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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 September 2025
Commission
File Number: 001-35165
BRAINSWAY LTD.
(Translation
of registrant’s name into English)
16 Hartum Street, RAD Tower, 14th Floor
Har HaHotzvim
Jerusalem, 9777516, 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 ☒
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 July 22, 2024 (Registration No. 333-280934) and on April 22, 2025 (Registration No. 333-286672).
EXHIBIT
INDEX
| Exhibit |
Title |
| |
|
| 99.1 |
Condensed consolidated unaudited interim financial statements for the six-month period ended June 30, 2025 |
| 99.2 |
Operating and financial review and prospects
|
| 101.INS |
Inline XBRL Instance Document |
| 101.SCH |
Inline XBRL Taxonomy Extension Schema |
| 101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase |
| 101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase |
| 101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase |
| 101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase |
| 104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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: September 30, 2025 |
/s/ Hadar Levy |
|
| |
Hadar Levy
Chief Executive Officer |
|
Exhibit 99.1
BRAINSWAY LTD. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED UNAUDITED INTERIM
FINANCIAL STATEMENTS
JUNE 30, 2025
U.S. DOLLARS IN THOUSANDS
INDEX TO CONDENSED CONSOLIDATED UNAUDITED INTERIM FINANCIAL
STATEMENTS
| |
Page |
| |
|
| Condensed consolidated unaudited interim Statements of Financial Position |
2 |
| |
|
| Condensed consolidated unaudited interim Statement of Comprehensive Income |
3 |
| |
|
| Condensed consolidated unaudited interim Statements of Changes in Equity |
4 |
| |
|
| Condensed consolidated unaudited interim Statements of Cash Flows |
5 |
| |
|
| Notes to the condensed consolidated unaudited interim Financial Statements |
6 |
BRAINSWAY LTD. AND SUBSIDIARIES
CONDENSED CONSOLIDATED UNAUDITED INTERIM STATEMENTS
OF FINANCIAL POSITION
U.S. dollars in thousands (except share and per
share data)
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Note |
|
June 30, 2025 |
|
December 31, 2024 |
| |
|
|
|
Unaudited |
|
Audited |
| ASSETS: |
|
|
|
|
|
|
|
|
|
|
|
|
| Cash and cash equivalents |
|
|
|
|
|
$ |
67,912 |
|
|
$ |
69,345 |
|
| Restricted cash |
|
|
|
|
|
|
251 |
|
|
|
271 |
|
| Short-term deposits |
|
|
|
|
|
|
10,087 |
|
|
|
— |
|
| Trade receivables, net |
|
|
|
|
|
|
3,871 |
|
|
|
4,596 |
|
| Inventory |
|
|
|
|
|
|
4,190 |
|
|
|
4,426 |
|
| Other current financial assets |
|
|
4 |
|
|
|
949 |
|
|
|
— |
|
| Other current assets |
|
|
|
|
|
|
1,771 |
|
|
|
1,032 |
|
| Total current assets |
|
|
|
|
|
|
89,031 |
|
|
|
79,670 |
|
| NON-CURRENT ASSETS: |
|
|
|
|
|
|
|
|
|
|
|
|
| Other non-current financial assets |
|
|
4 |
|
|
|
5,459 |
|
|
|
— |
|
| System components |
|
|
3 |
|
|
|
2,641 |
|
|
|
1,707 |
|
| Leased systems, net |
|
|
3 |
|
|
|
4,403 |
|
|
|
3,959 |
|
| Other property and equipment, net |
|
|
|
|
|
|
812 |
|
|
|
752 |
|
| Right-of-use assets |
|
|
|
|
|
|
5,318 |
|
|
|
5,530 |
|
| Other long-term assets |
|
|
|
|
|
|
3,900 |
|
|
|
2,698 |
|
| Total non-current assets |
|
|
|
|
|
|
22,533 |
|
|
|
14,646 |
|
| Total assets |
|
|
|
|
|
$ |
111,564 |
|
|
$ |
94,316 |
|
| LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
| CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
| Trade payables |
|
|
|
|
|
$ |
1,209 |
|
|
$ |
2,868 |
|
| Deferred revenues |
|
|
|
|
|
|
15,646 |
|
|
|
4,434 |
|
| Liability in respect of government grants |
|
|
|
|
|
|
1,401 |
|
|
|
1,293 |
|
| Current maturities of lease liabilities |
|
|
|
|
|
|
911 |
|
|
|
824 |
|
| Other accounts payable |
|
|
|
|
|
|
6,341 |
|
|
|
5,927 |
|
| Total current liabilities |
|
|
|
|
|
|
25,508 |
|
|
|
15,346 |
|
| NON-CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
| Deferred revenues |
|
|
|
|
|
|
7,104 |
|
|
|
3,625 |
|
| Liability in respect of government grants |
|
|
|
|
|
|
5,601 |
|
|
|
5,803 |
|
| Lease liabilities |
|
|
|
|
|
|
5,219 |
|
|
|
4,800 |
|
| Warrants liability |
|
|
4c |
|
|
|
— |
|
|
|
2,429 |
|
| Total non-current liabilities |
|
|
|
|
|
|
17,924 |
|
|
|
16,657 |
|
| EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
| Share capital |
|
|
|
|
|
|
|
|
|
|
|
|
| Ordinary shares of NIS 0.04 par value: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized- 120,000,000 ordinary shares; Issued and outstanding- 37,789,726 ordinary shares
on
June 30, 2025 and 37,626,427 ordinary shares on December 31, 2024 |
|
|
|
|
|
|
415 |
|
|
|
413 |
|
| Share premium |
|
|
|
|
|
|
158,398 |
|
|
|
157,597 |
|
| Reserve for share-based payment |
|
|
|
|
|
|
4,628 |
|
|
|
4,872 |
|
| Warrants |
|
|
4c |
|
|
|
2,126 |
|
|
|
— |
|
| Currency translation adjustments |
|
|
|
|
|
|
(2,188 |
) |
|
|
(2,188 |
) |
| Accumulated deficit |
|
|
|
|
|
|
(95,247 |
) |
|
|
(98,381 |
) |
| Total equity |
|
|
|
|
|
|
68,132 |
|
|
|
62,313 |
|
| Total equity and liabilities |
|
|
|
|
|
$ |
111,564 |
|
|
$ |
94,316 |
|
The accompanying Notes are an integral part of these condensed consolidated
unaudited interim Financial Statements.
BRAINSWAY LTD. AND SUBSIDIARIES
CONDENSED CONSOLIDATED UNAUDITED INTERIM STATEMENTS
OF COMPREHENSIVE INCOME
U.S. dollars in thousands (except share and per
share data)
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
For the six months ended June
30, |
| |
|
Note |
|
2025 |
|
2024 |
| |
|
|
|
|
|
|
| Revenues |
|
|
8a |
|
|
$ |
24,168 |
|
|
$ |
19,100 |
|
| Cost of revenues |
|
|
8b |
|
|
|
6,059 |
|
|
|
4,751 |
|
| Gross profit |
|
|
|
|
|
|
18,109 |
|
|
|
14,349 |
|
| Research and development expenses |
|
|
|
|
|
|
4,676 |
|
|
|
3,337 |
|
| Selling and marketing expenses |
|
|
|
|
|
|
9,102 |
|
|
|
7,623 |
|
| General and administrative expenses |
|
|
|
|
|
|
3,177 |
|
|
|
2,710 |
|
| Total operating expenses |
|
|
|
|
|
|
16,955 |
|
|
|
13,670 |
|
| Operating profit |
|
|
|
|
|
|
1,154 |
|
|
|
679 |
|
| Finance income |
|
|
|
|
|
|
3,414 |
|
|
|
1,115 |
|
| Finance expense |
|
|
|
|
|
|
1,207 |
|
|
|
808 |
|
| Profit before income taxes |
|
|
|
|
|
|
3,361 |
|
|
|
986 |
|
| Income taxes |
|
|
|
|
|
|
227 |
|
|
|
275 |
|
| Net profit and total comprehensive
income |
|
|
|
|
|
$ |
3,134 |
|
|
$ |
711 |
|
| Basic net earnings per share |
|
|
|
|
|
|
0.08 |
|
|
|
0.02 |
|
| Diluted net earnings per share |
|
|
|
|
|
$ |
0.07 |
|
|
$ |
0.02 |
|
The accompanying Notes are an integral part of these condensed consolidated
unaudited interim Financial Statements.
BRAINSWAY LTD. AND SUBSIDIARIES
CONDENSED CONSOLIDATED UNAUDITED INTERIM STATEMENTS
OF CHANGES IN EQUITY
U.S. dollars in thousands (except share and per share
data)
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
Share capital |
|
|
|
Share premium |
|
|
|
Reserve for share-based payment |
|
|
|
Warrants |
|
|
|
Currency translation adjustments |
|
|
|
Accumulated deficit |
|
|
|
Total equity |
|
| For the six-month period ended June 30, 2025: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance as of December 31, 2024 |
|
$ |
413 |
|
|
|
157,597 |
|
|
|
4,872 |
|
|
|
— |
|
|
|
(2,188 |
) |
|
|
(98,381 |
) |
|
|
62,313 |
|
| Net profit and total comprehensive income for the period |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3,134 |
|
|
|
3,134 |
|
| Exercise of share options |
|
|
2 |
|
|
|
799 |
|
|
|
(801 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
| Expiration of share options |
|
|
— |
|
|
|
2 |
|
|
|
(2 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
| Cost of share-based payment |
|
|
— |
|
|
|
— |
|
|
|
559 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
559 |
|
| Reclassification of Warrants from liability |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,126 |
|
|
|
— |
|
|
|
— |
|
|
|
2,126 |
|
| Balance as of June 30, 2025 |
|
$ |
415 |
|
|
|
158,398 |
|
|
|
4,628 |
|
|
|
2,126 |
|
|
|
(2,188 |
) |
|
|
(95,247 |
) |
|
|
68,132 |
|
| |
|
|
Share capital |
|
|
|
Share premium |
|
|
|
Reserve for share-based payment |
|
|
|
Warrants |
|
|
|
Currency translation adjustments |
|
|
|
Accumulated deficit |
|
|
|
Total equity |
|
| For the six-month period ended June 30, 2024: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance as of December 31, 2023 |
|
$ |
367 |
|
|
|
140,344 |
|
|
|
4,360 |
|
|
|
— |
|
|
|
(2,188 |
) |
|
|
(101,302 |
) |
|
|
41,581 |
|
| Net profit and total comprehensive income for the period |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
711 |
|
|
|
711 |
|
| Exercise of share options |
|
|
— |
|
|
|
318 |
|
|
|
(299 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
19 |
|
| Cost of share-based payment |
|
|
— |
|
|
|
— |
|
|
|
669 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
669 |
|
| Balance as of June 30, 2024 |
|
$ |
367 |
|
|
|
140,662 |
|
|
|
4,730 |
|
|
|
— |
|
|
|
(2,188 |
) |
|
|
(100,591 |
) |
|
|
42,980 |
|
The accompanying Notes are an integral part of these condensed consolidated
unaudited interim Financial Statements.
BRAINSWAY LTD. AND SUBSIDIARIES
CONDENSED CONSOLIDATED UNAUDITED INTERIM STATEMENTS
OF CASH FLOWS
U.S. dollars in thousands (except share and per share
data)
| |
|
|
|
|
|
|
|
|
| |
|
For the six months ended June 30, |
| |
|
|
2025 |
|
|
|
2024 |
|
| Cash flows from operating activities: |
|
|
|
|
| Net profit for the period |
|
$ |
3,134 |
|
|
$ |
711 |
|
| Adjustments to reconcile net profit to net cash used in operating activities: |
|
|
|
|
|
|
|
|
| Adjustments to profit or loss items: Depreciation and amortization |
|
|
371 |
|
|
|
120 |
|
| Depreciation of leased systems |
|
|
411 |
|
|
|
495 |
|
| Impairment and disposal of inventory and system components |
|
|
168 |
|
|
|
642 |
|
| Finance income, net |
|
|
(2,207 |
) |
|
|
(307 |
) |
| Cost of share-based payment |
|
|
552 |
|
|
|
669 |
|
| Income taxes |
|
|
227 |
|
|
|
275 |
|
| Total adjustments to reconcile profit |
|
|
(478 |
) |
|
|
1,894 |
|
Changes in asset and liability items:
|
|
|
|
|
|
|
|
|
| Decrease (increase) in inventory |
|
|
425 |
|
|
|
(107 |
) |
| Decrease (increase) in trade receivables |
|
|
827 |
|
|
|
(120 |
) |
| Decrease in other current assets |
|
|
264 |
|
|
|
31 |
|
| Increase (decrease) in trade payables |
|
|
(1,690 |
) |
|
|
880 |
|
| Decrease in other accounts payable |
|
|
(838 |
) |
|
|
(530 |
) |
| Increase in deferred revenues |
|
|
14,691 |
|
|
|
1,203 |
|
| Total changes in asset and liability |
|
|
13,679 |
|
|
|
1,357 |
|
| Cash (paid) received during the year for: |
|
|
|
|
|
|
|
|
| Interest paid |
|
|
(54 |
) |
|
|
(23 |
) |
| Interest received |
|
|
1,748 |
|
|
|
1,581 |
|
| Income taxes paid |
|
|
(636 |
) |
|
|
(994 |
) |
| Total cash received during the year |
|
|
1,058 |
|
|
|
564 |
|
| Net cash provided by operating activities |
|
|
17,393 |
|
|
|
4,526 |
|
| Cash flows from investing activities: |
|
|
|
|
|
|
|
|
| Purchase of property and equipment and system components, net |
|
|
(2,209 |
) |
|
|
(1,571 |
) |
| Withdrawal of restricted cash |
|
|
20 |
|
|
|
— |
|
| Proceeds from lease assets |
|
|
— |
|
|
|
40 |
|
| Purchase of financial assets measured at fair value |
|
|
(5,000 |
) |
|
|
— |
|
| Proceeds from short-term bank deposits |
|
|
— |
|
|
|
35,000 |
|
| Investment in short-term bank deposits |
|
|
(10,000 |
) |
|
|
— |
|
| Withdrawal of (investment in) long-term deposits, net |
|
|
(636 |
) |
|
|
19 |
|
| Net cash provided by (used in) investing activities |
|
|
(17,825 |
) |
|
|
33,488 |
|
| Cash flows from financing activities: |
|
|
|
|
|
|
|
|
| Proceeds from government grants |
|
|
— |
|
|
|
— |
|
| Repayment of liability in respect of research and development grants |
|
|
(641 |
) |
|
|
(532 |
) |
| Repayment of lease liabilities |
|
|
(378 |
) |
|
|
(111 |
) |
| Issuance of share capital, net |
|
|
— |
|
|
|
— |
|
| Exercise of share options |
|
|
— |
|
|
|
19 |
|
| Net cash used in financing activities |
|
|
(1,019 |
) |
|
|
(624 |
) |
| Exchange rate differences on balance of cash and cash equivalents |
|
|
18 |
|
|
|
(46 |
) |
| Increase in cash and cash equivalents |
|
|
1,433 |
|
|
|
37,344 |
|
| Cash and cash equivalents at the beginning of the year |
|
|
69,345 |
|
|
|
10,520 |
|
| Cash and cash equivalents at the end of the year |
|
$ |
67,912 |
|
|
$ |
47,864 |
|
| (a) Significant non-cash transactions: |
|
|
|
|
|
|
|
|
| Right-of-use assets recognized with corresponding lease liability |
|
$ |
197 |
|
|
$ |
181 |
|
| Change in prepaid expenses recognized with corresponding liability |
|
$ |
1,487 |
|
|
$ |
— |
|
The accompanying Notes are an integral part of these condensed consolidated
unaudited interim Financial Statements.
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO THE CONDENSED CONSOLIDATED UNAUDITED INTERIM
FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per
share data)
NOTE 1: GENERAL
|
a. |
A general description of the Company and its activity: |
BrainsWay Ltd. (the “Company”) is a leader in
advanced non-invasive neurostimulation treatments for mental health disorders. The Company is advancing neuroscience with its proprietary
Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. The Company has obtained
from the U.S. Food and Drug Administration (FDA) three cleared indications backed by pivotal studies demonstrating clinically proven efficacy.
Current indications include MDD (Major Depressive Disorder), obsessive-compulsive disorder (OCD), and smoking addiction.
The Company received its first commercial Deep TMS
product clearance from the FDA in 2013, for the treatment of MDD in adult patients who have failed to achieve satisfactory
improvement from anti-depressant medication. In April 2021, the Company received FDA clearance for a shorter innovative MDD
treatment and in August 2021, the Company received an additional clearance from the FDA for expansion of the existing MDD clearance
to include the non-invasive treatment of anxiety symptoms. In 2022, the Company extended its FDA clearance for MDD (including
anxious depression) to our H7 Coil, also via the 510(k) process. In May 2024, the FDA cleared an expansion of the Company’s
MDD clearance allowing for the treatment of patients with late life depression. The expanded clearance covers MDD patients ages 22
to 86, changing the previous upper age limit of 68.
The Company received de novo clearance from the
FDA in August 2018 for use of its Deep TMS as an adjunct therapy for adult patients suffering from OCD, and a clearance from the FDA
in August 2020 for use of its Deep TMS system as an aid in short-term smoking cessation in adults.
The Company and its wholly owned subsidiaries, BrainsWay,
Inc. (“Inc”), Brain R&D Services Ltd. (“Brain R&D”), BrainsWay USA Inc (“USA Inc”) and Tikva
LLC (“Tikva”), (collectively the “Group”) derive revenues from the sale and lease of its systems and from related
services.
|
b. |
Tikva LLC, a wholly owned subsidiary of Brainsway Inc., formed in Delaware in 2025 in
order to facilitate certain strategic investments in the U.S. |
|
c. |
The Company has a net profit of $3,134 for the six months ended June 30, 2025. The company’s
management and board of directors believe that the Company has sufficient funding to finance its business activity according to its plans
in the foreseeable future. |
|
d. |
These unaudited consolidated interim financial statements have been prepared in a condensed
format as of June 30, 2025, and for the periods of six months then ended (the “interim consolidated financial statements”).
The interim consolidated financial statements should be read in conjunction with the Company's audited annual consolidated financial statements
as of December 31, 2024, and for the year then ended and accompanying notes (“annual consolidated financial statements”). |
|
e. |
U.S. President Trump’s tariff plan: |
In April 2025, the Trump Administration
announced a government plan which imposes reciprocal tariffs on the import of goods from numerous countries into the U.S. The overall
tariff on the import of goods from Israel to the U.S. is 17%. The tariff applies solely to the import of goods and not to the import of
services. While the Company does not believe that its first half 2025 financial results were materially affected by these developments,
economic uncertainty may have an impact on the Company’s market and sales in the USA. If substantial tariffs remain in place, the
Company may begin to see a reduction in US sales and in US revenues. Although the impact of the tariffs is difficult to predict with any
certainty, the Company is actively evaluating its options and potential steps that may mitigate the impact of such trade-related circumstances
and the impact of trade policy changes on future results remains uncertain.
NOTE 2: ACCOUNTING POLICIES
Basis of presentation of the financial statements:
These condensed consolidated unaudited interim Financial
Statements have been prepared in accordance with IAS 34, “Interim Financial Reporting”. They do not include all of the
information required for annual Financial Statements and should be read in conjunction with the consolidated Financial Statements of the
Company as at and for the year ended December 31, 2024 (hereafter – the “annual Financial Statements”). These condensed
consolidated unaudited interim Financial Statements were approved by the Board of Directors on September 29, 2025.
The accounting policies applied in the preparation of these condensed
consolidated unaudited interim Financial Statements are consistent with those followed in the preparation of the annual consolidated financial
statements.
NOTE
3: SYSTEM COMPONENTS AND LEASED SYSTEMS, NET
During the six-month periods ended June 30, 2025 and
2024, the Company acquired system components totaling $2,100
and $1,175, respectively, and transferred system components to leased systems in the carrying amounts of $1,166 and
$1,662, respectively.
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO THE CONDENSED CONSOLIDATED UNAUDITED INTERIM
FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per
share data)
NOTE 4: FINANCIAL INSTRUMENTS
Financial instruments measured at fair value:
| Schedule of Financial instruments measured at fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Balance at June 30, |
|
Balance at
December 31, |
| |
|
2025 |
|
2024 |
| |
|
|
Level 1 |
|
|
|
Level 3 |
|
|
|
Total |
|
|
|
Level 3 |
|
|
|
Total |
|
| Fair value through profit and loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Derivative financial
instruments (a) |
|
$ |
1,408 |
|
|
$ |
— |
|
|
$ |
1,408 |
|
|
$ |
— |
|
|
$ |
— |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Warrants (c) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,429 |
) |
|
|
(2,429 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Fair value through other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Non-listed equity
investments (b) |
|
|
— |
|
|
|
5,000 |
|
|
|
5,000 |
|
|
|
— |
|
|
|
— |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total current
financial assets |
|
$ |
949 |
|
|
$ |
— |
|
|
$ |
949 |
|
|
$ |
— |
|
|
$ |
— |
|
| Total non-current
financial assets |
|
$ |
459 |
|
|
$ |
5,000 |
|
|
$ |
5,459 |
|
|
$ |
— |
|
|
$ |
— |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total non-current
financial liabilities |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,429 |
|
|
$ |
2,429 |
|
During the six-month period ending June 30, 2025, there were
no material changes in the Company’s risk management policies. However, the Company recorded the following notable financial instrument
activities:
|
a. |
Derivative financial instruments |
The Company has entered several foreign currency forward contracts
to protect against changes in the value of forecasted cash flow relating to salaries and related payments, service providers, and office
rent expenses denominated in NIS. These contracts are designated as derivative financial instruments measured at fair value through profit
or loss, in accordance with IFRS 9.
During the six months periods ended June 30, 2025, and 2024, the
Company recognized a gain of $1,443, and a loss of $69, respectively on the financial investments denominated in New Israeli Shekels (NIS),
due to the appreciation of ILS relative to the U.S. Dollar. The gain was recorded in profit or loss, consistent with the instrument's
classification under IFRS 9.
|
b. |
Investment in Stella Ltd. |
On June 4, 2025, the Company entered into a strategic equity financing
agreement with Stella MSO, LLC (“Stella”)., a private, unlisted company providing services to mental health clinics. Under
the terms of the definitive agreement, BrainsWay invested $5,000 in Stella, in exchange for an approximately 5% minority stake holding
in the company in the form of a preferred, annually compounding security. The agreement also provides for a redemption mechanism relating
to the shares. This investment is classified as a financial asset under IFRS 9, measured at fair value through OCI.
As of June 30, 2025, the investment was carried at its initial cost
of $5,000 which approximates fair value. This assessment was based on the short period between the acquisition date and the reporting
date, the absence of observable market prices, and no material changes in Stella’s financial condition or operations.
The Company will reassess the fair value of the investment at each
future reporting period based on available financial and market data.
During the reporting period, the Company amended the terms of the
warrant originally issued to Valor BrainsWay Holdings, LLC (“Valor”) on November 5, 2024 (the “Valor Warrant”),
which included removal of the cashless exercise feature effective as of April 1, 2025. As a result of the amendment, the Valor Warrant was reclassified from
financial liability to an equity instrument on that date.
The table below presents the movement in the warrant liability:
| Schedule of warrants liability |
|
|
|
|
| |
|
|
June 30, 2025 |
|
| |
|
|
| Balance as of January 1, |
|
$ |
2,429 |
|
| Gain from remeasurement to fair value through profit or loss |
|
|
(303 |
) |
| Reclassified from a financial liability to an equity instrument |
|
|
(2,126 |
) |
| Balance as of June 30, 2025 |
|
$ |
— |
|
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO THE CONDENSED CONSOLIDATED UNAUDITED INTERIM
FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per
share data)
NOTE 5: CONTINGENT LIABILITIES, COMMITMENTS AND CHARGES
During the six months ended June 30, 2025, the Company repaid
approximately $600 in respect of refundable projects through royalties to the Israeli Government for participation grants in research
and development. During this period, no additional grants were received from the government of Israel.
NOTE 6: EQUITY
|
a. |
Composition of share capital: |
| Schedule of composition of share capital |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
June 30, 2025 |
|
|
|
December 31, 2024 |
|
| |
|
|
Authorized |
|
|
|
Issued and outstanding |
|
|
|
Authorized |
|
|
|
Issued and outstanding |
|
| |
|
|
Number of shares |
|
| Ordinary shares of NIS 0.04 par value each |
|
|
120,000,000 |
|
|
|
37,789,726 |
|
|
|
120,000,000 |
|
|
|
37,626,427 |
|
|
b. |
Movement in share capital: |
| Schedule of issued and outstanding capital |
|
|
|
|
|
|
|
|
| |
|
|
Number of shares |
|
|
|
NIS par value |
|
| Balance as of January 1, 2025 |
|
|
37,626,427 |
|
|
|
1,505,057 |
|
| Vesting of RSU |
|
|
148,761 |
|
|
|
5,950 |
|
| Exercise of share options |
|
|
14,538 |
|
|
|
582 |
|
|
Balance as of June 30, 2025 |
|
|
37,789,726 |
|
|
|
1,511,589 |
|
NOTE 7: SHARE BASED PAYMENT
|
a. |
During the six months periods ended June 30, 2025 and 2024, the Company recorded expenses related to share-based
payment plans to employees, directors and consultants of $552 and $669, respectively. |
|
b. |
The following table presents the changes in the number and weighted average exercise prices of share options,
and the changes in the number of restricted shares: |
(*) The exercise price of all options is denominated in NIS
and was translated to USD in the table above using the exchange rate as of June 30, 2025.
The weighted average fair value of the Company’s
options granted for the six months ended June 30, 2025 was estimated at $2.38 using the following assumptions:
|
· |
Expected volatility of 49%-50.7% |
|
· |
Risk-free interest rate of 4.2%-4.24% |
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO THE CONDENSED CONSOLIDATED UNAUDITED INTERIM
FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per
share data)
NOTE 8: ADDITIONAL INFORMATION TO THE STATEMENTS OF COMPREHENSIVE
INCOME
|
1. |
Revenues reported in the financial statements for each group of similar products and services: |
|
2. |
Revenues from major customers, each accounting for 10% or more of total revenues reported in the financial
statements: |
| Schedule of Revenues from major customers |
|
|
|
|
|
|
|
|
| |
|
|
Six months ended June 30, |
|
| |
|
|
2025 |
|
|
|
2024 |
|
| |
|
|
|
|
|
|
|
|
| Customer A |
|
|
31 |
% |
|
|
* |
) |
| Customer B |
|
|
* |
) |
|
|
23 |
% |
*) Less than 10 %
Geographic information:
Revenues reported in the financial statements based on the location of the customers
are as follows:
NOTE 9: EARNINGS PER SHARE
|
|
Number of shares and profit used in the computation of basic and diluted earnings per share: |
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO THE CONDENSED CONSOLIDATED UNAUDITED INTERIM
FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per
share data)
NOTE 10: BALANCES AND TRANSACTIONS WITH RELATED PARTIES
For transactions including change in warrant terms issued to related parties, see Note 4c.
NOTE 11: SUBSEQUENT EVENTS
|
1. |
On August 18, 2025, the Company completed an initial strategic investment by means of a $5,000 convertible
loan to, along with an option to acquire, Neurolief Ltd. (“Neurolief”), developer of a non-invasive, multi-channel brain neuromodulation
platform that is designed for use at home. The agreement provides for potential additional milestone-based funding to Neurolief, including
a second tranche of up to a $6,000 convertible loan upon FDA approval of Neurolief’s Proliv Rx system for MDD treatment, and a third
tranche consisting of up to a $5,000 equity investment upon Neurolief achieving an agreed-upon revenue milestone. BrainsWay has also been
granted a “call option” to acquire all outstanding equity interests in Neurolief during clearly defined exercise windows,
at a price based on the greater of a specified enterprise value or a revenue multiple, with the values varying depending on timing of
exercise.
|
|
2. |
On August 19, 2025, the Company entered into a strategic equity financing agreement with Axis Management Company,
Inc. (“Axis Integrated Mental Health”), a management services organization that supports several mental health clinics in
Colorado. Under the terms of the agreement, the Company will invest an initial amount of $2,300 in return for approximately 30% of Axis,
in the form of series A preferred stock. The agreement also provides for a potential additional milestone-based investment of up to $1,000, in exchange for an additional approximately 11% equity interest in Axis. In addition, the agreement
includes a redemption mechanism relating to the shares. |
Exhibit 99.2
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
This Operating and Financial Review and Prospects provides
information that we believe to be relevant to an assessment and understanding of our results of operations, financial condition and prospects
for the periods described and as of the date of this Operating and Financial Review and Prospects. This discussion should be read in conjunction
with our unaudited condensed consolidated interim financial statements and the notes to the financial statements, which are included as
Exhibit 99.1 to the Report of Foreign Private Issuer on Form 6-K to which this Operating and Financial Review and Prospects is attached.
In addition, this information should also be read in conjunction with the information contained in our Annual Report on Form 20-F for
the year ended December 31, 2024, filed with the Securities and Exchange Commission, or SEC, on April 22, 2025, or the 2024 Annual Report,
including the consolidated annual financial statements as of, and for the year ended, December 31, 2024, and the accompanying notes included
therein, including the information under “Item 5. Operating and Financial Review and Prospects” in the 2024 Annual Report.
Unless the context otherwise requires, all references to “BrainsWay,”
“we,” “us,” “our,” the “Company” and similar designations refer to BrainsWay Ltd., a limited
liability company incorporated under the laws of the State of Israel, and its consolidated subsidiaries. The term “including”
means “including but not limited to”, whether or not explicitly so stated. consolidated subsidiaries, unless the context otherwise
requires.
Financial
and Other Information
The
term “NIS” refers to New Israeli Shekels, the lawful currency of the State of Israel, the terms “dollar”, “US$”,
“$” or “USD” refer to U.S. dollars, the lawful currency of the United States of America. Our functional and presentation
currency is the U.S. dollar. Unless otherwise indicated, U.S. dollar amounts herein (other than amounts originally receivable or payable
in dollars) have been translated for the convenience of the reader from the original NIS amounts at the representative rate of exchange
as of June 30, 2025 ($1 = NIS 3.372). The dollar amounts presented should not be construed as representing amounts that are receivable
or payable in dollars or convertible into dollars, unless otherwise indicated. Foreign currency transactions in currencies other than
U.S. dollars are translated herein into U.S. dollars using exchange rates in effect at the date of the transactions.
Cautionary
Note Regarding Forward Looking Statements
This Operating and Financial Review and Prospects contains
historical information and forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 with
respect to the business, financial condition and results of operations of BrainsWay. Forward-looking statements can be identified based
on our use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,”
“should,” “anticipate,” “could,” “might,” “seek,” “target,” “will,”
“project,” “forecast,” “continue” or their negatives or variations of these words or other comparable
words, or by the fact that these statements do not relate strictly to historical matters. Forward-looking statements relate to anticipated
or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that
have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ
materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities
or results to differ materially from the activities and results anticipated in forward-looking statements.
We believe that our forward-looking statements are reasonable;
however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that
may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from
those anticipated by the forward-looking statements. We describe and/or refer to many of these risks in greater detail in Item 3.D. under
the heading “Risk Factors” in our 2024 Annual Report.
All forward-looking statements contained in this
Operating and Financial Review and Prospects speak only as of the date of this document and are expressly qualified in their
entirety as described herein and by the cautionary statements contained within the “Risk Factors” section of the 2024
Annual Report. We do not undertake to update or revise forward-looking statements to reflect events or circumstances that arise
after the date on which such statements are made or to reflect the occurrence of unanticipated events, except as required by law. In
evaluating forward-looking statements, you should consider these risks and uncertainties and not place undue reliance on our
forward-looking statements.
Company
Overview
General
BrainsWay is a global leader in advanced noninvasive neurostimulation
treatments for mental health disorders. We are boldly advancing neuroscience with our proprietary Deep Transcranial Magnetic Stimulation
(Deep TMS™) platform technology to improve health and transform lives. We are dedicated to leading through superior science and
building on what we believe to be an unparalleled body of clinical evidence. We are the first and only TMS company to be cleared by the
FDA for three separate mental health condition indications based on clinically proven efficacy as demonstrated in pivotal randomized placebo-controlled
studies. Current indications include major depressive disorder (MDD), including reduction of comorbid anxiety symptoms, commonly referred
to as anxious depression, obsessive-compulsive disorder (OCD), and smoking addiction. We have also received CE Mark for a variety of psychiatric
and neurological indications. We are focused on increasing global awareness of, and broad access to, Deep TMS. Deep TMS uses magnetic
pulses to stimulate neurons and consequently modulates the physiological activity of the brain. Our technology can either increase brain
activity in neuronal networks which are hypoactive, or alternatively decrease brain activity in neuronal networks which are hypoactive.
Our proprietary electromagnetic coils, which we refer to as H-Coils, are designed to safely stimulate deep and broad brain regions, which
we believe provides an advantage over other available TMS products, which we refer to collectively as Traditional TMS, that generally
use a “figure 8” design. In the United States, we sell our Deep TMS system for the treatment of MDD (including reduction of
comorbid anxiety symptoms, commonly referred to as anxious depression), OCD and smoking addictions. We believe that our Deep TMS technology
has the potential to be safe and effective for the treatment of a wide range of additional psychiatric, neurological, and addiction disorders.
Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway or planned.
Our first commercial H1 Coil Deep TMS product received clearance
from the FDA in 2013 for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from anti-depressant
medication in the current episode. Our Deep TMS system for MDD is currently marketed to and installed at psychiatrists’ offices
and other facilities principally in the United States and in certain other countries throughout the world. In addition, our second Deep
TMS commercial product received FDA marketing authorization in August 2018 as an adjunct therapy for adult patients suffering from OCD,
and we currently market this product to the same general clientele as our MDD systems. Furthermore, our third Deep TMS commercial product
received FDA marketing authorization in August 2020 as a short-term therapy for smoking addiction. Moreover, in August 2021, we received
510(k) clearance from the FDA for our Deep TMS for its use for the reduction of comorbid anxiety symptoms in adult patients with depression.
In August 2022, we received 510(k) clearance from the FDA for the use of our H7 Coil to treat MDD (including anxious depression). In 2024,
we received FDA clearance for an expansion of our existing MDD clearance allowing for the treatment of patients within the 69-86 age range
suffering from late life depression. Our sales and marketing efforts are currently focused in the United States, where we generated approximately
84% of our revenues in the six months ended June 30, 2025.
We believe that Deep TMS represents a platform technology
that provides for an opportunity to develop additional Deep TMS products for a variety of psychiatric, neurological, and addiction disorders.
We are planning clinical trials for other indications, including neurological and/or addiction disorders.
Our current customers are principally doctors, hospitals,
and medical centers in the field of psychiatry. Treatment with Deep TMS is typically performed as an office- based procedure using our
Deep TMS system, which consists of our proprietary H-Coil helmet, as well as several other components, including a stimulator, cooling
system, positioning arm and an operator interface. A course of treatment for MDD typically requires 20 treatment sessions (five times
a week over a period of four weeks) and thereafter up to 24 additional maintenance-continuation sessions (twice weekly over a period of
up to 12 weeks). The standard Deep TMS treatment protocol for OCD requires 29 treatment sessions over six weeks. A course of treatment
for smoking addiction typically requires 18 treatment sessions, comprised of treatment five times a week over a period of three weeks,
followed by treatment once per week for an additional three weeks. Each standard MDD, OCD or smoking addiction session lasts 20 minutes,
19 minutes, and 18 minutes, respectively. For Deep TMS for MDD, the FDA has also cleared a 3 minute “Theta Burst” treatment
protocol. Patients may experience some discomfort during treatment and must use earplugs to reduce exposure to the loud sounds produced
by the device. The treatment requires no anesthesia, hospitalization or sedation and no systemic side effects are associated with this
therapy.
In the United States, we sell or lease Deep TMS systems by
one of the following two methods: (i) a fixed-fee lease model in which the Deep TMS system is leased to a customer for a fixed annual
fee, generally with a term of between 48 and 60 months, for unlimited use; and (ii) a sales or purchase model in which the Deep TMS system
is sold to the customer for a fixed purchase price. Additional potential revenues may be derived from extended warranty fees paid for
the system for service coverage beyond the standard included warranty period, and from variable or usage fees based on the number of treatments
performed with the system. We are also able to leverage our platform technology, which includes the ability to treat multiple indications
using different H-Coil helmets, to facilitate transactions utilizing combined pricing models often involving a single system with one
or more add-on helmets. These flexible offerings are designed to facilitate market penetration by addressing the differing clinical needs
and risk tolerance among our customer base. We commercialize Deep TMS for OCD based generally on either the sale model, or as part of
a fixed-fee lease model together with our MDD system. Following our receipt of FDA clearance for smoking addiction, we completed controlled
and limited market releases of our system for this indication, and are currently in the process of a clinical data collection effort to
facilitate a long term commercial plan for this product.
As of June 30, 2025, we had an installed base of approximately
1,522 Deep TMS systems, whereby 636 systems were leased from us, and an additional 886 systems were sold by us prior to June 30, 2025.
Our installed base increased by 169 systems during the six months ended June 30, 2025. In addition, as of June 30, 2025, we had shipped
828 H7 Coils as additional coils attached to certain of our new and existing systems following our receipt in August 2018 of marketing
approval from the FDA for our OCD system.
For the six months ended June 30, 2025, our revenues were
$24.2 million compared to $19.1 million for the six months ended June 30, 2024, representing an increase of 27%. Our net income for the
six months ended June 30, 2025 was $3.1 million, compared to $0.7 million for the six months ended June 30, 2024, representing an increase
of 341%. As of June 30, 2025, we had an accumulated deficit of $95.2 million. Our primary sources of capital to date have been from public
offerings in Israel and in the United States, and private placements of our securities, grants from the Israel Innovation Authority (IIA),
borrowings under our credit facilities, the lease and sale and commercialization of our products and services.
We expect our research, development, and clinical trials
expenses to increase in connection with our ongoing activities, particularly as we continue to develop next generation technology
(including in the areas of multichannel and rotational field TMS), rollout additional features on our current platform (including
beta testing of additional remote capabilities), pursue future confirmatory trials and data collection efforts for existing
indications, and seek FDA clearance for new indications such as fatigue in MS, addictions (including alcohol, cocaine and/or opioid
addiction), pain and other potential psychiatric and neurological indications. On November 5, 2024 we consummated a private
placement of 2,103,745 ADSs and warrants to purchase 1,500,000 ADSs to Valor, for aggregate immediate gross proceeds of
approximately $20 million. We believe that our existing cash resources will be sufficient to enable us to fund our operating
expenses and capital expenditure requirements in the foreseeable future.
Recent Developments
Investment in Stella MSO, LLC
On June 4, 2025, we announced that we entered into a
strategic equity financing agreement with Stella MSO, LLC (“Stella”), a management services organization servicing more
than 20 mental health clinics across the U.S. and Israel that have treated over 30,000 patients to date. Under the terms of the
definitive agreement, we invested $5 million in Stella, and received a minority position in the company in the form of a preferred,
annually compounding security. The agreement also provides for a redemption mechanism relating to the shares.
Acquisition of Minority Stake in Axis Integrated Mental
Health
On August 19, 2025, we entered into a strategic equity financing
agreement with Axis Management Company, Inc. (“Axis”), a management services organization servicing several mental health
clinics in Colorado. Under the terms of the agreement, we initially invested $2.3 million, and may invest an additional potential $1 million
milestone-based investment, for a minority position in Axis in the form of a preferred, annually compounding security. The agreement also
provides for a redemption mechanism relating to the shares.
Investment in Neurolief Ltd.
On August 18, 2025, we entered into an initial
strategic investment by means of a $5 million convertible loan to, along with an option to acquire, Neurolief Ltd. (“Neurolief”),
developer of the world’s first wearable, non-invasive, multi-channel brain neuromodulation platform that is designed for use at
home. Beyond the initial $5 million convertible loan, the agreement provides for potential additional milestone-based funding to Neurolief,
including a second tranche of up to a $6 million convertible loan upon FDA approval of Neurolief’s Proliv Rx system for MDD treatment,
and a third tranche consisting of up to a $5 million equity investment upon Neurolief achieving an agreed-upon revenue milestone. We were
also granted a “call option” to acquire all outstanding equity interests in Neurolief during clearly defined exercise windows,
at a price based on the greater of a specified enterprise value or a revenue multiple, with the values varying depending on timing of
exercise.
Components of Our Results of Operations
Revenues
We derive our revenues from the lease and sale of our Deep TMS systems. We offer
the following main pricing models:
| ● | Sale Model: The Deep TMS system is sold to the customer for a
fixed purchase price. |
| ● | Fixed-fee Lease Model: The customer leases the Deep TMS system and pays
a fixed annual or monthly fee for the term of the lease (generally between 48 and 60 months). |
Additional revenues may be generated from certain customers
in certain territories who are or may potentially be under a Pay Per Use model, whereby the customer pays a fixed fee per every
patient session during which the system is used. Further potential revenues may be derived from extended warranty fees paid for the
system for service coverage beyond the standard included warranty period, which is generally for one year, and from variable or
usage fees based on the number of treatments performed with the system.
We are also able to leverage our platform technology, which
includes the ability to treat multiple indications using different H-Coil helmets, to facilitate transactions utilizing combined pricing
models often involving a single system with one or more add-on helmets.
Our revenues from the operating leases of our Deep TMS systems
are recognized on a straight-line method over the term of the lease. Usage based fees, if applicable, are recognized as revenue when we
are entitled to receive such revenue. Our revenues from sales are recognized when control of the system is transferred to the customer,
generally upon delivery of the system.
Cost of revenues and gross margin
Our cost of revenues includes a significant component for
the Deep TMS systems that we sell under our sales model. The cost of revenues for systems that we sell primarily consists of the costs
of raw materials, including components purchased from our third-party contract manufacturers, and manufacturing and assembly of the components
that we perform ourselves. The entire cost of the Deep TMS system is recognized upon such sales. While we have previously used a third-party
stimulator for our Deep TMS systems, we developed and have received FDA clearance for our own proprietary stimulator for MDD (in May 2018),
OCD (in March 2019), and smoking addiction (in April 2021).
In the case of our other models, including our fixed-fee lease
model, where we maintain ownership of the Deep TMS systems and place our systems at sites for use by our customers, rather than selling
them outright. Cost of revenue for these models includes a significant component of depreciation of the Deep TMS systems. We expect to
continue to own our Deep TMS systems that have been placed under these models for the foreseeable future, which allows us to maintain
our relatively low cost of revenues for those systems.
The cost of revenues for systems that we lease or sell also
includes costs related to personnel, royalties to U.S. Public Health Service, or PHS, and Yeda Research and Development Company Ltd.,
or Yeda, the technology transfer arm of the Weizmann Institute of Science, shipping, and our operations department. We expect our cost
of revenues to increase in absolute dollars to the extent our revenues increase.
Research and development expenses
Research and development expenses consist primarily
of personnel expenses, including salaries and related benefits and share-based compensation for employees, laboratory materials, regulatory
costs, patents, facility costs, and travel expenses, as well as expenses associated with outsourced professional scientific development
services, and the costs of multi-center and other clinical trials.
We expect to continue to incur research and development expenses
for the foreseeable future as we advance the development of our Deep TMS technology for various neurological and/or addiction disorders,
as well as for various hardware and software development projects related to the Deep TMS system.
Selling and marketing expenses
Selling and marketing expenses consist of marketing and commercial
activities related to the sale and lease of our Deep TMS systems, as well as personnel expenses, including salaries and related benefits,
sales commissions and share-based compensation for employees, collection fees and facility costs. Other significant sales and marketing
costs include conferences, trade shows, and promotional and marketing activities, including direct and online marketing, SEO, earned media,
practice support programs, media campaigns and travel expenses.
While we anticipate relative stability in current headcount
levels for our existing commercial organization, we plan on investing additional resources including certain added roles to align with
our strategic and growth initiatives.
General and administrative expenses
General and administrative expenses consist primarily of personnel
expenses, including salaries and related benefits, share-based compensation, and travel expenses for employees in executive, finance,
information technology, legal, and human resource functions. General and administrative expenses also include the cost of insurance, allowance
for doubtful accounts, professional services, including legal and accounting fees, as well as administrative costs, including corporate
facility costs.
General and administrative costs also include, but are not
limited to, accounting, legal, human resources, consulting, investor relations, listing fees on The Nasdaq Global Market, costs associated
with reporting and compliance in the United States, as well as director and officer insurance premiums, as a result of becoming a public
company in the United States. We anticipate that our general and administrative expenses will decrease as we realign our corporate activities.
Finance income
Our finance income consists primarily of interest earned on
our bank deposits, foreign currency hedging transactions, and remeasurement of warrants.
Finance expenses
Our finance expenses consist primarily of financing costs
related to our outstanding liability to the IIA on account of grants received for financing our research and development activity, as
well as expenses related to bank charges and foreign currency exchange transactions.
Income Taxes Expense
Our income taxes expense is derived primarily from income
generated from the sales and lease of our Deep TMS systems from our U.S. subsidiary.
Critical Accounting Policies
and Estimates
The preparation of unaudited condensed consolidated interim
financial statements, in conformity with IFRS, requires companies to make estimates and assumptions that affect the reported amounts of
assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities at and as of the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. These estimates and judgments are subject to
an inherent degree of uncertainty, and actual results may differ. Our significant accounting policies are more fully described in Note
2 to our financial statements included in the 2024 Annual Report and in Note 2 to our unaudited condensed consolidated interim financial
statements included as Exhibit 99.1 to this Report. Critical accounting estimates and judgments are continually evaluated and are based
on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances,
and are particularly important to the portrayal of our financial position and results of operations.
Variability of Quarterly Operating Results
Our revenues and profitability may vary from quarter to
quarter and in any given year, depending primarily on the sales vs. lease mix of our products and the mix of the various components
of the products, sale prices, and production costs, as well as changes in the scope and composition of our expenses. Annual and
quarterly fluctuations in our results of operations may be caused by the timing and composition of orders by our customers and the
timing of our ability to recognize revenues. Our future results may also be affected by a number of factors, including our ability
to continue to develop, introduce and deliver new and enhanced products on a timely basis and expand into new product offerings at
competitive prices, to anticipate effectively customer demands and to manage future inventory levels in line with anticipated
demand. Our results may also be affected by currency exchange rate fluctuations and economic conditions in the geographical areas in
which we operate. In addition, our revenues may vary significantly from quarter to quarter as a result of, among other factors, the
timing of new product announcements and releases by our competitors and us. We cannot be certain that revenues, gross profit and net
income (or loss) in any particular quarter will not vary from the preceding or comparable quarters. Our expense levels are based, in
part, on expectations as to future revenues. If revenues are below expectations, operating results are likely to be adversely
affected. In addition, a substantial portion of our expenses are fixed (e.g., lease payments) and adjusting expenses in the event
revenues drop unexpectedly often takes considerable time. As a result, we believe that period-to-period comparisons of our results
of operations are not necessarily meaningful and should not be relied upon as indications of future performance. Due to all of the
foregoing factors, it is possible that in some future quarters our revenues or operating results will be below the expectations of
public market analysts or investors. In such event, the market price of our shares would likely be materially
adversely affected.
Operating Results
| | |
For the six months ended June 30, |
| | |
|
2025 |
| |
|
2024 |
|
| | |
|
Unaudited
(U.S. dollars in thousands except per share data) |
|
| Revenues | |
$ | 24,168 | | |
$ | 19,100 | |
| Cost of revenues | |
| 6,059 | | |
| 4,751 | |
| Gross profit | |
| 18,109 | | |
| 14,349 | |
| Research and development expenses | |
| 4,676 | | |
| 3,337 | |
| Selling and marketing expenses | |
| 9,102 | | |
| 7,623 | |
| General and administrative expenses | |
| 3,177 | | |
| 2,710 | |
| Total operating expenses | |
| 16,955 | | |
| 13,670 | |
| Operating profit | |
| 1,154 | | |
| 679 | |
| Finance income | |
| 3,414 | | |
| 1,115 | |
| Finance expense | |
| 1,207 | | |
| 808 | |
| Profit before income taxes | |
| 3,361 | | |
| 986 | |
| Income taxes | |
| 227 | | |
| 275 | |
| Net profit and total comprehensive income | |
$ | 3,134 | | |
$ | 711 | |
| Basic net earnings per share | |
$ | 0.08 | | |
$ | 0.02 | |
| Diluted net earnings per share | |
$ | 0.07 | | |
$ | 0.02 | |
Six Months Ended June 30, 2025 compared
to Six Months Ended June 30, 2024
Revenues
Our total revenues were $24.2 million for the six months
ended June 30, 2025, compared to $19.1 million for the six months ended June 30, 2024. The increase in revenues of $5.1 million, or
27%, is primarily attributed to an increase in leases and sales of our Deep TMS systems to customers. Revenues from sales and leases
were 64% and 24%, respectively, of the revenues for the six months ended June 30, 2025, compared to 42% and 48%, respectively, of
the revenues for the six months ended June 30, 2024.
Cost of revenues and gross margin
Our cost of revenues was $6.1 million
for the six months ended June 30, 2025, compared to $4.8 million for the six months ended June 30, 2024. The increase of $1.3 million,
or 27% is primarily attributed to an increase in sales volumes. There has been no material change in our gross margin as a percentage
of revenue for the last three years.
Research and development expenses
Our research and development expenses were $4.7 million
for the six months ended June 30, 2025, compared to $3.4 million for the six months ended June 30, 2024. The increase of $1.4 million,
or 42%, is primarily attributed to an increase in headcount and in investments in clinical trial and post-marketing studies.
Selling and marketing expenses
Our selling and marketing expenses were $9.1 million for the
six months ended June 30, 2025, compared to $7.6 million for the six months ended June 30, 2024. The increase of $1.5 million, or 20%,
is primarily attributed to an increase in head count of the commercial team in the United States, as well as an increase in collection
and selling fees in connection with increased sales.
General and administrative expenses
Our general and administrative expenses were $3.2 million
for the six months ended June 30, 2025, compared to $2.7 million for the six months ended June 30, 2024. The increase of $0.5 million,
or 19%, is primarily attributed to expenditure towards our new business development strategic initiative activities.
Finance income, net
Our finance income, net, was $2.2 million for the six months
ended June 30, 2025, compared to finance income, net of $0.3 million for the six months ended June 30, 2024. The increase of $1.9 million
is primarily attributed to higher returns on investments due to favorable exchange rate movements and effective currency hedging strategies,
along with improved interest income from cash and short-term investments and remeasurement of warrants.
For information on the impact of currency fluctuations on
our company, please see “Item 11. Quantitative and Qualitative Disclosures About Market Risk” of our 2024 Annual Report.
For more information regarding governmental economic, fiscal,
monetary or political policies or factors that have materially affected, or could materially affect, directly or indirectly, the Company’s
operations in Israel, please see also “Item 3D. Risk Factors—Risks Related to Our Functions in Israel” of our
2024 Annual Report.
Liquidity and
Capital Resources
As of June 30, 2025, we had cash,
cash equivalents, restricted cash and short-term deposits of $78.3 million and an accumulated deficit of $95.2 million, compared to
cash, cash equivalents, restricted cash and short-term deposits of $69.6 million, and an accumulated deficit of $98.4 million as of
December 31, 2024. We incurred positive cash flows from operating activities of $17.4 million and $4.5 million for the six months
ended June 30, 2025 and 2024, respectively. We incurred operating losses from our inception through the year ended December 31,
2023, and reached a net profit in the six months ended June 30, 2024 through the six months ended June 30, 2025, mainly due to an
increase in sales. Our primary sources of capital to date have been from public offerings in the U.S. and Israel and private
placements of our securities, grants from the IIA, and leases and sales of our Deep TMS systems. From inception through June 30,
2025, we raised approximately $149 million from placements of our securities and the exercise of options.
Our primary contractual obligations
consist of liabilities in respect of research and development grants received from the IIA, royalties in respect of license agreements
for the use of some of our intellectual property with Yeda and PHS, as well as lease liabilities in respect of corporate facilities and
vehicles. For information about our contractual obligations, see Notes 11 and 12 to our financial statements included in our 2024 Annual
Report.
In November 2024, we raised approximately $20 million in immediate
proceeds from a private placement of 2,103,745 ADSs and warrants to purchase 1,500,000 ADSs to Valor (as discussed below, please see “Outstanding
Warrants”). In June 2025, we invested $5 million toward the aforementioned strategic equity financing agreement with Stella.
Based on our current business plan, we believe that our cash resources as of June 30, 2025 and the anticipated revenues from sales of
our products will be sufficient to fund our operating expenses and capital expenditure requirements in the foreseeable future, including
the subsequent investments made toward our business development strategic initiative transactions with Axis and Neurolief.
Cash Flows
The table below summarizes our cash flow activities for the indicated periods:
| | |
Six Months Ended June 30, |
| | |
|
2025 |
| |
|
2024 |
|
| | |
|
(in U.S. dollars thousands) |
|
| Net cash provided by operating activities | |
| 17,393 | | |
| 4,526 | |
| Net cash provided by (used in) investing activities | |
| (17,825 | ) | |
| 33,488 | |
| Net cash used in financing activities | |
| (1,019 | ) | |
| (624 | ) |
| Exchange rate differences on cash and cash equivalents | |
| 18 | | |
| (46 | ) |
| Increase (decrease) in cash and cash equivalents | |
| (1,433 | ) | |
| 37,344 | |
Operating Activities
Net cash provided by operating activities was $17.4 million
during the six months ended June 30, 2025, compared to $4.5 million provided by operating activities during the six months ended June
30, 2024. The increase of $12.9 million is primarily attributed to deferred revenue receipts from customers and an increase in net profit
in 2025 compared to 2024.
Investing Activities
Net cash used in investing activities was $17.8 million during
the six months ended June 30, 2025, compared to $33.5 million provided by investing activities during the six months ended June 30, 2024.
The increase in cash used in investing activities is mainly due to the transfer during the six months ended June 30, 2024 of $35 million
that was held in bank deposits for a duration of over three months to bank deposits for a duration of less than three months and the deposit
of $10.0 million in bank deposits for a duration of over three months during the six months ended June 30, 2025. This resulted in a change
in the way these amounts are classified from “short term deposits” to “cash and cash equivalents”.
Financing Activities
Net cash used in financing activities was $1.0 million during
the six months ended June 30, 2025, compared to $0.6 million used in financing activities during the six months ended June 30, 2024. The
increase in net cash used in financing activities is primarily attributed to an increase in lease liability repayments in 2025.
Government Grants
During the six months ended June 30, 2025, we did not receive
any additional grants from the Israeli government, while we repaid approximately $0.6 million in respect of refundable projects through
royalties. For a discussion of our existing government grants related to our research and development efforts, please see “Item
5. Operating and Financial Review and Prospects— B. Liquidity and Capital Resources— Government Grants” in our 2024
Annual Report.
Outstanding Warrants
In connection with the private placement to Valor BrainsWay
Holdings, LLC (“Valor”), consummated on November 5, 2024, we issued Valor a warrant to purchase 1,500,000 ADSs (the “Valor
Warrant”), at an exercise price of $9.50686 per ADS , or the Valor Warrant Exercise Price. The Valor Warrant became exercisable
upon issuance thereof at the closing of the Valor investment and will remain exercisable for 18 months after the initial issuance date,
or the Exercise Period. Under the Valor Warrant, if at any time during the Exercise Period, the ADS closing price of any thirty (30) consecutive
trading day period exceeds the Valor Warrant Exercise Price by 40% or more, Valor shall be required to fully exercise the Valor Warrant
within five (5) trading days. During the six months ended June 30, 2025, we entered into an amendment to the Valor Warrant which, among
other amendments, removed the cashless exercise feature from the Valor Warrant, resulting in a reclassification of the Valor Warrant from
liability (as of December 31, 2024) to equity (as of June 30, 2025).
Research and Development,
Patents, and Licenses
No significant changes with respect to our research and development
efforts occurred during the six months ended June 30, 2025. For descriptions of our research and development, patent and licenses, please
see “Item 5. Operating and Financial Review and Prospects— C. Research and Development, Patents, and Licenses” in our
2024 Annual Report
Trend Information
No significant changes with respect to trends occurred during the
six months ended June 30, 2025. For descriptions of our trend information, please see “Item 5. Operating and Financial Review and
Prospects— D. Trend Information” in our 2024 Annual Report.
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