Senseonics Holdings, Inc.

Please stand by, your program is about to begin. Good day, everyone, and welcome to the Senseonics first quarter 2025 earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask questions by pressing the star N1 on your telephone keypad. You may withdraw your question by pressing star 2. Please note this call is being recorded and I will be sending by should you need any assistance. It is now my pleasure to turn the conference over to Jeremy Pfeffer from LifeSci Advisors. Please go ahead.

Thank you. This is Jeremy Pfeffer from LifeSci Advisors. Before we begin today, let me remind you that the company's remarks include forward-looking statements. These statements reflect management's expectations about future events, operating plans, regulatory matters, product enhancements, company performance, and other matters and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under risk factors and elsewhere in our annual report on Form 10-K for the year ended December 31st, 2024, and our 10-Qs and our other reports filed with the SEC. These documents are available on the investor relations section of our website at www.senseonics.com. We undertake no obligation to update publicly or revise these forward-looking statements for any reason except as required by law. Joining me today from Senseonics are Tim Goodnow, President and Chief Executive Officer, and Rick Sullivan, Chief Financial Officer. I'll now turn the call over to Tim Goodnow, President and CEO. Tim?

Thanks, Jeremy, and thank you to everyone on the call for joining us. Today, I'm happy to add detail about our latest step in transforming diabetes care, the integration of our ever-since 365 continuous glucose monitor with Sequel's Twist automated insulin delivery system. I'll also provide an update on a recent CE Mark submission, our European launch planning, our pipeline programs, and our ongoing initiatives for practice and healthcare systems integration. After that, Rick will run you through the numbers, and then we'll take your questions. We announced on April 29th our first AID integration of Eversense 365 with the Twist automated insulin delivery system. This partnership enables real-time readings from our CGM to be received by the Twist pump, which are then used in the loop algorithm to automatically adjust insulin delivery and predict future glucose levels. We're excited about this collaboration particularly joining the most technologically advanced innovations in pump, CGM, and algorithm technologies. And we see this as a significant step forward for both companies towards improving personalization, choice, and improved health outcomes for patients with diabetes. We believe this compatibility will enhance the patient's experience through simplification of insulin delivery and with only one CGM required over the course of a year patients will experience significantly less complexity in managing their diabetes. The teams are working on the systems integration, and we look forward to jointly launching our combined products in the coming quarter. The other collaboration we established during the quarter is with Sweet Spot, which enables endocrinology practices to provide virtual CGM monitoring and enhance patient care. By receiving real-time CGM data from a patient's Eversense 365 through SweetSpot's technology platform, providers can assess and make treatment decisions between patient appointments and keep patients more connected to their care teams. Endocrinologist practices can utilize SweetSpot's platform to capture reimbursable care events, improving efficiency and streamlining the totality of patient care. We believe this benefit will be particularly useful for accountable care organizations and health systems looking to improve network-wide health outcomes that decrease costs. Our key accounts teams continue to work with health systems to include Eversense 365 in their standard offering for patients with diabetes to monitor and improve overall glycemic control and reduce the frequency and cost of long-term complications due to diabetes. We are engaged in a series of discussions to that end. At the same time, Mercy Health Systems in St. Louis has recently undergone a significant executive level restructuring, which has caused them to pause many new initiatives as they evaluate programs within this new structure. While this was a broader action that does not reflect on Eversense, it does mean that the ongoing work to drive our Eversense with remote patient monitoring offering forward at Mercy is currently on hold and we do not yet have an estimate as to when the project will be restarted. Progress on the program to date has given us valuable insights about such an integration and the RPM element of the program, and we expect this to benefit us as we move forward with other health system initiatives. As the program is expanded, we had planned to see Mercy impact the back half of the year. However, With the progress we are seeing with the 365 launch, the expected European launch, and additional marketing initiatives planned, we reiterate the 2025 revenue guidance we previously issued. These complicated collaborations do take several quarters to implement, but we continue to expect these types of partnerships to be an important part of our growth strategy in the coming years. Looking at these ever since 365 expansion opportunities, We filed our CE mark application with the notified body in the first quarter. The review appears to be progressing as expected, and subject to receiving the anticipated approval, we remain on track for a European launch in the second half of this year. Our commercial partner, Essentia Diabetes Care, has initiated the planning and preparation for this launch. We look forward to users in our European markets being able to experience the convenience of a one-year CGM And our current expectation is that ever since 365 will be our single product offering by the end of 2025, offering meaningful global supply chain synergies and cost of goods improvements. Our commercial accomplishments in Q1 were all made possible by delivering on our promise of one year, one CGM. We continue to make good on our progress on our work with U.S. payers to transition reimbursement from $180 to 365 days for ever since, with many payers having already transitioned their coverage. Specifically, on the Medicare front, last month we were happy to see that the 2025 physician fee schedule was updated to provide payment for our full year of ever since, with effectiveness retroactive back to January 1st. We see many patients and providers enthusiastically embracing Eversense 365, and we continue to hear feedback on its convenience of use. We look forward to continuing to build more awareness and adoption of the product throughout the year. I'd also like to highlight the importance of our continued work on our pipeline products, Gemini and Freedom, as our development team worked diligently to continuously improve the patient's experience with Eversense. We remain on track to submit an IDE for a pivotal study by year end for Gemini using the data we are currently collecting in our human feasibility studies. The Gemini product includes a one-year sensor with a built-in battery that allows for both continuous as well as optional swipe testing, providing for more flexibility and choice for patients who decide when and where they want to wear something on-body. Our Freedom system, which incorporates Bluetooth within the sensor to eliminate the need for any on-body transmitter, is right behind and is built on the same sensing chemistry as the Eversense 365 and the Eversense Gemini. Freedom is designed to communicate directly with the user's phone to create the world's first and only invisible CGM. This offers the benefits of being able to monitor the glucose levels for an entire year without any on-body device or adhesive. I think it's easy to understand why we call this project Freedom. And our team is driving hard to advance this development. Over the next few quarters, we expect to share more collaborations, partnerships, and development advances with you. Our goal remains to transform the lives in the global diabetes community through technologically differentiated long-term implantable glucose monitoring And with each new collaboration, each technology interface and device integration, and with each development milestone, we move one step closer to that goal. Now, I'll turn it over to Rick to walk you through the financials from the quarter.