3/11/2025

speaker
Conference Operator
Moderator

Good day, and welcome to the Brain's Way fourth quarter and full year 2024 earnings conference call. All participants will be in listen-only mode. If you need assistance, please signal a conference specialist by 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 would now like to turn the conference over to Brian Ritchie of Lifestyle Advisors. Please go ahead.

speaker
Brian Ritchie
Lifestyle Advisors Representative

Thank you all, and welcome to BrainsWay's fourth quarter and full year 2024 earnings conference call. With us today are BrainsWay's Chief Executive Officer, Adar 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 and full year ended December 31st, 2024. 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 factor section contained in Brainsway's Form 20F. I would now like to turn the call over to Hadar. Please go ahead, Hadar.

speaker
Adar Levy
Chief Executive Officer

Thank you, Brian. Welcome everyone. And thank you for joining us today. We are excited to announce today that we completed 2024 with another quarter of rapidly growing sales of our market leading deep TMS system. The steady rise in our performance reflects the successful execution of our strategy focused on building sales momentum and scale of our commercial distribution around the world. As you will see, these results further reinforce Brainsway's true business and technological leadership position in the TMS field. On the top line, we generated $11.4 million in revenue, marking a 27% year-over-year increase. Our multi-year agreement with large enterprise networks strengthened customer partnership beyond one-time sales, ensuring alignment with their evolving needs. Additionally, our lease-based business model option continues to expand our recurring revenue base, providing a more stable foundation for long-term growth. In the fourth quarter of 2024, we shipped a total of 75 deep TMS systems, representing a 25% increase compared with the same period last year. I think it is worth noting that combined with our growing backlog and record revenues, we have established a positive book to bill ratio over the past several quarters. This underscores the exceptional execution of our commercial team as we continue to partner with larger enterprise customers. Those that have consistently delivered the highest return on our sales and marketing investment. We have significantly expanded our market presence, making deep TMS accessible to more customers than ever before. To support this growth, we optimize our sales force to accelerate expansion within larger institutional and enterprise accounts in the US and internationally. Our global reach now extend across key markets, including Canada, Asia, India, and Europe. As we successfully transition into this new phase of growth, we are driving increased profitability, further setting us apart in our industry. This is reflected in our strong growth margin, which was 75% in the fourth quarter and for the full year. We generated positive quarterly net income for the fifth consecutive quarter and positive adjusted EBITDA and cashflow from operation for the sixth consecutive quarter. Looking ahead, we are introducing full year 2025 revenue in the range of $49 million to $51 million. This would represent a growth of 20% to 24% over 2024. We also anticipate generating operating income of three to 4% and adjusted EBITDA of 11 and 12% for the full year 2025. We aim to further solidify our market leadership by leveraging our strong sales momentum and executing key strategic investment across three core areas. Advancing our next generation deep TMS 360 system. Conducting clinical trials to expand and enhance treatment capabilities and strengthening our commercial presence through targeted sales and marketing initiatives. Our primary objectives are to drive market awareness, execute on our R&D roadmap, and expand access to deep TMS. We believe that these are critical as we work to further cement our role in shaping the future of mental health treatment. On the commercial front, we expect to see increased sales around OCD in 2025, as our system is the first TMS therapy approved for obsessive compulsive disorder. OCD is a difficult to treat disease with limited treatment options, with substantial potential market of roughly 400,000 patients annually who are resistant to current treatment options. As a reminder, our most recent data for this indication are very positive, with over 60% of patients responding to deep TMS treatment. Turning to depression, Doctors have been reporting an increase in anxious depression deep TMS treatment in the US. As a reminder, this refers to the patient 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 US each year. As a reminder, our system was the first TMS device cleared by the FDA to effectively treat this condition. We have also seen an increase in utilization of DIP TMS to treat elderly patients with MDD in the second half of 2024. Destruction in the market follows the US FDA's groundbreaking decision to raise the upper age limit from 68 to 86 years old for the indication in June, 2024. As life expenses continue to rise, many are looking for innovative therapeutic solutions to alleviate the significant burden this condition places on our aging population. This clearance made our system the first and only TMS device approved to treat elderly patients with MDD. We are also working on collecting data on deep TMS for potential treatment for adolescent depression patients. and we'll update you all to the extent we make progress on this front as well. In September, we announced that the Israeli Ministry of Defense Rehabilitation Department granted approval for the reimbursement of deep TMS therapy for qualifying patients at Israeli public hospitals with post-traumatic stress disorder, or PTSD. We will continue working to extend the available reimbursement for PTSD in Israel with the goal of potentially including more Israeli medical centers as well as adding private clinic settings. Another recent development on the research front was recent publication in the Journal of Psychiatric Research showing that deep TMS therapy combined with psychedelic therapies was significantly more effective in reducing depression levels among adult patients compared with standard medication alone. We believe this promising data support additional research into the potential benefits of treating depression with a combination of deep TMS and psychedelic therapies. Importantly, we continue to make progress in our randomized multi-center US clinical trial evaluating an accelerated treatment protocol for the deep TMS system for 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 the treatment. This is 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 many prospective patients. According to alcohol use disorder or AUD, we recently announced positive pilot data from a small independent third party study conducted at Stanford University, evaluating an accelerated protocol using our DeepTMS technology to treat alcohol addiction patient, which was reported in a publication in the Brain Stimulation Journal. We believe these promising preliminary results will pave the way for further research into the potential benefit of treating AUD and other addiction with DeepTMS using an accelerated protocol. This critical investment in our long-term R&D and clinical vision are supported by a strong balance sheet with no debt. At December 31st, 2024, we reported $69.4 million in cash. This includes approximately $20 million in gross proceeds received to date from our equity financing successfully completed with Valor Equity Partners. This financing will be used to support the key action items I just discussed, which are aimed at expanding our commercial footprint and supporting broader access for patients to DeepTMS. Obviously, the most important aspect of our growth strategy centers around our innovative DeepTMS system and the large enterprise customers we are focused on servicing. As a growing segment of our customer base, these enterprise accounts have been a major driver behind the larger and repeat order for our deep TMS systems over the past year. In addition, by elevating our customer base, we have seen new doors open to additional enterprise customers of the same size and caliber, if not larger. With the opportunity to achieve additional large and repeat orders from both new and existing enterprise customers, we see additional meaningful room to grow in the years to come. In closing, our team is executing our strategy on several fronts. As a result, we now stand as the clear leader in TMS therapy, uniquely positioned to expand mental health access while delivering shareholder value through transformative therapies, innovation, operational excellence, and sustainable growth. With that, I will now turn the call over to Ido for his review of our fourth quarter and full year 2024 financial results. Ido.

Disclaimer

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