5/13/2026

speaker
Operator
Conference Operator

Good day and welcome to Brainsway First Quarter 2026 on e-conference call. All participants will bend the listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on a touchtone phone. To withdraw your question, please press star then 2. Please note that this event is being recorded. I now hand the conference over to Rajesh. Please go ahead.

speaker
Rajesh
Head of Investor Relations

Thank you. And welcome to BrainsWay's first quarter 2026 earnings conference call. With us today are BrainsWay's Chief Executive Officer, Hadar Levy, and Chief Financial Officer, Ido Moroni. 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. Then we will open up the call for your questions. Earlier today, Brainsway released its financial results for the three-month period ended March 31st, 2026. A copy of the press release is available on the company's Investor Relations website. Before I turn the call over to Hadar, I would like to remind you that this conference call, including both management's prepared remarks and the question and answer session, may contain projections or other forward-looking statements regarding, among other topics, Brainsway's anticipated future operating and financial performance, business plans and prospects, and expectations for its products and pipeline, which are all subject to risks and uncertainties, including shifting market conditions resulting from geopolitical, supply chain, and other factors, as well as use of non-GAAP financial information. 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 factor section contained in Branch Ways Form 20F. Finally, please note that the company's 6K will be filed tomorrow at approximately 6 a.m. Eastern Time in accordance with the SEC's operating schedule. With that, I would now like to turn the call to the governor.

speaker
Hadar Levy
Chief Executive Officer

Thank you. Welcome, everyone, and thank you for joining us today. I will keep today's comments brief, as we just provided a comprehensive business overview during our year-end call in mid-March. We are off to an excellent start in 2026. reporting a 35% increase in revenue to $15.5 million for the first quarter, compared with $11.5 million in the prior year period. This performance was driven by the strong execution of our core business and expanded market penetration. During the quarter, we achieved our 11th consecutive quarter of profitability, supported by expanding margins and the implementation of our recurring model. Let me take a minute to walk you through a few other key metrics that we monitor each quarter to measure our continuing pattern of growth. In the first quarter of 2026, we shipped 117 deep TMS systems, a 44% increase over the same period last year, bringing our total install base to approximately 1,820 systems. Remaining performance obligation have increased to $75 million as of March 31st, 2026. Notably, the vast majority of the new contracts signed during the quarter were multi-year long-term agreements, reflecting continued traction with our revenue model. We view the steady increase in RPO over the past three years as a clear indicator of strong market demand A success of our strategy focused on servicing enterprise customers while also providing greater visibility into future revenue streams. We are proud to have achieved this level of growth while maintaining operational discipline, resulting in increased profitability. In the first quarter, net income increased by over 100% to $2.3 million compared to $1.1 million for the prior year period. and adjusted EBITDA increased 119% to $2.8 million compared to $1.3 million for the same period last year. Let me take the next few minutes to offer some colors on our multi-prolonged growth strategy and provide updates on our execution across each aspect. First, I would like to remind everyone that our ADIP-CMS platform is backed by an extensive peer-reviewed published clinical evidence demonstrating efficacy and durability across a broad range of conditions, including major depressive disorder, or MDD, anxious depression, late-life depression, OCD, and smoking addiction. This robust set of clinical evidence has resulted in FDA clearances and brought attention across many of these indications, and resulting in accelerated adoption of deep TMS, and in many cases, exceeding our expectations. In addition to educating patients and physicians on the benefits of this treatment, we have actively worked with SPARE across the U.S. to expand reimbursement coverage. For example, since the FDA label extension for adolescents age 15 to 21, we have walked towards getting over 10 pairs to add coverage for adolescent depression. In addition, Evernote behavioral health has eliminated prior authorization requirements for TMS across Evernote and Cigna plans. We are also seeing extended reimbursements for clinicians that can deliver TMS. For example, a growing number of commercial insurers Medicare contractors and government pairs now allow trained nurse practitioners to administer deep TMS when practicing in according with applicable regulations and state scope of practice rules. Recently, Optum updated its policy to permit nurse practitioners to order, supervise, and administer TMS across plans covering nearly 35 million lives. with several other major pairs, the VA and TRICARE, adopting similar approaches. We view this as an important step towards reducing provider constraints and improving access, particularly in areas with psychiatry shortage, helping more patients benefit from non-pharmacologic treatment options. We are seeing a meaningful shift in the market as deep TMS continues to gain share from alternative treatment modalities, including Spravato. We believe this momentum is being driven by the strength of our clinical data, expanding reimbursement support, and growing demand for non-invasive, non-pharmacologic therapies. In particular, our six-day acute phase SWIFT protocol is gaining strong interest from providers and patients because it offers a much shorter treatment schedule while still delivering strong clinical results. In the first quarter, we published landmark data in the peer-reviewed journal Brain Stimulation, validating that SWIFT protocol reduces acute phase clinic visits by approximately 70% without compromising efficacy. We believe this represents a win for patients providers, and pair-like, and expect SWIFT reimbursement to continue expanding. We recently announced two large pairs as being among the first of issued final or draft coverage policies applicable to SWIFT. Moving to an update on clinical activities for DeepTMS. We are pleased to report that patient recruitment is now actively underway for our multicenter study on deep TMS for alcohol use disorder. This is a major unmet need affecting approximately 29 million Americans with up to 60% of patients relapsing within three to six months despite available treatments. We are also planning to submit an application to the FDA for clearance to treat PTSD symptoms in MDD patients in the next several weeks. Based on promising data we have collected from U.S. patients primarily treated with the VA system and our enterprise accounts. If cleared by the FDA, DIPTMS can offer several meaningful advantages compared with the other treatment options in light of the fact that it is an outpatient procedure that does not require hospitalization or anesthesia and is generally well tolerated. Let me move on, provide an update around our strategic initiative focused on securing minority equity investment in high-performing mental health providers. To date, we have completed minority investment in five mental health networks. I'm happy to report that this portfolio of providers is performing well. with our capital serving as a real growth catalyst to those networks. This growth also translate into successful . Beyond having an equity stake in these growing businesses, this strategy also provide us with a clear channel for both commercial and clinical collaboration, with the ability to have more direct impact on the field, which is an obvious benefit to our business. And we believe the value of these agreements is a two-way street as our clinics gain access to brain-free important know-how and enterprise which are second to none. I'm also very excited to report to you for the first time today that the company just signed another strategic equity agreement with an Illinois group known as HopeMark. The transaction which was made with the MSO servicing HopeMark multiple locations in Chicago area includes an initial $1.5 million investment, and up to an additional $1.5 million in potential future milestone-based investment, all in exchange for a preferred minority stake in Hope Mark. Additionally, we are on the go of signing another new minority stake transaction with an East Coast provider with location in New York, New Jersey, Pennsylvania, and Connecticut. We expect to announce more on this deal soon. Looking ahead, we have already identified more than 200 other qualified clinics as potential candidates for participation in this program. These transactions further demonstrate our continuing confidence in this strategic initiative. We firmly believe we'll further raise awareness and continue to expand patients' access to care. We look forward to providing updates on additional investment throughout 2026. Importantly, we are still in the early stage of building awareness and adoption of DeepTMS. We estimate that we have penetrated only a fraction of our addressable market, highlighting the significant runway for growth ahead. While DeepTMS remains our core strength, our long-term vision is to become the only company in mental health offering database integration of multiple treatment modalities across multiple care settings. As part of this strategy, we executed a strategic investment in NeurLIF, a developer of ProLiVarix, the world's first wearable, non-invasive, multi-channel brain neuromodulation platform that is designed for use at home. Since then, this relationship has advanced on multiple fronts. Following the FDA's pre-mark approval of the ProLivarex system for the treatment-resistant MDD, we made an additional $6 million milestone-based convertible loan to NeuroLeaf, which... ...to $11 million. As a reminder, our agreement provides for potential third tranche of up to $5 million upon New Orleans. The VA federal supply schedule contract has been secured and Polyvarex has received approved pricing of $11,800 per unit as an important step toward broader adoption with the VA system and beyond. We are excited to be working with the NeuroLift team on meaningful synergetic approaches that include the commercial and research infrastructure for both companies. We view Polyvarex as a complimentary offering to DeepTMS. Where DeepTMS serves patients in the clinical setting, Polyvarex is designed for home use, thereby expanding access to clinically validated neuromodulation for patients who cannot easily get to the clinic. Together, we believe these two platforms expand our total addressable market and reinforce our broader mission of increasing patients' access to effective non-pharmacological mental health treatments. This can also potentially fit within our broader vision for BrainSway360, a new fully integrated mental health ecosystem We are building around deep TMS, next generation rotational field, deep TMS 360, advanced digital tools, diagnostic, and intelligent cloud-based platform. Deep TMS 360 is our future platform. With rotational field technology, we can stimulate more neurons more effectively and in much shorter time. Clinical research in other fields, in either already underway or in planning stage in alcohol use disorder, dementia, and chronic pain. On another front, internationally, we are likewise seeing very strong momentum. Demand continues to grow with distributors across Asia Pacific, Canada, and Europe, accelerating adoption of DIP-TMS at an important pace. With that, I will now turn the call over to Ido for his review for our first quarter 2026 financial results. Ido? Thank you, Adar. During the third quarter of 2026, we continued to execute on our growth strategy, which drove a 35% increase in revenue to $15.5 million, compared with $11.5 million for the same period last year. During the quarter, we placed 117 50 MS systems, bringing our total install base to approximately 1,820 systems as of March 31st, 2026. Growth profit for the quarter was $11.6 million, up 35% from $8.6 million in the prior year period, while also keeping an healthy growth margin. This performance reflects our continued growth and increased market penetration both in the U.S. and the international markets. Turning to operating expenses. Sales and marketing expenses for the first quarter of 2026 totaled $4.9 million, compared to $4.2 million in the first quarter of 2025. The increase was primarily driven by targeted investment in commercial extensions and marketing programs. Research and development expenses were $2.8 million, compared with $2.3 million last year. The increase was primarily driven by investments in clinical development and research, including our multicenter trial for alcohol use disorder. General and administrative expenses were $1.8 million compared with $1.5 million in the prior year period, reflecting the organic growth of our business in addition to the investments we continue to make in strategic initiatives. Operating income was approximately $2 million, compared with $0.6 million reported for Q1 2025. This performance reflects the scaling of operations, strength of our recurring revenue model, and disciplined cost management. For the first quarter ended March 31st, 2026, we reported net income of $2.3 million, compared with $1.1 million in the same period of 2025. Adjusted EBITDA was $2.8 million, representing the 11th consecutive quarter of positive adjusted EBITDA, compared with $1.3 million in Q1, 2025. Remaining performance obligations grew to $75 million as of March 31st, 2026, a 25% year-over-year increase. We believe the steady increase in our RPOs reflect the strength of our business and execution on our long-term strategy. Cashflow from operation was positive in Q1, 2026, further reinforcing the confidence we have in our recurring model and high collection efficiency. The capital structure for the company remained debt-free, giving us significant flexibility to pursue strategic growth initiatives including the various investments Adar outlined earlier. This is especially notable given additional investments of approximately $9 million made during Q1 2026 in line with our strategic direction. We reported cash and cash equivalents of $58.9 million on March 31st, 2026. We believe our strong capital position will support the continued growth of our core scientific and technology operation as well as our strategic investment program, which aims to increase patient access to innovative treatments while also building long-term value for our shareholders. Looking ahead, we continue to expect revenue in the range of $66 to $68 million for the full year of 2026. This guidance represents a year-over-year growth rate of 27 to 30%. In addition, we expect operating income in the range of 13 to 14% of revenue and adjusted EBITDA of 12 to $14 million representing anticipated growth of 86 to 100% over 2025. This concludes my preferred remarks and I will now turn the call back to the operator to please open up the call for questions. Operator?

speaker
Operator
Conference Operator

Thank you. Thank you. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2. At this time, we will pause momentarily to ask a bell or rostrum. Next question comes from Jeffrey Cohen with Vanderbilt Elementary School.

speaker
Jeffrey Cohen
Analyst, Vanderbilt Elementary School

Good morning, Hedor and Ido, and congratulations on the drone quarter in progress. So a couple questions from Aaron. Firstly, could you talk about the upcoming PTSD filing, and can you talk to us a little more about the protocol you anticipate and if the trial is with or without and the course of patients.

speaker
Hadar Levy
Chief Executive Officer

Yeah, hey Jeff, thank you and good morning. We're very excited about the submission of the PTSD data. Just to remind everyone, this is a comorbidity PTSD treatment for people also suffering from depression. It's with medication, so we're not washing out patients from medication. But what we have seen, based on the data, that we are able to see some really, really good results on reducing the symptoms of PTSD for people suffering from depression as well. The protocol is very similar to the depression protocol. It's the exact same coil. It's the H1 coil targeting same areas of anxiety and anxiety and depression, but we do see some significant reduction in those symptoms for PTSD patients.

speaker
Jeffrey Cohen
Analyst, Vanderbilt Elementary School

Perfect. Okay, and then, Sofaro, can you talk about the SWIFT protocol a little bit and talk about what you're finding in this field as far as it being utilized and for what indications and perhaps give us a sense of percentage as far as patients using SWIFT versus a regular protocol, and then maybe also talk about the payer environment? Are the payers agnostic? Are the payers taking this on and accepting it as a similar protocol?

speaker
Hadar Levy
Chief Executive Officer

Yeah. Look, I believe the SWIFT protocol is a game changer in this field. We're talking about a six-day acute phase protocol. As compared to the standard protocol that is talking about 20 to 30 during SWIFT, being able to shorten the number of days that patients need to commit to come daily to the clinic to only six days, obviously make it really accessible for patients. Now, when you compare it also to the alternative treatments today in the market, like esketamine or some other psychedelic treatment, It's even more compelling because being able to complete the whole course of treatment within six days and see a very strong result, just to remind everyone, and we announced those results, we have seen 88% response rate for the SWIFT protocol within only six days of treatment and 78% remission rate with only six days, which means that both the provider and the patients are really now pushing or demanding this treatment modality. You mentioned also the pairs. So, you know, at the end of the day, the pair is asking themselves on an actuary basis, am I saving costs for those patients suffering from COVID? from depression and if they see good results within 6 days or within 30 days but they still see some very good response and remission rate So the answer will be that they will start to adopt it. So we have seen, we were very happy to see some very early adoption with some of the PERS, but we're starting to see more and more PERS now also adopting this SWIFT protocol. I believe we're gonna see some more serious momentum toward the end of the year. And I believe the The industry is looking for shorter treatment and effective treatment that are saving and improving patient's life.

speaker
Jeffrey Cohen
Analyst, Vanderbilt Elementary School

Perfect. Thanks for taking our questions.

speaker
Hadar Levy
Chief Executive Officer

Thank you, Jeff.

speaker
Operator
Conference Operator

Thank you. Our next question comes from Ram Selvaraju from SC Wenright. Please go ahead.

speaker
Ram Selvaraju
Analyst, SC Wenright

Thanks so much for taking our questions and congratulations on excellent operational performance this quarter. Firstly, I wanted to ask about when you submit the application for use of deep TMS in connection with treating PTSD associated with MDD, maybe give us some additional granularity on what you anticipate the review timeline to be once the application has been submitted, and if you can give us some sense of what you anticipate to be any new emergent promotional strategy that you might utilize, assuming that approval for this indication is granted. Secondly, I wanted to ask if you could provide some additional color on what you were just saying, Hadar, about the additional adoption of the SWIFT system from a reimbursement perspective. Potentially, you know, how many more covered lives might have access to the system? how many more reimbursement providers might ultimately ink agreements with you. Thirdly, I wanted to ask about the ProLiveRx system and what the sales and marketing strategy is underlying this, and if you have any sense of when it might be possible to share with us what the total addressable market looks like and what peak sales might be for this product. Thank you.

speaker
Hadar Levy
Chief Executive Officer

Yeah, great. Thank you for all these questions. Let's start with the PTSD. Usually, once we submit the data to the FDA, the clock starts ticking. It usually takes up to 90 days for us to get the first response. And then if everything goes well, we can expect to get the FDA approval. Usually there is some back and forth about that. So if I need to put it in the right time frame, we do expect to receive the FDA clearance before the end of the year. So that's about the PTSD and you also asked about marketing. How are we going to market this? So obviously, This is the exact same market that we're playing today, right? For all those outpatient clinics, and specifically the ones that are working with the police department or with active military folks, they got the volume of patients, most of them suffering from depression, anxiety, and also PTSD. So what will be very, very unique for us is that we have treated hundreds of patients suffering from PTSD in Israel and similar numbers or even greater number also in the US. So we are planning to do some meaningful marketing push toward the last quarter of the year to make sure that we're optimizing the revenue from this very, very, very important indication. I saw the second question on the adoptions of pair of the SWIFT protocol. So, you know, we are looking on this very, very closely. We're speaking today with more than 20 pairs, providing all the necessary data. I think that the feedback is very, very positive. I do expect to get reimbursement by pairs for... I would say 40 to 50 million covered life before the end of the year. So overall, very good momentum, even faster than we thought. But we truly do believe that, you know, at the end of the day, what really matters is the efficacy of the treatment. And if you can deliver great efficacy and greater ability in such a short time, I see no reason why the PERS will not adopt it. if they already fully adopt the standard protocol as well. With regards to your last question about the ProLiV Rx, so just to remind again, we're still not owning NeuroLiV. However, we are watching very carefully on some of their strategic and commercial approach. The main focus right now is penetration in the VA. The main reason is because they got listed in the VA contract and they got reimbursement over there. I mentioned on my call that they got a pricing of $11,800 per system. That's a really, really significant reimbursement for this treatment. So the main focus right now is to focus in all VA accounts and start generating some significant revenue. In parallel, the company also doing some limited market release in some leading enterprise, Brainsway Enterprise companies. accounts and they're looking also to define some contracts with some IDNs, big IDNs in the U.S. I also mentioned it, there is additional $5 million investment in Orif based on some significant commercial milestone, which I'll be more than happy to write the check if they're going to achieve it, but I think that Neurly puts within ProLivarex everything they need in order to execute and to deliver in this very, very important market. Remember, the main reason that we invested in this company is to increase the target market for Brainsway. It's specifically aimed for the people that find difficulties to come to the clinic. They are far away. That also could be a bridge to neuromodulation. It could be a complementary treatment after they are doing the deep TMS sessions within the clinic. So all in all, I do expecting a very, very growth trajectory for NeuroLIF specifically with the Apologies, Alex.

speaker
Ram Selvaraju
Analyst, SC Wenright

And then two other very quick ones. You mentioned in the press release the versus year-ago period growth in remaining performance obligations. Can you just provide us with the quarter-over-quarter change in remaining performance obligations? And then maybe if you could just comment on if you are seeing any disruption at all to operations, international sales. stemming from the ongoing, evolving situation in the Middle East. Thank you.

speaker
Hadar Levy
Chief Executive Officer

Yeah, I'm going to let you go just to shine in on the remaining performance obligation, and I will take the second question. Yeah, so we mentioned also on the call that our remaining performance obligation grew 25% year over year. So we have a backlog right now, which this is our remaining performance obligation of $75 million, comparing to approximately 60 that we had in the previous period. And this represents the growth of our remaining performance obligation backlog. And also, I believe Ada will mention, we'll add more about the international, but we also see a growth in the revenue, mainly in Q1 for the international market as well. We actually even saw a growth in our revenue and ordered this quarter compared to the previous one. Yeah, great. Thank you. And for your question, you know, our main business today is the U.S. and international. So we didn't see any disruption from the current situation. We have enough inventory just to support the demand. I think the TMS market is growing and experiencing a significant amount of consolidation. And with us focusing on those enterprise accounts and specifically with what we're seeing with shifting among providers toward deep TMS away from some other pharmacologic and alternatives like Spavado. I think all of these can really deliver on the record number of units that we were able to deliver in the first quarter. And remember, usually there is seasonality in our space. Usually Q1 is a light quarter. People are still sitting on the fence, about their budget decisions for the year. So overall, I'm very, very proud and very glad to see the good momentum, not only in the U.S., but also in the international. I think that on the international, we continue to strengthen our distribution channels across the world. We see some very, very growing demand, not only in mental health. We have some additional support approved indication in those markets in recovery area and addiction, and I do anticipate that this momentum will continue to grow.

speaker
IR Moderator
Investor Relations

Thank you so much. Thank you, Ram. Thank you. Thank you.

speaker
Operator
Conference Operator

This concludes our question and answer session. I would like to turn the conference back over to Adam Levy for any closing remarks. Over to you, sir.

speaker
Hadar Levy
Chief Executive Officer

Yeah, I would like to thank all of the investors, analysts, and other participants for their interest in Brainsway. Without, please enjoy the rest of your day. Thank you.

speaker
Operator
Conference Operator

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-