Senseonics Holdings (SENS) Q1 2026 earnings call transcript

Thank you. This is Jeremy Pfeffer from LifeSci Advisors. Before we begin today, let me remind you that the company's remarks include forward-looking statements. These statements reflect management's expectations about future events, operating plans, regulatory matters, product enhancements, company performance, and other matters, and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under Risk Factors and elsewhere in our annual report on Form 10-K for the year-end of December 31, 2025, and 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, and Rick Sullivan, Chief Financial Officer. Brian Hansen, Chief Commercial Officer, will also be available during the Q&A.

Now I'll turn the call over to Tim.

Thanks, Jeremy, and I appreciate everyone joining us today. Today, 2026 is off to a very strong start for Senseonics, commercially and strategically. In the first quarter, we delivered $11.7 million in revenue and 58% gross margin. We view the combination of top-line growth and margin expansion as early validation that our integrated commercial model can deliver with improving financial performance as we scale. Given all of this, we are raising our full-year 2026 global net revenue guidance to $60 million to $64 million, from $58 million to $62 million, representing year-over-year growth of 70% to 82%. Beyond the financial results, we successfully completed the integration of the U. S. commercial organization, continued progress towards completing the European commercial integration, launched our first AID partnership, advanced our Gemini and Freedom Development programs, and added over $100 million in growth capital to our balance sheet.

Taking together these accomplishments gives Senseonics the commercial control, the product pipeline, and the financial resources to drive ever since revenue growth. First, through our compelling ever since 365 offering, and then through the next generation CGM system that we are developing. We're at an exciting stage of our journey, and the opportunity ahead for Senseonics is significant. There's a lot more work to do, but we are now in control of our destiny with the right team, structure, and strategy in place to accelerate our recent momentum.

Now, I'd like to provide more detail on the encouraging progress so far this year. On the commercial side, execution was strong. The first quarter of 2026 was our first full quarter with direct ownership of the Eversense commercial organization in the U. S. following the January 1st transition from Ascencia diabetes care. Having the commercial team inside Senseonics gives us the ability to align sales strategy, field execution, and market access priorities with our product development and our qualified manufacturing partners. This has been invaluable, and that alignment contributed to an exceptional financial quarter.

In the quarter, we generated revenue of $11.7 million, a strong financial result that reflects growing ever since 365 adoption in the U. S. , and a focused reimbursement channel mix, which Rick will detail shortly. Equally important, gross margin reached 58%, driven by more new users, higher manufacturing volumes, and the structural benefit of eliminating the Ascentia revenue share.

We view the combination of top-line growth and margin expansion as early validation that our integrated commercial model can deliver with improving financial performance as we scale. Ever since sales have continued to grow, and we believe we remain on track to double patients this year in the U. S. , our direct-to-consumer channel continues to yield strong results. In 2025, DTC sourced new patient shipments doubled year over year.

And within the year, our monthly DTC new patient volumes grew more than fourfold from January through December as we scaled our investment. That momentum carried into 2026. In Q1, DTC sourced new patient shipments grew nearly 100% compared to the first quarter of 2025. With DTC accounting for roughly 60% of all new patient shipments in the quarter. The healthcare professional channel is also growing as our sales reps continue to become more efficient, with March providing the most HCPCL leads in the company's history. We're also encouraged that patient reorders track the vote plan in Q1, an early signal of the retention dynamics we expect from our year-long product.

Following the positive reception ever since 365 in the U. S. , we anticipate the current launch of our year-long sensor in Europe will support growth in these markets as well. In April, we inserted our first patients in Sweden. followed by Spain earlier this week. And we're in the process of launching across Germany and Italy, rounding out the four European markets we'll be serving following the transition of Asensia's commercial organization.

We also see Ion Care as an increasingly important growth driver for EverSense. E. ON now has over 70 nurses available for insertions, and the team is well on its way towards our goal of 100 nurses by the end of the year.

Critically, E. ON Care now performs more than one-third of all Eversense insertion procedures. To put the reach of our broadening network in perspective, we have established E. ON in 34 states and are continuing to grow its reach. This expansion across the country reduces geographic barriers that may have previously limited and plannable CGM adoption. That reach is significant for several reasons.

First, it means that we have built meaningful assertion capacity that is not dependent on individual physician practices. This lowers the barrier for prescribers to offer ever since. Second, it gives patients a more convenient path to access the only year-long CGN, including in markets where inserting physician availability has historically been a constraint.

And third, it provides Senseonics with a scalable service infrastructure that grows alongside our patient base. We expect IonCare's share of insertions to continue increasing over the rest of the year, as we add more nurses and further expand geographic coverage.

In addition, the availability of Eversense with our first automated insulin delivery platform will continue to support our growth. In February, we announced the integration of SQL MedTech's Twist Insulin Pump with Eversense 365, the first automated insulin delivery system to integrate with a year-long CGM. Not only does this integration expand the options available to people with diabetes, but it also provides a technology that fits the reality of their lives. Our efforts have brought two advanced platforms to users, this combining the precision of the TWIST insulin delivery system with the unmatched longevity and performance of Eversense 365 and a flexible, convenient offering. We continue to pursue additional opportunities to integrate Eversense with other platforms and are very encouraged by the early uptake of Eversense 365 as part of our first AID system.

We've seen good early adoption with TWIST. We've had exceptional anecdotal feedback from the initial users, and the data presented at ATTD puts early numbers to the positive impact this combination is having. I also encourage you to check out the data to be presented by our Chief Medical Officer, Dr. Francine Kaufman, at the ADA. This is further real-world evidence on Ever Since 365, and the data shows a full year of strong patient adherence, glucometrics, and hypoglycemic outcomes. It also validates our census performance and accuracy across an entire year, with the same performance between the first and second six-month periods.

Generally, we're very pleased with the progress we're making in advancing our penetration in the Type 1 population. All of these areas of commercial progress are encouraging, and I look forward to continuing the exciting commercial momentum that is building. Significantly, this momentum is driven by the successful integration of the Essentia commercial organization into Senseonics. As an update on this initiative, we brought the Essentia U. S. CGM organization into Senseonics on January 1st, and that transition has gone smoothly, as evidenced by our first quarter performance. The U territories are effectively running and showing progress We appreciate the continuing commitment of our new colleagues and we enjoying building our capabilities with them directly as part of one aligned team We continue to collaborate with Asensia to complete the OUS transition and build a dedicated European commercial team to execute launches in Germany Italy Spain and Sweden As mentioned earlier, we are now live in Sweden and Spain with Germany and Italy on track.

As part of this, we have hired key additional roles to support those countries. We are working to finalize our business systems and to transfer the contracts, tenders, and employees to within the new Senseonics organization. We are planning to close the European transition this quarter. Thank you. In addition, the full team is excited about being part of a single organization that is fully aligned and committed to building and growing the world's most advanced offering in continuous glucose monitoring.

While we continue our focused work to drive awareness and adoption of 365 today, we're also excited about further shaping the future of CGM with our compelling product pipeline for tomorrow. We remain on schedule to launch Gemini in the first half of 2027, as we target delivering a one-year sensor with a battery for continuous and optional on-demand readings. Moreover, in the second half of the year, we plan to initiate the first in-human trial for freedom, the one-year sensor with built-in Bluetooth that will connect directly to the user's phone and insulin pump without a transmitter. We've also begun the important steps of building and scaling the manufacturing processes with our manufacturing partners as we advance towards the clinical trial and ultimate launch.

Additionally, we're also working on enhancements to our EverSense 365 app. This is currently in development, and we expect that to launch later this year. The feedback that we've received during early testing has been positive, and we look forward to rolling out the app to advance our customers' diabetes management decision-making, and we're excited about advanced AI features that will be added as well.

Finally, I'd like to update you on our recent financing initiatives. Delivering on the value creation opportunity our share hopeers have and ever since requires us to have the growth capital to support these initiatives. Therefore, to position us to execute on our strategies, we took two steps to substantially strengthen our balance sheet. On Friday, we executed an amendment and expansion to our credit facility with Hercules Capital, increasing that facility from $100 million to $140 million.

We have drawn an additional $20 million above the $35 million that was previously outstanding, and there are additional draws of up to $85 million available subject to various terms and conditions. Additionally, on Monday, we closed on a public offering raising $92 million in gross proceeds through the sale of common stock and pre-funded warrants. As a result of these two financing steps, Senseonics is in a stronger position to build on the progress we are describing today.

I will now turn the call over to Rick to walk through the numbers.

Thanks, Tim. I'd like to begin today with an overview of our sales channels, reimbursement channels, and revenue recognition to help clarify the mechanics of our financials. Now that the sales and marketing team is fully integrated into the company, I think it is important to provide additional details on what you should expect over the course of 2026. Senseonics has three primary sales channels in the U. S. , direct-to-consumer, healthcare providers, and reorders.

Direct-to-consumer sales is the largest U. S. sales channel and currently accounts for approximately 60% of our new patient growth. In the second half of 2025, we made the strategic decision to invest heavily in the channel and will spend a similar amount this year at approximately $13 million. We learned a lot last year about effectively deploying and targeting this spending and have applied those learnings in 2026, resulting in lower cost per workable leads and higher conversion rates. Our second U. S. sales channel is healthcare providers, targeted by our sales force. While HCP sales currently account for about 40% of new patient growth, this channel has the highest ROI due to repeat prescribers.

In 2026, our sales forces continue to increase productivity, driving more and more new patient leads, and we expect this trend to continue each quarter. Last, but critical to our business, is our patient reorders, which will continue to grow each year. We expect 40% of our U. S. volume to come from reorders in 2026 and are focused on continuing to improve patient retention.

Now I'll move to U. S. reimbursement channels and the mix of bundled pay versus durable medical equipment. In bundled pay, the insertion procedure and the Eversense 365 sensor are combined in a single payment. It is the most profitable reimbursement channel, and with good support from our inside sales team, approximately 60% of our volume is now flowing through this channel.

This contributed to the favorable margins we saw in Q1. The remainder of the volume continues to flow through our DME reimbursement channel. The DME channel is serviced by distributors with payer contracts, and we recognize revenue upon shipment to the DME distributors.

These distributors maintain appropriate levels of inventory, typically 30 days or less. We service the bundled pay channel primarily in two ways. First, through our consignment program, where participating physicians keep inventory on their shelves so the product is readily available for patients.

Second, through EonCare, our wholly owned subsidiary that utilizes contracted nurses to perform the procedure once a patient has a prescription. In the bundled pay channel, we recognize revenue at the time of the procedure. With the integration of the commercial organization, we will no longer be reporting sales to Ascensia, so our reported revenue growth will more closely align with our patient-based growth.

I hope these descriptions were helpful. Now let's turn to the financials for the quarter. In the first quarter of 2026, net revenue grew 85% year-over-year to $11.7 million compared to $6.3 million in the prior year period on the continued momentum of ever since 365 new patient additions, retention rates slightly above plan, and more of our business transitioning into the more profitable bundled pay reimbursement channel. U. S. revenue for the fourth quarter was $9.3 million, and revenue outside the U. S. was $2.4 million.

In Q1-2026, gross profit was $6.9 million, an increase of $5.4 million from the prior year period. This increase in gross profit was primarily due to higher U. S. revenues driven by continued adoption of the Eversense 365 system, We are going to turn the call over to management for prepared remarks. We will now turn the call over to management for prepared remarks. were $30.2 million, an increase of $22.5 million compared to $7.7 million in the prior year period, primarily driven by the integration of the commercial organization, including increased personnel, transition support services from Ascensia, direct-to-consumer marketing, and other operational costs. Net loss was $32.3 million, or a $0.71 loss per share in the first quarter of 2026, compared to a net loss of $14.3 million, or a $0.40 loss per share in the first quarter of 2025.

Net loss increased by $18 million, primarily due to increased expenses resulting from the costs related to taking over the commercialization and distribution of ever since. As of March 31, 2026, cash, restricted cash, and cash equivalents totaled $64.6 million, and debt and accrued interest was $35.2 million.

Q1 delivers, and we're building on that momentum. We're raising our full-year 2026 global net revenue guidance to $60 to $64 million, compared to $58 to $62 million previously. This updated revenue range represents notable year-over-year growth of 70% to 82%. Our business is seasonal due to the resetting of patient deductibles at the beginning of the calendar year and heavier utilization of patient assistance programs at that time to offset out-of-pocket costs. The seasonality of our business the fact that we launched ever since 365 in the fourth quarter of 2024 and the second half focus of our investments in DTC to drive awareness in the back half of 2025 contribute to our revenue being more heavily weighted to the back half of the year We expect to see approximately 40% of the sales in the first half of the calendar year and 60% in the second half.

Taking into consideration our margin performance to date, along with the planned launch of ever since 365 in Europe, which will allow us to focus primarily on a single product globally, we now expect full-year 2026 gross profit margin to be between 55% and 58%, increasing in the back half of the year. We are excited by the financial results in Q1, driven by the integration of the commercial organization, and expect to see continued improvements in our top line and the expansion of our gross profit margins. Due to the integration of the commercial organization and supporting transition service agreements from Ascensia, we expect operating expenses to be between $150 million and $160 million, with increases primarily in SG&A and a smaller increase in R&D for the Gemini Pivotal trial.

We expect cash utilization in 2026 to be between $110 million and $120 million, largely as a result of increasing SG&A due to bringing the sales and marketing teams in-house.

Earlier this week, we completed an equity financing and expanded our debt facility with Hercules Capital, adding more than $100 million to our balance sheet. We issued common stock and pre-funded warrants to institutional investors for gross proceeds of $92 million and drew an additional $20 million on our $140 million debt facility, bringing total debt outstanding to $55 million. We believe this is the right mix of debt and equity in our capital structure, and we believe we now have the financing in place to get us to the anticipated launch of the Freedom product in 2028. We're excited that our strengthened balance sheet will allow us to drive shareholder value by supporting the continued investment ever since 365 and future generation products while focusing on executing our commercial strategy.

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

Thank you, Rick. To wrap up, I want to step back and frame where we stand. Senseonics entered 2026 with a clear thesis that bringing the commercial organization in-house, combined with the strength of the Eversense 365 product, would unlock revenue growth and margin improvement. The first quarter results support that thesis. $11.7 million in revenue, gross margins at 58%. DTC new patient shipments nearly doubling, and EonCare now performing more than a third of all insertions.

As well, patient reorders are tracking above plans. At the same time, our balance sheet is healthy. Our pipeline is advancing on schedule with Gemini targeted in the first half of 2027, and Freedom on Track to enter its first human trial later this year. And we have the organizational structure in place with a full U. S. team integrated.

The European transition is underway, and Eon Care is scaling. We believe Senseonics is positioned to become the company that reshapes continuous glucose monitoring, and we intend to execute with the discipline and urgency that this opportunity demands. With the momentum that we are building across our commercial, development, and financial initiatives, we're optimistic about the remainder of 2026 and beyond.

We look forward to speaking with many of you at our event during this year's American Diabetes Association Conference in New Orleans.

With that, I'll now turn the call over to the operator to answer any questions that you may have. Thanks once again for your time today. Operator, let's go ahead and open up the call for questions.

Thanks, Anthony. In regards to the transition, I'll speak to that, or at least introduce, and then Brian can come in. But it really has gone quite smooth, right? The sales reps were obviously, you know, we worked with them pretty extensively in the fourth quarter, made sure they had everything they need. You know, even simple things like keeping the exact same cell phone numbers, all of that happened. So we pretty much flipped the switch on December 31st, and they were calling on the same accounts, you know, really picked up everywhere that they should have. So we haven't seen and don't anticipate any lag in regards to their efforts and capability.

Brian, I don't know if you had any further qualification for that.

Yeah, Anthony, I'd probably add to that that on the EU side, right, for our four European countries, we're moving from the BGM sales efforts to hiring sales reps to now take over those activities. So if there's a lag, it's in our 4-0 U. S. countries, but as Tim said, the U. S. was fairly seamless.

Yeah, and then, Anthony, I'll cover the investment question. So, you know, we stuck to our original plan. Our original plan does call for an increase in DTC spend in the back half of the year from where it is in the first half, but still in that $13 million ballpark. And we are certainly monitoring the sales force. We have 43 territories today with a plan to maintain that level and increase it next year and the following with our future generation product launches.

Yeah, you're right. But historically, we've been about 50-50 DME and bundled pay, and we certainly have focused some of our DTC spending and inside sales efforts on that bundled pay channel. So we were pretty excited as that our channel mix moved to that channel, being more profitable, which was a good piece of the reason we saw the upside in our margins.

We're going to keep focusing on that channel over the course of the year, but right now thinking that the 60-40 is an appropriate target.

Yeah, we are. As Rick's pointing out, we are, you know, Brian's team is doing a great job to reaching out to the folks that are on Medicare, which is a pretty good portion of that. But we are also seeing some of the commercial payers transition to the bundled pay. So, Josh, I would expect that to transition, but over a couple-a-year time period. I don't think it's anything that will have precipitously in this year. Thanks for the help thinking through that. Maybe a follow-up, just a two-part pipeline question. The first part, just thinking about the data that hit at ATTD with the SQL integration.

And what will be put forward at ADA just on the performance for EverSense 365. There may be some other PUMP partners that are interested in integrating EverSense 365 here. Any updates on any partnership discussions? And then also just with the Freedom Progress and getting into a human trial the second half of this year, Let me just help us think about how de-risked that program is. Are there any further steps that need to be taken before you guys can move into that trial? I guess what boxes are left to be checked before that trial can kick off? Thanks for taking all the questions. Sure Josh On the first part on the data yes sorry the data with Fran going to speak too That going to be an extension of the work that she did We now have a notably much larger population of the SQL folks We seeing you know really encouraging results there She did get an oral presentation We also have a lot more extension of the 365 data So that will certainly be encouraging, and we're looking forward to the results from that.

And the PUMP partnership, we continue to be very active. We don't have anything to announce, but it is an important focus for us, and we're continuing to make progress. On Freedom?

Yeah, hey, Josh. This is Mikul. On Freedom, we have been making a lot of progress. We are doing a second preclinical in animals, and now we think we are at a stage where we can take, we've taken the risk out of the product and take it into humans. The first in human we'll be doing outside U. S. in a feasibility study, and then we'll bring the data over to start discussions with FDA to get a pivotal study IDE in by end of the year.

Yeah, obviously we don't have the multi-sensors at this point, but we are encouraged. The historical has been, you know, first to second is around 75 percent, second to third is around 85 percent. By the time you get to your third sensor, it's well into the 90s.

And I think we're continuing on that track. We don't yet have the data, obviously, for the second year, but the first data is quite encouraging and, frankly, was a little bit stronger than we had modeled. So we feel quite good about the experience we're seeing in the one-year sensor.

He was going to ask the question to follow up. Did you have a question on the battery, Matt?

Sure, Matt. So the battery comes from Integer, right? They're pretty much the only manufacturer of implantable batteries for all medical devices. So there's no technological risk. The chemistry we're using is very well known in the cardiac and neuromodulation devices used over two decades. So, and all those choices were made just to make sure that the risk is low. FDA knows that company pretty well.

So for Gemini, we have already attached the battery. We already have it in clinical study. So there is no technical risk left in Gemini. Okay. Going beyond the battery is the Bluetooth that comes new to Freedom, and we have made a lot of progress there, and as we have stated earlier, we are ready to go into humans to kind of start collecting data while we continue to refine the Bluetooth technology in that really small form factor.

Thanks so much. You're welcome.

Yeah, sure, Sean. I'll take that. So, I think if you remember the back half of 2025, we made significant investment in BTC, certainly drove increased awareness of our product, but those cost per workable leads were higher. It did become a little bit less efficient, and so in 2026, what we did is take the same amount of spend that we spent in the back half of 25 and spread it all year long. And so although we're making smaller investments on a monthly basis, we're seeing improvements in both cost per workable lead and in our conversion rates. So we've learned a lot with that investment we made in the back half of the year and are certainly tweaking algorithms and spend levels to make sure that it's extremely efficient.

So we're pretty happy with the progress we've made so far in Q1.

The value proposition for Eversense continues to be the same. They have made some changes from 14 to 15 days, but obviously that's significantly different than a year-long sensor. The primary premise, of course, for a person with diabetes is they'd like to think less about their diabetes technology and more about the rest of their life. So as we manufacturers can make it simpler and easier to use, they will reward you for the purchase of a quality product, and ever since, certainly fits that bill. So a year long, I'm not having to think about a sense of change, is really very attractive to people, and that's why we're seeing the growing penetration that we're seeing.

Yeah, we've actually received quite nice feedback from it. I think one of the things is we'll have an extension on that at the ADA that I think will get further coverage, but we're also, Ben, in the process of getting that peer-reviewed, written up and peer-reviewed, and that's really the next big step for us to get further visibility of it. So I would hope that, you know, later this summer we'll have a peer-reviewed publication that'll, you know, strengthen the, you know, publication and rollout of that information. But the feedback certainly has been positive.

You know, as we pointed out, we feel very comfortable. You get the long-term compliance, obviously, of ever since, at 365 days. And the algorithm, the loop algorithm, has some pretty attractive attributes and is performing pretty well. So when you put those together with a high-precision pump like you get out of SQL, you get those very, very good results. And then, you know, I guess this kind of dovetails with one of Josh's questions on that the data that was with the first hundred or whatever was SQL pump users was, did that help the level of attention and maybe get some of the other potential pump partners across the Fender plan, or is that, you know, not enough patients yet or how's the right way to put it?

I mean, it's definitely, you know, it's definitely helping, you know, with a partnership. Brian, you want to speak to that? Your team is spending a lot of time working with them.

Yeah, I think both the success we've had in the first couple months of the combined system has opened some eyes and exceeded our expectations. And clearly the data was good, both on the sensor and the sensor and the pump. And so anytime you can show that data in real life now, it substantiates a whole lot. It just helps a lot of conversations, Ben. So very happy with it. Yes, it's helping the conversations move forward.

Thanks, Ben. Thanks.

I'd like to thank everybody for participating, and we look forward to updating you next quarter. So with that, we'll go ahead and end the call.