AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Brainsway Ltd.

Foreign Filer Report Aug 13, 2025

6701_rns_2025-08-13_5eaeaadc-06f5-434b-a1bd-2348c059b9c4.pdf

Foreign Filer Report

Open in Viewer

Opens in native device viewer

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington,, D..C.. 2200554499

FORM 66--K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 1133a--1166 OR 1155d--1166 UNDER THE SECURITIES EXCHANGE ACT OF 11993344

For the month of August 22002255

Commission File Number:: 000011--3355116655

BRAINSWAY LTD..

((Translation of registrant''s name into English))

1166 Hartum Street RAD Tower,, 1144th Floor Har HaHotzvim Jerusalem,, 99777777551166,, Israel ((++997722--22)) 558822--44003300

((Address and telephone number of Registrant's principal executive office))

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 2200 --F or Form 4400--F.. Form 2200--F [ X ] Form 4400--F [ ]

This Form 66--K is incorporated by reference into the Company''s Registration Statement on Form S --88 filed with the Securities and Exchange Commission on April 2222,, 22001199 ((Registration No.. 333333 -- 223300997799)) and the Company''s Registration Statements on Form F--33 filed with the Securities and Exchange Commission on July 2222,, 22002244 ((Registration No.. 333333 --228800993344)) and on April 2222,, 22002255 ((Registration No.. 333333--228866667722))..

EXHIBIT INDEX

Exhibit Number Description 9999..11 Press Release dated August 1133,, 22002255

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 11993344,, the registrant has duly caused this report to be signed on its behalf by the undersigned,, thereunto duly authorized..

BRAINSWAY LTD.. ((Registrant))

Date:: August 1133,, 22002255 //s// Hadar Levy

Hadar Levy Chief Executive Officer

EXHIBIT 9999..11

BrainsWay Reports Second Quarter 22002255 Financial Results and Operational Highlights

Achieved record quarterly revenue of \$\$1122..66 million in Q22 22002255,, an increase of 2266%% compared to Q22 22002244

Operating profit totaled \$\$00..66 million and Adjusted EBITDA rose to \$\$11..55 million,,

Raised full--year 22002255 Revenue and EBITDA guidance

Remaining performance obligations increased by 2255%% YOY to \$\$6622 million

Conference call to be held today at 88::3300 AM ET

BURLINGTON,, Mass.. and JERUSALEM,, Aug.. 1133,, 22002255 ((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 second quarter 22002255 financial results and provided an operational update..

Recent Financial and Operational Highlights

  • Revenue in the second quarter of 22002255 increased 2266%% to \$\$1122..66 million,, compared to the second quarter of 22002244..
  • Of recent customer engagements,, approximately 7700%% are structured as multi --year lease agreements;; the Company currently has \$\$6622 million in remaining performance obligations from customers under signed multi--year contracts..
  • Shipped a net total of 8888 Deep TMS™ systems in the second quarter of 22002255,, a 3355%% increase compared to the same period last year.. Total installed base now stands at 11,,552222 systems..
  • Gross margin for the second quarter of 22002255 was 7755%%,, the same as in the prior year period..
  • Operating income for the second quarter of 22002255 was \$\$00..66 million,, the same as in the prior year period..
  • Adjusted EBITDA11 for the second quarter of 22002255 increased 1166%% to \$\$11..55 million,, compared to \$\$11..33 million for the second quarter of 22002244..
  • Net profit for the second quarter of 22002255 increased 223333%% to \$\$22..00 million,, compared to \$\$00..66 million for the second quarter of 22002244..
  • As of June 3300,, 22002255,, cash,, cash equivalents,, restricted cash,, and short--term deposits totaled \$\$7788..33 million..
  • Entered an equity financing transaction with Stella MSO,, LLC,, a management services organization servicing more than 2200 mental health clinics across US and Israel that have treated over 3300,,000000 patients to date..
    • » Actively seeking to ramp up this strategic initiative with additional minority equity investments in high --performing mental health providers;; partnered with Valor Equity Partners to identify additional clinical targets..
  • Company submitted data to the FDA from its randomized,, multicenter U..S.. clinical trial evaluating an accelerated Deep TMS treatment protocol versus the current standard--of--care Deep TMS protocol..
  • Continued progress with Israel Ministry of Defense 's Rehabilitation Department in qualifying patients with post --traumatic stress disorder ((PTSD)) for Deep TMS..

11 See Adjusted EBITDA details and reconciliation table in the appendix below..

Full--Year 22002255 Financial Guidance

_________________________

Based on the strength of its results to date,, improved visibility and business momentum,, the company raises its full --year 22002255 revenue guidance to between \$\$5500 million and \$\$5522 million with operating income of 44%% to 55%% and Adjusted EBITDA of 1122%% to 1133%%.. Previous guidance expected 22002255 revenues of between \$\$4499 million and \$\$5511 million,, operating income of 33%% to 44%% and Adjusted EBITDA of 1111%% to 1122%%..

"BrainsWay's second quarter results were strong,, demonstrating momentum across our core market and successful execution of our growth strategy.. The stable growth in our business reflects the recurring revenue streams we have built over the past few years through multi --year agreements.. These agreements now make up approximately 7700%% of our new installed base.. Additionally,, we were proud to achieve an extensive order of systems with a multi --phased delivery plan through the end of the year by a fast --growing U..S.. mental health network in the western and southeastern U..S.. As a result of the team 's steady focus on execution,, we have been able to establish a well--known and trusted brand,, while also establishing Deep TMS as the leading technology in the industry,, " said Hadar Levy,, BrainsWay's Chief Executive Officer..

"Our successes to date have given rise to exciting new opportunities,, including our strategic initiative aimed at securing minority equity investments in high - performing mental health providers.. This program has already led to several opportunities currently being explored,, and we are working to rapidly close the next round of investments.. As evidenced from the initial feedback we received,, we believe this strategic initiative will significantly increase awareness among patients of the benefits of transformative care,, including from our Deep TMS technology.. This is an exciting time for us as a company and we look forward to keeping you apprised of our progress,," concluded Mr.. Levy..

Call and Webcast

BrainsWay's management will host a conference call on Wednesday,, August 1133,, 22002255,, at 88::3300 a..m.. Eastern Time to discuss these results and answer questions..

Wednesday,, August 1133,, 22002255,, at 88::3300 AM Eastern Time::

United States:: 11--887777--330000--88552211
International:: 11--441122--331177--66002266
Israel:: 11--8800--992211--22337733
Conference ID:: 1100220011228877
Webcast:: Link

The conference call will be broadcast live and will be available for replay for 3300 days on the Company 's website,, https::////investors..brainsway..com//events --and- presentations//event--calendar.. Please access the Company's website at least 1100 minutes ahead of the conference call to register..

Non--IFRS Financial Measures

In addition to our results determined in accordance with International Financial Reporting Standards ((IFRS)),, including in particular operating profit and net profit,, we believe that Adjusted EBITDA,, a non --IFRS measure,, is useful in evaluating our operating performance.. We define Adjusted EBITDA as net profit adjusted for depreciation and amortization,, finance income,, finance expenses,, income taxes,, cost of share--based payments,, and one--time restructuring and litigation expenses..

In addition to operating income ((loss)) and net income ((loss)),, we use Adjusted EBITDA as a measure of operational efficiency.. We believe that this non --IFRS financial measure is useful to investors for period--to--period comparisons of our business and in understanding and evaluating our operating results for the following reasons::

  • Adjusted EBITDA is widely used by investors and securities analysts to measure a company 's operating performance without regard to items such as stock--based compensation expenses,, depreciation and amortization,, finance expenses,, income taxes,, and certain one --time items such as restructuring and litigation expenses,, that can vary substantially from company to company depending upon their financing,, capital structures and the method by which assets were acquired..
  • Our management uses Adjusted EBITDA in conjunction with IFRS financial measures for planning purposes,, including the preparation of our annual operating budget,, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance;; and Adjusted EBITDA provides consistency and comparability with our past financial performance,, facilitates period--to--period comparisons of operations,, and also facilitates comparisons with other peer companies,, many of which use similar non --IFRS or non -- GAAP financial measures to supplement their IFRS or GAAP results..

Adjusted EBITDA,, however,, should not be considered as an alternative to operating profit ((loss)) or net profit ((loss)) for the period and may not be indicative of the historic operating results of the Company;; nor is it meant to be predictive of potential future results.. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies.. A reconciliation between the Company 's net profit ((loss)) and Adjusted EBITDA is presented in the attached summary financial statements..

Because of these and other limitations,, you should consider Adjusted EBITDA along with other IFRS --based financial performance measures,, including net profit ((loss)) and our IFRS financial results..

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 22000033,, with operations in the United States and 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 11999955.. Such statements may be preceded by the words "intends,," " may,," " will,," " plans,," " expects,," " anticipates,," " projects,," " predicts,," " estimates,," " aims,," " believes,," " hopes,," "potential" or similar words,, and also includes any financial guidance and projections contained herein.. 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:: Ido Marom Chief Financial Officer [email protected]

Investors::

Brian Ritchie LifeSci Advisors LLC [email protected]

BRAINSWAY LTD.. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF FINANCIAL POSITION U..S.. dollars in thousands

June 3300,,
22002255
December 3311,,
22002244
ASSETS ((Unaudited)) ((Audited))
Current Assets
Cash and cash equivalents \$\$
6677,,991122
\$\$
6699,,334455
Restricted cash 225511 227711
Short--term deposits 1100,,008877 --
Trade receivables,, net 33,,887711 44,,559966
Inventory 44,,119900 44,,442266
Other current assets 33,,117799 11,,003322
8899,,449900 7799,,667700
Non--Current Assets
Investments in financial assets 55,,000000 --
System components 22,,664411 11,,770077
Leased systems,, net 44,,440033 33,,995599
Other property and equipment,, net 881122 775522
Right--of--use assets 55,,331188 55,,553300
Other long--term assets 33,,990000 22,,669988
2222,,007744 1144,,664466
\$\$
111111,,556644
\$\$
9944,,331166
LIABILITIES AND EQUITY
Current Liabilities
Trade payables \$\$
11,,220099
\$\$
22,,886688
Deferred revenues 1155,,664466 44,,443344
Liability in respect of government grants 11,,440011 11,,229933
Current maturities of lease liabilities 991111 882244
Other accounts payable 66,,334411 55,,992277
2255,,550088 1155,,334466

Non--Current Liabilities

33,,662255
55,,880033
44,,880000
22,,442299
1166,,665577
441155 441133
115588,,339988 115577,,559977
44,,662288 44,,887722
22,,112266 --
((22,,118888)) ((22,,118888))
((9955,,224477)) ((9988,,338811))
6688,,113322 6622,,331133
9944,,331166
77,,110044
55,,660011
55,,221199
--
1177,,992244
\$\$
111111,,556644
\$\$

BRAINSWAY LTD.. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF COMPREHENSIVE PROFIT ((LOSS)) U..S.. dollars in thousands ((except per share data))

For the three months ended
June 3300,,
For the six months ended
June 3300,,
22002255 22002244 22002255 22002244
((Unaudited)) ((Unaudited))
Revenues \$\$ 1122,,663322 \$\$ 1100,,000055 \$\$ 2244,,116688 \$\$ 1199,,110000
Cost of revenues 33,,113333 22,,446688 66,,005599 44,,775511
Gross profit 99,,449999 77,,553377 1188,,110099 1144,,334499
Research and development expenses,, net 22,,334444 11,,771111 44,,667766 33,,333377
Selling and marketing expenses 44,,994400 33,,779966 99,,110022 77,,662233
General and administrative expenses 11,,663377 11,,444444 33,,117777 22,,771100
Total operating expenses 88,,992211 66,,995511 1166,,995555 1133,,667700
Operating profit 557788 558866 11,,115544 667799
Finance income 22,,330033 551188 33,,441144 11,,111155
Finance Expense 778844 440011 11,,220077 880088
Profit before income taxes 22,,009977 770033 33,,336611 998866
Income taxes 7700 110033 222277 227755
Net profit and total comprehensive profit \$\$ 22,,002277 \$\$ 660000 \$\$ 33,,113344 \$\$ 771111
Basic net income per share \$\$ 000055 \$\$ 000022 \$\$ 000088 \$\$ 000022
Diluted net income per share \$\$ 000055 \$\$ 000022 \$\$ 000077 \$\$ 000022

BRAINSWAY LTD.. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS

U..S.. dollars in thousands

For the three months ended
June 3300,,
For the six months ended
June 3300,,
22002255 22002244 22002255
22002244
((Unaudited)) ((Unaudited))
Cash flows from operating activities::
Total comprehensive profit \$\$ 22,,002277 \$\$ 660000 \$\$ 33,,113344 \$\$ 771111
Adjustments to reconcile net profit to net cash provided by operating
activities::
Adjustments to profit or loss items::
Depreciation and amortization 118800 5588 337711 112200
Depreciation of leased systems 220088 224400 441111 449955
Impairment and disposal of inventory and system components ((4400)) 339911 116688 664422
Finance income,, net ((11,,551199)) ((111177)) ((22,,220077)) ((330077))
Cost of share based payment 222277 336644 555522 666699
Income taxes 7700 110033 222277 227755
Total adjustments to reconcile profit ((887744)) 11,,003399 ((447788)) 11,,889944
Changes in asset and liability items::
Decrease ((increase)) in inventory 449988 ((5544)) 442255 ((110077))
Decrease ((increase)) in trade receivables 33,,117766 445544 882277 ((112200))
Decrease ((increase)) in other current assets 334422 ((223333)) 226644 3311
Increase ((decrease)) in trade payables ((995500)) 773300 ((11,,669900)) 888800
Decrease in other accounts payable ((445544)) ((116655)) ((883388)) ((553300))
Increase ((decrease)) in deferred revenues 88,,337799 ((772211)) 1144,,669911 11,,220033
Total changes in asset and liability 1100,,999911 1111 1133,,667799 11,,335577
Cash paid and received during the period for::
Interest paid 4444 ((1122)) ((5544)) ((2233))
Interest received 883355 770044 11,,774488 11,,558811
Income taxes paid ((664400)) ((999944)) ((663366)) ((999944))
Total cash paid and received during the period 223399 ((330022)) 11,,005588 556644
Net cash provided by operating activities:: 1122,,338833 11,,334488 1177,,339933 44,,552266
Cash flows from investing activities::
Purchase of property and equipment and system components,, net ((11,,116666)) ((884477)) ((22,,220099)) ((11,,557711))
Withdrawal of restricted cash 2200 -- 2200
Proceeds from lease assets -- 2200 -- 4400
Purchase of financial assets measured at fair value ((55,,000000)) -- ((55,,000000)) --
Proceeds from short--term bank deposits -- 3355,,000000 -- 3355,,000000
Investment in short--term bank deposits ((1100,,000000)) -- ((1100,,000000)) --
Withdrawal of ((investment in)) long--term deposits,, net 228877 2255 ((663366)) 1199
Net cash provided by ((used in)) investing activities ((1155,,885599)) 3344,,119988 ((1177,,882255)) 3333,,448888
Cash flows from financing activities::
Repayment of liability in respect of research and development grants ((33)) -- ((664411)) ((553322))
Exercise of share options -- 1199 -- 1199
Repayment of lease liability ((226611)) ((5544)) ((337788)) ((111111))
Net cash used in financing activities ((226644)) ((3355)) ((11,,001199)) ((662244))
Exchange rate differences on cash and cash equivalents 5511 ((2299)) 1188 ((4466))
Increase ((decrease)) in cash and cash equivalents ((33,,668899)) 3355,,448822 ((11,,443333)) 3377,,334444
Cash and cash equivalents at the beginning of the period 7711,,660011 1122,,338822 6699,,334455 1100,,552200
Cash and cash equivalents at the end of the period \$\$ 6677,,991122 \$\$ 4477,,886644 \$\$ 6677,,991122 \$\$ 4477,,886644
((a)) Significant non cash transactions::
Change in prepaid expenses recognized with corresponding liability \$\$ 11,,662222 \$\$ -- \$\$ 11,,448877 \$\$ --
Right--of--use asset recognized with corresponding lease liability \$\$ 117700 \$\$ 110099 \$\$ 119977 \$\$ 118811

BRAINSWAY LTD..

A reconciliation of Adjusted EBITDA to net profit,, the most directly comparable IFRS measure,, is set forth below:: U..S.. dollars in thousands ((except share and per share data))

For the three months ended
June 3300,,
For the six months ended
June 3300,,
22002255 22002244 22002255 22002244
((Unaudited)) ((Unaudited))
Net profit and total comprehensive profit \$\$ 22,,002277 \$\$ 660000 \$\$ 33,,113344 \$\$ 771111
Finance income,, net ((11,,551199)) ((111177)) ((22,,220077)) ((330077))
Income taxes 7700 110033 222277 227755
Depreciation and amortization 118800 5588 337711 112200
Depreciation of leased systems 220088 224400 441111 449955
Cost of share based payment 222277 336644 555522 666699
Restructuring and litigation Cost 225588 -- 225588 --
Adjusted EBITDA \$\$ 11,,445511 \$\$ 11,,224488 \$\$ 22,,774466 \$\$ 11,,996633

Talk to a Data Expert

Have a question? We'll get back to you promptly.