SENS - NASDAQ

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 Feffer from LifeSci Advisors. Please go ahead.

Thank you. This is Jeremy Feffer 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 31, 2024, 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. Today, we also have Brian Hansen, 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 Goodnow, 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 SweetSpot, as well as our ongoing progress with insulin pump manufacturers. Finally, Rick will run you through the numbers and then we'll take your questions. On September 17, 2024, marked the US 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 systems, 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 pipeline. Our development teams are working continuously to improve the patients' 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 Eversense 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 patient 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 Eversense 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 tech-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.

Thanks, Tim. I'm excited to be here with you today and share some of the metrics that we've been tracking during the US launch. As a reminder, there are four pillars to our commercial strategy for Eversense 365: direct-to-consumer marketing to drive awareness; marketing the healthcare professionals to build a network of physicians and nurse practitioners to prescribe and insert the sensor; collaboration and targeted account efforts with hospital systems provide system-wide access to Eversense 365; and as we build our installed base, it is equally important that we retain and renew our existing users. Four months in, I'm pleased with the interest both users and prescribers have shown in the Eversense 365 product and its advantages over short-term CGMs. Feedback has been positive as to the sensor's continued superior performance, increased wear time of one year, and the reduced calibrations to once a week, a true game-changer for the patient. We are also seeing increased access to new accounts with the introduction of the 365-day sensor. In 2024, we saw the majority of our prescriptions coming from first-time prescribers and this bodes well for future growth. While early interest and uptake metrics have been favorable, we recognize that we are early in the launch. So, we have to remain focused on driving increased awareness and adoption of Eversense in order to realize its promise. We continue to work directly with payers to transition our 180-day reimbursement over to the full year sensor. This is particularly important for the Medicare segment so that reimbursement is clear and straightforward for our providers. With that in mind, Ascensia and Senseonics are focused on awareness campaigns through direct-to-consumer and sales force efforts, working to grow sales to support updated reimbursement specifically to the 365-day product. We are driving strong sales execution, continued refinement of our marketing message and campaigns, which to date have been very well-received, and refining our customer service efforts to simplify the customer journey for the patients and the physicians we serve. Up to this point, most of the progress we've been reporting has been qualitative, but today let me share some more tangible quantitative key performance indicators with you. In 2024, our patient base increased 56% to approximately 6,000 global patients. Our target growth was 50%. We also exceeded 2,400 annual US Eversense prescribers during the year, a 73% increase over the prior year, and we saw direct-to-consumer leads increase by 40% compared to 2023, with average monthly leads more than doubling following the launch of 365 in Q4. We reached new patient shipments of over 3,000 for 2024 and saw an impressive number of patients switch to Eversense from competitive CGMs. Approximately 81% of our patient base have switched from other CGMs. We also continue to see strong growth in the Type 2 segment. 69% of our new users during the year were people with Type 2 diabetes. This launch is going well and it's clear that we are making a positive impact for patients and healthcare providers. Lastly, we are excited to begin planning activities for the upcoming 365 launch in Europe. We will be previewing the 365 day sensor in a few weeks at ATTD in Amsterdam. Positive feedback has definitely spread to our European users, healthcare providers, and our commercial teams. They will also benefit from the learnings we gleaned from the launch here in the United States. Thank you for your time. And with that, I will turn it over to Rick to review our financial performance.

Thank you, Brian, and good afternoon, everyone. We appreciate the opportunity today to update you on our financials and provide top-line revenue guidance for 2025. In the fourth quarter of 2024, net revenue was $8.3 million compared to $8 million in the prior year period. US revenue for the fourth quarter was $6.2 million and revenue outside the US was $2.1 million. As always, a quick reminder regarding our revenue recognition. Our collaboration agreement with Ascensia is for revenue sharing, with the percentage of revenue to Ascensia increasing based on duration of the contract and annual revenue levels. For most sales, we recognize our portion of revenue when shipments are delivered to Ascensia. This begins the multi-step distribution to patients via Ascensia and their distributors. We manage our manufacturing based on patient demand generated from commercial activities, targeting 60 to 90 days of inventory across the various channels. Therefore, our shipments to Ascensia during the quarter are largely intended to support future demand for Eversense. Following the launch of Eversense 365, we are still increasing inventory to reach target levels through the first half of 2025. We also sell product through an office consignment program. In 2024, we saw this consignment program continue to grow and now approximately 15% of our revenue flows through this channel. We have well over 100 healthcare providers participating in the consignment program, which enables a physician to have the product on the shelves and ready for patients. This program increases the convenience to healthcare providers and patients facilitating faster and even same-day insertions. In the consignment program, we recognized revenue at the time of the procedure. We also record a sales commission expense for Ascensia's support with sales and marketing efforts on revenue through this channel. In Q4 2024, gross profit was $4 million, an increase from a gross profit of $1.1 million in the prior-year period. This increase in gross profit was primarily driven by increased margins on the 365-day product but also includes the positive impact of approximately $1.6 million in manufacturing costs previously expensed to research and development expenses prior to FDA approval of the 365-day product. When we include these costs in our gross profit margin calculation, we would still see margins north of 25%. This is very encouraging considering that we still have limited manufacturing scale with it being so early in the product life-cycle that we only had US 365-day product sales for part of the quarter and that European sales continue to be the lower-margin 180-day product. Research and development expenses in Q4 2024 were $9.4 million, a decrease of $1.4 million compared to the prior-year period. The decrease was primarily due to a reduction in clinical study spend and consultant costs due to the completion of the 365-day product trials. Fourth quarter 2024 selling, general and administrative expenses were $8.9 million, an increase of $1.5 million compared to $7.4 million in the prior year period, primarily driven by personnel costs, consulting fees, sales commissions and legal expenses. Net loss was $15.5 million or a $0.02 loss per share in the fourth quarter of 2024 compared to net loss of $17.2 million or a $0.03 loss per share in the fourth quarter of 2023. Net loss decreased by $1.7 million, primarily due to improved gross profit margins of Eversense 365. For the full year, total revenue was $22.5 million compared to $22.4 million in 2023. US revenue was $15.3 million in 2024 compared to $14.1 million in the prior year and revenue outside the US was $7.2 million in 2024 compared to $8.3 million in 2023. Although total revenue was consistent from 2023 to 2024, we did see patient growth increase by more than 50%. This difference in patients compared with revenue resulted primarily from the revenue recognition treatment previously explained and inventory stocking at the end of 2023 that was utilized for new patients in 2024. Gross profit for 2024 was $0.5 million, a decrease from $3.1 million in 2023. The decrease in gross profit was primarily driven by $4.8 million in one-time charges as a result of the transition from Eversense E3 to Eversense 365, partially offset by an estimated reduction of $1.6 million in pre-approval of manufacturing costs previously expensed to research and development. Excluding these one-time product transition costs, gross profit margin for full year 2024 would be more than 16%. Selling, general and administrative expenses for 2024 increased by $4.3 million year-over-year to $34.2 million. The increase was primarily driven by personnel costs, consulting fees, sales commissions and legal expenses. Research and development expenses for 2024 decreased by $7.6 million from 2023 to $41.1 million. The decrease was primarily due to a reduction in clinical study spend and other research costs due to the completion of 365-day product trials. These savings were partially offset by pre-approval inventory costs associated with the manufacturing of the 365-day product. Net loss was $78.6 million or a $0.12 loss per share in 2024 compared to net loss of $60.4 million or an $0.11 loss per share in 2023. Net loss increased by $18.2 million, primarily due to a reduction in gains due to the exchange of existing notes and gains driven by changes in the fair value of derivatives. As of December 31, 2024, cash, restricted cash and cash equivalents totaled $74.9 million, and debt and accrued interest was $56.2 million. Subsequent to year-end, we have been busy simplifying our capital structure and improving our balance sheet. In January, the remaining outstanding 2025 convertible notes in the principal amount of $20.4 million were repaid, reducing the total principal debt outstanding to $35 million. Additionally, after year-end, all preferred stock has been converted into shares of common stock. The 12,000 shares of Series B preferred stock were converted into about 30.4 million shares of common stock at the end of January. The common shares issued have been included in our diluted earnings per share calculation since the preferred shares were issued. Finally, we received gross proceeds of approximately $27 million from the sale of common stock by utilizing our at-the-market facility, which we expect will extend our cash runway into mid-2026 based on our current operating plans. Turning to our outlook for 2025, we expect full year 2025 global net revenue to be approximately $34 million to $38 million as we continue to transition US patients to Eversense 365 following its launch in Q4. The financial outlook takes into consideration several factors, including: the timeline for the regulatory approval and the planned commercial launch of Eversense 365 outside the United States; continuing work to transition US reimbursement from Eversense E3 to Eversense 365; plans with respect to spending on the US direct-to-consumer marketing campaigns to generate leads; and the status of other sales and marketing initiatives. Also, we expect greater seasonality in our business with Eversense 365, influenced by annual insurance deductible limits and out-of-pocket cost resetting in January and the resulting utilization of patient assistance programs to offset those costs. We expect to see a noticeable impact to our average selling price and, therefore, our revenue and gross profit margins in the first half of each year as we account for the patient assistance program as a reduction to revenue. We anticipate notably more favorable average selling prices and therefore gross profit margins in the second half of the year. The full year 2025 financial outlook assumes approximately doubling the global patient base in 2025 compared to 2024. We expect patients to grow steadily throughout the year, but as a result of the seasonality and program impacts previously described, we expect our revenue to be about one-third in the first half with the remaining two-thirds of revenue in the second half. We are excited about the unit economics of Eversense 365. Gross margins are expected to steadily increase each quarter in 2025 with full year gross margins projected to be between 25% and 30%. We are also focused on continuing to be cost-conscious and expect cash utilization in 2025 to be between $50 million and $60 million. With that, I'll turn it back to Tim.

Thanks, Rick. After hearing from Brian and Rick, you can see why I'm excited about Senseonics' growth potential in 2025. We have strengthened our balance sheet and we are performing well on key performance indicators for the 365 launch in the US. We plan to commercialize Eversense 365 in Europe this year, and we continue to build on the Eversense 365 technology platform to deliver Gemini and Freedom to patients in the upcoming years. The successful initial launch of our 365-day product represents one of the most significant catalysts in the company's history. And we're looking forward for 2025 to be another transformational year for the company. The CGM market remains one of the most exciting spaces in medical devices. Our technology offers unique solutions to help people manage their diabetes. There is a large opportunity in front of us as we work to continue to simplify the lives of more people with diabetes and drive higher growth to build shareholder value. In addition to Rick, Brian, and myself, joining us for questions today is Mukul Jain, our Chief Operating Officer. Thank you all for your time today. Operator, let's now open up the call for questions.

[Operator Instructions] And we'll take our first question from Mathew Blackman with Stifel. Your line is open.

Hey, Rick. Hi, Tim. A quick question on the OUS launch planned for later in the year. You've had a couple iterations with 180 and 365 in the US, and we've seen these inventory building dynamics happen. What should we expect when you take it OUS? Should we expect a similar type of inventory stocking, or is that going to be a more gradual thing that you do over time?

No, we anticipate that it will be more gradual, as Rick already alluded to. Even building in the US, we do expect it to be, frankly, three or four more months before we get to the planned level. And in Europe, we would plan to build pretty conservatively as well.

Got you. And then, quickly on Mercy, now that you guys have been inserting 365-day sensors for around a quarter now at least, how -- what are you seeing on the ground relative to what you've seen in other offices? And how are you thinking about the prescriber base going forward, whether it be people in the Mercy system, endos, PCPs, what are you seeing with regard to 365-day insertions? Thank you.

So, from the patient and physicians, there continues, of course, to be a lot of excitement around 365 as we talked about. The use attributes, the once-a-year sensor, and the single calibration a week continue to win the day for us. We have transitioned from the early work we did was on the endocrinology side with the Mercy system and we have opened it up for about the last month to primary care, which is frankly where we expect to see most of the patients coming in as these are predominantly Type 2 patients that are either on MDI or basal insulins. So, there is quite a bit of reach-out that we need to continue to do as we've expanded to the much, much larger population. So, we'll certainly continue to work on that over the next coming quarters. We're encouraged with the early signs that we're seeing, but also do have quite a bit more work to do as we go to the broader prescriber population.

Thanks for taking my questions. Congrats on the nice quarter.

Thank you.

We'll move next to Matt Taylor with Jefferies. Your line is open.

Hi. Thank you for taking the questions. So, I had a couple. One was, I was hoping just to clarify, I think on the pre-announcement a few weeks ago, you had said you had over 1,000 prescribers in the US. And then, in this one, you talked about 2,400. So, was it over 1,000 just in precise, and 2,400 was where you were a month ago, or have you had a large increase in the prescribers in the recent weeks?

We certainly had an increase not to that size. Rick, do you want to go ahead and clarify the numbers?

Yeah. I think the 1,000 was prescribers since launch, where the 2,400 was an annual number of prescribers. So, that's probably the difference that you're seeing.

Okay. And just on the guidance and with the dynamics in Europe and the US, could you talk to how much of the revenue growth you expect to come from international versus the US? And what should we -- could you help us with the forecast in Europe before you launch the new product?

Certainly, most of the growth will continue to come from the US as we've seen is -- in 2024. That said, we do expect at a significant rate of increase when we launch the 365-day product in Europe in the second half of the year. So, most of the investment with Brian and his team is in the US initiatives, but we will certainly ramp those up as the new product becomes available and, in Europe, when we get that CE Mark.

Maybe I'll just squeeze in one more, just on the prescribers. I mean, just thinking about those numbers, it seems like rough estimates you're seeing about and per prescriber in the US in terms of what you're forecasting. I was just wondering if you could comment on kind of the shape of your prescriber base. Are there some really heavy prescribers? Are you seeing both do that kind of average? Or what does that look like?

It's truly a distribution. Brian, do you want to speak to that?

Yeah, I do think that's the proper answer. Because we do a lot of direct-to-consumer advertising, about half of our inbound business is from direct-to-consumer advertising. We do get a lot of new prescribers. We get a lot of the primary care physicians where that patient is expressing interest from and therefore we connect with that physician, and quite honestly, then they become a new prescriber. We do have a couple of very large clinics that have multiple prescribers in them and they are doing a much higher volume. So, the goal, obviously, is to take those individual onesie, twosies, and now that we've driven awareness through capturing a patient or two in their practice, make them bigger prescribers, believers bring them on board. And then, there is some in the middle clearly, an endocrinologists just doing six, eight, 10 here or there, but it is truly a distribution throughout with a couple of very large ones and a lot of ones, twosies, especially on the new to Senseonics for us Type 2s.

Got you. Okay. Great. Thanks for the color. That's helpful.

We'll move next to Marie Thibault with BTIG. Your line is open.

Hi. Good afternoon. Thanks for taking the questions. Wanted to ask here for just a more qualitative or detailed update on the reimbursement efforts, especially at Medicare. What is sort of -- where are we in the transition to the 365 day? I know there is always a little bit of details that need to be worked out. So, when in the year do you expect that the majority of Medicare patients will be able to get the reimbursement for 365?

It's a good question. We're actually working on that arduously right now, Marie. We actually have -- the G-codes has been published. So, reimbursement is available to all patients on Medicare. What we're actually working with is the MAX on the pricing for that. So, there was a process that we we're going through. We certainly -- some of the government dynamics that are going on in regards to ability to meet are impacting that schedule. But we're continuing to push through and get that data pricing all in place. So, we're working with the prescribers and the reimbursement we're doing at ourselves with our Eon Care Services. So, we have the coverage, we're working on the pricing level. And I anticipate that will get resolved over the next quarter or so.

Okay. So...

Brian, I don't know if you want to add anything about it -- right. Brian, I don't know if you want to add anything more on commercial plans. We certainly have had some success, but we've also got some more working on there as well.

Yeah, I think that's spot-on.

Okay. Great. And then maybe I could ask for a little bit more quantitative detail as well on the spending side. You've talked about cutting about $10 million year-over-year on cash OpEx. And I know, of course, R&D and things, there might be some investments coming near the year-end with Gemini. So, just help us think through the cadence of some of this, especially as you go DTC, do some of these efforts, how we should be thinking about the OpEx cadence throughout the year? Thanks for taking the questions.

Sure. And remember, Marie, as I know you're aware, right, the sales and marketing expenses are coming from -- predominantly from Ascensia. So, we won't be speaking to that to their part of the contribution. But Rick, I'll let you go through the cadence of expense for us, mostly driven by that R&D work.

Right. From the SG&A perspective, Marie, it's pretty linear across quarters. It does increase slightly with those sales commissions that are a result of the consignment program and that success. And then, from an R&D perspective, when we start the Gemini and Freedom -- or Gemini pivotal trial, once we get that ID approval later in the year, there will be a slight increase to R&D.

And it does appear that there are no further questions at this time. I would now like to turn it back to management for any additional or closing remarks.

Well, great. I'd appreciate everybody's time this afternoon. I appreciate everyone's excitement about 365, we certainly are. And as you've heard, our focus absolutely is continuing to build the best product we can. Obviously, quarter-by-quarter revenue performance is important for us, but the long-term picture here is to have this highly-differentiated product and make it as absolutely successful as we can, both with the current 365 and the future generations Gemini and Freedom that we are very excited about, and we know that many are in this space as well. So, we look forward to continuing to report on that, our progress with our pump partners, as well as the future progress with Gemini and Freedom, and we look forward to updating you in the coming quarters. So with that, thanks all.