BrainsWay Ltd.

Greetings and welcome to the BrainsWay first quarter 2021 earnings conference 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. It is now my pleasure to introduce Bob Yedit of Lifestyle Advisors. Thank you. You may begin.

Thank you, Daryl, and thank you all, and welcome to BrainsWay's first quarter 2021 earnings conference call. With us today are BrainsWay's President and Chief Executive Officer, Chris Fagnacco, and the new Chief Financial Officer, Scott Arreglato. The format for today's call will be a discussion of the first quarter trends and business updates from Chris, followed by a detailed discussion of the financials from Scott. Then we will open up the call for your questions. Earlier this morning, BrandsWay released results for the first quarter ended March 31st, 2021. 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'd 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 future events or future performance of BrandsWay, including but not limited to any statements relating to commercial plans or activities, financial projections, clinical studies, R&D plans, and or anticipated timelines. These statements are only predictions and BrandsWay cannot guarantee that they will in fact occur. BrandsWay does not assume any obligation to update that information. Investors are cautioned that all forward booking statements involve risks and uncertainties. such as reliance on third parties and shifting market conditions, particularly due to the COVID-19 pandemic, which may cause actual results to differ from those anticipated by BrandsWay at this time. Additional risks concerning factors that can cause actual results, actual event, results or achievement to materially differ from those contained in the forward-looking statements can be found in the company's registration statement on Form 20-F, and Southern Filings, Securities, and Exchange Commission. For those remarks, it's my pleasure to turn the call over to the CEO, Fritz Vaniaco.

Fritz? Thank you, Bob, and welcome, everyone, and thank you for joining us today. We're extremely pleased with the current operating trends in our business and expect some of our recent achievements to drive further growth in our business. I'll discuss all of this further shortly, But first, I will provide a brief overview of our key first quarter financial results. We achieved $6.1 million in revenue for the first quarter of 2021, which represented a significant 47% increase over our first quarter of 2020, demonstrating the resiliency of our business following the impacts of the COVID-19 pandemic. Importantly, we believe that the momentum we began generating in our business late last year which continued into our first quarter of 2021 is expected to be sustained throughout the year. Key to the current and continued strong performance of our business is that the operating environment has improved, a trend that we expect to further progress as additional stability returns to the marketplace in everyday life. As evidence of this, patient treatments with DTMS have continued to increase Since the fourth quarter. I would like to highlight that we recently completed the 100,000 patient treatment with DTMS, which we view as a major milestone and a testament to the innovative, non-invasive mental health technologies we have developed. Looking ahead with approximately 40% of the US population currently fully vaccinated and another 10% that have received at least one dose of the vaccine, We anticipate that these positive patient trends will continue. Moreover, mental health issues continue to rise dramatically as we emerge from COVID-19. In fact, a recent study published in the Lancet Psychiatry indicated that 34% of about 235,000 primarily US patients studied who suffered and recovered from COVID-19 were diagnosed with a brain or psychiatric disorder within six months. With over 100 million people that have recovered from COVID-19 worldwide and with the United States ranking first among nations in number of cases, it is cause for concern that we may face a secondary epidemic of mental illness. In a separate recent study of about 4,000 recovered COVID-19 patients published in the Journal of American Medical Association, Over 52% met the criteria for symptoms for major depressive disorder. Of course, these studies do not include individuals with mental health issues who may not have necessarily been diagnosed with COVID-19, but nonetheless suffer from the ill effects of isolation, lack of support from family, friends, and colleagues, and other impacts from COVID-19 to their daily lives over the last 15 months. The importance of mental health, especially in light of COVID-19, has taken on a greater sense of urgency. As such, we continue to ramp up our patient awareness initiatives. To highlight May as Mental Health Awareness Month, we were honored to ring the NASDAQ closing bell earlier this month. We also launched a robust social media influencer campaign about mental health awareness. In addition, we recently initiated a significant patient awareness campaign with the goal of reaching any patient seeking an alternative to medical management of their mental health. We also continue to expand our efforts to educate prospective patients on the benefit of BrainsWay's deep TMS. This includes, for example, content on our new website clearly explains the important differences between deep TMS and traditional TMS, as well as our hosting of numerous well-attended webinars. including 10 in the first quarter alone aimed at informing patients and providers alike about the benefit of BrainsWay's unique approach to mental health treatment. In our continuation of recent trends, we are pleased to report that our organic website traffic has again increased significantly, up over 33% from Q4 2020 to Q1 2021. I would now like to turn to DTMS for the treatment of OCD, as well as our continued efforts to obtain reimbursement in this key indication. As of the end of the first quarter, we had shipped 225 OCD coils as add-on helmets to certain of our BrainWay's new and existing systems. As a reminder, we fully launched this innovative treatment in the first quarter of 2019, and already about one-third of our total installed base have opted to offer our OCD treatment, which is a clear-cut reflection that our customers strongly believe in the benefit of DTMS for OCD. We note that a number of these providers have been requesting coverage from healthcare plans for specific OCD patients and are also now advocating coverage for DTMS generally for this indication. During the first quarter, we dramatically improved both our depression and OCD resources. including features on our website and customer portal to guide our providers in navigating the sometimes complex coverage landscape. We also continue to reach out to payers with new clinical evidence, including eight additional studies published in 2020, highlighted by our real-world evidence study that analyzed 219 patients from 22 medical centers to support deep TMS treatment for patients with OCD. During the first quarter, we held 13 meetings, including with all seven Medicare administrative contractors and six large commercial payers. During these meetings, many of which included behavioral health medical directors, we presented our DTMS OCD clinical evidence, as well as information on appropriate patient selection criteria, proper placement of DTMS within the treatment continuum, and associated health economics. We continue to reach out to additional commercial payers to present this information. I would add that the Clinical TMS Society, a leading TMS medical association, recently published its 2021 recommended OCD coverage policy with guidance on patient selection criteria and treatment protocols, which we also shared with payers to demonstrate the medical society's support. Based on this collective work, we are awaiting current evidence reviews and coverage policy decisions from multiple payers. With that, I would now like to highlight two recent achievements that have the potential to drive meaningful further growth in our business. First, we recently successfully initiated our controlled market release of DTMS for smoking addiction. This new commercial offering, the first of its kind, was distributed to 10 customers. The initial patients at these sites have been treated or still undergoing treatment, and we have received excellent feedback from our customers in regard to the impact the therapy is having on their patients. As previously discussed, we received FDA clearance based on the data from our double-blind multi-center trial with 262 smokers. These smokers were highly addicted to cigarettes with a long history of smoking, and with 70% of them having failed three or more attempts to quit. Of the participants who received a full course of DTMS treatment, 28% achieved four consecutive weeks of abstinence from smoking. We have a significant opportunity to leverage this large target market with 34 million adult smokers in the U.S. Over time, we expect that DTMS with smoking addiction could have a significant impact on our business, and we look forward to providing you with further updates on this exciting commercial launch over the coming months. We were also pleased to have recently received FDA clearance for our Thetaverse three-minute protocol utilizing the deep TMS system for depression. This new FDA-cleared protocol, which is immediately available on our systems, provides patients with shorter duration of treatment option to manage their depression. The availability of a shorter treatment protocol has the potential to expand access to care by providing clinicians with added flexibility in selecting courses of treatment that may be better for certain patients. In support of our successful application to the FDA, BrainsWay's seventh clearance to date, we submitted safety and efficacy data from 146 subjects who had received either the standard deep TMS protocol or Thetaverse deep TMS protocol. Subjects in both groups demonstrated a statistically and clinically meaningful reduction in depression scores. Switching gears, our recent equity raise, which generated over $45.2 million of gross proceeds, favorably positions the company to invest more aggressively to increase the revenue growth rate and shareholder value. As previously mentioned, we are continuing to expand our sales coverage as well as accelerate our marketing and reimbursement initiatives. Finally, we're extremely proud of our R&D and clinical leadership position in the non-invasive neurostimulation space, and we will continue to invest to maintain this position. Turning to investor relations, we remain dedicated to sharing BrainsWay's compelling growth story with both institutional and retail investors. In the first quarter, both during and following our recent successfully completed equity offering, we met with a number of high-quality healthcare-focused U.S.-based institutional investors. We also presented at the annual Oppenheimer Healthcare Conference, as well as held meetings with a number of high network retail investors. We will be presenting at a number of additional healthcare investment conferences during the remainder of 2021. And later this year, we intend to host a KOL event for investors and analysts similar to the meeting we held last November. I would like to take the opportunity now to welcome Scott to the BrainsWay team. He joined us as Senior Vice President and CFO earlier this month. Scott brings more than 25 years of leadership experience across finance and accounting positions within the high-tech medical device industry. Most recently, he was the CFO of ICAD, a NASDAQ listed global med tech company that focuses on early detection and treatment of cancer. We are thrilled to have Scott on the BrainsWay team, as he is extraordinarily qualified to assist in our mission of Boldly Advancing Neuroscience to Improve Health and Transform Lives. I look forward to his interactions with many of you over the coming weeks. Finally, as always, I'd like to express my gratitude to our hardworking customers on the front line of this mental health crisis and to the entire BrainsWay team for their continued support and dedication to our mission. These extraordinary efforts by our customers and employees continue to generate significant achievements for BrainsWay positioning us well to leverage the many key catalysts ahead of us. Thank you again for joining us today. With that, I will now pass the call to Scott for his review on our first quarter 2021 financial results. Scott.