Senseonics Holdings, Inc. (NYSE:SENS) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Philip Taylor - IR Tim Goodnow - President and CEO Rick Sullivan - CFO Conference Call Participants Colin Clark - Stifel Sam Eiber - BTIG Jayson Bedford - Raymond James Operator Good day, and welcome to the Senseonics Second Quarter 2023 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Trip Taylor, In ...

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, 2023 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 ...

Senseonics Holdings, Inc. (NYSE:SENS) Q2 2023 Earnings Conference Call May 9, 2023 4:30 PM ET Company Participants Philip Taylor - IR Tim Goodnow - President and CEO Rick Sullivan - CFO Mukul Jain - COO Conference Call Participants Sam Eiber - BTIG Colin Clark - Stifel Operator Good day, and welcome to the Senseonics First Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Op ...

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, 2023 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 Table of Contents Senseonics Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware ...

Any statements in this presentation about future expectations, plans and prospects for Senseonics and its business, including statements regarding managements plans, objectives and goals for future operations (including preliminary targets for future financial performance and cash projections of Senseonics Holdings, Inc.), statements about the commercial launch of Eversense® E3, statements regarding increasing patient access, adoption and market share and the future growth of the CGM market, statement regar ...

Product Overview - The Eversense CGM system includes versions with a lifespan of 90 days, 180 days (Eversense E3), and is designed for continuous glucose monitoring, significantly longer than non-implantable systems which last 7 to 14 days[18]. - The Eversense CGM system became the first CGM technology reimbursed through the Part B Medical Services benefit for Medicare beneficiaries in November 2019[28]. - The Eversense CGM system is sold in two kits: the disposable Eversense Sensor Pack and the durable Eversense Smart Transmitter Pack[34]. - The Eversense E3 CGM system was commercialized in all EEA markets during Q3 and Q4 of 2022 following CE mark approval[22]. - The Eversense XL CGM system received CE mark in September 2017 and began commercialization in the U.S. in Q2 2022 after FDA PMA approval for Eversense E3[40]. - The mobile app provides real-time glucose readings and alerts, enhancing user experience and management of diabetes[57]. - The Eversense system offers advantages such as exceptional accuracy, longest sensor duration of up to six months, and continuous glucose monitoring capabilities[53]. Regulatory Approvals and Compliance - The FDA approved the Eversense E3 CGM system for marketing in the U.S. in February 2022, with commercialization beginning in the second quarter of 2022[22]. - The Eversense System is classified as a Class III medical device and requires pre-market approval (PMA) from the FDA[88]. - The company is subject to extensive regulation by the FDA, including compliance with quality system regulations and post-market surveillance requirements[90][91]. - Medical devices must comply with the General Safety and Performance Requirements (GSPRs) to obtain the CE mark, which is essential for marketing in the EEA[95]. - The Medical Device Regulation (MDR) entered into application on May 26, 2021, replacing previous directives and establishing new compliance requirements for medical devices[94]. - The FDA mandates Post Approval Studies and tracking systems for products, enforcing compliance through periodic inspections and market surveillance[99]. - Non-compliance with regulatory requirements can lead to severe penalties, including fines, product recalls, and potential criminal prosecution[102]. Market and Competition - The market for CGM systems is competitive, with significant players including Dexcom, Medtronic, and Abbott, all of which have received FDA approval for their systems[72]. - The company faces potential competition from various sources, including companies developing real-time intermittent sensing devices and non-invasive CGM systems[75]. - Competition in the CGM market is intense, with established players like Dexcom and Abbott having significant advantages, including FDA approvals and established market presence[178]. - The company anticipates increased competition from companies integrating CGM with insulin pumps, which could impact market share[179]. - The company operates in a highly competitive market for diabetes monitoring devices, facing risks from technological breakthroughs by competitors[144]. Financial Performance and Projections - The company incurred total net income (loss) of $142.1 million, ($302.5) million, and ($175.2) million for the years ended December 31, 2022, 2021, and 2020, respectively, with an accumulated deficit of $808.9 million as of December 31, 2022[145]. - The company has never been profitable in past years and does not expect to be profitable for at least the next several years, with future operating losses anticipated[146]. - The company expects that a substantial majority of future revenue will result from the Commercialization Agreement with Ascensia, which grants Ascensia exclusive rights to distribute Eversense worldwide[147]. - The company plans to derive nearly all revenue from Eversense sales in the U.S. and Europe for the next several years, making reimbursement from third-party payors essential for product acceptance[168]. - Significant sales generation is necessary for the company to achieve profitable operations, but there is uncertainty regarding the ability to do so[217]. - If sales growth is slower than expected or operating expenses exceed expectations, financial performance will be adversely affected[217]. Employee Engagement and Company Culture - As of December 31, 2022, the company had 121 full-time employees, with over half holding advanced degrees[130]. - The company emphasizes employee engagement and has implemented initiatives to strengthen connections between employees and the company's mission[131]. - The company has invested in new human resource software to collect weekly employee feedback and enhance engagement[131]. - The company has launched a new platform to improve employee health and safety training programs in 2022[132]. - The company recognizes the importance of diversity and collaboration in driving success[131]. - As of the end of 2022, the employee base comprised 40% female and 60% male, reflecting the company's commitment to diversity, equity, and inclusion[135]. Risks and Challenges - The company faces challenges in securing adequate reimbursement for Eversense, which could adversely affect its financial condition and operating results[168]. - The ongoing military action by Russia in Ukraine and surging energy costs in Europe pose risks to the company's operations and supply chain[144]. - The company is vulnerable to disruptions in its information technology systems, which could adversely affect its operations and financial results[201]. - The company acknowledges that economic downturns, inflation, and public health crises like COVID-19 could negatively impact its business and financial performance[213]. - The company may face challenges in integrating acquired products or technologies, which could adversely affect its business and financial condition[208]. - The company relies on third-party manufacturers for Eversense production, exposing it to risks related to quality, reliability, and production capacity[187]. Research and Development - The ENHANCE pivotal study for the Eversense 365-day system completed enrollment in Q3 2022, with data expected in the second half of 2023[19]. - Future product development aims to reduce calibration frequency to once per week and extend sensor duration to 365 days, targeting Type 2 diabetes patients[59]. - The company is exploring applications of its technology for measuring other analytes beyond glucose, indicating potential for future growth[59]. - The company intends to increase operating expenses for the commercialization of Eversense and ongoing R&D activities, including next-generation products[217]. Insurance and Reimbursement - Approximately 250 million people in the United States may have coverage and access to the Eversense E3 product via commercial or government payors[65]. - Some commercial payors have denied coverage for Eversense, labeling it as "experimental and investigational," which may limit patient access[66]. - The Health Technology Assessment (HTA) process in the EU may require additional studies for medical device candidates, influencing pricing and reimbursement decisions[173]. - The Eversense Bridge Program, launched in March 2019, provided financial assistance to uninsured patients but was terminated in December 2020, potentially affecting sales[175]. - Future coverage and reimbursement for Eversense products may face increased restrictions, impacting sales and profitability[172].

Senseonics Holdings, Inc. (NYSE:SENS) Q3 2022 Earnings Conference Call November 8, 2022 4:30 PM ET Company Participants Philip Taylor – Investor Relations Tim Goodnow – President and Chief Executive Officer Rick Sullivan – Chief Financial Officer Conference Call Participants Colin Clark – Stifel Sam Eiber – BTIG Operator Good day, and welcome to the Senseonics Third Quarter 2022 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there ...

Senseonics Holdings, Inc. (NYSE:SENS) Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET Company Participants Philip Taylor - Investor Relations Tim Goodnow - President and Chief Executive Officer Nick Tressler - Financial Officer Mukul Jain - Chief Operating Officer Conference Call Participants Sam Eiber - BTIG Alex Nowak - Craig-Hallum Capital Group Operator Good day and welcome to the Senseonics Second Quarter 2022 Earnings Conference Call. [Operator Instructions] Please note this event is being ...

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, 2022 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 ...

Senseonics... | --- | --- | --- | --- | |--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-------|-----------------------------------| | | | | | | | | | | | Eversense | ® E3 | | | | The world's FIRST and ONLY | CGM System long-term Continuous Glucose Monitoring System | | | | Tim Goodnow , PhD President and CEO © 2021 Senseonics™ Corporate Presentation, updated November 2021 | | | Corporate Pr ...