SENS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• On September 3, 2025 the Company and Ascensia signed a memorandum of understanding (“MOU”) related to the transfer of commercial operations relating to Eversense from Ascensia back to the Company. On December 31, 2025, the parties entered into the Master Asset Purchase Agreement formalizing this tra…

• 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 wit…

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

• commercialization activities were returned to the Company and in Europe, Ascensia continues to sell and market the Eversense product to support the orderly transition of the business to Senseonics anticipated in the second quarter of 2026. In both the United States and our overseas markets we will c…

• 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 measurin…

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• Our net revenues are derived from sales of the Eversense Systems, 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 …

• 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

• 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 agr…

• 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 June 2019, we received FDA approval for the non-adjunctive indication (dosing claim) for Eversense 90 and launched with an updated app in December 2019. With this approval, Eversense 90 can be used as a therapeutic CGM to replace fingerstick blood glucose measurement for treatment decisions, incl…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• In May 2024, the Company received notice and accepted service of a civil complaint that had been filed in the Eastern District of Texas and styled Cellspin Soft, Inc. vs. Senseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG Case No. 2:24-cv 263. The case was filed by a non-practicing en…

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• In May 2024, the Company received notice and accepted service of a civil complaint that had been filed in the Eastern District of Texas and styled Cellspin Soft, Inc. vs. Senseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG Case No. 2:24-cv 263. The case was filed by a non-practicing en…

Text added vs the prior filing · source: 10-Q · 2026-05-07

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

• On March 12, 2026, we entered into the Local Purchase Agreements with Ascensia, pursuant to which we agreed to acquire certain commercial assets and assume certain related liabilities in Italy, Germany, Spain and Sweden. The closing of each of the European Asset Purchases is subject to the satisfact…

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

• On May 1, 2026, we entered into the Second Amendment to our Amended Loan and Security Agreement with Hercules (the “Second Amendment”), which increased the total loan potential borrowings under the agreement from $100.0 million to $140.0 million. As of the date of this report, we have drawn an aggre…

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

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• The transition of commercial responsibility for Eversense to Senseonics is subject to the finalization and execution of a definitive agreement with Ascensia and, for certain European countries, an uncertain government approval process.

• We recently entered into a memorandum of understanding (“MOU”) with Ascensia related to the termination of our existing Commercialization Agreement and the transfer of commercial responsibility for Eversense from Ascensia back to the Company. As contemplated by the MOU, we expect to resume responsib…

• The commercialization of Eversense in certain European countries is subject to government tender systems within the various countries. The ability of the Company to participate in the various tenders will require the satisfaction of the requirements of these countries’ regulatory bodies, and in some…

• Our resumption of commercial responsibility for Eversense will require us to develop a number of internal functions and may not be successful.

• It has been more than five years since we had direct commercial responsibility for Eversense and, in order to resume commercial responsibility for the product, we will need to develop internal sales, marketing and distribution capabilities. This will require us to integrate, and in some cases, recru…