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Brainsway (TASE:BWAY) Q4 2020 Earnings Call

Brainsway (TASE:BWAY) Q4 2020 earnings call, held 2021-03-25. Watch the replay and read the transcript on 6ix.

Thu, March 25, 2021 at 8:30 AMendedReplay
Brainsway (TASE:BWAY) Q4 2020 Earnings Call
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Brainsway Ltd (TASE:BWAY)
Period
Q4 2020 earnings call
Date
Thu, Mar 25, 2021, 8:30 AM ET
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Automated transcript · Written by software from the replay's audio. It can mishear names and figures; the replay is the record.

0:00 Greetings and welcome to the BrainsWay fourth quarter and full year 2020 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. For anyone to require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Chase Oswald of Lifestyle 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 Vaniaco, 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.

1:03 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 that 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 timelines. 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.

1:48 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-19 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 20F and in its other filings with the Securities and Exchange Commission. I'd 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 healthcare-focused institutional investors in this transaction.

2:50 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 prospects 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 the 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.

3:53 While we are pleased with our performance in the fourth quarter and are confident that we will 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.

4:45 Importantly, business conditions have remained stable 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, one in three adults has been affected by the pandemic related to depression or anxiety.

5:39 This was a comprehensive study in which researchers performed A meta-analysis of 68 studies conducted during the pandemic and included 288,000 participants from 19 countries. Moreover, in a 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% 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 severity of total OCD symptoms, obsessions, and compulsions when comparing the pre-quarantine period versus during quarantine.

6:46 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 healthcare plans in the country, including their behavioral health medical directors, as well as a 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.

7:36 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 Review Journal of Psychiatric Research. As a reminder, this study showed that 73% of patients reached an 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 one-third of our total install base have opted to offer our OCD treatment, generally through an add-on helmet to their existing system.

8:31 This is a clear-cut reflection that, even without reimbursement, our customers strongly believe in the benefit of DTMS for OCD. Regarding the question, with a robust U.S. reimbursement place, our technology allows for an easily understood and, more importantly, an excellent return on investment for our customers, which includes physician offices, clinics, networks, DMS 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 and all seven MACs providing nationwide Medicare coverage.

9:25 These payers collectively represent more than 275 million covered lives. Also, our customers continue 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 Last month, we appointed Fran Hackett as Vice President of North American Sales. He brings more than 30 years of healthcare-focused sales experience, business development, and executive leadership to BrainsWay.

10:15 Over the course of 2021, Mr. Hackett will lead our plan to increase the number of U.S. sales territories we cover from 13 to 18, a planned increase of nearly 40%. This Salesforce 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, 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.

11:10 As a reminder, we received FDA clearance based on the data from our double-blind multi-center trial with 262 smokers. These smokers were highly addicted to cigarettes. with a long history of smoking and with 70% of them having failed three or more attempts to quit. Of their participants who completed a full course of deep TMS treatment, 28% achieved four 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.

11:56 As the controlled market release and smoking addiction continues, we also remain focused on increasing market penetration for deep TMS and 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.

12:49 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've met with a number of high-quality healthcare-focused U.S.-based institutional investors around our recent equity offering enjoy a very positive reception to the offering. Moreover, we hosted a well-attended key opinion leader virtual investor event last November. This informative event featured Dr. Owen Muir of Brooklyn Mines, who discussed the current treatment landscape and the unmet medical need in treating patients with depression and OCD.

13:44 In addition, we'll be presenting at a number of healthcare 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 systemic side effects. However, BrainWay 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.

14:50 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 hardworking 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 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.

15:38 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 was $3.4 million, consistent with the fourth quarter of 2019.

16:28 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 31st, 2020, BrainStrain's install 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, BrainStrain's install base has increased by 99 systems compared to year end 2019 or a solid 19%.

17:14 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 DCMS technology.

17:59 Research and development expenses for full year 2020 were $5.8 million as compared to $6.9 million in 2019. FG&A expenses for the fourth quarter $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, giving the financial impact of the pandemic. FG&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.

18:51 Operating expenses for 2020 totaled $21.8 million as compared to $26.5 million in 2019. Operating expenses 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 31st, 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.

19:37 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 equivalent 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 proceeds raised through our follow-on offering close in March 2021.

20:23 We believe that our strong balance sheet allows us to expand our sales and marketing efforts to drive additional adoption of the DTMS system and to continue to invest in research and development in order to explore new potential indications for innovative technology. This concludes our prepared remarks. I will now ask the operator to please open up the call for questions. Operator? Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in question queue. You may press star 2 if you would like to remove your question from the queue.

21:08 For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for your questions. Our first questions come from the line of Jason Bedford with Raymond James. Please proceed with your questions. Good morning and I hope everyone's 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? Yeah, good morning, Jason. Thanks.

21:56 Well, I think, you know, our first half – well, you know, 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 our business will continue to progress as we exit COVID and that we feel 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 them as similar to fourth quarter business conditions? I think you saw probably in the fourth quarter that we had a higher direct sale than we do from a leasing perspective, that percentage.

22:48 Typically, we have some seasonality in the business. We're typically in the fourth quarter. In 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. We're very pleased at how we finished the fourth quarter 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 were cautiously optimistic as we continue to exit the pandemic. Okay. And just on the fourth quarter, Of the 36 boxes sold in the quarter, how many went to existing users and what was the rough breakout between direct and recurring?

23:39 I would say that roughly around 40% went to existing customers and the other 60% were with new customers. Hadar, in terms of just kind of 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.

24:25 Has there been any indication there? I'm just trying to gauge your confidence level there. Yeah, Jason, 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 months, and they've been very receptive not only to these particular OCD patients, who, as you may remember, is a much more complex disorder than depression, and they only have a limited amount of alternatives with only five medications. I'm not giving any guidance. I'm feeling a lot better than I 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.

25:31 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 southern marketing line. That should be our main focus for this year. But I wouldn't accept to see some dramatic growth, but it will grow as compared to 2020. Jason? Is there any way to just quantify the spend in OPEX in 21?

26:25 We're not providing any guidance, but I think that, you know, we're 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. Okay, thanks. Thank you. Our next questions come from the line of Kyle Mixon with Cantor Fitzgerald. Please proceed with your questions. Hi, guys. Thanks for taking the questions. Congrats on a nice year and always solid updates too. I wanted to start with OCV reimbursement also.

27:11 I was wondering if you could just tell me what the typical demographic is of these OCV patients. I'm thinking like As you think about the MACs and the private payers coming on with reimbursement in the near term, next couple 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. Thanks. Yeah, 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.

28:02 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, right now we're out there presenting to as many of the payers that we can set up meetings with. We're sending tremendous amounts of coverage request letters out.

28:47 I've been on a lot of these calls myself with our head of market access as well as our chief medical officer. 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 Thank you very much for your time. So our plan is to complete all the recruitment on the missing territories by the end of Q3.

30:04 Our main goal, if we can do it even earlier, it's better, but it might take for the next two quarters just to hire the missing positions that we are looking to hire in the next six months or so. Sorry, Kyle. Did you have a specific question about smoking on the rollout with that as well? I mean, is part of that... Is part of that trajectory cadence going to be driven by smoking? It kind of sounded like it based on your prepared remarks. Yeah, no. I mean, obviously, the drive right now is for, obviously, expansion of the current, you know, depression and OCD products.

30:52 Okay. No, of course, of course. Thank you. Yep. 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 expectation in 21 going to be that ASP creeps back up to where it was pre-COVID, or could we see this, you know, lower level stick around for the, I guess, next year or so? I believe we're going to keep the ASP similar to the rate that we have seen in 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.

31:47 Perfect. Thanks, Hadar. Just a last question for me. Just looking at the record revenues, it's impressive in the quarter. Was there any pent-up demand from the second or third quarters that converted to sales this quarter? And I guess thinking about that, what was demand looking like exiting 2020 and then early 2021, recently? And then also, if you could comment on the pipeline, maybe at the end of the year or currently, 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.

32:38 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.

33:24 But our salespeople are, you know, every day they're getting more and more face-to-face meetings, which is very strong for us. All right, perfect. I appreciate that, Chris. Thanks, guys, for the questions again. Thanks, Val. Thank you. Our next questions come from the line of Jeffrey Cohen with Lattenberg Development. Please proceed with your questions. Hi, Chris and Hadar. How are you? Great. How are you doing? Just fine. So a few questions. You talked about the 12 sites with the smoking coils. Can you walk us through the logistics there, being that that is the So we actually developed an independent stand for the customers that may already have two helmets already with their current system.

34:23 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. 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, 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?

35:18 We have indicated in the past that our lease to direct purchase ratio in a year is about 60-40. I believe that's a very healthy for our growth, and I believe it's going to remain the same. I don't see any specific changes. Obviously, there is seasonality around it, but I believe it might even increase a little bit higher toward the lease as compared to the direct purchase that usually comes on the fourth quarter, but I believe that most of our customers still prefer just to lease the machines rather than to just buy it outright. Okay, got it. And then spot cash and shares, it sounded like 17.2 plus 41.9 got you to 59.1 in Q1 approximately. Is that a good guesstimate?

36:18 Yeah, before the burn? Yep. We haven't looked at the number, right? It's in that ballpark. It's in the ballpark, yeah. 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. Okay, got it. And then, 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?

37:10 I know that, you know, historically you've made commentary about two failures on drugs prior to TMS. Yeah, really good question. So, as I mentioned, I think in the prepared remarks last year, we saw 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 four medication failures. But we saw that relaxing down to from four down to two with some of those payers. And even some, I think at least one Medicare MAC has one failure, another Medicare MAC has two 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, you know, they're the most difficult patients, right?

38:06 Because they're treatment-resistant. And if we can get them early in their paradigm, it's only going to be 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. I think the trends are hopefully leaning towards bringing the TMS paradigm earlier in the treatments. 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, generally speaking, being stronger versus Q1 and Q3. But any reason to... 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?

39:02 Yeah, 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 will 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 will be opening up a completely new offering within their office, right, if they're offering DTMS, or for example, if an existing customer is expanding just because their business continues to expand.

39:53 And I think that with the pandemic starting roughly about a year ago, and Hadar and I were together on this 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 You know, at least one year, if everything goes well, to get up and down for medication failures. So, you know, our customers, you know, our current customers understand this, and they already know how to run the TMS business. So they've been very bullish about, you know, the business itself. Okay, got it. Thanks for answering the questions. I appreciate it, Christian Hadar. Have a good day.

40:40 Yeah, you too, Jeff. Thanks. Thank you. Our next question has come from the line of Stephen Lichtman with Oppenheimer. Please proceed with your question. Thank you. Good morning, guys. Just building on the NDD reimbursement wins last year, I'm 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? Yeah, 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.

41:35 I know, having spoken to a number of our customers over the last six months, that it is really great for them. If you may remember, most patients that have an onset of depression will get that primarily antidepressant medication coming from their general practitioner or maybe, say, an OBGYN if you're related to postpartum. And now what you're doing is you're getting those patients going to a psychiatrist after at least one failure, if not two. So if they're now in the psychiatrist's office with already two 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.

42:21 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? Yeah, so 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 Thank you for joining us. and we as part of this obviously we've already began collecting post-marketing data.

43:33 And then lastly, Chris, as you start thinking longer term and potential new indications, any update you can provide on the next areas you think may be targets for add-on indications? Yeah, sure. So, you know, 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 deck that shows that likely be an addiction, likely be one of the neurological indications, probably MS fatigue, hopefully starting one, if not a multiple of those later this year.

44:45 Okay, great. Thanks, Chris. Thanks for that. Thanks, Stephen. 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.

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