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Brainsway Ltd.

Earnings Release May 11, 2022

6701_rns_2022-05-11_1e139bef-818a-473a-85b7-f9cd947ad120.pdf

Earnings Release

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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 May 2022

Commission File Number: 001-35165

BRAINSWAY LTD.

(Translation of registrant's name into English)

19 Hartum Street Bynet Building, 3rd Floor Har HaHotzvim Jerusalem, 9777518, Israel (Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ X ] Form 40-F [ ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

This Form 6-K is incorporated by reference into the Company's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on April 22, 2019 (Registration No. 333-230979) and the Company's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on September 17, 2021 (Registration No. 333-259610).

EXHIBIT INDEX

Exhibit Title

99.1 BrainsWay Reports First Quarter 2022 Financial Results and Operational Highlights

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

BRAINSWAY LTD. (Registrant)

Date: May 11, 2022 /s/ Christopher R. von Jako, Ph.D Christopher R. von Jako, Ph.D President and Chief Executive Officer

BrainsWay Reports First Quarter 2022 Financial Results and Operational Highlights

Revenue Growth of 30% Year-over-Year in Q1 2022

Conference call to be held today, May 11, 2022, at 8:30 AM ET

BURLINGTON, Mass. and JERUSALEM, May 11, 2022 (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 first quarter 2022 financial results and provided an operational update.

Recent Financial and Operational Highlights

  • For the three months ended March 31, 2022, revenues were \$8.0 million, a 30% increase as compared to the prior year period.
  • As of March 31, 2022, BrainsWay's Deep TMS installed base was 790 total systems, a 21% increase from the installed base at the same point in the prior year.
  • As of March 31, 2022, the Company had shipped 337 OCD coils as add-on helmets to certain of BrainsWay's new and existing systems.
  • Cash, cash equivalents and short-term deposits as of March 31, 2022, amounted to \$54.7 million, compared with \$57.3 million as of December 31, 2021.
  • Hosted key opinion leader (KOL) webinar on Company's Deep TMS therapy for treating anxious depression.
  • Enhanced leadership structure to drive Company's growth:
    • Promoted Hadar Levy to Senior Vice President and Chief Operating Officer.
    • Appointed Joachim "Joe" Seidel, Ph.D., to the newly created position of Vice President of Corporate Development and Strategy.
    • Appointed Eric Hirt as Vice President of U.S. Sales.

"Our strong first quarter performance reflects the continued momentum in our overall business," stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. "We generated \$8.0 million in revenue for the first quarter of 2022, which represented a 30% increase as compared to the first quarter of 2021, and our seventh consecutive quarter of year-overyear growth. These results are especially impressive as the team faced meaningful operational challenges due to the Omicron surge in the first half of the quarter."

"Importantly, demand for our Deep TMS therapy in multiple indications continues to grow, and we anticipate that the current positive operating trends we are experiencing will continue throughout 2022 and beyond," continued Dr. von Jako. "As such, in order to leverage key tailwinds in our business, our recent strategically enhanced leadership structure is aimed at driving long-term growth globally."

First Quarter 2022 Financial Results

  • Total revenues for the first quarter of 2022 were \$8.0 million, compared to \$6.1 million in the first quarter of 2021, an increase of 30%.
  • Gross margin for the first quarter of 2022 was 77%, compared to 76% for the first quarter 2021.
  • Operating expenses for the first quarter of 2022 totaled \$7.6 million, compared with \$5.5 million for the first quarter of 2021.
  • Operating loss for the first quarter of 2022 was \$1.5 million, compared to a loss of \$801,000 for the same period in 2021.

Conference Call and Webcast

BrainsWay's management will host a conference call on Wednesday, May 11, 2022, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Wednesday, May 11, 2022, at 8:30 AM Eastern Time:

States:
United
877-407-3982
Israel: 1 809 406 247
International: 1 201-493-6780
ID:
Conference
13729554
Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=mHgZy2O9

To listen to a live webcast, please visit the Investors section of the BrainsWay website at www.BrainsWay.com. Please access the Company's website at least 10 minutes ahead of the conference call to register. The webcast replay will be available on the website for two weeks following the completion of the call.

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Forward Looking Statements

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. Moreover, the pilot data presented herein, including outcomes/results, patient safety information and adverse event data, remain subject to further analysis and may be subject to further modification. Certain results as expressed herein may be subject to further analysis, modification and/or statistical penalties. 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; continuation and/or exacerbation of the global supply chain crisis and its impact on the Company's ability to source components, meet customer demand, fill orders, maintain pricing levels and support the Company's service needs; and the effect of the global COVID-19 health pandemic on our business and continued uncertainty and market impact relating thereto.

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, including the Company's Annual Report on Form 20-F. Investors and security holders are

urged to read these documents free of charge on the SEC's web site at http://www.sec.gov.

Contacts:

BrainsWay: Scott Areglado SVP and Chief Financial Officer 844-386-7001 [email protected]

Investors: Bob Yedid LifeSci Advisors 646-597-6989 [email protected]

Media Contact: Will Johnson (201) 465-8019 [email protected]

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

March 31, December 31,
2022 2021
ASSETS (Unaudited)
Current Assets
Cash
and
cash
equivalents
\$
14,105
\$ 16,921
Short-term
deposits
40,553 40,428
Trade
receivables,
net
6,387 6,332
Inventory 1,538 -
Other
current
assets
1,557 1,766
64,140 65,447
Non-Current
Assets
System components 3,505 4,463
Leased
systems,
net
3,610 3,813
Other
property
and
equipment
945 1,055
Other
long-term
assets
987 954
10,285
\$
9,047
73,187
\$ 75,732
LIABILITIES
AND
EQUITY
Current Liabilities
Trade payables \$
601
\$ 1,102
Deferred revenue 2,240 2,195
Liability
in
respect
of
research
and
development
grants
952 978
Other
accounts
payable
4,336 4,792
8,129 9,067
Non-Current Liabilities
Deferred revenue and other liabilities 3,602 3,419
Liability
in
respect
of
research
and
development
grants
5,751 5,921
9,353 9,340
363 363
137,814 137,566
Share-based
payment
reserve
5,465 5,340
Currency Translation Adjustments (2,188 ) (2,188 )
Accumulated deficit (85,749 ) (83,756 )
55,705 57,325
Equity
capital
Share
premium
Share
\$
73,187
\$
75,732

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

For the three months ended
March 31,
2022 2021
(Unaudited)
Revenues \$ 7,970 \$ 6,121
Cost
of
revenues
1,867 1,463
profit
Gross
6,103 4,658
Research
and
development
expenses,
net
1,576 925
Selling and marketing expenses 4,146 3,129
General and administrative expenses 1,863 1,405
Total
operating
expenses
7,585 5,459
loss
Operating
(1,482) (801)
Finance
expense,
net
(324) (412)
Loss
before
income
taxes
(1,806) (1,213)
Income taxes 187 160
Net
loss
and
total
comprehensive
loss
\$ (1,993) \$ (1,373)
Basic
and
diluted
net
loss
per
share
\$ (0.06) \$ (0.05)

BRAINSWAY LTD. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS U.S. dollars in thousands

For the three months ended
March 31,
2022 2021
(Unaudited)
Cash flows from operating activities:
Total comprehensive loss \$ (1,993) \$ (1,373)
Adjustments
to
reconcile
net
loss
to
net
cash
used
in
operating
activities:
Adjustments to profit or loss items:
Depreciation and amortization 142 150
Depreciation
of
leased
systems
245 292
Impairments
and
disposals
(68) 253
Finance
expenses,
net
324 412
Cost
of
share
based
payment
374 803
Income taxes 187 160
Total
adjustments
to
reconcile
profit
(loss)
1,204 2,070
Changes in asset and liability items:
Increase
in
trade
receivables
(63) (1,093)
Increase
in
inventory
(1,313) -
Decrease
(increase)
in
other
accounts
receivable
(61) 18
Increase
(decrease)
in
trade
payables
(512) 291
Decrease
in
other
accounts
payable
(510) (212)
Increase
in
deferred
revenues
and
other
liabilities
273 162
Total changes in asset and liability (2,186) (834)
Cash
paid
and
received
during
the
period
for:
Interest paid (12) (20)
Interest received 3 2
Income
taxes
paid
(3) (160)
Total
cash
paid
and
received
during
the
period
(12) (178)
Cash used in operating activities: (2,987) (315)
Cash flows from investing activities:
Proceeds
from
(purchase
of)
property
and
equipment
and
system
components,
net
951 (379)
Investment
in
short-term
deposits,
net
(50) -
Investment in long-term deposits, net (3) -
Net cash provided by (used in) investing activities 898 (379)
Cash flows from financing activities:
Repayment
of
liability
in
respect
of
research
and
development
grants
(498) -
Receipt
of
government
grants
6 90
Repayment of lease liability (148) -
Issuance
of
share
capital,
net
1 42,260
Net cash provided by (used in) financing activities (639) 42,350
Exchange
rate
differences
on
cash
and
cash
equivalents
(88) (337)
Increase
(decrease)
in
cash
and
cash
equivalents
(2,816) 41,319
Cash
and
cash
equivalents
at
the
beginning
of
the
period
16,921 16,961
Cash
and
cash
equivalents
at
the
end
of
the
period
\$ 14,105 \$ 58,280
(a) Significant non cash transactions:
Purchase
of
property
and
equipment
on
credit
- 192

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