10-K: Senseonics Regains Commercial Control, Boosts CGM Sales

Senseonics Holdings, Inc. reports increased revenue and gross profit for 2025, driven by the Eversense 365 launch and regaining commercialization rights from Ascensia, despite ongoing net losses and liquidity concerns.

Summary

• Senseonics Holdings, Inc. is a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems, including Eversense E3 (6-month) and Eversense 365 (12-month) systems.
• The Eversense 365 CGM system received FDA approval in September 2024, with commercialization commencing in Q4 2024.
• Full commercial responsibility for Eversense 365 in the United States was taken over from Ascensia on January 1, 2026.
• CE Mark approval for Eversense 365 was obtained in January 2026, with an expected launch in European Territories by the second half of 2026.
• Total net revenue increased to $35.3 million for the year ended December 31, 2025, up from $22.5 million in 2024.
• Gross profit rose significantly to $15.8 million in 2025, compared to $0.5 million in 2024, with gross margin improving to 44.7% from 2.4%.
• Net loss decreased to $(69.1) million in 2025, an improvement from $(78.6) million in 2024.
• An accumulated deficit of $1.0 billion was reported as of December 31, 2025.
• Cash, cash equivalents, and marketable securities totaled $94.0 million as of December 31, 2025.
• Management has expressed substantial doubt about the ability to continue as a going concern for the next twelve months due to liquidity and potential debt covenant issues.
• Developing next-generation products, including the Gemini system (2-in-1 CGM/flash, self-powered) targeted for Q4 2027, and the Freedom system (Bluetooth in sensor, no on-body component) targeted for Q4 2028.
• Acquired the sensor insertion network assets of NPG in October 2024, establishing the Eon Care Network to expand patient access.
• A new direct-to-consumer marketing campaign, 'One Year. One CGM.', was launched in October 2024, leading to increased leads, patient shipments, new prescribers, and prescriptions.

Sentiment

Score: 6

Explanation: StockSavvy.ai views this as a moderately positive report, reflecting significant operational improvements in revenue and gross profit, and successful product launches and commercial transitions. However, the persistent net losses and explicit 'going concern' warning temper the overall sentiment, indicating substantial financial challenges remain.

Positives

• Total net revenue increased by $12.8 million to $35.3 million in 2025, demonstrating significant sales growth.
• Gross profit saw a substantial increase to $15.8 million in 2025 from $0.5 million in 2024, with gross margin improving to 44.7% from 2.4%.
• Net loss decreased to $(69.1) million in 2025, an improvement of $9.5 million compared to $(78.6) million in 2024.
• Received FDA approval for the Eversense 365 CGM system in September 2024, enabling commercialization of a one-year implantable sensor.
• Obtained CE Mark approval for Eversense 365 in January 2026, paving the way for European market expansion.
• Regained full commercial responsibility for Eversense 365 in the United States on January 1, 2026, and non-exclusive rights in European Territories, allowing for greater control over commercial strategy and revenue capture.
• Experienced higher direct-to-consumer leads, continued growth in patient shipments (December 2025 being the largest in company history), and an increase in new prescribers and prescriptions following the Eversense 365 launch.
• Medicare coverage for Eversense E3 was expanded in February 2024 to include all insulin users and non-insulin users with a history of problematic hypoglycemia, significantly broadening patient access.
• CMS updated payment amounts in April 2025 to account for the longer duration Eversense 365 for eligible Medicare beneficiaries.
• Acquired the sensor insertion network assets of NPG in October 2024, establishing the Eon Care Network to expand convenient in-office and at-home sensor insertion options.
• Entered into a collaboration agreement with Sequel Med Tech in April 2025 to integrate technologies for the first automated insulin delivery system with a once-yearly CGM, with first commercial patients in January 2026.
• Maintains a strong intellectual property portfolio with approximately 504 issued patents and pending applications worldwide.

Negatives

• Incurred significant operating losses since inception, with an accumulated deficit of $1.0 billion as of December 31, 2025.
• Management has concluded that substantial doubt exists regarding the ability to continue as a going concern for the next twelve months due to liquidity concerns and potential failure to meet debt covenants as early as Q3 2026.
• Highly dependent on the successful commercialization of a single product, Eversense, for nearly all revenue.
• Operates in a highly competitive market against well-capitalized companies like Dexcom, Medtronic, and Abbott, which possess greater financial resources, established relationships, and market recognition.
• Limited operating history as a commercial-stage company, facing inherent difficulties in competitive and rapidly evolving markets.
• The transition of commercial responsibility from Ascensia is complex and may incur greater resources and operational challenges than anticipated.
• Reliance on third-party manufacturers and suppliers exposes the company to risks of supply disruption, quality defects, and limited control over costs.
• Product revenue is subject to seasonal variation, typically lower in the first quarter due to annual health insurance deductible resets.
• Covenants under the Loan and Security Agreement impose limitations on business operations and require achieving minimum revenue and liquidity targets, which may restrict strategic flexibility.
• Servicing existing debt requires a significant amount of cash, and there is no assurance of sufficient cash flow from operations to meet these obligations.
• Exposure to foreign exchange risks due to international operations and revenue streams.
• Stock price has been highly volatile, and there is no assurance of stability or appreciation over time.
• Potential for product liability claims arising from undetected errors, defects, or off-label use of Eversense.
• Subject to ongoing patent litigation (Cellspin Soft, Inc. lawsuit) which could be costly and divert management attention.
• Regulatory approval processes are expensive, time-consuming, and uncertain, with potential for delays or denial of approvals for new products or modifications.
• Changes in healthcare reform legislation, such as the One Big Beautiful Bill Act (OBBBA), could lead to decreased reimbursement or increased operational costs.
• Inability to fully utilize tax attribute carryforwards (NOLs, R&D credits) due to potential ownership changes or limitations.

Risks

• Incurred significant operating losses since inception and cannot assure profitability.
• Inability to successfully transition commercial responsibility for Eversense back from Ascensia and expand commercialization in the United States and Europe.
• Highly competitive market with potential technological breakthroughs from competitors rendering Eversense less competitive or obsolete.
• Limited operating history as a commercial-stage company, facing difficulties in competitive and rapidly evolving markets.
• Actual operating results may differ significantly from any guidance provided, potentially causing stock price decline.
• Medical device development involves a lengthy and expensive process with an uncertain outcome, leading to potential delays or inability to complete development.
• Products and operations are subject to extensive governmental regulation; failure to comply could harm the business.
• Failure to secure or retain coverage or adequate reimbursement for Eversense systems and related procedures by third-party payors.
• Inability to establish a broad inserter network through Eon Care.
• Stock price has been highly volatile and may continue to be so.
• Substantial doubt about the ability to continue as a going concern due to recurring losses and liquidity uncertainty.
• Risks associated with third-party manufacturing, loss of key suppliers, or disruption to their facilities.
• Failure or perceived failure to comply with existing or future data privacy and security laws (e.g., HIPAA, GDPR).
• Holders of debt instruments may exert substantial influence over the company.
• Dependence on one product (Eversense); success relies on continued development, commercialization, and market acceptance.
• Various factors outside direct control may adversely affect manufacturing, sterilization, and distribution of products.
• Potential complications from Eversense or future versions may not be revealed by clinical experience.
• Undetected errors or defects in Eversense could harm reputation, decrease market acceptance, or expose the company to product liability claims.
• Collaborations, in-licensing arrangements, joint ventures, strategic alliances, or partnerships with third parties may not result in commercially viable products or significant future revenues.
• Failure to manage acquisitions or integrate them with existing business could harm business, financial condition, and operating results.
• Business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events, or other macroeconomic conditions.
• International trade policies, including tariffs, sanctions, and trade barriers, may adversely affect business.
• Need to generate significant sales to achieve profitable operations.
• Uncertainty regarding the ultimate effect of the one-for-twenty Reverse Stock Split on common stock share price and liquidity.
• Operating results may fluctuate significantly from quarter to quarter or year to year.
• Product revenue is subject to seasonal variation.
• Covenants under the Loan and Security Agreement may result in the acceleration of outstanding indebtedness and limit operations.
• Servicing debt requires a significant amount of cash, and there may not be sufficient cash flow from business to pay substantial debt.
• Ability to incur substantially more debt or take other actions which would intensify risks.
• Exposure to foreign exchange risks.
• If modifications to approved products require additional approvals or certifications, and these are not granted, it could prevent sales of modified products.
• Future success depends on the ability to retain key executives and to attract, retain, and motivate qualified personnel.
• Need to expand sales and marketing and potentially other capabilities, which may lead to difficulties in managing growth.
• Employees, independent contractors, consultants, manufacturers, and distributors may engage in misconduct or other improper activities.
• May incur product liability losses, and insurance coverage may be inadequate or unavailable.
• Ability to protect intellectual property and proprietary technology is uncertain.
• Subject to the patent laws of countries other than the United States, which may not offer the same level of protection.
• Intellectual property rights do not necessarily address all potential competitive threats or confer meaningful competitive benefits.
• Subject to the U.K. Bribery Act, the U.S. Foreign Corrupt Practices Act, and other anti-corruption and anti-money-laundering laws.
• Subject to additional federal, state, and foreign laws and regulations relating to the healthcare business; failure to comply could have an adverse impact.
• May be liable if the FDA, competent authorities of the EEA countries, or another regulatory agency concludes that the company has engaged in off-label promotion of products.
• International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country.
• Off-label use of products by patients could lead to product liability claims and regulatory action.
• Legislative or regulatory healthcare reforms may make it more difficult and costly to obtain regulatory clearance, certification, or approval of products or otherwise impact profitability.
• Issuance of additional stock in connection with financings, acquisitions, investments, or equity incentive plans will dilute existing stockholders.
• PHC may have the ability to exert substantial influence over the company.
• Rights granted to Abbott in connection with a recent private placement may affect the likelihood of a change of control.
• Estimates relating to critical accounting policies, if based on assumptions or judgments that change or prove incorrect, could cause operating results to fall below expectations.
• Does not intend to pay cash dividends in the foreseeable future.
• Provisions in corporate charter documents and under Delaware law may prevent or frustrate attempts by stockholders to change management and hinder efforts to acquire a controlling interest.
• Amended and restated certificate of incorporation and bylaws provide that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes.
• Failure to maintain proper and effective internal controls could impair the ability to produce accurate financial statements on a timely basis.
• Effective tax rate may fluctuate, and obligations in tax jurisdictions may exceed accrued amounts.
• May be unable to utilize tax attribute carryforwards to reduce income taxes.
• Changes in tax laws or regulations that are applied adversely may have a material adverse effect.
• Bank deposits in excess of Federal Deposit Insurance Corporation (FDIC) insurance limits could be impacted if underlying financial institutions fail.

Future Outlook

The company expects to launch Eversense 365 in European Territories by the second half of 2026 and aims to launch its next-generation Gemini and Freedom systems by Q4 2027 and Q4 2028, respectively. These initiatives are part of a broader strategy to enhance product offerings with features like integrated power sources and Bluetooth in sensors. Operating expenses are anticipated to increase significantly with the resumption of direct commercial responsibility for Eversense, with the expectation of capturing a larger portion of revenue. However, existing cash and cash equivalents are not projected to be sufficient to fund operations through the next twelve months, necessitating additional capital raises through various financing and strategic arrangements.

Management Comments

• 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.
• Following the launch of Eversense 365, the Company has experienced higher direct-to-consumer leads compared to pre-launch months, continued growth in patient shipments with December 2025 being the largest compared to any previous month in company history, an increase in the number of new prescribers and prescriptions, and an increase in new patients.
• In 2026 we continue to drive efforts to raise patient and prescriber awareness with targeted programs such as paid social ads, website optimization strategies, the Eversense 365 and twiistTM automated insulin delivery (or AID) campaign, and other focused marketing strategies.
• We believe that our future success depends upon our continued ability to attract and retain highly skilled and qualified employees who share in our mission to transform lives in the global diabetes community with differentiated, long-term implantable glucose monitoring technology.
• Our management has concluded that the capital considerations required to assume Eversense commercialization and distribution responsibilities, our existing unrestricted cash and cash equivalents, and the minimum cash requirements and satisfaction of performance milestones to comply with debt covenants under our Amended Loan and Security Agreement raise substantial doubts regarding our ability to continue as a going concern for the next twelve months after issuance of our financial statements in this Annual Report.

Industry Context

StockSavvy.ai notes that Senseonics operates in the rapidly evolving and competitive continuous glucose monitoring (CGM) market, which is experiencing significant growth driven by increasing diabetes prevalence and demand for advanced monitoring solutions. The company's focus on long-term implantable sensors differentiates it from competitors like Dexcom and Abbott, whose products typically have shorter wear times and factory calibration. The strategic shift to direct commercialization in the US and Europe, coupled with the development of next-generation products like Gemini and Freedom, positions Senseonics to capture a larger share of this expanding market, particularly as integration with automated insulin delivery systems becomes a key trend. However, the industry's high capital requirements and intense competition from well-established players with greater resources pose significant challenges.

Comparison to Industry Standards

• Eversense offers the longest available sensor duration at up to one year, significantly exceeding the seven to 15 days for non-implantable CGM systems from competitors like Dexcom (G6 and G7) and Abbott (Freestyle Libre 2 and 3).
• Competitors Dexcom (G6 and G7) and Abbott (Freestyle Libre 2 and 3) offer factory calibration, eliminating the need for user calibration, whereas Eversense 365 requires once-weekly fingerstick calibrations after day 13.
• Dexcom was the first to receive FDA iCGM indication, allowing interoperability with insulin pumps; Senseonics is pursuing this with its iCGM designation for Eversense 365 and collaboration with Sequel Med Tech for the twiist AID system.
• Senseonics competes with major CGM manufacturers such as Dexcom, Medtronic, and Abbott, all of whom have FDA approval and CE Marks for their respective products and generally possess greater financial and human resources.
• In the self-monitoring of blood glucose (SMBG) market, Senseonics competes with established providers like Roche Diabetes Care, Abbott, and Ascensia.

Management Changes

Corporate Governance

Legal Proceedings

• In May 2024, received notice of a civil complaint from Cellspin Soft, Inc. vs. Senseonics Holdings, Inc., and Ascensia Diabetes Care Holdings AG (Case No. 2:24-cv-263) in the Eastern District of Texas, alleging patent infringement of three patents.
• The validity of these three patents is currently being challenged in Inter Partes Review (IPR) proceedings at the U.S. Patent and Trademark Office by TikTok Inc. (TikTok IPR), with a review instituted on September 30, 2024.
• On October 30, 2024, Senseonics, LifeScan, Inc., and Ascensia filed a joint motion to join the TikTok IPR and their own independent, similar IPR petitions challenging these patents.
• On February 5, 2025, the court issued an order staying the proceedings in the Eastern District of Texas pending resolution of the Inter Partes Reviews.
• On June 5, 2025, the Acting Director of the U.S. Patent and Trademark Office ordered a sua sponte review of the TikTok IPR based on novel issues relating to TikTok's Chinese ownership status.
• On January 23, 2026, the Director of the U.S. Patent and Trademark Office issued an order authorizing additional briefs regarding TikTok's real party in interest and the impact of its announced joint venture.
• TikTok, Inc. and Cellspin Soft, Inc. filed additional briefs on February 2, 2026; no decision has been rendered on whether the TikTok IPR can proceed, and all IPR proceedings are stayed.
• The company intends to vigorously defend the lawsuit if any asserted claims in the three patents survive the invalidity challenge in the IPR proceedings.

Related Party Transactions

• PHC Holding Corporation beneficially owns approximately 9.6% of common stock as of the filing date.
• PHC's designee to the Board of Directors resigned on December 31, 2025, but PHC retains the right to designate one individual to serve on the board as long as it beneficially owns in excess of 5% of outstanding common stock.
• Ascensia Diabetes Care Holdings AG, through the ownership interests of its parent company PHC, is a related party.
• Sales to Ascensia accounted for 53% of total revenue for the year ended December 31, 2025, and 82% for the year ended December 31, 2024.
• Ascensia earned commissions of $3.7 million in 2025 and $1.2 million in 2024 on sales made through the consignment channel.
• The amount due from Ascensia was $5.3 million as of December 31, 2025, and $4.9 million as of December 31, 2024.
• The amount due to Ascensia was $5.2 million as of December 31, 2025, and $1.8 million as of December 31, 2024.
• Purchases of certain medical supplies from Ascensia for clinical trials were less than $0.1 million during both 2025 and 2024.
• On December 31, 2025, entered into a Master Asset Purchase Agreement and an Amended and Restated Collaboration and Commercialization Agreement with Ascensia related to the transfer of commercial operations for Eversense back to the company.

Stakeholder Impact

• **Shareholders**: Face potential dilution from future equity raises, continued stock price volatility, and the influence of major shareholders like PHC. Anti-takeover provisions and exclusive forum clauses may limit their ability to influence corporate control or pursue certain legal actions.
• **Employees**: The workforce significantly expanded by over 150 employees, primarily in commercial roles, effective January 2, 2026, indicating growth opportunities. The company emphasizes employee engagement, health, wellbeing, organizational development, and inclusion, offering competitive compensation, stock options, and comprehensive benefits.
• **Customers (People with Diabetes)**: Benefit from the availability of longer-term CGM systems (Eversense E3, 365-day), ongoing product development (Gemini, Freedom), expanded Medicare coverage, and patient assistance programs (PASS). The Eon Care Network aims to provide more convenient sensor insertion options.
• **Healthcare Providers**: Gain access to the Eversense system and benefit from educational efforts and the expanding Certified Eversense Specialist (CES) and Eon Care Networks for sensor insertion services. However, heterogeneity in reimbursement processes may initially cause disruption.
• **Suppliers/Contract Manufacturers**: The company's continued reliance on third-party manufacturers suggests ongoing business for these partners, with potential for increased demand and per-unit cost decreases. However, they also face risks related to supply chain disruptions and compliance with regulatory standards.
• **Creditors (e.g., Hercules Capital, Inc.)**: The company's debt obligations and associated covenants require careful management. Failure to meet minimum revenue and liquidity targets could lead to the acceleration of outstanding indebtedness, impacting the company's financial stability.

Next Steps

• Launch Eversense 365 in European Territories by the second half of 2026.
• Expect to enter into a series of asset purchase agreements to acquire additional assets related to Ascensia's commercial Eversense activities in the European Territories on or before March 31, 2026.
• Expect to close European Asset Purchases on or before June 30, 2026.
• Complete the GEMINI pivotal trial in 2026 to support a 510(k) submission to the FDA.
• Continue to drive efforts to raise patient and prescriber awareness with targeted marketing programs in 2026.
• Work with payors to transition their policies to Eversense 365.
• Expand the inserter network through Eon Care in select geographic areas.
• Aim to launch the Gemini system by the fourth quarter of 2027.
• Aim to launch the Freedom system by the fourth quarter of 2028.
• Evaluate strategies to obtain additional funding for future operations.
• Monitor capital structure and market conditions for potential public or private debt and equity financings, collaborations, strategic alliances, and licensing arrangements.

Key Dates

Recommendation

The company shows promising operational improvements and strategic advancements with its long-term CGM technology and regaining commercial control. However, the persistent net losses and the explicit 'going concern' warning, coupled with intense competition and the need for further capital, suggest a high-risk, high-reward profile. A 'Hold' recommendation allows investors to monitor the execution of the commercial transition and the path to profitability without taking on immediate additional risk.

Keywords

Continuous Glucose Monitoring, CGM, Diabetes Management, Eversense, Medical Technology, Financial Performance, Commercialization, FDA Approval, CE Mark, Ascensia, Sequel Med Tech, Implantable Sensor, Healthcare, Biotechnology, Risk Factors, Liquidity, Debt Covenants, Intellectual Property, Regulatory Compliance, Market Volatility, Eon Care Network, Sarbanes-Oxley Act