BrainsWay Ltd.

Greetings and welcome to Brain's Way first quarter 2022 earnings conference call. At this time, all participants are on 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. It is now my pleasure to introduce your host, Bob Yeted, with Lifesize 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 Vaniaco, and Chief Financial Officer, Scott Arreglato. The format for today's call will be a discussion of recent trends and business updates from Chris, followed by a detailed discussion of the financials from Scott. Then we will open up your call. Then we open up the call for your questions. Earlier today, Brandsway released financial results for the three 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 are rather forward-looking statements regarding, among other topics, brands' ways in anticipated future 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 the Securities and Exchange Commission, including the risk factors section contained in branch ways, Form 20F. With those prepared remarks, it's my pleasure to turn the call over to Chris Vaniaco, 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 and 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. BrainsWave'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 have assembled a best-in-class commercial team. Most recently, we appointed Eric Hurt 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, Telefex, and Integral Life Sciences, 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 two regions with 18 territory sales managers to three regions with 21 territory sales managers. Collectively, these sales professionals are focused on broadening our U.S. customer base. Our territory sales managers are complemented 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 our 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, HCoil, logged nearly 1,200 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 Don't Miss Another Moment. This will feature deep TMS patients describing certain experiences they are now able to enjoy following treatment. We'll share further details of 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 two months as we will participate in seven 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 achieve FDA clearance for this hard-to-treat condition and remains the only TMS company to have received this clearance based on pivotal placebo-controlled data conducted on its own device. During the first quarter, we shipped 35 add-on helmets for OCD treatments, increasing that total number to 337. We are pleased that nearly 45% of our total installed base now includes OCD treatment capability. We view this progress as a testament to our customers' 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 a 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 four failed medications to just two failed medications. Further expansion of OCD reimbursement is an ongoing area of focus for BrainsWay. I'm also excited that on May 1st, 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 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 are 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 two leading peer-reviewed journals highlighting the durability and cost-effectiveness of DTMS and OCD. Moving on, the second pillar in our 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. Joe 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 three-year period, Brainsway's U.S. revenues and total number of assistants 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, refine ideal addressable patient population, and build post-marketing data to develop a reimbursement strategy. We previously completed the first phase, which was a controlled market release, and more recently concluded our limited market release. We transitioned to a full market release earlier 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-controlled deep TMS study that used the Brain's Way H4 coil to treat schizophrenic patients who are also smokers. The results, which 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 in 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. Sean Siddiqui, a neuropsychiatrist at the Brigham Women's Hospital and assistant professor of psychiatry at Harvard Medical School. He provided a terrific overview of the clinical and market importance of the recent expansion of our depression label to include anxious depression. We also conducted multiple institutional and high net worth focused virtual non-deal roadshows in the first quarter. And we will present at several healthcare investment conferences throughout 2022. Finally, and as always, I would like to thank our valued partners and providers who battle the mental health crisis each and every day, as well as the entire Brain's Way 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.