SENS - NASDAQ

Good afternoon, everyone, and welcome to the Senseonics First Quarter 2024 Earnings Conference Call. [Operator Instructions] 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.

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 would like to turn the call over to Tim Goodnow, President and CEO. Tim?

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 implantable 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 fits 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 by a 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 1/4 of patients eligible for CGM are using one, giving both the clinical and health care economic benefits for people using CGM there remains substantial opportunity to reduce the health care 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 sub-optimally 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 health care system, an accountable care organization based in St. Louis, Missouri, this spans across 4 states and is consistently recognized for their innovative breakthroughs in health care. 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 multistate 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 we'll 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 trailed 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 health care 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 health care 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 health care 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, device, Mercy and remedy 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 health care 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 business, 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 are 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 the Ascensia manages inventory towards normalizing levels. Now I'll turn to our pipeline. We're 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 2 key milestones in our broader pipeline plan. First, we recently announced 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 2 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, this last week, we filed our FDA submission for our next-generation 365-day system, as a 510(k) premarket notification. This de novo iCGM designation facilitated this down-regulation of submission 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 work 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 1-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, 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.

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 multistep distribution to patients via Ascensia and their distributors. We manage our manufacturing based on patient demand generated from commercial activities, targeting 60 to 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 ENHANCE 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 3 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 3 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 $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 31, 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.

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 futures 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 health care systems 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 file 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 Instructions] And our first question today comes from Marie Thibault from BTIG.

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 you're a bit ahead of your own expectations? Just ways to kind of understand how that process is going?

Thanks, Marie. ADC continues to make good progress at working through their inventory. We do -- we are certainly seeing quarter-on-quarter patient growth. I think in 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.

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?

Yes. 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 the same level of growth and more.

Okay. Great to hear. And 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 run very effective RPM programs, but I know it does require some focus and time and perhaps some hand holding. So any more details on investments you need to make there?

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.

Yes. And 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, et cetera, and 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, and 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? And 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. And so the RPM solution is key to the success of that. And it's also a very -- from our perspective, we believe it's a very sustainable and scalable program as the cost 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 #1 is to improve the clinical outcomes of the patient. Goal #2 is to improve the cost of care overall for the health system. If we do that, we win. And we're fortunate that the reimbursement of the existing health care system allows us to do that in a way that is financially viable for us along the way.

Our next question comes from Matthew Blackman from Stifel.

This is Colin on for Matt. 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 costs upfront for the patient, what does the revenue recognition look like in this channel? And does the RMG partnership allow you to more easily add other system partnerships to the business?

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 a 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 of what we 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.

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

This is predominantly -- the highest risk population is predominantly Type 2. 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?

Sure. Sure. The reason there -- 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 customer doing procedures in the office, in the cath labs, et cetera. 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 they'll extend their reach beyond as needed throughout their mid-level practitioners, et cetera, throughout some of their community clinics throughout the 4 states that they serve. Yes, as it relates to where the patient is 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 some sort of population as they recognize is in their Type 2 patient population. So they're excited about the opportunity to really reach the 3/4 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. So we'll be working closely with the primary care teams as well as the endocrinologists who are a very important instrumental part of the overall program.

Understood. And one last question from me. I'm encouraged to hear about the 365-day approval time line being still 4Q. Just a quick question about your confidence in being able to have that approved and possibly launched in time for the annual Medicare process around December?

Yes. So we're actually working with Medicare here in the next few days that now that we've submitted with it. So obviously, the transition to the 365 in government pay and 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) time line 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 a quick review as they can provide.

Our next question comes from Jayson Bedford from Raymond James.

This is Glenn on for Jayson. 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?

Yes. 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 health care 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.

Yes. So Glenn, thanks for the question. So just again to reiterate, so since our 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.

Okay. And then just quickly on iCGM. What does this mean commercially? And when should you expect some commercial integration with pumps?

So 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 time lines on it or to communicate time lines 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. And we'll do all we can to work to accelerate that where we can.

Our next question comes from Matt Taylor from Jefferies.

I guess I wanted to ask a couple of 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 or those patients who are CGM eligible but not currently on a CGM or what makes them fall into the 30,000 bucket?

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. And 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, and there's a gap right now in their system and their ability to do monitoring of those patients. So predominantly Type 2 and focused, of course, they are insulin using Type 2s or those with hypoglycemia. Jeff, anything else?

I think that answers the question, sure.

And I guess with 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 are they being asked to switch. How does it work with the competitive set?

Jeff, do you want to step through that?

Yes, I got -- no, I'd be happy to. Mercy -- this is not an exclusive agreement with Mercy and I want to make sure we're clear on that. And 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 our health system right now, and this is really important, the patients that are not on CGM. Those patients are at risk and 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 could be very costly to these health care systems. So that's the priority #1. 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. So you'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 Eversense into the hands of these patients.

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

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.