BrainsWay Ltd.

Greetings and welcome to BrainsWay fourth quarter and full year 2021 earnings conference 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, Bob Yedit of LifeSci Advisors. Please go ahead.

Thank you, Brock, and thank you all, and welcome to BrainsWay's fourth quarter and full year 2021 earnings conference call. With us today are BrainsWay's President and Chief Executive Officer, Christopher Vaniaco, 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 this morning, Friendsway released financial results for the three months and 12 months ended December 31, 2021. A 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'd like to remind you that this conference call, including both management's prepared remarks and the Q&A session, may contain projections or other forward-looking statements regarding, among other topics, brands' ways 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 financial information. Additional information regarding these and other risks are available in the company's earnings release and its other filings with the SEC, including the risk factors section contained in Bransway's Form 20-F. With those prepared remarks, it's my pleasure to turn the call over to Christopher Bagnaco, CEO. Chris?

Thank you, Bob. Welcome, everyone, and thank you for joining us today. We're extremely pleased with the continued strong momentum throughout our business. We expect that the current positive operating trends that drove our robust performance in 2021, highlighted by achievements on the commercial, clinical, regulatory, and reimbursement fronts, will lead to further growth for Brainsway in 2022 and beyond. While I will review our future prospects in greater detail shortly, First, I will provide a brief summary of our full year 2021 accomplishments and an overview of our key fourth quarter financial results. In 2021, we overcame a number of challenges, primarily driven by COVID and the overall operating environment and continued advancing our business. We achieved year over year growth in each quarter during 2021, and have now demonstrated year-over-year growth in six consecutive quarters. Our full year 2020 run revenue of $29.7 million represents growth of 34% over 2020. From a regulatory perspective, we were proud to receive two significant FDA clearances during 2021 and three over the past 18 months. Other key commercial highlights in 2021 included the expansion of our sales force from 12 to 18 professionals and the successful launch of our deep TMS system in anxious depression and smoking addiction. Our substantial reimbursement accomplishments included establishing positive payer coverage policies in 2021 for OCD. with the number of covered lives at approximately 50 million, a number that recently increased even further. This is a topic that we'll cover shortly. Looking at the fourth quarter specifically, demand for our deep TMS system remains strong in multiple indications, despite various challenges posed by Omicron to many industries, including ours. Importantly, this demand was driven by both depression and anxious depression, as well as OCD. We generated $8.5 million in revenue for the fourth quarter of 2021, which represents both a quarterly record and a substantial 20% increase over our fourth quarter 2020. With that, I'd like to discuss our key, our 2022 key priorities with plan to carry that out within the broader context of the five-year plan which we began executing in 2021. A strategic plan is based on four core pillars. The first of these pillars is becoming the market leader in the non-invasive brain stimulation market. Brains with strong revenue growth in 2021 demonstrates that we are leading the way and we are taking steps that we believe will allow us to continue this trend. To achieve this revenue growth, we have assembled a best-in-class commercial team. In 2022, we are building out our infrastructure by going from two regions with 18 territory sales managers to three regions with 21 territory sales managers. Collectively, these sales professionals are focused on broadening our US customer base. Our territory sales managers are complemented and supported by skilled teams of practice development consultants and field clinical engineers. These highly knowledgeable professionals have in the past and will continue to be laser focused on achieving customer success, cultivating our expanding customer base, and delivering on our overall mandate to provide superior support to our customers. The expansions in the commercial team are made possible by our strong balance sheet, differentiated deep TMS technology, expanding number of indications, and superior clinical evidence. Another aspect of the strategic pillar is increasing market awareness, which will remain a key priority for us in 2022. 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 increased substantially in 2021 as compared to 2022, up 93% year over year. Our new website chat robot aptly named H-Coil logged 13,000 engagements with individuals from September through December 2021. Importantly, Approximately 10% of these online chats led to live discussions, many with prospective patients. Moreover, a meaningful number of sales meetings with psychiatrists and clinics have also been booked via this new innovative tool. You may recall our recent patient awareness initiatives included posting a patient story each week via our social media channels. Each patient detailed their experience with DTMS. and we held a live moderated Q&A session for prospective interested patients in the fourth quarter. We also continued to develop patient testimonials through the usage of mobile apps, and these stories are being used as a strong advocacy tool by our clinics to help promote their practices. 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 increased website engagement and greater use of social media channels will ultimately lead to more patient engagement and awareness of our breakthrough technology. We also 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. Where and whenever possible, we continue to leverage critical in-person interactions. As was the case with many other companies, our sales professionals in-person access to customers was impacted by Omicron in the fourth quarter, making our strong performance during the period that much more impressive. Our return to live in-person conferences, which began in the second quarter, continued this past quarter as well. In December, Professor Abraham Zangen of Ben-Gurion University and a scientific consultant for the company recently spoke about addiction, including the results of our alcohol and smoking addiction studies at the Fourth International Brain Stimulation Conference in Charleston, South Carolina. Also at this conference, we displayed a future version of the platform that will serve as the basis for our fourth generation deep CMS system. And we hosted a key opinion event with several leading industry psychiatrists and researchers. I'll now turn to the progress of DTMS for the treatment of OCD, which is another aspect of our first strategic pillar. As a reminder, Brainsway is the first TMS company to achieve FDA clearance for this hard-to-treat condition and remains the only TMS company to have received this clearance based on pivotal sham-controlled data conducted on its own device. During the fourth quarter, we shipped 22 add-on helmets for OCD, increasing the total number to 302. We're pleased that 40% of our total install base now includes OCD treatment capability. We view this progress as a testament to 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. Most recently, in January, of this year, we received a final local coverage determination providing coverage applicable to DTMS for the treatment of OCD. The final LCD was issued by Palmetto, a Medicare Administrative Contractor, or MAC, which covers 9 million Medicare patients in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia. The formal policy issued by Palmetto, one of seven MACs in the U.S., brings the total number of covered lives now eligible for OCD coverage to approximately 60 million. The Palmetto LCD also positively impacted those using deep TMS to treat depression and anxious depression by moving from a requirement of four failed medications to two failed medications. Further expansion of OCD reimbursement is an ongoing area of focus for Brain's Way. The collective OCD developments achieved to date, both in terms of customer adoption and reimbursement, are indicative of the significant traction we're seeing with this key indication. In order to further accelerate customer adoption and additional reimbursement progress, we continue to publish compelling data in support of the use of deep TMS and OCD. To this end, we were excited to have an important research data recently published in two leading peer-reviewed journals highlighting the durability and the cost effectiveness of DTMS and OCD. First, a study published in Brain Stimulation shows the durability of DTMS and the significant reduction in functional disability. Secondly, positive data recently published in the Journal of Psychiatric Research supports the cost effectiveness of DTMS relative to other available OCD treatment options. Moving on, the second key pillar in our strategic plan is to lead through superior science and evidence. To further advance on this front, we added two highly experienced individuals to our scientific advisory board over the past five months. Professors Jeff Deskalakis and Marcus Heilig Professor Deskalakis is a chair of the Department of Psychiatry at UCSD School of Medicine. His research is focused on developing a better understanding of neurophysiology of severe psychiatric disorders and the role of brain stimulation in treating these conditions. Professor Deskalakis has authored more than 450 peer-reviewed publications and serves on the editorial board of multiple journals. Professor Heilig is the founding director of the Center for Social and Effective Neuroscience of Linköping University in Sweden. His center focuses on the study of brain mechanisms behind addiction and anxiety disorders using translational approaches. Notably, from 2004 to 2015, Professor Heilig served as the director of clinical and translational research at the National Institute on Alcohol Abuse and Alcoholism, a division of the U.S. National Institutes of Health. We also completed multiple important feasibility studies in 2021, including one in adults with alcohol use disorder. This randomized placebo-controlled double-blind clinical trial in 46 subjects measured the reduction in the percentage of heavy drinking days over a 12-week period after deep TMS treatment. While subjects receiving a placebo treatment averaged 10.9 heavy drinking days during the follow-up period, subjects who had undergone a deep TMS therapy averaged only 2.9% of heavy drinking days. This is a clinically meaningful and statistically significant difference. We intend on continuing our real-world data collection efforts in all of our major indications, including depression, anxious depression, OCD, and smoking, with a focus on publications and presentations at key industry conferences. In addition, we also plan to initiate several new feasibility studies in 2022 in certain psychiatric, neurologic, and addiction indications. Finally, from an IP perspective, several new important patents for deep TMS were issued in 2021. We now have nearly 80 issued patents that extend protection on our technologies for up to another 10 years. The third and fourth pillars of our strategy are capitalizing on our platform and enhancing business development activities. These are both critical long-term drivers for us. While we prefer not to get into too much detail on these matters, I will generally reiterate Brainsway's ongoing commitment to continue pursuing new indications and new market opportunities in both the U.S. and internationally in a way that maximizes value for our stakeholders. With that, I'd like to now provide a brief update on a commercialization plan for the DTMS for 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. We pursued this strategy in order to further cultivate our messaging, develop optimized business models for customers, refine ideal addressable populations, and build post-marketing data to develop a reimbursement strategy. We previously completed the first phase, which was a controlled market release, and more recently concluded our limited market release. We now have data on numerous commercial patients in our database. During the fourth quarter, we successfully held our second users group meeting to share best practices among practitioners. And our existing customer base has received materials educating them on how to integrate this offering within their practice. We recently transitioned to a full market release and we are looking forward to sharing additional details and updates with you in the future. I would also add that smoking trends are unfortunately rising, which underscores the need for smokers to have additional treatment options and may increase demand for smoking addiction treatment. Accordingly to a study published in October of 2021, cigarette sales across the country were up more than 14% from March 2020 to June 2021. This is in contrast to the long-term declining trend in cigarette sales from January 2007 to February 2020. While the need for solutions to address this addiction is thus clear, our ultimate commercial success in this market will be, of course, influenced by insurance landscape. And as you know, coverage does not yet exist for DTMS for smoking addiction. To facilitate our efforts in this regard, we're planning on conducting post-marketing research and data collection efforts in 2022. which we believe will serve us well in our commercialization efforts. Turning to investor relations. Following our well-attended KOL event for investors and analysts in the third quarter, which highlighted the OCD indication, we will be hosting another KOL event on March 22nd. This virtual event will feature Dr. Sean Siddiqui, a neuropsychiatrist at the Brigham Women's Hospital and instructor of psychiatry at Harvard Medical School. He will discuss the clinical and market importance of the recent expansion of our depression labeling to include anxious depression. We also presented at several healthcare investment conferences in recent months and conducted multiple institutional and high net worth focused virtual non-deal roadshows. Our proactive investor marketing efforts will continue throughout 2022. Finally, and as always, I would 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 in delivering on our mission of advancing neuroscience to improve health and transform lives. With that, I will pass the call to Scott for his review of our fourth quarter and full year 2021 financial results. Scott.

Thank you, Chris, and good morning, everyone. As Chris noted, the Brainsway team delivered a record fourth quarter and full year of revenue growth. Revenue for the fourth quarter of 2021 was $8.5 million, a strong 20% increase compared to the prior year quarter revenue of $7.1 million and an increase of $0.4 million on a sequential basis versus the third quarter of 2021. Revenue for fiscal year 2021 was 29.7 million, an increase of 34% when compared to the total revenue of 22.1 million for 2020. Revenue growth in the fourth quarter and for fiscal year 2021 was driven by increased demand for our Brainsway Deep TMS system with 37 system placements in the fourth quarter of 2021. This increases our install base to 754 systems as of December 31st, 21 as compared to 629 systems or 20% growth versus year end 2020. Gross profit for the fourth quarter of 2021 was $1.9 million or 77% compared to $1.6 million or 78% during the prior year period. Gross margin for fiscal year 2021 was $6.6 million or 78% as compared to $5.1 million, or 77% for fiscal year 2020. Moving on to operating expenses. For the fourth quarter of 2021, research and development expenses were $2 million as compared to $1.6 million in the fourth quarter of 2020. Research and development expenses for the full year 2021 were $6.4 million as compared to $5.8 million in 2020. Sales and marketing expenses for the fourth quarter of 2021 were $4.5 million compared to $3 million for the fourth quarter of 2020. Sales and marketing expenses for full year 2021 were $15.9 million compared to $11.3 million in 2020. This increase reflects our continued investment in our digital marketing activities and our sales team to drive future growth. We have also invested in additional clinical and field support personnel guided by our mission of superior support. Moving on to G&A, expenses for the fourth quarter of 2021 were $1.5 million compared to $1.3 million for the fourth quarter of 2020 and $5.8 million for the full year of 21 as compared to $4.7 million in 2020. Total operating expenses were $8 million for the fourth quarter of 2021 compared to $5.9 million for the same period of 2020. Total operating expenses for 21 totaled $28.1 million as compared to $21.8 million in the prior year period. As I mentioned last quarter, the increase in operating expenses on a year-over-year basis is partially reflective of cash preservation efforts to mitigate the effects of the pandemic in 2020 as well as the increased investments I have highlighted above. Looking ahead, we continue to invest in our commercial and research activities and expect our operating expenses to reflect these additional levels of investment. Operating loss for the fourth quarter was $1.5 million compared to an operating loss of $407,000 for the same period in 2020. Operating loss for 2021 totaled $5 million as compared to $4.8 million in 2020. So the fourth quarter ended December 31, 2021. We incurred a net loss of $1.3 million, compared to a net loss of $406,000 in the same period of 2020. For the full year of 2021, net loss was $6.5 million, as compared to a net loss of $5.4 million in the prior year. Moving on to the balance sheet. We ended the year with cash, cash equivalents, and short-term deposits of $57.3 million, an increase of $2 million as compared to Q3 2021. Cash at December 31, 2020 was $24.3 million. We believe that our strong balance sheet and prudent management of expenses in 21 have positioned us well for 2022. We will 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 for deep TMS to keep our technology differentiated. We are confident that these initiatives and investments will support long-term shareholder value. This concludes our prepared remarks. I will now ask the operator to please open up the call for questions. Operator?

Thank you. At this time, we'll 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 the question queue. You may press star 2 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 keys. One moment, please, while we pull for questions. Our first question today is from Jeffrey Cohen of Leidenberg Thalmann. Please proceed with your question.

Hi, Chris and Scott. How are you?

Good morning, Jeff. Good morning. Great, thanks.

Congratulations on the quarter and the year. Two questions, I think. Firstly, from a scientific standpoint, wanted to get your opinion or information related to alcohol abuse as it compares to smoking cessation. So you're using the H4 coil for smoking addiction and the data from December was using the H7 coil for alcohol abuse. How are you thinking about the difference both technically as well as mentally?

Yeah, Jeff, thanks for that question. Appreciate it. So you're right. So the H4 actually targets the bilateral insula where the H7 targets the ACC, which is the same area that we're targeting for OCD. So I think we've looked at it from an H4 perspective and some of the early trials that we did, and then we were excited to run this Another early feasibility trial with the H7 with great results. So we're really excited about this in another addiction space.

So going forward, how should we think about the equipment related to the addiction space as far as H7 versus H4?

Yeah, so I think I pointed it out before on calls and maybe sometime even in my investor decks in the past. There are certain places where we feel the H7 works. certain addictions as well as OCD. And then for smoking and some other areas, uh, potentially like, um, food addiction would be the H4. So it's certainly, you know, there's just different areas of the brain, uh, that we're focused on with our, with our deep TMS technology.

Okay. Perfect. God. And then, uh, secondly for us, how should we think about growth in 2022? I know that you don't have any, uh, outlook, but I think consensus down in the mid-teens, let's call it, and year 21 was a 34% growth on the top line. So how do we try to rationalize that going forward?

Yeah, Jeff, it's a great question. Thank you. So, you know, I think, you know, looking at 21 and the growth rates over 2020, obviously 2020 was pandemic-induced, but I do think You know, we're still expecting and thinking and modeling for our business and our plans for 2022, you know, modeling strong double-digit growth.

Yes, sorry, modeling strong double-digit growth in 2022. But, Jeff, we're still not giving guidance, right?

Okay. Perfect. Thanks for taking our questions.

Thanks, Jeff. Appreciate it.

The next question is from Jason Bedford of Raymond James. Please proceed with your question.

Hi, good morning. Just maybe to follow on the last question, you alluded to the impact of Omicron in the fourth quarter. Can you just talk about the current conditions today that you're seeing in the market versus what you saw back in December and maybe some comment on the backlog exiting the fourth quarter?

Yeah, Jason, great question. So, you know, we obviously in December and November saw, you know, some of the in-person meetings with our sales folks kind of declined. And interestingly enough, though, looking at the patients, we heard obviously from the field that there was some declines in the patients, either patients getting COVID or the treaters, you know, the providers getting COVID. but we didn't see a decline at all in our patient volume in the back half there. So actually November and December were our highest months of treatments that we saw. And then, of course, things were a little slower in January, and I think we're starting now to see a pickup of our sales professionals be able to get in front of people again. So I think things are clearing up, and we're very excited about the prospect of moving into the future here.

In the backlog, Chris? The backlog related to what specifically? Oh, sorry, orders, order flow.

So from an order perspective, yeah, from an order perspective, all the orders that we got in Q4, we shipped in Q4. So we had no backlog. I don't know if you're alluding to maybe, you know, supply chain issues.

We haven't had any supply chain issues either. We've been managing those. Okay.

Just in terms of OCD, can I assume that the vast majority of OCD helmets went with new systems and just it looked like it was down a little bit from 3Q. Can we assume that this was part Omicron related or was 3Q a bit of an anomaly or are folks just waiting for reimbursions?

I think definitely Q3 was an exciting time for the H7 helmet, specifically for OCD. I think we still had, what, roughly about 60% or maybe over 60%, Scott, of our systems that got shipped. They were all with new systems, by the way, like you mentioned. And we had a few international sales also in Q4 that didn't go with the H7. Maybe that sort of tipped it a little bit. But still, I would say, Jason, just to add on to that point, lots of interest in OCD, especially, obviously, with Palmetto, you know, picking up their coverage next Monday. Right.

Okay. And then I'll ask one more and jump back in the queue. Sure. You alluded to a new platform, the fourth-gen system. What's the timing on that?

Yeah, thanks for... Thanks for asking about that. I really appreciate it. Yeah, we were really excited to show that platform in December at the brain stimulation meeting. That's really comprised of a lot of researchers in the area of brain stimulation. That meeting only happens every two years, and we were excited to be able to demonstrate the system there, show it to some key opinion leaders in the field, and it's going to be the basis for our future system. So what we intend on doing Probably most likely later this year is installing some systems into the research space and really better understanding the technology as we move forward for our next generation. It has some really exciting advances. Maybe not for this call, but I'll just say that, you know, traditional TMS, even deep TMS, typically, well, it only treats neurons that are in the same plane with a magnetic stimulation being attached to it. This new technology, which has the patent of being able to treat not only those neurons in that location, but full 360-degree neurons within the brain, is a huge and impactful thing that we believe is going to really bring us to the next generation of TMS.

Okay. Thank you. Sure. Thanks, Jason.

The next question is from Jason Witts of Loop Capital. Please proceed with your question.

Hi, thanks for taking the questions. Actually, first a follow-up. So announcing this new system doesn't actually impact ongoing sales right now, especially since you guys are leasing most of your systems? Or how does that work mechanically in terms of the marketplace?

Yeah, we don't envision the new system, right? We just – we're actually highlighting the new system. It's not FTE clear. It's going to have to go through a process on that. I don't have a timetable of when we're going to introduce the new system. I just think it's exciting. You know, one of the three things that we highlight from a company perspective is superior science, evidence, and support. And it really kind of shows and is a testament of the superior science side that we're working to further advance the technology in deep TMS to be able to better treat the current indications we have today, as well as expand it to other indications. So I'm really excited about it. But, you know, right now, you know, there's no, you know, particular guidance or anything on the timing of that. It'll be going into some clinical trials later this year and early next year. And we'll, you know, we'll provide additional information when the time is right. Okay, thanks.

And then on OCD, I mean, you mentioned I think 40% of the install base has OCD. As the helmets, do you have utilization data on that? And are there any trends that you could pick out to kind of get a sense of what the interest, the real world interest is out there?

Yeah, there's no question. We do have the data on that. Thanks for the question, Jason. Yeah, there's no question that there has been a ramp up specifically around OCD treatments with our H7 helmets. And yeah, we're pretty excited about that. We think that's, you know, that's a combination of coupled with the excitement of reimbursement, but also coupled with, you know, sort of the more our salespeople and our marketing people are getting the information out there. You know, anecdotally, I continue to get even direct feedback from patients, sometimes patients that are educating our customers of the reimbursement and then going and having the treatment done. It's really encouraging with great results, by the way, so very encouraged overall about where we're heading with OCD. We think it's an important driver for the future of our business as well.

Okay, and then is 18 sales reps or sales reps slash managers the right number, or should we anticipate that expanding? And in terms of your coverage, I think you mentioned you went from three to four regions. No.

Sorry, Jason. Yeah, I didn't mean to cut you off.

It was two to three regions, Jason. Sorry, yeah. In Chris's prepared remarks, I think he said he was going from 18 to 21. 18 to 21.

And we're at 19 right now, just if you wanted to know the number. We're at 19 right now.

So then I'll address my question. I apologize for not getting all the details. So is 21 enough for full U.S. coverage? And it sounds like also there's also opportunities for international expansion as well.

Well, yeah, certainly the case for international. I'd say the U.S. side, you know, we're coupling the U.S. side as we always have done in the past, and we've actually expanded our support team there, both practice development consultants as well as field clinical engineers who are allowing our, you know, our territory managers to be more, I would say, efficient in going out and cultivating and expanding the business. We feel this is the right number for right now to fit our plans for 2022, and we're going to continue to, you know, invest in the right places where we feel necessary at the time.

And then just one last question, I'll jump back in queue, and that is in terms of your outlook for cash burn, cash generation in 2022, can you give us some general guidance?

Yeah. So, you know, I think we had a good fourth quarter here. I think I mentioned we We actually generated $2 million worth of cash. So we were on a run rate. We had burned $4 million through Q3. We generated $2 million. So we ended up with $2 million use in 2021. But I think a lot of that was working capital and certainly just some management of expenses in Q4. That said, we're planning to invest. We mentioned and highlighted some of the investment areas And I think our cash burn would probably be more like, you know, annualizing our Q3 burn rate from 2021 in 2022 is sort of how we modeled it, right? So increasing our level of investment, increasing our expenses. Obviously, you know, we're anticipating investing and building for revenue growth as well, but I think we're going to invest in some key areas, especially on the clinical side.

I'll just add to that. If you may remember the fourth quarter of 2020, we also had a million dollars from operations, and this time we had two. And I think obviously we show we can run the business on a profitable or break-even basis, but that's not our intent. Our intent is to continue to grow. That's what we're trying to do is invest in the business to continue that growth.

Great. Thanks a lot.

The next question is from Carl Burns of Northland Capital. Please proceed with your question. Hi, Carl. How are you?

Hi, guys. Congratulations on the results, and thanks for the question. With the recent OCD reimbursement additions, how long or how fast do you see these adoptions taking in terms of translating into system placements? Thanks.

Yeah, great question. I will highlight that the Palmetto, I think, is going to be extremely important for current users in that base as well. Really, the Palmetto followed exactly the guidance that we gave when we put together the Clinical TMS Society, which is they get 29 treatments, and if they show a response of 30% or greater, they can get up to an additional 20 treatments. And I think that's powerful because in our clinical, you know, our post-marketing data, we show that the patients actually don't plateau. And I think that coupled with great reimbursement from that area will continue to kind of fuel the efforts that we've had. And I think, you know, the sales team is extremely excited about it. Our customer base, I think, is extremely excited about it. So we're hoping to launch that out. And, you know, we're still working hard to get coverage in other areas, other coverage areas, including the other six Medicare administrators, as well as other large insurance companies.

Great, thanks. That's very helpful. And then just as a housekeeping item, what was the fully diluted share count at the end of the year? Thanks.

Yeah, it was 32 million shares.

Sorry.

Remember, yeah, that's a share count in the U.S. because we have ADRs.

Yeah, 32.9. Great, thanks, and congratulations again. Thank you.

The next question is from Stephen Lickman of Oppenheimer & Co. Please proceed with your question.

Thank you. Good morning, guys. I guess first on OCD. Given the progress you guys made on reimbursement in 2021, how should we think about the tailwind from OCD in 2022? Overall, how are you thinking about OCD contribution this year versus last? And are you seeing an increase in blended average lease levels as customers start using the OCD more with reimbursement in hand?

So, as you know, the OCD, we use the H7 helmet. This is a big year for, I think, the H7 helmet in general, and we're excited about the potentials of everything that the H7 helmet can do, including OCD. I think there's going to be, you know, what's happening every time or most of the time or 60% of the time right now, but I think it will increase as we start to increase reimbursement efforts throughout the United States. is that more and more customers are getting both the H1 as well as the H7 helmet, and that will increase basically our overall ASPs as we continue to move forward with our efforts.

Got it.

So we should be thinking about higher blended ASP on the leaf side with more OCD coils going out.

Yeah, both on the leaf side as well as on the direct sale side as well.

Okay, great. On smoking cessation, you're now in full launch. Congratulations on that. How should we think about contribution there? Will it be similar to OCD initially in that you'll see some modest revenue from coil sales? And based on your visibility today, how should we think about what kind of data you'll need to get coverage for that indication?

so i think i think you should look at it the same way as the h7 so the h4 with smoking addiction will be an add-on uh to it as well um but we're actually looking one of the big things that was there's a few things that we're doing this year specifically on smoking uh one we're looking at the international market two we're also looking at um collecting data to help us real world data to help us with reimbursement and the third thing that we're doing is we're looking at alternate sites. So looking at sort of business development opportunities for alternate sites outside of specifically the psychiatric centers. So I think we're pretty excited about that. And what we're really excited about, I think, is that the data that we have thus far in the real world and our efforts right now is to really amp up that real-world data to give us additional opportunities you know, overall to be able to make a, you know, publication and to help support our reimbursement efforts. So we're pretty excited about that. And I think that, you know, in fact, we just did a video down at Medical College of South Carolina with an individual who I think is in his late 30s and started smoking when he was at 11 years old. And he had a great outcome with this, and we're looking forward to launching that video in the short term.

Great, great. And then lastly, Scott, just following up on margins, gross margin held up well in 2021. Anything we should be factoring in for 2022 given inflationary pressures, or do you think it stays up here in the higher 70s levels?

Yeah. So I think, you know, our team has did a great job in 2021 at managing the supply chain and really sort of, and I think I mentioned last quarter that in the fourth quarter with some of the longer lead times, we had our inventory in place to ship in Q4. I do think we are, we are seeing some price pressure and some of our longer lead times and some of our components are, are, getting price increases. So I do think we will see some margin pressure. Again, we're managing it well and we're trying to minimize that, you know, bigger buys, those kinds of things from a supply chain standpoint. But I can't imagine it's going to be significant, but I do think we will see some margin pressure in 22 just with the ongoing supply chain issues and inflation and, you know, Costa Oil, just name all the things going on in the world right now.

Yeah, makes sense. Thank you, guys. Yeah. Thank you, Steve.

Thanks. The next question is from Bubalin Pachiapin of HC Wainwright. Please proceed with your question.

Good morning.

How are you today?

Hi. Doing great. How are you?

Great. Thank you.

Yeah. A few questions from our side. Obviously, congrats on the strong revenue growth. So what are some of the trends that I got in 2021 that might reappear in 2022? And also, what new trends do you anticipate in 2022 that would impact your business positively or negatively? That's just a start.

Yeah, I think great question. Obviously, I don't want to think about the negative trends, right? But COVID is one of those negative trends that could happen. Scott obviously went through the issues around supply chain and inflationary issues. I'm looking at more positive trends, right? I think overall there's an amazing, much better awareness of the technology since I joined back in January 2020. We've done an amazing job of really getting the word out there, both from digital as well as obviously our best marketing billboards are our sales professionals getting into the field. So I think that overall awareness is going to continue. We have a bunch of different initiatives that we're going to be launching this year that I'm really excited about. Obviously, May is a big month for us because it's Mental Health Awareness Month. So we'll be doing a bunch of things around May. But I think in general, we continue to work on a number of really important things from a clinical aspect. We'll be doing some things from a regulatory aspect as well that I'm pretty excited about. So I think The trends are only going to improve, you know, patient access, obviously, through reimbursement. So I think there's just a number of really great trends that are happening in the space, and I'm really excited about where we are today.

That's super helpful. Secondly, what would be your next steps in alcohol use disorder using TMS? And can we expect a potential 510K in the near future?

Sorry, I missed that.

Yeah. So what would be your next step in treating alcohol use disorder using deep PMS? And can we expect a potential fight on K?

Great, great question. So, you know, we have this great visibility study on alcohol, which is amazing results. And, you know, Professor Heilig, who is on our scientific advisory board, who was at the NIH for a number of years, is very excited about those results. He was a I think he was also a principal investigator on that as well, a co-principal investigator. So we're looking into that. We haven't made any public announcements about sort of what our next addiction is going to be, but we have a number of exciting things that were planned from a new indication, and we'll give updates when I'm prepared to do it.

Okay, understood. And maybe this is for Scott. So can you comment on the revenue mix for 2021 and also what percentage of the revenue was recurring revenue?

So, again, we talk about lease versus sale. Overall, the sale piece was 55%, lease was 45%, and lease is really the component of recurring revenue. I think as we grow and as we achieve our growth metrics in 2022, I think we're going to be tilting more towards sale. Obviously, the math around increasing recurring revenue gets a little harder in terms of number of placements. And we want to get boxes out. We want to place systems and get our technology out to everyone who needs it. And I do think that's going to drive a higher percentage of what we call sale in our financials versus the recurring components. That said, you know, the sales will drive additional service revenue, so there will be some modest increases on that side.

And I'll just add to that. It's like, you know, obviously predominantly before most of our revenue is coming from lease, and we're working with our customers, and we're allowing them to understand what they want to do as well, right? So we've had some customers that have leased the product and over time have upgraded from the previous version to the current version and chose to actually own the technology. So, you know, we just want to do in the end what's best for the customer as well.

That's it from me. Thanks. Thank you.

There are no additional questions at this time. I would like to turn the call back to Christopher Vaniaco for closing remarks.

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

This concludes today's conference. Thank you for your participation, and have a pleasant day.