BrainsWay Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights
Achieved record quarterly sales of $11.4 million in Q4 2024, an increase of 27% compared with Q4 2023
Full year 2024 revenue increased nearly 30% YoY to $41 million
Exceeded full year 2024 operating income and Adjusted EBITDA margin guidance
Company expects continued strong growth in 2025, with revenue of $49 million to $51 million and further improvement in profit and profitability
Conference call to be held today at 8:30 AM ET
BURLINGTON, Mass. and JERUSALEM, March 11, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today reported fourth quarter and full year 2024 financial results and provided an operational update.
Fourth Quarter 2024 Financial and Operational Highlights
-- Achieved fourth quarter 2024 revenue of $11.4 million, a 27% increase as
compared to the fourth quarter 2023.
-- Shipped a net total of 75 Deep TMS$(TM)$ systems, a 25% increase from the
amount shipped in the fourth quarter of 2023.
-- Gross margin for the fourth quarter of 2024 was 75%, the same as in the
prior year period.
-- Operating income for the fourth quarter of 2024 was $0.4 million,
compared to $0.2 million for the same period in 2023.
-- Adjusted EBITDA1 for the fourth quarter of 2024 was approximately $1.4
million, compared to $0.8 million for the fourth quarter of 2023.
-- Net income for the fourth quarter of 2024 was $1.5 million (including $1
million due to a positive impact from the valuation of warrants issued to
Valor Equity Partners), compared to $0.1 million for the fourth quarter
of 2023.
-- Continued progress in the Company's randomized, multicenter U.S. clinical
trial evaluating an accelerated treatment protocol for the Deep TMS
system for major depressive disorder (MDD) treatment as compared to 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.
-- Published positive feasibility clinical data evaluating the analgesic
effects of Deep TMS in patients with peripheral neuropathic pain in the
Neuromodulation journal.
-- The Brain Stimulation journal published positive pilot data from an
independent, third-party study conducted at Stanford University
evaluating an accelerated protocol using the Company's Deep TMS
technology to treat alcohol use disorder (AUD) patients.
Full Year 2024 Financial and Operational Highlights
-- Full year 2024 revenue of $41.0 million, a 29% increase as compared to
full year 2023.
-- Gross margin for the full year 2024 was 75%, up slightly from 74% in the
prior year.
-- Operating income for the full year 2024 was $1.4 million, compared to an
operating loss of $5.0 million in the prior year.
-- Net income for the full year 2024 was $2.9 million, compared to a net
loss of $4.2 million in the prior year.
-- Adjusted EBITDA2 for the full year 2024 was approximately $4.5 million,
compared to an adjusted EBITDA loss of $2.4 million for the prior year.
-- Completed $20 million strategic equity financing transaction with Valor
Equity Partners, aligning BrainsWay with premier U.S. tech investor to
expand access to BrainsWay Deep TMS(TM).
-- As of December 31, 2024, cash and cash equivalents and short-term
deposits totaled $69.4 million.
-- Received expanded FDA labeling for Deep TMS to treat late life depression,
increasing upper limit of age range from 68 to 86 and broadening
availability of Deep TMS therapy.
-- Doctors reported significant increase in second half of 2024 Deep TMS
treatments for anxious depression, a large, addressable medical condition
affecting 10 to 16 million adults in the U.S. each year.
-- Broadly entered Canadian market via exclusive multi-year distribution
agreement with a specialty distributor, including minimum quantity orders
that increase successively over several years.
-- Continued U.S. expansion through collaboration with large mental health
networks.
-- Increased penetration of international markets, including through
significant deals in East Asia.
(2) See Adjusted EBITDA details and reconciliation table in the appendix below.
Full Year 2025 Financial Guidance
-- Announced full-year 2025 revenue guidance of between $49 million to $51
million, which represents 20% to 24% growth over 2024 revenue.
-- Anticipating continued profitability and positive cash flow, targeting
operating income of 3% to 4% and Adjusted EBITDA of 11% to 12% for
full-year 2025.
"We are very pleased with our performance over the past year which reflects the evolution of our business to a new phase of growth and profitability. We are rapidly growing sales of our Deep TMS system through broadened global channels and have increased our market presence thereby bringing Deep TMS to more patients than ever before. Over the course of the past year, our relationships with enterprise customers have flourished, resulting in large and recurring agreements that have allowed us to build a robust sales backlog," said Hadar Levy, BrainsWay's Chief Executive Officer.
"This is a very exciting time for our business, and we see tremendous room for further growth driven by multiple key catalysts, including our next-generation Deep TMS 360(TM) system, expanded indications, and broadened and enhanced treatment capabilities supported by new clinical data. In order to leverage these significant opportunities, we have deepened our commitment to pioneering advancements in neuromodulation research, further cementing our role in shaping the future of mental health treatment, while also solidifying our position as the clear technological and clinically-backed leader in TMS therapy," concluded Mr. Levy.
Call and Webcast
BrainsWay's management will host a conference call on Tuesday, March 11, 2025, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
Tuesday, March 11, 2025, at 8:30 AM Eastern Time:
United States: 1-877-300-8521
International: 1-412-317-6026
Israel: 1-80-921-2373
Conference ID: 10196869
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1
707646&tp_key=bc6ba7895 7
The conference call will be broadcast live and will be available for replay for 30 days on the Company's website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company's website at least 10 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 income and net income, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net income 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 income (loss) or net income (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 income (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 income (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(TM)) 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 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 1995. Such statements may be preceded by the words "intends," "may," "will," "plans, " "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company's anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company's intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's filings with the U.S. Securities and Exchange Commission.
Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com
Investors:
Brian Ritchie
LifeSci Advisors LLC
britchie@lifesciadvisors.com
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
December 31, December 31,
2024 2023
-------------- ----------------
ASSETS (Unaudited) (Audited)
--------------------------------------
Current Assets
Cash and cash equivalents $ 69,345 $ 10,520
Short-term deposits - 35,465
Restricted cash 271 271
Trade receivables, net 4,596 3,780
Inventory 4,426 3,717
Other current assets 889 1,712
79,527 55,465
--------- ---------
Non-Current Assets
System components 1,707 1,273
Leased systems, net 3,833 3,700
Other property and equipment 6,333 817
Other long-term assets 2,587 1,717
14,460 7,507
--------- ---------
$ 93,987 $ 62,972
========= =========
LIABILITIES AND EQUITY
--------------------------------------
Current Liabilities
Trade payables $ 2,772 $ 758
Deferred revenues 4,446 2,504
Liability in respect of research and
development grants 1,293 1,008
Other accounts payable 6,462 5,491
14,973 9,761
--------- ---------
Non-Current Liabilities
Deferred revenues and other
liabilities 8,469 5,553
Liability in respect of research and
development grants 5,803 6,077
Warrants 2,429 -
16,701 11,630
--------- ---------
Equity
Share capital 413 367
Share premium 157,597 140,344
Share-based payment reserve 4,872 4,360
Currency Translation Adjustments (2,188) (2,188)
Accumulated deficit (98,381) (101,302)
62,313 41,581
--------- ---------
$ 93,987 $ 62,972
========= =========
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
U.S. dollars in thousands (except per share data)
For the three
months ended Year ended
December 31, December 31,
----------------- ----------------------------
2024 2023 2024 2023
------- ------- ------------- ----------
(Unaudited) (Unaudited) (Audited)
Revenues $11,414 $9,029 $ 41,016 $ 31,785
Cost of
revenues 2,903 2,290 10,435 8,308
Gross income 8,511 6,739 30,581 23,477
------ ----- --- -------- ------
- -
- -
Research and
development
expenses, net 2,044 1,434 7,190 6,665
Selling and
marketing
expenses 4,472 3,959 16,203 16,456
General and
administrative
expenses 1,564 1,162 5,797 5,315
Total
operating
expenses 8,080 6,555 29,190 28,436
------ ----- --- -------- ------
- -
Operating
income
(loss) 431 184 1,391 (4,959)
- -
Finance income 1,640 588 3,585 2,171
Finance Expense 335 809 1,517 1,158
Income (loss)
before income
taxes 1,736 - (37) 3,459 (3,946)
Taxes on income 188 (164) 538 251
------ ----- --- -------- ------
Net income (loss)
and total
comprehensive
income (loss) $ 1,548 $ 127 $ 2,921 $ (4,197)
====== ===== === ======== ======
Basic and diluted
net income
(loss) per
share $ 0.04 $ 0.00 $ 0.09 $ (0.13)
====== ===== === ======== ======
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
For the three months For the year ended
ended December 31, December 31,
---------------------- --------------------------
2024 2023 2024 2023
----------- --------- ------------- -----------
(Unaudited) (Unaudited) (Audited)
Cash flows from
operating
activities:
Total
comprehensive
income (loss) $ 1,548 $ 127 $ 2,921 $ (4,197)
Adjustments to reconcile net
income (loss) to net cash
provided by (used in) operating
activities:
Adjustments to
profit or loss
items:
Depreciation and
amortization 154 83 462 362
Depreciation of
leased systems 482 256 1,237 975
Impairments and
disposals 276 509 1,518 1,447
Finance expenses
(income), net (1,305) 221 (2,068) (1,013)
Cost of share
based payment 384 234 1,441 381
Income taxes 188 (164) 538 251
Total adjustments to
reconcile income
(loss) 179 1,139 3,128 2,403
------ ------- --- ------- -------
Changes in asset and
liability items:
Decrease
(increase) in
trade
receivables (1,162) (315) (867) 1,089
Increase in
inventory (348) $(500.SI)$ (920) (506)
Decrease
(increase) in
other current
assets 1,663 (69) 1,735 (312)
Increase
(decrease) in
trade payables 1,509 312 2,023 (327)
Increase in
other accounts
payable 114 418 40 62
Increase
(decrease) in
deferred
revenues and
other
liabilities (768) 1,391 383 1,629
Total changes in
asset and
liability 1,008 1,237 2,394 1,635
------ ------- --- ------- -------
Cash paid and
received during the
period for:
Interest paid (21) (150) (125) (253)
Interest
received 728 121 2,922 1,707
Income taxes
paid (16) - (1,010) (11)
Total cash paid and
received during the
period 691 (29) 1,787 1,443
------ ------- --- ------- -------
Net cash provided by
operating
activities: 3,426 2,474 10,230 1,284
------ ------- --- ------- -------
Cash flows from
investing
activities:
Purchase of
property and
equipment and
system
components,
net (851) (442) (3,722) (2,387)
Proceeds from
sub-lease
asset 33 - 73 -
Withdrawal of
(investment in)
deposits, net (956) (35,014) 34,029 (35,022)
Net cash provided by
(used in) investing
activities (1,774) (35,456) 30,380 (37,409)
------ ------- --- ------- -------
Cash flows from
financing
activities:
Repayment of
liability in
respect of
research and
development
grants (4) (442) (1,108) (787)
Exercise of
share options (2) - 17 -
Receipt of
government
grants - - - 32
Proceeds from
issuance of
shares, net 16,353 - 16,353 -
Issuance of
warrants 3,425 - 3,425
Repayment of
lease
liability (187) (85) (424) (271)
Net cash provided by
(used in) financing
activities 19,585 (527) 18,263 (1,026)
------ ------- --- ------- -------
Exchange rate
differences on cash
and cash
equivalents (19) 136 (48) 90
------ ------- --- ------- -------
Increase (decrease)
in cash and cash
equivalents 21,218 (33,373) 58,825 (37,061)
Cash and cash
equivalents at the
beginning of the
period 48,127 43,893 10,520 47,581
--- ------- -------
Cash and cash
equivalents at the
end of the period $ 69,345 $ 10,520 $ 69,345 $ 10,520
====== ======= === ======= =======
(a) Significant non
cash transactions:
Recognition of
new lease
liability and
right-of-use $ (177) $ 101 $ 5,473 $ 308
====== ======= === ======= =======
Termination of
lease
liability and
right-of-use $ 15 $ (169) $ 32 $ (99)
====== ======= === ======= =======
BRAINSWAY LTD.
A reconciliation of Adjusted EBITDA to net income
(loss), 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 For the Year ended
December 31, December 31,
---------------- ----------------------------
2024 2023 2024 2023
-------- ------ ------------- -------------
(Unaudited) (Unaudited) (Audited)
Net income
(loss) and
total
comprehensive
income (loss) $ 1,548 $ 127 $ 2,921 $ (4,197)
Finance
expense
(income),
net (1,305) 221 (2,068) (1,013)
Income taxes 188 (164) 538 251
Depreciation
and
amortization 84 83 392 362
Depreciation
of leased
systems 482 256 1,237 975
Cost of share
based
payment 363 234 1,420 381
Restructuring
and
litigation
Cost - - - 852
Adjusted EBITDA $ 1,360 $ 757 $ 4,440 $ (2,389)
------ ---- --- -------
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