Senseonics Holdings, Inc. (SENS) Q1 2020 Earnings Report, Transcript and Summary

Good afternoon and welcome to the Senseonics First Quarter 2020 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [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 very much and welcome to the Senseonics first quarter 2020 earnings call. 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 reflects 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, 2019, our 10-Q for the quarter ended March 31, 2029 and our 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 2020 outlook in light of the COVID-19 pandemic, 2020 financial guidance was suspended on March 26, 2020. On this call, we will be providing investors U.S. GAAP net revenues and gross revenue measures to provide meaningful supplemental information regarding our performance and provide better transparency on the impact of reimbursement in the Eversense Bridge program. In accordance with U.S. GAAP, Senseonics reports revenue in its financial statements on a net basis, which includes gross to net reductions, primarily related to the Eversense Bridge program. Gross revenue measures do not reflect the gross to net reductions and accordingly may be considered to be non-GAAP financial measures. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for or superior to the financial information prepared and presented in accordance with U.S. GAAP and Senseonics non-GAAP measures may be different from non-GAAP measures used by other companies. For more information on these non-GAAP financial measures, please see the reconciliation of these non-GAAP financial measures to their nearest comparable GAAP measures in this afternoon's earnings release, which is available on our corporate website at senseonics.com. Joining me from Senseonics are Tim Goodnow, 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, [Trip] [ph] and thank you all for joining us. Before starting our review, our thoughts are with everyone that's been affected by COVID-19 virus and the resulting economic impact. We at Senseonics would like to express our deep gratitude to all members of the health care system, especially the frontline providers treating the important needs of our users, who have also been impacted by the pandemic. As we announced in the last week of March, we have responded to the current environment and the company's financial challenges in several ways, culminating in this decision to explore strategic alternatives to enhance stakeholder value. As part of the strategic review, we've refocused our operations on core activities to pursue the long-term success of our Eversense CGM system and to help people with diabetes continue to access its benefits. On today's call, I will provide an update on our current corporate priorities and operational focus, then provide an overview of our first quarter results and additional business updates. Nick will provide additional details on our financials, the impact of our operational changes and our current balance sheet. As we have shared in the past two months, we have made significant changes to our organization. We have repositioned the business to move forward in an efficient and effective manner in response to our financial situation. Following the fourth quarter earnings call, in the heightened economic state and health system, COVID-19 isolation efforts, together with the challenges of a covenant in our senior facility, the company was in a position that required us to terminate our loan and security agreement with Solar Capital. We repaid all amounts outstanding and the associated prepayment fees, which totaled $48.5 million. At the time, we also announced the Board's decision to explore strategic alternatives to enhance stakeholder value. Over the past eight weeks, we have been engaged in the process of exploring a range of strategic alternatives with third-parties. We continue to be in these strategic discussions as this process moves forward. Mindful of the Securities laws, we cannot say more about the progress at this time and will, of course, update you when we have more information we can appropriately share. Importantly, in April, in support of this strategic process, we entered into a loan and security agreement with Highbridge Capital that provides for up to $20 million in near-term financing. This funding was important in extending our cash runway and to support our ability to run a full and thoughtful strategic process. The second component of our strategic review included streamlining the organization to ensure the long-term success of Eversense. To preserve value and provide the opportunity for future value creation, we have materially reduced monthly cash burn and focused our resources on steering core objectives, namely; first, limiting commercialization to existing users; second, driving long-term market access; and third, preparing for the 180-day sensor launch in the U.S. We have evaluated the cost structure across the entire organization, reducing spending, and eliminating a number of positions and expenditures to support these core objectives. Future investments will be significantly limited and focused on driving these aspects for long-term value creation. These material changes to our operation and cost structure will greatly improve operating cash flow, reduce our cash use, and considerably extend our runway. Our first objective remains focused on our users. We are actively supporting our existing users and their health care providers. We are pleased to share that patient feedback on their experience with Eversense remains strong, especially during these times. We are working to ensure minimal disruption to patients on Eversense and to ensure that they are receiving the support they will need to continue on their systems. In response to the current financial impact, we have temporarily suspended commercial activity to acquire new users in the United States with the current 90-day sensor. This means marketing campaigns have been cut, sales initiatives have been stopped and on-boarding new clinics have been halted. This decision is to no longer invest in commercial activities to acquire new customers has impacted a majority of the organization, including, unfortunately, reducing our field and operational staffing and will greatly reduce our operating expenses. As with many others who have experienced recent hardships, the COVID-19 health crisis has been extremely disruptive to our business. The implementation of stay-at-home orders and limiting of office-based procedures and in-person clinic visits have noticeably reduced the number of patients to be inserted by their providers in the recent past. The closing of clinics and our limited access to those that remained open, as well as orders limiting in-person visits caused a material dislocation in our markets and was an important consideration of us foregoing marketing to new customers as we work through responding to the financial challenges. By mid-March, we experienced the full impact of these changes in the market. Many offices closed and providers pivoted to telehealth visits with patients. Given the implantable nature of our product, these contingent workflows adopted in response to COVID, this reduced the number of insertions performed. The extent to which Eversense was deemed necessary or elective varied across geographies and healthcare providers. Through this, we did experience a reduction of at least 50% in insertion rates across each of our markets during the height of the pandemic. Very recently, however, we are starting to see a positive change in reinsertions again. We expect to report an update on insertion rates on coming calls. While the COVID response and strategic alternatives process has been the primary focus for the organization, important progress with new payers covering Eversense has been achieved of late. We recently received positive coverage decisions from several Blue Cross Blue Shield plans, adding approximately 10 million covered lives. Plans, including coverage for Eversense and the associated reimbursement for the health care provider's time has been added to their coverage policy. And these have included Blue Cross and Blue Shield of Arizona, Tier First Blue Cross and Blue Shield, Independence Blue Cross, Amerihealth, and Exelis Blue Cross and Blue Shield in New York. Another critical component to the reimbursement landscape for Eversense is coverage by CMS. At this point, we have confirmed a coordinated effort across the Medicare Administrative Contractors, or MACs, to expand access through the development of local coverage determinations for implantable continuous glucose monitoring devices. Six of the seven MACs have now posted their LCDs and have scheduled or completed their open meetings for comments. We are encouraged to see a very consistent coverage policy across all the MACs as this will allow for Medicare beneficiaries to have access to Eversense with the same criteria as been observed in the DME benefit for other CGMs. Beyond the development of coverage policies by the MACs, it is important that patients have access today. We have seen four MACs make Eversense immediately available through retirement of the non-coverage policies or have specifically removed the codes used to report the insertion of Eversense from their non-coverage policies. First co-service options, Novitas Solutions, Palmetto GBA and CGS administrators led the way in making Eversense available to patients through the removal of these CPT codes for their non-covered lists. We expect the other MACs will follow the same process in the very near future. The MACs that have taken the step to remove our codes from the non-covered list can immediately begin processing claims for Medicare beneficiaries as Part B physician service as defined in the calendar year 2020 rulemaking for the physician fee schedule. This is a very positive development for Eversense. Coverage as a Part B physician service is a great benefit to our patients and healthcare providers, as it will not be required to navigate the more complex durable medical equipment supply channel or the pharmacy benefit channel. We are excited about the actions taken by CMS to formalize coverage of our long-term CGM as this will establish clear criteria for HCPs to utilize in determining appropriate candidates for Eversense. It also demonstrates that CMS recognizes the need for CGM options for patients with diabetes who have an array of needs and a need for individualized care options. We also believe this foundation of coverage by Medicare will further compel commercial insurers to adopt positive coverage policies for Eversense as well. We look forward to more positive coverage decisions by health insurance companies in the future. Important for the advancement of our business is the continued evolution of our product pipeline which is our third core objective for the year. We are very pleased to announce the completion of the PROMISE trial in the quarter for the 180-day sensor. The team is working diligently on analyzing the data and preparing the package to be submitted to the FDA later this summer. We expect the submission to include a calibration reduction to once per day in addition to the extended duration of up to 180 days, as well as other improvements. Our current expectation remains for approval around the New Year, barring any unforeseen impact due to further COVID-19. We are excited by the potential for our patients in the United States to experience the life-changing benefits that the system offers, as our patients in Europe have enjoyed. We had previously planned a submission for iCGM using the 90-day data from the PROMISE study in this second quarter. However, with the change in commercial direction over the past 8 weeks, we have decided not to pursue the 90-day iCGM product. So you can expect our next filing to be the planned 180-day submission later this summer. We do, however, plan to make a 180-day iCGM submission in the fourth quarter following our 180-day supplemental submission. Following on these three core objectives for the remainder of 2020, while preserving cash and actively exploring strategic alternatives, will allow the company to provide the opportunity 2020, while preserving cash and for value creation now and for the long term. I'd like to conclude by turning to the impact of COVID on the financial pressures on our distributors and our decision to notably reduce sensor shipments into our U.S. distribution channel in late Q1. Certainly, with the eliminated efforts on establishing new users and only focusing on existing patients, and with the impact of closed clinics, we knew future product pull from the distributor shelves would be materially impacted in Q2. As a result, we reduced shipments in the first quarter and placed $2 million of gross revenue with distributors. In the quarter, adjustments were taken on the revenue, which included Bridge payment adjustments, as well as considerations to distributors reflecting the evolving economic uncertainty, including offering extended payment terms. These actions resulted in net U.S. revenue of $24,000 in the quarter. In addition and as forecasted on the prior call, OUS revenue was negligible for the quarter. As previously mentioned, Roche had inventory remaining from the 2019 purchase commitment, which was sufficient in this environment to serve the customers during the first quarter. The European markets were, of course, highly impacted by COVID-19 which also significantly limited our European distributors' ability to place systems and clinics. Our data also showed that European sensor insertions bottomed out at approximately 50% of prior levels during the health crisis. This disruption will continue to be a factor in our patients and partners reordering patterns. At this time, we cannot yet fully forecast these impacts on demand in the coming quarters. And we will continue to work with our distributor partners through this situation. We will communicate updates, as soon as we have better clarity on the recovery progression. With the timing of the reestablishment of the full-scale European reinsertions and not fully known, as well as our given U.S. commercial cost reductions, we withdrew guidance in late March and anticipate updating guidance at a future date. With that, I will now turn the call over to Nick for further details on our financial results.

Thank you, Tim, and good afternoon, everyone. In our financial update today, we will provide additional details on how the previously announced changes to the business have impacted our financial statements in accordance with a U.S. GAAP accounting basis. As disclosed publicly through our 8-K filings, on March 23, we announced the repayment of the Solar Capital debt. Additionally on March 26, we announced a strategic review in connection with the evaluation of considered alternatives. The suspension of commercial activities in the U.S. for the 90-day system for new patients, the current suspension of financial guidance for 2020, cost reduction measures, and additional impacts from COVID-19. Subsequent to the closing of the first quarter of 2020 on March 31, in late April, we announced new financing with hybrid capital and the attainment of a loan under the Paycheck Protection Program. Our results for the first quarter of 2020 reflect these announcements and our assessment of the evolving impact of COVID-19 on our overall financial condition, including asset recoverability, liquidity and third-party obligations. In the first quarter of 2020, total net revenue was $36,000 compared to $3.4 million in the first quarter of 2019. U.S. net revenue for the first quarter was $24,000 after accounting for gross to net reductions. Reductions consisted of two primary drivers. Approximately 40% of the reduction was due to the previously described Eversense Bridge program and 60% was due to onetime considerations to distribution partners for expected inventory depletion slowdown due to both our commercial changes and the COVID-19 impact. Because early Q1 shipments were sent to distributors in anticipation of normal unrestricted patient access to doctors clinics and in consideration of expected reduced product flow, we have also extended longer payment terms to distributors for this transition. At this point, it is possible that U.S. Eversense systems may not be placed with patients or may not be inserted prior to expiration. In light of this potential, we provided certain distributors one-time allowances up to a specified amount of Q1 purchases that may expire or are not inserted by the expiry date. We have, therefore, adjusted U.S. revenue and corresponding accounts receivable for an additional $1.2 million in the quarter for this consideration. In the OUS, net revenue was $12,000. As we mentioned on the year-end call, we did not expect Roche to make a meaningful order in the first quarter. Gross revenue for the first quarter of 2020 was $2 million, nearly all of which was generated in the United States. Gross profit in Q1 2020 decreased by $16.3 million year-over-year to $19.6 million. The decrease in gross profit was predominantly related to the increase in cost of goods sold as a result of the $15.7 million expense for impairment charges on inventory and related assets. This write-down included a large portion of finished goods, work in progress and component inventory, corresponding to the significant changes in our commercial activities and uncertainty regarding forecasted demand and related potential expiry concerns. We remain committed to the current users of our Eversense systems and are doing everything possible to ensure their ability to obtain product through our distribution partners. First quarter 2020 sales and marketing expenses decreased by $1.7 million by year-over-year to $11.1 million compared to $12.8 million in the prior year period. The decrease was primarily due to marketing and consulting expenses, offset slightly by severance expenses related to the change in commercial activities and our operational focus. Research and development expenses in Q1 2020, increased by $0.3 million year-over-year to $7.4 million compared to $7.1 million in the prior year period. The increase was primarily driven by PROMISE clinical study costs and personnel-related expenses, offset slightly by a decline in general research and development activities. General and administrative expenses in Q1 2020 were $5.7 million, a decrease of $0.8 million compared to the prior year period, mostly due to personnel-related expenses. For the three months ended March 31, 2020, total net loss was $42.6 million or $0.21 per share compared to $29.4 million or $0.17 per share in the first quarter of 2019. Now turning to the balance sheet. Following the Solar loan repayment in the first quarter, as of March 31, 2020, cash, cash equivalents and restricted cash totaled $18.8 million. Subsequent to the quarter, we completed a financing with Highbridge, an existing holder of our 2025 senior convertible notes, which provided gross proceeds of $15 million, and we received funding of almost $5.8 million under the Paycheck Protection Program. As of April 30, 2020, cash, cash equivalents and restricted cash totaled $30.1 million. To summarize, in the quarter, we took actions to dramatically change the financial and operational profile of the company including suspending commercial activities in the U.S., eliminating all non-essential spend that is not aligned to our streamlined operational focus, and limiting future investments to only those initiatives that will support the long-term success of Eversense. As a result of these comprehensive cost reduction measures, we now expect our monthly cash burn to be reduced significantly. Our new cost structure, in combination with the new financings, will extend our cash runway through the strategic alternatives assessment process and beyond. We expect operational ongoing cash burn, excluding any one-time production-related or debt service costs to be approximately $3 million to $4 million per month for the second half of the year reduced from approximately $10 million a month. The value that Eversense delivers to patients daily as a more convenient and accurate diabetes management technology remains the driving force at Senseonics. Through this strategic review process, our efforts are focused on finding the best solutions for all stakeholders. We are hard at work with our partners, exploring alternatives to ensure the best possible alternatives to bring Eversense to people with diabetes. There is no stated timeline for this process and it should not be expedited. We will remain diligent to achieve the optimal outcome for our patients and for our stakeholders. We realize the interest in this matter, but please understand that currently, we are not in a position to provide further comments or updates on the process. Gary, I'll now turn the call over to you for questions.

We will now begin the question-and-answer session [Operator Instructions] The first question is from Chris Pasquale with Guggenheim. Please go ahead.

Thanks. Tim, can you say anything about the performance of the 180-day sensor in PROMISE and when we might see that data?

Obviously, we're not going to speak to the data on this call. We do feel very good about the 180-day product in light of the fact that, of course, we have pretty significant commercial experience with it in Europe. I'll let Mukul speak to the timing when we may want to announce some topline results. Mukul?

Certainly. Hey, Chris. So, we do expect to submit it later this summer. And at that time, the data would be available. We certainly will like to discuss with the agency as to whatever we do in terms of sharing the results at that time. It shouldn’t interfere with the process at FDA. So, that would be the time that we'll be looking at sharing that data.

Okay. And then I think previously you had talked about potentially getting into the clinic with a 360-day sensor in early 2021. Has the reorganization thrown that timeline off, or was that product already in good enough shape that you could move it forward once you had the 180-day on track, just an update on that, that next-generation product would be helpful. Thanks.

Yes. We are still targeting, Chris, to be in the clinic in 2021 with some of the investment re-strategizing that may get pushed out a quarter or so. But we're actively still working on it. But we do expect next year in the 2021 calendar time period to be starting the 365.

Our next question is from Rebecca Wang with SVB Leerink. Please go ahead.

Hi, guys. Thank you for taking the question. Actually, more of a follow-up on the last question. So it actually feels, like, we still have people pushing back and saying 90-day isn't enough for [intangible] [ph]. Should we think about 180-day sensor as being a more potential adoption infection driver, or do you guys think, it will take six -- the one -year sensor to really drive adoption inflection?

We see a continued improvement with each one of the elongations. Obviously, you add more independence in the use as it gets longer and longer. As we've seen in Europe, when you go to the 180-day product, is greater interest. We would anticipate that, of course, that gets even stronger with the 365. But we certainly expect the 180 to have some pretty compelling differentiation as well.

Thank you.

The next question is from Matt Blackman with Stifel. Please go ahead.

Good afternoon, everyone. Thanks for taking my questions. Tim, when you spoke about the 180-day product, you mentioned other enhancements beyond calibration and 180 days. Is there anything specific worth calling out on those other improvements?

Yeah, there's a number of improvements that we've taken feedback from the users, especially in regards to the user interface and the app. So we'll be bringing those out as well. Primary changes are, of course, the longevity, the [cow] [ph] reduction, but there are other important improvements that will come as well.

Okay. And then just two quick follow-ups. Are there any updates on the flash sensor partnership discussions? Is that a separate pathway from the strategic alternative process you're running now, or are they somehow linked? And then I'll just throw my follow-up. Anything at ADA worth calling out this week -- this weekend? And thanks, appreciate it.

Sure. We -- in regards to the whole portfolio development that is an active part of the conversations that we're having. I won't go further than that. But obviously, the ability to flash the sensor is pretty attractive, especially for expansion into a type 1 non-insulin population. From the ADA, we do have a poster on Saturday. That will be -- you can see that up on our website when we're done. And we'll be showing some pretty significant clinical data from, I think, the first 1,600 patients in the United States that have been on Eversense.

All right. Thank you so much.

The next question is from Jayson Bedford with Raymond James. Please go ahead.

Good afternoon. So I apologize if I missed this, but I'm a little unclear on the commercial efforts. Are you expecting to implant new patients this year?

Jayson, we've curtailed the new patients with the one exception that we are now piloting and have inserted our first Medicare patients. So where we have doctors that are currently certified on doing the insertion, now that we have Medicare coverage, there has been a good interest in some of those folks coming on the product. So we don't have the sales reps right now to do the detailing or the incremental training of new doctors. But if you're an existing doctor, we are doing some Medicare patients. And in fact, that's already occurred.

Okay. And is Roche selling the device in Europe to new patients?

Correct. Yes, there's been no change in Europe with Roche, other than just the COVID impact on their clinic access with patients and providers. We are seeing that rebound as well.

Okay. And I appreciate the commentary around expanded access. But when you get to the 180-day approval, do you have to go through this process again for this device?

No. No, Jayson. Much like you saw as the transcutaneous CGMs transition from 3 to 5, to 7, to 10, to 14 days. What that has created is, many of the payers are paying on a per day basis. And so, they just consider that in the length of the sensor. So we wouldn't anticipate that we would have to go through this approval process with a new elongated sensor.

Okay. And then maybe last one for Nick. What is the current monthly burn?

So we haven't provided guidance there. In the first quarter on an operational basis, it was $10 million a month. As we mentioned on the call, we do expect in the second half to be in that $3 million to $4 million range with those exceptions as noted. Clearly, there's a bit of a transition going from where we were in Q1 to where we expect to be in the second half of the year.

Okay. Thank you.

You're welcome.

[Operator Instructions] The next question is from Alex Nowak with Craig-Hallum Capital. Please go ahead.

Hey, good afternoon, everyone. Tim, how do you plan to conduct the 180-day launch differently than the 90 day? What went wrong with 90? What went right? And what do you plan to do differently here for the 180-day?

Yes. Well, certainly, the 180-day product, as we noted, we think is going to continue have a lot of interest as well. There's a couple of key elements. We'll certainly be much further along in regards to the payer reimbursement. We should be -- when we get the final three MACs, we should be close to 200 million covered lives. I think, the official count we're giving today is right about 170 million. So, obviously, that will be much, much further along, as well as the training and the certification of the docs to do the insertion people -- insertion of people. Recall that we've got approximately 500 folks that are doing insertions now and about something like 1,600 that were doing the prescriptions. So we'll continue to work on the network of additional inserters that are not endocrinology folks. We found that to be very successful, and we'll continue to support the patient with a longer product.

And once the 180-day is approved, how long is it going to take to go out there, rehire sales force, get them trained up? And would you expect to do something along the lines of the 90-day, where you hit the ground running with 30 or so reps, or is this going to be a little bit more of a slower-go approach?

Yes. I'd say, Alex, at this point, it's probably best. That's all part of the strategic conversations, depending on the direction that we had, would change the implementation of the commercial plan. So I'd like to defer that, let us go through the strategic process, and then we'll be able to really describe how we or partner organizations, strategic partners would approach that.

Okay. Got it. And then I just want to touch on the cash burn again. At the low end there; at the end of this year works out to basically 39 per year; obviously, there isn't a U.S. sales force and a lot of these initiatives have been halted. So I guess my question is, isn't that burn still pretty high on a – if you look at a per-year basis? And what are the options there for more lean organization going into the 100-day there?

Nick, do you want to take that?

Sure. Yes. So right now, based on the strategic – or the initiatives that Tim outlined, we have – we made reductions of approximately 60% of the employment base. So certainly, with the initiatives that we have, being a public company we continue to maintain staff of approximately 80 FTEs. And so certainly as Tim mentioned, we'll continue to go through our strategic process and we look forward to updating you all when we can.

Okay, got it. Thanks.

You’re welcome.

The next question is from Kyle Rose with Canaccord. Please go ahead.

Great. Thank you for taking the question. So a lot has been asked, but I just wanted to circle back. I think you talked about some attrition rate numbers for, I guess, the height of the pandemic and some of those restrictions. I just wanted to see; one, could you provide those again? And then also the trends you're seeing as far as reinsertion rates? And then just how we should think about, I guess, the size of the install base now and on a go-forward basis, maybe what happens to those patients who didn't have the chance to get reinserted over the course of the last 8 to 12 weeks?

Yes. I think to start with the end there, Kyle. I wouldn't suggest that we've indicated an attrition rate. What we've seen is that, insertions were down to about half. So 50% of what they were prior to going into the COVID impact. So there certainly were some patients that were not able to get sensors on their -- on their 90-day expiration, but we are – see them starting to come back. So that is why we're hesitant at this point with frankly, just really a few weeks of -- here to see that response happening at this point. But I don't expect it to say that, this is a 50% attrition, I think we're going to see it's less than that, but we'll know in a little bit more time.

Okay. Thank you. I appreciate the additional color there. I must have misheard the comments. Thank you.

This concludes our question-and-answer session. I would like to turn the conference back over to Tim Goodnow for any closing remarks.

Well, thank you. We appreciate everybody's time and interest and we look forward to updating you here as we move through the second quarter and through the strategic process. With that, good day.

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.