UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of March 2022

Commission File Number: 001-35165

BRAINSWAY LTD.
(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):  

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) and the Company's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on September 17, 2021 (Registration No. 333-259610).


EXHIBIT INDEX 

Exhibit Title
   
99.1 BrainsWay Reports Fourth Quarter and Full-Year 2021 Financial Results and Operational Highlights


SIGNATURES

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.    
  (Registrant)
   
  
Date: March 9, 2022     /s/ Christopher R. von Jako, Ph.D    
  Christopher R. von Jako, Ph.D
  President and Chief Executive Officer
  
EdgarFiling

EXHIBIT 99.1

BrainsWay Reports Fourth Quarter and Full-Year 2021 Financial Results and Operational Highlights

Revenue Growth of 34% in 2021, with Record Quarterly and Annual Revenues

Continued Progress in Expanding FDA Labeling for Deep TMS™ and Increasing Payor Coverage

Conference call to be held today, March 9, 2022, at 8:30 AM ET

BURLINGTON, Mass. and JERUSALEM, March 09, 2022 (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 fourth quarter and full year 2021 financial results and provided an operational update.

Recent Financial and Operational Highlights

“Our fourth quarter revenues reflect the continued solid execution by our team,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “We generated $29.7 million in revenue for full-year 2021, which represented a 34% increase over full-year 2020. Moreover, demand for our Deep TMS therapy in multiple indications led to a strong close to the year, as we generated $8.5 million in revenue for the fourth quarter of 2021 – a robust 20% increase over our fourth quarter 2020. This is particularly noteworthy given the recent Omicron surge, and we have now demonstrated year-over-year growth in six consecutive quarters. We anticipate that the current positive operating trends that drove our significant momentum in 2021, highlighted by recent achievements on the commercial, clinical, regulatory, and reimbursement fronts, will lead to further growth for BrainsWay in 2022 and beyond.”

 

 

“Importantly, we continue to achieve important progress in securing reimbursement for Deep TMS in OCD,” continued Dr. von Jako. “Our most recent achievement in this arena was the final LCD issued by the Palmetto GBA MAC, which covers over 20% of the Medicare population and now brings the total number of covered lives eligible for Deep TMS OCD coverage to approximately 60 million. We also continue to publish compelling data on Deep TMS in multiple key areas, with our most recent publications highlighting our innovative technology in alcohol use disorder, OCD, and anxious depression.”

Fourth Quarter 2021 Financial Results

Financial Results for the Full-Year Ended December 31, 2021

Conference Call and Webcast

BrainsWay’s management will host a conference call on Wednesday, March 9, 2022, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Wednesday, March 9th, at 8:30 AM Eastern Time:

United States: 877-407-3982
Israel: 1 809 406 247
International: 1 201-493-6780
Conference ID: 13727217
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1530336&tp_key=1c81195bcb

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.

 

 

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 (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.

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; continuation and/or exacerbation of the global supply chain crisis and its impact on the Company’s ability to source components, meet customer demand, fill orders, maintain pricing levels and support the Company’s service needs; 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
844-386-7001
Scott.Areglado@BrainsWay.com

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




 

 

BRAINSWAY LTD.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
         
    December 31, December 31,  
    2021   2020
ASSETS   (Unaudited)
Current Assets        
Cash and cash equivalents   $ 16,921   $ 16,961
Short-term deposits   40,428   221
Trade receivables, net   6,332   5,582
Other current assets   1,766   1,534
Total current assets   65,447   24,298
         
Other long-term assets   954   163
System components   4,463   3,642
Leased systems   3,813   5,198
Other property and equipment   1,055   710
Total assets   $ 75,732   $ 34,011
         
LIABILITIES AND EQUITY        
Current Liabilities        
Trade payables   $ 1,103   $ 781
Other accounts payable   4,792   3,769
Deferred revenue   2,195   1,543
Liability in respect of research and development grants   978   707
Total current liabilities   9,068   6,800
         
Deferred revenue and other liabilities   3,419   2,053
Liability in respect of research and development grants   5,921   5,524
Total Liabilities   18,408   14,377
         
Equity:        
Share capital   362   233
Share premium   137,566   95,135
Share-based payment reserve   5,340   3,748
Currency Translation Adjustments   (2,188)   (2,188)
Accumulated deficit   (83,756)   (77,294)
Total Equity   57,324   19,634
         
Total Liabilities and Equity   $ 75,732   $ 34,011
         



 

 

BRAINSWAY LTD.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands (except per share data)
                   
    For the twelve months
ended December 31,
    For the three months
ended December 31,
      2021       2020         2021       2020  
    (Unaudited)     (Unaudited)
Revenues   $ 29,657     $ 22,057       $ 8,470     $ 7,066  
Cost of revenues     6,599       5,058         1,906       1,566  
Gross profit     23,058       16,999         6,564       5,500  
                   
Research and development expenses, net     6,393       5,823         2,032       1,576  
Selling and marketing expenses     15,880       11,283         4,518       2,999  
General and administrative expenses     5,784       4,722         1,466       1,332  
Total operating expenses     28,057       21,828         8,016       5,907  
                   
Operating loss     (4,999 )     (4,829 )       (1,452 )     (407 )
                   
Finance expense, net     (1,420 )     (319 )       (379 )     (239 )
Loss before taxes on income     (6,419 )     (5,148 )       (1,831 )     (646 )
Taxes on income     43       237         (484 )     (240 )
Net loss    $ (6,462 )   $ (5,385 )     $ (1,347 )   $ (406 )
                   
Basic and diluted net loss per share   $ (0.21 )   $ (0.24 )     $ (0.04 )   $ (0.02 )
                   


 

 

BRAINSWAY LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
         
    For the twelve months
ended December 31,
      2021       2020  
    (Unaudited)
Cash flows from operating activities:        
Net loss   $ (6,462 )   $ (5,385 )
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Adjustments to profit or loss items:        
Depreciation and amortization     560       438  
Depreciation of leased systems     1,126       1,180  
Impairment and Destructions     1,295       1,061  
Withdrawal of lease due to termination of contract     -       (5 )
Finance expenses, net     1,420       319  
Cost of share based payment     1,893       799  
Taxes on income     43       237  
         
Changes in asset and liability items:        
Increase in trade receivables     (849 )     (7 )
Increase in other assets     (1,226 )     (97 )
Increase (decrease) in trade payables     289       (552 )
Increase in other accounts payable     815       515  
Increase in deferred revenues and other liabilities     2,039       320  
         
Cash paid and received during the year for:        
Interest paid     (62 )     (71 )
Interest received     17       61  
Taxes on income paid     (14 )     (249 )
         
Cash provided by (used in) operating activities:     884       (1,436 )
         
Cash flows from investing activities:        
Purchase of property and equipment and system components, net     (2,238 )     (2,470 )
Investment in short-term deposits     (40,000 )     -  
Investment in long-term deposits     22       5  
Net cash used in investing activities     (42,216 )     (2,465 )
         
Cash flows from financing activities:        
Repayment of liability in respect of research and development grants     (761 )     (655 )
Receipt of government grants     492       42  
Repayment of lease liability     (475 )     (417 )
Issuance of share capital     42,260       -  
Net cash provided by (used in) financing activities     41,516       (1,030 )
Exchange rate differences on cash and cash equivalents     (224 )     218  
Decrease in cash and cash equivalents     (40 )     (4,713 )
Cash and cash equivalents at the beginning of the year     16,961       21,674  
Cash and cash equivalents at the end of the year   $ 16,921     $ 16,961  
         
(a) Significant non cash transactions:        
Purchase of property and equipment on credit     -       23  
Recognition of new lease liability and right-of-use     587       48  
Termination of lease liability and right-of-use     (64 )     (51 )