BrainsWay Ltd.

Greetings and welcome to BrainsWay fourth quarter and full year 2022 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Brian Ritchie, with LifeSci Advisors. Thank you. You may begin.

Thank you all, and welcome to BrainsWay's fourth quarter and full year 2022 earnings conference call. With us today are BrainsWay's Chief Executive Officer, Hadar Levy, and Chief Financial Officer, Scott Arreglato. The format for today's call will be a discussion of recent trends and business updates from Hadar, followed by a detailed discussion of the financials from Scott. Then we will open up the call for your questions. Earlier today, Rain's Way release financial results for the three and 12 months ended December 31st, 2022. A copy of the press release is available on the company's investor relations website. Before I turn the call over to Hadar and Scott, 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, among other topics, Rainsway'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, the global supply chain crisis, as well as the use of non-GAAP plans. Additional information regarding these and other risks are available in the company's earnings release and in its other filings with the SEC, including the risk factors section contained in BrainsWays Form 20F. I would now like to turn the call over to Hadar.

Thank you, Brian. Welcome, everyone, and thank you for joining us today. I am thrilled to be leading my first joining conference call as BrainsWays CEO. As I have previously served as the company's Senior Vice President and Chief Operating Officer and Chief Financial Officer, and GM of North America before that, I've had the opportunity to interact with many of you over the years. However, for those of you who do not know me, please allow me to briefly introduce myself. I've been a member of Brainsway's senior leadership team since 2014, and during this time, I've been deeply involved in the sales, financial, and operational aspects of our business. I look forward to leveraging my broad expertise and extensive experience to capture the significant growth opportunities that lay ahead for this great company. And I'm excited to work closely with our board of directors, outstanding executive leadership team, and all of our dedicated employees to strategically grow our business and position Brainsway as a global leader in the TMS industry. I would also like to take this opportunity to welcome Ami Bam, who was recently appointed chairman of the board. and succeed Dr. David Zakut, co-founder of Brainsway, who will now serve as a director on the board. Ami is an experienced and well-respected leader in capital market and advising in multiple global industries. I'm also pleased to continue working with David, whose strategic insight has supported Brainsway's evolution from an R&D startup to a world-class commercial company, offering the industry's leading TMS technology and solutions. Moving on, I will let Scott provide you with the key details of our financial performance in the fourth quarter and full year 2022. While I will share with you some of the strategic vision that we have developed to grow our business, as well as many tailwinds that we see positively impacting our company. Please note, over time, we look forward to sharing further aspects of this strategic vision with you. For the time being, though, For competitive purposes, it is important that we deliberate in communicating our plan for long-term success. I will also review some of our key recent achievement before turning the call over to Scott. Since assuming the role of CEO earlier this year, I have focused on implementing key initiatives aimed at growing the company's top line while simultaneously advancing toward profitability. I'd like to take a moment to briefly review some of these key initiatives. First, we continue to optimize our existing commercial process. Of course, this begins with building a best-in-class commercial team. We remain focused on hiring the right type of salespeople. In addition, we continue to enhance our emphasis on larger institutional and enterprise customers that are playing an increasingly important role within the industry. Our goal is to add deep TMS technology into this expanding large mental health group or networks. I'm pleased to report that our pipeline of these types of opportunities is steadily growing. To this end, we expect our US business to resume momentum beginning in the first quarter and anticipate that this progress will continue throughout 2023. Our core messaging will continue to focus on superior science, evidence, and support, as well as flexible pricing. The power of this messaging is evidenced by the continued momentum in our international business. From financial perspective, we are executing certain measures to optimize our cost structure. We expect to see the result of this cost reduction effort beginning in the second half of this year. Specifically, we are re-evaluating our R&D strategy and reprioritizing the allocation of our R&D resources. As we move forward, we will show some of the new exciting clinical development focus area for us. We also intend to reprioritize our commercial investment with less a focus on digital marketing than previously seen. Importantly, our other impactful sales initiative will continue aggressively. Our goal with this cost structure modification is to target break even operating income in the fourth quarter of 2023 while demonstrating fully revenue growth over 2022. In addition, we intend to be opportunistic on the business development front with respect to collaborating with certain mental health clinic where doing so might allow us to expand faster and deliver more value. As specific opportunities present themselves here in the coming months, we'll share further details on what an attractive partnership might look like for us. I'd now like to pivot to some of our recent accomplishments. On the reimbursement front, a major private insurance company in Washington State recently extended positive coverage applicable to Deep TMS for treatment of OCD. This policy extension provided coverage of Deep TMS for OCD to approximately 2.2 million members. We now have over 90 million covered life for the OCD indication. Moreover, nearly 50% of our total install base now include OCD treatment capability. We view this progress not only as a key indicator of our customers' strong belief in the benefit of deep TMS treatment for OCD, but also our growing success in securing reimbursement in this important indication, which is critical tailwind for our business. The policy change also reduced MDD TMS coverage criteria from four failed medication trials to only two. We also continue to build clinical evidence in support of deep TMS for use in multiple indication. Most recently, a comparative study of our deep TMS H1 coil, which target the lateral prefrontal cortex, and our H7 coil, which target the medial prefrontal cortex, was published in the Journal of Clinical Investigation Insights. The study validated the efficacy of both brain sway coils for depression and also identified preliminary predictors that could help optimize treatment based on individual patients' attributes. We view this study as an important scientific step forward toward personalized psychiatry and are conducting additional research to evaluate which target is better for which depression patients. Further evidence of the power of our science came recently when Brainsway named two fast companies prestige annual list of the world's most innovative companies for 2023. The world's most innovative companies list is fast company signature franchise and one of its most highly anticipated editorial effort of the year. We are proud of this important acknowledgement. Before I turn the call over to Scott, I would like to express our confidence in our outlook for 2023. To reiterate, we expect to demonstrate revenue growth over 2022 and are targeting break-even operating income in the fourth quarter of 2023. Importantly, TMS remained a large market with strong momentum and there is ample room from Brainsway to capture meaningful market share, both in the U.S. and internationally. Finally, as always, we would like to thank our valued partners and providers who battle the mental health crisis each and every day, as well as to the entire Brainsway team for elevating their commitment to excellence in delivering on our mission of boldly advancing neuroscience to improve health and transform lives. With that, I will now pass the call to Scott for his review of our fourth quarter and full year 2022 financial results. Scott?

Thank you, Hadar, and good morning, everyone. Revenue for the fourth quarter of 2022 was $6 million, a 29% decrease compared to the prior year period revenue of $8.5 million. Total revenue in the fourth quarter was impacted by the inability to recognize approximately $1 million of lease revenue due to the deteriorating financial condition of one of our customers. We expect that their condition may impact our 2023 recurring revenue as well. However, the momentum in direct sales in both the US and internationally was not impacted by this customer. We placed 33 deep TMS systems in the fourth quarter and continued to experience strong international momentum, a sustainable trend for us. Our total installed base is now 884 systems as of December 31st, 2022, compared to 754 systems or 17% growth as compared to December 31st, 2021. For the full 12 months of 2022, revenues were $27.2 million, minimally lower as compared to full-year revenue of $29.7 million in 2021. Gross profit for the fourth quarter of 2022 was $5.2 million or a 75% gross margin compared to $6.6 million or a 78% gross margin during the prior year period. The decrease in gross margin was largely attributable to revenue mix as well as expenses related to inventory obsolescence charge and increased shipping and inventory costs versus the prior year. Gross profit for the full 12 months of 2022 was approximately $20.9 million, or a 75% gross margin, compared to $23.1 million, or a 78% gross margin, during the prior year period. Moving on to operating expenses, for the fourth quarter of 2022, research and development expenses were $4.8 million, compared to $4.5 million in the fourth quarter of 2021. Sales and marketing expenses for the fourth quarter of 2022 were $2.2 million compared to $2 million for the fourth quarter of 2021. Moving on to G&A, expenses for fourth quarter of 2022 were $1.7 million compared to $1.5 million for the fourth quarter of 2021. With respect to expenses in 2023, we expect costs to moderately decrease as compared to 2022. As Hadar noted, we are more strategically and prudently investing in our commercial and research activities. Operating loss for the fourth quarter was $3.4 million compared to an operating loss of $1.5 million for the same period in 2021. For the fourth quarter ended December 31st, 2022, we incurred a net loss of $3 million compared to a net loss of $1.1 million in the same period of 2021. Moving to the balance sheet, we ended the fourth quarter with cash, cash equivalents, and short-term deposits of $47.9 million, as compared to $57.3 million at December 31, 2021. Based on our robust U.S. pipeline and continued momentum internationally, we are confident in our positive outlook for 2023. To reiterate what Hadar said, we anticipate annual revenue growth over last year and to show improvements in cost containment over 2022. This concludes our prepared remarks. I will now ask the operator to open the call for questions. Operator?

Thank you. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd 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 keys. Our first question comes from the line of Steve Lichtman with Oppenheimer. Please proceed with your question.

Thank you. Morning, guys. Hi, Steve. Hadar. Hadar, hi. I know it's only been a little bit since you've been in the CEO role. You alluded to some things during your prepared remarks, but I wonder if you could talk a little bit more about some of the changes, perhaps, under your leadership as CEO that you would look to institute.

Oh, hi, Steve. Good morning. Thank you for the question. You know, as I said earlier, you know, we have taken some action those far in order to reduce some of our costs. And I believe the main goal for us for this year is to continue to grow year over year. And we are targeting breakeven operating income in the fourth quarter of 2023. So, you know, I think that the market is big enough, is massive, and I think that with the necessary changes and reduction that we already performed, we'll see some pretty good results by the end of the year.

And relative to your focus on some of the larger customers, the enterprise customers, I know this is something you all talked about on the last earnings call. Can you give us an update there in terms of progress in that opportunity and how big the opportunity you think is that's sort of left untapped?

Yeah, sure. So, you know, I believe that we do anticipate a growth coming from existing customers and and some of them are new customers, and specifically some of those network. I think the ratio today is around 50-50, which demonstrates the strength and the balance of our business. However, what we have learned is that, you know, we know how to grow some of our networks with our practice development team, and we see them growing. They continue to grow. demand for more and more deep TMS technology. We're helping them to grow from all the purposes, you know, starting from, you know, patient flow. It can be also providing them the right training, how to build a successful clinic. So we are highly going to continue and focus on building a successful practice with our customers, current customers and new customers.

Got it. Okay. And then maybe lastly for me, and I'll jump back in, on the one customer you mentioned that impacted lease revenue, I guess a few questions. One, was that an issue in 3Q? Because if not, it looks like the sequential, if you X that out, was a little bit better. But then two, can you talk a little bit more about this customer? It sounds like it was a large customer, given the percent of total revenue and Any assistance that can be provided to the customer such that the impact would be mitigated as you go through this year?

Yeah. Hi, Steve. So the impact to our revenue was really contained in the fourth quarter for the deteriorating financial condition that occurred recently. It is one of our largest customers on a recurring revenue basis. You know, we've taken steps in our plan to mitigate the impact of, you know, potential financial condition in 2023. So we've already sort of built that into our plan, knowing that that may be a risk. Does that answer your question?

Yeah. And so the million dollars, was that sort of a cumulative effect?

That was just for the quarter.

Okay. Okay. Understood. I'll let others jump in. Thanks.

Thank you. Our next question comes from the line of Jeffrey Cohen with Lautenberg-Solomon. Please proceed with your question.

Oh, hi, Hadar and Scott. How are you?

Hi, Jeff. Hi, Jeff.

Good morning. So a few questions from Aaron. It looks like Q4 you placed more systems than we were modeling. So should we assume that the vast majority of Q4 was lease arrangements versus purchases or other structures?

Go ahead. Revenue in the fourth quarter was primarily direct sales or what we call capital sales. As I mentioned, we actually had a reduction in lease revenue because of the financial condition of one of our customers. It also has to do with revenue mix because we've been selling internationally as well and we're starting to see some momentum there.

If

If I can add on this, Jeff, we see the pipeline growing. Yes, we have a very nice large of demands of our system, of our technology. I think that, you know, Brent will remain flexible in their pricing model. So we, you know, we're aiming to put this technology out there for every patient that needs it or every customer that needs it. So we'll continue to see and we continue to see this pipeline growing, specifically also toward 2023. And I believe that the main change that you see right now in Q4 was mainly because of the reduction of revenue for this specific customer.

Okay, got it. Could you talk a little bit about any charges from Q4 related to, uh, leadership changes where there's specific charges in the fourth quarter, or we should anticipate seeing those in Q1.

Yeah. All of those, all of those changes will be, uh, uh, will be accumulated in Q1.

Okay. Got it. And, um, Hadar, maybe could you talk a little bit about the payer environment on the OCD side over the past quarter?

So, you know, there is always improvement on the pairs on the OCD side. We continue to see more and more pairs adopting this very essential treatment. and we remain very positive that this number of PERS will continue to grow. We are now covering 90 million people in the U.S., and we're sticking with most, if not all, the PERS, and I do anticipate some additional growth with the number of PERS that are going to cover the OCD.

Okay, God. And then lastly for us, as far as structural changes anticipated for 23, it's sounding like you're expecting those most predominantly within the commercial organization. Is that accurate? And could you expand upon that, please?

So I think we know, I think we are pretty familiar with some of the barriers, and I think that we have the right mitigation for that. Again, I remained very, very... optimistic about the market potential, about our ability to grow. We are hiring the right salespeople that are going to help us to execute our plans. No dramatic change on the forefront of our sales team. We just need to be much more focused, target the right audience, and come up with the right messaging And we know, listen, we have a superior science and we have a superior product, so I don't see any reason why we won't continue to grow with the current sales team. And we're just getting, I believe, that we have the right sales team in place right now. And, again, I'm really, really optimistic about this year.

Perfect. Okay. Fedora, Scott, thanks for taking our questions.

Thank you, Jeff.

Thanks, Jeff.

Thank you. Ladies and gentlemen, as a reminder, if you'd like to join the question queue, please press star 1 on your telephone keypad. Our next question comes from the line of Bubalan Pachayapan with HC Wainwright. Please proceed with your question.

Hi, Hadar and Scott. This is Bubalan. Can you hear me? Yes.

Yes.

Hi, Bubalan. All right. Great. A few questions from us. Scott, maybe firstly, can you comment on your cash runway?

Sure. I mean, we have almost $48 million of cash. I think, as Hadar mentioned, we're targeting to get to break-even operating income by the end of the fourth quarter. So I think we're taking steps to mitigate and slow down our cash burn. I believe we certainly have plenty of runway here.

Okay, thank you for that. And then I want to get your thoughts on healthcare policy update from National Government Services. So essentially, we should allow non- physician practitioners to order and provide TMS treatment to patients with major depressive disorder. So can you clarify whether this update is applicable to deep TMS users as well?

Sorry, can you repeat that question? I'm not sure I followed you.

Okay. So there is this healthcare policy update from national government services, which essentially will allow non-physician practitioners, like nurse practitioners, to order and provide.

Yeah, listen. As I said, you know, we see lots of tailwinds to approve this treatment outside of the psychiatry field. We see more and more... PERS that are approving this treatment also for nurse practitioners. And I believe this momentum will continue. That's part of our strong belief on the market potential. It's definitely, you know, one momentum just to grow and continue to increase, first of all, not just the pipeline and the target market for us, but also you know, increase the top-line revenue growth based on that.

Okay. And one final question from me. Speaking of targeting breakeven operating income in the fourth quarter of 2023, so what are your assumptions and key risks associated with this?

So we're taking very, you know, I believe that we're going to probably slow down some of our projects on our R&D. This is something that we know how to do in a pretty good way. We're also going to be much more focused on our marketing initiatives. Like most companies, we look at the ROI of our various marketing efforts, and we're trying to optimize for the ones that yield the best return for us. I believe that we can we can do some better job, and we will do a better job about reducing some of those costs, but without really damaging our potential growth in 2023. So again, I believe that, and I said it before, we already took those necessary measures in order to reduce this cost, and I'm expecting to see the outcome in the second half of 2023. All right.

Thanks for taking our questions.

Thank you.

Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Mr. Levy for any final comments.

Thank you. I would like to thank you all of the investors, analysts, and other participants for their interest in Brainsway. With that, please enjoy the rest of your day.

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.