Brainsway Ltd (BWAY) 2022 Q1 法說會逐字稿

Greetings, and welcome to BrainsWay First Quarter 2022 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host Bob Yedid with LifeSci Advisors. Thank you. You may begin.

Thank you, Doug, and thank you all. And welcome to BrainsWay's First Quarter 2022 Earnings Conference Call. With us today, are BrainsWay's President and Chief Executive Officer, Chris von Jako; and Chief Financial Officer, Scott Areglado. The format for today's call will be a discussion of recent trends and business updates from Chris followed by detailed discussion of the financials from Scott. Then we open up the call for your questions.

Earlier today BrainsWay released financial results for the 3 months ended March 31, 2022. 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 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, BrainsWay's, the anticipated future or operating of 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 Securities and Exchange Commission, including the risk factors section contained in BrainsWay's Form 20-F.

With those prepared remarks, it is my pleasure to turn the call over to Chris von Jako CEO. Chris?

Thank you, Bob. Welcome, everyone, and thank you for joining us today. To begin our business continues to perform extremely well while the Omicron variant had a slight impact early in the first quarter, demand for our therapy in multiple indication continues to remain steady. Importantly, we expect that our current positive operating trends that are driving our strong growth in recent quarters, highlighted by our latest achievements on commercial clinical, regulatory and reimbursement fronts will lead to further growth for BrainsWay throughout 2022 and beyond. While I will review our future prospects in greater detail shortly, first I will provide a brief summary of our most recent accomplishments and an overview of our key first quarter financial results.

Our first quarter revenue of $8 million represented both a 30% increase over the first quarter of 2021 and our seventh consecutive quarter with year over year growth. The demand for deep TMS was driven by depression, anxious depression, and OCD therapies, reflecting an emerging balance in the business. In fact, we shipped a nearly equal number of H1 helmets for depression and H7 helmets for OCD during the quarter. I'd like to discuss our key recent accomplishments within the prism of the 2022 key priorities, I outlined on our last call.

The first of these pillars is becoming the market leader in the non-invasive brain stimulation market. BrainsWay's continued strong growth demonstrates that we are leading the way and we are taking steps that we believe will allow us to further this trend. To achieve this revenue growth, we've assembled a best-in-class commercial team. Most recently we appointed Eric Hirt as our new vice president of sales. Eric is a veteran sales leader with more than 20 years of experience in the medical device sales at leading medical device companies such as Covidien, Teleflex and Integra LifeSciences as well as some smaller growing companies. We look forward to him leveraging his deep expertise to increase visibility for BrainsWay and its market leading deep TMS therapy.

As I said in our last call, our focus for this year is to build out our infrastructure by going from 2 regions with 18 territory sales managers to 3 regions with 21 territory sales managers. Collectively these sales professionals are focused on broadening our U.S. customer base. Our territory sales managers are complimented 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 an overall mandate to provide superior support to our customers. Another aspect of this strategic pillar is increasing market awareness. Our recently overhauled website has been enhanced for search engine optimization to make deep TMS therapy more visible for all in need.

I am pleased to report that our organic website traffic continues to grow increasing 46% in the first quarter of 2022, as compared to the first quarter of 2021, our website chat robot H coil logged nearly 1200 engagements with individuals in the first quarter. Importantly, approximately 20% of these online chats led to further discussions for prospective customers and patients.

Additionally, nearly 50 sales meetings with potential clinics were also booked with this tool. Moreover, May is mental health awareness month and we have a number of exciting initiatives planned, including an online patient-centric campaign, utilizing the hashtag #DontMissAnotherMoment. This will feature deep TMS patients describing certain experiences. They are now able to enjoy following treatment. We'll share further details on mental health awareness month activities on our next call.

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 marketing 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 with existing and prospective customers. In fact, it picks up quite a bit over the next 2 months as we will participate in 7 medical meetings on site, including the clinical TMS society, the American Psychiatric Association, annual meeting, and other psychiatric and mental health conferences across the U.S., Europe and Australia.

I will now turn to our progress on deep TMS for the treatment of OCD, another aspect of our first strategic pillar. As a reminder, BrainsWay is the first TMS device to achieved FDA clearance for this hard to treat condition and remains the only TMS company to ever receive this clearance based on pivotal placebo controlled data conducted on its own device. During the first quarter, we shipped 35 add -- helmets for OCD treatments increasing that total number to 337. We are pleased that nearly 45% of our total install base now includes OCD treatment capability. We view this progress as a testament to our customer's strong belief in the benefits of deep TMS treatment for OCD and within the broader context of our emerging reimbursement in this area.

As a reminder with our recent Palomino coverage determination, the total number of lives now eligible for OCD reimbursement on our device is approximately 60 million. The Palmetto LCD also positively impacted those using deep TMS to treat depression and anxious depression, since it reduced the requirement of 4 failed medications to just 2 failed medications. Further expansion of OCD reimbursement is an ongoing area of focus for BrainsWay.

I'm also excited that on May 1 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's customers in order to facilitate their access to and increase the likelihood of broader OCD coverage. The collective OCD developments achieved to date both in terms of customer adoption and in reimbursement are indicative of the significant traction we're seeing in 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 in OCD. To this end, we are excited to have important research published earlier this year in 2 leading peer review journals, highlighting the durability and cost effectiveness of Deep TMS in OCD.

Moving on the second pillar in the strategic plan is to lead through superior science and evidence. We continue to advance our real world data collection efforts in all of our major indications, including depression and anxious depression and OCD and smoking addiction with a focus on publications and presentations at key industry conferences. In addition, we intend to initiate several new key feasibility studies in certain psychiatric, neurological and addiction indications.

The third and fourth pillars of this strategy are capitalizing on our platform and enhancing business development activities. These are both critical long term drivers for us. To this end, we appointed Dr Joachim Seidel to the newly created position of Vice President of Corporate Development and Strategy. Dr Seidel has more than 20 years of experience in the medical device industry and has held positions in business development, corporate strategy, program management and research and development. He is responsible for pursuing strategic opportunities for BrainsWay and overseeing our global corporate development initiatives. Dr Seidel's appointment reflects our commitment to continue pursuing new market opportunities in both the U.S. and internationally in order to continue growing our business.

In addition, this week, we promoted Hadar Levy, previously Senior Vice President and General Manager of North America to Chief Operating Officer. In this role Hadar who has been with BrainsWay since July, 2014 will be responsible for leading operations for the entire organization with a focus on developing and implementing a strategic plan for long term international business growth and enhancing our customer support function. In his prior role, Hadar's focus was on the U.S. business. During this 3 year period, BrainsWay's U.S. revenues and total number of systems nearly doubled. We look forward to Hadar's broader impact on our business, including in international markets in his new role.

With that, I would like to now provide a brief update on our commercialization plan for deep TMS 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 about a year ago, we pursued this strategy in order to further cultivate our message, develop optimized business models for customers, refined ideal addressable patient population and build post-marketing data to develop a reimbursement strategy. We previously completed the first phase, which was a control market lease. And more recently concluded our limited market lease. We transitioned to a full market lease early this year, and we're pleased with the progress to date.

We are currently developing patient testimonials to support our sales and marketing efforts. As in our other key indications, we continue to publish compelling data, highlighting the efficacy of deep TMS in treating smoking addiction. Most recently, Nature, a leading scientific journal published a randomized placebo control deep TMS study that used the BrainsWay H4 coil to treat schizophrenic patients who are also smokers. The results which we presented along with—were presented along with imaging data confirmed that active Deep TMS successfully reaches its deepest, target the Insula and alters blood flow in that region, allowing therapeutic intervention. Data such as these will be leveraged in our efforts to secure reimbursement and smoking addiction, which as you know, does not yet exist for deep TMS for this indication. To further facilitate our efforts in this regard, we also intend to conduct post-marketing research and data collection efforts in 2022, which we believe will serve us well in our commercialization efforts.

Turning to investor relations, we hosted a well-attended KOL event in March focused on anxious depression. This virtual event featured Dr Shan Siddiqi, a neuropsychiatrist at the Brigham Women's hospital, an assistant professor psychiatry at Harvard Medical School. He provided a terrific overview of the clinical and market importance of the recent expansion of deep—of our depression label to include anxious depression. We also conducted multiple institutional and high net worth focused virtual non-deal road shows in the first quarter and we will present at several healthcare investment conferences throughout 2022.

Finally, in all as always, I would like to thank our value 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 boldly advancing neuroscience to improve health and transform lives with that.

I'll now pass the call to Scott for his review of our first quarter 2022 financial results. Scott.

Thank you, Chris. As Chris noted, revenue for the first quarter of 2022 was $8 million, a significant 30% increase compared to the prior year period revenue of $6.1 million. Revenue growth in the first quarter was driven by increased demand for our BrainsWay deep TMS system with 36 system placements in the first quarter of 2022. This increases our install base to 790 systems as of March 31, 2022, as compared to 652 systems or 21% growth versus March 31, 2021. Gross profit for the first quarter of 2022 was $6.1 million or a 77% gross margin compared to $4.6 million or 76% during the prior year period.

Moving on to operating expenses. For the first quarter of 2022, research and development expenses were $1.6 million as compared to $925,000 in the first quarter of 2021. Expenses are due primarily to: data collection to drive reimbursement, expansion of our platform and other key indications and development of our next generation system. We expect these priorities to be a focus for our R&D team. Sales and marketing expenses for the first quarter of 2022 were $4.1 million compared to $3.1 million for the first quarter of 2021. As Chris mentioned earlier, we have increased our investments in our commercial team and have expanded our in-person and digital marketing efforts. Awareness is key to driving long term growth.

Moving on to G&A. Expenses for the first quarter of 2022 were $1.9 million compared to $1.4 million for the first quarter of 2021. Operating loss for the first quarter was $1.5 million compared to an operating loss of $801,000 for the same period in 2021. For the first quarter ended March 31st, 2022. We incurred a net loss of $2 million compared to a net loss of $1.4 million in the same period of 2021.

Moving on to the balance sheet. We ended the quarter with cash, cash equivalents and short term deposits of $54.7 million, a decrease of $2.7 million as compared to Q4 2021. On the equity side, our current ordinary shares outstanding at the end of Q1 is approximately 33 million or 16.5 million American depository shares. With a strong balance sheet, we have the flexibility 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. However, we will continue to be prudent in managing our investments. 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.

(Operator Instructions) Our first question comes from the line of Jeffrey Cohen with Ladenburg Thalmann.

So firstly, from our end, if you could talk about the commercial force, I know you went through a expansion on the regions and managers to 3 and 21, but what's the size of the practice development consultants at least domestically and also field engineers in North America.

Yes, we have 8 practice development consultants as we talked about this, supporting our soon to be 21 territory managers with 3 regions and we have I believe 11 field clinical engineers.

Perfect. Okay. You talked about current operational challenges, at least in the press release from Q1. How does that look into Q2? And can you talk about recent findings?

Yes. well, in my prepared state answer, it was really focused on the beginning of the year with Omicron the pandemic, I mean, sorry COVID coming back. I don't foresee that at this time we obviously, we're not feeling that at all at this point, Jeff.

Okay. Got it. And as far as system placements, I think you talked about, was it 45% now? Placements have OCD Helmets. Yes. How would that look for new placements?

So Jeff, yes, that's right. I think I mentioned a number of times when I first started. I think we were, I think we're around 30%. So we continue to see an increase in the demand for the H7 for OCD and now we're up to about 45%. I think if you looked at the numbers almost, we'd almost equal the amount of H1 and H7 helmets. I think I said in previous comments that I think that number will probably reach up to about 60% at some point, but we just had a really great demand in the first quarter for the H7 helmets. I think really driven by really, I was going to say really driven by obviously the product, the progress we've made in, in the reimbursement side there, obviously.

Which leads to my next question. Any trends across the board on your pricing psychiatric pricing and reimbursement trends that you can call out a note?

Yes, not nothing. I mean, obviously Palmetto was a big thing from getting the OCD clearance to start on March 13 covering a bunch of Southern states on the east coast. And I think I mentioned also in the prepared statements that they went from 4 on the depression side and anxious expression side down to 2 which was great that I think puts over 60% of Medicare now at either one or 2 failed medications for depression in anxious expression.

Okay. Got it. And then lastly a shout out and congrats to Hadar in the promotion.

Thanks so much. Appreciate it.

Our next question comes from the line of Jayson Bedford with Raymond James.

Just a few questions for me, maybe just to follow up on one of the questions earlier. When do you anticipate having 21 reps?

You know, probably my guess is before the end of this quarter, sometime that range beginning of next quarter.

Perfect. And then just maybe more broadly the selling environment there's been some mixed feedback, these earnings call on capital trends and I'm just curious as to how you would characterize the environment for capital right now. And then maybe just to put a finer point on it in terms of kind of the new boxes going out there, they going to existing customers, new customers would love to get a little bit more visibility there.

Yes, sure. When you said capital trends on this call, you mean during this earning season or were you talking about…

Yes, so no, so capital and I realize that your end market is much different than most other companies in medical technology, but there's been some mixed trends in terms of some folks saying it it's a tighter capital environment. Some saying, no, there's no issue it's pretty loose. So I'd just be curious as to your thoughts on appetite for capital from your customer base.

Yes. I mean obviously our customer base is a little bit different. We're dealing with clinics in the community. Obviously, and you know, I think in general, our pipeline is pretty full. So we continue to be obviously very positive on how we see Q2 and the rest of the year trending. So I don't -- obviously, it's different in the hospital environment for sure.

And then just a question about sort of the mix there. I think over the, over the course of the you know, pandemic -- the 2 years we had the pandemic a large majority of our boxes that were going out were more focused, I think towards or high majority were focused to existing customers. And I think that was obvious they understood the need, they understood the product, they understood you know, how to actually make a great business. And they were expanding in either their current facility or an additional facility. We had seen in Q1, we kind of expanded into a number of new sites. So that number came down a bit, but I think our customers continue to fuel our growth and I think they will continue to fuel our growth in the future.

Okay. And then maybe just lastly, for me, it looks like there's a new player in the OCD space, just wondering, does this change your perception of the opportunity at all and just from a positioning standpoint, does it changed the message?

Well, I think there's a number of ways to look at this. Obviously, the information on that is pretty fresh, right. It came out yesterday and I'll continue to highlight we're the only company that's has deep TMS and we're the only deep TMS company out there that's received the clearance with pivotal sham controlled data on its own device. But you can look at another view as well, right. In general, the market basically is pretty big from an OCD perspective. And I think it's going to bring more awareness and develop the market, which ultimately probably serves the benefits of everybody in the market itself. So we can look at it in 2 ways. I think obviously we stand behind our product and we've represented it and we've seen really great things with it. So we're looking for, for future success and driving continued OCD, both from adoption to new customers, existing customers, as well as also getting access with reimbursement.

Our next question comes from the line of Steven Lichtman with Oppenheimer.

I wanted to jump back onto the solid jump in OCD coils as a percent of total. Can you talk about where you're seeing that picked up momentum? You know, obviously you're talking about reimbursement, is where you're seeing it correlated in areas where reimbursement turned on or is there a broader halo effect that you're starting to see.

That's a great question. I think in general, it's been since we started this and started getting reimbursement, I think a year ago after this call was the first time we got coverage that was big with Centene as you remember, I think I called you after the call, but in general it has been a halo effect because people kind of feel the tide moving in the right direction. Obviously in the some of the coverages that we have are Centene is covered kind of across the country. So I think in general, it's been a halo effect. You saw almost a hundred percent of the systems that we shipped had H7 coils. So I think it just speaks volume about the technology and what it's doing for this very difficult disorder.

Great. Chris, I guess just turning to the recent executive announcements with Hadar and Dr. Seidel it seems like international expansion might be increasingly in focus when we—as you were talking about both, is that right in a primary reason for the announcements and, and what do you see as the initial opportunities for expansion outside of the U.S., if so.

Yes, Steve, thanks. That's a great question. So with Joe Seidel it's an absolute pleasure to get him on board. He's had really great experience from a corporate development standpoint and strategy. We're obviously going to utilize his resources in that, and you're exactly correct from a Hadar standpoint we are looking up internationally as well. We want to make sure that we're growing both in the U.S. as well as internationally and for had for Hadar and what his achievements and what he's done in the U.S. have been just phenomenal.

And we wanted to lever, we want to sort of like lean on his expertise and be less, I would say opportunistic, which has been our specifically our strategy internationally to be a little bit more strategic. So he is working on plans with that effort as we continue to move forward and I look forward in future calls to kind of highlight what our strategy will be internationally. But we're focused in the few different markets internationally. We've had the, obviously some good luck you know, with opportunities in Europe as well as in Asia. So we're looking forward to expanding that, and that's why we thought right now is the, the right time to make this call.

Okay, great. Then just lastly, just wondering what your latest thoughts are on how on smoking cessation now with the full launch obviously just beginning, but do you see potential for out of pocket pay for that indication or are you really thinking it's -- you need to see sort of that reimbursement and you'll, you'll build bill toward that, like with OCD.

It's a mix with some of our customers, some of our customers have actually done well with cash pay. But we did some analysis on the market and actually looked at smokers in particular to find the ideal smoker that would be looking to quit and would want to pay for the technology. And we continue to have with the group, from our limited and control market lease to have calls, we just had another call a couple weeks ago to update and educate them on that. And we're trying to learn from them as well. And then addition to that, we are really focused on specifically on collecting data for reimbursement. And we just started that effort in a grand way in the last 3 weeks. So the more data we get the better and we can use that data to help us in our reimbursement strategy. So that's what we're doing today.

Our next question comes from the line of Jason Wittes with Loop Capital.

I don't know if you have any comment about the, this lawsuit that was just filed relating to anxious depression from neurotics.

Thanks, Jason. Thanks for bringing that up. Yes, I guess it just got, there's a press release that was done. I mean, in general, we stand behind our studies, which are peer reviewed and the representation of our data. Without getting too much into the detail, our depression labeling expansion to include anxious depression followed our submission to the FDA of data from several pivotal studies, as well as other publicly available data. So we look forward to examining the specific factual and legal allegations in Neuronetics' complaint and intend to mount a vigorous defense as to the allegation that Neuronetics' effect size was manipulated by presenting an endpoint, representing an incomplete course of therapy. We used the endpoint of 4 weeks after the start of the treatment, which is in the same as Neuronetics' FDA cleared protocol. Hope I hope that clarifies well for you, Jason.

No, that, that that's very helpful. It does clarify a lot, so I appreciate that response. So moving on then in terms of the distribution expansion from 2 to 3 regions how long should that process take and in terms of when that gets fully executed, and I assume we'll start to see the benefits immediately or starting in the next couple quarters in terms of the effect on revenues.

Yes, so we start that process towards the end of last year Frank Hackett, our previous Vice President of Sales did an amazing job of actually developing 3 regions. We now have 3 sales directors that head up that area. So that expansion is already done with the 3 regions. Now, we're now filling in the territory sales managers into each one of those regions as part of the expansion. We also, as I talked to a little bit before, well, I think Jeff asked the question, we enhanced our practice development consultant group, as well as our field clinical engineers to continue our, I would say, unrivaled support when it comes to making sure that we're enhancing customer success.

Our next question comes from the line of Carl Byrnes with Northland Capital Markets.

Congratulations on the progress. What are your expectations with respect to gross profit margin through the balance of 2022 in considering the OCD placement growth, expansion of reimbursement and also expansion of the sales force.

Thanks, Carl. Thanks for the congrats there. Scott, you want to take this?

Yes, so look, I think the increasing our revenues will well—our gross profit should still remain sort of within the same range, Carl, like we're going to expand the markets, but our gross profit should stay right where it is, right where it's been consistent with prior quarters.

There are no further questions in the queue. I'd like to hand the call back over to Chris von Jako for closing remarks.

I just want to thank everybody for making the call today. I appreciate the time and effort and your continued support of BrainsWay. With that, we'll end the call.

Ladies and gentlemen. This does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.