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Brainsway Reports Financial Results for Second Quarter of 2018 and Provides Corporate Update

Second quarter revenues of $3.7 million represent a quarterly record and a 57% increase over second quarter 2017

Recently announced FDA clearance of Deep TMS system for treatment of OCD expected to drive further revenue growth

HACKENSACK, N.J., Aug. 27, 2018 (GLOBE NEWSWIRE) -- Brainsway Ltd. (TASE: BRIN), a leader in the advanced non-invasive treatment of brain disorders, today announced the Company’s financial results for the three months ended June 30, 2018, and provided a corporate update.

Second Quarter 2018 Financial Highlights
• Total second quarter 2018 revenue was a quarterly record $3.7 million, up 57% over the $2.4 million of total revenues in the second quarter of 2017

  • Recurring leasing revenues of $2.3 million, an increase of 42% over the second quarter of 2017
  • Sales revenues of $1.5 million in the second quarter of 2018, an increase of 85% over the second quarter of 2017

• Quarterly record of newly signed contracts in the second quarter of $4.5 million increased Brainsway’s backlog at June 30, 2018, to $29.3 million in total committed projected revenues from current leasing customers, not including additional potential usage fees
• Gross margin for the second quarter of 2018 was 77%
• 45% reduction in operating loss to $1.0 million in the second quarter of 2018, as compared to an operating loss of $1.8 million in the second quarter of 2017

“We continue to generate significant revenue growth through the leasing and use of our Deep Transcranial Magnetic Stimulation system (Deep TMS),” said Yaacov Michlin, Chief Executive Officer of Brainsway. “Our strong second quarter revenues of $3.7 million represented growth of 57% over the second quarter of 2017.  Additionally, our backlog of committed projected revenues grew to more than $29 million at the end of the second quarter of 2018.”

“We were extremely pleased to recently receive De Novo clearance from the U.S. Food & Drug Administration (FDA) for our Deep TMS system for the treatment of obsessive-compulsive disorder (OCD) in adults.  With more than two million U.S. adults suffering from OCD, this indication represents a substantial market opportunity for Brainsway.  As such, we expect the launch of Deep TMS for OCD to drive further revenue growth for the Company, and are already receiving significant interest from current and new customers in potentially adding our OCD helmet to their clinics.  With FDA clearances for Deep TMS in major depressive disorder (MDD), and now OCD, Brainsway continues to strengthen its leadership position in the non-invasive treatment of common brain disorders, and we look forward to continuing to develop our innovative technology for additional psychiatric indications,” concluded Mr. Michlin.

Corporate Highlights
• Received FDA clearance for Deep TMS for treatment of OCD

  • First ever non-invasive medical device clearance for the treatment of OCD
  • Second indication granted FDA clearance for Deep TMS; MDD cleared in 2013

• Received FDA clearance for next-generation stimulator, enhancing the complete Deep TMS system and streamlining treatment for physicians and their patients
• Established a research collaboration with Cohen Veterans Bioscience and the Stanford University School of Medicine to identify potential biomarkers in patients suffering from Post-Traumatic Stress Disorder (PTSD)

  • Collaboration designed as an add-on study involving the collection and analysis of electroencephalogram data from patients currently enrolled in Brainsway’s ongoing multi-center trial evaluating the safety and efficacy of Deep TMS for the treatment of PTSD

• Continued patient recruitment into multi-center smoking cessation and PTSD clinical trials for Deep TMS; completion of recruitment in smoking cessation study expected shortly

Balance Sheet
At June 30, 2018, the Company had cash, cash equivalents and short-term deposits of $11.6 million, as compared to cash, cash equivalents and short-term deposits of $14.6 million as of December 31, 2017.  

About Brainsway
Brainsway is engaged in the research, development and sales and marketing of a medical system for non-invasive treatment of common brain disorders. The medical system developed and manufactured by the company is based on a unique breakthrough technology called deep transcranial magnetic simulation (Deep TMS), which can directly reach significant depth and breadth of the brain and produce broad stimulation and functional modulation of targeted brain areas. In the U.S., the Company’s device has been FDA cleared for the treatment of major depressive disorder (MDD) since 2013, and for OCD since August 2018.   The Company's systems have also received CE clearance and are sold worldwide for the treatment of various brain disorders.

Forward Looking Statements  
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions.  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. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our device studies; our products may not be approved by regulatory agencies: we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.

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 Brainsway Ltd.'s periodic filings with the Tel-Aviv Stock Exchange.

Brainsway Ltd.
Hadar Levy
Chief Financial Officer 

Bob Yedid
LifeSci Advisors

Sara Zelkovic
LifeSci Public Relations


Monday, August 27, 2018 - 08:00