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 ...

Financial Data and Key Metrics Changes - In Q1 2022, total net revenue was $2.5 million, a decrease from $2.8 million in the prior year period [25] - U.S. revenue for Q1 was $0.8 million, while revenue outside the U.S. was $1.7 million [25] - Gross profit remained stable at $0.5 million, consistent with the prior year [25] - Operating loss for Q1 2022 was $15.2 million, compared to a loss of $11.3 million in Q1 2021 [26] - Total net income was $86.7 million or $0.19 per share, a significant increase from a net loss of $249.5 million or $0.68 per share in Q1 2021, primarily due to noncash gains related to embedded derivatives [29] Business Line Data and Key Metrics Changes - The first quarter results were driven by inventory transition plans to the new E3 product [10] - The company is focused on transitioning current users to the E3 system and expanding new patient and clinician adoption [11] Market Data and Key Metrics Changes - The global market for continuous glucose monitoring (CGM) is approximately $7 billion, with significant growth opportunities as many individuals are not yet using CGM [40] - The company anticipates a notable increase in market penetration with the E3 product, particularly among patients new to CGM [40] Company Strategy and Development Direction - The company achieved FDA approval for the Eversense E3 continuous glucose monitoring system, extending the wear duration to 6 months [7] - The strategy includes a comprehensive commercial rollout of the E3 product in the U.S. and anticipated launch in Europe in Q3 [33][21] - Significant investments are being made to enhance access and awareness initiatives for the E3 product [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early interest from patients and healthcare providers, indicating a positive commercial outlook for 2022 [39] - The company expects gross margins to approach breakeven in Q4 2022 as payer coverage transitions from the 90-day to the 6-month product [30] - The outlook for full-year 2022 global net revenue is projected to be in the range of $14 million to $18 million [30] Other Important Information - The company is actively engaged with payers to transition coverage for the E3 product, with early wins from Aetna and Humana [17] - A patient assistance program has been implemented to attract patients with commercial insurance coverage [18] Q&A Session Summary Question: What metrics are being tracked for the E3 commercial launch? - Management noted that patient and physician interest is driving metrics, with direct-to-consumer leads higher than anticipated [39] Question: What is the size of the E3 opportunity relative to the 90-day product? - Management expects significant growth, with many potential users not currently on CGM [40] Question: What is the expected timing for additional payer transitions to E3? - Management anticipates quick transitions for Medicare patients in the next couple of months, with most transitions expected in the next quarters [42] Question: How many healthcare professionals are currently implanting the 90-day sensor? - Approximately 550 medical professionals are trained for insertion, with no additional training required for the transition to the 180-day product [45] Question: What is the current inventory situation at Ascensia? - The transition from the 90-day to the E3 product is actively managed, with inventory levels being adjusted accordingly [46] Question: What is the plan for the 365-day sensor? - The IDE filing is anticipated in Q2, with the first patient insertions expected in Q4 [47] Question: How to think about cash burn over the course of the year? - Management anticipates operational expenses of about $60 million to $70 million for the year, translating to approximately $5 million per month [48]

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, 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 ...

Financial Data and Key Metrics Changes - In Q4 2021, total net revenue was $4 million, compared to $3.9 million in the prior year period, with U.S. revenue at $700,000 and international revenue at $3.3 million [33][15] - Gross loss in Q4 2021 was $0.5 million, a decrease of $3.1 million from a gross profit of $2.6 million in the prior year, primarily due to increased cost of goods sold [33] - Operating loss for Q4 2021 was $13.9 million, compared to a loss of $10.3 million in Q4 2020 [36] - Total net income for Q4 2021 was $84.4 million or $0.19 per share, compared to a net loss of $101.6 million or $0.41 per share in Q4 2020 [38] - Cash, cash equivalents, and investments totaled $181.8 million as of December 31, 2021 [41] Business Line Data and Key Metrics Changes - The company generated $4 million in revenue in Q4 2021, with $700,000 from the U.S. and $3.3 million from outside the U.S. [33][15] - The transition to Ascensia for commercialization has led to a decrease in selling, general, and administrative expenses to $5.8 million in Q4 2021, down from $8.2 million in the prior year [34] - Research and development expenses increased to $7.7 million in Q4 2021, up from $4.7 million in the prior year, due to expanded R&D headcount and clinical studies [35] Market Data and Key Metrics Changes - The company added over 8 million additional covered lives with positive coverage decisions from payers such as Blue Cross Blue Shield of Michigan and others [13] - The total number of covered lives for the 90-day product is approximately 210 million [65] Company Strategy and Development Direction - The company is focused on the commercial launch of the Eversense E3 system in the U.S. scheduled for April 2022, which includes product availability and broader marketing efforts [18][20] - Ascensia is establishing a dedicated CGM commercial organization to enhance patient engagement and optimize sales strategy [16] - The company plans to transition current patients to the E3 system and expand new patient and clinician adoption [17] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of COVID-19 on the organization and the delay in U.S. approval, which affected rollout and progression [55] - The company expects full-year 2022 global net revenue to be in the range of $14 million to $18 million, with significant revenue expected in the second half of the year [42][46] - Management expressed confidence in the E3 product's potential to drive patient adoption and market penetration [10][49] Other Important Information - The E3 system is the longest-lasting CGM system approved in the U.S., with a wear duration of 6 months and an accuracy of 8.5% MARD [8] - The company is working on a 1-year sensor and plans to submit for IDE approval in Q2 2022 [30][31] Q&A Session Summary Question: Revenue guidance and underlying assumptions - Management discussed the impact of COVID-19 and the transition to the 180-day sensor, indicating that they expect reasonable use of the patient assistance program [53][55] Question: Recent patient volume falloff - Management noted that the biggest impact was from the withdrawal of funding for the commercial organization, with COVID-19 contributing to the decline [62][64] Question: Reimbursement progress and covered lives - Management confirmed that they are still counting about 210 million covered lives and are hopeful for coverage from major payers [65][70] Question: Pilot-at-home insertion program - Management expressed excitement about the pilot program but stated it is still in a test configuration [71] Question: Guidance modification and future ramp - Management indicated that they are not in a position to provide specific guidance for 2023 and 2024 due to the impact of COVID-19 [74] Question: Positioning against competitors - Management highlighted that Eversense remains the only implantable CGM and expects to capture a fair share of the growing market [75][76] Question: Patient assistance program impact on revenue - Management clarified that the patient assistance program is an investment that will reduce net revenue but aims to drive adoption [82]

Product Development and Approval - The Eversense E3 CGM system received FDA approval in February 2022, with commercialization expected to begin in the U.S. in Q2 2022[22]. - The Eversense CGM system can now be used as a therapeutic device to replace fingerstick blood glucose measurements, following FDA's non-adjunctive indication approval in June 2019[32]. - The company plans to seek Investigational Device Exemption from the FDA for a 365-day sensor clinical trial in the first half of 2022[19]. - The Eversense system demonstrated a Mean Absolute Relative Difference (MARD) of 8.8% during the 90-day trial, indicating high accuracy compared to YSI blood reference values[52]. - The PROMISE trial showed a MARD of 8.5%-9.6% for the Eversense system, with reduced calibration requirements and an extended sensor life of 180 days[55]. - The Eversense sensor is designed to last up to six months, significantly longer than other CGM sensors that last between 7 and 14 days[59]. - The Eversense CGM system is sold in two kits: the disposable Eversense Sensor Pack and the durable Eversense Smart Transmitter Pack[41]. - The company is developing a next-generation sensor designed to extend sensor duration up to 365 days, aiming to support long-term implantable CGM for Type 2 patients not on intensive insulin therapy[65]. Commercialization and Market Strategy - The company entered a commercialization agreement with Ascensia in August 2020, granting exclusive distribution rights for the 90-day and 180-day Eversense CGM systems worldwide[20]. - Ascensia is responsible for sales, marketing, and patient onboarding, while the company retains product development and manufacturing responsibilities[21]. - The commercialization agreement with Ascensia grants exclusive rights to distribute the 90-day and six-month Eversense CGM systems worldwide, with sales support for the 90-day product starting on October 1, 2020[67]. - Approximately 200 million people in the U.S. may have coverage for the Eversense 90-day product through commercial or government payors, with a focus on transitioning to six-month coverage for successful commercialization of the Eversense E3[71]. - The company aims to grow the installed base of users and increase patient awareness of Eversense through targeted marketing efforts[23]. - The company expects a substantial majority of future revenue to come from its Commercialization Agreement with Ascensia, which is critical for the growth of product adoption[149]. - The company's revenue is heavily dependent on Ascensia's success in marketing Eversense and establishing necessary commercial infrastructure[170]. - Market acceptance of Eversense is contingent upon effective education of patients and healthcare providers regarding its benefits compared to traditional monitoring methods[176]. Financial Performance and Challenges - As of December 31, 2021, the company had incurred significant net losses totaling $302.5 million, $175.2 million, and $115.5 million for the years ended December 31, 2021, 2020, and 2019, respectively, with an accumulated deficit of $951.0 million[147]. - The company has not achieved profitability and does not expect to do so for several years, anticipating significant increases in expenses[148]. - The company's stock price has been highly volatile, influenced by broader market conditions and the performance of emerging medtech and biotechnology companies[150]. - The company is reliant on a single product, Eversense, for its business strategy and market acceptance[176]. - The ongoing impact of COVID-19 on global financial markets could affect the company's liquidity and overall financial condition[162]. Regulatory Compliance and Risks - The Eversense System is classified as a Class III medical device and requires pre-market approval under section 515 of the FDCA[93]. - Compliance with the FDA's Quality System Regulation (QSR) is mandatory, which includes stringent design, testing, and quality assurance procedures[95]. - The company must conduct post-market surveillance studies and report any incidents that may have caused or contributed to death or serious injury[96]. - The Medical Device Regulation (EU) 2017/745 requires compliance with General Safety and Performance Requirements (GSPRs) to affix the CE mark, essential for marketing in the EEA[100]. - Non-compliance with regulatory requirements can lead to significant penalties, including fines, product recalls, and criminal prosecution[108]. - The company must adhere to labeling and promotional regulations, prohibiting off-label promotion of medical devices[97]. - International sales of medical devices are subject to varying local regulations, which may differ significantly from FDA requirements[98]. - The company must navigate stringent foreign regulations, which could impose severe penalties for noncompliance[175]. Operational and Market Competition - The CGM market is competitive, with major players like Dexcom, Medtronic, and Abbott, all of which have received FDA approval for their systems[78]. - The company faces challenges with some commercial payors denying coverage, labeling Eversense as "experimental and investigational," which may hinder widespread adoption[72]. - The company operates in a highly competitive market for diabetes monitoring, with risks from technological advancements by competitors[146]. - The competitive landscape includes well-capitalized companies like Dexcom and Abbott, which have received FDA approval for their CGM systems[194]. - The introduction of new technologies and competitive products could render Eversense less competitive or obsolete, significantly reducing potential sales[200]. - The diabetes market is highly competitive, with frequent product introductions by competitors potentially leading to market confusion and pricing pressures that could adversely affect sales[201]. Supply Chain and Manufacturing - The company relies on third-party manufacturers for Eversense production, which poses risks to gross margins and operating results if manufacturing capabilities are not met[204]. - The company depends on a limited number of suppliers for Eversense components, and any loss or inability of these suppliers to deliver could harm business operations[206]. - Manufacturing disruptions at suppliers' facilities could adversely affect the company's business and operating results[210]. - Regulatory compliance issues with suppliers could expose the company to significant risks, including product recalls and increased expenses[209]. Employee and Organizational Structure - The company has a workforce of 89 employees, with over half holding advanced degrees, and no employees are represented by a labor union[134]. - The company has implemented a year-end market adjustment review process to ensure competitive pay, resulting in adjustments effective January 1, 2022, to maintain pay equity[139]. - The company is committed to diversity, with approximately one third of its workforce being female as of the end of 2021[136]. - The company has a focus on continuous employee development, requiring quarterly feedback sessions between employees and managers[138].

Senseonics. | --- | --- | --- | --- | |--------------------------------------------------------------------------------------|-------|-------|--------------------------------------| | Eversense® | | | | | CGM System The world's FIRST and ONLY long-term Continuous Glucose Monitoring System | | | | | Tim Goodnow, PhD President and CEO | | | Corporate Presentation November 2021 | FORWARD-LOOKING STATEMENTS This presentation, including the remarks of management contains forward-looking statements, as defined in ...

Senseonics Holdings, Inc. (NYSE:SENS) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Tim Goodnow – CEO Carsten Beckwith – Investor Relations Nick Tressler – CFO Conference Call Participants Mathew Blackman – Stifel Jayson Bedford – Raymond James Connex Stephenson – Craig Hallum Operator Good day, and welcome to the Senseonics Third Quarter 2021 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there ...

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 September 30, 2021 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) 3841 ...

Senseonics Holdings, Inc. (NYSE:SENS) Q2 2021 Results Conference Call August 9, 2021 4:30 PM ET Company Participants Philip Taylor - IR Tim Goodnow - President and CEO Nick Tressler - CFO Mukul Jain - COO Mirasol Panlilio - VP and General Manager, Global Commercial Operations Conference Call Participants Mathew Blackman - Stifel Chris Pasquale - Guggenheim Danielle Antalffy - SVB Leerink Jayson Bedford - Raymond James Trent McCarthy - Craig-Hallum Capital Operator Good day and welcome to the Senseonics Seco ...

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, 2021 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 ...