Senseonics Holdings, Inc.

To withdraw your question, please press star then two. Please note, today's event is being recorded. I would now like to turn the conference over to your host today, Tripp Taylor. Mr. Taylor, please go ahead.

Thank you. This is Tripp Taylor from the Gilmartin Group. 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, 2022, and our 10-Q for the quarter ended March 31st, 2023, and our other reports filed with the SEC. These documents are available in the investor relations section of our website at www.censionix.com. We undertake no obligation to update publicly or revise these forward-looking statements for any reason except as required by law. Joining me from Censionix are Tim Goodnow, President and Chief Executive Officer and Rick Sullivan, Chief Financial Officer. With that, I'd like to turn the call over to Tim Goodenough, President and CEO. Tim?

Thank you, Tripp, and thank you all for joining us this afternoon. Today, we'll open up with our first quarter performance, comment on Essentia and Sensionics' key commercial priorities for driving patient adoption of Eversense, and discuss the key milestones for advancing the Eversense technology pipeline, all to enhance shareholder value. Then our Chief Financial Officer, Rick Sullivan, will discuss the first quarter financials in detail and will open up the call for questions. In the first quarter, Senseonics generated total revenue of $4.1 million, representing 66% growth compared to the prior year period, including $2.1 million of revenue from the U.S. and $2 million from outside the U.S. As a reminder, net revenue to Sensionics in 2023 will represent approximately 70% to 75% of total ever since revenue generated in the global markets, as the revenue share for our partner increases according to our collaboration agreement with Essentia. Recently, Essentia Diabetes Care and their parent company, PHC Holdings, made incremental financial and strategic investments in Sensionics to further demonstrate their commitment to the partnership and have resulted in a stronger Eversense commercial infrastructure and a stronger Senseonics balance sheet. During the first quarter, Essentia's investments in the commercialization of Eversense increased, focusing on U.S. patient and healthcare provider awareness, as well as commercial access to drive patient adoption. Specifically, Essentia is targeting driving interest and recommendations for Eversense by utilizing direct-to-consumer marketing and by expanding the dedicated U.S. CGM sales force. Additionally, Senseonics and Essentia continue to take steps to improve access through the progress of commercial programs, such as the collaboration with the nurse practitioner group, the consignment program, and patient assistance programs. To increase awareness of Eversense among people with diabetes, ADC is primarily utilizing direct-to-consumer marketing. In the last year, there have been over 1 million unique visitors to the Eversense website. Essentia plans to increase this number with additional DTC investment. Traffic to the Eversense website creates leads for inside sales representatives who connect the leads with healthcare providers who offer Eversense. To complement the DTC marketing, Essentia continues to make investments in growing the dedicated USCGM sales force. To broaden the commercial footprint for Eversense, Essentia is expanding the US sales force from approximately 20 sales reps in the fourth quarter of 2022 to a planned approximately 50 professionals this year. This growing team is focused on increasing physician interactions, engaging new accounts and expanding awareness. The Salesforce plans to build on the HCP focused exposure by hosting peer-to-peer events and having increased presence in expanded territories. It will take a few quarters for reps to ramp to full productivity in their territory So we expect to see the first impacts of the expanded team later this year and plan for their contributions to be more material in 2024. To incentivize ever since growth and to align these activities with building Senseonics shareholder value, we have designed and implemented a plan to remunerate these first sales professionals with a previously described Senseonics equity program. These performance-based equity awards will further incentivize sales reps towards the CINCIA and CINCIONIC shared goal of bringing Eversense to more patients. There are currently several commercial programs underway to improve access to Eversense for people with diabetes. These include the collaboration with the nurse practitioner group, our office consignment program, and the expanded patient assistance program. To increase patient access to inserters, In service of the DTC leaves who manage their diabetes with a primary care physician that might not yet be an Eversense inserter, we established a partnership with a nurse practitioner group to provide Eversense users with convenient sensor insertion options. NPG now has providers certified and performing insertions in approximately 25 cities. The reimbursement for sensor insertion makes this partnership an attractive endeavor for this group. In geographies with an NPG provider, the medical professionals is a strong complement to the Essentia sales associate. The Eversense rep can focus more on educating endocrinologists on the value of the system and its compelling benefits for their patients, rather than detailing insertional logistics that can be effectively managed by NPG. We believe offering greater availability and access to this streamlined path supports growing prescriptions for the product. The nurse practitioner group offers an effective path to build out our network of certified Eversense inserters that makes insertions more convenient for patients, and we see tangible benefits to this approach. We plan to scale this model further by incorporating additional partnership territories during the remainder of the year. Another commercial program we have established to increase access to Eversense is the consignment program. Having product on the shelf in the HCP's office at all times increases convenience to healthcare providers and patients to enable fast and even same-day insertions. A number of accounts are participating in the consignment program today, and we expect the program will continue to grow, providing patients with easy access to Eversense. All in, Eversense is covered for approximately 250 million lives in the U.S. While ADC has ongoing efforts to further expand coverage, they are offering an attractive patient assistance program. Ascensia has further extended this program in two ways. It is now available for all commercially insured patients, regardless of coverage, and Eversense users can now use the program for two $99 sensors. This allows patients to wear and become familiar with the convenience and benefits of Eversense for a full year without worrying about co-pays or deductibles. And we believe this program will be important in expanding access to more people with diabetes. Similarly, on the reimbursement front, the Q1 implementation of the 2023 Medicare physician fee schedule has streamlined access to Eversense for Medicare patients. This is a population in particular who benefits from the features of Eversense, and we are pleased with the adoption that we have seen from this group. Shifting to our partners' efforts in Europe, here ADC is focused on addressing some of the challenges we have previously discussed. The changing market dynamics in Germany specifically have created European growth headwinds. ADC is taking action to transition the sales channel for Eversense and address reimbursement. While ADC continues to incorporate fundamental changes, we anticipate these challenges in Germany will persist. In other markets, such as Italy, we've seen positive growth tailwind throughout the quarter, driven by the recent and continued efforts of ADC's team. New tenders in Italy were won in the first quarter. This is our second largest European market, and we expect it will have a positive impact in the coming quarters. Overall, commercially in Q1, ever since system shipments were executed according to the plan, Ascensi continues destocking inventory as previously described, and we expect the distribution channel to normalize in the second half of the year. As E3 awareness and access continues to increase, the installed base of patients grew in the first quarter, and we expect continued growth for the remainder of the year. The majority of that growth is expected to come from the U.S. To drive further advancement, the primary focus of Senseonics is centered around innovation and our core implantable sensor technology. Propelling the Eversense system forward, we have described several products in development that we are excited about, including driving towards the market's first 365-day sensor. as well as the Gemini system and a revolutionary freedom system. A top focus for us right now is on extending the wear time duration of Eversense to 365 days. Patients enrolled in the expanded enhanced study have all completed 180 days of wear time. This keeps us on track with our plan to make an FDA submission for the 365-day product in early 2024. A component of the enhanced trial included approval to evaluate EverSense and a pediatric patient cohort, and we are pleased to announce that we have initiated enrollment for this important group. In addition to extending our market-leading duration, our teams continue to make significant strides in both our battery-powered systems, Gemini and Freedom. And as described in more length during our March presentations, we plan for both systems to offer patients increased flexibility, ease of use and simplicity, with the ultimate goal to remove the need to have any device on the skin, a top request for people considering using a CGM. With our unique Gemini product, we are designing to offer patients the flexibility of having both on-demand intermittent glucose monitoring as well as full real-time CGM. We are achieving important milestones in this development program. We have built the first functional sensors for the Gemini system, where the battery can power the sensor autonomously. We have started in vitro evaluation of these sensors, and so far we continue to be on track for the first in-human evaluation towards the end of this year. If successful, we plan to prepare for an IDE submission in early 2024. This all pays away for the third system in development, the Freedom System. We see this as the ultimate solution for glucose monitoring. Removing the need for an on-body component is the product feature most requested by patients. We believe that this product configuration would represent the most revolutionary development in CGM since our invention of a long-term implantable sensor and are excited to drive this development program forward. The next generation sensor configuration that is enabling Gemini and Freedom includes redundant sensing channels that lends itself very well as a multi-analyte sensing platform. We have started initial feasibility work on incorporating continuous ketone monitoring in addition to glucose as we understand the importance of ketone monitoring for people with diabetes and preventing further complications from ketoacidosis. We are very excited about the prospects of continuous glucose ketone monitoring and plan to explore other relevant analytes in addition to glucose in the near future. I'll now turn the call over to our CFO, Rick Sullivan, to go over details of our first quarter financials.