BrainsWay Reports Third Quarter 2024 Financial Results and Operational Highlights

Robust 26% Year-over-Year Revenue Growth in Q3 2024

Raising Full-Year 2024 Revenue Guidance to $40-41 Million and Initiating Profitability Guidance

Conference Call to be Held Today at 8:30 AM ET

BURLINGTON, Mass. and JERUSALEM, Israel, Nov. 12, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today reported third quarter 2024 financial results and provided an operational update.

Recent Financial and Operational Highlights

   -- For the three months ended September 30, 2024, revenues were $10.5 
      million, a 26% increase compared to the same period in 2023. 
 
   -- Gross margin for the third quarter of 2024 was 74%, steady from the same 
      period in 2023. 
 
   -- Operating income for the third quarter of 2024 was $0.3 million, compared 
      to a loss of $0.1 million for the same period in 2023. 
 
   -- Net income for the third quarter of 2024 was $0.7 million, compared to a 
      net loss of $0.2 million for the third quarter of 2023. 
 
   -- Adjusted EBITDA1 for the third quarter of 2024 was approximately $1.1 
      million, compared to $0.3 million for the third quarter of 2023. 
 
   -- As of September 30, 2024, cash and cash equivalents and short-term 
      deposits totaled $48.4 million, reflecting a $0.3 million increase from 
      June 30, 2024. 
 
   -- Following the end of the third quarter, the Company closed on an equity 
      financing by Valor Equity Partners, receiving gross proceeds of 
      approximately $20 million to date, before deducting offering expenses and 
      before any potential exercise of warrant rights by Valor. BrainsWay 
      intends to leverage this new capital and Valor's expertise for strategic 
      initiatives aimed at building market awareness, its R&D roadmap, and 
      expanding access to Deep TMS$(TM)$. 
 
   -- Through the first nine months of 2024, BrainsWay shipped a total of 177 
      Deep TMS systems, representing a 12% increase from the same period last 
      year. 
 
   -- Israel Ministry of Defense's Rehabilitation Department approved 
      reimbursement for Deep TMS therapy for qualifying PTSD patients in public 
      hospitals. 
 
   -- Appointed Dr. Richard Bermudes, who is widely considered one of the 
      preeminent U.S. clinicians in the TMS field, as BrainsWay's new Chief 
      Medical Officer $(CMO)$, effective September 1, 2024. 
 
   -- Expanded U.S. East Coast access to Deep TMS with order of 14 new systems 
      by large enterprise mental health treatment network. 
 
   -- Expanded the presence of Deep TMS in East Asia through the placement of 
      15 new systems in Taiwan and South Korea. 
 
   -- Continued progress in the Company's randomized, multicenter U.S. clinical 
      trial evaluating an accelerated treatment protocol for the Deep TMS 
      system for major depressive disorder (MDD) treatment as compared to the 
      current standard-of-care Deep TMS protocol. 

(________________________1) See Adjusted EBITDA details and reconciliation table in the appendix below.

Full Year 2024 Financial Guidance

   -- Increasing full-year 2024 revenue guidance to between $40 million to $41 
      million, which represents 25% to 29% growth over 2023 revenue. 
 
   -- Anticipating continued profitability and positive cash flow, and 
      expecting operating income of 3-4% and Adjusted EBITDA of 10-11% for the 
      full year. 

"Global demand for our Deep TMS system continued to grow throughout the first nine months of 2024, strengthening our leadership position in the market. Our focus remains on building sustainable growth by investing strategically in our long-term vision. Our commitment to driving innovation and expanding treatment possibilities is stronger than ever, with key investments across three core areas, including the development of our next-generation Deep TMS 360(TM) system, conducting clinical trials to broaden and enhance treatment capabilities, and expanding our commercial presence through targeted sales and marketing efforts. These critical investments reflect our dedication to leading the industry in mental health and neurological care, providing impactful and accessible solutions for patients worldwide," said Hadar Levy, BrainsWay's Chief Executive Officer.

"Our recent private financing with Valor Equity Partners will enable us to explore new markets and revenue channels, including different customer types and commercial partnerships. This will further strengthen our potential for accelerated growth and enhance access to Deep TMS," concluded Mr. Levy.

Call and Webcast

BrainsWay's management will host a conference call on Tuesday, November 12, 2024, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Tuesday, November 12, 2024, at 8:30 AM Eastern Time:

 
  United States:                                                1-877-300-8521 
  International:                                                1-412-317-6026 
  Israel:           1-80-921-2373 
   Conference ID:    10193781 
  Webcast:          https://viavid.webcasts.com/starthere.jsp?ei=16 
                    93565&tp_key=866e8470e a 
 
 

The conference call will be broadcast live and will be available for replay for 30 days on the Company's website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company's website at least 10 minutes ahead of the conference call to register.

Non-IFRS Financial Measures

In addition to our results determined in accordance with International Financial Reporting Standards (IFRS), including in particular operating income and net income, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net income adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses.

In addition to operating income (loss) and net income (loss), we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-IFRS financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons:

   -- Adjusted EBITDA is widely used by investors and securities analysts to 
      measure a company's operating performance without regard to items such as 
      stock-based compensation expenses, depreciation and amortization, finance 
      expenses, income taxes, and certain one-time items such as restructuring 
      and litigation expenses, that can vary substantially from company to 
      company depending upon their financing, capital structures and the method 
      by which assets were acquired. 
 
   -- Our management uses Adjusted EBITDA in conjunction with IFRS financial 
      measures for planning purposes, including the preparation of our annual 
      operating budget, as a measure of operating performance and the 
      effectiveness of our business strategies and in communications with our 
      board of directors concerning our financial performance; and Adjusted 
      EBITDA provides consistency and comparability with our past financial 
      performance, facilitates period-to-period comparisons of operations, and 
      also facilitates comparisons with other peer companies, many of which use 
      similar non-IFRS or non-GAAP financial measures to supplement their IFRS 
      or GAAP results. 

Adjusted EBITDA, however, should not be considered as an alternative to operating income (loss) or net income (loss) for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. A reconciliation between the Company's net income (loss) and Adjusted EBITDA is presented in the attached summary financial statements.

Because of these and other limitations, you should consider Adjusted EBITDA along with other IFRS-based financial performance measures, including net income (loss) and our IFRS financial results.

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS(TM)) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

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November 12, 2024 07:30 ET (12:30 GMT)