GERMANTOWN, Md., Oct. 16, 2024 (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, today announced it will host a virtual KOL event on Friday, October 25, 2024 at 11:00am ET. To register, click here. The event will feature David T. Ahn, MD, and endocrinologist and Chief of Diabetes Services at Hoag Medical Group, and Jeff C ...

Senseonics' Eversense 365 is approved in the US as an integrated continuous glucose monitoring (iCGM) system for people with Type 1 and Type 2 diabetes aged 18 and older Commercial launch by Ascensia Diabetes Care underway with a new campaign to highlight the unique benefits of having just one CGM for one full year GERMANTOWN, Md. and ST. LOUIS, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American: SENS) ("Senseonics" or the "Company"), a medical technology company focused on the devel ...

Senseonics Holdings, Inc. (SENS) , along with Ascensia Diabetes Care, announced the receipt of the FDA's clearance for the next-generation Eversense 365 continuous glucose monitoring (CGM) system for people with Type 1 and Type 2 diabetes aged 18 years and above. Eversense 365 has been cleared as an integrated CGM (iCGM) system, indicating that it can integrate with compatible medical devices, including insulin pumps, as part of an automated insulin delivery system. Ascensia, a subsidiary of PHC Holdings Co ...

GERMANTOWN, Md., Sept. 06, 2024 (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, today announced plans to participate in the upcoming H.C. Wainwright 26th Annual Global Investment Conference, being held in New York, NY. Management is scheduled to participate in the H.C. Wainwright 26th Annual Global Investment Conference ...

Senseonics Holdings, Inc. (NYSE:SENS) Q2 2024 Earnings Conference Call August 8, 2024 4:30 PM ET Company Participants Philip Taylor - Gilmartin Group, IR Tim Goodnow - President and CEO Rick Sullivan - CFO Mukul Jain - Chief Operating Officer Conference Call Participants Operator Good afternoon, everyone, and welcome to the Senseonics Second Quarter 2024 Earnings Conference Call. All participants will be in a listen-only mode. [Operator Instructions]. After today's presentation, there will be an opportunity ...

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 June 30, 2024 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 ...

Revenue and Growth - Generated revenue of $4.9 million in Q2 2024, representing an 18% growth compared to the prior year period[2] - U.S. revenue was $3.0 million in Q2 2024, up from $1.8 million in Q2 2023, while international revenue was $1.9 million, down from $2.3 million in the prior year period[3] - Total revenue for June 2024 increased to $4.865 million, up from $4.126 million in June 2023[11] - Net revenue from related parties rose to $4.087 million in June 2024, compared to $3.689 million in June 2023[11] - Full-year 2024 global net revenue is expected to be in the range of $22 million to $24 million, with U.S. new patient starts projected to more than double and the global installed base to increase by approximately 50% compared to 2023[7] Profit and Loss - Gross profit decreased to $0.3 million in Q2 2024 from $0.4 million in Q2 2023, primarily due to increased fixed manufacturing costs[3] - Gross profit for June 2024 decreased to $0.298 million from $0.417 million in June 2023[11] - Net loss was $20.3 million in Q2 2024, slightly improved from $20.4 million in Q2 2023, driven by reduced R&D expenses[4] - Operating loss for June 2024 was $19.493 million, slightly improved from $19.868 million in June 2023[11] - Net loss for June 2024 was $20.287 million, compared to $20.423 million in June 2023[11] - Total comprehensive loss for June 2024 was $20.292 million, slightly better than $20.323 million in June 2023[11] - Basic net loss per common share was $0.03 in June 2024, improved from $0.04 in June 2023[11] - Diluted net loss per common share was $0.03 in June 2024, improved from $0.04 in June 2023[11] Cash and Financial Position - Cash, cash equivalents, short-term investments, and restricted cash totaled $84.9 million as of June 30, 2024, with outstanding indebtedness of $56.2 million[4] Research and Development - Research and development expenses dropped to $10.8 million in June 2024 from $12.83 million in June 2023[11] - Began first-in-human testing for the Gemini System, a fully implantable self-powering system for type 2 diabetes patients[2] Product Development and Launches - The 365-day Eversense system is under FDA review, with a planned product launch in Q4 2024[2] - Collaboration with Mercy healthcare system aims for large-scale implementation of Eversense and remote patient monitoring services, with initial insertions planned for Q3 2024[2] - Established Eon Care Services to provide Eversense insertion procedures and training, supporting expanded access to the product[2] Share Information - Basic weighted-average shares outstanding increased to 616,585,664 in June 2024 from 567,125,022 in June 2023[11]

Financial Data and Key Metrics - Q1 2024 total revenue was $5.1 million, representing 22% growth compared to the prior year period [18] - U S revenue for Q1 2024 was $3 7 million, while revenue outside the U S was $1 4 million [18] - Gross profit in Q1 2024 was $0 3 million, a decrease of $0 1 million from the prior year period, primarily due to higher fixed manufacturing costs [85] - Q1 2024 selling, general and administrative expenses were $8 1 million, an increase of $0 4 million compared to the prior year period, driven by corporate, legal, and patent expenses [22] - Operating loss for Q1 2024 was $18 2 million, compared to $19 7 million in Q1 2023, due to decreases in R&D expenses [22] - Total net loss for Q1 2024 was $18 9 million, or a $0 03 loss per share, compared to a net income of $1 3 million in Q1 2023 [98] - Cash, cash equivalents, and short-term investments totaled $99 1 million as of March 31, 2024, with debt and accrued interest at $55 9 million [98] Business Line Data and Key Metrics - The company is advancing its Eversense CGM system, with a focus on Type 2 patients on basal insulin, who historically have lower adoption rates of advanced technologies [2] - The Eversense RPM program aims to provide comprehensive diabetes management, combining CGM with remote patient monitoring to optimize care [6][19] - The company is collaborating with Mercy, a leading healthcare system, to implement a diabetes population management program using Eversense, targeting 30,000 patients across four states [42][51] - The company is working on a next-generation 365-day Eversense product, with a 510(k) submission filed with the FDA, aiming for a Q4 2024 launch [45][94] Market Data and Key Metrics - The company estimates that less than one quarter of patients eligible for CGM are currently using one, indicating significant growth potential [7] - The U S market remains a key focus, with Q1 2024 sales totaling $3 7 million, while international sales were $1 4 million [18] - The collaboration with Mercy is expected to drive growth, with a controlled launch in the St Louis metro area in July 2024, followed by a broader rollout in Q4 [8] Company Strategy and Industry Competition - The company is focusing on integrating Eversense into large health systems and accountable care organizations, leveraging its iCGM designation and RPM program to differentiate itself [14][17] - The iCGM designation allows Eversense to integrate with insulin pumps, positioning it as a strong competitor in the automated insulin delivery market [83][106] - The company is exploring partnerships with insulin pump manufacturers to further enhance its market position [20][72] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the growth potential of Eversense, particularly with the upcoming 365-day product launch and the RPM program [13][46] - The company expects Q2 2024 revenue to be consistent with Q1, with full-year guidance to be provided at the upcoming ADA conference [35][71] - Management highlighted the importance of the Mercy collaboration as a key growth catalyst, with the potential to replicate the program across other health systems [9][51] Other Important Information - The company has secured iCGM designation from the FDA, allowing Eversense to integrate with insulin pumps and other medical devices [83] - The 365-day Eversense product is expected to reduce calibration frequency and offer a full year of protection from a single sensor, enhancing its competitive position [63] - The company is working on future-generation products, including Gemini and Freedom, which aim to eliminate the need for an on-body transmitter [63] Q&A Session Summary Question: Update on Ascensia's inventory and new patient growth [88] - The company is seeing over 80% growth in new patient additions compared to the prior year, with inventory levels being managed towards normalization [99] Question: Potential impact of the Mercy collaboration and RPM program [54] - The collaboration with Mercy represents a significant opportunity, with 30,000 eligible patients identified The RPM program is designed to be scalable, with fixed costs per patient and reimbursement handled by Mercy [75] Question: Confidence in the 365-day product approval timeline [76] - The company is confident in the 510(k) submission process and is working closely with the FDA to ensure a timely approval, targeting a Q4 2024 launch [94] Question: Commercial implications of the iCGM designation [77] - The iCGM designation opens opportunities for integration with insulin pumps, though the timeline for commercial integration is still under discussion [106] Question: Details on the 30,000 eligible patients in the Mercy system [78] - The 30,000 patients are CGM-eligible but not currently using CGM, primarily Type 2 patients on insulin or with a history of hypoglycemia [104] Question: Economics of the Mercy collaboration and RPM program [92] - The RPM program follows standard healthcare reimbursement models, with fixed costs per patient and no risk-sharing arrangements [102] Question: Competitive dynamics with other CGMs in the Mercy system [107] - Mercy does not intend to switch existing CGM users but will offer Eversense to all patients, with a focus on those not currently using CGM [80]

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, 2024 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 ...

Exhibit 99.1 SENSEONICS HOLDINGS, INC. REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS GERMANTOWN, MD, May 13, 2024 —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, today reported financial results for the quarter ended March 31, 2024. Recent Highlights & Accomplishments: "It has been a very productive start to the year for Senseonics as we c ...