Senseonics - Q1 2024

Transcript

Operator (participant)

Good afternoon, everyone, and welcome to the Senseonics First Quarter 2024 news conference call. All participants will be in a listen-only mode. Should you need assistance, please send a call to a specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Trip Taylor. Please go ahead.

Trip Taylor (Principal)

Thank you. This is Trip Taylor from the Gilmartin Group. Before we begin today, let me remind you that the company's remarks include forward-looking statements. These statements reflect management's expectations about future events, operating plans, regulatory matters, product enhancements, company performance, and other matters, and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under Risk Factors and elsewhere in our annual report on Form 10-K for the year ended December 31, 2023, our quarterly report on Form 10-Q for the quarter ended March 31, 2024, and other reports filed with the SEC. These documents are available in the Investor Relations section of our website at www.senseonics.com.

We undertake no obligation to update publicly or revise these forward-looking statements for any reason except as required by law. Joining me from Senseonics are Tim Goodnow, President and Chief Executive Officer, and Rick Sullivan, Chief Financial Officer. With that, I'd like to turn the call over to Tim Goodnow, President and CEO. Tim?

Tim Goodnow (President and CEO)

Thank you, Trip, and thank you all for joining us this afternoon. We'll begin today by providing an update on our performance during the first quarter and then transition to the several important milestones recently achieved by the company that represent critical growth catalysts for the future of Senseonics. Then our Chief Financial Officer, Rick Sullivan, will discuss the first quarter financials in detail, and we'll open up the call for questions. We've had a very successful start to the year at Senseonics. We've advanced key strategic initiatives intended to amplify the benefits of our long-term and plannable CGM to appeal to more patients. We are making commercial progress, both with our quarter-over-quarter growth in new patient additions and by advancing a transformational collaboration with one of the 20 largest health systems in the country.

Mercy has chosen to use Eversense as the foundational technology to facilitate a broad-based diabetes population management program intended to optimize care in a large targeted patient population. Importantly, we have significantly progressed our product pipeline by establishing the new Eversense remote patient monitoring solution and achieving iCGM designation from the recent FDA approval, as well as filing the 510(k) submission for our next-generation 365-day product. With the advancement of the product pipeline and the development of new commercial initiatives, we believe the Eversense platform sits in its strongest position ever. We anticipate continuing to build on these accomplishments throughout the remainder of 2024. On the financial front, in the first quarter, Senseonics generated total revenue of $5.1 million, representing 22% growth compared to the prior year period. In the U.S., first-quarter sales totaled $3.7 million, and sales outside the U.S. totaled $1.4 million.

On the commercial front, with Ascensia Diabetes Care, their main objectives remain rooted in driving expanded awareness and access to Eversense within the diabetes population. They continue to drive quarter-over-quarter patient growth, both via DTC and professional sales efforts. Additionally, as we have previously announced, industry veteran Brian Hansen was appointed president of the ADC CGM business and has also been recently appointed to the Senseonics board. We are working closely together as he ramps into this role and formalizes plans to improve Eversense commercial strategy and execution. Importantly, we continue to explore additional growth avenues for Eversense, notably with the expansion by Medicare to cover CGM for all patients on insulin, as well as diabetes patients not on insulin with a history of hypoglycemia. And now, with similar adoption by many commercial payers, we estimate that less than one-quarter of patients eligible for CGM are using one.

Giving both the clinical and healthcare economic benefits for people using CGM, there remains substantial opportunity to reduce the healthcare cost of diabetes while helping patients live healthier lives. To that end, we believe Eversense is ideally suited for integration across large health systems and accountable care organizations who are facing increased pressures to improve patient outcomes and their quality of care, all while driving down costs resulting from suboptimally managed diabetes. With their ability to influence care pathways and the breadth of providers in their system, including those who would regularly conduct office-based procedures such as interventional cardiologists, together with the professionals who care for people with diabetes, specifically endocrinologists and primary care physicians, we believe these health systems could certainly benefit from Eversense and manage the efficient patient workflows to enable the broad adoption of our implantable CGM.

For this front, today we announced our innovative collaboration with Mercy, a leading healthcare system and accountable care organization based in St. Louis, Missouri, that spans across four states and is consistently recognized for their innovative breakthroughs in healthcare. Mercy clearly recognizes the potential value Eversense can bring to its diabetes population health management program. Together, we are working to build an innovative approach that combines Eversense CGM, advanced data analytics with Mercy's artificial intelligence capabilities, and our new Eversense RPM program to systemically monitor patients at risk. Mercy has identified up to an estimated 30,000 patients across their system who could benefit from CGM. We believe this represents a substantial opportunity to help these patients better manage their diabetes and avoid costly short- and long-term expenditures.

We look forward to working with Ascensia to bring as many of these patients to Eversense as we can in the coming quarters and years as we roll out this multi-state collaboration with Mercy. We are working with Mercy's executives and operational teams to design and implement the program. Mercy plans to begin a controlled launch focused on making Eversense initially available to a cohort of patients in the St. Louis metro area in July and will then look to further ramp operations in conjunction with the planned 365-day product launch targeted for Q4. Together, we see the opportunity to place an emphasis on Type 2 patients on basal insulin who historically trail in the adoption of advanced technologies. Our perspective is that access to advanced technologies and personalized Remote Patient Monitoring can reduce risk to both the patient and the healthcare system.

Our shared goal with Mercy is to use their innovation leadership to develop this comprehensive diabetes management approach so that it can be replicated for other healthcare organizations. With an estimated 1,300 health systems in the U.S., we are excited to develop this strategic approach to enhance the value Eversense could bring to health systems. An important component of this collaboration includes our newly announced Eversense RPM program, which we believe will further differentiate Eversense by providing a comprehensive solution for patients, providers, and the healthcare systems. While it has been well established that CGM alone produces better outcomes for people with diabetes, we're confident there is an opportunity to deliver even more. Today, patients are simply provided a CGM device, but we feel there is often limited ongoing support for understanding and utilizing the data for personal optimization, particularly in between office visits.

Our RPM program aims to fill in these key gaps. First, it is designed with the intent to provide patients with a strong foundation through better understanding of their CGM data and how to use it for optimal glucose control, supported by diabetes counselors. These counselors are intended to provide coaching and insight into things impacting their glucose levels, such as medications, food, and exercise, and to enable participants in the program to make better-informed choices about managing their diabetes. The program devised with Mercy and Rimidi is designed to meet the requirements for Medicare and commercial RPM reimbursement. In addition, we also see the program as providing an invaluable communication loop between our RPM counselors and the patient's healthcare provider, enabling key interventions. By engaging with patients on a monthly basis, we aim to improve this optimization loop.

The goal is that identifying corrective actions and making appropriate improvement changes, which previously occurred during office visits, will now be able to be done in between visits, accelerating progress and bridging the gap between traditional in-person visits. After we have finalized the development and implementation of the program and rolled it out with Mercy, we intend to make Eversense RPM system available to patients and clinicians who use Eversense generally. We see the Eversense CGM and RPM combination as providing more reasons for clinicians to make Eversense their CGM of choice. We believe our partnership with Mercy is an important testament of the need for this more comprehensive care solution, and they're excited to build this program further. As we finalize the plans for these opportunities, which are expected to occur in the second half of the year, we are developing our full-year financial outlook.

We plan to provide our full-year guidance in June at the upcoming ADA conference. As for the first half of 2024, we continue to expect global net revenue for Senseonics to be $10 million, representing growth of approximately 16% over the first half of 2023. Second-quarter revenue is expected to be consistent with revenue in the first quarter and assumes continued new patient growth as Ascensia manages inventory towards normalizing levels. Now, I'll turn to our pipeline, where continuing to advance innovation in CGM technology remains a key strategic imperative for Senseonics and the focus of our product development teams. I'm pleased today to highlight important progress with two key milestones in our broader pipeline plan. First, we recently announced that the Eversense CGM system received iCGM designation from the FDA.

The iCGM designation indicates that the Eversense iCGM product can integrate with the compatible medical devices, including insulin pumps, as part of an automated insulin delivery system. As the first fully implanted device in the category, Eversense has been authorized to be marketed as an iCGM through the FDA's De Novo pathway. This authorization demonstrates that Eversense meets the high bar set by the FDA for analytical performance and accuracy, and our intent is for all future substantially equivalent devices of similar type to be submitted as Class II devices as 510(k) submissions. The iCGM designation has been a core component of our strategic initiatives to advance our pipeline, and we're excited to move forward with the next step to advance integration partnership discussions with leading insulin delivery device companies.

At this point, we are in discussion stages with various manufacturers and aim to offer people a new interoperable CGM option that we believe is exceptionally well-suited for automated insulin delivery systems. Both Senseonics and pump manufacturers recognize the opportunity to positively impact the lives of more people with diabetes with an Eversense integrated system, and we are excited by the potential to further these discussions. We plan to provide more updates as they develop. Now, for our second exciting key pipeline development. Following our iCGM approval, today we are pleased to report that this last week, we filed our FDA submission for our next-generation 365-day system as a 510(k) pre-market notification. This De Novo iCGM designation facilitated this downregulation of submissions for devices of the same type.

I would like to note that despite now being on a 510(k) pathway, we have generated high-quality clinical data and worked to put together a submission with the same rigor as a PMA submission. Relying on the confidence in our technology and high-quality submission, we continue to work towards our goal of a fourth quarter launch this year. The 365-day system is unique in that it offers several differentiators. First, an anticipated full-year protection from a single sensor and a significant reduction in planned calibration frequency. We are confident that a one-year sensor with reduced calibration will be a compelling combination, and are excited that this submission moves us one important step closer to that goal. Importantly, the 365-day system platform with redundant sensing capability for longer life and retained accuracy is also the basis for further development within our pipeline.

Both of our subsequent generation Gemini and Freedom self-powered products are designed to leverage this technology and FDA approval as we work towards the now-approaching goal of removing the need for any on-body transmitter. We're excited to continue to be on plan for the first-in-human testing of Gemini in the second half of this year. We continue to innovate and prioritize our pipeline progression to continue to move our CGM technology forward. With this exciting news, I'll now turn the call over to Rick for a review of our financials.

Rick Sullivan (CFO)

Thank you, Tim, and good afternoon, everyone. We appreciate the opportunity today to update you on our business. In the first quarter of 2024, net revenue was $5.1 million compared to $4.1 million in the prior year period. U.S. revenue for the first quarter was $3.7 million, and revenue outside the U.S. was $1.4 million. As a reminder, our collaboration agreement with Ascensia is for revenue sharing, with the percentage of revenue to Ascensia increasing based on duration of the contract and annual revenue levels. We recognize our portion of revenue when shipments are delivered to Ascensia, and they take title and ownership of the inventory. This begins the multi-step distribution to patients via Ascensia and their distributors. We manage our manufacturing based on patient demand generated from commercial activities, targeting 60-90 days of inventory across the various channels.

Therefore, our shipments to Ascensia during the quarter are largely intended to support future demand for Eversense. We are monitoring inventory levels closely based on Ascensia's prior purchases and sales and with consideration of the approach for the currently planned transition to the 365-day product later this year. Gross profit in Q1 2024 was $0.3 million, a decrease of $0.1 million from a gross profit of $0.4 million in the prior year period. The decrease in gross margin was primarily driven by higher fixed manufacturing costs. Research and development expenses in Q1 2024 were $10.4 million, a decrease of $2 million compared to $12.4 million in the prior year period. The decrease was primarily due to reductions in clinical trial expenses associated with the enhanced Pivotal trial as patients completed the study. These decreases were slightly offset by planned continued investments in our product pipeline for development of next-generation technologies.

First quarter 2024, selling, general, and administrative expenses were $8.1 million, an increase of $0.4 million compared to $7.7 million in the prior year period, primarily driven by increases in corporate legal and patent expenses. For the three months ended March 2024, operating loss was $18.2 million compared to $19.7 million in the first quarter of 2023 due to decreases in R&D expenses. For the three months ended March 2024, total net loss was $18.9 million, or a $0.03 loss per share compared to a net income of $1.3 million, or a $0.00 gain per share in the first quarter of 2023. Net income decreased by $20.2 million due to the accounting for embedded derivatives, fair value adjustments, and the exchange of a portion of the 2025 notes. As of March 31st, 2024, cash, cash equivalents, and short-term investments totaled $99.1 million, and debt and accrued interest was $55.9 million.

Turning to our outlook for 2024, we continue to expect first-half 2024 global net revenue to be $10 million and second quarter revenue to be consistent with the first quarter. At the upcoming ADA meeting, we plan to provide second-half and full-year revenue guidance along with the expectations for 2024 revenue share percentages, taking into consideration greater visibility on the status of the review of our 365-day filing and the progress of our various commercial initiatives. For full-year 2024, operating expenses are expected to be similar to 2023 at approximately $80 million. With that, I'll turn it back to Tim.

Tim Goodnow (President and CEO)

Thanks, Rick. The recent progress made by Senseonics includes pivotal milestones that we believe will propel the company to its next phase of growth. We expanded the features of Eversense to make it appealing to more patients, and with optimized commercial execution, we aim to drive increased adoption. Its innovative capabilities lend to it to be uniquely suited for a strategic partnership within the diabetes management environment. Mercy's collaboration and future healthcare system strategy represents an opportunity that could drive an inflection in our growth over the years to come. With the ICGM designation secured, the upcoming 365-day product filed, and our RPM program progressing, the Eversense platform is in its strongest competitive position of all time. We're excited to build on this momentum and provide more updates as the year unfolds.

I'd like to take this opportunity to thank all of the Senseonics employees for their hard and tenacious work to bring all of this together. Thank you all for your time today. Also joining us for questions is Mukul Jain, our Chief Operating Officer, and Jeff Ruiz, our Head of Strategy and Business Development. Operator, let's go ahead and open up the call for questions.

Operator (participant)

Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then one on your touchscreen telephones. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys to ensure the best sound quality. To withdraw your questions, you may press star and two. Once again, that is star and then one to join the question queue. We'll pause momentarily to assemble the roster. Our first question today comes from Marie Thibault from BTIG. Please go ahead with your question.

Marie Thibault (Managing Director)

Good afternoon, Tim, Rick, Mukul. Thanks for taking the questions. I wanted to ask a high-level one here to start. On the last quarter call, you mentioned that Ascensia had built up some inventory as they were trying to work through the high volume of leads that were generated and turn those into new starts, new Eversense starts. Can you give us an update on how that has been going, how much of that backlog has been worked through, whether we're a bit ahead of your own expectations? Just ways to kind of understand how that process is going.

Tim Goodnow (President and CEO)

Thanks, Marie. ADC continues to make good progress at working through their inventory. We are certainly seeing quarter-on-quarter patient growth. I think at our last update, we're seeing over 80% growth in the first portion of this year compared to last year, so we're certainly excited about that. The reality of the 365-day product and the opportunity to have that approved under the 510(k) pathway gives us a further opportunity there. So we're anticipating that we'll be fully working through that inventory over the next quarter, plus the time that it takes for us to transition with the 365 product as we bring that along in the hopefully really set in the very beginning of the fourth quarter.

Marie Thibault (Managing Director)

Okay. That makes sense. And just to clarify, I think there were some metrics last quarter you'd given hopes that first-half new patients would grow 150% year-over-year and perhaps exceed new patient sales. I'm not sure if I got that. New patient sales in 2023. Are you still able to kind of confirm that that's on track?

Tim Goodnow (President and CEO)

Yeah. We still believe we're on track. As I said, at this point, we're well over 80% at this point in the year, so we certainly expect we're going to continue at this same level of growth and more.

Marie Thibault (Managing Director)

Okay. Great to hear. Then my follow-up here certainly sounds intriguing, the Mercy collaboration and your RPM program. Can you give us a way to think about how meaningful this could become if it does become successful? And then what investments are needed from Senseonics' side in those RPM programs? We've talked with doctors in the past who've run very effective RPM programs, but I know it does require some focus and time and perhaps some handholding. So any more details on investments you need to make there? Thanks for taking the questions.

Tim Goodnow (President and CEO)

Sure. Well, we certainly recognize that this is a unique opportunity and blends very well with the long-term nature of the Eversense product. Mercy really recognized this very early on when they reached out to us, and they really are looking for a proactive way that they can monitor their at-risk patients. As you said, they've identified about 30,000 right now that are candidates that we're going to be jointly working on. So it's a very significant opportunity for us and for Mercy as well. Jeff, I'll ask you to speak to a little bit about the operational parts of it. Jeff Ruiz has been leading this activity for us and is living it day by day.

Jeff Ruiz (Head of Strategy and Commercial Business Development)

Yeah. I'll just elaborate a little bit more on what Tim has kind of mentioned in the first part of your question around kind of the opportunity, the size, etc. Certainly, an account such as Mercy represents a large opportunity for us, of course. What we know and through our assessment and the strategy that we have been developing now in concert with Mercy is that the vast majority of patients that could be benefiting from CGM are not on it. Mercy recognizes that, and we've heard that from other health systems. As we look at that, the opportunity then becomes, how can we collectively get the right care to the right patient, in this case, CGM therapy?

Mercy sees that opportunity right within their own ranks because of their own provider network and their ability to easily facilitate the process from prescription to insertion with their extensive network of proceduralists. They'll be starting with their interventional cardiologists and expanding that to other proceduralists that can easily facilitate the insertion for these patients. In terms of the RPM program, and I appreciate the question because it's a very integral part to the health system strategy that we have, it's the way that health systems can even further attempt to optimize the outcomes that they're looking for from patients. So the RPM solution is key to the success of that.

And it's also, from our perspective, we believe it's a very sustainable and scalable program as the costs and the fees that we are paid to do it are known upfront and allows us to scale that. Mercy will be doing the reimbursement for the services, and they'll file for the reimbursement. They'll pay us the fee, and we know we have our fixed costs on a per-patient basis pretty clearly identified as we go forward. So the investments from our side are not overly significant, and we feel like we've got a good model here that we can scale going forward. It's important to note that the financial side of the program in and of itself is really kind of lower on the tier in terms of our goals and objectives. Goal number one is to improve the clinical outcomes of the patient.

Goal number two is to improve the cost of care overall for the health system. If we do that, we win. We're fortunate that the reimbursement of the existing healthcare system allows us to do that in a way that is financially viable for us along the way.

Marie Thibault (Managing Director)

That's very helpful. Thanks so much.

Operator (participant)

Our next question comes from Matthew Blackman from Stifel. Please go ahead with your question.

Colin Clark (Healthcare Equity Research Associate)

Hi. This is Colin Clark on for Matthew Blackman. I guess I wanted to come at the Mercy collaboration from a slightly different angle and kind of ask what your sense of the potential penetration ceiling is for this 30,000 patient opportunity and any early color on the economics, whether they're driven by outcomes. You've talked about how it's a relatively set cost upfront for the patient. What does the revenue recognition look like in this channel? And does the Rimidi partnership allow you to more easily add other system partnerships to the business? Thank you.

Tim Goodnow (President and CEO)

Well, certainly, we do recognize that this is going to be the first system implementation, but we expect that it's, quite frankly, the basis which we will be designing others from. And that, quite frankly, is an objective of Mercy as well. They want to lead here, get it established, and be able to replicate it out to other hospital systems. So the 30,000 patient opportunity is in front of us right now, and we're going to continue to work very hard in partnership with Ascensia. So this is part of our current commercialization agreement with Ascensia, and the economics will be considered as such. So it's business as usual from that financial perspective. It's just a very large opportunity for us, and we're looking forward to the folks at Mercy through their systems driving patients towards the Eversense product.

Colin Clark (Healthcare Equity Research Associate)

Where are most of these patients found in this Mercy system? Is it PCP-weighted where you've had some success with NPGs recently, or is it more endo-focused? I guess you're having interventional cardiologists as the proceduralists. Is there a learning curve in that set of offices that needs to be worked through?

Tim Goodnow (President and CEO)

This is predominantly their highest-risk population is predominantly Type 2s. So yes, it is primary care treatment. Jeff, do you want to go ahead and speak through how we look at this systemically with Mercy to reach these patients?

Jeff Ruiz (Head of Strategy and Commercial Business Development)

Sure. Sure. I'll say this. The reason they're starting with their interventional cardiologists is because they are. This is what they do. They are proceduralists. They are accustomed to doing procedures in the office, in the cath labs, etc. Our procedure is rather straightforward for them, and so it seems, from their perspective, makes a lot of sense for them to go ahead and just have the cardiologists begin doing this and now extend their reach beyond as needed throughout their mid-level practitioners, etc., throughout some of their community clinics, throughout the four states that they serve. Yep. As it relates to where the patients are coming from, the majority of patients today that are at risk of some of these immediate complications on the patient side and then the cost complications on the hospital side, the biggest unserved population, as they recognize, is in their Type 2 patient population.

So they're excited about the opportunity to really reach the three-quarters of patients today that are being underserved in a way, if you will, by not having CGM and presenting risk to themselves as patients as well as to the health system from a financial perspective. We'll be working closely with the primary care teams as well as the endocrinologists who are a very important and instrumental part of the overall program.

Colin Clark (Healthcare Equity Research Associate)

Understood. One last question from me. Encouraged to hear about the 365-day approval timeline being still on queue. Just quick question about your confidence in being able to have that approved and possibly launched in time for the annual Medicare process around December.

Tim Goodnow (President and CEO)

Yeah. So we're actually working with Medicare here in the next few days now that we've submitted with it. So obviously, the transition to the 365 in government pay and in commercial pay is a process that we do need to go through. Recall that we did, with pretty good success, go through that when we went from our 90-day product to 180. So we feel pretty good about it, but we will begin meeting with Medicare literally within the next week and commercial pay shortly right after that. So the confidence is quite good. As you know, the 510(k) timeline is notably quicker than the PMA supplement process that we've been in. But that said, there are always variations, and we'll continue to work very closely with the agency to make sure that we've provided everything they'll need for as quick a review as they can provide.

Colin Clark (Healthcare Equity Research Associate)

Thank you.

Operator (participant)

Our next question comes from Jayson Bedford from Raymond James. Please go ahead with your question.

Jayson Bedford (Managing Director of Equity Research)

Oh, great. Thanks. This is Glenn on for Jason. Just on the economics, Jeff, you mentioned that Senseonics will receive a fixed price on a per-patient basis. How does this compare to selling into an office that is not part of the Mercy system?

Jeff Ruiz (Head of Strategy and Commercial Business Development)

Yeah. Let me just make sure to clarify here. The sensor itself will go through its normal process and channels just as we do today. So there's no risk-sharing or any other kind of alternate type model when it comes to the device side. The RPM side is simply following the RPM healthcare reimbursement that exists today where, according to the Accountable Care Act, allows for a physician to prescribe the services of remote patient monitoring and obviously pay a fee for that service to be provided. That will go to us. Our fixed cost on our side come out of that payment that will be made to us from Mercy. Mercy, in return, will file for the appropriate reimbursement and receive the reimbursement accordingly.

Tim Goodnow (President and CEO)

Yeah. Yeah. So Glenn, thanks for the question. So just again, to reiterate, so sensor economics will be as usual. We'll continue to commercialize with our partnership with Ascensia as we have always done into the Mercy hospital system. The economics for the RPM are, as Jeff referred to.

Jayson Bedford (Managing Director of Equity Research)

Okay. Thank you. Then just quickly on iCGM, what does this mean commercially, and when should you expect some commercial integration with pumps?

Tim Goodnow (President and CEO)

Obviously, the iCGM gives us the opportunity. As we shared earlier, we are in conversations with the pump manufacturers. We're not ready to put timelines on it or to communicate timelines on it here, at least out in the public domain. We'll certainly keep you updated as that goes on. Recall that it does take some time. It's typically been 18 months or so for the integration to occur. At least that's been the history from the other CGM manufacturers. We'll do all we can to work to accelerate that where we can.

Jayson Bedford (Managing Director of Equity Research)

Okay. Thank you very much.

Operator (participant)

Our next question comes from Matt Taylor from Jefferies. Please go ahead with your question.

Matt Taylor (Managing Director)

Hi. Thank you for taking the question. I guess I wanted to ask a couple detailed questions on the Mercy collaboration. So just to clarify, you mentioned the 30,000 patients that are eligible in their system. How do you define those patients? Are those patients who are CGM eligible but not currently on a CGM, or what makes them fall into the 30,000 bucket?

Tim Goodnow (President and CEO)

Jeff, I'll go ahead and let you expand on it. But yes, these are CGM eligible. So they're either on insulin or have episodes of hypoglycemia. These are the ones that are identified as the highest risk by Mercy as an ACO that they are because of their risk-sharing agreements. They are very much looking to keep those folks out of the ED. They'd like to reduce the total cost of care. There's a gap right now in their system in their ability to do monitoring of those patients. So predominantly Type 2 and focused on of course, they are insulin-using Type 2s or those with hypoglycemia. Jeff, anything else?

Jeff Ruiz (Head of Strategy and Commercial Business Development)

I think that summarizes it. It answers the question. Sure.

Matt Taylor (Managing Director)

I guess in this partnership and just understanding how it may develop with other systems, what does that mean for other CGMs? Are they still being used in Mercy's system, or are yours used preferentially? Presumably, some of these patients are already on another CGM, or they're being asked to switch. How does it work with the competitive set?

Tim Goodnow (President and CEO)

Jeff, do you want to step through that?

Jeff Ruiz (Head of Strategy and Commercial Business Development)

Yep. I got it. No, I'd be happy to. This is not an exclusive agreement with Mercy. I want to make sure we're clear on that. Mercy doesn't intend to switch any active CGM users that they currently have, say, on a competitive product. That said, the big opportunity for a health system right now, and this is really important, are the patients that are not on CGM. Those patients are at risk in having their own suboptimal clinical outcomes. That's detrimental to the patient, first and foremost. Secondarily, those patients are highest risk to Mercy, in particular in this day and age where health systems are contracting in their risk-based and value-based agreements with payers. This can be very costly to these healthcare systems. So that's priority number one.

Of course, Mercy will offer Eversense to all patients throughout their system in the event that patients want to switch over to Eversense, particularly as we move into the 365 era. They're not excluding the existing patients on CGM, but they recognize that the majority of patients are not on CGM, and they're looking to fill that gap and solve that proactively by using CGM in their existing network to get CGM and Eversense into the hands of these patients.

Matt Taylor (Managing Director)

Okay. Great. Thanks for the color.

Operator (participant)

Ladies and gentlemen, in showing no additional questions, I'd like to turn the floor back over to management for any closing remarks.

Tim Goodnow (President and CEO)

Well, great. Thank you for the opportunity to speak today. We very much appreciate your time and look forward to updating you on these continuing exciting developments here at Senseonics. With that, have a good day.

Operator (participant)

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your line.