Good day, everyone, and welcome to the Eversense 365 Commercial Update 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. You may register to ask questions by pressing the Star and one on your telephone keypad. You may withdraw your question from the queue by pressing Star two. Please note this call is being 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, Investor Relations. 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 that 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, in our 10-Qs 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, Brian Hansen, Chief Commercial Officer, and Rick Sullivan, Chief Financial Officer. I'll now turn the call over to Tim.
Thanks, Jeremy, and thank you to everyone for joining us on the call this morning. Yesterday evening, we were happy to announce an exciting change in the commercialization of Eversense 365. We announced that we have signed a Memorandum of Understanding with Ascensia to integrate the full CGM commercial organization led by Brian Hansen back into Senseonics effective January 1, 2026. We see this change as very positive and enabling for us to ensure clear focus and targeted resourcing to build the Eversense brand. Through this standalone strategy, we will recognize margin expansion and recaptured revenue share, which we expect will enable us to make the necessary strategic investment to drive awareness and adoption to accelerate Eversense penetration and revenue growth. The term sheet provides for Senseonics to assume full commercial distribution rights in the U.S. on January 1. For all U.S.
markets, we will utilize transition service agreements with Ascensia while we build a focused and appropriately scaled commercial infrastructure to serve those markets, with full European transition currently targeted for later in 2026. Additionally, I couldn't be more pleased to announce that Brian Hansen, who leads Ascensia's Eversense commercial operations, will transition to become our new Chief Commercial Officer, a role he previously held at Tandem Diabetes. There, Brian helped transform the company into a worldwide market leader in the competitive insulin pump market. He will also continue to play a key role on our board of directors. Brian's leadership team, as well as much of his commercial team, will be joining him at Senseonics, and we're excited that the team currently responsible for the successful 365 launch will continue to drive Eversense sales from within Senseonics.
Both Senseonics and Ascensia remain jointly committed to ensuring that our patients and providers have a positive experience with the growing access to Eversense. We are currently working closely with the teams at PHC and Ascensia to finalize arrangements and agreements for this transaction to ensure a smooth transition. Our collaboration has been strong, and we're working together to deliver minimal disruption for patients and providers and a smooth transition for our employees. In short, we expect the strong momentum of the Eversense 365 growth to continue and to build further under Senseonics. Undertaking this transition now makes sense for both Senseonics and Ascensia, and Brian will have more to add in a moment. But in a nutshell, tapping into Eversense's full potential will require levels of investment and approaches that increasingly depart from the Ascensia's core fingerstick blood glucose monitoring model.
As adoption of Eversense has grown, its differentiated features and sales channels increasingly set it apart from Ascensia's BGM business, and it requires strategic investment to scale. By bringing manufacturing, research and development, and commercial responsibilities together under Senseonics' control, we can better respond to market needs and more directly determine the investment needed to expand adoption of Eversense at such a critical juncture in the launch. This decision also aligns with PHC Group's strategic focus announced last year in its 2027 Value Creation Plan. Before I turn the call over to Brian for additional color, I want to express my gratitude to our collaborators at PHC and Ascensia for their partnership and support in launching Eversense 365, the world's first and only one-year CGM. Not only have they been a key partner, but an important shareholder, owning nearly 10% of the company and investment they intend to maintain.
We have appreciated a cooperative working relationship with our Ascensia and PHC colleagues, and we look forward to continuing both companies' work together to support patients, providers, and employees through a smooth transition while also staying focused on improving the lives of people affected by diabetes. Now I'll turn it over to Brian to provide more color on the transition and why we are opting to do this now.
Thanks, Tim. I'm thrilled to join the Senseonics executive team. Having worked closely with the team for almost two years now, I continue to be energized by the promise of this product, the market opportunity, and those around us who also share a deep commitment to our providers and our patients living with diabetes. Eversense 365 is a differentiated CGM that has tapped into a critical unmet need in this fast-growing diabetes care market. As Tim discussed, we are less than one year into the 365 launch, and we have already made tremendous progress. We are building awareness through our DTC and HCP efforts and are capitalizing on the strong interest in the product, with lead and conversion rates continuing to accelerate.
We have broad commercial and Medicare coverage in place for Eversense 365, and we continue to see growth in our first-time prescribers, and our inserter network is at an all-time high. You may recall that just last month, we reported that new patient starts in the second quarter grew 79% year over year, and we are continuing to see the acceleration with weekly new patient shipments up nearly 50% so far in the third quarter compared to the second quarter. Building on that, we are now seeing new highs for the total number of leads and insertions performed in a single day. We set a record in August for the greatest number of sensor insertions in a single day this year, and August was also a record month for Eversense, with the most new patient shipments in the history of Senseonics.
I am very proud of the work the commercial team is doing in driving this exceptional growth, and with the final 180-sensor patients having implanted in the fourth quarter of 2024, we will begin to see the start of the important replacement cycle to close out this year. Additionally, we have the upcoming launch of the Eversense 365 in our European countries, and we've learned quite a bit from the U.S. launch to help the teams really hit the ground running. We expect to begin those launch activities in Q4 upon receiving our CE Mark approval. Lastly, we are especially excited about the upcoming launch of our first pump integration with Sequel's Twist later this year.
We have been working closely with their commercial team to plan our joint marketing and launch activities, and from what we have heard, the initial feedback on the Twist AID system has been extremely positive. All of this is a long way of saying that our multi-pronged commercial strategy is working and should continue to work as we build momentum and increase awareness and adoption of Eversense 365. At the same time, while both Senseonics and PHC recognize the attractiveness of the Eversense product and the CGM market, the ongoing efforts to drive Eversense 365 require growth investment and focus that can be better driven from within Senseonics. The reimbursement and sales channels for the one-year CGM are becoming less aligned with PHC's traditional BGM sales model.
And importantly, this attractive market opportunity would be competing for growth capital within PHC, with areas in which it has longer-term rights to the products than Ascensia's more limited return horizon with its Eversense distribution rights. I'm appreciative of the time I got to spend with Ascensia and the support of the executive team at PHC. We remain committed to providing best-in-class solutions to our patients and our healthcare providers, and I'm confident that we will work together for a smooth transition of business both here and in Europe. I could not be more enthusiastic about how we're positioned today and what this transition will mean for patients, providers, employees, and all other stakeholders. With that, I will turn the call to Rick Sullivan for a discussion on the financial implications. Rick?
Thank you, Brian. We are all very excited to bring the commercial organization back to Senseonics under your leadership. Our organization will be more efficient with the elimination of alliance management activities and a closer alignment of the development and commercial organizations. This will allow us to invest more into patient-focused commercial activities and respond to the market more rapidly while remaining focused on responsibly managing our capital. The integration of the commercial organization will require additional investment in sales and marketing, which we plan to fund in two ways. First, which I'm thrilled about, we expect to see an improvement in our revenue as we eliminate the Ascensia revenue share, enabling us to capture more of the value of Eversense. This improved top line translates to a meaningful improvement to our gross profit margin, enabling us to fund more of our operating expenses.
To put this in perspective, last quarter, without the Ascensia revenue share, we would have reported revenue more than 20% higher, and our gross profit margin would have been more than 45% after excluding the benefits of the accounting adjustments I mentioned on the quarterly call. Under the planned transaction, our gross profit margin for next year is expected to be greater than 50%, and at scale, we expect gross margin for the business to increase to 70% or more. Second, we have expanded our partnership with Hercules Capital for a non-dilutive debt facility up to $100 million, providing access to an additional $65 million of non-dilutive capital to fund our commercial organization.
We will need to finalize negotiations and agreements with Ascensia and perform the standard reviews for accounting treatment, but based on the current strength of our balance sheet, elimination of the Ascensia revenue sharing, stronger gross profit margins, access to additional non-dilutive capital, and our current plans and assumptions for commercial investments and funding our exciting product pipeline, we continue to be funded into 2027. As a combined organization, our path to profitability remains on a similar timeline as we continue to expect our patient base to approximately double over each of the next several years, along with our increased revenue and expanding profit margins to largely offset the commercial investment. Long-term, this supports our goal of maximizing shareholder value through increased profitability.
Finally, through the close interaction with Ascensia and their parent company PHC, which remains our largest shareholder, we expect a smooth transition with minimal disruption for our commercial organization. It is 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, although we intend to provide initial 2026 guidance in January. We are reiterating our outlook for 2025, expecting global net revenue to be approximately $34 million to $38 million. I'll now turn it back to Tim for closing remarks.
Thanks, Rick. This is a new chapter for Eversense and Senseonics. With the evolution of the 365 product and the ability to directly manage Eversense commercialization, this is a great opportunity for us to control our own destiny, and I'm excited about several elements of what we've announced today. I'm pleased to welcome the Eversense commercial team from Ascensia to Senseonics. It's exciting to have the team that has been driving success in the initial 365 launch joining and closely aligned with our full organization as we continue to execute the launch in the U.S., and we expect soon in Europe. This also means that the sales and marketing team will be in place and running smoothly prior to the launch of the Gemini and Freedom systems, which we continue to expect in late 2026 and late 2027, respectively.
It is likewise important that eliminating the revenue share, we will now be able to recognize 100% of the product revenues. Together with a more favorable 365 economics, we expect the revenue pickup to enable us to expand product margins and that the margin expansion will support the ensuing Eversense benefits from the right marketing and advertising spend for an innovative product growth. We are very pleased with the early returns from our expanded DTC campaign, as Brian mentioned. With direct control of such sales and marketing initiatives, while being good stewards of capital, we believe we can better drive sales and shareholder value.
In summary, regaining full commercial rights for Eversense 365, increasing balance sheet capacity to fund both our commercial growth plans and our Gemini and Freedom pipeline development plans, and putting the commercial team back by these investments in place are all crucial steps for us as we seek to capitalize on the large and fast-growing market opportunity in front of us. Our team is energized by the opportunities that these positive changes bring for driving a business that meets patient needs and realizing the true potential of Eversense. We appreciate your support of Senseonics as we embark on this important chapter in our growth. Operator, let's now open up the call for questions.
At this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may withdraw your question by pressing star two. Once again, to ask a question, please press the star and one on your telephone keypad. We'll take our first question from Matt Miksic with Barclays. Please go ahead. Your line is open. Matt, your line is open.
Hi, Matt.
Hi, Tim. So sorry about that. We actually do not have a question at this time. We will move next with Anthony Petrone with Mizuho Group. Please go ahead. Your line is open.
Thank you. And I just want to make sure you can hear me okay. Can you hear me?
Yeah. Sounds good, Anthony. Good morning.
Oh, okay. Great. Good morning. First, congratulations to the team on the announcement, and certainly, it has been a good collaborative agreement between Ascensia and Senseonics, so congratulations all around. I did want to get into just the timing in a little bit more detail. When you read through the commercial agreement and the filings, it did have certain grounds for termination, but what I want to confirm, it's a memorandum of understanding, so this is not being terminated. So that's my first question. It seems like this is mutually agreed upon because of where we are with the E365 launch. So just to start off, I want to confirm that either party is not terminating here because it has not met its obligations, and again, this is more a mutual understanding to separate on good terms, and then I'll have a few follow-ups.
Thanks, Anthony. That's a very good characterization. Both organizations fully recognize that the best opportunity for Eversense growth is in the structure they're moving forward. It is a memorandum of understanding as these are recent decisions that have been made both at the PHC level and at the Senseonics level. So we'll work over the next couple of months on a definitive agreement that gets us to a transition and termination, but it'll be done in a collaborative way such that commitments that have been made over the years by Ascensia are certainly fulfilled, and the opportunity for Senseonics to be successful is established as well. Do recall, as I mentioned, that PHC is a significant shareholder and continues to be very positive on the opportunity and plans to stay as such. So they're as motivated as we are for this to be successful.
No, absolutely. And I guess you've sort of referenced a few months for a final agreement, but should we expect certainly that it will be done by the targeted January 1, 2026 timing for the U.S. transition? And then another one just on the mechanics of this agreement, change of control was mentioned, and there has not been, but you do have a new shareholder in Abbott. Was the addition of Abbott as a large shareholder here in any way that this influenced the decision? And then I'll just have two financial questions for Rick. Thanks.
Sure. Sure, Anthony. No, absolutely. We believe it's best to do this transition as quickly as possible. Frankly, we're in very good shape in the U.S. market. As you heard, the vast majority of the commercial team is coming over and has already made commitments. So we're excited that they're going to be able to hit the ground running. A lot of work for us to do on the business and legal side, but we feel confident that we can get it done. A fair amount of characterization work that we need to do to work on transferring tenders in Europe, which is probably the long pole in the tent, but we're starting on that immediately. So one month's an important date. We're certainly hitting the ground running to do everything we can to be there. The Abbott participation in the financing, of course, is important.
Abbott, of course, is a big badge of validation for us. But as you know, that relationship is really for future products. Their primary interest is in the Freedom product because of its characteristics. And although they continue to be an important shareholder now, this decision was really independent of anything that we have with Abbott or anything that we have going forward.
Fair enough. And Rick, just two financial ones here. So $60 million cash burn confirmed for 2025. I guess does that now include some of the kind of standalone costs, if you will, to set up the organization coming in? And if so, where are the offsets? And on the gross margin target now for 2026, it's a substantial number. You're up from mid-30s% in 2025. How much of that is simply revenue ramp, maybe perhaps versus benefits of weaning off the transition services agreements? Thanks for taking the questions, and congrats again on the announcement here.
Thanks, Anthony. For 2025, I'm still comfortable with our operating expense guide, including some of the transition costs that we may incur as we set up for the 2026 commercial organization to be onboarded. And then for 2026 gross profit margins, much of that increase is due to the elimination of the Ascensia revenue share. But as you mentioned, there is still a bit that is as a result of scale and being on a single product for a full year in anticipation of that 365-day launch outside the United States.
Thanks again.
Thank you. We will move next with Joshua Jennings with TD Cowen. Please go ahead. Your line is open.
Thanks. Good morning. And I'll echo Anthony's congratulations. Exciting news for Senseonics. I was hoping to just get a better understanding of maybe the timing of these discussions with Ascensia. I'm sure certainly it wasn't yesterday. And I think the reiteration of guidance and Brian's comments and Tim's comments on the traction and momentum you guys are seeing in 3Q here, that there wasn't a dropping of the ball. But maybe just the timing and just how any more color you can share just on 3Q momentum?
Sure. I'll let Brian speak to Q3, but specifically on the timing. Just as you can imagine, as a responsible business, we're always having conversations about what the right strategy is, what the right approach. We have very consistently recognized that the launch of 365, given the innovation, the characteristics of the product, the attractiveness of the product, is certainly going to take a pretty significant investment for awareness in the space. So we have been working with our partner with that effort for some time. As you know, we announced after the last financing that we would be augmenting that to really drive awareness and really hit the timing. The excitement around 365 is high, and we want to make sure that the word gets out there.
So we've transitioned from the original agreement here a number of months ago in regards to at least the commercial expense and shown positive results for it. In regards to the actual decision itself, that actually just has been made, but we have anticipated this transition for some time period, at least in regards to what we need to do commercially to really advance the Eversense 365. And as you know, we really made that decision in the June time period or so and augmented those commercial results. So think of it really as a continuation, if you will, of what's the right business strategy. I think this just makes a lot of sense. We've got an exciting opportunity at Eversense 365. We need to really focus on the commercial execution, and PHC has been a very good partner with it.
But given the horizon that they have left with access to the Eversense products and the investments that's really needed to launch the product, that's where just putting all that together made sense for us to pick it up and take it from here.
Thank you. Our next question comes from Ben Haynor with Lake Street Capital Markets. Please go ahead. Your line is open.
Good morning, gentlemen. Can you hear me okay?
Yes, Ben. Good morning. How are you?
Doing well. Just curious, I know you had touched on it here in the last answer, but your own DTC efforts, you kicked off in the current quarter. It sounds like, based upon what you've been able to share, that those have been going quite well. But just any more commentary there on how that's going, how that kind of dovetails with the commercial transition here?
I'll let Brian speak to it. It is probably a month among all of these priorities that we have going. Really, the number one thing, of course, that we're focused on is the effectiveness of that DTC investment. It's high targeting. It is close watch. I am personally involved every week with Brian and his team. So we're very excited about the awareness that we're gaining. You heard us talk about August isn't necessarily one of your commercially strongest months, just given the distractions, vacations, preschool, and so forth. So we're very excited to be breaking records, if you will, in regards to new leads, interest, insertions, new sensors, new patients, and remember, again, as we said on the last call, all of the patients that we're putting on the product today are brand new because of the transition of the cycle that we're in.
We're not even yet up to the reinsertion, so to be able to be breaking records with brand new patients, we are very excited about, and of course, hyper-focused on the management of it because we're going to continue to drive the success of the ramp, and Brian, I'll let you speak to your perspective on how it's going.
I just think one comment I would make is we had a very structured and somewhat formal investment strategy with the Ascensia guidance, and to be able to put more money into DTC from the Senseonics side, quite frankly, was fun for me because I wanted to test to see what more would do, right? Are we going to start to see a lower result as we start to pour more in, and quite frankly, the last couple of months have shown a very steady growth and still very well-characterized leads coming from the additional investment, so I don't feel like we've hit the top yet, and we don't really need to continue to pour too much more in, but it's nice to see that that demand can be driven with variable investment.
And so far, we've seen, like Tim said, August is normally a slow month, and we saw anything but slow results coming in. And the same ratios we've been enjoying with our prior investment, we're seeing with the incremental investment. So as we get into the more busy months now, September tends to kick off as kids get back to school, people settle down a little bit. The next four months should be really busy for us. That's very encouraging. And then just lastly for me, do you think having full control over the commercialization helps at all with nailing down any additional pump partnerships?
It certainly is going to be helpful, being integrated success show the penetration. I think it's important for us to get the first one out. Brian and his team are working closely with the folks at Sequel, so we're excited about what can come. There's clearly going to be pent-up demand for an opportunity with Eversense, so we're excited for that. Some of our largest accounts are literally collecting the names and putting their patients on a waitlist for us to get started with it. So I think that success will certainly help as well. There's always a competitive dynamic in regards to who's got the most comprehensive coverage that's out there. So we're willing to support that as well. So I don't know if there's any particular advantage to have it all under one roof, but certainly the focus that's going to come is important for us.
It's an important segment. We continue to do extremely well in the Medicare population. It is still the predominance of our patients that are going on Eversense, but the pump access will allow us into that AID space as well.
Got it. Well, congrats on the MOU, and I'll take the rest of my questions offline.
Great.
Thank you. Our next question comes from Jason Bedford with Raymond James. Please go ahead. Your line is open.
Hi, Good morning. Just maybe a couple. I think you mentioned that the vast majority of the Ascensia commercial team is coming over. Can you just frame the number of reps that you're adding? Just how big is that team?
Yeah, Jason, we have about 45 territories here in the U.S., and then we support the six countries OUS. We're making a few changes in our country-specific support OUS. But from a U.S. perspective, where it's a dedicated unit, the majority of that team is, in my opinion, committed to come. My management team is Rudy's management team is committed to come already. There was a new announcement for them yesterday. So we'll be working through some town halls and some communications today. But the 45 territories, the 50-plus folks we have inside, 60, 70 folks we have inside doing inside sales, following- up on all the DTC, there's a full expectation that Ed's team will join as well. The marketing team is committed to come. So I see very little changes in the way we go about it. And quite frankly, Jason, we've worked so closely together with Senseonics.
We've been one company in so many ways all along. This isn't a big change for them.
Okay. And just so Brian, maybe just number of people, 45 territory managers, 50 to 60 inside reps, and then plus marketing. Is it 100, 150 folks?
Yeah. So you have about 150 folks in the U.S., then you've got a group in Europe, depending on how we structure everything going forward in Europe, but you've got another 50 folks in Europe that'll be joining the organization, give or take, right? It just depends on how we hire. We're going to be splitting the BGM responsibilities from the CGM responsibilities. So we have some work to kind of carve out there and make some decisions in certain countries, how we approach that market. So I'll just kind of leave that one vague for now because we have some work to do there. But all very positive. And again, taking control in a broader way now under the Senseonics piece will simplify a lot of what we're doing. But we were already so well working together. You saw that, Jason. You've seen us for a while together.
The teams do well together. This just takes out a level of alliance management that we can now put back into the focus on the commercialization of things that matter.
Right. Right. Okay. Maybe Tim, I think you mentioned Ascensia ownership near 10%. I think you also mentioned that they intend to keep the position. Is there a lockup or anything like that tied to this agreement?
Yeah. We haven't spoken to that yet, Jason. Obviously, they do continue to be a supporter. This is an important growth investment. Recall, just administratively, it's actually held at the PHC level. So it's at the corporate level where the ownership is, not at the Ascensia division level. But certainly, they're very interested in our success. Obviously, this reduces their investment level, which is important to PHC. But from a strategy and CGM, it's still very important for them economically.
Okay. Thank you.
Thank you. We will move next with Sean Lee with H.C. Wainwright. Please go ahead. Your line is open.
Hey, good morning, guys. Thanks for taking my questions. Just have a follow-up on the size of the organization thing. How easy is it for you to expand it should the need arise? And do you expect to need to expand this organization, especially in the U.S., over the next year or so? Thanks.
Yeah. Sean, thanks for the question. We're certainly looking at 2026 and beyond for the commercial investment. We're not ready to make a commitment on that yet as we're focused right now on this transition. I would expect that we certainly will be expanding the field sales force as we continue to grow, right, so that we can go into deeper penetration. As Brian said, today we're at about 45 reps, but I do expect it to go north of that. As to whether we do it in 2026 or 2027, stay tuned. We'll give you an update on that as we get that formulation and expense plan in place.
Okay. Great. Thanks. That's all I have.
Thank you. And once again, that is star and one on your telephone keypad if you would like to join the queue. We will move next with Joshua Jennings with TD Cowen. Please go ahead. Your line is open.
Hi. Thanks for the follow-ups here. I just wanted to check back in. I had asked just about Q3 momentum. You guys gave some metrics and maybe just to review those. And also, if you can share anything just on the expectations for the consignment model as a percentage of total? I know Ascensia was getting revenue share through that channel as well. And maybe just to help us think through whether that success in that channel was one of the drivers of this decision to take over the commercial organization back.
Sure. I'll let Brian speak to the recap of the Q3 momentum. Certainly, Josh, one of the realities is as the go-to-market strategy is changing, specifically, as you point out, the consignment. It has become a much larger proportion of our business than we had anticipated when we put the partnership together. And the way that that is constructed is, as you are aware, all of the revenue for consignments as we ship the product actually comes in. And then we would return to them about 30% of the revenue as opposed to the commercial payers that come in predominantly through the DME channel. They would collect 100% of the revenue and pay us 70% approximately based on the agreement. So that changes the dynamics for them. It changes on the total revenue. And it also changes really doesn't really impact their margin, but it certainly did impact their revenue.
I would imagine that that is part of the consideration. Again, over the horizon that they have access to the product left, I'm sure it's one of their considerations as well. Obviously, it was a very important segment for us. We were doing everything we can. As you are aware, the reimbursement level is appropriate for Medicare. It's an area that we do particularly invest in and certainly something that we're going to stay very, very focused on. Brian, I don't know if you want to kind of recap the Q3 momentum metrics that.
Yeah. I mean, I think we shared in the prepared remarks that we're having a nice start to Q3. Our interest in 365 continues to be very consistent and strong. Again, putting more dollars into the DTC is yielding very positive results for us. And that's a very promising sign that we're not diluting that by investing more right now. So we brought 12, 13 additional inside folks on to handle those leads that are moving through them. And we really expect to go into this last part of the year where folks' deductibles are met with some real strength and try to close the year out strong. It's as simple as that. This process really doesn't change anything for my team today. They're focused through the end of the year. This is an end of the year. Hopefully, get to the final arrangement, move it over on January 1st.
So my job is to keep the team laser-focused and do the things that they need to do and finish the year strong. And through the calls we've had last night and this morning, I see nothing that would change that.
And Josh, just as a reminder, this is right on target with what we planned. As you know, the second half of the year, we had said one-third, two-thirds. So we're absolutely on target with that. It is a big step up for us. But we knew that with this investment, we were going to be able to achieve it. And I would say that we're exactly right on plan, which even with this transition, you heard Rick say, and we are reiterating our guidance in the 34 to 38 range because of the success we have at meeting this ramp.
Well, that's very fresh, thanks, Tim and Brian. And then just lastly on just it may be too early, but you're talking about the MOU and TSA with Ascensia for the international business. And I mean, should we be thinking that you'll take full control of that of OUS operations in 2027? And just you mentioned CE mark. Any details you can share just in terms of discussions with regulators as you're moving through that process for Eversense 365? Thanks so much for taking all the questions.
Yeah. I'd just say we're evaluating our structure OUS today. We have six countries. Three or four of those countries are really providing the lion's share of that volume and that opportunity going forward. The BGM folks today carry the product in their bag. We really need a more dedicated sales force like we have here in the United States that is specific to the CGM sales process. It's a little bit more of a complicated sale, so that was part of the thinking behind this arrangement and as we move forward, so we'll be communicating with them and standing that up correctly and hiring in the appropriate talent to sell the products in those countries.
And as we get the CE Mark, as we get that approval here, we'll probably hold off on launching it to the very end of the year, beginning of the year as we kind of get everything stood up. But we're right on track and prepared and been working behind the scenes to launch 365. So we expect the same success OUS that we saw here are seeing here, enjoying here, and quite frankly, having set up really well for them and learned a lot from our launch year to make our European launch quite fruitful. So all things are to go and really not a lot of change for the OUS team until we get to that kind of shared service, stand up the legal entities, rig the things we're already starting to work on behind the scenes.
Hopefully, we get that in place pretty quickly and we can move away from the Ascensia umbrella that we'll have to have for a little while probably going into 2026, but I certainly don't see that going into 2027.
Josh, I would say just as reported a few weeks ago at the quarterly call, we continue to be right on track. We are actively working with BSI. We are certainly moving towards the end of the process. And we still anticipate that we will have the approval for that certainly here in the fourth quarter.
Excellent. Thanks again.
Thank you, and we show no further questions at this time. I will turn the call back to management for closing remarks.
Great. Thank you and appreciate everyone's time this morning. We apologize for the last-minute call, but it is an exciting opportunity for us, and we did want to get the information out absolutely as quickly as we can, so appreciate you participating. Look forward to following up and updating you on the transition when we next speak here in a couple of months in November. So, with that, thank you, operator, and thanks all for the time today.
Thank you. And this does conclude today's program. Thank you for your participation. You may disconnect at any time.