Good day, and welcome to the Senseonics Fourth Quarter and Full Year 2021 Earnings Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Philip Taylor, Investor Relations. Please go ahead.

Thank you. This is Philip 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, 2021, our 10-Q for the quarter September 30, 2021, 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. Also on this call, we will be discussing our 2022 outlook. Joining me from Senseonics are Tim Goodnow, President and Chief Executive Officer; and Nick Tressler, Chief Financial Officer. With that, I’d like to turn the call over to Tim Goodnow, President and CEO. Tim?

Thank you, Taylor, and thank you all for joining us this afternoon. On the call today, we’ll provide an update on our launch plans and collaboration with Ascensia for the recently approved Eversense E3 CGM system. We’ll discuss strategic updates in Europe, and we’ll touch on our product pipeline. Nick will discuss the fourth quarter financials in detail, and then we’ll open up the call for questions. To start off, last month, we announced a major milestone for Senseonics, achieving FDA approval of the Eversense E3 continuous glucose monitoring system. This is the third generation product approved for Senseonics, and speaks volumes about the leading scientific and technical pedigree of the company. We are very proud to extend the duration of the longest lasting CGM system to 6 months in the United States. Not only is this the longest lasting CGM by over 12-fold, but it also offers patients top-tier glucose measurement accuracy with an MARD of 8.5%. I’d like to thank our team, the PROMISE study investigators and study participants and the diligent professionals at the FDA managing through the demands of the pandemic, all of whom helped us achieve this milestone. This is a major advancement for patients who continue to seek alternatives to the short-term transcutaneous sensors and for the limited choices that exist in the market today. Six months of wear just 2 insertion procedures per year makes E3 even simpler, more convenient and less expensive for patients. From our market feedback, it is clear that users have profound interest in the CGM that lasts for 6 months. We believe each sensor wear duration advancement represents a stepwise market penetration and market expansion opportunity. Later in the call, we’ll touch on the commercial launch plans we’ve been developing in collaboration with Ascensia. Before we look ahead,…

Thank you, Tim, and good afternoon, everyone. In the fourth quarter of 2021, total net revenue was $4 million compared to $3.9 million in the prior year period. U.S. revenue for the fourth quarter was $700,000 and revenue outside the U.S. was $3.3 million. Gross loss in Q4 2021 was $0.5 million, a decrease of $3.1 million from a gross profit of $2.6 million in the prior year period. The decrease in gross profit was predominantly related to the increase in cost of goods sold due to the sale of previously written off material in 2020. Fourth quarter 2021 selling, general and administrative expenses were $5.8 million, a decrease of $2.4 million compared to $8.2 million in the prior year period. The decrease was primarily the result of a decline in salary and personnel costs from the reduction in sales support due to the transition to Ascensia for the commercialization of Eversense. Research and development expenses in Q4 2021 were $7.7 million, an increase of $3 million compared to $4.7 million in the prior year period. The increase was primarily due to the expansion of our R&D headcount and increase in clinical studies, lab supplies and an increase in outside expenses to further advance our product pipeline. For the 3 months ended December 31, 2021, operating loss was $13.9 million compared to $10.3 million loss in the fourth quarter of 2020. The decline in the company’s share price at the end of the fourth quarter as compared to the company's share price at the end of the third quarter of 2021, led to a significant noncash gains in Q4. As a result, total other income increased by $189.7 million compared to the prior year period, primarily related to noncash charges resulting from the accounting for embedded derivatives and fair value…

Thank you, Nick. As we transition into 2022, we are excited for the E3 commercial rollout in the U.S. during the second quarter and the expected later launch in Europe later this year. This next generation of product is an exciting advancement in diabetes management. Our patients and providers have been waiting for such a product, and we are eager now to bring them the benefits of the world’s longest-lasting CGM system. Ascensia is steadfast in their commitment to CGM and the Eversense product. Investing millions to drive awareness and access for the product this year, along with launching a new dedicated CGM commercial organization and building a dedicated sales force in the U.S. This investment is ramping meaningfully and demonstrates their continued support to our partnership and the product. Before we open up the call for questions, I’d like to take this opportunity to thank Mirasol Panlilio, our Vice President and General Manager of Global Commercial Operations for her over 7 years of establishing and leading the growth of Eversense and her commitment throughout her career of improving the lives of people with diabetes. I and the whole Senseonics team wish her the best in her retirement. Thank you for your time today. Also joining us for questions is Mukul Jain, our Chief Operating Officer. Operator, let’s open up the call for questions.

[Operator Instructions] Our first question comes from Chris Pasquale with Guggenheim.

So the revenue guidance, which you guys laid out at the time of the approval announcement were certainly a little bit surprising relative to where consensus was. But you guys just walked through a lot of the moving pieces that you’re dealing with this year between the transition to the 180-day sensor, inventory drawdown, the patient assistance program. So it would be helpful to understand some of the underlying assumptions behind the guidance? And if you can give us a sense for where do you expect to be at the end of the year in terms of the number of patients who are on a sensor? What percentage of patients in the U.S. do you expect you’re going to need to take advantage of that patient assistance program? Just anything around those assumptions would be helpful.

Sure. Thanks, Chris. Well, we’re certainly excited to be where we are on the cusp of launching this great new product for a very exciting time. With that said, we certainly would like to be further. We recognize that the impact that COVID had on the organization as well as the delay from the U.S. approval also related to COVID with the FDA, certainly has impacted the rollout and progression here in the United States. But we do believe that we have all the pieces in place with Ascensia, their commitment to the space and the programs that we’ve talked about, we think are going to be – are very, very meaningful. We’re not going to speak to patient count as there still do continue to be a lot of moving pieces associated with it. But as we -- as you’ve heard, we do start with the basis of about a little bit over 2,500 patients in Europe that continue to be on the product and a little bit over 600 here in the United States. You will recall that the previous efforts we put about 4,000 patients on the product in a full year. I don’t anticipate in this partial year we’d be able to approach that. But we certainly are looking to drive as many new folks on the product as obviously we can get access to and have industry. We do expect there to be reasonable use of the assistance program as is typical, especially early in the year when deductibles haven’t been met. But at the same time, the attractive thing about having a 180-day product is once the patients do come on even with some financial support upfront, we’re able to make to them, and they are able to meet to us a pretty significant commitment. So 6 months of using the product without turnover opportunity. So we believe that we’re going to get a lot of value out of that. So as Nick said, we do expect that a little bit more than half will still be coming from Europe, but it does indicate that there’s pretty good U.S. growth behind it, which, of course, is a very important market for us. And also, as Nick said, the majority of the revenue is coming later in the year, really driven by this transition in Q1 where we essentially draw down all of the 90-day inventory in the U.S. and really start cleaning here on April 1, it was a 180-day product. So I hope that helps.

And I just want to follow up on that last point you made, because the back half weighting and the weighting towards international, is there any risk of disruption internationally? Let’s say, you do get the CE mark and you’re in a position to launch that product in the third quarter. Is there the potential that you could see a drawdown of inventory of the old sensor or the need to book contra revenue for inventory that’s no longer going to be sold that could end up actually hurting the international business later in the year, the same way the U.S. business is being held back early in the year?

Yes. We’re going to work to very much minimize that. The timing is being monitored very closely. As you’ll note, especially here in the first quarter, we are being very judicious with the amount of product that we put into the channel to really minimize the likelihood that, that should happen. In Europe, they are on the 180-day 2 time a day calibration product. We’ll transition them to the onetime a day calibration. And it’s our expectation we can manage that quite tightly and it’s certainly a shared objective between the 2 organizations.

Our next question comes from Marie Thibault with BTIG.

I wanted to follow-up here on the question around kind of patient volumes. I understand you can't give us some sort of what you're thinking of to end the year. But I did want to try to understand the recent falloff a little bit better. Understand obviously, COVID and some of the transitions have been an overhang. But how recent with some of that fall off? I'm just kind of trying to get at the question of how easily won back some of these patients and prescribers might be?

Sure. On all Canada, the biggest impact on the organization was when we pulled the ability to fund the commercial organization at Senseonics. So much of that loss really happened in the late 2020 time period and certainly built into the start of 2021. The continued dynamics with COVID certainly contributed to that. So there was a pretty significant contribution to that pullback in all of 2021.

Okay. Fair enough. And I did want to also understand, you called out the 8 million additional lives, covered lives that win. Where are we in terms of total covered lives, I guess, for the 90-day product? Just trying to understand what kind of the starting base is as we head into this payer transition for the 180-day?

Sure. We're still counting about 210 million covered lives. Obviously, the 365-day product is important for us and the IDE approval will include the pediatric population in the clinical testing. So that's obviously a big piece. And then in addition, we still continue to work with Anthem and United that still hold the E&I on ever since. And we're certainly hopeful that the a 180-day product will help move that forward with them.

Okay. Last very brief, Tim. On the MDR process in Europe, is that adding any extra complexity? What are you hearing from your notified body or what gives you confidence in the 3Q time line?

Yes, it is a very good question. Yes, there absolutely is impacting the transition to MDR. We have been in it quite some time. There have been much more extensive reviews than would have been typical without this new regulation. We are in pretty constant conversation with our notified body. And just given where we are and the amount of material that we submitted and the review cycles, we do feel that we're at the point that we can forecast this Q3 time period for us to be running with it.

Our next question comes from Mathew Blackman with Stifel.

This is Colin on for Matt. Congratulations on the recent E3 approval. I just had a question around the reimbursement progress you've made, you mentioned Blue Cross Blue Shield and a couple of other payers and expanding to 8 million covered lives. I was wondering, how has the progress gone really with the main holdouts at this time? And what kind of time frame are you thinking for reaching the higher number of covered lives, whatever that may be?

Well, certainly, the biggest one that's frankly in our control and right in front of us is the pediatric indication. So we will begin that testing here in the second half of the year. That's, of course, an important constituency for people with diabetes. So it's high on our priority list and the 1-year product is a great time for us to do that. The 2 remaining are 2 of the largest, unfortunately, but as it's been typical, especially in the space with diabetes technology, they tend to be much later in the approval process because of their size. So we certainly would have hoped that we would have gotten coverage. I don't know if COVID has impacted that, but I do think with a more longer duration, more compelling product that there's going to be a lot more push from their users to push for it. So I certainly hope that in later this year and next year, we'd be looking at a point where they'd be strongly considering coverage of the product.

And I have a couple on the pilot-at-home insertion program. How has the reception been so far for that pilot? And what should we be expecting in 2022 for the expansion beyond the initial limited geographies? And will it have a visible effect on the reimbursement profile of E3 this year?

We're certainly excited about it. I'm not ready to speak to a larger rollout at this point because it's still in a test configuration, if you will in the Houston area, but it's a compelling opportunity and one that we have certainly talked about in micro sites pushing out to larger geographies. The way that it works, there is a mobile -- typically, it's a nurse, NNP that will come to visit people at their house and actually do the insertion and removal. So it's got a great user benefit. But obviously, we want to make sure that we keep it. We learn everything from the early start-up and make sure that the process is going swim only for everybody before we expand it. So a little bit too early for us to make broad conclusions, but we're excited as one more opportunity to look at for new insertion approaches.

Our next question comes from Alex Nowak with Craig-Hallum Capital Group.

This is Trent on for Alex. I wanted to dive a little deeper into the guidance here. How does the change in guidance for 2022 modify the ramp into 2023 and 2024 that was provided on the Ascensia call or partnership call in 2020?

I don't think we're in a position to answer that here Trent that was done coming up on 2 years ago at this point. We did anticipate that we would have had the review with the agency last April. I would anticipate, it's our expectation, obviously, that much of the focus is going to be in the U.S. and the commercial activities will focus on that. It continues to be a very exciting space that we're in, and there is a lot of interest in the 180-day products. So we're encouraged by the ramp future. But I don't want to rely on something that was done pre-COVID at this point and pre the COVID impact on the FDA approval to look in the future here on this call.

Got it. That makes sense. I could ask another one here. With Libre 3 and DexCom G7 coming to market, how do you see Eversense being positioned and how will adoption be different this time than when 180-day in Europe was biting the G6?

So as I'm sure you're fully aware, the market dynamics are different. It's predominantly Libre and much more predominantly Libre in Europe. Obviously, when the full function CGM comes, that's going to have an impact. I expect there'll be more noise and activity in the transcutaneous sensors as they compete for a physician. At the end of the day, it's the patients that win as the technologies get more mature, more flexibility and more capability. And what that does is it brings more and more people to the CGM testing family, which is a big opportunity for Eversense. We still continue to be the only implantable. Obviously, not only the only implantable that's commercial, but certainly with the U.S. approval. So we feel that we have a pretty good a pretty good lead in that segment. And that as our duration expands, as I said earlier, that really drives greater and greater interest in participation. So at the end of the day, more interest is a bigger pool, and we certainly are going to continue to drive for our fair share of that increased pool size with the impanel sensor.

Our next question comes from Jayson Bedford with Raymond James.

I wanted to ask about the patient assistant program. So I guess, early on, you mentioned E3 is less expensive for patients. Were you referring directly to the patient assistance program there?

No. I mean the biggest outside of that is really the -- any insertion expense, right, just got cut in half from 4 year to 2 year. That's the That's, of course, the biggest driver.

Right. Okay. But reimbursement is still -- your expectation is there's no change to reimbursement?

Yes. We haven't seen reimbursement, as you know, we continue to see in the range of about $17 -- excuse me, $10 per day in commercial pay, although there is some variance from payer to payer and Medicare is a little bit higher than that.

Okay. And then just on the $99 patient assistance program, can you just put some context around it, meaning kind of what did the average user pay out of pocket in '21? What do we compare that $99 to?

Yes. So there's a pretty good variation. One of the key differences with this, we are going to restrict this to people that have coverage. So in our prior bridge program, we did get a lot of utilization for people on United and Anthem that didn't have coverage. So that drove, I think average utilization was around $600. I think without those that have no coverage; this will be quite a bit less. So a couple of hundred dollars perhaps.

Okay. And I guess just -- I haven't fully thought through this, but maybe can you explain how this program impacts your revenue? I guess I have to think through the billing, but I'm just kind of curious as to the impact of this program on your and Ascensia revenue?

Yes. So it is any revenue that is not collected as part of this, obviously, is an offset. So we'll continue to report as we have been net revenue. And although there is some expected, it is an investment that we are jointly making with Ascensia in the space to bring people to try the 180-day product. But at the end of the day, it is a net revenue reduction, which is part of the basis for the guidance that we've built.

Okay. And just the basis for the guidance, the $14 million to $18 million, that assumes that the patient assistance program lasts 6 months, is that right or the full year?

Well, it lasts for the first sensor when someone comes on, Jayson. So right, it could even go into next year for the second half starts.

And then just on the iCGM submission, I may have missed this, but this is after you start the 365-day trial?

We want to get the 365 IDE approved, Jayson, right? Given the size, the obvious opportunity for the 1-year product and the pediatrics, that's our regulatory focus at this point. So not after we start the trial per se, but certainly after we get the approval for the IDE.

Okay. And then maybe just for Nick. Nick, you broke up for me at least a little bit on the cash burn. I caught the upper end of $70 million, what was the lower end?

Yes, $65 million to $70 million for the year.

This concludes our question-and-answer session as well as our call for today. Thank you for attending today's presentation. You may now disconnect.