BrainsWay Ltd.

Greetings and welcome to BrainsWay fourth quarter and full year 2022 earnings 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, Brian Ritchie, with LifeSci Advisors. Thank you. You may begin.

Thank you all, and welcome to BrainsWay's fourth quarter and full year 2022 earnings conference call. With us today are BrainsWay's Chief Executive Officer, Hadar Levy, and Chief Financial Officer, Scott Arreglato. 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 from Scott. Then we will open up the call for your questions. Earlier today, Rain's Way release financial results for the three and 12 months ended December 31st, 2022. A copy of the press release is available on the company's investor relations website. Before I turn the call over to Hadar 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, Rainsway'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 the COVID-19 pandemic, the global supply chain crisis, as well as the use of non-GAAP plans. 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 Hadar.

Thank you, Brian. Welcome, everyone, and thank you for joining us today. I am thrilled to be leading my first joining conference call as BrainsWays CEO. As I have previously served as the company's Senior Vice President and Chief Operating Officer and Chief Financial Officer, and GM of North America before that, I've had the opportunity to interact with many of you over the years. However, for those of you who do not know me, please allow me to briefly introduce myself. I've been a member of Brainsway's senior leadership team since 2014, and during this time, I've been deeply involved in the sales, financial, and operational aspects of our business. I look forward to leveraging my broad expertise and extensive experience to capture the significant growth opportunities that lay ahead for this great company. And I'm excited to work closely with our board of directors, outstanding executive leadership team, and all of our dedicated employees to strategically grow our business and position Brainsway as a global leader in the TMS industry. I would also like to take this opportunity to welcome Ami Bam, who was recently appointed chairman of the board. and succeed Dr. David Zakut, co-founder of Brainsway, who will now serve as a director on the board. Ami is an experienced and well-respected leader in capital market and advising in multiple global industries. I'm also pleased to continue working with David, whose strategic insight has supported Brainsway's evolution from an R&D startup to a world-class commercial company, offering the industry's leading TMS technology and solutions. Moving on, I will let Scott provide you with the key details of our financial performance in the fourth quarter and full year 2022. While I will share with you some of the strategic vision that we have developed to grow our business, as well as many tailwinds that we see positively impacting our company. Please note, over time, we look forward to sharing further aspects of this strategic vision with you. For the time being, though, For competitive purposes, it is important that we deliberate in communicating our plan for long-term success. I will also review some of our key recent achievement before turning the call over to Scott. Since assuming the role of CEO earlier this year, I have focused on implementing key initiatives aimed at growing the company's top line while simultaneously advancing toward profitability. I'd like to take a moment to briefly review some of these key initiatives. First, we continue to optimize our existing commercial process. Of course, this begins with building a best-in-class commercial team. We remain focused on hiring the right type of salespeople. In addition, we continue to enhance our emphasis on larger institutional and enterprise customers that are playing an increasingly important role within the industry. Our goal is to add deep TMS technology into this expanding large mental health group or networks. I'm pleased to report that our pipeline of these types of opportunities is steadily growing. To this end, we expect our US business to resume momentum beginning in the first quarter and anticipate that this progress will continue throughout 2023. Our core messaging will continue to focus on superior science, evidence, and support, as well as flexible pricing. The power of this messaging is evidenced by the continued momentum in our international business. From financial perspective, we are executing certain measures to optimize our cost structure. We expect to see the result of this cost reduction effort beginning in the second half of this year. Specifically, we are re-evaluating our R&D strategy and reprioritizing the allocation of our R&D resources. As we move forward, we will show some of the new exciting clinical development focus area for us. We also intend to reprioritize our commercial investment with less a focus on digital marketing than previously seen. Importantly, our other impactful sales initiative will continue aggressively. Our goal with this cost structure modification is to target break even operating income in the fourth quarter of 2023 while demonstrating fully revenue growth over 2022. In addition, we intend to be opportunistic on the business development front with respect to collaborating with certain mental health clinic where doing so might allow us to expand faster and deliver more value. As specific opportunities present themselves here in the coming months, we'll share further details on what an attractive partnership might look like for us. I'd now like to pivot to some of our recent accomplishments. On the reimbursement front, a major private insurance company in Washington State recently extended positive coverage applicable to Deep TMS for treatment of OCD. This policy extension provided coverage of Deep TMS for OCD to approximately 2.2 million members. We now have over 90 million covered life for the OCD indication. Moreover, nearly 50% of our total install base now include OCD treatment capability. We view this progress not only as a key indicator of our customers' strong belief in the benefit of deep TMS treatment for OCD, but also our growing success in securing reimbursement in this important indication, which is critical tailwind for our business. The policy change also reduced MDD TMS coverage criteria from four failed medication trials to only two. We also continue to build clinical evidence in support of deep TMS for use in multiple indication. Most recently, a comparative study of our deep TMS H1 coil, which target the lateral prefrontal cortex, and our H7 coil, which target the medial prefrontal cortex, was published in the Journal of Clinical Investigation Insights. The study validated the efficacy of both brain sway coils for depression and also identified preliminary predictors that could help optimize treatment based on individual patients' attributes. We view this study as an important scientific step forward toward personalized psychiatry and are conducting additional research to evaluate which target is better for which depression patients. Further evidence of the power of our science came recently when Brainsway named two fast companies prestige annual list of the world's most innovative companies for 2023. The world's most innovative companies list is fast company signature franchise and one of its most highly anticipated editorial effort of the year. We are proud of this important acknowledgement. Before I turn the call over to Scott, I would like to express our confidence in our outlook for 2023. To reiterate, we expect to demonstrate revenue growth over 2022 and are targeting break-even operating income in the fourth quarter of 2023. Importantly, TMS remained a large market with strong momentum and there is ample room from Brainsway to capture meaningful market share, both in the U.S. and internationally. Finally, as always, we would like to thank our valued partners and providers who battle the mental health crisis each and every day, as well as to 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 will now pass the call to Scott for his review of our fourth quarter and full year 2022 financial results. Scott?