Senseonics Holdings, Inc.

Good day and welcome to the Senseonics first quarter of 2022 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference 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 then one on a touch-tone phone. To withdraw your question, please press star then two. Please note, today's event is being recorded. I'd now like to turn the conference over to Malcolm McLeod, Investor Relations. Please go ahead.

Thank you. This is Malcolm McLeod 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 ended March 31, 2022, and our other reports filed with the SEC. These documents are available in the investor relations section of our website at www.sensionix.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 Sensionix are Tim Goodenow, President and Chief Executive Officer, and Nick Tressler, Chief Financial Officer. With that, I would like to turn the call over to Tim Goodnow, President and CEO. Tim?

Thank you, Malcolm, and thank you all for joining us this afternoon. On the call today, we'll focus on the first quarter performance, the initiatives designed to increase the Eversense user base, as well as support the E3 launch, and to provide updates on the progress for our product pipeline. Nick will then discuss the first quarter financials, and we'll open up the call for questions. In February, we achieved FDA approval for the Eversense E3 continuous glucose monitoring system. With this important step, we have now extended the duration of the longest-lasting CGM system to six months of wear in the U.S. Not only is this the longest-lasting CGM by over 12-fold, but it also offers patients top-tier glucose measurement performance with a high degree of accuracy, the MARD of 8.5%. I would like to thank our team, the PROMIS study participants and investigators, and the professionals at the FDA managing through the demands of the pandemic, whom were all instrumental in us achieving this milestone. I've spent time in the field recently to engage with HCPs and patients as part of the E3 launch. In the first week of April, at the insertion of our first six-month commercial patient in the U.S., which was performed at the impressive East Alabama endocrinology practice, it was clear how the E3 system represents a major advancement for people with diabetes. Patients both new to CGM and those experienced with CGM continue to seek alternatives to the limited choices of short-term transcutaneous sensors that exist in the market today. Six months of wear, which means just two insertion procedures per year, makes E3 even simpler, more convenient, and less expensive for patients. Interest in our long-term CGM is high, and we're excited about the opportunity to help this large and important population with the revolutionary benefits of E3. We continue to believe each advancement we achieve in sensor wear duration represents a stepwise evolution in product differentiation, market penetration, and market expansion opportunities for Eversense. Before we move to the April launch activities for our commercial partner, Essentia, I would like to highlight our first quarter results. For revenue, Sensionics generated $2.5 million, which included $0.8 million from the U.S. and $1.7 million from Europe, as we wound down the current generation products. The first quarter results were notably driven by inventory transition plans to the new E3 product. As Sensionics maintains focus on the design, development, and manufacturing of the innovative CGM systems, our global commercial partner, Essentia, is implementing a comprehensive commercial strategy to launch the 180 product in the U.S. While it is still early in the launch of E3, we are just six weeks in, I would like to outline key elements of our strategies and initiatives and share some early impressions from the past few weeks as we have worked with Essentia to roll E3 out to the physicians and users in the US. We look forward to sharing more information on patient and provider adoption in future calls. In the first half of the year, ADC will be primarily focused on transitioning current users to the E3 system, expanding new patient and clinician adoption, and ensuring continued patient access through the payer transition from 90-day to six-month insurance coverage. significant investments are being made to support programs targeted at enhancing these access and awareness initiatives. In just six weeks following the FDA approval, we delivered the E3 system to HCPs for the first sensors for insertion. This demonstrates the operational integration across the Essentionics-Essentia collaboration, as well as HCP and patient excitement for the new product. In this short period of time, we completed manufacturing, updated packaging according to the new FDA labeling, and shipped products into the distribution channel. Essentia executed distributor contracts, trained the sales force on the new label as well as the new patient assistance programs, and initiated product introduction with HCBs. We believe these initiatives and programs will enable Essentia to serve more patients and providers. We are pleased with the swift commercial readiness of the new and growing dedicated CGM team in the U.S. The ADC reps are incentivized to transition existing patients to E3 and new patients and to increase the number of certified inserters to support patient demand. We're also excited that they have hired Rudy Toms, the former Sensionics head of sales, to lead the U.S. Eversense sales and marketing activities for Essentia. As part of the U.S. launch efforts to promote E3 availability and increase overall Eversense awareness, ABC has ramped up the direct-to-consumer digital advertising campaign across the largest social media platforms. These advertisements leverage the population algorithms targeting the diabetes community in specific geographies through Facebook and other channels. Since patients have the ability to choose the CGM they would like to use, the DTC advertising promotes product awareness and familiarity at broad scale. This has proven to be an effective and efficient tool for generating patient leads in geographies with the highest insulin prescription concentrations, where coverage for Eversense continues and currently exists, and where there are active inserters. We are pleased with the early indications that this targeted approach is generating positive impressions and lead generation. On the professional marketing front, Senseonics and ADC are both actively participating in all major diabetes industry meetings and conferences. The ATTD conference in Spain just 10 days ago was successful with robust HCP engagement. Energy was high as the diabetes community was excited to meet again in person. The team was pleased with the many opportunities to interact live with attendees and introduce them to Eversense. Booth traffic was strong as HCPs demonstrated interest in gaining a deeper understanding of E3 and the incoming improvements to the 180-day product. The clinical training manager were very busy providing product demonstrations, and we were pleased with the engagement at the product symposium. We also plan to have a significant presence at the upcoming ADA annual meeting in June. This is the largest diabetes conference of the year and a great opportunity to introduce HCPs to the new E3 system and share clinical data that supports the value proposition of our long-term implantable CGMs. At the ADA this year, there will be a booth highlighting E3, a product theater, two presentations on the floor of the exhibit hall, and three posters presenting clinical data, including our first data from our pilot 365-day sensors. Regarding patient access, ADC is actively engaged with payers to transition coverage and payment mechanisms from the E3 90-day sensor We are pleased with some of the early progress, such as Aetna and Humana's immediate inclusion of E3, as well as ADC's interim solutions to ensure patients previously covered for the 90-day sensor will have no limitations or delays obtaining E3. Positive discussions with Medicare are ongoing, and we are confident both our commercial and government players will continue to recognize the strong value proposition of our implantable CGM. As we described in the last call, Essentia has implemented an updated patient assistance program that offers E3 to any patient with commercial insurance coverage for a $99 out-of-pocket maximum cost for their first E3 sensor. We believe this is a very enticing program that should attract patients to Eversense. Ultimately, this is an investment to drive adoption and increase the user base. We expect patients new to CGM to try the product and for users on other systems to convert to the benefits of Eversense. Following a patient's first E3 sensor, their out-of-pocket expenses are then limited to $100 per month, with copay options providing ongoing assistance to support access. In Europe, Ascensi is implementing important strategic changes and investments to provide the higher-touch patient and HCP experience required for CGM commercializations. Essentia has been holding national sales conferences the past several weeks, attended by the various commercial country organizations. During these meetings, they are making E3 launch preparation and designing targeting initiatives. In Germany, Essentia continues to transition from an indirect distribution model while increasing the focus resources dedicated to Eversense. This includes an Eversense internal sales specialist team to support patients from prescription to insertion and to provide patient training. These changes enable greater control and visibility of the sales process and an ability to directly provide reliable levels of support. Another important aspect of serving the European market is being successful with competitive tenders in the different countries, and Essentia continues to optimize their tender preparation process based on experience with Eversense. Now, transitioning to our product pipeline, where we continue to make strides to advance CGM innovation. The E3 system is currently under final review by our notified body in the EU to achieve the CE mark. At this point, we anticipate launching E3 in Europe early in the third quarter. To this end, country preparations are underway to support regional launches and to bring the new product attributes of this enhanced six-month product to our European users. In research and development, progress on our 365-day sensor configuration continues as well. Human pilot clinical testing is underway, and we continue to be encouraged by the product performance as we move towards their full-year performance. Additionally, we are encouraged by positive progress we've demonstrated with our implanted battery design partner and currently anticipate batteries being ready for pilot clinical testing at the end of this year. This implantable battery would allow us to pair 180-day or 365-day sensor chemistry to create a swipe version of our system. We are committed to deliver this targeted implantable flash product to people looking for the freedom and flexibility of an on-demand product and look forward to providing further updates on the progress with our range of innovation on future calls. I would now like to turn the call over to Nick to go over to the details of our first quarter financial results.

Thank you, Tim. Good afternoon, everyone. In the first quarter of 2022, total net revenue was $2.5 million compared to $2.8 million in the prior year period. U.S. revenue for the first quarter was $0.8 million and revenue outside the U.S. was $1.7 million. Gross profit in Q1 2022 was $0.5 million, in line with gross profit of $0.5 million in the prior year period. First quarter 2022 selling, general, and administrative expenses were $7.9 million, an increase of $1.3 million compared to $6.6 million in the prior year period. The increase was primarily the result of increased professional fees and payroll and related expenses. Research and development expenses in Q1 2022 were 7.8 million, an increase of 2.5 million compared to 5.3 million in the prior year period. The increase was primarily due to the expansion of our R&D headcount, an increase in clinical studies, lab supplies, and an increase in outside expenses to further advance our product pipeline. For the three months ended March 31st, 2022, operating loss was 15.2 million, compared to $11.3 million loss in the first quarter of 2021. The decline in the company's share price at the end of the first quarter as compared to the company's share price at the end of the fourth quarter of 2021 led to significant non-cash gains in Q1. As a result, total other income increased by $340.1 million compared to the prior year period, primarily related to non-cash charges resulting from the accounting for embedded derivatives and fair value adjustments related to the company's financings, including the 2023 and 2025 notes, along with the PHC 2024 notes and energy capital equity line of credit. As required by U.S. generally accepted accounting principles, or GAAP, we mark the value of these instruments to market for each reporting period, and the change in these values are recorded as non-cash charges to the income statement. Each quarter, the value of these non-cash gains or losses will vary based on the volatility in the company's share price. So generally, as share price increases, we incur a non-cash loss, and as share price decreases, we recognize a non-cash gain. For the three months ended March 31, 2022, total net income was $86.7 million, or 19 cents per share, compared to a net loss of $249.5 million, or 68 cents per share in the first quarter of 2021. Net income increased by $336.2 million due to the accounting for embedded derivatives and fair value adjustments previously mentioned. As of March 31st, 2022, cash, cash equivalents, short and long-term investments totaled $166.9 million. Turning to our outlook for 2022, we continue to expect our full-year 2022 global net revenue to be in the range of $14 million to $18 million we communicated previously. As transition of payer coverage policies occur from the 90-day to the six-month product, we expect gross margins to approach break-even in the fourth quarter. For the four-year 2022, net cash used in operations is projected to be in the range of $65 to $70 million. We expect the majority of expenses in 2022 to be for research and development, for ongoing feasibility and pivotal clinical trials for additional products in our product pipeline, including the start of the 365-day pivotal trial subject to IDE approval. With that, I will turn the call back to Tim.

Thank you, Nick. As we transition into providing our E3 product to people with diabetes, we are excited to continue the commercial rollout of our six-month product in the U.S. through the second quarter and the expected launch across Europe in the coming quarters. This next generation of product is an exciting advancement in diabetes management. We believe our patients and providers have been waiting for such a product, and we are eager to now bring them the benefit of an improved version of the world's longest-lasting CGM system. We are pleased to see Essentia's commitment to CGM and the Eversense product, as they invest to drive awareness and access for the product this year along with launching a newly dedicated CGM commercial organization and building a dedicated sales force in the U.S. This investment is ramping and demonstrates their support for our partnership and product. Together, our collaboration has the potential to make a positive, meaningful impact for people with diabetes by bringing them our unique, compelling solution. Thank you for your time today. With that, concluding our prepared remarks, we'll turn the call to Q&A. Also joining us for questions is Mukul Jain, our chief operating officer. Operator, let's open up the call for questions.

Yes, sir. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, we ask that you please pick up your handset before pressing the keys. To withdraw your question, please press star then two. Today's first question comes from Matthew Blackman with Steeple. Please go ahead.

Hi, this is Colin on for Matt. I wanted to start with the first six weeks of E3 commercial launch. Obviously, it's early days, but beyond new patient ads, what are the leading indicators or metrics are you tracking, whether it's website traffic, physician interest? Is there anything you can share that gives you confidence in the 2022 commercial outlook? Thank you.

Colin, it's really driven by the patient and physician interest. As we noted, the DTC has ramped meaningfully. by Essentia, and the leads that they generate based on the request for information is very meaningful. In fact, it's higher than we had anticipated, which is, of course, very encouraging news. Additionally, through the professional channel, that being the doctors that treat the patients, we do see a notable rise in that interest as well, as many doctors are you know, we're certainly waiting for the 180-day launch. So their interest is important and positive for us as well.

Great. And you've talked about each duration advancement being a stepwise in market penetration and market expansion, those opportunities. Is there any way you could frame the size of the E3 opportunity, maybe relative to the market you addressed with a 90-day product? Thank you.

Well, we certainly anticipated being significant growth. It is a big market, as you are certainly aware. There are still a number of people that are not on CGM that can benefit from it. We see about a third of the people that have interest in Eversense are folks that haven't participated in CGM before, even though they need to. So we expect that there will be both a share transition from the existing players, which you know is about a global $7 billion market, as well as the growth of people that aren't on it yet. So we look at it to be notable.

Thank you.

Thank you. And as a reminder, ladies and gentlemen, if you'd like to ask a question, please press star then 1. Today's next question comes from Marie Thibault with BTIG. Please go ahead.

Hey, good afternoon. This is Sam Iberon from Marie. Thanks for taking the questions. Maybe we can start here on some of the conversations with both commercial and Medicare. It sounds like some early wins here. I was just wondering maybe if you could provide any additional color on maybe expected timing or pace of additional payer transitions to E3.

Sure. We look at it as a continuum. You did see that we had some very early wins immediately. You know, we saw folks like Aetna and Humana went right over to the 180-day product. There are others that are in the process as well. We've had active conversations with Medicare, and we do anticipate that they'll be putting some plans in place that will allow us very quickly in the next couple of months to transition to the 180-day product for the Medicare patients. So we do expect it to happen soon. fairly quickly in the next quarter or two, but we do fully recognize that there are some payers that do annual updates, and it may be as late as, you know, fourth quarter or so. But we do expect to get the transition done, the majority of it, in the next couple of quarters.

Great. That's great to hear. And maybe I could ask one more here on the patient assistance program. Is there a threshold or maybe a time where you'll have a certain amount of coverage where maybe those programs will start to roll off, or is that still to be worked out?

We do anticipate using it for the first patients that are trying the sensor at this point. So you do need to have some form of commercial coverage. So if you have absolutely no coverage, you're not a candidate for this patient assistance program. But we do expect that to go on through the rest of this year. Obviously, six months from now, when the second sensor comes in, they'll transition to the other, where we do anticipate that there'll be a monthly cap for the product. So expect it to happen here in Q2 and Q3, and potentially start to roll reinserted patients to the second half of the program in the fourth quarter, all while continuing to put new patients on throughout the remainder of the year.

Great. Thanks for taking questions.

Thank you. And our next question today comes from Alex Snowlock with Craig Hallam. Please go ahead.

Great. Good afternoon, everyone. Just what was the latest number of HEPs implanting the 90-day sensor here in the U.S.? And just For the 180-day, I know we're only six weeks into launch, is that coming out to be about 5%, 10% of ultimately converted over? And I guess just how much training in addition needs to be done to convert those physicians over?

So, Alex, there's currently about 550 medical professionals that are trained to do the insertion. There is no difference, and there's no additional training that's required to go from the 90 to the 180. It's really the exact same process, sensor dimensions, and tools that are required. So it's an automatic transition from one to the other.

Got it. And then maybe give us an update on the inventory situation at your partner. Just curious how much inventory is ultimately sitting at Ascentia. And then how does that, the 90-day inventory in the U.S. and then also the older European inventory from the 180-day sensor once we get E3 approved there, how is that ultimately being factored into the sales step up into Q2, Q3, Q4?

Yeah, so that's part of the guidance we've given. We've been very active with the transition. The 90-day is fully transitioned. As I noted, that really occurred in Q1. which where there was some softness in Q1 was the fact that we were running down the 90, and we didn't put new product into the market until the very beginning of Q2. Similarly, in Europe, we do know that the E3 product is coming, and as I said, we anticipate it will be starting here in early Q3. So we are actively taking the inventory level down for the current 188 XL product in Europe down so that we can begin that transition here in in not too many weeks to E3.

Okay, helpful. And then on the 365-day sensor, are you still planning on the IDE submission here in Q2? It did sound like you might already be doing some human pilot testing, so maybe that's not necessarily needed. And then also, when are you planning to launch the pit load? That's the second half of that there.

Yeah, so the dates still remain. IDE filing, as you noted, and we do anticipate, likely in the fourth quarter, inserting the first patients. So those are my thoughts. Perfect.

And then just lastly on the cash burn, how to think about with Q1 being kind of the low watermark and E3 ramping up here, Q2, Q3, just how to think about cash burn over the course of the year.

Well, as Nick said, I think we're anticipating about $60 to $70 million of OPEX, so it's just about just a little bit over $5 million per month. Okay. Perfect. Thank you. Great.

Great. Ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference back over to management for any final remarks.

Great. Well, I want to thank everyone for their time again today. We're very excited here to have the new E3 product, and thank are encouraged by the initial results, continue to have a focus here in Q2 and ramping both in Europe and the transition here from the 90 to 180 in the U.S. So I appreciate everybody's support and look forward to updating you next quarter. Have a good day. Thank you.

Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.