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BrainsWay Ltd.
5/13/2025
Good day, and welcome to the Brain's Way first quarter 2025 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please see to a conference specialist for pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I'll now turn the conference over to Brian Ritchie of Life Science Advisors. Please go ahead.
Thank you all, and welcome to BrainsWay's first quarter 2025 earnings conference call. With us today are BrainsWay's Chief Executive Officer, Hadar Levy, and Chief Financial Officer, Ido Marom. 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 financial results for the three months ended March 31st, 2025. 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 the use of non-GAAP financial information. Additional information regarding these and other risks are available in the company's earnings release and in its other filings with the SEC, including the risk factors section contained in Brainsways Form 20F. I would now like to turn the call over to Hajar. Please go ahead.
Thank you, Brian. Welcome, everyone, and thank you for joining us today. We're excited to share that we have carried the strong momentum from last year into 2025. In the first quarter, we generated $11.5 million in revenue, marking a 27% increase year over year. In addition, We shipped a total of 81 deep TMS systems, representing a 42% increase compared to the first quarter of 2024. In addition, we have signed the backlog and remaining performance obligation totaling nearly $60 million, providing clear visibility into future growth. This overall performance reflects the growing demand for our deep TMS platform and further reinforce our leadership position in the non-invasive normal dilation space. Our commercial growth, particularly in the U.S., is being driven by expanded adoption of deep TMS in the treatment of obsessive-compulsive disorder, or OCD, anxious depression, and other mental health conditions. Let me take a minute to review the execution of our sole strategy. Over the past year, We have been highly focused on strengthening our customer base and driving near-term growth by engaging large enterprise networks with multi-year agreements. As part of these agreements, we have elevated our customer service to better handle the unique and evolving need at each of these accounts. As a result, we are taking this engagement deeper and building valuable partnerships that offer both sides real value beyond the traditional one-time sales approach we used previously. We have also continued to scale our pay-per-use and list-based model, which supports recurring revenue and provides more flexibility for providers. These efforts are creating a more predictable and sustainable foundation of Brainsway's future. However, what truly sets Brainsway apart and confirms our position as an undisputed leader in the TMS market is our technological and clinical differentiation. In fact, a growing number of customers have switched from other TMS technologies to Brainsway, citing our clinical performance and economic value as primary reasons. Building on this market positioning, the next phase of our growth strategy focus on three key pillars. One, further elevating market awareness of deep TMS and its clinical impact. Two, advancing our R&D roadmap to unlock new and expanded treatment indication. And three, broadening patient access through global expansion and health system integration. We believe that these activities are critical as we walk to further cement a role in shaping the future of mental health treatment. In terms of opportunities to drive greater access to deep TMS through new and expanded indication, we are well positioned to ramp up activity around OCD in 2025. Our data for this indication are highly encouraging, demonstrating that over 60% of patients respond positively to deep TMS therapy. This highly response rate underscores the efficacy of our system and its potential to help improve the quality of life for approximately 400,000 patients suffering from OCD annually. It's also worth noting that we are the first TMS therapy approved for OCD, further elevating over the rest of the industry. Anxious depression, is another indication where our system was the first TMS device cleared by the FDA as an effective treatment. I'm pleased to announce that doctors in the US are continuing to report an increase in deep TMS treatment for anxious depression. As a reminder, this refers to patients with major depressive disorder who also exhibit comorbid and anxiety symptoms. This is a large addressable medical need that affects approximately 10 to 16 million adults in the U.S. each year. We are also making steady progress in bringing increased attention to our clinical data supporting the use of deep TMS therapy for post-traumatic stress disorder, or PTSD. We have already made steady progress over the last two quarters following the initial approval for reimbursement of deep TMS therapy in Israel. As we look ahead, we are working to expand the available reimbursement for PTSD in Israel with the goal of potentially include more Israeli medical centers as well as adding private clinic settings. I will conclude this section of my comments by saying that we continue to advance the randomized multicenter US clinical trial evaluating an accelerated treatment protocol for the deep TMS system for major depressive disorder or MDD treatment as compared to the current standard of care deep TMS protocol. As a reminder, the traditional deep TMS protocol involves a four-week acute treatment phase with one session on each day of treatment. This now being compared to an accelerated protocol which involves a significantly shorter acute phase taking place over several treatment days. This has the potential to improve convenience and thereby make deep TMS substantially more appealing to prospective patients. While I have spent a lot of time today discussing our top-line performance and future growth drivers, our team has done a tremendous job balancing our expense management while generating this high level of revenue growth. This has allowed us to consistently report strong gross margin of 75%. We also increased our operating income and adjusted EBITDA margin and generated positive cash flow from operation. This brings me to the international trade and tariff policies that have dominated the global news cycle for the past few months. We are actively monitoring our potential exposure to the recent changes to these policies especially as they pertain to the US, Israel, and European Union. While specific policies and timing of implementation remain fluid, we do not accept there to be a material impact to our gross margin for the current year. As a result, we are reiterating our full year 2025 financial guidance of between $49 million to $51 million in revenue. This would represent a growth of 20% to 24% over 2024. We also anticipate generating operating income of 3% to 4% and adjusted EBITDA of 11% to 12% for full year 2025. With that, I will now turn the call over to Ido for his review of our first quarter 2025 financial results.
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