for CE mark authorization of Eversense 365 in the first quarter of 2025.

Current wording

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

Previous wording

In February 2025, we submitted Eversense 365 to our notified body for CE Mark approval. The submission was prepared in compliance with the EU medical device regulation and, upon approval, would enable the commercialization of Eversense 365 in European Union member countries. Following CE Mark approval, if received, we plan to launch Eversense 365 with our global commercial partner, Ascensia, in the second half of 2025.

Current wording

In February 2025, we submitted Eversense 365 to our notified body for CE Mark approval. The submission was prepared in compliance with the EU medical device regulation and, upon approval, would enable the commercialization of Eversense 365 in European Union member countries. Following CE Mark approval, if received, we plan to launch Eversense 365 in European markets during the first half of 2026.

Previous wording

We generate product revenue from sales of the Eversense system and related components and supplies to Ascensia, through the Commercialization Agreement, third-party distributors outside the United States and to strategic fulfillment partners in the United States (collectively “Customers”), who then resell the products to health care providers and patients. We are paid for our sales directly to the Customers, regardless of whether or not the Customers resell the products to health care providers and patients. The Company also generates product revenue from sales of the Eversense system and related components and supplies through a consignment model with our network of healthcare professionals in the United States and revenue is recognized when the product is consumed by a patient.

Current wording

strategic fulfillment partners in the United States (collectively “Customers”), who then resell the products to health care providers and patients. We are paid for our sales directly to the Customers, regardless of whether or not the Customers resell the products to health care providers and patients. The Company also generates product revenue from sales of the Eversense system and related components and supplies through a consignment model with our network of healthcare professionals in the United States and revenue is recognized when the product is consumed by a patient. Following the expected termination of the Ascensia Commercialization Agreement we expect certain changes in this distribution channel.

Previous wording

A significant portion of the Company’s revenue is derived from one customer, Ascensia. For the three months ended June 30, 2025 and 2024, sales to Ascensia accounted for 52% and 84% of total revenue, respectively. For the six months ended June 30, 2025 and 2024, sales to Ascensia accounted for 61% and 86% of total revenue, respectively.

Current wording

A significant portion of the Company’s revenue is derived from one customer, Ascensia. For the three months ended September 30, 2025 and 2024, sales to Ascensia accounted for 48% and 78% of total revenue, respectively. For the nine months ended September 30, 2025 and 2024, sales to Ascensia accounted for 56% and 84% of total revenue, respectively.

Previous wording

A portion of the Company’s revenue is earned under consignment arrangements with healthcare providers. For the three months ended June 30, 2025 and 2024, sales under consignment arrangements accounted for 40.9% and 14.7% of total revenue, respectively. For the six months ended June 30, 2025 and 2024, sales under consignment arrangements accounted for 32.5% and 11.3% of total revenue, respectively. Ascensia earns a 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.

Current wording

A portion of the Company’s revenue is earned under consignment arrangements with healthcare providers. For the three months ended September 30, 2025 and 2024, sales under consignment arrangements accounted for 46.5% and 20.1% of total revenue, respectively. For the nine months ended September 30, 2025 and 2024, sales under consignment arrangements accounted for 36.0% and 14.6% of total revenue, respectively. Ascensia earns a 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.

Previous wording

The following table sets forth net revenue derived from our two primary geographical markets, the United States and outside of the United States, based on the geographic location to which we deliver the product, for the three and six months ended June 30, 2025 and 2024:

Current wording

The following table sets forth net revenue derived from our two primary geographical markets, the United States and outside of the United States, based on the geographic location to which we deliver the product, for the three and nine months ended September 30, 2025 and 2024:

Previous wording

Our total revenue increased to $6.6 million for the three months ended June 30, 2025, compared to $4.9 million for the three months ended June 30, 2024, an increase of $1.7 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.

Current wording

Our total revenue increased to $8.1 million for the three months ended September 30, 2025, compared to $4.3 million for the three months ended September 30, 2024, an increase of $3.8 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.

Previous wording

Research and development expenses were $15.0 million for the six months ended June 30, 2025, compared to $21.2 million for the six months ended June 30, 2024, a decrease of $6.2 million. The decrease was driven by a $2.6 million decrease in personnel and consultant costs, a $1.8 million decrease in clinical studies spend, a $1.6 million decrease in contract fabrication costs, and a $0.2 million decrease in other general research and development expenses. These reductions are primarily driven by the completion of the Eversense 365 system clinical trials.

Current wording

Research and development expenses were $7.8 million for the three months ended September 30, 2025, compared to $10.5 million for the three months ended September 30, 2024, a decrease of $2.7 million. The decrease was driven by a $0.5 million decrease in employee services costs, a $0.7 million decrease in clinical study expenses, and a $1.5 million decrease in contract fabrication 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.

Previous wording

Total other (expense) income, net was ($0.9) million for the six months ended June 30, 2025, compared to other (expense) income, net of ($1.4) million for the six months ended June 30, 2024, a decrease in other expense of $0.5 million. The change was primarily due to lower interest expense of $1.6 million primarily due to repayment of the 2025 Notes offset by a decrease in interest income of $0.9 million and a $0.2 million reduction in other non-recurring income.

Current wording

Total other income (expense), net was $0.07 million for the three months ended September 30, 2025, compared to other expense, net of ($1.1) million for three months ended September 30, 2024, an increase in other income (expense), net of $1.2 million. The change was primarily due to lower interest expense of $1.0 million primarily due to repayment of the 2025 Notes offset by an increase in total interest income of $0.2 million as the result of higher investments in marketable securities.

Previous wording

Our total revenue increased to $12.9 million for the six months ended June 30, 2025, compared to $9.9 million for the six months ended June 30, 2024, an increase of $3.0 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.

Current wording

Our total revenue increased to $21.0 million for the nine months ended September 30, 2025, compared to $14.2 million for the nine months ended September 30, 2024, an increase of $6.8 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.

Previous wording

Our cost of sales decreased to $3.5 million for the three months ended June 30, 2025, compared to $4.6 million for the three months ended June 30, 2024 and our gross profit increased to $3.1 million for the three months ended June 30, 2025, compared to $0.3 million for the three months ended June 30, 2024. Gross profit as a percentage of revenue, or gross margin, was 46.9% and 6.1% for the three months ended June 30, 2025, and June 30,2024, respectively. The improvement in gross margin is due to several factors, including more favorable margins on the 365-day product sales, lower fixed manufacturing costs, and the impact of a $0.7 million one-time gain as the result of previously expensed value-added tax (VAT) recovered through amended filings. These improvements are slightly offset by an increase in revenue share to Ascensia under the terms of the Commercialization Agreement.

Current wording

Our cost of sales decreased to $12.9 million for the nine months ended September 30, 2025 compared to $17.6 million for the nine months ended September 30, 2024 and our gross profit increased to $8.1 million for the nine months ended September 30, 2025, compared to ($3.4) million for the nine months ended September 30, 2024. Gross profit as a percentage of revenue, or gross margin, was 38.5% and (24.1%) for the nine months ended September 30, 2025, and September 30, 2024, respectively. The improvement in gross margin is primarily 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.

Previous wording

Research and development expenses were $7.7 million for the three months ended June 30, 2025, compared to $10.8 million for the three months ended June 30, 2024, a decrease of $3.1 million. The decrease was driven by a $1.6 million decrease in personnel and consultant costs, a $0.7 million decrease in contract fabrication costs, a $0.6 million decrease in clinical studies spend, and a $0.2 million decrease in other general research and development expenses. 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.

Current wording

Research and development expenses were $22.8 million for the nine months ended September 30, 2025, compared to $31.8 million for the nine months ended September 30, 2024, a decrease of $9.0 million. The decrease was primarily driven by a $5.6 million decrease in clinical study and development (contract fabrication) costs, a $2.1 million decrease in personnel costs, a $1.1 million decrease in consulting costs, and a $0.1 million decrease in other research and development expenses. 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.

Previous wording

Selling, general and administrative expenses were $17.4 million for the six months ended June 30, 2025, compared to $17.1 million for the six months ended June 30, 2024, an increase of $0.3 million. The increase was primarily driven by an increase of $0.8 million in sales commission expenses to Ascensia as we increased consignment sales, a $0.3 million increase in personnel costs to support expansion of our Eon Care subsidiaries, and $0.5 million in other general & administrative costs. These increases were offset by a $1.3 million decrease in legal expenses in general and administrative costs.

Current wording

Selling, general and administrative expenses were $32.7 million for the nine months ended September 30, 2025, compared to $25.4 million for the nine months ended September 30, 2024, an increase of $7.3 million. The increase was primarily driven by an increase of $4.7 million increase in promotional expenses as a result of investments in direct-to-consumer marketing, $1.6 million increase in sales commission expenses to Ascensia as we increased consignment sales, and $1.7 million increase in other general & administrative costs. These costs were offset by $0.9 million decrease in corporate legal costs.

Previous wording

Total other expense, net was ($0.2) million for the three months ended June 30, 2025, compared to other expense, net of ($0.8) million for the three months ended June 30, 2024, a decrease in other expense of $0.6 million. The change was primarily due to lower interest expense of $0.9 million primarily due to repayment of the 2025 Notes offset by a decrease in interest income of $0.2 million and a $0.1 million non-recurring gain on change in the fair value of derivatives.

Current wording

Total other expense, net was ($0.9) million for the nine months ended September 30, 2025, compared to other expense, net of ($2.6) million for the nine months ended September 30, 2024, a decrease of $1.7 million. The change was primarily due to lower interest expense of $2.5 million primarily due to repayment of the 2025 Notes offset by a decrease in interest income of $0.7 million as the result of higher investments in marketable securities and a $0.1 million derivative fair value gain.

Previous wording

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 $78.6 million and $60.4 million for the years ended December 31, 2024 and 2023, respectively. For the six months ended June 30, 2025, the Company had a net loss of $28.8 million, and an accumulated deficit of $976.6 million. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, warrants, convertible notes, and debt. As of June 30, 2025, the Company had unrestricted cash, cash equivalents, and marketable securities of $126.4 million.

Current wording

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 $78.6 million and $60.4 million for the years ended December 31, 2024 and 2023, respectively. For the nine months ended September 30, 2025, the Company had a net loss of $48.3 million, and an accumulated deficit of $996.2 million. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, warrants, convertible notes, and debt. As of September 30, 2025, the Company had unrestricted cash, cash equivalents, and marketable securities of $111.0 million.

Previous wording

On May 15, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with several underwriters for the sale of 100,000,000 shares of its common stock (the “Public Offering”), at a public offering price of $0.50 per share (the “Public Offering Price”). Under the terms of the Underwriting Agreement, the Company also granted the underwriters a 30-day option to purchase up to an additional 15,000,000 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 40,539,265 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.

Current wording

also 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.

Previous wording

In the past two years, we have taken a number of measures to strengthen our financial position, including the repayment of our 2023 Notes, the sale of common stock in 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, the entry into a term loan facility and the issuance of shares of common stock pursuant to an at the market offering program. We have also taken measures to manage our operating expenses, including through a company restructuring in 2024.

Current wording

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.

Previous wording

On September 8, 2023, Company entered into the Loan and Security Agreement with the Lenders and Hercules, pursuant to which the Lenders have agreed to make available to the Company the Term Loan Facility, consisting of (i) an initial Tranche 1 Loan, which was 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 Tranche 3 Loan, which will become available to the Company upon the Company’s satisfaction of certain terms and conditions set forth in the Loan and Security Agreement. The loans under the Loan and Security Agreement mature on September 1, 2027.

Current wording

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.

Previous wording

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 45,714,286 shares of common stock at $0.35 per share and simultaneously issued the PP Warrants to these investors in a private placement to purchase an aggregate of 45,714,286 shares of common stock at an exercise price of $0.35 per share. 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.

Current wording

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.

Previous wording

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 40,130,560 shares under the Equity Distribution Agreement, after deducting sales commissions and offering expenses.

Current wording

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.

Previous wording

On September 8, 2023 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with the several financial institutions or entities party thereto (collectively, the “Lenders”) and Hercules Capital, Inc., a Maryland corporation (“Hercules”), pursuant to which the Lenders have agreed to make available to the Company 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) two additional tranches of term loans in the amounts of up to $10.0 million (the “Tranche 2 Loan”) and $15.0 million (the “Tranche 3 Loan”), respectively, which will become available to the Company upon the Company’s satisfaction of certain terms and conditions set forth in the Loan and Security Agreement. In December 2023, we met the terms and conditions to draw on the Tranche 2 Loan and the loan was funded on January 2, 2024 in an amount of $10.0 million. The loans under the Loan and Security Agreement mature on September 1, 2027.

Current wording

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.

Previous wording

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. These activities, including our ongoing focus to grow covered lives through positive insurance payor policy decisions and continued development of Eversense 365 in the United States, will require significant uses of working capital through 2025 and beyond. As of June 30, 2025, the Company had unrestricted cash, cash equivalents and marketable securities of $126.4 million.

Current wording

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. The Company is negotiating a definitive agreement related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company. Completion of the transfer of commercial operations relating to Eversense from Ascensia back to the Company will be subject to the terms set forth in the definitive agreement and ongoing implementation activities, which 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 September 30, 2025, the Company had unrestricted cash, cash equivalents and marketable securities of $111.0 million.

Previous wording

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. Beginning in the first quarter of 2024, management

Current wording

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 capital considerations 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 substantial doubt exists regarding its ability to continue as a going concern for the one-year period following the date these condensed consolidated financial statements are issued. To sustain its future operations beyond such one-year period, the Company will require additional funding. 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.

Previous wording

Net cash used in operating activities was $25.3 million for the six months ended June 30, 2025, and consisted of a net loss of $28.8 million and a net change in operating assets and liabilities of $3.0 million (most notably decreases in accrued expenses and other liabilities of $2.5 million), partially offset by $4.7 million of stock-based compensation and $1.8 million related to depreciation/amortization and other non-cash items.

Current wording

Net cash used in operating activities was $41.2 million for the nine months ended September 30, 2025, and consisted of a net loss of $48.3 million and a net change in operating assets and liabilities of $2.5 million partially offset by $7.5 million of stock-based compensation and $2.1 million related to depreciation/amortization and other non-cash items.

Previous wording

Net cash used in operating activities was $31.4 million for the six months ended June 30, 2024, and consisted of a net loss of $39.2 million, partially offset by a net change in operating assets and liabilities of $0.7 million (most notably increases in accounts payable of $3.3 million offset by $1.5 million in inventory and $1.6 million in deposits and other assets) $4.7 million of stock-based compensation and $2.4 million related to depreciation/amortization and other non-cash items.

Current wording

Net cash used in operating activities was $46.2 million for the nine months ended September 30, 2024, and consisted of a net loss of $63.1 million, partially offset by a net change in operating assets and liabilities of $2.6 million, $7.1 million of stock-based compensation and $7.2 million related to depreciation/amortization and other non-cash items.

Previous wording

Net cash used in investing activities was $18.2 million for the six months ended June 30, 2024 and consisted of $33.9 million in proceeds from the sale and maturity of marketable securities, offset by $49.6 million in purchase of marketable securities and $2.4 million of capital expenditures.

Current wording

Net cash used in investing activities was $76.1 million for the nine months ended September 30, 2025, and consisted of $100.7 million in purchase of marketable securities and $0.7 million of capital expenditures, offset by $25.4 million in proceeds from the sale and maturity of marketable securities.

Previous wording

Net cash used in investing activities was $95.0 million for the six months ended June 30, 2025, and consisted of $94.4 million in purchase of marketable securities and $0.6 million of capital expenditures.

Current wording

Net cash used in investing activities was $14.8 million for the nine months ended September 30, 2024 and consisted of $58.0 million in purchase of marketable securities and $2.2 million of capital expenditures, offset by $45.4 million in proceeds from the sale and maturity of marketable securities.

Previous wording

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

Current wording

Net cash provided by financing activities was $77.1 million for the nine months ended September 30, 2025, and primarily consisted of $72.3 million in net proceeds from the Public Offering and Private Placement, $26.7 million in net proceeds from issuances of common stock under the Equity Distribution Agreement, offset by $20.4 million used to repay the remaining outstanding 2025 Notes, $1.2 million from taxes paid related to net share settlement of equity awards and $0.4 million used to repay the debt modification costs.

Previous wording

Net cash provided by financing activities was $9.0 million for the six months ended June 30, 2024, and primarily consisted of $10.0 million in proceeds from the Tranche 2 Loan, net offset by $1.0 million from taxes paid related to net share settlement of equity awards.

Current wording

Net cash provided by financing activities was $12.8 million for the nine months ended September 30, 2024, and primarily consisted of $10.0 million in proceeds from the Tranche 2 Loan and $3.8 million in proceeds from the issuance of common stock, net offset by $1.0 million from taxes paid related to net share settlement of equity awards.