Senseonics Holdings, Inc.

Please stand by. Your program is about to begin. If you need assistance on today's conference, please press star zero. Good day, everyone, and welcome to Syncyonics second 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. Please note, today's call will be recorded. and I'll 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 10Qs 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 Goodenough, President and Chief Executive Officer, and Rick Sullivan, Chief Financial Officer. I'll now turn the call over to Tim.

Thanks, Jeremy, and thank you to everyone on the call for joining us today. In the second quarter, we executed on a number of programs to drive shareholder value and position Senseonics for long-term growth. Rick and I will walk you through these initiatives today. One of our main objectives is to drive EverSense awareness and adoption, and we're doing this by further supporting our product with added Senseonics commercial investment. Additional objectives include enhancing 365 access with the EonCare build-out, while expanding capabilities with our device integration efforts and advancing our key product development pipeline programs. We are making solid progress across each of these areas. Q2 completes two quarters with Eversense 365 on the U.S. market, and we continue to be pleased with our launch momentum. We expect that through expanded DTC marketing, more people will learn about the unique performance attributes and convenience of our one-year sensor, resulting in more people choosing Eversense to help manage their diabetes. In Q2, we saw meaningful progress in that direction. Our new patient starts were up 79% over the prior year and 37% from Q1. Leads were more than doubled over the prior year, and June leads were up 50% over the prior three-month average. We are seeing true acceleration in the growth of Eversense, the expanded DTC, and we plan to continue to augment Essentia's DTC spending through the remainder of this year. To support this increased volume, Essentia has hired a dozen new inside sales reps to handle these calls. Our plan is for the increased DTC spending to expand awareness and the enhanced inside sales capacity to support sales conversion, combining directly to translate into increased new patient starts. We expect that these results to be bolstered by ever since reorders in the U.S. in the fourth quarter. Recall that in transitioning from a six-month to one-year product, The cadence for repeat ever since users to have a new sensor inserted has changed to a 12-month cycle. Instead of coming back for reinsertion in 180 days, users now return in 365 days. This means that following the Q4 launch of ever since 365, our overall U.S. shipments during Q2 and Q3 naturally reflected significantly reduced reorder volume compared with the prior year. Therefore, nearly all sensors sold in Q2 and Q3 are for new patient starts. In Q4, with the first 365 adopters coming up for their next insertions, reorders will make more meaningful contributions to sales. Beyond the US launch execution, we are advancing a series of initiatives to broaden access, support adoption, and enhance the user experience. We continue to expect our development work to translate into CE mark approval for ever since 365 in Europe. And we are planning for the European launch later this year. We have begun training the OUS Essentia sales team to be ready upon approval. We anticipate this will translate into more people in more markets having access to the promise of one year, one sensor. Additionally, we are collaborating with other companies to further improve the market presence of Eversense 365. Last month, Sequel began the launch of their Twist Pump, and we announced during the quarter our respective development teams are collaborating on the final integration work, and we expect to see the Eversense 365 available for use with the Twist Pump later this year. We believe combining the advanced technologies of both companies will offer a real differentiation and unique benefits to people with diabetes. We all know that our users have to monitor their carb intake, exercise, and their glucose levels to determine the safe amount of insulin they need. This constant management requires significant patient involvement, and through the integration of Eversense with the Sequel Twist Pump, patients can simplify their lives, simplify the diabetes overhead, de-stress the CGM complexity for an entire year, and rest assured that the world's most advanced diabetes technology is working for them. The integration with the TWiTS pump is the first of multiple partnerships we hope to announce with pump manufacturers and other parties. With the world's first and only 365-day continuous glucose monitor approved as an ICGM, we have a unique and convenient offering to integrate with any pump on the market, and we look forward to announcing updates in the future. In another important initiative, we continue working to make it easier for patients to have access to Eversense, and for physicians to prescribe it. During Q2, we completed the planned transition of inserters from the nurse practitioner group to EonCare, our network of providers that can perform ever since 365 insertion procedures. The goal of this initiative is threefold. To make it more convenient for interested people with diabetes to be served by an inserter, to enable practitioners who want to prescribe our product but not insert to simply do so, And third, to ensure a consistent, high-quality insertion experience. Following the transition from NPG, our EonCare network is nearly 40 strong and handles approximately 20% of our insertions. The volume of insertions through EonCare continues to grow, increasing nearly 30% in Q2 versus Q1 this year. With the foundation of EonCare established, we are working to quickly expand it, Our current goal is to increase this network to approximately 50 practitioners by the end of this year and roughly 100 by the end of next year. Through the combination of EonCare nurses and prescribing providers perform their own insertions, we continue to add further insertion depth and breadth targeting the major U.S. geographies. Our aim is to ensure that anyone who wants Eversense 365 has a convenient option to access it. Further, supporting access, in Q2, CMS updated the Medicare position fee schedule to provide payment for a full year of Eversense. This inclusion was announced in April and was retroactive to January 1st. And as a result, we did see a notable increase in the business that flows through our consignment program. We are also seeing some commercial payers begin to transition to a bundled payment reimbursement, similar to Medicare. As the product is consigned to the office until its use, you'll hear us refer to this channel as either bundled pay, buy and bill, or consignment. This reimbursement pathway covers both the product cost and provider's procedure fee through a single claim. This simplifies payment for insurers, providers, and patients. Furthermore, because Eversense is an implanted device, Medicare reimbursement for the product is included as part of CPT codes 446T and 448T. These codes are established on a physician fee schedule and covered through a member's medical benefit, Medicare Part B. Medicare correctly does not characterize EverSense as a DME product, meaning that EverSense will be excluded from the pending DME competitive bidding program. Now I'd like to turn to the important development work and progress being made by our R&D teams. Synthionics was founded to develop and deliver on the best-in-class, once-a-year continuous glucose monitor. Having delivered on that promise, our mission is to now drive further advances to make the one-year sensor more convenient, less intrusive, and more appealing to patients. Gemini is the next step in that continued evolution. As a reminder, Gemini includes a self-powered battery, and offers both swipe and prospective CGM functionality, all incorporated into a tiny under-the-skin sensor. This offers the option to wear a transmitter when the full functionality of alarms and alert protection is required, and swipe when a user does not want to wear anything on their skin. This product will be especially attractive to the large population of people with diabetes on both basal insulin and those on non-insulin regimens. We're very excited about the growing Type 2 opportunity with Gemini, and I'm pleased with the development team's progress. We remain on schedule to start an IDE pivotal study for Gemini later this year. Our target is to then have a U.S. submission mid-next year, with a commercial launch in the U.S. starting near the end of 2026. The next exciting evolution beyond Gemini is our work on the Freedom Program. With Freedom, we are trying to deliver the world's first truly invisible CGM. Freedom will eliminate any on-body component to offer people continuous readings with real-time alarms and alerts directly to the phone with nothing on the skin. Our team is working towards the goal of launching Freedom about a year after Gemini. All of us at Syncyonix remain committed to pushing the boundaries of technology and continue to provide the world's most advanced CGM to people with diabetes. Lastly, we raised approximately $78 million in gross proceeds during the second quarter, including $20 million from Abbott in a concurrent private placement. This capital supports the critical work that I've been speaking about, expanding the ongoing launch of Eversense 365, including increased direct-to-consumer advertising, supporting access and other initiatives to the product, and continuing our development pipeline. We believe our progress on these initiatives positions us well to further drive product awareness, innovation, long-term growth, and shareholder value. Now I'll turn the call over to Rick to walk you through financials from the quarter and provide some additional details.