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.

Thank you, Tim, and good afternoon, everyone. We appreciate the opportunity today to update you on our business. In the first quarter of 2023, net revenue was $4.1 million compared to $2.5 million in the prior year period. U.S. revenue for the third quarter was $2.1 million and revenue outside the U.S. was $2 million. As a reminder, Senseonics recognizes revenue based on our revenue share. When shipments are delivered to Essentia, initiating the multi-step distribution to patients via Essentia and their distributors. Gross profit in Q1 2023 was 0.4 million, a decrease of 0.1 million from a gross profit of 0.5 million in the prior year period. Gross margins were in line with expectations for the full year. Research and development expenses in Q1 2023 were 12.4 million, an increase of 4.6 million compared to 7.8 million in the prior year period. The increase was primarily due to investments in our product pipeline for development and clinical trials of next-generation technologies. First quarter 2023, selling, general, and administrative expenses were 7.7 million, a decrease of 0.2 million compared to 7.9 million in the prior year period. The decrease was a result of reduced personnel costs and other general and administrative costs. For the three months ended March 31, 2023, operating loss was $19.7 million compared to $15.2 million in the first quarter of 2022 due to the increased investments in research and development. The decrease in the company share price at the end of the first quarter as compared to the company share price at the end of Q1 2022 and the exchange of the PHC notes led to non-cash gains in Q1. As a result, total other income decreased by $80.8 million compared to the prior year period, primarily related to non-cash charges resulting from the accounting for embedded derivatives, fair value adjustments, and the PHC note exchange. As required by U.S. generally accepted accounting principles, we mark the value of these instruments to market for each reporting period, and the changes in these values are recorded as non-cash charges to the income statement. Each quarter, the value of these non-cash gains or losses will vary based on the volatility in the company's share price. So generally, as share price increases, we incur a non-cash loss, and as the share price decreases, we recognize a non-cash gain. The magnitude of these non-cash gains and losses will be less in future periods as a result of the 2023 note repayment and exchange of the PHC note, eliminating several of the embedded derivatives. For the three months ended March 31, 2023, total net income was $1.3 million, or $0 per share, compared to net income of $86.7 million, or $0.19 gain per share, in the first quarter of 2022. Net income decreased by $85.4 million due to the accounting for embedded derivatives, fair value adjustments, and the exchange of the PHC notes previously mentioned. In 2020, PHC invested $35 million in the form of a convertible note, and Senseonics also received an option to sell PHC up to $15 million of convertible stock that would have resulted in the issuance of approximately 96 million shares. We're very pleased to have exchanged the $35 million convertible note and to have received an incremental $15 million investment for approximately $84 million warrants. This reduced dilution by 12 million shares compared to if we had exercised the option to sell shares under the pricing of the previously disclosed 2020 agreement. The incremental investment strengthens our partnership with PHC and the exchange of the note will save us over $4 million of cash and interest expense that we plan to use to further our development programs. As of March 31, 2023, cash, cash equivalents, and shortened long-term investments totaled $136.6 million. Turning to our outlook for 2023, we are reiterating our full-year 2023 global net revenue to be in the range of $20 million to $24 million. Our guidance reflects three factors. Expected patients' growth, which is expected to accelerate in the back half of the year, continued destocking from ADC through the second quarter, leading second quarter's revenues to be in line with the first quarter, and a decrease in sentient share of the Eversense revenue under the collaboration agreement in 2023 compared to 2022, based on both sales growth and being further along in the partnership. For gross margins, we continue to expect full year gross margins to be between 7.5% and 12.5%. The year over year decrease in our gross profit margins are the result of the decrease in our share of ever since revenue. For the full year 2023, operating expenses are expected to increase compared to 2022 based on investments in research and development targeted to complete the adult 365-day trial, the beginning stages of the pediatric trial, and investments in our future products, Gemini and Freedom. With that, I will turn it back to Tim.

Thank you, Rick. In the first quarter of 2023, we are pleased with the initiatives that the team at our global commercial partner, Essentia, and our team have undertaken to expand our commercial reach and awareness, including facilitating increased access to Eversense. and further develop our product pipeline. The team at ADC is committed to driving awareness of our Eversense E3 sensor through increased DTC investment and expanding its U.S. commercial organization by onboarding several additional sales reps. Our collaboration with the nurse practitioners group has stretched across more U.S. territories, supporting our hub-and-spoke model and facilitating patient and HCP convenience through our at-home or in-office insertions. Looking ahead, we are very excited about the progress with our ongoing clinical trial for the 365-day system and our Gemini product advances, as well as the Freedom product development. With each program, it's intended to transform the diabetes market. While reaching for these goals, we continue to work to improve our manufacturing margins and operational execution. We believe we are well positioned to grow our franchise to create shareholder value and look forward to updating you on our progress in the future. Thanks for your time today. Also joining us for question is Mughal Jain, our Chief Operating Officer. Operator, let's open up the call for questions.

Yes, thank you. At this time, we will begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, Please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble the roster. And the first question comes from Marie Thibault with BTIG.

Hey, good afternoon, everyone. This is Sam Iber on for Marie. Thanks for taking the questions here. Maybe I can start on the added sales force from Essentia. I just want to try to understand the pace of new ads throughout the year. Is that something where we could see maybe a bolus to start or is it going to be more evenly weighted throughout this year?

I think it'll progress fairly evenly weighted, you know, pretty much over some of it's already actually begun and into the second quarter. I would anticipate that the majority of that should be finished through the second quarter. but our experience has typically been it's a couple of quarters of learning, training, coming up to speed before they're really highly contributory. So we expect it to happen pretty quick, but there is some typical ramp-up time.

Right, okay, that makes sense. And then, you know, it's been a couple of quarters now since E3's been commercial here in the U.S. I guess, any insights in terms of how those first groups of patients what those repeat rates are looking like?

Yeah, we've continued to see the 70% to 75% transition from first to second sensor. And as you go beyond, it just incrementally gets better with each sensor transition. So I don't think there's been a material change in that, really, since the original 90-day product.

Got it. OK, so it sounds like nice, sticky adoption here. Thanks for taking the questions.

Great. Thank you, Sam.

Thank you. And once again, please press star and then 1 if you would like to ask a question. And the next question comes from Matthew Blackman with Stifel.

Hey, guys. This is Colin on for Matt. I believe E3 has been reimbursed differently than competitors' transcutaneous sensors, so I'm curious what the pathway is. to reimbursement looks like to participate in the basal-only opportunity, first through this first Medicare tranche of patients, and then later through commercial payers in the U.S.?

Yeah, so Medicare, through the physician fee schedule, has established payment for ever since as what we call the global payment model. So that's the combined purchasing of the product as well as remunerating the medical professional for actually doing the insertion and removal itself. And in consideration of what's encouraged, you know, Medicare and the MACs have established the rate for that. You know, we are encouraged and think that that's an appropriate investment for the product and the procedure. On the commercial pay, we continue to see reimbursement that's been pretty consistent with the With the general market for CGM at about $4,000 per year for the patients on the commercial pay side.

And with the physician fee schedule being implemented this January, I'm curious about the Medicare patient mix in the first quarter and if that's changed significantly since the end of last year.

We're certainly seeing an increase. You know, we ended last year at about 52%, and we do see the index greater towards type 2 as we evolve. I don't have an update through the quarter as of yet, but my expectation is it would be a couple of points higher than that just based on the blended growth that we're seeing.

Great. Thank you.

Thank you. And the next question comes from Jason Bedford with Raymond James.

This is Glenn Schell on for Jason. And I just had a question about the ICGM data being submitted to the FDA. Previously, we have it that you said end of 2Q. Did that get submitted this or will that be submitted this upcoming quarter?

You want to speak to where we are?

Yes, I can take that. Hey, this is Mukul. Yes, we are very much on track to finish up the ICGM. The patient data has been completed, we are cleaning up the data, the clinical team is cleaning up data, and we expect it to be in front of FDA in the coming months. Then the review process should take us to the end of the year where we expect approval.

Okay, wonderful, thank you. And I just had one follow-up question. From your Investor Day 4Q, you said that around 70% of your users are coming from other CGM platforms. Does that still hold true?

It does, yeah, that's consistent.

Okay, thank you very much.

Thank you. Once again, press star and then one if you would like to ask a question. Okay, and as there are no more questions at the present time, this does conclude both the question session as well as the call. Again, thank you for attending today's presentation, and you may now disconnect your lines.