Senseonics Holdings, Inc.

Good day, everyone, and welcome to today's Senseonics fourth quarter and full year 2024 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. Please note, today's call will be recorded, and I will be standing 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 other reports filed with the SEC. These documents are available in 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 Goodenow, President and Chief Executive Officer, and Rick Sullivan, Chief Financial Officer. Today, we also have Brian Hanson, president of CGM at Ascensia Diabetes Care, our global distribution partner for Eversense, joining us. With that, I would like to turn the call over to Tim Goodenow, president and CEO.

Tim? Thanks, Jeremy, and thank you to everyone on the call today for taking the time to join us. As Jeremy mentioned, we'll have Brian with us again today, who can provide a boots-on-the-ground perspective on how Eversense 365 has been received in the marketplace since its launch in November. Before we hear from Brian, I'll provide a look back on 2024 and the strong progress that we've made. I'll provide an update on our recent CE Mark submission, our European launch planning, our pipeline programs, Gemini and Freedom, and I'll touch on our current partnerships with Mercy and Sweet Spot, as well as our ongoing progress with insulin pump manufacturers. Finally, Wick will run you through the numbers, and then we'll take your questions. On September 17, 2024, marked the U.S. approval of Eversense 365, the world's first and only once-yearly continuous glucose monitor. The company was founded on the premise of a one-year sensor, and we have been working for many years to reach this goal, increasing from a 90-day sensor to a 180-day sensor, and finally to Eversense 365. As a reminder, the Eversense 365 sensor is the backbone of both the Gemini and Freedom system, which I'll elaborate on in a few minutes. Since the launch, we've been very pleased with the positive reception and feedback we've received from both providers and patients. We have more patients than ever switching to Eversense 365, more doctors prescribing Eversense, and more health systems interested in partnering with us than we've ever had before. Brian will tell you more about our performance metrics, but I'm extremely pleased with our early performance on the 365 launch and with what has been accomplished over the past couple of months. As you may have seen, we have now filed our CE mark for approval for Eversense 365, and pending clearance, we are planning for a launch in the European Union later this year. Ascensia has sales and distribution channels in place in Europe to support our launch, And we look forward to the opportunity to increase the number of patients benefiting from Eversense by bringing the value proposition of our one year, one sensor to patients in the European market that we serve. We expect to launch Eversense 365 in the second half of 2025. I also want to highlight the important work we continue to do to advance our product pipelines. Our development teams are working continuously to improve the patient's experience with Eversense. Our feasibility study for Gemini, the one-year sensor with the battery, which allows for both continuous as well as optional swipe testing, is expected to be complete this year, and we are on target to submit our IDE for a pivotal study by year end. We are also making progress on our Freedom system, which incorporates Bluetooth within the sensor, thereby eliminating the need for an on-body transmitter. by allowing the sensor to communicate directly with the phone. The backbone for both of these systems is the updated chemistry and technology already approved in the Eversense 365. We believe these advances will create a strong platform on which to add the battery, Bluetooth technology, and other features that will continue to improve the patient experience. With our integrated continuous glucose monitor designation received last year, we are also working actively towards pump integration. This will allow, ever since 365, to communicate wirelessly to pumps to augment and control insulin delivery. Currently, this is only possible with short-term CGMs, requiring entirely new sensors, disposable insertion hardware, and bulky packaging, and a repetitive insertion process with every two-week sensor replacement. We expect to provide you with additional updates in the coming quarters on our ongoing discussion with insulin pump manufacturers. In addition, we continue to focus our efforts on expanding relationships with additional health systems and accountable care organizations. Our partnership with Mercy Health provides access to 365 for its patients' populations that could benefit from wearing a CGM. Based on this cost-containing strategic arrangement, several other health systems have been in contact with us to inquire about ever since use, and to discuss whether they could implement a similar program. Stay tuned for additional details on these types of partnerships and our initiatives to create greater access to Eversense. Lastly, we continue to explore collaborations similar to our recently announced integration with SweetSpot, where Eversense 365 populates glucose readings directly into SweetSpot's PEC-enabled diabetes service that includes clinical support for patients and accessibility for endocrinologists. From our own development efforts to our collaborations with commercial and development partners, we continue advancing our technology offering and access to make managing diabetes more convenient for the patients we serve. Now, I'd like to transition the call to Brian, Ascensia's president of CGM, for an overview of our 365 launch progress. Brian, the mic is yours.