Strong Revenue Growth of 45% Year-over-Year in Q2 2021
Gained Meaningful Traction in Reimbursement for Deep TMS™ in both OCD and Depression
Conference Call to be held Today at 8:30 AM ET
BURLINGTON, MA. and JERUSALEM, Israel, August 11, 2021 – BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today reported second quarter 2021 financial results and provided an operational update.
Recent Financial and Operational Highlights
“We are pleased with our strong performance in the second quarter and the increasingly positive trends impacting our company,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Our revenues of $7.0 million represented a substantial 45% increase over the pandemic-impacted second quarter of 2020, as our business continues to demonstrate significant momentum.”
“Importantly, we are beginning to gain meaningful traction in OCD reimbursement, which we believe will be an important long-term growth driver in enhancing patient access to Deep TMS. Specifically, we received key positive coverage policies from Centene and HCSC, which collectively represent approximately 42 million covered lives. In addition, the first draft LCD was published proposing coverage applicable to the Deep TMS system for the treatment of OCD by Palmetto, a regional Medicare administrator, which represents over 9 million covered lives. This progress in reimbursement is already driving further interest in this strategic indication, with approximately two-thirds of recently shipped systems including an OCD add-on helmet. Moreover, we ended the second quarter with $55.9 million in cash, allowing us to operate the business from a position of financial strength,” concluded Dr. von Jako.
Second Quarter 2021 Financial Results
Conference Call and Webcast
BrainsWay’s management will host a conference call today, August 11, 2021, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
Wednesday, August 11, at 8:30 AM Eastern Time:
To listen to a live webcast, please visit the Investors section of the BrainsWay website at www.BrainsWay.com. Please access the Company’s website at least 10 minutes ahead of the conference call to register. The webcast replay will be available on the website for two weeks following the completion of the call.
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) 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 studies demonstrating clinically proven efficacy. Current indications include major depressive disorder, 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 and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, and the effect of the global COVID-19 health pandemic on our business and continued uncertainty and market impact relating thereto.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward- looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission, including the Company’s Annual Report on Form 20-F. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov.
SVP and Chief Financial Officer