8/6/2024

speaker
Operator
Conference Operator

All participants will be in listen-only mode. Should 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 LifeSci Advisors. Please go ahead.

speaker
Brian Ritchie
Moderator, LifeSci Advisors

Thank you all, and welcome to BrainsWay's second quarter 2024 earnings conference call. With us today are BrainsWay's Chief Executive Officer, Hadar 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, Rainsway released financial results for the three and six months ended June 30th, 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 pipelines, which are all subject to risks and uncertainty, 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 Brainswaste Form 20F. I would now like to turn the call over to Hadar.

speaker
Hadar Levy
Chief Executive Officer, BrainsWay

Thank you, Brian. Welcome, everyone, and thank you for joining us today. As reported earlier this morning, we had another outstanding quarter of growth. Most importantly, demand for our industry-leading deep TMS system continues to be strong, resulting in a year-over-year increase in revenues of 28% to $10 million for the second quarter of 2024. In addition, we generated positive quarterly net income for the third consecutive quarter and positive adjusted EBITDA and cash flow from operations for the fourth consecutive quarter. We also continue to be supported by an extremely strong balance sheet with $48.1 million in cash and no debt as of June 30th, 2024. Our outlook for the second half of 2024 remains strong and we are now raising the lower end of the guidance for full year 2024 revenue to a range of $38.5 million to $40 million. Therefore, we are now projecting growth of between 21% and 25% over our 2023 revenues. We also continue to anticipate that our profitability momentum and positive cash generation will extend for the full year. I would like to take a few moments to dive a little deeper into our key growth drivers. Looking more closely at the second quarter performance, We shipped a net total of 114 systems during the first two quarters, a 13% increase compared to the first half of 2023, resulting in an install base of 1,215 total deep TMS systems. Demanding our OCD treatment indication remains strong, and we continue to maintain treatment capability for this important indication on about 50% of our total install base. We also remain laser-focused on catering to the needs of our diverse customer base, their businesses, and the patients they serve. We continue to make progress in our penetration of both existing and new customer bases. This includes continuing to strengthen and expand partnerships with larger institutional and enterprise customers, which play an increasingly important role within the industry. We remain committed to incorporating our proprietary deep TMS technology into this expanding mental health group and networks. We have also looked to generate new sources of growth by increasing our international footprint through existing and new strategic distribution agreements. Currently, we have an exclusive distribution and agent agreement in several important countries around the globe, including in Asia and Europe. In June, we announced adding Canada to this list after signing an exclusive multi-year distribution agreement with a strong Canadian specialty distributor that services both the acute hospital and non-acute health care spaces. This agreement offered us broad market entry into Canada via its team of over 35,000 professionals. The agreement establishes a multi-year framework of minimum quantity orders beginning with 11 deep TMS systems in the first year, with successively increasing quarters in subsequent years. In order to support our future commercial efforts, our clinical development, medical, and regulatory teams continue their work on expanding the clinical benefits of our system. Most recently, we announced that the FDA granted us with an extended indication following for deep TMS treatment major depressive disorder patients ages 22 to 86. This represents an important change from the previous upper age limit, which had been set at 68. It also marks an important regulatory achievement, making deep TMS as the first and only form of TMS indicated for the treatment of patients over the age of 68 suffering from major depressive disorder, including those with comorbid and anxiety symptoms. We believe this important decision by the FDA will have a direct impact on our patients since depression does not disappear at age 68. On the contrary, it is prevalent but often more challenging to treat because certain brain targets sometimes move further away from the scalp at patient age. We believe that the deeper and broader stimulation of deep TMS helps overcome these age-related challenges. and we were able to demonstrate compelling clinical data on the efficacy of DeepTMS in older patients as part of our application to the FDA that preceded this labeling extension. Moving on, we also recently initiated clinical trial evaluating an accelerated depression treatment protocol for our DeepTMS system. Previously published post-marketing data that has shown that outcome achieved with accelerated deep TMS protocol were comparable with those from longer traditional protocols. We believe that an accelerated treatment protocol has the potential to improve convenience and make deep TMS substantially more appealing to many prospective patients. In closing, the BrainSweat team has executed extremely well across multiple fronts of our corporate strategy during the first half of 2024. As a result, we have generated strong growth, increased profitability, and are opening up new pathway for future growth. I could not be prouder of the progress we have made and look forward to a strong second half of the year and beyond. With that, I will now turn the call over to Ido for his review of our second quarter 2024 financial results.

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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