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 November 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 Third Quarter 2022 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: November 16, 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 Third Quarter 2022 Financial Results and Operational Highlights

Conference call to be held today, November 16, 2022, at 8:30 AM ET

BURLINGTON, Mass. and JERUSALEM, Nov. 16, 2022 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a world leader in advanced and non-invasive treatment for brain disorders, today reported third quarter 2022 financial results and provided an operational update.

Recent Financial and Operational Highlights

“While the current macroeconomic environment continues to present challenges to both our smaller customers and patients, we remain vigilant in controlling expenses,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “We are confident that we have the right plan in place for growth. One of our key growth initiatives is the planned strengthening of our salesforce. As we target larger, enterprise customers that are somewhat more insulated from economic fluctuations, we are focused on ensuring that when the sales team is appropriately built out, it is comprised of experienced professionals who can effectively communicate our differentiation and the significant return on investment that can be generated with Deep TMS.”

“Importantly, we are fortified with a strong balance sheet and believe that there are several tailwinds in our business. We continue to achieve sustainable success internationally, make further progress with reimbursement, execute on key clinical and regulatory milestones, and increase market awareness for Deep TMS. In addition, we believe that we have multiple growth catalysts ahead of us and favorable industry trends should present a highly compelling long-term outlook for our business,” concluded Dr. von Jako.

Third Quarter 2022 Financial Results

Conference Call and Webcast

BrainsWay’s management will host a conference call on Wednesday, November 16, 2022, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Wednesday, November 16, 2022, at 8:30 AM Eastern Time:

United States: 1-877-407-3982
International: 1-201-493-6780
Conference ID: 13733745
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1577185&tp_key=a7877d8429

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 clinical 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 Statement
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. 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 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, 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.

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. AND SUBSIDIARIES
  CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
  U.S. dollars in thousands
           
      September 30,

December 31

        2022       2021  
  ASSETS   (Unaudited)
  Current Assets        
  Cash and cash equivalents   $ 49,352     $ 16,921  
  Short-term deposits     271       40,428  
  Trade receivables, net     5,598       6,332  
  Inventory     3,235       -  
  Other current assets     1,736       1,766  
        60,192       65,447  
  Non-Current Assets        
  System components     2,036       4,463  
  Leased systems, net     3,557       3,813  
  Other property and equipment     1,018       1,055  
  Other long-term assets     863       954  
        7,474       10,285  
      $ 67,666     $ 75,732  
           
  LIABILITIES AND EQUITY        
  Current Liabilities        
  Trade payables   $ 1,286     $ 1,103  
  Deferred revenue     2,483       2,195  
  Liability in respect of research and development grants     1,095       978  
  Other accounts payable     3,927       4,792  
        8,791       9,068  
  Non-Current Liabilities        
  Deferred revenue and other liabilities     4,250       3,419  
  Liability in respect of research and development grants     5,715       5,921  
        9,965       9,340  
           
  Equity        
  Share capital     363       362  
  Share premium     137,944       137,566  
  Share-based payment reserve     6,029       5,340  
  Currency Translation Adjustments     (2,188 )     (2,188 )
  Accumulated deficit     (93,238 )     (83,756 )
        48,910       57,324  
           
      $ 67,666     $ 75,732  
           

 
 

                       
  BRAINSWAY LTD. AND SUBSIDIARIES  
  CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS  
  U.S. dollars in thousands (except per share data)  
                       
        For the three months ended September 30,   For the nine months ended September 30,  
          2022       2021       2022       2021    
        (Unaudited)   (Unaudited)  
  Revenues     $ 5,168     $ 8,061     $ 21,144     $ 21,187    
  Cost of revenues       1,341       1,930       5,400       4,693    
  Gross profit       3,827       6,131       15,744       16,494    
                       
  Research and development expenses, net       2,220       1,786       5,527       4,361    
  Selling and marketing expenses       4,751       4,042       13,449       11,362    
  General and administrative expenses       1,726       1,536       5,128       4,318    
  Total operating expenses       8,697       7,364       24,104       20,041    
                       
  Operating loss       (4,870 )     (1,233 )     (8,360 )     (3,547 )  
                       
  Finance expense, net       (99 )     (360 )     (752 )     (1,041 )  
  Loss before income taxes       (4,969 )     (1,593 )     (9,112 )     (4,588 )  
  Income taxes       70       211       370       527    
  Net loss and total comprehensive loss     $ (5,039 )   $ (1,804 )   $ (9,482 )   $ (5,115 )  
                       
  Basic and diluted net loss per share     $ (0.15 )   $ (0.05 )   $ (0.29 )   $ (0.17 )  
                       

 
 

                     
  BRAINSWAY LTD. AND SUBSIDIARIES  
  CONSOLIDATED STATEMENTS OF CASH FLOWS  
  U.S. dollars in thousands  
                     
      For the three months ended September 30,   For the nine months ended September 30,  
        2022       2021       2022       2021    
      (Unaudited)   (Unaudited)  
  Cash flows from operating activities:                  
  Total comprehensive loss   $ (5,039 )   $ (1,804 )   $ (9,482 )   $ (5,115 )  
  Adjustments to reconcile net loss to net cash used in operating activities:    
  Adjustments to profit or loss items:                  
  Depreciation and amortization     160       109       457       390    
  Depreciation of leased systems     244       279       735       859    
  Impairments and disposals     183       405       416       885    
  Finance expenses, net     99       360       752       1,041    
  Cost of share based payment     339       394       1,121       1,477    
  Income taxes     70       211       370       527    
  Total adjustments to reconcile loss     1,095       1,758       3,851       5,179    
  Changes in asset and liability items:                  
  Increase (decrease) in trade receivables     1,770       (656 )     635       (1,787 )  
  Decrease in inventory     (846 )     -       (2,952 )     -    
  Increase (decrease) in other accounts receivable     (340 )     107       (658 )     (892 )  
  Increase (decrease) in trade payables     (392 )     222       169       136    
  Increase (decrease) in other accounts payable     461       (395 )     (433 )     (595 )  
  Increase in deferred revenues and other liabilities     835       227       1,103       439    
  Total changes in asset and liability     1,488       (495 )     (2,136 )     (2,699 )  
  Cash paid and received during the period for:                  
  Interest paid     (10 )     (16 )     (34 )     (46 )  
  Interest received     313       2       620       4    
  Income taxes paid     (70 )     -       (336 )     (12 )  
  Total cash paid and received during the period     233       (14 )     250       (54 )  
  Net cash used in operating activities:     (2,223 )     (555 )     (7,517 )     (2,689 )  
                     
  Cash flows from investing activities:                  
  Proceeds from (purchase of) property and equipment and system components, net     108       (145 )     1,508       (1,062 )  
  Withdrawal of (investment in) short-term deposits, net     -       -       40,254       (40,000 )  
  Investment in long-term deposits, net     (15 )     (1 )     (20 )     (12 )  
  Net cash provided by (used in) investing activities     93       (146 )     41,742       (41,074 )  
                     
  Cash flows from financing activities:                  
  Repayment of liability in respect of research and development grants     (479 )     -       (977 )     (373 )  
  Receipt of government grants     9       302       15       469    
  Repayment of lease liability     (162 )     (133 )     (460 )     (360 )  
  Issuance of share capital, net     (53 )     -       (52 )     42,260    
  Net cash provided by (used in) financing activities     (685 )     169       (1,474 )     41,996    
  Exchange rate differences on cash and cash equivalents     (7 )     (81 )     (320 )     (211 )  
                     
  Increase (decrease) in cash and cash equivalents     (2,822 )     (613 )     32,431       (1,978 )  
  Cash and cash equivalents at the beginning of the period     52,174       15,596       16,921       16,961    
  Cash and cash equivalents at the end of the period   $ 49,352     $ 14,983     $ 49,352     $ 14,983    
                     
  (a) Significant non cash transactions:                  
  Recognition of new lease liability and right-of-use     117       404       240       587