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SENS Stock Up as Eversense 365 Enters AID Market With twiist System
ZACKS· 2026-01-09 16:55
Key Takeaways SENS launched Eversense 365 with twiist, the first one-year implantable CGM integrated with an AID system.The SENS integration reduces sensor changes while enabling automated, real-time insulin dosing for users.SENS said first commercial patients are using the system, with broad availability expected by March 2026.Senseonics Holdings, Inc. (SENS) recently reached an important commercialization milestone with the launch of its Eversense 365 continuous glucose monitor (CGM) integrated with the t ...
Senseonics(SENS) - 2025 Q3 - Earnings Call Transcript
2025-11-05 22:32
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]
Senseonics(SENS) - 2025 Q3 - Earnings Call Transcript
2025-11-05 22:30
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]
Senseonics Holdings, Inc. Reports Third Quarter Financial Results
Globenewswire· 2025-11-05 21:05
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].
Senseonics Holdings, Inc. Schedules Third Quarter 2025 Earnings Release and Conference Call for November 5, 2025 at 4:30 P.M. Eastern Time
Globenewswire· 2025-10-22 20:05
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]
Senseonics Holdings, Inc. (SENS) Eversense 365 Commercial Update Call (Transcript)
Seeking Alpha· 2025-09-04 15:23
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]
Senseonics Signs Memorandum of Understanding with Ascensia Diabetes Care to Take Over Commercialization and Distribution of Eversense 365
Globenewswire· 2025-09-03 21:17
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].
Senseonics(SENS) - 2025 Q2 - Earnings Call Transcript
2025-08-06 21:30
Financial Data and Key Metrics Changes - In Q2 2025, net revenue grew 37% to $6.6 million compared to $4.9 million in the prior year period, driven by new Eversense three sixty five insertions [22][28] - Gross profit for Q2 2025 was $3.1 million, an increase of $2.8 million from the prior year, primarily due to increased margins on the three sixty five day product and a one-time gain of $700,000 from VAT recoveries [26][27] - Net loss decreased to $14.5 million or $0.02 loss per share in Q2 2025, compared to a net loss of $20.3 million or $0.03 loss per share in Q2 2024 [27][28] Business Line Data and Key Metrics Changes - New patient starts for Eversense increased by 79% year-over-year and 37% from Q1 2025, with leads more than doubling compared to the prior year [6][8] - The consignment channel accounted for over 40% of revenue in Q2 2025, with revenue recognized at the time of procedure [25][26] - The average selling prices in the consignment channel are approximately two times the ASPs through the Ascensia direct shipment channel [26] Market Data and Key Metrics Changes - U.S. revenue for Q2 2025 was $4.9 million, while revenue outside the U.S. was $1.7 million [22] - The company expects to double the global patient base in 2025 compared to 2024, with the majority of revenue expected in Q4 due to new patient starts and reorders [28][29] Company Strategy and Development Direction - The company aims to enhance Eversense awareness and adoption through increased direct-to-consumer (DTC) marketing and expanding the EON Care network [4][5] - Plans include launching Eversense three sixty five in Europe later this year and collaborating with other companies to improve market presence [9][10] - The company is focused on developing the Gemini and Freedom systems, targeting a U.S. submission for Gemini in mid-2026 and a launch for Freedom about a year after Gemini [15][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth of Eversense, with expectations for increased patient starts and reorders as the first three sixty five adopters approach their next insertions [7][29] - The company anticipates full-year 2025 global net revenue to be approximately $34 million to $38 million, considering various factors including regulatory approval timelines and marketing spending [28][30] - Management is monitoring the impact of tariffs and expects to mitigate negative effects while maintaining favorable gross profit margins [30] Other Important Information - The company raised approximately $78 million in gross proceeds during Q2 2025, which will support ongoing initiatives and product launches [18][20] - A reverse stock split is being considered to facilitate broader investment opportunities and inclusion in indices with stock price requirements [21][22] Q&A Session Summary Question: Retention rates for Eversense - Management indicated that historical retention rates are around 75% from sensor one to two, increasing to about 85% from sensor two to three, and about 95% from sensor three and beyond [36][37] Question: Consignment channel revenue contribution - The consignment channel is expected to continue increasing as a percentage of total revenue, supported by Medicare pricing and EON Care efforts [41][42] Question: Mix of diabetics using Eversense - Currently, approximately 75% of patients using Eversense are type 2 diabetics, reflecting a shift from the initial focus on type 1 patients [47][48] Question: EON Care revenue contribution - EON Care services contribute low single-digit percentages to revenue, but this is expected to grow as the network expands [53] Question: Commercialization of the Twist pump - The company plans significant co-marketing efforts with Sequel for the Twist pump, with a formal development agreement in place [56][57] Question: CMS proposal for competitive bidding - Management confirmed that Eversense is compensated as a medical benefit under Medicare and will not be part of the competitive bidding process [66][67] Question: Timing for EON Care benefits - The company currently has around 40 professionals in the EON Care network, with plans to increase this to 50 in the next few months and double that by 2026 [68][69]
Senseonics Holdings, Inc. Reports Second Quarter Financial Results
Globenewswire· 2025-08-06 20:05
Core Insights - Senseonics Holdings, Inc. reported a 79% increase in new patient starts in the U.S. compared to the previous year, indicating strong market demand for its Eversense 365 continuous glucose monitoring system [1][9]. Financial Performance - Total revenue for Q2 2025 was $6.6 million, a 37% increase from $4.9 million in Q2 2024. U.S. revenue was $4.9 million, up from $3.0 million, while international revenue decreased slightly to $1.7 million from $1.9 million [4][9]. - Gross profit for Q2 2025 was $3.1 million, significantly higher than $0.3 million in Q2 2024, driven by improved margins on the Eversense 365 product and a one-time recovery of previously expensed value-added tax [5]. - The net loss for Q2 2025 was $14.5 million, or $0.02 per share, an improvement from a net loss of $20.3 million, or $0.03 per share, in Q2 2024, primarily due to better gross profit margins and reduced R&D costs [8][9]. Operational Highlights - The company expanded its direct-to-consumer advertising campaign, resulting in a 50% increase in leads during the first month compared to the previous three-month average [9]. - Senseonics completed the transition of providers to its Eon Care network, now including 38 providers to enhance patient access to insertions [9]. - The company entered a commercial development agreement with Sequel Med Tech to integrate its automated insulin delivery system with Eversense 365, with a launch expected in Q4 2025 [9]. Future Outlook - For the full year 2025, Senseonics expects global net revenue to be approximately $34-38 million, anticipating a doubling of its global patient base. Revenue generation is expected to be skewed towards the second half of the year [10]. - Gross margins are projected to increase throughout 2025, with expected margins between 32.5% and 37.5% for the full year [10].
Senseonics Holdings, Inc. Schedules Second Quarter 2025 Earnings Release and Conference Call for August 6, 2025 at 4:30 P.M. Eastern Time
Globenewswire· 2025-07-16 20:05
Company Overview - Senseonics Holdings, Inc. 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 worn externally, sending glucose data to a mobile app every 5 minutes [3] Financial Results Announcement - Senseonics plans to release its second quarter 2025 financial results after market close on August 6, 2025 [1] - A conference call to review the company's performance for the second quarter 2025 will take place at 4:30 p.m. (Eastern Time) on the same day, with a webcast available on the company's website [2]