BrainsWay Reports First Quarter 2024 Financial Results and Operational Highlights

Rhea-AI Summary

BrainsWay reported a 37% year-over-year revenue growth in Q1 2024, achieving positive net income for the second consecutive quarter. The company also recorded positive Adjusted EBITDA and cash flow from operations for the third consecutive quarter. Revenues reached $9.1 million, with a gross margin of 75%. Operating income was $0.1 million compared to a loss of $3.7 million in the same period last year. Net income was $0.1 million, an improvement from a net loss of $2.4 million in Q1 2023. The Company's cash, cash equivalents, and short-term deposits stood at $47.8 million as of March 31, 2024. BrainsWay shipped 57 Deep TMS™ systems in Q1 2024, bringing the total installed base to 1,158 systems. Collaboration with partner Katie’s Way Plus expanded, and the Company installed its 11th Deep TMS system in Israel. With strong Q1 results, BrainsWay reaffirmed its full-year 2024 revenue guidance of $37 million to $40 million, expecting continued growth and profitability throughout the year.

Positive

• 37% year-over-year revenue growth in Q1 2024

• Positive net income for the second consecutive quarter

• Recorded positive Adjusted EBITDA and cash flow for the third consecutive quarter

• Gross margin of 75%

• Increased cash, cash equivalents, and short-term deposits to $47.8 million

• Shipped 57 Deep TMS™ systems in Q1 2024, reaching a total installed base of 1,158 systems

• Expanded collaboration with partner Katie’s Way Plus

• Installed the 11th Deep TMS system in Israel

• Reaffirmed full-year 2024 revenue guidance of $37 million to $40 million

Negative

• None.

Insights

Financial Analyst

The report from BrainsWay demonstrates a robust year-over-year revenue growth of 37%, which notably exceeds the industry standard for medical device companies. The transition from a net loss in Q1 2023 to a net income and positive Adjusted EBITDA in Q1 2024 is indicative of operational efficacy and cost management improvements. The gross margin improvement, now at 75%, suggests enhanced profitability per unit sold. Furthermore, the installation of the Deep TMS systems with a 24% increase in the installed base and the expansion with Katie’s Way Plus are indicators of market penetration and increased demand for the company's product. These factors, combined with a strong cash position of $47.8 million, position BrainsWay to potentially sustain its growth trajectory and further operational expansion. However, investors should be cognizant of the company's reliance on continued positive reimbursement rates and expanding collaborations to maintain this growth.

Medical Device Market Analyst

Observing BrainsWay's substantial growth in the Deep TMS™ systems installed base, particularly the 50% OCD treatment capability integration, reflects a strategic move towards diversifying the therapeutic applications of their technology. This diversification can cater to broader clinical needs and create multiple revenue streams. The positive shift in Israel's reimbursement rates also underscores a favorable policy environment that could encourage further adoption and integration of BrainsWay's technology in healthcare settings. The company's focus on increasing presence through strategic partnerships, as seen with the Katie’s Way Plus collaboration, is a sound tactic in scaling operations and potentially capturing more market share. However, investors should consider market competition and the rate of technological advancements which could influence BrainsWay's market positioning in the future.

Healthcare Policy Analyst

BrainsWay's operational update reveals a significant interplay between regulatory environments and the business's financial health. The enhanced reimbursement rates in Israel, for instance, are likely contributing to the company's revenue growth and may serve as a bellwether for similar advancements in other regions. Policy shifts in healthcare reimbursement can be a double-edged sword. They can either offer tailwinds for medical device companies like BrainsWay or present challenges if policies are reversed or if reimbursement rates decline. Investors should, therefore, monitor policy developments closely as they can have a direct impact on the company's bottom line and its capacity to continue expanding its installation base.

Generated Significant 37% Year-over-Year Revenue Growth in Q1 2024

Recorded Positive Quarterly Net Income for Second Consecutive Quarter, and Positive Adjusted EBITDA and Cash Flow from Operations for Third Consecutive Quarter

Conference Call to be Held Today at 8:30 AM ET

BURLINGTON, Mass. and JERUSALEM, May 08, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a world leader in advanced and non-invasive treatment for brain disorders, today reported first quarter 2024 financial results and provided an operational update.

Recent Financial and Operational Highlights

• For the three months ended March 31, 2024, revenues were $9.1 million, a 37% increase as compared to the first quarter of 2023.
• Gross margin for the first quarter of 2024 was 75%, an increase from 73% in the first quarter of 2023.
• Operating income for the first quarter of 2024 was $0.1 million, compared to a loss of $3.7 million for the same period in 2023.
• Net income for the first quarter of 2024 was $0.1 million, compared to a net loss of $2.4 million for the first quarter of 2023.
• Adjusted EBITDA¹ for the first quarter of 2024 was approximately $0.7 million, compared to a loss of $2.9 million for the first quarter of 2023.
• Cash, cash equivalents, and short-term deposits as of March 31, 2024, amounted to $47.8 million, an increase of $1.6 million from December 31, 2023.
• The Company shipped a net total of 57 Deep TMS™ systems during the first quarter of 2024, bringing BrainsWay’s Deep TMS installed base to 1,158 total systems as of March 31, 2024, a 24% increase from the installed base at the same point in the prior year.
• During the first quarter of 2024, the Company shipped 31 obsessive-compulsive disorder (OCD) coils as add-on helmets to certain of BrainsWay’s new and existing systems, representing OCD treatment capability on 50% of its total installed base.
• Increased collaboration with significant existing partner, Katie’s Way Plus, which recently ordered an additional 18 Deep TMS systems and will now have an extensive network of approximately 40 devices.
• Installed the 11^th Deep TMS system in Israel, steadily increasing presence in this geography following the recent increase in the country’s reimbursement rates.

“Our revenues grew 37% year-over-year in the first quarter of 2024, reflecting the significant tailwinds present throughout our entire business,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “In addition, we generated positive quarterly net income for the second consecutive quarter, and positive Adjusted EBITDA and cash flow from operations for the third consecutive quarter.”

“Based on our excellent first quarter results, and expectations for continued strong performance throughout the remainder of the year, we are reiterating our previously provided full-year 2024 revenue guidance of $37 million to $40 million. This would represent growth of 16% to 26% over full-year 2023 revenue. In addition, we continue to anticipate that our profitability momentum and positive cash generation will continue throughout 2024,” concluded Mr. Levy.

Conference Call and Webcast
BrainsWay’s management will host a conference call on Wednesday, May 8, 2024, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Wednesday, May 8, 2024, at 8:30 AM Eastern Time:

United States:	1-888-886-7786
International:	416-764-8658
Israel:	1-809-468-221
Conference ID:	50552862
Webcast:	https://viavid.webcasts.com/starthere.jsp?ei=1666254&tp_key=5dcb324538

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

Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” 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
britchie@lifesciadvisors.com

^{_____________________________
1} See Adjusted EBITDA details and reconciliation table in the appendix below.

BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
	March 31,					December 31,
	2024					2023
ASSETS	(Unaudited)					(Audited)
Current Assets
Cash and cash equivalents	$	12,382				$	10,520
Short-term deposits		35,196					35,465
Restricted cash		271					271
Trade receivables, net		4,339					3,780
Inventory		3,832					3,717
Other current assets		1,373					1,712
		57,393					55,465
Non-Current Assets
System components		1,495					1,273
Leased systems, net		3,600					3,700
Other property and equipment		779					817
Other long-term assets		1,876					1,717
		7,750					7,507
	$	65,143				$	62,972
LIABILITIES AND EQUITY
Current Liabilities
Trade payables	$	892				$	758
Deferred revenues		5,480					2,504
Liability in respect of research and development grants		1,035					1,008
Other accounts payable		5,415					5,491
		12,822					9,761
Non-Current Liabilities
Deferred revenues and other liabilities		4,483					5,553
Liability in respect of research and development grants		5,841					6,077
		10,324					11,630
Equity
Share capital		367					367
Share premium		140,449					140,344
Share-based payment reserve		4,560					4,360
Currency Translation Adjustments		(2,188	)				(2,188	)
Accumulated deficit		(101,191	)				(101,302	)
		41,997					41,581
	$	65,143				$	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 March 31,
	2024			2023
	(Unaudited)
Revenues	$	9,095		$	6,625
Cost of revenues		2,283			1,792
Gross income		6,812			4,833
Research and development expenses, net		1,626			1,785
Selling and marketing expenses		3,827			4,912
General and administrative expenses		1,266			1,803
Total operating expenses		6,719			8,500
Operating income (loss)		93			(3,667	)
Finance income		618			1,424
Finance expenses		428			17
Income (loss) before income taxes		283			(2,260	)
Taxes on income		172			171
Net income (loss) and total comprehensive income (loss)	$	111		$	(2,431	)
Basic and diluted net income (loss) per share	$	0.00		$	(0.07	)

BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
	For the three months ended March 31,
	2024				2023
	(Unaudited)
Cash flows from operating activities:
Total comprehensive income (loss)	$	111			$	(2,431	)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Adjustments to profit or loss items:
Depreciation and amortization		62				93
Depreciation of leased systems		255				233
Impairments and disposals		251				246
Finance expenses, net		(190	)			(1,407	)
Cost of share based payment		305				(51	)
Income taxes		172				171
Total adjustments to reconcile income (loss)		855				(715	)
Changes in asset and liability items:
Increase in trade receivables		(574	)			(493	)
Increase in inventory		(53	)			(928	)
Decrease (increase) in other current assets		264				(222	)
Increase (decrease) in trade payables		150				(535	)
Increase (decrease) in other accounts payable		(365	)			447
Increase in deferred revenues and other liabilities		1,924				700
Total changes in asset and liability		1,346				(1,031	)
Cash paid and received during the period for:
Interest paid		(11	)			(31	)
Interest received		877				674
Income taxes paid		-				(7	)
Total cash paid and received during the period		866				636
Net cash provided by (used in) operating activities:		3,178				(3,541	)
Cash flows from investing activities:
Proceeds from (purchase of) property and equipment and system components, net		(724	)			66
Proceeds from sub-lease assets		20				-
Investment in long-term deposits, net		(6	)			(2	)
Net cash provided by (used in) investing activities		(710	)			64
Cash flows from financing activities:
Repayment of liability in respect of research and development grants		(532	)			-
Repayment of lease liability		(57	)			(66	)
Net cash used in financing activities		(589	)			(66	)
Exchange rate differences on cash and cash equivalents		(17	)			13
Increase (decrease) in cash and cash equivalents		1,862				(3,530	)
Cash and cash equivalents at the beginning of the period		10,520				47,581
Cash and cash equivalents at the end of the period	$	12,382			$	44,051
(a) Significant non cash transactions:
Recognition of new lease liability and right-of-use		72				24
Termination of lease liability and right-of-use		-				11

 

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 March 31,
	2024				2023
	(Unaudited)
Net income (loss) and total comprehensive income (loss)	$	111			$	(2,431	)
Finance income, net		(190	)			(1,407	)
Income taxes		172				171
Depreciation and amortization		62				93
Depreciation of leased systems		255				233
Cost of share based payment		305				(51	)
Restructuring and litigation Cost		-				535
Adjusted EBITDA	$	715			$	(2,857	)

FAQ

What was BrainsWay's revenue growth in Q1 2024?

BrainsWay reported a significant 37% year-over-year revenue growth in Q1 2024.

Did BrainsWay achieve positive net income in Q1 2024?

Yes, BrainsWay achieved positive net income for the second consecutive quarter in Q1 2024.

What was BrainsWay's cash position as of March 31, 2024?

As of March 31, 2024, BrainsWay had cash, cash equivalents, and short-term deposits amounting to $47.8 million.

How many Deep TMS™ systems did BrainsWay ship in Q1 2024?

BrainsWay shipped a total of 57 Deep TMS™ systems in Q1 2024.

What is BrainsWay's full-year 2024 revenue guidance?

BrainsWay reaffirmed its full-year 2024 revenue guidance of $37 million to $40 million.