BrainsWay Reports First Quarter 2021 Financial Results and Operational Highlights

Image

*Note, the numbers contained herein reflect certain updates to the previous unaudited financial results for the first
Quarter 2021, pursuant to BrainsWay’s May 24, 2021 filing with the SEC, available free of charge at
http://www.sec.gov

Strong Revenue Growth of 47% Year-over-Year in Q1 2021

Successfully Executed Initial U.S. Controlled Market Release of Deep TMS for Smoking
Addiction

Strengthened Balance Sheet Through Successful Equity Offering; Ended Q1 2021 with $58.5
Million in Cash

CRESSKILL, N.J. and JERUSALEM, Israel, May 20, 2021 (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 first quarter 2021 financial results and provided an operational update.

Recent Financial and Operational Highlights

  • For the three months ended March 31, 2021, revenues were $6.1 million, a 47% increase as compared to the same period in 2020.
  • Operating loss for the first quarter of 2021 was $0.8 million, which included a one-time $0.6 million expense for stock-related compensation, as compared to $3.6 million for the first quarter of 2020.
  • As of March 31, 2021, BrainsWay’s Deep TMS installed base was 652 total systems, a 19% increase from the installed base at the same point in the prior year.
  • During the first quarter 2021, the Company shipped 9 OCD coils as add-on helmets to certain of BrainsWay’s new and existing systems, increasing the total number of OCD addon helmets to 225.
  • Surpassed 100,000 patients treated with Deep TMS therapy.
  • Launched Deep TMS as an aid for short-term smoking cessation in the U.S.
  • Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s Theta Burst three-minute protocol utilizing Deep TMS for the treatment of major depressive disorder (MDD).
  • Appointed seasoned healthcare industry finance executive R. Scott Areglado as Senior Vice President and Chief Financial Officer.

“We are extremely pleased with the overall trends in our business, and are working to continue the strong momentum achieved late in 2020 and during the first quarter throughout the year,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Our revenues of $6.1 million represented a significant 47% increase over our first quarter of 2020, demonstrating the resiliency of our business and continued emergence from the COVID-19 pandemic. We marked a true milestone for our revolutionary approach to mental health treatment with the recent treatment of our 100,000th patient, and this was complemented by impressive commercial and regulatory achievements, including our successful follow-on raise of $45.2 million in gross proceeds, the controlled market release of our smoking addiction system, and the FDA’s clearance of our three-minute Theta Burst depression protocol. We believe these accomplishments position us well to generate long-term shareholder value and to advance in our mission to improve health and transform lives.”

First Quarter 2021 Financial Results

  • Total revenues for the first quarter of 2021 were $6.1 million, compared to $4.2 million in the first quarter of 2020, an increase of 47%. Quarterly recurring lease revenues were $3.5 million, remaining consistent with the first quarter of 2020, and comprising approximately 56% of total revenues.
  • Gross margin for the first quarter of 2021 was 75%, compared to 76% for the first quarter of 2020.
  • Operating expenses for the first quarter of 2021 were $5.5 million, including a one-time $0.6 million expense for stock-related compensation, compared to $6.8 million for the first quarter of 2020.
  • For the three months ended March 31, 2021, operating loss was $0.8 million, of which $0.6 million was a one-time expense for stock-related compensation. This is compared to an operating loss of $3.6 million during the same period in the prior year.
  • As of March 31, 2021, the Company had cash and short-term deposits of approximately $58.5 million, compared to $17.2 million at December 31, 2020. The significantly increased cash position reflects the completion of the Company’s public offering, which was closed in March 2021 and generated gross proceeds of $45.2 million.

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) 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 Cresskill, NJ 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.

Contacts:
BrainsWay:
Scott Areglado
SVP and Chief Financial Officer
Scott.Areglado@BrainsWay.com

Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com

 

 

Consolidated statements of Financial Position 01 picture

 

 

 

Consolidated statements of comprehensive loss 01 picture

 

 

 

Consolidated statements of Cash Flows 01 picture