Solana Co (HSDT) 2020 Q4 法說會逐字稿

Good evening, ladies and gentlemen, and welcome to the Fourth Quarter and Fiscal Year 2020 Earnings Conference Call for Helius Medical Technologies. (Operator Instructions). Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly.

Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including, among other things, risks and uncertainties around the clinical development process and FDA regulatory submission and approval process and other risks identified in the Risk Factors section of our most recent annual report on Form 10-K and quarterly reports on Form 10-Q.

Such factors may be updated from time to time in our other filings with the SEC, which are available on our website. All statements made during this call are as of March 10, 2021. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

I would now like to introduce -- to turn the call over to Mr. Dane Andreeff, Helius Medical's Interim President and Chief Executive Officer. Please go ahead, sir.

Thank you, operator, and welcome, everyone, to Helius Medical's Fourth Quarter and Full Year 2020 Earnings Conference Call. I'm joined on this call today by Joyce LaViscount, our Chief Financial Officer and Chief Operating Officer; and Mark Leno, our Vice President and General Manager of our Canadian operations.

Let me provide you with a quick agenda of what we are going to focus on today as part of our continued strategy to reposition Helius to create intermediate and long-term shareholder value. I'll begin my remarks with a brief update on our U.S. regulatory strategy and the recent progress we have made. Following this discussion, Mark will provide you with an update on our commercial activities in Canada. Joyce will then review our fourth quarter financial results, the recent progress we have made to secure additional capital and enhance our balance sheet condition and share some thoughts on our expectations as we enter 2021. Following Joyce's remarks, I will share some closing thoughts on our near-term initiatives in 2021 and longer-term outlook before we open the call for questions.

With that, let's get started with an update on our U.S. regulatory strategy and progress. As we announced in March of 2020, our U.S. regulatory strategy is focused pursuing an indication in multiple sclerosis, or MS, as the pathway for obtaining the first U.S. clearance for our PoNS device. Our target indication represents a large patient population with a high unmet need -- medical need. As a reminder, in the United States, there are approximately 1 million patients estimated to be living with MS. Our aim is to provide MS patients with gait deficit a nondrug, nonimplantable treatment that has the potential to significantly improve their walking, which may greatly impact their safety and quality of life.

Despite the onset of COVID-19 pandemic, we made strong progress throughout 2020, obtaining breakthrough device designation from the FDA for our MS indication in May and submitting our request to the FDA for de novo classification and clearance of the PoNS device on August 4. During the fourth quarter of 2020, we received a request from the FDA for additional information approximately 75 days into the review process for our de novo request, which we announced on October 19. As a reminder, the FDA's stated goal is to provide a decision within 150 days for 60% of the de novo requests that were submitted in 2020. A request for additional information stops the FDA's review clock until the agency receives a response from the sponsor.

Our regulatory affairs team worked swiftly to prepare and submit a thorough response to the FDA's request. As part of this effort, they conducted an analysis of each aspect of the request with the goal of precisely aligning our response to address the information requested. As a result of their efforts, we were proud to announce on January 11 that we submitted our formal response in the FDA's request. We look forward to the FDA's continued review of our de novo request and hope to receive de novo classification and U.S. clearance during the first half of 2021.

In addition to our strong pace of progress on the regulatory front, we have been closely monitoring the development of the Medicare Coverage of Innovative Technology or MCIT rule. MCIT represents a new pathway to Medicare coverage for FDA-designated breakthrough medical devices, which receive clearance, developed by the Centers for the Medicare & Medicaid Services, or CMS. MCIT will provide national Medicare coverage as early as the same day as FDA clearance for breakthrough devices.

Importantly, device manufacturers will be able to choose a start date for coverage, enabling them to potentially align the start of Medicare coverage with the commercial launch of their device. However, the coverage period is limited to 4 years from the date of clearance.

CMS completed their collection of public comments on MCIT during the fourth quarter and announced that they were finalizing this rule on January 12. With approximately 60 million Americans enrolled in Medicare, obtaining coverage via MCIT represents an important potential tailwind to our initial U.S. commercialization efforts, and we look forward to continue to work with CMS to obtain more information on the pathway and to move forward with implementation activities.

Mark Leno will now provide you with a review of our fourth quarter revenue performance and an update on our commercial activities in Canada.

Thank you, Dane. For the fourth quarter, we reported a total revenue of $191,000 compared to $152,000 in the fourth quarter of prior year. Our revenue in both periods was driven by sales to neurotherapy clinics in Canada that have been authorized to provide our PoNS treatment.

During the quarter, we continued to experience significant business disruption in Canada as a result of the COVID-19 pandemic and the protocols implemented to ensure patient health and safety, which impacted our sales performance. Similar to the trends experienced in Q3, our PoNS authorized clinics continue to be constrained by federal and provincial requirements, limiting their capacity to approximately 50% of normal services.

Based on surveys of our clinics, we also continued to see that capacity and productivity throughout Q4 remains significantly lower than the 50% due to several factors we've discussed on our recent earnings calls, most notably, the impact of clinic-specific protocols that have been implemented to ensure social distancing and the impact of COVID on patient willingness to seek in-clinic treatment. As a result, MS patients typically represent a high-risk patient population when it does come to COVID as they often take disease-modifying medications that suppress their immune system.

In addition to these factors, beginning in late November, many of the largest cities and provinces in Canada implemented lockdowns and stay-at-home orders in response to the resurgence in COVID cases. The resurgence in cases, along with these government restrictions, represented some incremental headwinds that further impacted this patient willingness to pursue treatment during the quarter.

Importantly, our commercial team, however, continued to execute on our 2020 commercial strategy, including engaging, training and authorizing targeted clinics in the most densely populated areas of Canada. In response to the disruption caused by COVID, we developed a new approach to avoid or minimize in-person interaction. Our focus has been on engaging with clinics that fit our targeting criteria via virtual means. Once a clinic has been engaged, we then employ a virtual process to authorize them and conduct a series of live online training modules for their therapists in order to provide PoNS treatment.

As a result of our efforts, in the fourth quarter, we were able to further expand our clinic network of PoNS authorized clinics to 31 clinic locations by year-end, exceeding our previously stated expectations. And given that we entered the year with a total of 7 PoNS authorized clinic locations, our impressive progress on this front is a reflection of our successful shift to a virtual approach, and more importantly, the hard work and dedication of our team under these challenging circumstances.

While the COVID-related restrictions and headwinds that we experienced during the fourth quarter have continued to persist into 2021, we believe that our expanded clinic network represents an important foundation that will improve our access to PoNS treatment and position us for growth once COVID restrictions are lifted and the overall environment begins to normalize.

And with that, I'll turn it over to Joyce to discuss our fourth quarter financial results.

Thanks, Mark. For the fourth quarter of 2020, our gross loss decreased by $146,000 or 94% year-over-year to $10,000 due to changes in the inventory reserves impacting the cost of goods sold and lower direct cost of manufacturing support personnel versus the prior year. Operating expenses for the fourth quarter of 2020 decreased by $2.5 million or 45% year-over-year to $3 million, reflecting the continued benefits of the cost reduction initiatives that we implemented during the past year. Operating loss for the fourth quarter of 2020 was $3 million compared to $5.6 million for the prior year period.

We reported a net loss for the fourth quarter of 2020 of $2.5 million or minus $1.77 per basic and diluted common share compared to a net loss of $5.3 million or minus $6.71 per basic and diluted common share for the same period last year.

As a reminder, on December 31, 2020, we completed a 1-for-35 reverse split of our Class A common stock in order to regain compliance with the NASDAQ stock market's continued listing requirements. We received written notice from NASDAQ on January 19, 2021, which confirmed our compliance with all applicable listing standards.

Turning to a discussion of our balance sheet condition and recent financing activities. As of December 31, 2020, we had $3.3 million of cash compared to $5.5 million as of December 31, 2019. We had no outstanding debt obligations in either period. Our average cash burn from operations during the fourth quarter of 2020 was approximately $700,000 per month compared to approximately $1.5 million per month in the fourth quarter of last year, reflecting our continued efforts to control our expenses and allocate capital prudently.

On October 26, 2020, we closed a private placement, resulting in net proceeds of approximately $3.2 million, which was led by Dane and myself and included participation from existing and new shareholders. Subsequent to quarter end, we raised $1.3 million in net proceeds through the exercise of warrants in January and closed an underwritten public offering of common stock and warrants for net proceeds of approximately $9.6 million, including a full 15% overallotment. On February 1, this was completed. We believe the proceeds raised from these transactions, along with our existing cash, will be sufficient to fund our operations into the first quarter of 2022.

Importantly, this expectation does not include any potential incremental benefit to our cash position due to proceeds raised from the exercise of additional warrants during the remaining months of 2021. There are currently approximately 594,000 warrants with a weighted average price of $16.32, which could yield an additional $9.7 million if exercised, although there is no assurance that these warrants will be exercised in 2021 or ever.

Looking ahead, we will continue to maintain a disciplined approach to spending while evaluating options to strengthen our balance sheet and support our operations. In terms of our outlook for 2021, given the uncertainties associated with the duration and impact of the COVID-19 pandemic, we are not providing revenue guidance for the full year 2021 at this time. However, we understand the investment community's focus on obtaining additional clarity during this period and would like to provide some thoughts regarding the near-term trends and our assumptions for 2021.

As Mark mentioned, the headwinds and restrictions experienced in Canada during the fourth quarter have continued to persist in 2021, impacting clinic capacity and patient willingness to seek treatment. Given these continued headwinds, we would anticipate total revenue in the first quarter of 2021 to be approximately $80,000. We expect our sales performance will continue to be significantly impacted by the COVID-related business disruption in Canada during the first half of '21, followed by gradually improving trends as the environment begins to normalize during the second half of the year. And lastly, we do not anticipate any revenue from sales of our PoNS device in the U.S. during 2021. Assuming we receive FDA clearance during the first half of this year, we would expect to begin our commercialization in the U.S. during the first quarter of 2022.

With that, I'll turn the call back to Dane. Dane?

Thank you, Joyce. In summary, while 2021 was undoubtedly a challenging year, we are very impressed by the resourcefulness demonstrated by our team as well as their commitment to advancing our regulatory and commercial initiatives. With our de novo request currently under review by the FDA, an expanded network of 31 Canadian clinic locations and enhanced balance sheet to support our operations, we are pleased by the progress made this past year and excited about our long-term growth prospects.

As we enter 2021, we remain focused on executing as efficiently as possible against our 2 near-term growth initiatives: obtaining U.S. regulatory clearance and facilitating the commercial adoption of our PoNS treatment in Canada. In the United States, we will continue to work with the FDA as necessary to facilitate the review of our de novo request while proactively engaging with CMS to obtain clarity on the new MCIT rule and work towards obtaining coverage via this pathway with FDA clearance. In Canada, we will expand access to our PoNS treatment by continuing our clinic targeting, virtual engagement and virtual training efforts with the goal of adding 9 target clinic locations to our network of PoNS clinics by year-end and working closely with the clinics to increase patient throughput.

We will also focus on supporting our recently expanded network of Canadian clinics during this challenging period by partnering with them to: first, raise awareness and reduce potential barriers to patient engagement during COVID; and second, educate the base of clinician prescribers on PoNS treatment and its potential benefits.

Let me take a minute to elaborate on 2 developments related to these aspects of our Canadian strategy. As our existing clinics reopened in 2020, we began working with them, offering promotions with reduced pricing for PoNS treatment. We continued this activity throughout the second half of the year, which helped to mitigate the impacts on patient willingness to seek treatment. In addition to our traditional raising awareness efforts, we would expect to continue working with our clinics in 2021 to offer promotions while the effects of the pandemic persists.

I'm also pleased to announce that in December 2020, we added a new member to our commercial team in Canada. As a former therapist and clinic director, she will be focused on working with our existing and newly engaged clinics to help them raise awareness of PoNS treatment and educate their clinician referral networks on its ability to help patients suffering from the effects of MS and mild to moderate traumatic brain injury. We look forward to her contributions to our team in 2021 and beyond.

Stepping back, by pursuing near-term initiatives I've outlined, our goal is to position Helius to bring PoNS treatment to the large unserved population of MS patients in the United States and Canada as quickly as possible. Simply stated, we believe this approach represents the best pathway to creating value for our shareholders. In addition to these initiatives, we continue to develop our longer-term strategy to capitalize on the innovation of the PoNS technology and its potential as a platform technology by expanding its existing indications for use, pursuing new indications and exploring new potential applications.

Before opening up the call for questions, I'd like to discuss the recent announcement that we made this afternoon in our 10-K filing with the SEC. Our Chief Medical Officer, Dr. Jonathan Sackier, is transitioning from his current role to a consulting position with Helius effective as of Monday, March 8. In his new role as a Helius consultant, Jonathan will continue working with Helius for at least 1 year following the transition date. I'd like to take a minute to personally thank Jonathan for his important achievements as our Chief Medical Officer. I look forward to our continued work together in his new role.

I would like to close today's remarks by thanking our existing long-term shareholders and welcoming the new shareholders who participated in our recent financing. We remain committed to repositioning Helius for the next phase of growth with an eye on creating shareholder value, and we appreciate your support for our company and its mission. And lastly, I'd like to acknowledge the dedication and ingenuity of our team during 2020, which made our rapid progress possible.

I remain more convinced than ever that our talented employees and their commitment to bring PoNS to our customers and patients are one of the defining attributes of our company and its potential for future successes.

With that, operator, let's now open the call for questions.

(Operator Instructions) And our first question will come from Jeffrey Cohen with Ladenburg Thalmann.

So I just wanted to review a couple of your previous commentary points. So firstly, as far as the agency is concerned, so the August 4 date was halted on October 19-ish and then you submitted a response back on the 11th of January. So that restarts the clock? And what does that look like as far as the anticipated 120 days in totality? What does that get you to, sometime in April?

Yes, Jeff. Actually, it's 150 days, just to correct what you said. It's 150 days. The first possible chance would be in April. But just being very conservative minded in setting expectations, we've always stated that we would expect a first half decision by the FDA.

Okay. And were there 2 points to that? You mentioned the de novo status. And then the second point was the clearance. So is one contingent upon the other?

Jeff, can you just clarify that? I'm sorry, I...

You had mentioned that you would expect the -- at some point in the first half, perhaps hearing about the de novo status as well as the clearance status. Was it one or the other or both?

It's both. Yes, it's a de novo classification and clearance that come together.

Correct. So there wouldn't be any further questions regarding the classification, it's really an issue of the clearance?

Yes.

Okay. I got it. And then secondly, I guess more for Mark, just trying to get a better understanding of the centers there that it sounded like certainly way less than 50% were open due to regulations, but you now have 31 in totality training from 7. So how many of those now are open or are enrolling or patients are visiting? Could you give us an indication of how many might be open today? Is it 5, 10?

Yes. So I'm happy to clarify that. So in Ontario, we have approximately 17 clinics, and out of those 17, the vast majority of them are in the Greater Toronto area. And so capacity-wise, we're seeing anywhere from a 20% to probably a 30% to 40% capacity across the country. And I think that the challenge continues to be that our biggest center of population, if you think of Canada, it's 37 million people roughly. 13.5 million live in Ontario and roughly 9 million live in the sort of broader Toronto area.

So Toronto, just this week, came out of a very strict lockdown stay-at-home type of order. So it's very restrictive here. And in-person visiting our clinics, it's a very sort of challenging environment. I have to say it's very dynamic and unique, and it's a headwind that we are fighting against every day.

Got it. So then the 31 trained, so 17 would be the subset out of the total trained of 31, meaning potentially there are 14 kind of in the queue once things may open up?

No, I was just sort of giving you a snapshot of our -- sort of our biggest population center here in the Greater Toronto area. But we have -- out of the 31, almost all of them are open to some small capacity, but again, at that 15% to 30% range across the country based on a whole lot of factors and provincial regulations being primarily the main driver of their ability to open.

It's further impacted by, of course, risk tolerance of patients that may be prospective considered for PoNS treatment that then they want to wait until things have cleared up, particularly knowing that MS patients have a lot of other health issues that are exacerbated by potential COVID risk.

Right. So it sounds like, if I were to hope or assume that COVID continues to decrease as far as its impact in Canada with vaccinations and cases at some point in the coming months or quarters, the company could be at 30-ish clinics open?

Yes. Again, maybe I'll clarify it. We have 31 clinics that are open, but they're all at varying rates of small capacity. And when you're in the most restrictive environment, that being Toronto, Vancouver and Montreal, Toronto being the biggest, the level of governmental restrictive measures for COVID have the greatest impact because this is where our most density of clinics is located. But all of the clinics are open to some degree, just very, very small percentage of throughput. Is that helpful?

Yes. No, that's super helpful. And then lastly, Joyce, on the cash front. Can you -- I know you went through a few metrics. So give us a snapshot of current that we can use. So $9.6 million, plus $1.3 million, plus $3.2 million, plus the end of year would get you to about what now? About -- and you had $3.3 million, so $15 million?

Yes. So -- well, you have to take your burn rate out of there as well. So if you have $3.3 million, you would have to take out roughly that $1.2 million a month from that number, and then put the additions that you've spoken of, and that would get you there.

Yes. Okay. So -- okay. Okay. That gets me to around $13.5 million to $14 million range. Somewhere in that vicinity currently.

Reasonable. Yes.

Okay. That's reasonable to assume. Okay. Super. So well, that does it for me. We're anticipating and looking forward to the agency having a response for you that puts a smile on our faces.

(Operator Instructions) Our next question comes from [Mary Peronn].

This might be unfair. You probably don't know the answer, but I've been using the PoNS. Obviously, I got trained in Canada, but I live in The States, and I'm also a Medicare patient. So if and when it gets approved here in The States, do you have any idea if they would pay for the treatment even though I got it in Canada because I don't imagine clinics are going to be opening up here real soon if I needed to switch to U.S. treatment? Is that clear? I don't know if I asked that very clearly for you to understand.

Joyce, do you want to take that one regarding the MCIT?

Yes. Yes. Yes. So as far as MCIT, we are working with CMS now to understand when the timing -- what the timing will be to be able to get all of the quoting and reimbursement put in place. We're developing our strategy for the U.S. And as we said, there will be a delay in the time it will take us to get the commercial strategy to get our distribution licenses as well as building relationships the key neurorehabilitation centers.

From a reimbursement perspective for Medicare, certainly much more to come. I can't say for certain, but if you have a prescription from a U.S. physician, then it's up to the policy and the practice that's put in place to be able to get the reimbursement or not.

Our next question comes from Anthony Lamport with Lambda Fund Management.

Could you please amplify the insurance reimbursement situation in Canada? Is there any mandatory coverage the way we might have here for MS? And number two, absent that, the private insurers, are they willing to pay? Or basically, your revenue is all coming from just out of pocket at 100% from the patients?

Yes. Mark, do you want to answer that and update Anthony?

Sure. I'll take the question. Thank you, Anthony. So essentially, we are currently working on a strategy on the TBI side. If you recall here in Canada, we have also been given clearance by Health Canada for traumatic brain injury. And so as a result, we feel that that's probably the best strategy for us to lead with in an effort to get reimbursement through the government side of health care here, and so we have a strategy we're working on in an effort to move that forward.

As it relates to the private insurers, we're also working diligently with a couple of our key clinics and some private insurance companies on sort of a pilot in order to demonstrate the -- to these folks the efficacy and outcomes that we're seeing in the real world, but oftentimes, they want to see it for themselves. And so we have some of those underway right now, and I will simply say that things are moving in the way in which I would hope. So that's good news.

But it's a long process because, again, due to COVID, this whole process has been heavily restricted. But as it relates to the private insurance, that's the commentary there. But the -- there is a strategy to also work at trying to find a way for us to use the TBI piece for getting government support for the product. And so for now, we are seeing, once in a while, some insurers will cover in certain cases. And mostly, though, however, in this current environment, we're seeing people having to pay out of pocket for the most part for the device.

But again, if people have insurance through their employment for covering physical therapy, there are elements of that, that can help offset some of the cost. And Canada does have a taxation -- a federal income tax indication that you can apply for some additional medical expenses that are out of pocket that are also -- in some cases, offset through your federal income tax.

You used the word strategy. Strategy is sort of like our strategy is to win the war or something. I mean it doesn't imply any time, action or anything. So I mean you would say when we're going to market our product, our strategy will be to obtain reimbursements, but there's no time attached to it. The strategy could take 3 years to put into effect or 3 months.

You -- now of course, in COVID, things may take longer than expected. But how long does it take to -- I mean in the U.S., of course, it's different because it's basically private insurers, although, of course, we have Medicaid, too. But it can take a very long time unless you have that special MS immediate payment. As you know, it can take 3 years for a device to become insurable or to get reimbursement. So is that similar in Canada, that time, 3 years?

I would hesitate to put any time on it. I think in the spirit of your question, what you may be asking is, are we actively working on this project or on the strategy? And the answer would be, yes, at the rate-limiting step of COVID. But there is nothing on the Helius side that is impeding us from continuing to execute against what we know will be the best strategy for us to do this. But in the COVID environment, it is incredibly restrictive right now to get patient throughput for this.

Well, I'm not -- I understand the patients in the end. If you build it, they have to come. But how long does it typically take, leave out COVID, to obtain -- you have a new device, a de novo device that is approved in Canada, which it was a year ago or 2 years ago now, how long does it take to convince the insurers that government insurance should be applied? Certainly, there must have been some experience, maybe, obviously, not for Helius, but other products. Generally, how long does it take to obtain insurance? In the U.S., that number is 3 to 4 years. Is it the same in Canada, more, less?

So Mark, let me -- Anthony, let me answer this. So in Canada, we're starting to see small amounts of reimbursement. It's small. And you're absolutely right, it takes anywhere from 2 to 3 years. If we look at the United States, it could be up to 3 years, like you said. The great thing is that we have a breakthrough designation. And with the new policy with CMS, that jump starts our commercialization...

I'm restricting it to Canada because, obviously, it's smooth in the United States until you get approval, and then it's "instant" for at least CMS. The question is in Canada, you think it also would take 2, 3 years. Now you've been in -- you were approved in Canada about 2 years ago, weren't you?

Yes, it was March of 2019, and it's taken 18 to 24 months to start getting reimbursement in Canada. It's been slow. It's been steady, but it's been very small.

Interesting. You mean Canada that is the government or the provincial governments are giving you -- are able to give reimbursement now? Or it's -- there were some special cases, it seems strange. If you're willing to give reimbursement, it seems to me, once patients want it, then you're willing to give it if they qualify.

Yes. I think just to clarify, the reimbursement that we have seen has come through private insurance, not the government insurance. So to just circle back, Anthony, to your question around government, there is no -- unfortunately, there is no sort of set time lines. When you have a predicate device that's already approved, that's different than bringing a completely new device to any market, as you can imagine, right? You're creating a new classification or category, and that's a challenge. But again, there's a plan in place that we're working through to do that.

And what is -- how long would it take to implement that plan? What's your plan? We're asking. It doesn't mean it will occur, but is the plan to obtain approval by the year 2030? Or is it a plan to get an approval within the next 18 months? Give some idea of what your plan is.

Sure. Bottom line is we're working as fast as possible with some pretty critical individuals in the medical space here in Canada at large academic centers that will, we believe, bear fruit. I can't tell you how long that's going to take because we really have to work within the COVID environment in which we are unfortunately hampered by right now. But I would -- everything was at one point not standard of care, and our efforts are trying to move that in that direction as fast as possible. I can't give you an exact date, but we are working fervently to try and find the fastest way for that to happen.

Well, you're working with some academics implies that in one case, they're part of a committee that advises the government. In another, it could be the academics now want to run a clinical trial and see what happens and have their own pilot so they can advise the government. Is that the case? Or is it the former case?

It's a mix, actually. So we have some pilot programs working with 2 private insurance companies in the TBI space here in Canada that are large insurers. I'm not going to disclose who they are, but that is...

Yes. I know who they are. Would this pilot be of use to the academics who are advising the government? Do they want their own separate trial?

Yes. They're probably -- they're a bit of both, to be very candid with you. Insurers -- private insurers have different mandates than sort of the health care system as it relates to acute patients and things like that. So without going down too far on this, I will say this, it's a parallel path. You have to do both because not everybody is going to fall within the public health care system all the time, and the one that is probably more nimble is the private paying side. So we're doing both.

(Operator Instructions) Our next question comes from Mark Palin with AALRR.

Given that you guys -- that we've got the breakthrough device or breakthrough device designation from the FDA, and I understand that means that there's enhanced communications with the FDA, I'm just wondering whether you've heard anything from them since you submitted your response to the questions that they asked and if you're able to tell us about your communications with them since then if you've had any.

Joyce, do you want to take this one?

Yes. So we have not had formal communications. Most would be described as informal back and forth, clarifying questions or whatever. But nothing that we've heard can give any more clarity than what we have already disclosed through the prepared comments and what's in our filings.

Thank you. We are currently showing no additional participants in the queue. That does conclude our conference call for today. Thank you for your participation.