Summary of Senseonics Conference Call Company Overview - **Company**: Senseonics - **Product**: Eversense Continuous Glucose Monitoring (CGM) System - **New Product Launch**: 365 Day CGM, designed for one-year use without the need for frequent sensor replacements [2][3] Key Points and Arguments Product Differentiation - The 365 Day CGM is a significant advancement over previous models (90-day and 180-day) and is designed to provide continuous monitoring for a full year [2] - Unique feature: No through-skin component, allowing for easier user experience post-insertion by a medical professional [2][3] - Calibration requirements have been reduced from daily to once a week, enhancing user convenience [5] Commercial Strategy - Transitioning to a direct-to-consumer (DTC) sales model starting January 1, 2026, to capture full revenue and improve margins [6][10] - The U.S. sales force will consist of 100 representatives, focusing on high-prescribing endocrinologists and diabetes centers [10] - Anticipated revenue growth due to the elimination of revenue sharing with Ascensia, which previously accounted for a 20% revenue reduction [11][12] Market Dynamics - The CGM market is valued at $13 billion, growing at a 20% CAGR, with only 10 million patients currently using CGM technology [25] - Senseonics aims to double its patient base from 6,000 to 12,000, indicating significant growth potential [25][27] Patient Retention and Growth - Historical retention rates show that 70%-75% of patients remain on their first sensor, with retention improving with subsequent sensors [19][20] - The company is focused on maintaining communication with patients to address any issues promptly [23] Direct-to-Consumer Campaign - The DTC campaign has shown success, with new patient growth up 160% and leads increasing by 300% [17][15] - The DTC budget is expected to remain between $10 million and $15 million, spread throughout 2026 [28] International Expansion - CE Mark approval for the 365 product is expected by the end of the year, with a planned launch in Europe after establishing a dedicated sales force [29][30] - The company faces challenges in international DTC marketing due to regulatory limitations, relying more on healthcare professional (HCP) sales [31] Pipeline Development - Upcoming products include Gemini, which will feature an internal battery for continuous data collection, and Freedom, which will integrate Bluetooth technology for type one diabetes management [34][35] - Clinical trials for Gemini and Freedom are anticipated to cost around $5 million each [40] Financial Outlook - The break-even point remains at approximately 50,000 patients, with expectations for increased profitability due to improved revenue recognition and margins from the direct sales model [43][44] - Recent insider purchases of shares indicate confidence in the company's growth trajectory and valuation [45] Additional Important Insights - The company is focused on pump integration and partnerships with other pump providers to enhance product offerings [42] - The transition from Ascensia to Senseonics' direct sales model is expected to streamline operations and improve financial performance [11][14] This summary encapsulates the key points discussed during the Senseonics conference call, highlighting the company's strategic direction, product innovations, market opportunities, and financial outlook.

Core Insights - Senseonics Holdings, Inc. is set to participate in the Stifel 2025 Healthcare Conference, indicating its active engagement in the healthcare investment community [1][2]. Company Overview - Senseonics is a medical technology company that specializes in developing and manufacturing long-term implantable continuous glucose monitoring (CGM) 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 fully implanted under the skin and communicates with a smart transmitter worn externally, providing glucose data to a mobile app every 5 minutes [3]. Event Details - The Stifel 2025 Healthcare Conference will take place on November 12, 2025, at 4:40 pm ET, featuring a fireside chat format and one-on-one meetings [2]. - Interested parties can access a live and recorded webcast of the presentation through the company's website [2].

GERMANTOWN, Md., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, has announced that as a decision in the best interest of the Company and its stockholders, it will transfer the listing of its common stock from the NYSE American to the Nasdaq Global Select Market (“Nasdaq”), effective after the market closes ...

分组1 - Senseonics Holdings reported a quarterly loss of $0.43 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.33, representing an earnings surprise of -30.30% [1] - The company posted revenues of $8.1 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 1.79%, and showing a significant increase from $4.26 million in the same quarter last year [2] - Senseonics has surpassed consensus revenue estimates three times over the last four quarters, but has only exceeded EPS estimates once in the same period [2] 分组2 - The stock has underperformed, losing approximately 36.1% since the beginning of the year, while the S&P 500 has gained 15.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.32 on revenues of $15.05 million, and for the current fiscal year, it is -$1.40 on revenues of $35.91 million [7] - The Zacks Industry Rank for Medical Info Systems is in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Data and Key Metrics Changes - In Q3 2025, net revenue grew by 90% to $8.1 million compared to $4.3 million in the prior year period, driven by Eversense 365 US revenue of $6.4 million and $1.7 million from outside the US [15][18] - Gross profit was $3.5 million, an increase of $7.5 million from the prior year, primarily due to improved margins on the 365-day product sales [17] - Net loss decreased to $19.5 million, or $0.43 loss per share, compared to a net loss of $24 million, or $0.77 loss per share in Q3 2024 [18] Business Line Data and Key Metrics Changes - The third quarter saw a 160% increase in new patient shipments year-over-year, contributing to the overall revenue growth [5] - New insertions increased nearly 150% year-over-year and more than 50% sequentially, reflecting accelerating adoption of Eversense 365 [6] - Approximately 60% of new patients in Q3 originated from direct-to-consumer (DTC) advertising, with 40% from healthcare provider (HCP) referrals [6] Market Data and Key Metrics Changes - The number of providers actively prescribing Eversense grew by more than 55% year-over-year, indicating broadening awareness and confidence in the 365-day system [7] - Eon Care accounted for approximately one quarter of all insertions nationwide, enhancing access and standardizing patient experience [8] Company Strategy and Development Direction - The company executed a memorandum of understanding with Ascensia Diabetes Care to reassume control of Eversense commercialization, allowing for better control over strategy and investments [4] - The CE Mark application for Eversense 365 in Europe was submitted in February, with expectations for approval before the end of 2025 [8] - The company anticipates gross margins to grow to roughly 50% in 2026 and reach approximately 70% at scale for the unified business [13][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, highlighting record new patient starts and the effectiveness of DTC marketing [24] - The company expects full-year 2025 global net revenue to be approximately $35 million, with a significant portion anticipated in Q4 due to new patient starts and reorders [19][20] - Management noted that cash utilization in 2025 is expected to be approximately $60 million, with a cash balance of $111.3 million as of September 30 [22] Other Important Information - The company is focused on expanding access to its unique system and advancing technology to simplify glucose testing for people with diabetes [13] - The transition from Ascensia is expected to enhance operational efficiency and improve margins [10][21] Q&A Session Summary Question: Can you discuss the growth opportunities in DTC? - Management noted a significant increase in switchers from existing CGM systems, with 90% of new patients coming from this group, primarily from Dexcom and Libre [28][29] Question: What is the expected timeline for the integration with Twist? - The first patients are expected to start in early Q1 2026, with a ramp-up anticipated later in the year [31][32] Question: How is the inserter network evolving? - The Eon network is crucial for expanding access, with a focus on training providers and increasing the number of inserters [36] Question: What is the status of private payers transitioning to bundled payment reimbursement? - Management expects continued transitions, with significant progress made in the first half of the year [40] Question: Can you provide an update on the CE Mark for Eversense 365? - The CE Mark application is in the final stages of review, with expectations for approval soon [72]

Financial Data and Key Metrics Changes - In Q3 2025, net revenue grew by 90% to $8.1 million compared to $4.3 million in the prior year period, driven by Eversense 365 US revenue of $6.4 million and $1.7 million from outside the US [17][20][24] - Gross profit was $3.5 million, an increase of $7.5 million from the prior year, primarily due to improved margins on 365-day product sales [18][19] - Net loss decreased to $19.5 million, or $0.43 loss per share, compared to a net loss of $24 million, or $0.77 loss per share in Q3 2024 [20] Business Line Data and Key Metrics Changes - Revenue growth was driven by a 160% increase in new patient shipments year-over-year, with new insertions increasing nearly 150% year-over-year [5][6] - Approximately 60% of new patients in Q3 originated from direct-to-consumer (DTC) advertising, with 40% from healthcare provider (HCP) referrals [6][8] - The number of providers actively prescribing Eversense grew by more than 55% year-over-year, with 75 new trained inserters added, representing a 140% increase from the same time last year [8][9] Market Data and Key Metrics Changes - The installed base of Eversense grew over 150% year-over-year and nearly 40% sequentially, reflecting accelerating adoption among patients and providers [6][8] - The DTC campaign led to a 300% increase in patient leads year-over-year and an 85% increase sequentially [5][6] - The company anticipates that the transition from Ascensia will allow it to recognize 100% of revenues, which is expected to positively impact future revenue growth [18][20] Company Strategy and Development Direction - The company executed a memorandum of understanding with Ascensia Diabetes Care to reassume control of Eversense commercialization, allowing for greater control over strategy and investments [4][10] - The company plans to continue investing in DTC marketing, primarily through social media, to drive demand and awareness [6][8] - Future product development includes the anticipated CE Mark approval for Eversense 365 in Europe, expected before the end of 2025, and the launch planned for the first half of 2026 [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, citing significant new patient additions and top-line growth due to expanding awareness and adoption of Eversense 365 [25][26] - The company expects full-year 2025 global net revenue to be approximately $35 million, with a strong Q4 anticipated due to new patient starts and reorders from first US 365 patients [20][22] - Management highlighted margin improvements, projecting gross profit margins to grow to roughly 50% in 2026 and approximately 70% at scale [14][23] Other Important Information - The company is focused on expanding access to its unique system and advancing technology to simplify glucose testing for people with diabetes [14][25] - The transition to resume control of Eversense commercialization is progressing well, with nearly all employees from Ascensia's US CGM business electing to join Senseonics [11][12] Q&A Session Summary Question: Follow-up on growth opportunities in DTC - Management noted a significant increase in switchers from existing CGM systems, with 90% of new patients coming from this group, primarily from Dexcom and Libre [30][31] Question: Integration with Twist insulin delivery system - The first patients are expected to start in early Q1 2026, with a ramp-up anticipated later in the year [32][34] Question: Update on inserter network evolution and reimbursement - The EonCare model is expanding, with a focus on primary care and Medicare patients, and the company is seeing growth in providers interested in institutionalizing the insertion process [38][40] Question: Update on private payers and bundled payment reimbursement - Management expects continued transitions among private payers, with significant progress made in the first half of the year [42][44] Question: Details on DTC marketing spend and its effectiveness - Increased DTC spending has shown a direct correlation with patient acquisition, though there is a need for education and conversion [62][63] Question: Revenue guidance and inventory dynamics for 2026 - The company anticipates some inventory dynamics affecting revenue recognition in 2026, but remains on track for patient growth [55][66]

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]