8-K: Senseonics Q3 Revenue Jumps 90%, Reclaims Commercial Control

Senseonics Holdings, Inc. reported a 90% year-over-year revenue increase to $8.1 million in Q3 2025, driven by strong U.S. patient growth, and announced plans to transition commercial responsibility for Eversense back from Ascensia Diabetes Care.

Summary

• Generated revenue of $8.1 million in the third quarter of 2025, an increase of 90% versus the third quarter of 2024.
• Achieved a 160% increase in U.S. new patient starts over the prior year.
• Planning for the transition of CGM commercial responsibility for Eversense from Ascensia Diabetes Care back to Senseonics.
• Gross profit for Q3 2025 was $3.5 million, a significant improvement from a gross loss of $(4.1) million in Q3 2024.
• Net loss decreased by $4.5 million year-over-year to $19.5 million, or a $0.43 loss per share.
• Research and development expenses decreased by $2.7 million year-over-year to $7.8 million.
• Selling, general and administrative expenses increased by $7.0 million year-over-year to $15.3 million.
• Executed a 1-for-20 reverse stock split on October 17, 2025, resulting in approximately 41 million outstanding shares.
• Planned transfer of stock exchange listing to the Nasdaq Global Market from the NYSE American effective November 17, 2025.
• Anticipate receiving CE Mark approval for Eversense 365 by the end of 2025, with EU launch in H1 2026.
• Working towards the IDE submission for the next-generation Gemini product by year-end 2025.

Sentiment

Score: 7

Explanation: The company reported strong revenue growth and a significant improvement in gross profit, along with positive patient adoption metrics. The strategic move to reclaim commercial control and upcoming product milestones (CE Mark, Gemini IDE) are positive. However, the company continues to operate at a net loss and has a substantial cash burn, which are ongoing concerns, though the net loss did decrease.

Positives

• Total revenue increased 90% year-over-year to $8.1 million in Q3 2025.
• U.S. new patient starts increased by 160% over the prior year, driving revenue growth.
• Achieved a gross profit of $3.5 million in Q3 2025, a substantial improvement from a gross loss of $(4.1) million in Q3 2024, primarily due to 365-day product margins.
• Net loss decreased by $4.5 million year-over-year to $19.5 million.
• Research and development expenses decreased by $2.7 million year-over-year due to the completion of Eversense 365 system clinical trials and development efforts.
• Reported a record-setting quarter with all-time highs in new patient shipments, insertions, and patient base.
• Approximately 90% of new Eversense 365 users are switching from other CGMs, indicating strong product competitiveness.
• Anticipate CE Mark approval for Eversense 365 by the end of 2025, with an EU launch in H1 2026.
• Continuing to work towards the IDE submission for the next-generation Gemini product by year-end 2025.

Negatives

• Reported a net loss of $19.5 million in Q3 2025.
• Selling, general and administrative expenses increased by $7.0 million year-over-year to $15.3 million, primarily driven by higher selling and marketing personnel costs and direct-to-consumer campaign investments.
• Cash and cash equivalents decreased from $74.597 million at December 31, 2024, to $34.458 million at September 30, 2025.
• Cash used in operations in 2025 is expected to be approximately $60 million.
• Revenue outside the U.S. decreased to $1.7 million in Q3 2025 from $1.9 million in Q3 2024.

Risks

• Uncertainties inherent in the negotiation and transition of commercial responsibility for Eversense from Ascensia and the establishment of those functions at Senseonics.
• Uncertainties in insurer, regulatory, and administrative processes and decisions.
• Uncertainties inherent in the development and registration and roll-out of new technology and solutions.
• Uncertainties inherent in finalizing integration and commercial terms and coordination with health systems and other new collaboration partners and third parties.
• Uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense product and Senseonics and its partners activities.
• Uncertainties relating to the current economic and regulatory/political environment, including the effects of tariffs.

Future Outlook

Senseonics expects full-year 2025 global net revenue to be approximately $35 million, with revenue heavily weighted to the fourth quarter due to Eversense 365 reorder dynamics. Full-year 2025 gross margins are projected to be between 35% and 40%, increasing throughout the year. Cash used in operations for 2025 is anticipated to be around $60 million. The company also expects CE Mark approval for Eversense 365 by year-end 2025, with an EU launch in H1 2026, and plans to submit the IDE for its next-generation Gemini product by year-end.

Management Comments

• "The third quarter of 2025 was a record setting quarter, highlighted by all-time highs in new patient shipments, insertions and our patient base."
• "Our hybrid DTC and provider commercial approach continues to accelerate awareness, competitiveness, and growth in Eversense 365 with now approximately 90% of our new users switching from other CGMs."
• "We expect resuming commercialization of Eversense will enable us to control our own destiny and continue the momentum behind Eversense driving further revenue growth."
• "We continue to anticipate receiving CE Mark approval for Eversense 365 by the end of the year, with the EU launch anticipated in H1 2026, and continue to work towards the IDE submission for our next generation Gemini product by year end."

Industry Context

Senseonics operates in the competitive continuous glucose monitoring (CGM) market, aiming to differentiate with its long-term implantable technology. The strategic decision to reclaim commercial responsibility for Eversense from Ascensia Diabetes Care indicates a move to gain more direct control over market penetration, brand building, and potentially leverage its successful direct-to-consumer marketing efforts. The high rate of new users switching from other CGMs (approximately 90%) suggests that Eversense 365 is a strong competitive offering within the industry.

Corporate Governance

Related Party Transactions

• Revenue, net related parties was $3.893 million in Q3 2025, compared to $3.308 million in Q3 2024.
• Accrued expenses and other current liabilities, related parties were $3.732 million at September 30, 2025, compared to $1.870 million at December 31, 2024.
• Accounts receivable, net related parties were $2.683 million at September 30, 2025, compared to $4.921 million at December 31, 2024.
• Signed a memorandum of understanding with Ascensia Diabetes Care and is collaborating with Ascensia to transition commercial responsibility for Eversense back to Senseonics, indicating an ongoing related party relationship.

Stakeholder Impact

• Shareholders: Positive impact from strong revenue growth, improved gross profit, and strategic moves like reclaiming commercial control and Nasdaq listing. Negative impact from continued net loss and cash burn. The reverse stock split impacts share count but not total value.
• Patients: Positive impact from continued rollout and adoption of Eversense 365, especially with 90% of new users switching from other CGMs, indicating product satisfaction. Anticipated EU launch and next-gen product development are also positive.
• Employees: Potential changes and growth opportunities as Senseonics reclaims commercial responsibility, likely requiring expansion of sales and marketing teams.
• Ascensia Diabetes Care: The transition of commercial responsibility means a change in their role regarding Eversense, potentially reducing their revenue stream from this partnership.

Next Steps

• Transition commercial responsibility for Eversense from Ascensia Diabetes Care back to Senseonics.
• Continue direct-to-consumer (DTC) marketing to drive awareness and adoption.
• Receive CE Mark approval for Eversense 365 by the end of 2025.
• Launch Eversense 365 in the EU in H1 2026.
• Submit IDE for the next-generation Gemini product by year-end 2025.
• Transfer stock exchange listing to the Nasdaq Global Market effective November 17, 2025.
• Continue progress with the transition of reimbursement from Eversense E3 to Eversense 365.

Key Dates

Recommendation

While Senseonics demonstrated strong Q3 revenue growth, significant gross profit improvement, and positive patient adoption, the company continues to incur substantial net losses and projects considerable cash burn for the full year. The strategic move to reclaim commercial control and upcoming product milestones are positive long-term indicators, but the execution risk associated with this transition and the ongoing need for capital management warrant a "hold" stance. Investors should monitor the successful integration of commercial operations, progress on CE Mark and Gemini IDE, and the trajectory towards profitability.

Keywords

Senseonics, SENS, Continuous Glucose Monitoring, CGM, Eversense, Diabetes, Medical Technology, Financial Results, Q3 2025, Revenue Growth, Patient Growth, Ascensia Diabetes Care, Commercialization, Reverse Stock Split, Nasdaq Listing, CE Mark, Gemini Product