Financial Data and Key Metrics Changes - In Q1 2025, net revenue grew 24% to $6.3 million compared to $5 million in the prior year period [18] - U.S. revenue for Q1 was $4.5 million, while revenue outside the U.S. was $1.8 million [18] - Gross profit increased to $1.5 million from $300,000 in the prior year, driven by increased margins on the Eversense three sixty five product [21] - Net loss decreased to $14.3 million or $0.02 loss per share from a net loss of $18.9 million or $0.03 loss per share in the prior year [23] Business Line Data and Key Metrics Changes - The Eversense three sixty five continuous glucose monitor (CGM) is positioned as a significant product, with a focus on integration with automated insulin delivery systems [7][9] - The company is working on expanding its Eversense three sixty five offering and has filed for CE Mark approval, anticipating a European launch in the second half of 2025 [12] - The consignment program continues to show strong utilization, contributing approximately 13% of revenue in Q1 [20] Market Data and Key Metrics Changes - The company is seeing positive responses from both U.S. and international markets, with expectations for significant growth in patient adoption [36] - The Medicare reimbursement update is expected to facilitate broader adoption of the Eversense three sixty five sensor [40] - The company anticipates doubling its global patient base in 2025 compared to 2024, with revenue expected to be approximately one-third in the first half and two-thirds in the second half of the year [26] Company Strategy and Development Direction - The company aims to transform diabetes care through technological advancements and partnerships, focusing on the integration of its CGM with insulin delivery systems [7][9] - Collaborations with companies like Sequel and Sweet Spot are part of the growth strategy to enhance patient care and streamline monitoring processes [9][10] - The company plans to continue developing its pipeline products, GEMINI and Freedom, to improve patient experience and expand its market offerings [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the launch metrics and revenue numbers, indicating a positive trajectory for the Eversense three sixty five product [29] - The company is closely monitoring the evolving tariff situation and expects to mitigate any negative impacts on gross profit margins [27] - Full-year 2025 global net revenue is projected to be approximately $34 million to $38 million, reflecting confidence in the product's market acceptance and growth potential [25] Other Important Information - The company received gross proceeds of approximately $27 million from the sale of common stock, extending its cash runway into mid-2026 [24] - As of March 31, 2025, cash and cash equivalents totaled $64.6 million, with total principal debt outstanding reduced to $35 million [23] Q&A Session Summary Question: Guidance despite Mercy contract pause - Management noted that early launch metrics for Eversense three sixty five are positive, and while the Mercy contract pause is a factor, the overall trajectory remains strong [34][36] Question: Direct-to-consumer (DTC) efforts - The company is focusing on social media channels like Facebook, TikTok, and Instagram for DTC marketing, targeting insulin users, particularly in the Medicare population [38][40] Question: Twist integration timeline - Management confirmed that integration work is ongoing, with verification and validation of the system expected to be completed by Q3 [44][46] Question: Update on commercial plans converting to three sixty five sensor - Management expects the majority of commercial plans to convert by the end of the year, with significant progress already made [47][48]

Financial Data and Key Metrics Changes - In Q1 2025, net revenue grew 24% to $6.3 million compared to $5 million in the prior year period [16] - U.S. revenue for Q1 was $4.5 million, while revenue outside the U.S. was $1.8 million [16] - Gross profit increased to $1.5 million from $300,000 in the prior year, driven by improved margins on the Eversense three sixty five product [19] - Net loss decreased to $14.3 million or $0.02 loss per share, compared to a net loss of $18.9 million or $0.03 loss per share in Q1 2024 [21] - Cash, restricted cash, and cash equivalents totaled $64.6 million as of March 31, 2025 [21] Business Line Data and Key Metrics Changes - The Eversense three sixty five product is expected to be the single product offering by the end of 2025, enhancing global supply chain synergies [11] - Approximately 13% of revenue flowed through the office consignment program, with over 100 healthcare providers participating [18] - The company is transitioning reimbursement from 180 days to 365 days for Eversense, with many payers already transitioning their coverage [12] Market Data and Key Metrics Changes - The company anticipates doubling the global patient base in 2025 compared to 2024, with revenue expected to be approximately one-third in the first half and two-thirds in the second half of the year [23] - The European launch of Eversense three sixty five is planned for the second half of 2025, pending regulatory approval [11][22] Company Strategy and Development Direction - The company is focused on transforming diabetes care through technological advancements, including collaborations with Sequel and Sweet Spot [6][7] - The integration of Eversense three sixty five with Sequel's Twist automated insulin delivery system is seen as a significant step forward [6] - Continued development of pipeline products, GEMINI and Freedom, is a priority, with plans to submit an IDE for a pivotal study by year-end [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch metrics for Eversense three sixty five, indicating strong interest and conversion rates [32] - The company expects to mitigate any negative impacts from tariffs on gross profit margins through operational changes and industry exemptions [24] - Full-year gross margins are projected to be between 25% and 30%, with expectations for steady increases each quarter in 2025 [24] Other Important Information - The company received gross proceeds of approximately $27 million from the sale of common stock, extending its cash runway into mid-2026 [22] - All preferred stock was converted into common stock, impacting the diluted earnings per share calculation [21] Q&A Session Summary Question: Guidance despite Mercy contract pause - Management noted that early launch metrics for Eversense three sixty five are positive, and while the Mercy contract pause is a concern, the overall trajectory remains strong [30][32] Question: Direct-to-consumer (DTC) efforts - The company is focusing on social media channels like Facebook, TikTok, and Instagram for DTC marketing, targeting insulin users, particularly in the Medicare population [36][38] Question: Twist integration timeline - Integration work is ongoing, with most efforts focused on verification and validation of the integrated system, expected to be completed by Q3 [41][43] Question: Update on commercial plans for reimbursement - Management expects the majority of commercial plans to convert to the 365-day sensor by the end of the year, with significant progress already made [44][45]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission file number: 001-37717 Senseonics Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware ...

[Filing Information](index=1&type=section&id=Filing%20Information) This section details the foundational information of the Form 8-K filing, including registrant identity, incorporation, and stock trading specifics [Registrant and Filing Details](index=1&type=section&id=Registrant%20and%20Filing%20Details) This section provides foundational details of the Form 8-K filing, including registrant identity, incorporation state, and stock trading specifics - The filing is a Form 8-K for **Senseonics Holdings, Inc.**, dated May 8, 2025[1](index=1&type=chunk) | Detail | Value | | :--- | :--- | | Registrant Name | SENSEONICS HOLDINGS, INC. | | State of Incorporation | Delaware | | Commission File Number | 001-37717 | | Principal Executive Office | 20451 Seneca Meadows Parkway, Germantown, MD 20876-7005 | | Telephone Number | (301) 515-7260 | | Class of Stock | Trading Symbol | Exchange | | :--- | :--- | :--- | | Common Stock | SENS | NYSE American | - The registrant is not an emerging growth company[3](index=3&type=chunk) [Item 2.02. Results of Operations and Financial Condition.](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition.) This section details the announcement of Senseonics Holdings, Inc.'s financial results for the quarter ended March 31, 2025 [Announcement of Financial Results](index=2&type=section&id=Announcement%20of%20Financial%20Results) Senseonics Holdings, Inc. announced its financial results for the quarter ended March 31, 2025, through a press release furnished as Exhibit 99.1 - **Senseonics Holdings, Inc.** announced financial results for the quarter ended March 31, 2025, via a press release on May 8, 2025[4](index=4&type=chunk) - The press release (Exhibit 99.1) details a conference call, corporate highlights, and outlook[4](index=4&type=chunk) - Information in this 8-K and Exhibit 99.1 is furnished, not 'filed,' under Section 18 of the Securities Exchange Act of 1934[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 filing, including the press release and interactive data [List of Exhibits](index=2&type=section&id=List%20of%20Exhibits) This section details the exhibits accompanying the Form 8-K filing, specifically identifying the press release and interactive data | Exhibit Number | Description | | :--- | :--- | | 99.1 | Press Release of Senseonics Holdings, Inc. dated May 8, 2025 | | 104 | Cover Page Interactive Data (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=SIGNATURES) This section formally certifies the report on behalf of Senseonics Holdings, Inc. by its Chief Financial Officer [Report Certification](index=3&type=section&id=Report%20Certification) The report is formally signed by Rick Sullivan, Chief Financial Officer of Senseonics Holdings, Inc., on May 8, 2025 - The report was signed on **May 8, 2025**, by **Rick Sullivan**, Chief Financial Officer of **Senseonics Holdings, Inc.**[9](index=9&type=chunk)

Core Insights - Senseonics Holdings, Inc. reported a first quarter revenue of $6.3 million, representing a year-over-year growth of 24% from $5.0 million in Q1 2024 [4] - The company has partnered with Sequel to integrate its twiist™ automated insulin delivery system with the Eversense® 365 continuous glucose monitor, with a launch expected in Q3 2025 [1][9] - The company aims to improve access and flexibility for diabetes patients through its Eversense platform, with significant milestones achieved in reimbursement and product development [3] Financial Performance - Total revenue for Q1 2025 was $6.3 million, with U.S. revenue at $4.5 million and international revenue at $1.8 million, compared to $3.7 million and $1.3 million respectively in Q1 2024 [4] - Gross profit for Q1 2025 was $1.5 million, up from $0.3 million in Q1 2024, driven by increased margins on the 365-day product [5] - The net loss for Q1 2025 was $14.3 million, a reduction from a net loss of $18.9 million in Q1 2024, attributed to improved gross profit margins and reduced R&D costs [7] Expense Management - Selling, general and administrative expenses decreased by $0.4 million year-over-year to $7.7 million, primarily due to lower personnel costs and consulting fees [5] - Research and development expenses decreased by $3.1 million year-over-year to $7.3 million, mainly due to reduced spending on clinical studies following the completion of trials for the 365-day product [6] Future Outlook - The company expects full-year 2025 global net revenue to be approximately $34-38 million, anticipating a doubling of its global patient base [8] - Gross margins are projected to increase throughout 2025, with expectations of reaching between 25% and 30% for the full year [10] - Cash used in operations for 2025 is expected to be between $50 million and $60 million [10]

Core Viewpoint - Senseonics Holdings, Inc. is set to release its first quarter 2025 financial results on May 8, 2025, after market close, indicating ongoing developments in its financial performance and product offerings [1]. Group 1: Financial Results Announcement - The company will announce its first quarter 2025 financial results after market close on May 8, 2025 [1]. - A conference call to discuss the financial performance will take place at 4:30 p.m. (Eastern Time) on the same day, which will also be available via webcast [2]. Group 2: Company Overview - Senseonics is a medical technology company focused on developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems for diabetes management [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 - Sequel Med Tech and Senseonics have announced a commercial development agreement to integrate the twiist Automated Insulin Delivery (AID) System with Senseonics' Eversense 365 CGM system, making it the first AID system compatible with a one-year CGM [2][3][5] - The integration aims to enhance diabetes management for individuals with type 1 diabetes by providing more tools for glucose control, convenience, and personalization [3][5] - The twiist AID System is designed to automatically adjust insulin delivery based on real-time sensor readings, offering flexibility in diabetes management [6][8] Company Overview - Sequel Med Tech is focused on developing innovative insulin delivery technologies and aims to simplify disease management through advanced systems [8] - Senseonics specializes in long-term implantable glucose monitoring systems, with the Eversense 365 being the only implantable CGM that offers continuous monitoring for up to one year [9][11] - The collaboration between Sequel and Senseonics represents a significant advancement in diabetes care, providing users with a comprehensive solution that combines advanced pump, algorithm, and sensor technologies [4][5] Product Details - The twiist AID System is FDA-cleared for individuals aged six and up with type 1 diabetes, allowing for precise insulin delivery tailored to individual needs [6] - Eversense 365 received FDA clearance as an integrated continuous glucose monitoring system, enabling its use within automated insulin delivery systems [5][10] - The integration of twiist and Eversense 365 is expected to be commercially available in Q3 2025, enhancing the options available for diabetes management [5][6]

Core Viewpoint - Senseonics Holdings (SENS) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Senseonics indicates an expected earnings of -$0.10 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 16.7% [9]. - Over the past three months, the Zacks Consensus Estimate for Senseonics has increased by 17%, showcasing a trend of rising earnings estimates [9]. Zacks Rating System - The Zacks rating system is based solely on a company's changing earnings picture, which is tracked through EPS estimates from sell-side analysts [2]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) to Zacks Rank 5 (Strong Sell), and has a strong historical performance, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [8]. Market Implications - The upgrade to Zacks Rank 2 positions Senseonics in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11]. - Rising earnings estimates and the corresponding rating upgrade imply an improvement in Senseonics' underlying business, which could lead to increased buying pressure and a higher stock price [6][4].

Financial Data and Key Metrics Changes - In Q4 2024, net revenue was $8.3 million, an increase from $8 million in the prior year period [27] - For the full year 2024, total revenue was $22.5 million compared to $22.4 million in 2023, with US revenue at $15.3 million and revenue outside the US at $7.2 million [35] - Net loss for Q4 2024 was $15.5 million, a decrease from $17.2 million in Q4 2023, primarily due to improved gross profit margins [34] - Full year net loss was $78.6 million, compared to $60.4 million in 2023, with the increase attributed to reduced gains from note exchanges and derivative fair value changes [39] Business Line Data and Key Metrics Changes - The Eversense 365 product launch has seen a 56% increase in the patient base to approximately 6,000 global patients in 2024 [23] - The number of annual US Eversense prescribers increased by 73% to over 2,400 [24] - Approximately 81% of the patient base switched from other continuous glucose monitors (CGMs) [25] Market Data and Key Metrics Changes - US revenue for Q4 2024 was $6.2 million, while revenue outside the US was $2.1 million [27] - The company anticipates launching Eversense 365 in Europe in the second half of 2025, following CE Mark approval [12] Company Strategy and Development Direction - The company is focused on expanding its product pipeline, including the Gemini and Freedom systems, which will enhance patient experience [13][14] - Partnerships with health systems like Mercy Health are aimed at increasing access to Eversense for patient populations [16] - The company plans to commercialize Eversense 365 in Europe and continue building on the technology platform [47] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in 2025, highlighting the successful initial launch of Eversense 365 as a significant catalyst [46] - The CGM market is viewed as an exciting space in medical devices, with a large opportunity to simplify diabetes management [48] - The company expects full year 2025 global net revenue to be approximately $34 million to $38 million, with a focus on transitioning US patients to Eversense 365 [42] Other Important Information - The company has simplified its capital structure, repaying $20.4 million in convertible notes and converting preferred stock into common stock [40][41] - Cash, restricted cash, and cash equivalents totaled $74.9 million as of December 31, 2024 [39] Q&A Session Summary Question: What should we expect when taking Eversense 365 OUS? - Management anticipates a more gradual inventory stocking in Europe compared to the US [53] Question: What are the early signs of 365-day insertions in the Mercy system? - There is excitement around the 365 product, with a focus on expanding to primary care for Type 2 patients [55] Question: Clarification on prescriber numbers? - The 2,400 prescribers represent an annual number, while over 1,000 was since launch [62] Question: Revenue growth expectations from international versus US? - Most growth is expected from the US, with significant increases anticipated from the European launch in the second half of the year [64] Question: Update on Medicare reimbursement efforts? - Reimbursement is available for Medicare patients, with ongoing work on pricing expected to resolve in the next quarter [74] Question: OpEx cadence throughout the year? - SG&A expenses are expected to be linear across quarters, with slight increases due to sales commissions from the consignment program [81]

Financial Data and Key Metrics Changes - In Q4 2024, net revenue was $8.3 million, an increase from $8 million in the prior year period [27] - For the full year 2024, total revenue was $22.5 million compared to $22.4 million in 2023, with US revenue at $15.3 million and revenue outside the US at $7.2 million [35] - Net loss for Q4 2024 was $15.5 million, a decrease from $17.2 million in Q4 2023, primarily due to improved gross profit margins [34] - Full year net loss was $78.6 million, compared to $60.4 million in 2023, with the increase attributed to reduced gains from note exchanges and changes in derivative fair value [39] Business Line Data and Key Metrics Changes - The patient base increased by 56% to approximately 6,000 global patients in 2024, exceeding the target growth of 50% [23] - The number of annual US Eversense prescribers increased by 73% to over 2,400 [24] - Approximately 81% of the patient base switched from other continuous glucose monitors (CGMs) [24] Market Data and Key Metrics Changes - US revenue for Q4 2024 was $6.2 million, while revenue outside the US was $2.1 million [27] - The company anticipates launching Eversense 365 in Europe in the second half of 2025, following the CE Mark approval [12] Company Strategy and Development Direction - The company plans to commercialize Eversense 365 in Europe and continue developing the Gemini and Freedom systems [47] - Focus on expanding relationships with health systems and accountable care organizations to increase access to Eversense [16] - The company is working on transitioning US reimbursement from Eversense E3 to Eversense 365, particularly for the Medicare segment [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in 2025, highlighting the successful initial launch of Eversense 365 as a significant catalyst [46] - The CGM market is viewed as an exciting space with a large opportunity for growth [48] - The company expects full year 2025 global net revenue to be approximately $34 million to $38 million, with a focus on transitioning US patients to Eversense 365 [42] Other Important Information - Gross profit for Q4 2024 was $4 million, an increase from $1.1 million in the prior year period, driven by increased margins on the 365-day product [32] - Research and development expenses for 2024 decreased by $7.6 million from 2023, primarily due to the completion of 365-day product trials [38] - The company received gross proceeds of approximately $27 million from the sale of common stock, extending its cash runway into mid-2026 [41] Q&A Session Summary Question: What should we expect when taking Eversense 365 OUS? - Management anticipates a more gradual inventory stocking in Europe compared to the US [53] Question: What are the observations from the Mercy system regarding 365-day insertions? - There is excitement around the 365 product, with a focus on expanding to primary care physicians to reach more Type 2 patients [55] Question: Clarification on the number of prescribers in the US? - The 2,400 prescribers represent an annual number, while the previous figure was since launch [62] Question: How much revenue growth is expected from international versus the US? - Most growth is expected to come from the US, with significant increases anticipated upon the launch of the 365-day product in Europe [64] Question: Update on reimbursement efforts, especially at Medicare? - Reimbursement is available for Medicare patients, with ongoing work on pricing expected to be resolved in the next quarter [74] Question: Details on the cadence of operating expenses throughout the year? - SG&A expenses are expected to be linear across quarters, with slight increases due to sales commissions from the consignment program [81]