Great. Good morning. My name is Bill Plovanic. I'm a Senior Medical Device Analyst here. Welcome to the Canaccord Genuity's MedTech, Diagnostics and Digital Health & Services Forum. With us next is Tim Goodnow. Tim is President and CEO of Senseonics. With that, I'll hand it over to Tim.
Great. Thank you, Bill. Appreciate the opportunity to speak today. Senseonics is a technology company in the MedTech space, obviously in continuous glucose monitoring. Many of you are familiar. It is a significant space. It's evolved over the last 15 years with a couple of large players. Senseonics has a new and differentiated technology. We're happy to report some good success here of late, as we transition the organization over the last year or so. Technology is very different. The CGMs that are out there today have evolved to somewhat similar. They're transcutaneous devices that measure glucose every five minutes. Senseonics' approach is different. We've gone for a long-term solution, so we have a sensor that's inserted in a doctor's office just under the skin, and it stays resident for an entire year.
Bringing folks kind of a freedom and ease of use, which is different from the replaceable products that happens about on a two-week basis. We've transitioned the business pretty significantly. We had a partnership with Ascensia Diabetes Care, a traditional strip and meter business, in 2025 that we transitioned, started January 1st of 2026. So, results that we're now showing are for the standalone business, which has had some encouraging results, not only from a control and a destiny perspective, but also from a financial consolidation. We're very, very focused on the space. As you can imagine, the diabetes glucose market is huge, $15 billion this year. But for us, it's really about the commercial growth, which we've shown good success.
We've announced essentially a doubling of sales this year, and we're on track to approach that for 2027, as well as an innovation pipeline that's highly differentiated and leverages the full implant capability of the sensor. Strong commercial momentum. We announced the other night 140% growth year-over-year, as well as strong growth quarter-over-quarter. As I said, with a quite differentiated roadmap. If one looks at the market, growth has been CAGR of high double digits. We anticipate that we'll be about $15 billion this year. There's 11 million people on CGM, and that's evolved pretty significantly over the last few years. As I said, we are the long-term sensor. The positive, of course, is that long-term duration. Put the sensor in and forget about it. The negative is you do need to go to the doctor's office to do the procedure.
We've worked hard to facilitate that as much as we can and give people that 365 days of freedom. As a result of it being obviously a long-term implant, there's very, very low threshold for failures. We've designed the product to be very, very stable. It is very accurate. There are three what's designated as iCGMs on the market. Those are the sensors that can be interchangeable with the pump connectivity, and Eversense is one of the three, along with the Dexcom and the Abbott product. That's really allowed us to not only brand the product, but develop a well-earned reputation for a high-quality product. One of that aspects is, as we'll see, is to get away from some of the short-term sensor replacements that happen with those transcutaneous sensors.
Because we don't have to have a skin adhesive that locks the sensor in place for long term, we've really minimized the skin irritations, which is one of the points of frustrations and one of the reasons that we are able to move the product that we're able to do it. Also, especially important in the AID or the automated insulin delivery, is we've eliminated the compression lows, which is a false low that happens when you roll over and sleep on one of the transcutaneous sensors. In a combined pump, it'll actually give you an alarm for hypoglycemia, but it also turns the pump off. It's a pretty significant nuisance for the real world living with a integrated product. What we are noting is that the vast majority, 90% of our patients, are all switching from one of the other CGMs. Why is that?
It really comes from the sensor survivability. If you look at the competing transcutaneous products, the reality is about 15%-20% of those sensors don't go to the full 15 days. That creates a hassle of having to replace the product. If you're at the office and it comes off or it terminates, it's really a pain in the neck to do it. When a lot of people get frustrated with it is when they'll come and look for another alternative, and we offer a good solution to that. As I said, about 90% are coming from one of the other products. It's a pretty equal split between the Dexcom G7 or the Abbott Libre 3. 10% are new. Those are folks that are looking for a solution and have identified the long-term implant as being something that can work for them.
Importantly, as I mentioned, is the AID integration for people with type 1 diabetes that are pumping. There's a couple million folks that actually pump, and tying it to a CGM gives that autonomous or that ability, like the thermostat on your wall, to control the temperature and keep it in range. We do the same thing. You give insulin when you're high blood sugar, and you stop that insulin delivery when you're low. We partnered with two. We've had a great year with twiist Sequel Med Tech. Delivered a new pump at the beginning of the year that we partnered with, and it's really been strong performance for us. The acceptance of the product was encouraging and higher than we had anticipated. We're also excited to announce that we have also partnered with Beta Bionics, and we'll actually be launching that product in about the next week.
We will be pretty significantly expanding the capability of AID integration. I said this is predominantly type 1 diabetes. There is a little bit of pumping in type 2, but for people that have the autoimmune disease, this is a great solution, and Eversense has worked out extremely well for them. That is demonstrated by here are our early results. If one looks, putting people on Eversense, and this is real-world experience, you will see that if you put a population on Eversense, the bottom line is they will increase their time in range to about 66%. That is normal glycemic levels in about two-thirds of the patients. When you put them on an AID system, specifically with the Sequel pump and Eversense, you see that jumps to 76%. That is actually the highest published results of time in range of any of the combined integrated systems.
We are really encouraged. That comes from the compliance of a one-year sensor. As I said, it does not come off every week, as well as the Loop algorithm that is part of the Sequel product is highly advanced and pretty differentiated. I think that will be the next area that people will start to peel the onion skin back on and take a look, is in regards to the differences between the different treatment algorithms that are out there. We are real excited to have that relationship. Also excited about the opportunity to work with Beta Bionics, which is also an easy-to-implement pump with their algorithm choice. You just enter the weight and actually can get patients started right away.
The Loop algorithm is really for an advanced user that is looking for a lot of flexibility, a lot of capability, whereas the Beta Bionics is really one that you can put on, especially folks that are newly diagnosed, and help them come up to speed. We are excited to be able to cover both of those aspects with Eversense now. As I said, this is the growth trajectory. We have really expanded. The earlier data was with a partnership, so we shared the revenue. In 2025, we ended that, and as I said, we have been able to grow at essentially 100% or very near 100% here this year, both in revenue, and that is driven by the new patient growth. Those are the folks that I described that are coming over from the other products.
We focused on significant increase in the number of people that are doing the insertion. I will talk about our Eon Care network, as well as the prescribers have grown significantly as well. This is all a result of the focus work that we have done with our high-capable commercial organization. How have we done that? For us, it is really, as you can imagine, as the third real entrant into the standalone CGM space, it has been important for us to get a share of voice. We focus very significantly on awareness and investment in digital marketing, which allows us to be very, very directed, and that has resulted in now about 60% of our new patients are actually coming from DTC.
We will put out predominantly on Meta, solicit interest, and they will come to us, and we have an inside sales team that will do the detailing, the education, the insurance adjudication, and move people towards it. Access has been another area, of course, that we focused on. Obviously, you want to be able to make sure you've got all the reimbursement in place. We've done a very good job with that, not only with commercial pay, but also through Medicare reimbursement. Also this Eon network that I'll talk about. Eon is our subsidiary. We have about 100 nurses that do the insertion for us, and our team has done a great job at not only expanding the breadth of the offices that we call on. There's also another 43 reps that call on the large diabetology clinics, endocrinology.
We've gone deeper into the clinics, but also gone to more clinics as well. Once you earn the patient, of course, being able to retain them and have them stay with you for sensor after sensor is important as well. We've done a very good job at people staying on the product. Once they have it for an entire year, they get very comfortable with it becomes part of their life, and they're renewing at an exciting pace for us. That's the razor blade part of the business model as well. How do we commercialize? As I said, about 60% of our patients are coming from the DTC channel, so they're coming into us based on that awareness that we're creating, all web-based at this point, social media. About 40% are coming from the HCP or the healthcare professional channel.
Those are the sales reps that are going out and calling on the doctors, and then they're recommending the product for their patients. That's a traditional approach. They'll make a recommendation. There's a pretty high conversion rate when the doctor recommends the product. On the DTC channel, it's the typical solicitation that you'd expect. Somebody will submit a lead, we'll follow up on it. We do need to filter those for what we call workable leads. That generally means people that are eligible for reimbursement, right? There's a lot of people today that have diabetes that are not yet on insulin, and if you're not on insulin, you're typically not reimbursed for the product. So it would have to be a cash pay.
So we'll work with them, filter for that, understand what exactly type of insurance they have, where they're geolocated, how close they are to an insertion site, and so forth, and then that will convert them to an opportunity. We will work from there to go to a shipment based on the economics, whether that be through the buy and bill channel, which is mostly Medicare patients, or the DME channel, which is a third-party entity that actually has the contracts with the private payers, and they provide the product as well. In both cases, once you have that patient, you want them to have a good experience, you want them to enjoy the product, get value out of it, so we work on a retention program to stimulate the reorders when they're up for the renewal a year later.
That's the U.S. In Europe, it's quite a bit different. We're actually in four markets. Three of those are tender markets, so those are contracts with the hospitals or with the local region. We work to participate in those based on the features and benefits and capability of the product, and the sales teams will manage that. The fourth market is Germany. It is a larger market and one that we are excited to be growing in, and that is a little bit more like the U.S. There is DTC available, but not at the same level that exists. It is more of a traditional sale through the treatment clinic centers where they do the detailing and the education on the clinicians and nurses to make their recommendations over there.
Our split today is about 85% of our revenue is coming from the United States, and 15% is currently coming from Europe. Eon Care, I mentioned. Eon Care is our network of nurses. We have an indication that a nurse practitioner or a PA can actually do the insertion. As we have expanded and really grown the users, we are seeing a pretty significant influx of people with type 2 diabetes. Type 2 diabetes, as you are likely aware, is more treated with primary care, right? More distributed. The diabetology clinics have an interest. They may be doing the insertions themself, but in primary care, they are not going to take the time to do that. We have put together a network of 100 today, 1099 nurses, so they are contracted with us to do the insertion.
We will do the training on it, we will help them do the credentialing if they need to do any of that with any of the local insurance coverage in that area, and then we will send the folks that we have created the opportunities for to them, and they will do a white glove experience for us in regards to doing the insertion. The economics for that actually come from the CPT code. We have three CPT codes for doing the insertions and removals, and that actually pays for those nurses to do the insertion procedure. It is attractive to us to do it. It is contributory. In some cases, the nurses will actually buy the product. In other cases, we will actually provide it, and they will get an insertion fee from us from those CPT codes for it.
It is an exciting area for it, but when I referred to reducing the access or increasing the access, reducing the barriers, this is a key area that we have invested in. Although today we have 100 nurses, we will expand that probably to 120 here over the next couple of months, and I would anticipate we will continue to make an investment, and this will be hundreds of nurses as we grow and expand the area, just covering the zip codes around the United States. Places that have worked extremely well for us, the med clinics, aesthetic clinics, right? Those types of nurses are looking for fee-for-service type approaches, so partnering with them, they are a very presentable environment, and it has been a great alternative for us.
This has been one of the big advancements that we have made in the last couple of years to really ease and advance the ability to do the insertion and expanding our market. The primary domain that we are focused on, of course, is on the commercial execution, but the innovation pipeline is the second big primary focus for us. The focus right now with both of the two big competitors is they are looking to take their transmitter down in size to make it as minimally intrusive as they can. If you follow either Dexcom or Abbott, as you know, they are looking to reduce the transmitter size on the outside. Everybody would like to eliminate that. We, of course, are not going to try to compete in the size reduction. We need to leapfrog them. We are taking the approach of going to the full implant.
Right now, the product that we commercialize is shown in the center. There is an external component. The implantable sensor is tiny. It is 3 millimeters by 16. It is implanted in the doctor's office by those nurses we spoke of just under the skin, and then the surface mount transmitter does two things. It powers the sensor with near field, so every five minutes, it can generate the optical signal that generates the glucose, but it also talks the Bluetooth to the outside world, to the pump or to your phone. We are internalizing both of those in the next generation. We call that product the Freedom product. We are putting the power inside with an implant-grade battery, the same battery technology they use in a cardiac pacemaker or neurostimulation device.
That will power the sensor for an entire year, and it will also power the Bluetooth that is being incorporated as well. The near-field antenna will come out, and the Bluetooth technology will go in. We call that first step is the Gemini product. It just has the battery in it. That is more targeted for type 2. But the Freedom product that we announced just a few weeks ago that we have now done our first in-man insertions on those, which is the data that we collect to generate and approve our IDE trial for product authorization to market, commercialize it. We are really focused on a year-long sensor, invisible, full implant, nothing on the skin. That will be, frankly, a very revolutionary product for the space. There is a lot of excitement.
It is the number 1 request that we hear is, "I do not want to show that I have diabetes. Can you make it invisible for me?" And we are very comfortable that we are going to be the first to be able to deliver that product. As I said, we announced the first in-man trial that we initiated here about a month ago. That data is the safety and effectiveness data that we will need, we will take to the agency and use that to support an IDE submission in the first half of 2027. That investigational device exemption will allow us to enroll probably 100 patients or so and initiate a pivotal trial that we will use for approval of the product in the middle of next year. Submit a 510(k).
As an iCGM, these are down-regulated from a Class III PMA product to a Class II 510(k), so we will show equivalency from the full implant product to our currently approved 365-day Eversense product, and then we anticipate a 90-day review on that, so mid-2028. We anticipate that we would be on market with the Freedom product. Large opportunity, big breakthrough product for us that we are pretty excited about. We do work extensively. As I said, for us, it's all been about education and awareness, that this is an alternative, folks, so a lot of social media support. We really have increased the brand's presence and visibility in the last year, and that's resulted in the growth that we've talked about, 100% this year, and we'll be close to that next year as well. Pretty exciting times and space for us.
As I said, a couple of nights ago, we announced $19.6 million in revenue for the quarter. That's 140% growth year-over-year. Because it's a single consumable for an entire year, it's a very attractive gross margin. So even in our current scale, we've got a 62% gross margin for the quarter. We have about $127 million of cash and restricted cash that's available to us, and we did do a growth capital raise here earlier in 2026 to support all of these initiatives. Once again, for the third quarter in a row, because of the performance, we're able to raise guidance for the year. We're now anticipating being in the range of $68 million-$70 million in revenue. And we did up our full year gross margin to at least 60%. So, excited about the potential profitability and the ability to pay for this future investment going forward.
That said, as we bring out that Freedom product and get some more larger economies of scales, we will be a 70% gross margin business. Again, that all comes back to that once-a-year consumable, which, of course, is leveraged over 365 days. EBITDA breakeven and profitability right after that in the 2028 time period, and that gives us the ability to fund, of course, these continued investment that we're making in DTC, as well as the pipeline investment in R&D. So, we spoke about the currently we have two pump partnerships. I would anticipate by 2028, we'll have at least two more in place. So, exciting times in regards to the type 1 expansion, as well as the type 2 capability for this product as well. With that, I want to thank you for the opportunity, and should there be any questions, I would be happy to answer.
Great. Since we have a little over four minutes for questions, I think your last statement was my first question. Additional pump partnerships. I mean, first of all, congratulations. 10-year overnight success story.
Yeah.
I mean, you are on your path to $100 million in revenues, which is impressive, and it is never linear, and it is never easy. You are getting to the scale now that I would imagine those other pump partners, especially considering your customers are coming from traditional CGM, have got to be more motivated than in the past to actually have discussions with you and push forward. You are saying 2028. Is this something we could see sooner than that?
You know, I do not want to commit to anything sooner than that. I think the last commitment I made is that we would have our next partner by 2027. We actually were able to announce it about a quarter early. The unfortunate side for the integration is all of the work is done on the pump side, right? If it were in the sensor side control, you would actually see it a lot faster. They do need to fit it into their portfolio, into their R&D funding. There is very high interest in connecting with the Freedom product, which we will certainly, of course, support, especially with our current partners, right? They will have it first.
The new guys that are coming in will need to get in line at that point, and the best way to do it is to get it done during 2027 when we need it. Stay tuned. Obviously, we are supportive, but we would love to see it.
I think it was interesting on the renewal rate. To me, that is a huge opportunity. Have you shared the metrics on what that looks like today?
What we've shared, our experience has been, and you'll recall, we first, years ago now, we commercialized the 90-day product. We extended the technology to 180. Now, the last two years, we've been on 365. We've been evolving the technology, stabilizing it in vivo. What we've pretty consistently seen is from the first sensor to the second sensor, there's about a 75% retention rate. From the second to the third is about 85%, and then by the time you're in your third or more, it's over 90% retention. What happens is people, they build it into their life, they get comfortable with it, and they just keep coming back. We first launched this product under a CE mark. We have customers today that are on their 30th sensor. There's a long history.
Now, they were on a 90-day, so they got to go through it a little bit faster, but they work extremely hard. We've had Europeans before the one-year product was available in Europe, and they would actually fly to the U.S. to have the one-year product inserted. They'll do a lot to stay on it. We're pretty encouraged with the aggregate retention that we see. See if there's a
Is reimbursement any different for you guys versus your competitors?
Because we are a medical benefit, CMS clearly gave us CPT codes, and it is about 40%-50% higher CMS gave us. They much prefer the product to come out of the medical benefit, so the doctor owns the prescription, not the DME channel. Yes, the reimbursement is better for Medicare patients and for those that are on what we call the bundled pay, and they reimburse it as a bundle, the procedure plus the product. That does allow us about 60% of our product is through that bundled pay, so our economics are a little bit more attractive than the DME channel. It's not only that reimbursement is better, but also there's no DME distributor margin. Then we also, because it's an implantable, we do not participate in the pharmacy benefit. There's no haircut associated with that as well.
On the CMS, with the decision pending on the non-insulin patients for type 2, how do you think about that? What do you think timing is for that? That sounds like that is something that can make the DTC channel even more efficient if you are having to qualify patients. If all of a sudden that becomes much bigger, that makes that channel more efficient.
Yeah. Obviously, clinically it makes sense. Anybody that, especially type 2, that is not yet on insulin, they are fighting hyperglycemia. So knowing where that is all the time, it makes a lot of sense. That is why you will get a clinical benefit. That is why reimbursement does make sense. I think there are probably two things that are going on. I think, one, they are looking to bundle that decision close to when they are ready to make decisions on the competitive bidding. If they are going to open up the floodgates for a lot more people, they want to make sure that they can manage the economics as well. So my feeling is those may be somewhat timed together.
I do think it is very exciting, and for a one-year product, one of the top reasons when I say that we qualify somebody for access that we cannot qualify them today is because they are not on insulin, right? If that limitation goes away, we are now going to be able to qualify those. So our biggest issue when we go broad-based DTC advertising, like when we tested running television commercials, is everybody comes in, more than just the people with insulin. So we had to turn a lot away that I am excited in the future we may not have to be able to.
Yeah. We saw the same thing happen in the pump market when they added type 2 labeling.
Right.
Just makes DTC that much more efficient.
Right. Exactly.
Any other questions from the audience?
Running over.
Nope.
Great. Appreciate it. Thank you.
Thank you.