Brainsway Ltd (BWAY) 2020 Q4 法說會逐字稿

Greetings, and welcome to the Brainsway Fourth Quarter and Full Year 2020 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce Chase Oswald of LifeSci Advisors. Thank you, Chase. You may begin.

Thank you, all, and welcome to Brainsway's Fourth Quarter and Full Year 2020 Earnings Conference Call.

With us today are Brainsway's President and Chief Executive Officer, Christopher von Jako; and Senior Vice President and General Manager of North America and Interim Chief Financial Officer, Hadar Levy.

The format for today's call will be a discussion of fourth quarter trends and business updates from Chris, followed by a detailed discussion of financials from Hadar. Then we will open up the call for your questions.

Yesterday, Brainsway released financial results for the fourth quarter and full year ended December 31, 2020. A copy of the press release is available on the company's Investor Relations website.

Before I turn the call to Chris and Hadar, I would like to remind you of this conference call, including both management's prepared remarks and the question-and-answer session, may contain projections or other forward-looking statements regarding future events or the future performance of Brainsway, including, but not limited to, any statements relating to commercial plans or activities, financial projections, clinical studies, R&D plans and/or anticipated time lines.

These statements are only predictions and Brainsway cannot guarantee that they will, in fact, occur. Brainsway does not assume any obligation to update that information. Investors are cautioned that all forward-looking statements involve risks and uncertainties, such as reliance on third parties and shifting market conditions, particularly due to the COVID pandemic, which may cause actual results to differ from those anticipated by Brainsway at this time.

Additional risks concerning factors that could cause actual events, results or achievements to materially differ from those contained in the forward-looking statements can be found in the company's registration statement on Form 20-F and in its other filings with the Securities and Exchange Commission.

I would like to now turn the call over to Chris.

Thank you, Chase. Welcome, everyone, and thank you for joining us today. I'd like to begin by thanking the investors who participated in our recent successfully completed follow-on offering that generated approximately $45 million in gross proceeds for Brainsway.

We were grateful to have the support of many high-quality, health care-focused institutional investors in this transaction, which we truly believe provides an important validation of Brainsway's innovative technology and growing business.

We were successful in attracting these top tier investors because of both the strong performance of our existing business as well as our future prospect for significant growth. To this end, we achieved record quarterly revenues in the fourth quarter of 2020 of $7.1 million, representing a strong 17% increase over our third quarter and a 12% increase over the same period of last year, which, of course, was prior to the onset of COVID-19. We are thrilled that our business is now getting back to what we believe will be a significant growth trajectory as it was prior to COVID-19, when, as you may recall, we generated a robust growth of 41% in a full year 2019 over 2018.

I would like to highlight that we generated these excellent top-tier results while also achieving positive cash flow from operations in the fourth quarter. While we are pleased with our performance in the fourth quarter and are confident that we can continue to operate on a cash flow positive basis, going forward, we believe it's critical to continue investing in our business in order to drive further market penetration and accelerate growth. Therefore, we intend to utilize the proceeds from the financing primarily to expand our sales force and to invest in various commercialization and marketing initiatives.

I will review our specific objectives in the critical areas of sales and marketing shortly. First, though, I'd like to provide a brief update on the current operating environment. In the fourth quarter, a significant majority of clinics operated at or near normal levels, with some even experiencing patient treatment volumes above pre-COVID levels. Importantly, business conditions have remained stable as these -- at these levels during the early months of 2021, though not all clinics are operating at pre-COVID levels yet. Of course, we will continue to monitor the impact of the pandemic on our operations in 2021.

With that said, based on the current operating environment, the ongoing vaccine rollout and our general outlook for the year, we anticipate a steady progression of our business in the second half of 2021.

While the pandemic continues to evolve and unfortunately persist, depression and OCD trends are likely to continue to increase as well. Accordingly -- according to a recent journal article, 1 in 3 adults has been affected by the pandemic-related depression or anxiety. This was a comprehensive study in which research has performed a meta-analysis of 68 studies conducted during the pandemic and included 288,000 participants from 19 countries. Moreover, in the recent JAMA open survey of over 6,500 patients before and after the pandemic, patients with depression symptoms more than tripled from 8.5% with depression symptoms before COVID-19, compared to 27.8% having depression symptoms during the pandemic.

In OCD, an article published last September in the Journal of Psychiatry Research examined the difference in the gold standard OCD scoring scale among adult patients with a mean age of 43. The results of the study showed substantial worsening among OCD patients with statistically significant changes in severities of total OCD symptoms, obsessions and compulsions when comparing the pre-quarantine period versus during quarantine.

Staying with OCD, our second major indication, we remain focused on securing reimbursement in this high-value area. After the publication of the Clinical TMS Society Coverage Guidance for OCD in late January 2021, we have made considerable progress with our OCD payer communications. Since that time, our market access and medical affairs leadership team has made presentations to a number of the largest health care plans in the country, including their behavioral health medical directors as well as the majority of the Medicare administrative contractors, or MACs.

In addition, we've sent a significant number of OCD coverage request letters containing the important clinical publications to commercial and Medicare payers, including many of the nation's largest private plans.

Our clinical evidence includes post-marketing clinical data on 219 OCD patients at 22 Deep TMS sites, which was published in the peer-reviewed Journal of Psychiatric Research. As a reminder, this study showed that 73% of patients reached initial response at an early stage of Deep TMS treatment, which was administered as an adjunct form of therapy. The data also revealed that the therapeutic effect can be maintained for weeks after the treatment.

We hope to begin securing OCD reimbursement coverage over the coming months. Though I should add that already about 1/3 of our total installed base have opted to offer our OCD treatment generally through an add-on helmet to their existing system. This is a clear-cut reflection that even without reimbursement, our customers strongly believe in the benefit of Deep TMS for OCD.

Regarding depression. With a robust U.S. reimbursement in place, our technology allows for easily understood and, more importantly, an excellent return on investment for our customers, which includes physician offices, clinics, networks, PMS providers and hospitals. Importantly, 2020 saw several large payers relax their requirements for Deep TMS reimbursement. This is a significant trend, as it increases the already sizable total addressable market for depression. At the end of 2020, Deep TMS for depression was covered by over 60 commercial insurers in all 7 MACs, providing nationwide Medicare coverage. These payers collectively represent more than 275 million covered lives.

Also, our customers continued to enjoy steady reimbursement for Deep TMS treatments of depression, which we view as a positive indicator for our business.

Beyond seeking to secure reimbursement in OCD and continued favorable reimbursement trends in depression, an important catalyst for us, as I noted earlier, and the rationale for our recent successful capital raise, is the desire to expand our sales and marketing efforts. Last month, we appointed Fran Hackett as Vice President of North American sales. He brings more than 30 years of health care-focused sales experience, business development and executive leadership to Brainsway. Over the course of 2021, Mr. Hackett will lead our plan to increase the number of the U.S. sales territories we cover from 13 to 18, a planned increase of nearly 40%.

This sales force expansion will be especially critical as we execute on our controlled market release of Deep TMS for smoking addiction, which began recently. We intend to introduce this new commercial offering, the first of its kind, up to 12 customers initially.

Several of these sites are already offering Deep TMS for smoking addiction patients, and I'm pleased to report today that the first patients have now been treated. You will recall that smoking addiction represents our third FDA-cleared indication for Deep TMS, making us the most versatile TMS platform by far.

As a reminder, we received FDA clearance based on the data from our double-blind multicenter trial with 262 smokers. These smokers were highly addicted to cigarettes with a long history of smoking, and with 70% of them having failed 3 or more attempts to quit. Of the participants who completed a full course of Deep TMS treatment, 28% achieved 4 consecutive weeks of abstinence from smoking. These data have us very excited about the large market opportunity among the 34 million adult smokers in the U.S. and the potential impact that Deep TMS for smoking addiction can have on our business and revenues over time.

As the controlled market release in smoking addiction continues, we also remain focused on increasing market penetration for Deep TMS in depression and OCD, and we intend to expand our digital marketing strategy and other critical initiatives that will be supported by our recent financing. Specifically, we plan to execute campaigns aimed at enhancing website content, search engine optimization, increasing social media advertising and enhancing the utilization of social media influencer networks. An excellent example of this is our digital efforts around OCD Awareness Week, which took place in October and was highlighted on our last call.

I would also like to note the impressive gains we have seen from the data we are tracking on our website user volume and patient education initiatives. For example, our new website, which serves as both a patient and provider resource, saw a massive 70% increase in organic users from 2019 to 2020.

Turning to Investor Relations. I want to emphasize that we continue to remain dedicated to sharing Brainsway's compelling growth story with both institutional and retail investors. We met with a number of high-quality health care-focused, U.S.-based institutional investors around our recent equity offering, and enjoyed a very positive reception to the offering.

Moreover, we hosted a well-attended key opinion leader in virtual investor event last November. This informative event featured Dr. Owen Muir of Brooklyn Minds, who discussed the current treatment landscape and the unmet medical need in treating patients with depression and OCD.

In addition, we'll be presenting at a number of health care investment conferences throughout 2021, and we plan to host an additional KOL event for investors and analysts this year.

To put our competitive position in the TMS marketplace into perspective, our Deep TMS system has been subject of no less than 32 completed randomized controlled clinical trials, which is more than any other company in our field. Furthermore, Brainsway's Deep TMS has been utilized to treat over 95,000 patients for depression and OCD, and this translates into over 2.5 million individual treatment sessions.

As far as our positive safety profile, as you may know, our device is not associated with any systematic side effects -- systemic side effects. However, Brainsway has been diligently collecting comprehensive safety data to provide us with a better understanding of the risks of the treatment and recently published analysis in the Journal of Brain Stimulation. Importantly, we now have the most comprehensive published clinical safety data by far of any TMS company and believe this suggests a safety profile that is second to none in the TMS industry.

Finally, as always, I want to express my gratitude to our hard-working customers on the front line of this mental health crisis, and to the entire Brainsway team for their continued support and dedication in boldly advancing neuroscience to improve health and transform lives.

These extraordinary efforts by our customers and employees produced a significant achievements in 2020, positioning us well to complete our recent equity financing and has us poised to leverage the many key catalysts ahead of us.

Thank you again for joining us today. With that, I will now pass the call to Hadar for his review of our fourth quarter and full year 2020 financials. Hadar?

Thank you, Chris. We are excited by the momentum in our business and believe we are well positioned for potential continued growth in the foreseeable future.

We generated fourth quarter revenue of $7.1 million, a 17% increase sequentially from the third quarter of 2020 and a 12% increase for the fourth quarter of 2019. This revenue growth was driven by the increase in our direct sales. Our reoccurring revenue primarily derived from this were $3.4 million, consistent with the fourth quarter of 2019.

Revenue for full year 2020 was $22.1 million, down 5% when compared to total revenue for 2019, primarily due to the impact of the pandemic on our customers and a lower level of in-person patient visits.

As of December 31, 2020, Brainsway installed base totaled 629 Deep TMS systems, which reflect quarter-over-quarter increase of 36 systems. Over 2020, even taking into account the impact of COVID-19 through the fourth quarter of 2020, Brainsway's installed base has increased by 99 systems compared to year-end 2019 or a solid 19%. Gross profit for the fourth quarter of 2020 was $5.5 million compared to $4.9 million during the prior year period.

Gross margin for the quarter was 78% as compared to 77% in fourth quarter of 2019. Gross margin for full year 2020 was over 77% compared to 78% in 2019.

Research and development expenses for the fourth quarter were $1.6 million as compared to $1.8 million in the fourth quarter of 2019 and primarily consisted of costs associated with the continued development of our patent Deep TMS technology. Research and development expenses for full year 2020 was $5.8 million as compared to [$7.9 million] in 2019.

SG&A expenses for the fourth quarter was $4.3 million compared to $5 million for the fourth quarter of 2019. The decrease is in line with the company's effort to enhance efficiency as well as to lower operational expenses given the financial impact of the pandemic. SG&A expenses were $16 million for full year 2020 as compared to $18.6 million in 2019, a reduction of 15%. Total operating expenses for fourth quarter were $5.9 million compared to $6.8 million in the same period last year.

Operating expenses for 2020 totaled $21.8 million as compared to $26.5 million in 2019. Operating loss for the fourth quarter was $407,000 compared with a loss of $2 million for the same period in 2019. Operating loss for 2020 totaled $4.8 million as compared to $8.5 million in 2019. For the fourth quarter ended December 31, 2020, we incurred a net loss of $267,000 compared to a net loss of $1.7 million in the fourth quarter of 2019, a year-over-year improvement of $1.5 million.

Net loss for full year 2020 was $5.4 million as compared to a loss of $10.3 million in 2019 a year-over-year improvement of $4.9 million.

As for the balance sheet, we ended the year with cash, cash equivalents and short-term deposits of $17.2 million compared to $21.9 million as of December 31, 2019. Cash used during 2020 of $4.7 million was in line with our expectations. Of course, this figure does not include $41.9 million in net proceed raised through our follow-on offering closed in March 2021.

We believe that our strong balance sheet allows us to expand our sales and marketing efforts to drive additional adoption of the Deep TMS system and to continue to invest in research and development in order to explore new potential indication for innovative technology.

This concludes our prepared remarks. I will now ask the operator to please open up the call for questions. Operator?

(Operator Instructions) Our first questions come from the line of Jayson Bedford with Raymond James.

I hope everyone is well. So I guess, Chris, just to jump off your comment around steady progression of the business in the second half. Can you just comment on first half trends?

Yes, Jayson. Thanks. Well, I think our first half -- well, we're now through the first quarter, obviously. And we've seen, I think, similar to things that we saw in the fourth quarter as far as patients coming in and getting treated. We anticipate that the -- our business will continue to progress as we exit COVID and that we feel in the second half will be better than the first half of the year. That's our current thinking.

Okay. But I guess current business conditions, would you characterize it as similar to fourth quarter business conditions?

I think from a -- from -- you saw probably in the fourth quarter that we had a higher direct sale than we do from a leasing perspective, that percentage that typically, we have some seasonality in the business. We're typically -- in the fourth quarter and the second quarter, we see a higher direct volume. But again, our business typically is around that 60%, 40%, when you're looking at lease compared to direct. So we're very pleased with how we finished the fourth quarter with our -- with some of those direct sales.

But as far as the business, I think we see the similar trends as we saw in the fourth quarter. We -- obviously, we're cautiously optimistic as we continue to exit the pandemic.

Okay. And just on the fourth quarter, of the 36 boxes, let's call them, sold in the quarter, how many went to existing users? And what was the rough breakout between direct and recurring?

So I would say that roughly around 40% went to existing customers and the other 60% were with new customers.

Okay. Hadar, in terms of just kind of the 36, how many went to the direct bucket versus the lease bucket, roughly?

So it was roughly around 50%, 60% between direct and lease.

Okay. And then just maybe jumping over to OCD reimbursement. I think you said you hope for payer coverage in the next several months. Just kind of what -- has there been any indication there? I'm just trying to gauge your confidence level there.

Yes, Jayson, thanks for the question. So I think that my confidence level has improved. We've been having some really good meetings with a lot of the payers over the last couple of months, and they've been very receptive not only to these particular OCD patients who, as you may remember, it's a much more complex disorder than depression, and they only have a limited amount of alternatives with only 5 medications.

I'm not giving any guidance. I'm feeling a lot better than it did a year ago about where we're heading with reimbursement, and particularly because we're leveraging this new study that got published last year. And the payers have been very receptive to meet with us. And I think that, in general, I wouldn't be surprised that later this year that we started getting some payers to actually cover us.

Okay. Last question and I'll jump back in queue. Any commentary on OpEx levels here in '21 versus '20?

We do anticipate the OpEx to go high, specifically on the sales and marketing line. That should be our main focus for this year. But not -- I wouldn't expect to see some dramatic growth, but it will grow as compared to 2020.

Jayson?

Is there any way to just quantify the spend in OpEx in '21?

We're not providing any guidance, but I think that we are going to go back to the similar OpEx that we had prior to COVID, with a roughly burn rate of up to $2 million per quarter.

Our next questions come from the line of Kyle Mikson with Cantor Fitzgerald.

Congrats on a nice year and always, solid updates, too. I wanted to start with OCD reimbursement also. I was wondering if you could just tell me what the like the typical demographic is of these OCD patients. Like I'm thinking like age, sex, et cetera.

And as you think about the MACs and the private payers coming on with reimbursement in the near term, next couple of months, hopefully, which of these groups could come first? Because, obviously, Medicare, private like commercial payers, different reimbursement rates. So just curious if you can provide some comments there.

Yes. Thanks, Kyle. I appreciate your comments about the year. So with OCD, in particular -- I mean you can look at the onset is typically in the early teens. And most of the time, these patients actually don't seek treatment until they get into their 30s and 40s, which is obviously not a great thing.

From a payer perspective, we've actually met with some of the largest payers already, and we've met with actually all the Medicare MACs. With OCD, depending on how severe the OCD is, these patients actually could be disabled and they could be covered under Medicare even if they're under the age of 65. So I think for us, we're -- right now, we're out there presenting to as many of the payers that we can set up meetings with, and we're sending tremendous amounts of coverage request letters out. And I just -- I've been on a lot of these calls myself with our Head of Market Access as well as our Chief Medical Officer.

So the comments that we're getting back, they're very receptive, and I'm quite hopeful as we continue through the year that we'll start achieving reimbursement from some of these payers.

All right. That's helpful. And obviously, the sales force expansion is positive. It was brought up in the past. But to hear the -- that spend will increase in that area, in that bucket in 2021, it's great.

So I guess Hadar, can you just talk about the progression throughout the year in terms of the hiring? And obviously -- or I guess, smoking cessation is going to kind of be the relapse a little bit muted early on and then maybe pick up in the second half? And so I'm thinking that the cadence could be a little bit stronger hiring in the second half of the year? Can you just confirm that and maybe talk about how you kind of get to that 18 territory level at this -- in this year?

Yes. So our plan is to complete all the recruitment on the missing territories by the end of Q3. So our main goal, if we can do it even earlier, it's better. But it might take for the next 2 quarters just to hire the missing position that we are looking to hire in the next 6 months or so.

And then -- sorry, Kyle did you have -- did you have a specific question about smoking on the rollout with that as well?

I mean is part of that trajectory of cadence going to be driven by smoking? It kind of sounded like it is, based on your prepared remarks.

Yes. No. I mean obviously, the drive right now is for, obviously, expansion of the current depression and OCD products?

Okay. Yes. No, of course, of course. Yes. And just looking at the model, the lease ASP declined dramatically in 2020. I'm sure that was due to some of the pricing arrangements that we talked about in the past.

But is the expectations in '21 going to be that, that ASP creeps back up to where it was pre-COVID? Or could we see this lower level stick around for the, I guess, next year or so?

I believe we're going to keep the ASP similar to the rates that we have seen in 2020, and we have some good reason to believe that we're going to keep it that way. We see a very good momentum and good demand, specifically with our OCD platform. So I believe that we will be able to keep the margin and the ASP as similar to the rate that we've seen in the past.

Perfect. Hadar, just a last question for me. Just looking at the record revenues, it's impressive in the quarter. Was there any like pent-up demand from the second or third quarters that converted to sales this quarter? And I guess thinking about that, like what was demand looking like exiting 2020 and then early '21 recently? And then also, if you could comment on the pipeline, maybe at end of the year or currently? I mean that would be really helpful, too.

So I think, as I mentioned earlier, obviously, Q4, we have some seasonality in the business. Q4 and Q2, we tend to drive additional direct revenue as opposed to lease revenue there. That obviously has a dramatic effect on the business, and that's for a number of different reasons with that seasonality. I think we had really great demand, and that demand sometimes slips down a little bit into the first quarter as we enter the first quarter. We're trying to tie up a lot of things at the end of the year, but we feel very strong about -- and bullish about where we're heading right now.

Okay. And Chris, just for the pipeline, how is the health of the pipeline at this point?

The pipeline is extremely healthy and continues to grow. I think that obviously, as we continue to exit the pandemic, things are coming back to normal. We see it, obviously, very strongly with our current businesses that are increasing their success and are looking to add either systems at their current locations or other locations. But our salespeople are -- every day, they're getting more and more face-to-face meetings, which is very strong for us.

Our next questions come from the line of Jeffrey Cohen with Ladenburg Thalmann.

So a few questions. You talked about the 12 sites with the smoking coils. Can you walk us through the logistics there, being that there is the third helmet offering? How is that being affixed to the actual unit?

Oh, that's a great question. So we actually developed an independent stand for the customers that may already have 2 helmets already with their current system. And in fact, the first several systems that we deployed this quarter needed that third stand because those customers already had both a depression coil as well as a -- or helmet as well as a OCD. That's a great question.

Okay. So one would be detached for the smoking coil to be attached?

No. So there is actually a separate stand that holds an additional coil -- or additional helmet, in essence, that can be -- it's mobile, it can be rolled around.

Okay. Interesting. Okay. I got it. And Hadar, any read into lease versus purchase trends? I know there was a previous question about that from fourth quarter. Or generally speaking, any commentary on lease versus purchase going forward?

We have indicated in the past that our lease to direct purchase ratio is, in a year, is about 60/40. I believe that's very healthy for our growth, and it's -- I believe it's going to remain the same. We don't see any specific changes. Obviously, there is seasonality around it, but I believe it might even increase a little bit higher the -- toward the lease as compared to the direct purchase, that usually comes from the -- on the fourth quarter. But I believe that most of our customers still prefer just to lease the machine rather than to just buy it outright.

Okay. Got it. And then spot cash and shares, it sounded like $17.2 million plus $41.9 million led you to $59.1 million in Q1, approximately. Is that a good guesstimate?

Yes. But I -- before the burn?

Yes.

We haven't looked at the number, right? It's in that ballpark.

It's in the ballpark, yes.

Okay. And then commentary on shares, please, for end of year as well as currently, can you give us a guesstimate there?

I mean we -- there's [11]. Jeff, I don't think we know the number offhand, to be honest with you. I can get back to you on that.

Yes. Okay. Got it. And then last I guess lastly for me, Chris, could you comment a little bit on what you're seeing, generally speaking, from the macro environment on drugs versus energy delivery and treatment paradigms and energy getting earlier in the space? I know that historically, you made commentary about 2 failures on drugs prior to TMS.

Yes, really good question. So as I mentioned, I think in the prepared remarks, last year, we saw a number of the large payers relaxing their reimbursement and where a majority of the payers still, today, continue to be at about 4 medication failures. But we saw that relaxing down to -- from 4 down to 2 in some of those payers. And even some -- I think at least one Medicare MAC has 1 failure, another Medicare MAC has 2 failures. We hope to see that trend continue.

I think that the alternative for our technology, we're showing really great results with these patients that have -- they're the most difficult patients, right? Because they're treatment-resistive, and if we can get them early in their paradigm, it's only getting better for them because after they fail that first medication, it becomes even more likely that they'll fail a second and a third medication.

So I think the trends are hopefully leaning towards bringing the TMS paradigm earlier in the treatment.

Okay. Got it. And then lastly for me on seasonality of the year. I know you talked about back half being stronger relative to front half, and Q4 and Q2 are, generally speaking, being stronger versus Q1 and Q3. But any read into the reimbursement and the out of pockets? Do you expect this year that, that will have a greater or lesser severity on the first quarter?

Yes. I think generally, with our business, like I said, we do have a seasonality because we have a lot more direct purchases, like I said, in Q4 and in Q2. So typically, we'll see that as we go into Q1, so the direct purchases will be a little bit less. I don't think it has much of an effect on deductibles or co-pays or things like that for the patients, in particular, on what the drive will be.

Again, our customers would be opening up a completely a new offering within their office, right? If they're offering Deep TMS or, for example, if the existing customer is expanding just because their business continues to expand. And I think that with the pandemic starting roughly about a year ago, and Hadar and I were together almost fall about a year ago during that period, we're going to start seeing an increase in [bolus] of patients probably in the second half of this year, specifically because it takes at least 1 year, if everything goes well, to get up and down 4 medication failures.

So our customers, our current customers understand this, and they already know how to run the TMS business, so they've been very bullish about the business itself.

Our next questions come from the line of Steven Lichtman with Oppenheimer.

Just building on the NDD wins, reimbursement wins last year. Wondering how that's impacted conditions on the ground so far? Are you seeing increased interest from psychiatrist offices, given the potential to use dTMS earlier in the treatment paradigm?

Yes. So I think that it's definitely a great driver for us, and it's a great message when we're speaking to psychiatrists that are in those regions or that -- take that specific insurance carrier.

I know, having spoken to a number of our customers over the last 6 months, that it is really great for them. I mean if you may remember, most patients that have an onset of depression will get that primarily anti-depressant medication coming from their general practitioner or maybe, say, an OBGYN, if you're related to post partum. But -- and now what you're doing is you're getting those patients going to a psychiatrist after at least 1 failure, if not 2. So they -- if they're now in the psychiatrist office with already 2 failures and they have the ability to now use TMS as opposed to trying another medication, it's been really beneficial to those particular physicians.

So that message, I think, is definitely resonating with our customers and our sales force is obviously using that message with new potential customers as well.

Got it. On smoking cessation, should we expect a similar playbook in terms of data collection to support reimbursement? Are there plans for a post-marketing study here in 2021?

Yes. So that's what we're -- that's one of the aims of our controlled market release right now. Obviously, the goal is to get these 12 centers up and running and treating patients and understanding the market and working together with them on -- particularly on the cash pay and trying to see what resonates and see how we can repeat this business in multiple places, and that's really the goal.

But the other part of the goal that we're looking at, for the controlled market release is to ensure that we're collecting the data correctly. So equally important on both those things. So -- and we will -- we -- as part of this, obviously, we've already begun collecting post-marketing data.

Got it. And then lastly, Chris, as you start thinking longer term on potential new indications, any update you can provide on the next areas you think maybe targets for add-on indications?

Yes, sure. So unfortunately, the pandemic had slowed down some of the work that we were doing around future indications. We have a number of clinical trials that are going on now, most of them are pilot trials that are going on now, and we were looking last year to launch a couple of new studies for new indications, and we plan to do that later this year. I'm not giving any public guidance on what those indications would be. But we have those listed, obviously, in our in our deck that shows that likely be an addiction, likely be one of the neurological indications, probably MS fatigue. So hopefully starting one, if not a multiple of those later this year.

Thank you. There are no further questions at this time. I would like to turn the call back over to management for any closing comments.

Thanks so much. In conclusion, I would like to thank all of the investors and our participants for their interest in Brainsway, and look forward to keeping you up-to-date on our progress throughout the year. With that, please enjoy the rest of your day.

Thank you for your participation. This does conclude today's teleconference. You may disconnect your lines at this time. Have a great day.