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 May 2023

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 [   ]

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 Number Description
   
99.1 BrainsWay Reports First Quarter 2023 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: May 17, 2023     /s/ Hadar Levy     
  Hadar Levy
  Chief Executive Officer
  
EdgarFiling

EXHIBIT 99.1

BrainsWay Reports First Quarter 2023 Financial Results and Operational Highlights

BURLINGTON, Mass. and JERUSALEM, May 17, 2023 (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 first quarter 2023 financial results and provided an operational update.

Recent Financial and Operational Highlights

“We remain focused on implementing key initiatives aimed at growing the Company’s top-line while simultaneously advancing toward profitability,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “Importantly, we are gaining strong interest from our international business which increased significantly during the first quarter and helped facilitate our shipment of a net total of 48 systems during the quarter.”

“We also executed a number of cost optimization measures late in the first quarter that we expect to begin seeing the benefits of in the second quarter, and more meaningfully in the second half of this year,” continued Mr. Levy. “We continue to target breakeven operating income in the fourth quarter of 2023, while demonstrating full-year revenue growth over 2022.”

First Quarter 2023 Financial Results

Conference Call and Webcast

BrainsWay’s management will host a conference call on Wednesday, May 17, 2023, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Wednesday, May 17, 2023, at 8:30 AM Eastern Time:

United States: 1-877-407-3982
International: 1-201-493-6780
Israel: 1-809-406-247
Conference ID: 13738617
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1613817&tp_key=17843474e5

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,” “aiming,” “targeting” 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:
Brian Ritchie
LifeSci Advisors
212-915-2578
britchie@lifesciadvisors.com

 

 

 
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
       
  March 31,   December 31,
    2023       2022  
ASSETS (Unaudited)
Current Assets      
Cash and cash equivalents $ 44,051     $ 47,581  
Short-term deposits   271       271  
Trade receivables, net   5,350       4,844  
Inventory   4,736       3,837  
Other current assets   1,738       1,556  
    56,146       58,089  
Non-Current Assets      
System components   483       1,220  
Leased systems, net   3,315       3,118  
Other property and equipment   947       1,008  
Other long-term assets   1,064       1,042  
    5,809   -   6,388  
  $ 61,955     $ 64,477  
       
LIABILITIES AND EQUITY      
Current Liabilities      
Trade payables $ 584     $ 1,116  
Deferred revenues   2,263       1,477  
Liability in respect of research and development grants   1,158       1,057  
Other accounts payable   5,159       4,491  
    9,164       8,141  
Non-Current Liabilities      
Deferred revenues and other liabilities   4,766       4,923  
Liability in respect of research and development grants   5,108       6,016  
    9,874       10,939  
       
Equity      
Share capital   364       364  
Share premium   138,146       138,146  
Share-based payment reserve   6,132       6,180  
Currency Translation Adjustments   (2,188 )     (2,188 )
Accumulated deficit   (99,537 )     (97,105 )
    42,917       45,397  
       
  $ 61,955     $ 64,477  
       

 

 

BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands (except per share data)
       
  For the three months ended March 31,
    2023       2022  
  (Unaudited)
Revenues $ 6,625     $ 7,970  
Cost of revenues   1,792       1,867  
Gross profit   4,833       6,103  
       
Selling and marketing expenses   4,912       4,146  
Research and development expenses, net   1,785       1,576  
General and administrative expenses   1,803       1,863  
Total operating expenses   8,500       7,585  
       
Operating loss   (3,667 )     (1,482 )
       
Finance income (expense), net   1,407       (324 )
Loss before income taxes   (2,260 )     (1,806 )
Taxes on income   171       187  
Net loss and total comprehensive loss $ (2,431 )   $ (1,993 )
       
Basic and diluted net loss per share $ (0.07 )   $ (0.05 )
       

 

 

BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
       
  For the three months ended March 31,
    2023       2022  
  (Unaudited)
Cash flows from operating activities:      
Total comprehensive loss $ (2,431 )   $ (1,993 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Adjustments to profit or loss items:      
Depreciation and amortization   93       142  
Depreciation of leased systems   233       245  
Impairments and disposals   246       (68 )
Finance expenses, net   (1,471 )     324  
Cost of share based payment   (51 )     374  
Income taxes   171       187  
Total adjustments to reconcile loss   (779 )     1,204  
Changes in asset and liability items:      
Increase in trade receivables   (493 )     (63 )
Increase in inventory   (928 )     (1,313 )
Increase in other accounts receivable   (222 )     (61 )
Decrease in trade payables   (535 )     (512 )
Increase (decrease) in other accounts payable   511       (510 )
Increase in deferred revenues and other liabilities   700       273  
Total changes in asset and liability   (967 )     (2,186 )
Cash paid and received during the period for:      
Interest paid   (31 )     (12 )
Interest received   674       3  
Income taxes paid   (7 )     (3 )
Total cash paid and received during the period   636       (12 )
Net cash provided by (used in) operating activities:   (3,541 )     (2,987 )
       
Cash flows from investing activities:      
Proceeds from property and equipment and system components, net   66       951  
Withdrawal of (investment in) short-term deposits, net   -       (50 )
Investment in long-term deposits, net   (2 )     (3 )
Net cash provided by (used in) investing activities   64       898  
       
Cash flows from financing activities:      
Repayment of liability in respect of research and development grants   -       (498 )
Receipt of government grants   -       6  
Repayment of lease liability   (66 )     (148 )
Issuance of share capital, net   -       1  
Net cash used in financing activities   (66 )     (639 )
Exchange rate differences on cash and cash equivalents   13       (88 )
       
Decrease in cash and cash equivalents   (3,530 )     (2,816 )
Cash and cash equivalents at the beginning of the period   47,581       16,921  
Cash and cash equivalents at the end of the period $ 44,051     $ 14,105  
       
(a) Significant non cash transactions:      
Recognition of new lease liability and right-of-use   24       -  
Termination of lease liability and right-of-use   11       -