11/15/2023

speaker
Conference Operator
Call Operator

G'day and welcome to Brainswave third quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the film and presentation. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, this conference is being recorded. I will now turn the conference over to Brian Ritchie. Please go ahead.

speaker
Brian Ritchie
Moderator / Investor Relations

Thank you all, and welcome to BrainsWay's third quarter 2023 earnings conference call. With us today are BrainsWay's Chief Executive Officer, Padar Levy, and Chief Financial Officer, Ido Marom. The format for today's call will be a discussion of recent trends and business updates from Padar, 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 and nine months ended September 30th, 2023. 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 the COVID-19 pandemic, the global supply chain crisis, as well as the use of non-GAAP financial information. Additional information regarding needs 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 Brainsway's Form 20F. I would now like to turn the call over to Hadar. Please go ahead.

speaker
Hadar Levy
Chief Executive Officer

Thank you, Brian. Welcome, everyone, and thank you for joining us today. To begin, I would like to extend our gratitude to so many of you who have continued to reach out to us to express your concern regarding the health and safety of our employees given the horrible acts of violence taking place in and around Israel. While no one in Israel is unaffected by the events unfolding, we remain resilient and will emerge stronger. We have encouraged our team in Israel to prioritize their well-being, look after their physical and mental health, and spend time with loved ones. As a company, we remain committed to the consistent availability and delivery of our products and services, and the impact of our current events on our operation remains limited. We are taking steps to ensure that we have enough inventory and stock on hand to continue our supply of devices on an uninterrupted basis to meet our projections and have additional contingency plan in place should there be any need for alternative supply channel in the future. Of course, we will provide further updates if and when material events so warrant. With that, I will now discuss the strong momentum that currently exists throughout our entire business. You will recall our goal of growing the company's 2023 top line over 2022 while targeting breakeven operating income and positive adjusted EBITDA in the fourth quarter. Our plan for the achievement of these objectives remain on track and in some areas ahead of initial projections. We will discuss this further shortly, but we are very pleased to nearly reach brick-haven operating income and to record positive adjusted EBITDA in the third quarter, one quarter sooner than anticipated. We continue to optimize our existing commercial process, including enhancing our emphasize on larger institutional and enterprise customers that are playing an increasingly important role within the industry. We remain focused on adding deep TMS technology into this expanding large mental health group or networks. As our results indicate, we are executing well on this strategy. Recent key agreements include the formation of an important partnership with a mental health clinical treatment provider with an increasingly expanding footprint in the Northeast region of the US. As a result of this partnership, and the series of successive order, a total of 10 deep TMS systems will be installed by this provider in 2023 alone, with the potential for additional systems thereafter. In addition, our longstanding partner, Katie's Way Plus, has ordered an additional 10 deep TMS systems, which will be more than double its existing offering. This agreement is especially gratifying that it will support Katie's Way Plus in its vital mission to provide focused care to U.S. service members, veterans, and their families. Moreover, our international business continues to perform very well. To this end, we expanded the availability of our deep TMS technology in Taiwan, where the most recent delivery of system increased the install base in this important Asia Pacific country to 16 systems. Importantly, the momentum we experienced in our business during the first half of the year continued in the third quarter, and our outlook for the fourth quarter is positive as well. On the top line, our third quarter revenue increased 61% year over year, and we shipped a net total of 56 systems during the third quarter. Moreover, demand for OCD treatment indication continued to grow as we shipped 48 OCD coils as a head-on helmet to certain new and existing systems. Nearly 50% of our total install base now includes OCD treatment capabilities. As we said would be the case, our third quarter bottom line included meaningful benefit of the cost optimization measures we executed on earlier this year as we generated substantial improvement in operating and adjusted EBITDA results. we expect further bottom line improvement in the fourth quarter. In addition, we continue to be supported by an extremely strong balance sheet, having ended the period with $44.2 million in cash with no debt. Moreover, we were cash flow positive in the third quarter. As our third quarter results reflect, we are confident in the upward trajectory of our overall business, and look forward to further progress in the fourth quarter. In order to achieve further growth, we continue to achieve significant progress in expanding the clinical and real-world evidence in support of deep TMS. We recently presented two deep TMS posters at the World Congress of Psychiatry. The first poster highlighted the benefit of deep TMS in the difficult to treat elderly population. The second poster focused on the positive results from a group of patients receiving an accelerated deep TMS regime. This accelerated treatment approach was also the subject of the publication of new real-world post-marketing data demonstrating the efficacy of deep TMS administered over the multiple sessions each day to allow for quicker overall treatment time for depression patients. The compelling results were published in the peer-reviewed journal Psychiatry Research and the data suggested that outcome can be achieved with accelerated deep TMS, which are comparable to those resulting from longer traditional protocols. These preliminary results could be leveraged to support effort to expand current labeling for deep TMS, and we intend to further investigate the potential efficacy of accelerated deep TMS in the treatment of depression. On the commercial front, following the reprioritized allocation of our commercial investment, we have decided to seek a distribution partner for smoking cessation indication. Importantly, the data from the initial patients utilizing deep TMS therapy for smoking continues to look favorable, and we are beginning to gain commercial traction with this offering. In addition, the recent positive recommendation issued by the Clinical TMS Society that advocates for reimbursement related to TMS for the treatment of smoking addiction is an important step toward securing insurance coverage for this indication. Moving on, before I pass the call over to Ido for his review of our financial results, I would like to reiterate our confidence in the Brainsway outlook for full year 2023 and beyond. For full year 2023, we continue to expect to demonstrate revenue growth over 2022, and are now targeting positive operating income in the fourth quarter, as well as positive adjusted EBITDA for the second consecutive quarter. Looking ahead, the market dynamic continue to show that TMS is a large market with strong momentum, and there is ample room for BrainSway to continue capturing significant market share both in the U.S. and internationally. With that, I will now turn the call over to Ido for his review of our third quarter 2023 financial results. Ido?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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