BrainsWay Ltd.

Good morning, and welcome to BrainsWay's second quarter 2022 earnings conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please signal an operator by pressing star, then zero. Please note that this call is being recorded. I would now like to turn the conference over to your host, Bob Hiddard. Please go ahead, sir.

Thank you, and welcome to BrandsWay's second quarter 2022 earnings conference call. With us today are BrandsWay's President and Chief Executive Officer, Christopher Vagnaco, and Chief Financial Officer, Scott Arreglato. The format for today's call will be a discussion of recent trends and business updates from Chris, followed by a detailed discussion of the financials from Scott. Then we will open up the call for your questions. Earlier today, Brainsway released financial results for the three and six months ended June 30th, 2022. Copy of the press release is available on the company's investor relations website. Before I turn the call over to Chris and Scott, I would like to remind you that on this conference call, including both management's prepared remarks and the question and answer session, may contain projections or other forward-looking statements regarding, among other topics, Brainsway's anticipated future operating and financial performance, business plans and prospects, and expectations for its products and pipeline, which are all subject to risks and uncertainties, including shifting market conditions resulting from the COVID-19 pandemic, global supply chain crisis, as well as the use of non-GAAP financial information. Additional information regarding these and other risks are available in the company's earnings release and in its filings with the SEC, including the risk factor section contained in Brantway's Form 20F. With those remarks, it's my pleasure to turn the call over to Chris Vaniaco, CEO. Chris?

Thank you, Bob. Welcome, everyone, and thank you for joining us today. To begin, we recorded solid second quarter results in the face of headwinds caused by the macroeconomic challenges impacting existing and potential new customers. The company has made progress in Q2 with achievements on the commercial, clinical, regulatory, and reimbursement fronts. Now I'll provide a brief summary of our most recent accomplishments and an overview of our key second quarter financial results. Our second quarter revenue of $8 million represented both a 14% increase over the second quarter of 2021 in our eighth consecutive quarter with year-over-year growth. The demand for Deep TMS was driven by our treatments for depression, anxious depression, and OCD, reflecting a continued emerging balance in the business. In fact, as we did in the first quarter, we shipped nearly an equal number of H1 helmets for depression and H7 helmets for OCD during the second quarter. In addition, our international sales were very strong during the second quarter, though the sales mix was a slight detriment to price and gross margins. Our future international prospects were further boosted by the recent announcement that for the first time, the Israeli Ministry of Health has approved coverage which applies to our deep TMS system for the treatment of depression. The inclusion of the treatment within Israel's health basket of essential medical services means that the country's health funds must now make the treatment available to qualifying patients free of charge. From a reimbursement perspective in depression, two Medicare administrative contractors, or MACs, First Coast and Novitas, recently proposed policy updates to their local coverage terminations that would reduce the number of prior medication failures for deep TMS eligibility from four down to one. An additional proposed change would remove the requirement for patients to first undergo psychotherapy. The comment period for these proposals closed on July 23rd, 2022, after which time the Centers for Medicare and Medicaid will decide about the final policies. First Coast Coverage Area includes two million Medicare beneficiaries in Florida, Puerto Rico, and the US Virgin Islands. Novitas coverage includes over 8 million Medicare members in 12 states and regions, including Colorado, New Mexico, Texas, Oklahoma, Arizona, Louisiana, Mississippi, Pennsylvania, New Jersey, Maryland, Delaware, and Washington, DC. Brainsway is also pursuing strategic initiatives to increase market awareness of our technology as part of our market leadership theme. As we've discussed previously, our recently overhauled website has been enhanced for search engine optimization to make deep TMS therapy more visible for all in need. I'm pleased to report that our organic website traffic continues to grow significantly, increasing 50% in the second quarter of 2022, as compared to the second quarter of 2021. Moreover, May was Mental Health Awareness Month, and we successfully executed on several exciting initiatives, including our most successful online patient campaign to date, utilizing the hashtag, don't miss another moment. This featured deep TMS patients describing certain life experiences that they are now able to enjoy following treatments. Collectively, the goal of these initiatives is to reach any patient seeking an alternative to traditional medical management of their mental health. We believe that our increased website engagement and greater use of social media channels will ultimately lead to more patient engagement and awareness of our breakthrough technology. We have a number of other exciting market awareness-related initiatives planned for 2022 that we look forward to sharing with you in the coming months. We also participated in seven on-site medical meetings in and outside the U.S. during the second quarter, including the Clinical TMS Society, the American Psychiatric Association Annual Meeting, and the Annual Meeting of the International OCD Foundation. The current quarter will be another busy one in terms of on-site presence at medical meetings with a total number of six plans. I'll now turn to our progress on deep TMS for the treatment of OCD. As a reminder, Brain's Way is the first TMS device to have achieved FDA clearance for this hard to treat condition with the clearance received four years ago and maintains the important first to market advantage in this key indication. Furthermore, our clearance in this indication is based on our patented H7 helmet, which was specifically designed to reach certain targets within the brain and is the only TMS treatment to demonstrate clinical efficacy in a multicenter randomized placebo-controlled study. Moreover, I'd like to highlight a study that was recently published in the World Journal of Biological Psychiatry. The study conducted by the National Institute of Mental Health and Neurosciences in India was a comprehensive meta-analysis comparing the efficacy of all interventions for selective serotonin reuptake inhibitors, or more commonly known as SSRIs. The study reviewed SSRI-resistant OCD patients in 55 randomized clinical trials from around the world that involved 19 treatments in over 2000 patients. DTMS was determined to be the best treatment strategy for SSRI-resistant OCD. and the study concluded that DTMS could be considered a first-line intervention for these patients. During the second quarter, we shipped 31 add-on helmets for the OCD treatments, including a total number up to now 368. We are pleased that about 45% of our total installed base now includes OCD treatment capability. We view this as progress, as a testament of our customers' strong belief in the benefits of deep TMS treatment for OCD and within the broader context of our emerging reimbursement in this area. To this end, Highmark Blue Cross Blue Shield recently issued a positive coverage policy applicable to BrainsWay's deep TMS system for the treatment of OCD that was effective May 2, 2022. Highmark is the fourth largest Blue Cross Blue Shield health plan in the US and covers 6.8 million members in the states of New York, Pennsylvania, West Virginia, and Delaware. Highmark's parent company, Highmark Health, serves 40 million Americans in all 50 states. And Highmark Health Enterprise is the third largest integrated healthcare delivery system in the nation. This positive policy brings the total number of lives eligible for deep TMS coverage to nearly $70 million. Further expansion of OCD reimbursement is an ongoing focus for Brainsway. Also, as discussed in our last call, we launched a brand new and upgraded program to better support our customers with reimbursement. This new program enhances the support, resources, training, and materials available to Brainsway customers in order to facilitate their access to and increase the likelihood of broader OCD coverage. With that, I'd like now to provide a brief update on our commercialization plan for deep TMS and smoking addiction. As a reminder, this offering, the first of its kind in the medical device space, and our first addiction product, was launched in a phased rollout about a year ago. Our full market release was initiated earlier this year, and we're pleased with the progress to date, given the current absence of reimbursement. We are having steady success selling our smoking addiction products, and equally important, collecting real-world patient data supporting its efficacy that will ultimately be leveraged in our efforts to secure reimbursement. As I mentioned earlier, in the current macroeconomic environment, both our customers and patients are facing higher interest rates, inflationary concerns, and general recession concerns, which we believe impact the Q2 and is impacting our outlook for Q3 and Q4 of 2022. While this is understandably difficult to fully appreciate the moment, we still believe we are well-positioned for long-term commercial success with a strong balance sheet, and our team is determined to manage through this environment by making our selling efforts more effective and efficient while also controlling our costs. Finally, as always, I'd like to thank our valued partners and providers who battle the mental health crisis each and every day. as well as the entire Brainsway team for elevating their commitment to excellence and delivering our mission of boldly advancing neuroscience to improve health and transform lives. With that, I'll now pass the call to Scott for his review of our second quarter 2022 financial results. Scott.

Thank you, Chris. As Chris noted, the Brainsway team delivered a solid second quarter in the face of inflationary and recessionary headwinds. Revenue for the second quarter of 2022 was $8 million, a 14% increase compared to the prior period revenue of $7 million. Revenue growth in the second quarter was driven by increased demand for our deep TMS system with 39 system placements in the second quarter of 2022. Our installed base is now 829 systems as of June 30th, 2022, compared to 682 systems or 22% growth as compared to June 30, 2021. For the first half of 2022, revenues were $16 million, representing a $2.9 million, or 22% increase, compared to revenue of $13.1 million in the first half of 2021. Gross profit for the second quarter of 2022 was $5.8 million, or a 73% gross margin, compared to $5.7 million or 81% during the prior year period. The decrease in gross margin was largely attributable to expenses related to inventory obsolescence charges in the quarter, as well as increased shipping and inventory costs and a higher mix of international sales. We expect continued margin pressure in 2022 due to these factors. Gross profit for the first half of 2022 was approximately $11.9 million, or a 75% gross margin, compared to $10.4 million, or a 79% margin during the prior year period. Moving on to operating expenses. For the second quarter of 2022, research and development expenses were $1.7 million, essentially flat as compared to the second quarter of 2021. Sales and marketing expenses for the second quarter of 2022 were $4.6 million compared to $4.2 million for the second quarter of 2021. Moving on to G&A. Expenses for the second quarter of 2022 were $1.5 million compared to $1.4 million for the second quarter of 2021. Looking ahead, as the macroeconomic challenges Chris outlined earlier impact our operating environment, We intend to prudently manage expenses for the remainder of the year and expect to more modestly invest in our commercial and research activities to reflect current market dynamics. Operating loss for the second quarter was $2 million compared to an operating loss of $1.5 million for the same period in 2021. For the second quarter ended June 30, 2022, we incurred a net loss of $2.4 million compared to a net loss of $1.9 million in the same period of 2021. Moving on to the balance sheet, we ended the second quarter with cash, cash equivalents, and short-term deposits of $52.4 million, a decrease of $4.9 million as compared to December 31, 2021. We believe that our strong balance sheet and ongoing prudent management of expenses has positioned us well for the remainder of 2022 and beyond. While we continue to expand our sales and marketing efforts to drive additional adoption of our multi-indication deep TMS system, as well as invest in product development and clinical research to explore innovative new indications and markets for deep TMS to ensure our technology remains highly differentiated, we will do so mindful of the current economic climate. We are confident that this approach will support shareholder value now and into the future. This concludes our prepared marks. I will now ask the operator to please open up the call for questions. Operator?

Thank you, sir. Ladies and gentlemen, at this time, we will be conducting a question and answer session. If you would like to ask a question, please press start and 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and then two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. The first question we have is from Steve Lichman from Oppenheimer.

Thank you. Good morning. Good morning, Steve. Chris, I was wondering if you could talk a little bit more about the macro headwinds I guess specifically how you're seeing them impacting your customers and the sales side. Of course, we know on the margin side, but I was wondering specifically if you could talk more so on the revenue impact you're seeing from the macro headwinds.

Yeah, thanks, Steve. You know, I would say it's kind of similar to when we first started in COVID, when I first started with the company. We have a strong pipeline, I would say that, but some of the decision-making and moving forward, and it was more from not our current customers, but expanding customers, was kind of delayed, and it was kind of a wait-and-see approach. Obviously, we're continuing to increase our pipeline, which has been great over the past several years, but it's just getting those new customers to convert over in sort of the light of, you know, interest rates, inflation, and things like that. So I think, you know, I was asked this question, actually, on the last quarter, if we saw anything. And early in the quarter, we didn't. But as I've said many times before, most of our magic happens in the last three weeks of a quarter. So we had some sales that we had in the pipeline that essentially pushed.

Are you seeing any shift in interest toward toward more leases versus outright purchases as a result? Or is it really just delaying decisions in general?

So, you know, when I first came on, obviously we were doing quite a bit of leasing and some purchasing. And we, you know, we want to do what's best for the customer in the end. But I think to your point is, you know, we did see a little bit of shift. towards leasing. I mean, first of all, we ship the most systems we've ever shipped since I've been with the company, 39 in a quarter, which is great. And as I mentioned in my prepared remarks, obviously some of that, you know, we had a little bit more from an international side. So price went down a bit on that because we deal with distributors for the most part internationally.

Okay. Got it. On the On the updates to the two coverages, reducing the number of required prior medications, is that specifically in depression? Is that specifically for deep PMS? Would that be specifically for you guys?

No, it's for all PMS in general, right? The policies by Medicare, it's for all PMS. I think that, you know, as you know from prior quarters, We are actively speaking to, you know, all of Medicare MACs that are out there, as well as private insurers continuously always talking about OCD, presenting our OCD data. As part of that effort, we're also talking from a depression standpoint of trying to get people to move from four to one and remove some of the other burdens that are in the policies. So I'm really happy that these two Medicare MACs, as we've talked to them in the past, have made this you know, this policy. It's not finalized yet, but we're hoping it gets finalized. And it's just the ongoing trend that we've seen since 2019 and beyond of really relaxation for allowing, you know, the benefits of DTMS for these patients.

Great. And then lastly, Scott, you noted a couple of things on the P&L Any broad guidance you can give us in terms of what you do see for gross margin for the year and how OPEX may trend relative to Q2 as you indicated you're tightening the belt a bit?

Yes, Steve. So I think, you know, I alluded to margin pressure in Q2. You know, we're seeing, you know, some increased shipping costs, obviously transportation, things like that. um you know we internationally we tend to ship systems air freight so we've seen some real cost pressures there um and we're starting to see uh some cost pressures on the supply side and i would say not so much disruption but more just increased material costs starting to pass through to us so sort of you know you look at margin year to date i think uh margin year-to-date is probably more reflective of where I see margin in the back half of 2022. Got it.

Thanks, guys. Thanks, Steve.

Thank you. The next question we have is from Jason Bedford from Raymond James.

Morning, Jason.

Morning. Just a few questions and I'll kind of jump around a little bit, but just maybe to follow on the last line of questioning. Scott, you mentioned obsolescence impacting gross margin in 2Q. Will that not go away in the second half, or was the real pressure in the quarter on the GM side more from the geographic mix and the higher shipping costs?

Yeah, I would say the latter, that it's definitely... geographic mix and higher shipping and some inventory costs. Obviously, one-time inventory costs affect the P&L. Those are just things that happen sort of organically throughout the cycle. You can't predict when that's going to happen.

Okay. And then you've mentioned the strength internationally a couple times, just out of curiosity of the 39 H1 coils sold, how many were international?

So roughly about a quarter of the systems were international. So it's just a little bit stronger mix than in prior quarters.

Okay. And then just out of curiosity, I think it was 31 OCD coils, 39 H1 coils. Those folks who are not taking on OCD at the time they take on H1, what's the primary pushback there? Is it reimbursement or is it maybe it's the international? I'm not sure.

So it's probably it's a combination of international and then also remember when we expand systems into our current sites, if they already have an H7 helmet that's used for OCD, Perhaps they don't want another one because obviously the bigger driver continues to be depression within those customers.

Okay. Okay. And then last one, just an update on the sales, the size of the sales force.

Yeah. So at the end of the quarter, we had 17 regional territory managers that were in place with three regional managers. directors. And as I talked about before, our goal was to get up to 21. And, you know, I think a lot of people are talking about sort of like, in general, the, you know, the tight labor market and getting the talent. And as you know, we brought on Eric Hurt as our brand new vice president of sales in May. And so he's been working through that progress as we've been moving forward as well.

Okay. Thank you. Sure.

Thank you. The next question we have is from Jeffrey Cohen from Ladinburg, Poland.

Hi, Chris and Scott. How are you?

Hi, Jeff. Hi, Jeff. Good morning.

Just a few from our standpoint. So to follow up on a couple of Jason's questions, can you give us a sense of geographies, XUS, outside of Israel where you're sitting? some success and perhaps some future successes.

Yeah. So as you may remember from our last quarter, Hadar is now, you know, elevated to the chief operating officer and he, we were developing a plan towards the end of last year and going to this year to focus in specific areas. And I think that we've had success in the past, mainly I would say in Europe, and we're still having some success in Europe as well. And then we've tried to focus a little bit more on Asia Pacific as well. And I think that there's some few geographies in Asia Pacific like India and a few other places that have been very successful in sort of the short term and looking at the long term as well.

Okay, got it. Secondly, could you talk a little bit about H4 and any progress that you may be having with any of the payers out there?

So you're talking about smoking addiction, right?

Yes.

Yeah. So in essence, what we have planned for this year, similar plan as we did with OCD. You know, we got the clearance for OCD in 2019. We immediately began, you know, selling the product into the space without reimbursement. and we continue to have good progress in doing that and then sort of the next step is collecting data so we started collecting data real world data using that real world data very effectively and uh using you know utilizing that data in order to uh speak with payers so right now you know we're in this period we have this great pivotal study and now we're placing systems out into the market in collecting data so That data needs to be collected. It needs to be analyzed. It needs to be, you know, then obviously published at some point. So we're sort of in the data collection mode today.

Got it. And then lastly for us, any commentary from a macro standpoint on landscape of providers out there and perhaps some labor shortages out there and any effect or net change from some of the tuck-ins or I guess I'm referring to the success tuck-ins?

Oh, with success and Greenbrook, the combination of those two?

Is that what you're saying, Jeff? Sorry.

Yeah. Any kind of macro standpoint as far as what you're seeing for labor and psychiatry and roll-ups?

Yeah. I think that in general, we have seen within our customer base, obviously you mentioned success and Success TMS and Greenbrook, they just combined together just recently. They're obviously our biggest customer combined. They're our biggest customer that's out there. But in general, we've heard from them, you know, obviously equally on their call last week that they've had a tight labor market and it's sort of affected what they've done from a patient perspective. But we've heard equally from other of our customers that patients, you know, are looking at treatment and the treatment costs. As you know, some of these, depending on what their insurance plans are, they have co-pays and things like that. So I think it has affected, in general, patients out there and sort of the demand for the technology. Typically, you see a ramp-up in the Q2 with patients. We saw a little ramp-up in Q2 versus Q1 this year. So we know that sort of the macroeconomic effects are affecting in general the patient population as well. And then we've heard, we haven't heard so much from our customers on the tight labor market outside of, I would say, Greenbrook and Success TMS.

Perfect. Thanks for taking the questions. Thank you, Jeff.

Thank you. The next question we have is from from HC Wainwright.

Hello. Thank you very much for taking my questions. Firstly, I was wondering, in addition to kind of some of the other queries that have been asked about macro factors, are you seeing any ongoing impact from COVID-19 at this juncture? or has that more or less ceased to be a macro factor at this point?

Yeah, that's a great question. I think in general, we have seen it be a factor over the last couple of years, obviously, with our customers and their ability from a labor standpoint, their own personal labor standpoint, be able to treat patients at times when the providers have had people out with COVID. So I think that's sort of I think in general it's becoming sort of a routine and they've been able to overcome it. But from a standpoint of, you know, from a selling standpoint, I think it's becoming less of a factor and really the economic situation has become more of a factor.

Okay, that's very helpful.

I was also wondering if you could comment on the Greenbrook TMS success TMS combination. and what implications that have for DTMS and for Brainsway in general. Also, if you could comment on kind of whether or not the relationship between Brainsway and an entity like Greenbrook may be considered a template for future relationships with other TMS providers going forward, or if you're gonna expect to institute relationships that are meaningfully different.

Um, so I think I understand most of your question there, but if I, if I don't answer it, please, uh, please do a follow up for me. So in general, as I mentioned before success, uh, TMS was, it was a customer of Brainsways for a number of years before they, uh, uh, combined together with Greenbrook. Obviously Greenbrook has been a customer of ours for a while as well. Uh, they had bought, uh, both Achieve West and Achieve East, um, which were, 100% Brainsway customers at the time when they purchased them. I mean, I think we have a great relationship with Greenbrook. We work very closely with them. We're working closely with them all the time on clinical trials. We just finished up a clinical trial that they were part of. And we look forward to continued collaboration with them going into the future. You know, we consider them a very good partner for us moving into the future. And I think in general, Greenbrook has done that very nice job. And they're always looking at, you know, different, you know, TMS centers out there to acquire. And so happens to be the last three have been really big Brainsway customers. So I think it's a good testament to our customers and to our technology.

Thank you. That's very helpful, Culler.

Last one from me. When we look at the international markets for Brainswave systems, can you just give us a sense of the extent to which Israel may be differentiated from other international markets? And if there are any characteristics of the Israeli market in particular that might position it as one of the better international markets, international opportunities for Brainswave going forward?

Well, that's very easy to answer. You know, I think internationally, the biggest issue internationally is reimbursement, right? There's just not a lot of countries out there. There's not many countries that actually have reimbursement outside the U.S. and good reimbursement like the U.S. has. Israel now, after many, many years of working on it, has now put it into their basket for their health care. So if people actually fit the criteria. They're now eligible to get it for free within their health care plan, which is great. So this news just came out, obviously, in the past month or so. And as I mentioned, Hadar, now our chief operating officer, is really heading up our strategy from an OUS perspective. But in general, it's still a small market, right? Israel is still a small market. And one of the key things there is the From a healthcare perspective, it's just right now focused on the hospital setting. But we're looking forward to try to exploit that right now and going into the future.

Thank you. Thank you.

Thank you. The last question we have is from Jason, which is from Loop Capital.

Hi, thanks for taking the questions. Just maybe to revisit serum commentary about your customer discussions. I guess if I heard it right, you kind of characterize it as wait and see. I mean, what's your take on what obviously macro pressures are affecting them? Are they playing wait and see on what's going on with inflation or is this more of an extended sales cycle that you're looking at?

Yeah, I think it's probably a little of both, to be honest with you. You know, I think it's a wait and see. We had the same problem, obviously, when COVID came out in Q1 of 2020. And then, you know, it fell into 2020, Q2 of 2020 as well. And then we started to see growth again back in Q3. And then, you know, I mean, we still had pretty solid growth this quarter as well. But we saw the effects really as the quarter, towards the end of the quarter, in sort of the delaying of the decision to move forward, where we hadn't seen that at all in, you know, literally since probably Q2 of 2020.

Okay, thanks. It's helpful.

And then how should, you know, I assume we should anticipate these effects lingering into the second half of the year, right? I guess, you know, how does that play into revenue expectations and quarter cadence in terms of, you know, seasonality and things like that for the rest of the year?

Yeah, Jason, I think, you know, we're being cautiously optimistic here in terms of the back half. You know, I still think, as Chris alluded to, we have a decent pipeline here. but just given the macroeconomic environment, we're just trying to be cautious thinking about the back half.

Okay, and then this last question, maybe a clarification on, it sounds like you're making some progress on smoking cessation, and it sounds like you're building the groundwork for some reimbursement later on. I take it right now, most of what you see has been out of pocket from customers in terms of, you know, who's actually electing to do the therapy?

Yes, exactly. Obviously, it's out of pocket. There's no reimbursement at the moment. And we've done a lot of market analysis. I think I mentioned on the previous quarter call as well. But we've been working pretty closely with our customers. One customer in particular, we just actually, we just, I think, published just recently a really great video of a patient that smoked for, I don't know, over 20 years and had really great relief and had tried many, many times to quit before. And he's still not smoking today, which is great. So we're trying to publicize more around the technology and get it out there, obviously, with our customers.

But, yes, today it's still a cash pay. Great. I'll jump back into you. All right. Thanks, Jason.

Thank you, Celeste. Ladies and gentlemen, we have reached the end of our question and answer session, and I would like to turn the call back to Chris Fonyaku for closing remarks.

Thank you so much. I'd like to thank all the investors, the analysts, and other participants for their interest in Brainsway. And with that, please enjoy the rest of your day. Thank you.

Thank you, sir. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your lines.