Washington, D.C. 20549

Form 6-K


For the month of March 2020

Commission File Number: 001-35165

(Translation of registrant's name into English)

19 Hartum Street
Bynet Building, 3rd Floor
Har HaHotzvim
Jerusalem, 9777518, Israel
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  

The following document, which is attached as an exhibit hereto, is incorporated by reference herein:

Exhibit       Title
99.1 Brainsway Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights

This Form 6-K is incorporated by reference into the Company's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on April 22, 2019 (Registration No. 333-230979).


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

      BRAINSWAY LTD.    
Date: March 23, 2020     /s/ Hadar Levy     
  Hadar Levy
  Chief Financial Officer


BrainsWay Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights

Fourth quarter revenues were $6.3 million, up 32% over the same quarter in the prior year

PATTERSON, N.J., March 23, 2020 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in the advanced non-invasive treatment of brain disorders, today reported financial results for the quarter and full-year ended December 31, 2019, and provided an operational update.

“We are very pleased with our solid fourth quarter and full-year 2019 results. Our strong results are indicative of the continued growing demand for our deep transcranial magnetic stimulation (Deep TMS) system in major depressive disorder (MDD) and obsessive compulsive disorder (OCD). In addition, we have achieved key progress in advancing our clinical pipeline for future potential applications,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Like other organizations, BrainsWay continues to monitor the rapidly evolving impact of the coronavirus closely, and our thoughts are with all of those affected. Without question, our top priority is the health and well-being of our loyal and growing customer base, their patients, and our employees. We have already taken steps to minimize the spread of coronavirus, while at the same time ensuring our customers that we remain fully operational as patients continue to receive their Deep TMS treatments.”

Financial Results for the Full-Year Ended December 31, 2019

Financial Results for the Fourth Quarter Ended December 31, 2019

Recent Corporate Developments

Conference Call and Webcast
BrainsWay’s management will host a conference call on Monday, March 23, 2020, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Monday, March 23, at 8:30 AM Eastern Time:

Telephone conference
Dial in information:
Standard international: +44 (0) 2071 928000
Israel, Tel Aviv (Local): +972-3 721 7998       
United States, New York (Local): +1 631-510-7495    
Confirmation Code:  7074659

To listen to a live webcast, please visit the Investors section of the BrainsWay website at www.BrainsWay.com. The webcast replay will be available on the website for two weeks following the completion of the call.

About BrainsWay
BrainsWay is a commercial stage medical device company focused on the development and sale of non-invasive neuromodulation products using the Company’s proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) technology for the treatment of major depressive disorder (MDD) and obsessive compulsive disorder (OCD), for which BrainsWay received marketing authorization from the U.S. Food and Drug Administration (FDA) in 2013 (for MDD) and in August 2018 (for OCD). BrainsWay is currently conducting clinical trials of Deep TMS in other psychiatric, neurological and addiction disorders.

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. For example, such uncertainties include the recent outbreak of the Coronavirus (COVID-19), which has led governments and authorities around the globe to take various precautionary measures in order to limit the spread of the outbreak, including government-imposed quarantines and other public health safety measures. These measures could have an adverse effect on the global markets and its economy, including on the availability and pricing of materials, manufacturing and delivery efforts, sales to existing and potential customers and leads, collections from accounts and other aspects of the global economy. Therefore, the Coronavirus could disrupt production and cause delays in the supply and delivery of products used in our operations, may further divert the attention and efforts of the medical community to coping with the Coronavirus,  impact the recruitment of subjects to existing and planned clinical trials, disrupt the marketplace in which we operate, and may have a material adverse effects on our operations, sales, revenues, collections, and R&D efforts. 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: 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 in 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, 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 the Company’s filings with the U.S. Securities and Exchange Commission.

BrainsWay Ltd.
Hadar Levy
Chief Operating Officer and Chief Financial Officer

Bob Yedid
LifeSci Advisors



U.S. dollars in thousands (except share and per share data)

    December 31, 
    2019  2018 
    U.S. dollars in thousands 
Cash and cash equivalents   $21,674  $8,968 
Short-term deposits    221   101 
Trade receivables, net    5,507   2,904 
Other accounts receivable    1,427   1,505 
     28,829   13,478 
Restricted deposit       1,007 
Long-term prepaid expenses       1,345 
Long-term deposit    168   146 
Leased systems    5,491   4,690 
System components and other property and equipment   $4,248  $2,936 
     9,907   10,124 
    $38,736  $23,602 
Trade payables   $1,320  $2,243 
Other accounts payable    3,379   3,459 
Deferred revenues    1,305   1,333 
Loan from bank       750 
Liability in respect of research and development grants    714   554 
     6,718   8,339 
Loan from bank       2,083 
Deferred revenues and other liabilities    2,353   1,108 
Liability in respect of research and development grants    5,367   4,980 
Warrants    78   140 
     7,798   8,311 
Share capital    233   171 
Share premium    93,649   67,193 
Share-based payment    4,435   3,357 
Adjustments arising from translating financial statements from functional currency to presentation currency    (2,188)  (2,188)
Accumulated deficit    (71,909)  (61,581)
     24,220   6,952 
    $38,736  $23,602 



U.S. dollars in thousands (except share and per share data)

 Year ended
December 31,
 Three months ended
December 30,
  2019  2018   2019  2018 
Revenues$23,101 $16,397  $6,292 $4,772 
Cost of revenues 5,129  3,589   1,442  1,105 
Gross profit 17,972  12,808   4,850  3,667 
Research and development expenses, net 7,876  6,156   1,809  1,822 
Selling and marketing expenses 13,269  8,345   3,604  2,529 
General and administrative expenses 5,303  3,421   1,428  1,068 
Total operating expenses 26,448  17,922   6,841  5,419 
Operating loss 8,476  5,114   1,991  1,752 
Finance expense, net 1,430  1,156   178  322 
Loss before income taxes 9,906  6,270   2,169  2,074 
Income taxes 422  209   147  75 
Net loss and total comprehensive loss$10,328 $6,479  $2,316 $2,149 
Basic and diluted net loss per share$(0.50)$(0.39) $(0.10)$(0.13)



U.S. dollars in thousands

 Year ended
December 31,
Three months
December 31,
  2019  2018  2019  2018 
Cash flows from operating activities:    
Total comprehensive loss$(10,328)$(6,479)$(2,316)$(2,149)
Adjustments to reconcile net loss to net cash used in operating activities:    
Adjustments to the profit or loss items:    
Depreciation, amortization and impairment 1,741  463  340  37 
Depreciation of leased systems 1,054  765  319  210 
Finance expenses, net 1,430  1,157  178  323 
Cost of share‑based payment 1,263  710  282  249 
Income taxes 422  209  147  75 
  5,910  3,304  1,266  894 
Changes in asset and liability items:    
Decrease (increase) in trade receivables (2,634) (419) (469) 219 
Decrease (increase) in other accounts receivable 136  (595) 123  (538)
Decrease in long-term prepaid expenses -  (217) -  (217)
Increase (decrease) in trade payables 175  859  (251) 1,058 
Increase (decrease) in other accounts payable (385) 482  (128) (155)
Increase (decrease) in deferred revenues and other liabilities 555  (314) 536  (61)
  (2,153) (204) (189) 306 
Cash paid and received during the period for:    
Interest paid (296) (239) (29) (50)
Interest received 175  37  48  5 
Income taxes paid (552) (192) (10) (10)
  (673) (394) 9  (55)
Net cash used in operating activities (7,244) (3,773) (1,230) (1,004)

Cash flows from investing activities:
Purchase of property and equipment and system components (3,311) (1,972) (338) (532)
Investment in short‑term deposits, net (120) (50) (36) - 
Withdrawal of (Investment in) long‑term deposits, net 985  886  (22) 1,017 
Net cash used in investing activities (2,446) (1,136) (396) 485 

Cash flows from financing activities:    
Repayment of loan from bank, net (3,000) -  -  - 
Receipt of government grants 176  149  35  17 
Repayment of liability in respect of research and development grants (601) (414) (326) - 
Repayment of lease liability (434) -  (123) - 
Proceeds from issuance of shares, net 26,333  -  -  - 
Net cash provided by (used in) financing activities 22,474  (265) (414) 17 
Exchange rate differences on cash and cash equivalents (78) (367) (27) (32)
Increase (decrease) in cash and cash equivalents 12,706  (5,541) (2,067) (534)
Cash and cash equivalents at the beginning of the period 8,968  14,509  23,741  9,502 
Cash and cash equivalents at the end of the period$21,674 $8,968 $21,674 $8,968