Product Development and Approval - The Eversense E3 system, approved by the FDA in February 2022, offers a 180-day continuous glucose monitoring (CGM) solution, while the Eversense 365 system, approved in September 2024, extends this duration to 365 days[123][139]. - The mean absolute relative difference (MARD) for the Eversense 90 system was reported at 8.5% during a pivotal clinical trial, demonstrating its accuracy over a 90-day period[129]. - The ENHANCE pivotal study for Eversense 365 completed enrollment in the third quarter of 2023, supporting its FDA 510(k) submission approved on September 17, 2024[137][139]. - The FDA approved the Eversense E3 system with proprietary technology that doubles sensor life to six months, maintaining a MARD of 8.5%[136]. - The company began first-in-human testing for the Gemini product in July 2024, which is expected to enhance its product offerings for diabetes management[142]. - Eversense 365 was submitted for CE Mark approval in February 2025, with plans to launch in European markets in the first half of 2026 upon approval[145]. Market Access and Coverage - Approximately 300 million covered lives in the United States have access to Eversense systems due to positive insurance payor coverage decisions, including coverage from UnitedHealthcare effective July 1, 2023[126]. - 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, increasing access for millions of Medicare patients[126]. - The company has entered into strategic partnerships and distribution agreements to promote Eversense systems, including a 2-in-1 glucose monitoring system called "Gemini" and a Bluetooth-enabled product variation[128]. - Eon Care Services, LLC and Eon Management Services, LLC were established to enhance patient access to Eversense systems, with an increase in insertions noted during the second and third quarters of 2025[140]. Financial Performance - Total revenue increased to $8.1 million for the three months ended September 30, 2025, compared to $4.3 million for the same period in 2024, representing a growth of 88.7%[160]. - Revenue from sales to Ascensia accounted for 48% of total revenue for the three months ended September 30, 2025, down from 78% in the same period of 2024[152]. - Revenue from consignment arrangements accounted for 46.5% of total revenue for the three months ended September 30, 2025, compared to 20.1% for the same period in 2024[153]. - Gross profit increased to $3.5 million for the three months ended September 30, 2025, with a gross margin of 42.8%, compared to a gross loss of $4.1 million and a margin of (95.0%) in the same period of 2024[161]. - Total revenue increased to $21.0 million for the nine months ended September 30, 2025, compared to $14.2 million for the same period in 2024, an increase of $6.8 million[167]. - Gross profit increased to $8.1 million for the nine months ended September 30, 2025, compared to a loss of $3.4 million for the same period in 2024, resulting in a gross margin of 38.5%[168]. Expenses and Losses - Research and development expenses decreased to $7.8 million for the three months ended September 30, 2025, down from $10.5 million in the same period of 2024, a reduction of 25.7%[162]. - Selling, general and administrative expenses rose to $15.3 million for the three months ended September 30, 2025, compared to $8.3 million in the same period of 2024, an increase of 84.3%[163]. - Research and development expenses decreased to $22.8 million for the nine months ended September 30, 2025, down from $31.8 million in 2024, a reduction of $9.0 million[169]. - Selling, general and administrative expenses increased to $32.7 million for the nine months ended September 30, 2025, compared to $25.4 million in 2024, an increase of $7.3 million[170]. - The company incurred a net loss of $48.3 million for the nine months ended September 30, 2025, compared to a net loss of $63.1 million in 2024, an improvement of $14.8 million[166]. Cash Flow and Financing - Net cash used in operating activities was $41.2 million for the nine months ended September 30, 2025, compared to $46.2 million for the same period in 2024, reflecting a decrease of 6.5%[186][187]. - Net cash used in investing activities increased significantly to $76.1 million for the nine months ended September 30, 2025, from $14.8 million in 2024[188][189]. - Net cash provided by financing activities was $77.1 million for the nine months ended September 30, 2025, a substantial increase from $12.8 million in 2024[190][191]. - The company entered into an at-the-market sales agreement with TD Securities for the sale of up to $100.0 million in common stock[173]. - The company completed a public offering of 5,000,000 shares at a price of $10.00 per share, raising gross proceeds of $57.5 million[176]. - The company had $72.3 million in net proceeds from a public offering and private placement during the nine months ended September 30, 2025[190]. Going Concern and Future Outlook - The company has determined that substantial doubt exists regarding its ability to continue as a going concern for the one-year period following the issuance of the financial statements[183]. - There is no assurance that the company will be successful in obtaining sufficient funding on acceptable terms, which could adversely affect its business prospects[183]. - The company plans to finance its cash needs through public or private debt and equity financings, collaborations, strategic alliances, and licensing arrangements[183]. - The company is negotiating the transfer of commercial operations related to Eversense from Ascensia back to itself, which may enhance revenue generation and market adoption[182].

Core Insights - Senseonics Holdings, Inc. reported a record-setting third quarter in 2025, with total revenue of $8.1 million, marking a 90% year-over-year increase driven by a 160% rise in new patient starts in the U.S. [1][4][9] - The company is transitioning commercial responsibility for its Eversense product line back from Ascensia Diabetes Care, which is expected to enhance control over its commercialization strategy [1][3][9]. Financial Performance - Total revenue for Q3 2025 was $8.1 million, compared to $4.3 million in Q3 2024, with U.S. revenue at $6.4 million and international revenue at $1.7 million [4][9]. - Gross profit for Q3 2025 was $3.5 million, a significant improvement from a gross loss of $(4.1) million in Q3 2024, attributed to better product margins and the absence of prior year inventory write-offs [5][8]. - Research and development expenses decreased to $7.8 million from $10.5 million year-over-year, primarily due to the completion of clinical trials for the Eversense 365 system [6]. - Selling, general, and administrative expenses rose to $15.3 million from $8.3 million, driven by increased marketing and personnel costs [7]. Market Strategy and Outlook - The company anticipates receiving CE Mark approval for Eversense 365 by the end of 2025, with a European launch expected in the first half of 2026 [3]. - Senseonics expects full-year 2025 global net revenue to reach approximately $35 million, with a projected doubling of its global patient base [11]. - The company executed a 1-for-20 reverse stock split, reducing the number of outstanding shares to approximately 41 million [9][10]. Product Development - The Eversense CGM systems are designed for continuous glucose monitoring, with Eversense 365 capable of measuring glucose levels for up to 365 days [13][14]. - The company is working towards the IDE submission for its next-generation Gemini product by the end of 2025 [3].

Core Viewpoint - The market anticipates that Senseonics Holdings (SENS) will report a year-over-year increase in earnings driven by higher revenues in its upcoming earnings report for the quarter ended September 2025, with a focus on how actual results compare to estimates [1][2]. Financial Expectations - The consensus estimate indicates a quarterly loss of $0.33 per share, reflecting a year-over-year improvement of +58.8% [3]. - Expected revenues are projected to be $8.1 million, representing a significant increase of 90.1% from the same quarter last year [3]. Estimate Revisions - Over the past 30 days, the consensus EPS estimate has been revised down by 5.56%, indicating a reassessment by analysts regarding the company's earnings prospects [4]. - The Most Accurate Estimate for Senseonics is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -20.00%, suggesting a bearish outlook from analysts [12]. Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that a positive or negative reading can predict the deviation of actual earnings from consensus estimates, but it is more reliable for positive readings [9][10]. - Senseonics currently holds a Zacks Rank of 4, which complicates the prediction of an earnings beat [12]. Historical Performance - In the last reported quarter, Senseonics was expected to post a loss of $0.40 per share, matching the actual result with no surprise [13]. - Over the last four quarters, the company has only beaten consensus EPS estimates once [14]. Industry Comparison - Another company in the medical technology sector, Inspire Medical Systems (INSP), is expected to report a loss of $0.09 per share, indicating a year-over-year change of -115%, with revenues projected at $221.44 million, up 9% from the previous year [18][19]. - Inspire Medical Systems has an Earnings ESP of +68.18% and has consistently beaten consensus EPS estimates in the past four quarters, indicating a more favorable outlook compared to Senseonics [20].

Core Insights - Senseonics Holdings, Inc. is set to release its third quarter 2025 financial results on November 5, 2025, after market close [1] - A conference call to discuss the financial performance will take place at 4:30 p.m. Eastern Time on the same day, with a webcast available for investors [2] Company Overview - Senseonics is a medical technology company specializing in long-term implantable continuous glucose monitoring systems aimed at improving the lives of individuals with diabetes [3] - The company's CGM systems, Eversense 365 and Eversense E3, feature a small sensor that is implanted under the skin and communicates with a smart transmitter, sending glucose data to a mobile app every 5 minutes [3]

Core Insights - Recent market activity has shown significant gains among top performers, including GSI Technology, Beyond Meat, Replimune Group, and Alto Neuroscience, driven by technological advancements, strategic partnerships, and positive market developments [1] Company Summaries - **GSI Technology, Inc. (GSIT)**: Stock price increased by 149.80% to $12.69, attributed to breakthroughs in associative processing unit products and key contracts in networking and telecommunications, with a year-to-date stock climb of 62% [2][7] - **Beyond Meat, Inc. (BYND)**: Stock price rose by 127.42% to $1.46, driven by a short squeeze following a 56% drop due to a $1.5 billion debt-for-equity swap, reflecting a positive shift in consumer demand with a trading volume of 815,077,138 shares [3][7] - **Replimune Group, Inc. (REPL)**: Stock price experienced a 115.22% rise to $9.68, linked to the FDA's acceptance of its Biologics License Application resubmission for RP1, a treatment for advanced melanoma, with a PDUFA target action date set for April 10, 2026 [4] - **Alto Neuroscience, Inc. (ANRO)**: Stock price increased by 79.11% to $10.89, although the company is under investigation by Johnson Fistel, PLLP regarding potential claims on behalf of long-term shareholders related to fiduciary duties [5] Market Overview - The significant market activity among these companies reflects a dynamic environment with potential growth opportunities driven by strategic initiatives and technological advancements [6]

[Filing Information](index=1&type=section&id=Filing%20Information) [Company and Filing Details](index=1&type=section&id=Company%20and%20Filing%20Details) This section provides the foundational details of the Form 8-K filing, including the registrant's identity, jurisdiction, trading information, and confirmation of its non-emerging growth company status - The registrant is Senseonics Holdings, Inc., incorporated in Delaware, with Commission File Number 001-37717[1](index=1&type=chunk) - The registrant is not an emerging growth company[3](index=3&type=chunk) Trading Information | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock | SENS | NYSE American | [Current Report Items](index=2&type=section&id=Current%20Report%20Items) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Senseonics Holdings, Inc. announced business updates and preliminary, unaudited financial information for the quarter ended September 30, 2025, via a press release issued on October 6, 2025, which is furnished as Exhibit 99.1 - On October 6, 2025, Senseonics Holdings, Inc. issued a press release announcing business updates and preliminary, unaudited financial information for the quarter ended September 30, 2025[4](index=4&type=chunk) - The press release (Exhibit 99.1) is furnished with this Form 8-K and is not deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934[4](index=4&type=chunk)[5](index=5&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits accompanying the Form 8-K, primarily the press release containing the financial and business updates, and the interactive data for the cover page Exhibits | Exhibit Number | Description | | :------------- | :-------------------------------------------------- | | 99.1 | Press Release of Senseonics Holdings, Inc. dated October 6, 2025. | | 104 | Cover Page Interactive Data (embedded within the Inline XBRL document). | [Signatures](index=3&type=section&id=Signatures) The Form 8-K was officially signed on behalf of Senseonics Holdings, Inc. by its Chief Financial Officer, Rick Sullivan, on October 6, 2025 - The report was signed by Rick Sullivan, Chief Financial Officer of Senseonics Holdings, Inc., on October 6, 2025[10](index=10&type=chunk)

Core Insights - Senseonics Holdings, Inc. reported preliminary unaudited revenue of approximately $8.1 million for Q3 2025, marking a 91% increase compared to Q3 2024, driven by a 160% growth in new patients in the U.S. [2][10] - The company announced a reverse stock split at a ratio of 1:20, effective October 17, 2025, which will reduce the number of outstanding shares from approximately 816 million to about 41 million [3][5]. Financial Performance - The preliminary revenue of $8.1 million in Q3 2025 reflects significant growth, attributed to increased investments in direct-to-consumer marketing and the highest number of new patient starts in the company's history occurring in September 2025 [2][4]. - The company anticipates that the reverse stock split will not affect stockholders' ownership percentages significantly, aside from minor adjustments due to cash payments for fractional shares [6]. Business Strategy - Senseonics is focusing on enhancing its direct-to-consumer marketing efforts, which have led to increased awareness and adoption of its Eversense 365 continuous glucose monitoring system [4][8]. - The decision to bring the sales and marketing organization in-house is expected to bolster the company's ability to drive revenue and meet patient expectations [4]. Product Information - The Eversense CGM systems are designed for long-term glucose monitoring, with the Eversense 365 capable of continuous measurement for up to 365 days [9]. - The systems utilize a small sensor implanted under the skin, which communicates with a smart transmitter to provide real-time glucose data to users [8].

Group 1 - The call is focused on the Eversense 365 Commercial Update, indicating a significant update regarding the company's product and market performance [1] - Jeremy Feffer from Lifesci Advisors is leading the call, emphasizing the importance of forward-looking statements related to the company's future expectations and plans [2] - The company acknowledges the presence of risks and uncertainties that could affect actual results compared to the forward-looking statements made [3] Group 2 - Tim Goodnow, President and Chief Executive of Senseonics, is participating in the call, suggesting leadership involvement in discussing the company's strategic direction [4]

Summary of Eversense Three Sixty Five Commercial Update Call Company and Industry - **Company**: Senseonics - **Product**: Eversense three sixty five (CGM - Continuous Glucose Monitoring) - **Industry**: Diabetes care and medical devices Core Points and Arguments 1. **Commercialization Strategy Change**: Senseonics announced a memorandum of understanding with Ascensia to integrate the full CGM commercial organization back into Senseonics effective January 1, 2026, aiming for clearer focus and targeted resources to build the Eversense brand [4][5][6] 2. **Leadership Transition**: Brian Hansen, previously leading Ascensia's Eversense Commercial Operations, will become the new Chief Commercial Officer at Senseonics, bringing his leadership team to drive Eversense sales [5][6][12] 3. **Market Growth**: Eversense three sixty five has seen significant growth, with new patient starts in Q2 growing 79% year-over-year and weekly new patient shipments up nearly 50% in Q3 compared to Q2 [12][15] 4. **Record Performance**: August set records for the highest number of sensor insertions and new patient shipments in the history of Senseonics [12][13] 5. **Financial Implications**: The elimination of the Ascensia revenue share is expected to improve revenue by over 20% and gross profit margin to exceed 50% next year, with potential to reach 70% at scale [19][20] 6. **Investment in Growth**: Senseonics plans to fund additional investments in sales and marketing through improved revenue and a partnership with Hercules Capital for a non-dilutive debt facility of up to $100 million [19][20] 7. **Transition Plans**: The transition to full commercial rights is expected to be smooth, with minimal disruption for patients and providers, and is aligned with PHC's strategic focus [9][21] 8. **International Expansion**: The company is preparing for the launch of Eversense three sixty five in European markets, with activities expected to begin in Q4 upon receiving CE Mark approval [14][85] Other Important Content 1. **Patient-Centric Focus**: The integration aims to enhance patient experience and access to Eversense, with a commitment to improving the lives of people affected by diabetes [9][10] 2. **DTC Campaign Success**: The direct-to-consumer (DTC) campaign has shown promising results, with increased awareness and lead generation [53][80] 3. **Future Product Pipeline**: The transition will also support the upcoming launches of the Gemini and Freedom systems, expected in late 2026 and late 2027 respectively [22][25] 4. **Shareholder Commitment**: Ascensia, owning nearly 10% of Senseonics, intends to maintain its investment, indicating continued support for the company's growth [9][65] 5. **Operational Efficiency**: The integration of commercial and development organizations is expected to enhance operational efficiency and responsiveness to market needs [18][19] This summary encapsulates the key points discussed during the Eversense three sixty five Commercial Update Call, highlighting the strategic changes, growth metrics, financial implications, and future plans of Senseonics in the diabetes care market.

Core Viewpoint - Senseonics Holdings, Inc. is transitioning the commercialization and distribution of its Eversense 365 continuous glucose monitoring system from Ascensia Diabetes Care to itself, aiming for improved growth and operational efficiency [1][2][3]. Group 1: Transition Details - The transition will take effect on January 1, 2026, with Senseonics assuming global sales, marketing, and commercialization responsibilities [2]. - Brian Hansen, currently President of CGM at Ascensia, will join Senseonics as Chief Commercial Officer on the same date [2]. - The companies are collaborating to finalize the documentation for this transition [2]. Group 2: Strategic Rationale - The decision to bring Eversense commercialization in-house is driven by the need for strategic investment and dedicated commercial efforts to respond to market demands [3]. - Senseonics believes that unifying the Eversense business will accelerate growth and realize its full potential more effectively than under the current structure [3]. Group 3: Financial Implications - Senseonics has expanded its non-dilutive debt facility with Hercules Capital to $100 million to fund its commercial organization [1]. - The company anticipates immediate revenue improvement and gross margin expansion to 50% in 2026, with a target of over 70% gross margins at scale [4]. - For the full year 2025, Senseonics expects global net revenue to be approximately $34-38 million, with a projected doubling of its global patient base [5][6]. Group 4: Conference Call - A conference call is scheduled for September 4, 2025, at 8:00 A.M. Eastern Time to discuss the commercial transition [1][7].