Senseonics Holdings (SENS) Q3 2025 earnings call transcript

Thank you. This is Jeremy Pfeffer from Lifestyle 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 10-Qs 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 Goodnow, President and Chief Executive Officer, and Rick Sullivan, Chief Financial Officer. I'll now turn the call over to Tim.

Thanks, Jeremy, and I appreciate everyone's time joining us today. As mentioned in our earnings release earlier today, the third quarter was truly exceptional for Senseonics. We're pleased to see the growth in interest and adoption of Eversense 365, supported by Senseonic's DTC campaign and sales efforts. Our third quarter revenue grew by 90% from Q3 last year. During the quarter, we also executed a memorandum of understanding with the Sensea Diabetes Care to reassume control of Eversense commercialization. We are excited about the upcoming change and seeing it as enabling us to control the strategy and investments into building ever since.

Through this change, commercialization efforts will continue to be led by Brian Hansen, who has been appointed as Chief Commercial Officer of Senseonics. I'll provide some additional details on the progress we've made with the Ascensia CGM Division in a few minutes. But first, I'll share some additional accomplishments from the third quarter.

This time last year, we committed to doubling the number of patients on ever since in 2025, and we are on track to achieve that goal. The 90% year-over-year revenue growth in the third quarter was driven by 160% in new patient shipments for the quarter over the prior year period. These growth numbers are a testament to the effectiveness of our direct-to-consumer marketing, which we continue to invest in, driving demand with patients asking their physicians to prescribe the world's only 365-day continuous glucose monitor. During the quarter, we made meaningful DTC investments to augment Asensia's spend, leading to an increase in patient leads through our digital campaigns of 300% year-over-year and 85% sequentially.

Approximately 60% of our new patients in Q3 originated from our DTC advertising and 40% from HCP referrals. A historically larger portion now coming from BTC due to the scaling of our direct-to-consumer strategy and investments. We will continue to invest in direct-to-consumer marketing, primarily through social media. Our increased spending has directly contributed to our increased number of leads, prescribing referrals, and prescriptions written. In the third quarter, we continued to break records for the most new patient starts, with September being our highest number of new patient starts in a month and Q3 being our highest quarter in the company's history.

New insertions increased nearly 150% year-over-year and more than 50% sequentially. As a result, our installed base grew over 150% year-over-year and nearly 40% sequentially, reflecting accelerating adoption of Eversense 365 among both patients and providers. As expected, reorder volumes were minimal for the quarter following the one-time transition to the 365-day sensor. This means that essentially all of those patients inserted with Eversense in the quarter were new users.

In Q4, with the first 365 adopters coming up for reinsertion, reorders will make a more meaningful contribution to sales.

Our HCP channel continues to expand and deepen engagement as well. The number of providers actively prescribing ever since grew more than 55% year-over-year, reflecting broadening awareness and confidence in the 365-day system. Importantly, we added 75 new trained inserters in the quarter, 140% more than the same time last year. The capacity of our inserter network continues to expand, ensuring continued access and scalability as demand accelerates. Many of these new patients that we added are now supported by our EonCare direct insertion business, which provides greater access to Eversense through our network of providers.

EonCare delivered a standout quarter, advancing its role as a key strategic driver of insertion capacity, access, and standardized patient experience. While still early in its development, Ion now represents approximately one quarter of all insertions nationwide, and we continue to expand Ion's capacity by adding significantly more inserters in the network in Q3.

Ion is a central enabler of nationwide access and adoption. Patients love the convenience and affordability, and prescribers appreciate having a trusted, certified Eversense inserter they can refer patients to. We will continue to expand Eon's capacity in Q4 and beyond as it becomes an increasingly important enabler of Eversense growth.

In new product development, our CE mark application for Eversense 365 in Europe was submitted in February. And while in the final stages of review, we continue to expect to receive the approval before the end of 2025.

Approval in Europe is anticipated to support additional growth beginning with our planned launch in the first half of 2026, now utilizing our own Senseonics European sales force after the transition away from the Asensia BGMT. Prior to the European launch of 365, we expect to work with Asensia through transition service agreements while we set up our own infrastructure to support a smooth transfer of some employees, the hiring of new CGM-dedicated sales reps, and transferring current customer contracts and tender agreements. In contrast with the U. S. commercial integration, which we expect to be in place by January 1st, the European transition will be taking place in the first half of 2026 with support from ADC.

We are currently finalizing these arrangements with Asensia and planning this transition in a collaborative process. We've made good progress since the announcement in early September. Nearly all of the employees from ADC's U. S. CGM business have elected to join the Senseonics team for the planned transition on January 1st, including Brian Hansen's leadership team. The European CGM employees are expected to transition over later in the first quarter. The sales operation team has been extremely busy getting our CRM system up and running, and many of our distribution agreements between the distributors and Senseonics are already in place or in the process of being transitioned.

We appreciate the cooperation between the Senseonics and EDC teams for working hard to ensure that we get this right for the patients and the providers. I'm pleased with the execution that's taken place over the past 60 days to bring a CENCIA's CGM business into Senseonics.

Our partner, Sequel, is working towards expanding its launch of the Twist insulin delivery system and to include compatibility with EverSince365, representing another top-line growth driver for us in 2026. As a first pump integration, we're excited for the opportunity to be part of the closed-loop system, with Sequel's Twist Pump making insulin delivery decisions based on the data received from EverSense. We expect this closed-loop system to allow patients to forget about glucose monitoring for an entire year, as their EverSense 365 communicates directly with the Twist for real-time adjustments in insulin delivery. Beyond SQL, we hope to make additional announcements on insulin pump integration in the coming quarters.

In addition to the integration work, our R&D team remains focused on delivering our seminal pipeline of products, Gemini and Freedom, with the IDE for Gemini on track to be submitted in the fourth quarter and the U. S. approval still planned for late 2026. We expect to file the IDE for freedom in the second half of next year with a commercial launch of our truly invisible, transmitterless 365-day CGM targeted by early 2028.

I'd also like to highlight the margin improvements that Rick will speak to. We are currently seeing meaningful improvements from the 365 product and expect to see even more as a result of the commercial integration. Based on what we've seen in the first three quarters of 2025, we are on track to head out of the year with gross profit margins now north of 40%, compared to 25% at the end of 2024, based on the benefits and performance of ever since 365.

And we expect our transition with ADC to further positively impact our margins. As noted when the deal was announced, we currently project that our gross margin would grow to roughly 50% in 2026 and reach approximately 70% at scale for the unified business.

Hopefully, this update on our growth drivers and our strong performance during the first year of the Eversense 365 launch gives you a good sense of where we are headed. To continue to drive shareholder value and meet the needs of our patients and providers, we remain committed to expanding access to our unique system and continuing to advance our technology to simplify glucose testing for people with diabetes.

I now turn the call over to Rick to walk through the Q3 financials highlighting revenue growth margin improvement cost reduction and steady progress on execution Thank you Tim and thanks to everyone joining us this afternoon First of all, this has been an extremely busy quarter for Senseonics, and I'm grateful for all the team has achieved this quarter. Since announcing our plans to reassume CGM commercial operations from Asensia Diabetes Care, We've made enhancements to the CRM system, expanded our ERP system, planned the transition of most of the necessary contracts with U. S. distributors, and have offers accepted from almost all of the U. S. employees joining Senseonics from Asensia.

We continue to invest in DTC advertising, and as we've said previously, we plan to continue this spend for the foreseeable future. This investment has been extremely helpful in driving awareness and adoption, as evidenced by our strong top-line revenue growth.

As you may have seen, with support from our shareholders, we executed a reverse stock split. This was an important step for the company, as we had the opportunity to speak with many investors that were interested in the story, but were unable to invest in a sub-$1 stock. The reverse split enables access to new large investors and significantly simplifies our cap table. Following the split, we currently have approximately 41 million shares of common stock outstanding. Now transitioning to the quarterly results. In the third quarter of 2025, net revenue grew 90% to $8.1 million compared to $4.3 million in the prior year period, on the strength of top-line Eversense 365 U. S. revenue. U. S. revenue for the third quarter was $6.4 million, and revenue outside the U. S. was $1.7 million.

Also, as a quick reminder regarding revenue recognition, through our collaboration agreement with Ascensia, we recognize a portion of the Eversense revenue under our revenue sharing agreement. With the expected transition from Ascensia distribution, we anticipate that we would recognize 100% of revenues due to elimination of the revenue share. Without the collaboration, reported revenue in Q3 would be nearly 20% higher based on the current channel mix, and we expect a similar channel mix going forward.

We also sell products through an office consignment program, which continues to grow, now making up over half of our global revenue in Q3. In this channel, we recognize revenue at the time of procedure and at the same time record a commission expense to sales and marketing expenses based on the current revenue sharing percentage for Ascensia's commercial support, which we also anticipate being eliminated on January 1st. In Q3 2025, gross profit was $3.5 million, an increase of $7.5 million from the prior year period. This increase in gross profit was primarily driven by the one-time charges incurred in the prior year as a result of the transition from ever since E3 to ever since 365, as well as more favorable margins on the 365-day product sales.

Research and development expenses in Q3 2025 were $7.8 million, a decrease of $2.7 million compared to the prior year period. The decrease was primarily due to the completion of the Eversense 365 system clinical trials and development efforts, as well as a reduction in headcount. Third quarter 2025, selling general and administrative expenses were $15.3 million, an increase of $7 million compared to $8.3 million in the prior year period, primarily driven by higher selling and marketing personnel costs, promotional expenses mainly due to the DTC investments, sales commission expenses to Ascensia as we increased consignment sales, and other general and administrative costs.

The net loss was $19.5 million, or a $0.43 loss per share in the third quarter of 2025, compared to a net loss of $24 million, or a $0.77 loss per share in the third quarter of 2024. Net loss decreased by $4.5 million, primarily due to improved gross margins of ever since 365 sales in the United States and the overall reduction in research and development costs. We now expect full-year 2025 global net revenue to be approximately $35 million as we progress the launch of Eversense 365 in the U. S. This financial outlook takes into consideration several factors, including the timeline for regulatory approval and the planned commercial launch of Eversense 365 outside the United States, plans with respect to spending on the U. S. DTC marketing campaigns to generate leads, continued progress in our launch activities, reinsertion and pricing dynamics with the shift from a 6- to 12-month product, the status of other sales and marketing initiatives, and importantly, this excludes any one-time accounting adjustments related to the technical review of the final Ascencia agreement, including the transition of inventory back to Senseonics during the year.

The full-year 2025 financial outlook assumes approximately doubling the global patient base in 2025 compared to 2024. We achieved our target of approximately one-third of planned annual revenue in the first half of the year, with the remaining two-thirds of revenue expected in the second half because of the steady increase in patients and the seasonality of program discounts and patient deductibles. We expect the majority of revenue in the fourth quarter due to the continued momentum in new patient starts, and importantly, reorders from our first U. S. 365 patients as we pass the first anniversary of our Eversense 365 launch. Excluding accounting adjustments and one-time benefits that have a positive impact to gross profit margins, we continue to see favorability due to our sales channel mix and the execution of our manufacturing and supply chain teams.

We are continuing to monitor the impact of tariffs and currently expect that we'll be able to mitigate much of the negative impacts. Taking into consideration our margin performance to date, the anticipated continued favorability, and excluding favorable accounting adjustments, we now expect full-year gross profit margins to be between 35% and 40%. As Tim mentioned, we are excited about our margin expansion next year as a result of bringing the commercialization of ever since back to Senseonics and expect gross profit margins north of 50% next year growing to approximately 70% or more with scale. It is still too early to provide guidance for 2026 at this time, as we execute the transition of the commercial team and work closely with them on our financial plans, considering balanced investments in DTC, Salesforce expansion, other commercial programs, inventory balances across the various channels, and inventory transitioning back to Senseonics, depending on the final agreement with Asensia.

We intend to provide initial 2026 guidance in early January. We continue to expect cash utilization in 2025 to be approximately $60 million, largely as a result of tight cash management while meaningfully contributing to the DTC spend. Our September 30th cash, restricted cash, and cash equivalence balance was $111.3 million, and debt and accrued interest was $35.3 million.

With that, I'll turn it back to Tim.

Thanks, Rick. These are exciting times for Eversense and the accelerating growth of our revolutionary 365-day product. We are seeing significant new patient additions and top-line growth due to expanding awareness and adoption of Eversense 365 in the U. S. BTC investments are paying dividends as more people become aware of the compelling benefits of our product. Our margins are improving, the sales force is gaining traction, rep productivity is improving, and we are now entering a cycle where renewals will contribute to the sales as the initial 365 patients restart the clock on 365 days of carefree continuous glucose monitoring. The Gemini and Friedrich programs are advancing, and our European approval is on track, as is our compatibility with Sequel's Twist Insulin Pump.

We are making good progress in executing the transition to resume control of ever since commercialization and look forward to our full independent direction in a couple of months. Overall, this was a record-setting quarter, highlighted by all-time highs in new patient shipments, insertions, and installed base. Our hybrid BTC and provider model, amplified by EonCare's growing network, continues to accelerate awareness, access, confidence, and growth ever since 365, and positioning us for sustained growth heading into 2026.

Thank you all for joining us today and for your continued interest. With that, I'll now turn the call over to the operator to answer any questions that you may have. Operator, let's go ahead and open up the call for questions.

Sure, Matt. Appreciate the time as well. So, overall, geographically, it's a very nice distribution as, you know, we are certainly focused on, obviously, the highest prescribing, you know, best reimbursement, highest insulin utilization. So you know no one locale I would say is driving it but we are definitely seeing and we gave a hint to it is we are seeing a significant growth in the number of switchers So as you may recall we typically saw about 75 were folks that were coming from existing CGM and now with its increased DTC we seeing that right around at 90 So we clearly are reaching out to the folks that are currently on CGM I would say of those switchers, it's probably 60%, 65% coming from Dextom, and 35%, 40% coming from Libre.

So good distribution there. Typical demographics, we're still seeing a nice utilization and interest in the Medicare space, with probably, you know, two-thirds of it still coming from commercial pay. So hope that helps. Yeah, absolutely. And then just on the follow-up, the integration with Twist, maybe if you could talk a little bit about how that ramps. I know Twist and SQL are now kind of ramping up their launch. You know, maybe give us a sense of when you think and expect that'll start to make a note, you know, a measurable contribution that we can start talking about and recognizing in the numbers. Thanks again.

Yeah, Matt, we are excited about that opportunity in 2026. You know, they are still executing on some of their early launch activities. So our expectation at this point is that our first patients will go on early in the first quarter, and that we would ramp from there. We've got a number of our large sites that are very interested, but there does need to be enough capacity on the pump site to support all of that. So my expectation is that for the first couple of quarters, it may be gated by the pump availability, but expecting that later in the year that that will be an expansion. And certainly, we are excited about the work that we're doing with SQL.

We are working with them quite close. You know, we've got a number of joint accounts that we're already calling on. So expect that to be a bigger part later in the second half of the year.

That's great. Well, congrats again, and thanks so much for the color.

Yeah, so, Josh, as we've spoken, the EON is an important part because it really, you know, helps fulfill the need for our expansion, really in a lot of the primary care focus. When we go out and offer the opportunity to train on doing insertion, of course that's driven by the clinician's perspective. You know, many have an interest in doing it themselves, and they'll institutionalize it. We'll do the training on them, and we saw growth certainly in the quarter in that population of folks.

For those that don't have an interest in bringing it in, and we're seeing that in some cases in primary care where we're getting some of our new Medicare patients from, they don't yet have the installed base to go through. That's where the neon care works extremely well. So we'll have a nurse in the area that they can refer to, somebody that has a nice connection with the, you know, with the patients and with the clinical staff. And, you know, we can work hand in hand to get that all coordinated to really help with a white glove type handoff and treatment. And there are some folks that have recognized the attractiveness from the CPT code, and some of our largest prescribers and utilizers come from those as well.

So they're more than willing and more than happy to institutionalize that insertion process, and that certainly continues to grow for us as well. We've got a number of very large accounts that are concentrated on it because they see the benefit of ever since for the patients, but also being able to control that whole insertion process and be appropriately remunerated for it from the CPT codes is attractive for them as well.

Sure. We are still more heavily weighted towards the endos, but the PCPs is certainly growing primary care, you know, especially with that Medicare expansion. I don't have the exact numbers, but I can certainly get that and get back to you, Josh, on it.

Yeah, I do expect to continue to transition. I would say the first half of the year, we had a couple of large payers that transitioned, United, of course, being the largest. That was one of them that went to the bundle payment. But, you know, I would expect that to continue to go as well. We are still working on the Kaiser partnership, and I would anticipate it will go in that direction as well, which would be in 2026. But otherwise, I do expect because of the one-time use per year, it is more, you know, consistent with that buy-and-build approach, and obviously we'll continue to support that. There are a fair number of folks that continue to, of course, offer it to the DME channel, and we support those with our distributors, and we'll work as best works for those payers, whether it's in that consignment buying bill or the traditional DME commercial.

So right now, as you heard us say, it's about half and half, but we do expect that consignment channel to grow faster in 2026.

Great. Thanks again.

Yeah, so we've definitely seen progress, Anthony, as you've heard of the DTC. You know, clearly awareness is an area that we can invest in and continue to grow. And it's exciting to bring those new patients to the product. You know, I would anticipate that the level of DTC that we've invested in 2025 will materially be We'll be consistent in 2026. We'll, of course, gate it to the buying patterns. As you'll recall, the fourth quarter is really the largest, especially for a more expensive piece of medical equipment with new deductibles and so forth in Q1. It tends to soften a little bit. So I do expect that to be a material part of the combined investment that we're going to make as the new Senseonics after January 1st, and we do expect that it will continue to show good positive trends for us.

Yeah, I would say, as you're aware, you know, the guidance that we've given calls for a very material Q4. And certainly, you know, October appears to be no disappointment in heading us down that path, which is obviously the basis of us giving that very big guidance. You know, from a supply perspective, there's certainly no issues on the management side. We continue to supply.

Finally, you know, from a competitive perspective, as I said, I don't know really where it comes from. I think the majority of it, honestly, is the reach, right? As we get awareness up higher and higher with that DTC investment in our way to, you know, the first people that typically respond are those that are currently on a product. They may be looking for some element, whether it's duration, the approved accuracy that we have, or just that long-term, you know, put the sensor in and enjoy it for the next 365 days is really attracting people over to it. So, no supply issues, certainly no de-stocking. As Rick has told you, we, you know, Senseon's kept about 60 days worth of supply in the channel.

You know, we're going to work to tighten that up in 2026, but there's been no impact in 2025. Basal only continues to be very interesting for us A good portion of our Medicare patients are of course basal only And those that we convinced to try the product have been very excited with it and very happy with the performance It does take a little bit longer to do the sale on the basal only patients just because they coming from more of a naive position on CGM where, of course, anybody that might be on a pump or even MDI is just further up that technology learning curve.

Yeah. Hey, John. Thanks for the question. So, you know, as I think about it, and I alluded to briefly in my prepared remarks, there's likely going to be some inventory dynamics. I've mentioned before with Asensia holding somewhere between 60 and 90 days between them and the other sales channels, and we're going to reduce that. We're going to be closer to 30 days, so that means there's one or two months of inventory in the channel that we won't recognize revenue on for next year. So we're not going to see the full 20%, so it's not as simple as that. But we will see the margin improvement that I've talked about for everything that we do sell, so we will see those margins up at 50%.

I think we talked about it briefly, excited to launch the 365-day product OUS with our own sales force. We made that conscious decision to wait until we had our entities established and had hired our own reps to really launch the product the way we want to. That will be in the first half of the year. Until then, it's going to be steady state in Europe, And then we'll expect to see the similar growth as we did in the U. S. outside the U. S. Okay, fair enough. Thanks for that, caller.

John, no, no change in the development schedule at all. I was referring to really the commercial contribution would really be in 28, right, as the anticipated approval is just that, continues to be that in the fourth quarter 27. But it really has the ability to contribute in the 28 fiscal year.

Yeah. Thanks, Ben. Yes, there's a number of observations. Clearly, as you increase the Senseon DPC, there absolutely is a direct increase on the number of patients come to ever since, which is good news. It is, however, obviously a conversion process you need to go through. There is quite a bit of education, and obviously we've been continuing to optimize the algorithms of who we reach. Obviously, the reimbursement for folks that are on insulin is one of the key things that we look for.

We did run some pilot work where we were doing some linear television, and in that, recognize that we got a much broader audience. Many of those folks were actually not on insulin or were looking for, you know, starter material in the sense of, you know, something that they could try for free, perhaps Medicaid patients where there isn't good reimbursement yet. So, what we certainly recognize is that as you go very broad in the advertisements, you do get less and less in the center of the bullseye. So, therefore, you know, the effectiveness of the investment can drop off in that. So, we've tried to stay pretty pointed, pretty geo-targeted, as you know, that you can do with the, you know, these days.

But we also, of course, tie that to where we make sure that we have good depth of insertion capability. EON gave us an opportunity as well. We're approaching 50 EON nurses, and we're excited. One of the reasons that we're going to double that to 100 next year is just because of that breadth that we can get with it and then further expand the DTC investment from that.

No, we're still driving, John, to do exactly that. Ben, I'm sorry. And making the investments that we talked about with the DPC. I do want to echo Rick's comments. We do have this one-time dynamic as we switch from Asensia and Senseonics, right, where they had product in the channel. You know, they kept about 30 days. They put up to 60 days with the distributors. We're certainly going to try to pull that back, but, you know, in the normal practice, they, of course, do have that in the channel, so that'll have a one-time impact on 2026. It's not going to impact patient starts, but since the product is in the channel, there'll need to be some consideration for that for the first 60 days or so of the year as we go through that transition.

No, we're right in that range, Jason. I think as we get more fine-tuned and manage this inventory transition between Asensia and us, it just gives us a little bit better visibility. As I said, we're still absolutely on track for doubling the patient. So, you know, the revenue behind it is just dictated by timing or, you know, some of these transition accounting dynamics.

Yeah, I mean, much of the lift was the DTC spend that we made in the third quarter, and it'll be similar in the fourth quarter. I think we raised our cash utilization range to the top at 60, and so it's somewhere up to $10 million in DTC for the year that we're going to be spending to bring up the awareness.

So, there's joint marketing activities that need to be done. There's some scaling activities that Twist is going through at this point. So, we're essentially ready to go, and I know they're getting pretty close as well. So, we're down to the, you know, five or 10-yard line.

Sure, Sean. Hey, it's Rick.

CE Marketing, Rick, and then I'll let you pick up on those transition and our thoughts on launching 365.

On CE Marketing, Sean, we continue to be on track. Obviously, we'd like to have it sooner rather than later. We did submit it in February, so it has been under review for some time period. There are no issues. We are down to the very final stages, so that's why we continue to believe that we'll have the approval on it here this quarter. Unfortunately, the CE marking, we use BSI. They're not actually a little bit less predictable than the FDA is, and I think we're just in their normal process of final review. So, no issues, nothing new. You know, we're certainly happy to get it over to the folks in Europe.

But with the transition, we are thinking a little bit different about when to bring it out. And Rick, I'll let you speak to that.

Yeah, that's right. So we are transitioning the European business over the first half of the year. We're in the process of setting up our entities. We'll transition the current CGM-dedicated employees and then hire our own sales force. And so there was some 365 contribution that we had previously thought for revenue in 2025, but making the decision to launch the product with our own sales force that we direct and control is certainly the way to go. So we'll launch that product in the first half of the year with our own sales force outside the U. S. Great.