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2026-09-08
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Investor releaseQuarter not tagged2026-09-08

BrainsWay Reports Promising Pilot Study Results in Patients with Depression and Comorbid Early-Stage Alzheimer’s Disease Treated with Deep TMS™

GlobeNewswire
Peer-reviewed pilot study shows 83.3% response rate and 50% remission rate in depressive symptoms, alongside measurable neurophysiological changes in brain activity and connectivity BURLINGTON, Mass. and JERUSALEM, Sept. 08, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced the publication of results from a pilot study evaluating the Company’s proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology in patients with co-occurring Major Depressive Disorder (MDD) and early-stage Alzheimer’s disease. The results were published in the peer-reviewed Journal of Geriatric Psychiatry and Neurology. The study, conducted by researchers from the Delray Center for Brain Science and the Department of Psychology at Florida Atlantic University, included 12 patients who received 36 Deep TMS sessions using BrainsWay’s H1 and H7 Coils. The treatment protocol involved stimulation of the left dorsolateral prefrontal cortex with the H1 Coil, followed by stimulation of the temporal regions with the H7 Coil. The study reported an 83.3% response rate (defined as a ≥50% reduction on the Patient Health Questionnaire-9 [PHQ-9] rating scale) and a 50% remission rate (defined as a PHQ-9 score of 4 or less) in depressive symptoms following Deep TMS treatment. In addition to the clinical outcomes, researchers observed changes in brain activity using quantitative electroencephalography (QEEG), a technique that compares electrophysiological brain patterns, before and after treatment. This included a reduction of power in the delta frequency band (i.e., 0-3 Hz) in the right temporal lobe after treatment, which could suggest reduced cortical slowing – a common biological phenomenon associated with Alzeimer’s disease. In addition, an increase in alpha coherence – a measure of synchronization and functional connectivity between different brain regions – was observed between several frontal and temporal sites, suggesting an improvement upon the brain dysconnectivity often implicated in Alzheimer’s disease. “Depression in patients living with Alzheimer’s disease represents a particularly complex clinical challenge, with significant consequences for patients, caregivers, and families,” said Hadar Levy, Chief Executive Officer of BrainsWay. “The response and remiss…Read full document

Peer-reviewed pilot study shows 83.3% response rate and 50% remission rate in depressive symptoms, alongside measurable neurophysiological changes in brain activity and connectivity BURLINGTON, Mass. and JERUSALEM, Sept. 08, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced the publication of results from a pilot study evaluating the Company’s proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology in patients with co-occurring Major Depressive Disorder (MDD) and early-stage Alzheimer’s disease. The results were published in the peer-reviewed Journal of Geriatric Psychiatry and Neurology. The study, conducted by researchers from the Delray Center for Brain Science and the Department of Psychology at Florida Atlantic University, included 12 patients who received 36 Deep TMS sessions using BrainsWay’s H1 and H7 Coils. The treatment protocol involved stimulation of the left dorsolateral prefrontal cortex with the H1 Coil, followed by stimulation of the temporal regions with the H7 Coil. The study reported an 83.3% response rate (defined as a ≥50% reduction on the Patient Health Questionnaire-9 [PHQ-9] rating scale) and a 50% remission rate (defined as a PHQ-9 score of 4 or less) in depressive symptoms following Deep TMS treatment. In addition to the clinical outcomes, researchers observed changes in brain activity using quantitative electroencephalography (QEEG), a technique that compares electrophysiological brain patterns, before and after treatment. This included a reduction of power in the delta frequency band (i.e., 0-3 Hz) in the right temporal lobe after treatment, which could suggest reduced cortical slowing – a common biological phenomenon associated with Alzeimer’s disease. In addition, an increase in alpha coherence – a measure of synchronization and functional connectivity between different brain regions – was observed between several frontal and temporal sites, suggesting an improvement upon the brain dysconnectivity often implicated in Alzheimer’s disease. “Depression in patients living with Alzheimer’s disease represents a particularly complex clinical challenge, with significant consequences for patients, caregivers, and families,” said Hadar Levy, Chief Executive Officer of BrainsWay. “The response and remission rates for depressive symptoms in this study, together with the observed changes in brain activity, provide an encouraging scientific signal that warrants further investigation. We believe this study further validates the broad potential of our Deep TMS platform to noninvasively engage clinically relevant brain networks in patients with complex neuropsychiatric conditions.” The study adds to the continuously growing body of scientific research evaluating BrainsWay’s Deep TMS technology in complex patient populations and exploring its ability to modulate brain networks involved in psychiatric and neurological disorders. Deep TMS is not FDA-cleared for the treatment of Alzheimer’s disease. Additional controlled clinical research will be required to further evaluate these preliminary findings. Discover the findings of the pilot study by accessing the full publication. About BrainsWay BrainsWay is a global leader in advanced noninvasive 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. 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,” “targets,” “believes,” “hopes,” “potential” or similar words, and also includes any financial guidance and projections contained herein. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Historical results or conclusions from scientific research and clinical studies – especially preliminary pilot data from a small sample size such as that reflected in this press release – 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. It is important that the reader access the full publication via the link above in order to obtain more detail and context on the findings referenced herein. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; 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 MaromChief Financial [email protected] Investors: Brian RitchieLifeSci [email protected]

Investor releaseQuarter not tagged2026-08-13

Brainsway Q2 Earnings Call Highlights

MarketBeat
Interested in Brainsway Ltd. Sponsored ADR? Here are five stocks we like better. BrainsWay reported strong Q2 results, with revenue up 35% to $17.1 million, adjusted EBITDA up 141% to $3.5 million, and its 12th consecutive profitable quarter. The company shipped 125 Deep TMS systems, expanding its installed base to approximately 1,950. Demand and revenue visibility improved, with remaining performance obligations rising 30% year over year to $80.4 million. Broader reimbursement for the accelerated SWIFT protocol now reaches an estimated 57 million U.S. covered lives, while clinical data showed sustained benefits and strong responses among patients with comorbid PTSD and depression. BrainsWay raised its 2026 revenue outlook to $68 million-$70 million, representing expected growth of 30%-34%. The company ended the quarter debt-free with $62.4 million in cash and is continuing strategic investments in behavioral-health providers and Neurolief. Brainsway (NASDAQ:BWAY) reported second-quarter revenue growth of 35% and raised its full-year 2026 revenue outlook, citing continued demand for its Deep TMS systems, expanding reimbursement for its accelerated SWIFT treatment protocol and growth in its installed base. Revenue for the three months ended June 30 rose to $17.1 million from $12.6 million a year earlier. Operating income increased to $2.4 million from $0.6 million, while net income rose 34% to $2.7 million. Adjusted EBITDA increased 141% to $3.5 million, and adjusted EBITDA margin expanded to 20% from 11%, according to the company. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Chief Executive Officer Hadar Levy said the quarter marked BrainsWay’s 12th consecutive quarter of profitability and reflected the company’s effort to evolve beyond a Deep TMS device provider into a broader interventional psychiatry platform. BrainsWay shipped 125 Deep TMS systems during the quarter, a 42% increase from the prior-year period, bringing its installed base to about 1,950 systems as of June 30. Levy said each placement can create opportunities for multiyear recurring revenue, greater utilization, additional clinical indications and closer relationships with providers. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Remaining performance obligations reached $80.4 million at quarter-end, up 30% year over year. The company said the…Read full document

Interested in Brainsway Ltd. Sponsored ADR? Here are five stocks we like better. BrainsWay reported strong Q2 results, with revenue up 35% to $17.1 million, adjusted EBITDA up 141% to $3.5 million, and its 12th consecutive profitable quarter. The company shipped 125 Deep TMS systems, expanding its installed base to approximately 1,950. Demand and revenue visibility improved, with remaining performance obligations rising 30% year over year to $80.4 million. Broader reimbursement for the accelerated SWIFT protocol now reaches an estimated 57 million U.S. covered lives, while clinical data showed sustained benefits and strong responses among patients with comorbid PTSD and depression. BrainsWay raised its 2026 revenue outlook to $68 million-$70 million, representing expected growth of 30%-34%. The company ended the quarter debt-free with $62.4 million in cash and is continuing strategic investments in behavioral-health providers and Neurolief. Brainsway (NASDAQ:BWAY) reported second-quarter revenue growth of 35% and raised its full-year 2026 revenue outlook, citing continued demand for its Deep TMS systems, expanding reimbursement for its accelerated SWIFT treatment protocol and growth in its installed base. Revenue for the three months ended June 30 rose to $17.1 million from $12.6 million a year earlier. Operating income increased to $2.4 million from $0.6 million, while net income rose 34% to $2.7 million. Adjusted EBITDA increased 141% to $3.5 million, and adjusted EBITDA margin expanded to 20% from 11%, according to the company. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Chief Executive Officer Hadar Levy said the quarter marked BrainsWay’s 12th consecutive quarter of profitability and reflected the company’s effort to evolve beyond a Deep TMS device provider into a broader interventional psychiatry platform. BrainsWay shipped 125 Deep TMS systems during the quarter, a 42% increase from the prior-year period, bringing its installed base to about 1,950 systems as of June 30. Levy said each placement can create opportunities for multiyear recurring revenue, greater utilization, additional clinical indications and closer relationships with providers. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Remaining performance obligations reached $80.4 million at quarter-end, up 30% year over year. The company said the increase reflected demand for Deep TMS and its focus on leasing systems to enterprise customers. “The backlog is growing, and we are very proud with this 30% increase in the backlog,” Levy said during the question-and-answer session. He said the obligations represent orders for which revenue has not yet been recognized and provide visibility into the second half of 2026 and into 2027. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Gross profit increased 34% to $12.8 million, while gross margin remained at 75%. Sales and marketing expense was unchanged from a year earlier at $4.9 million. Research and development expense rose to $3.2 million from $2.3 million, driven primarily by clinical development and research initiatives involving post-traumatic stress disorder and alcohol use disorder. General and administrative expense rose to $2.3 million from $1.6 million, reflecting higher professional fees and administrative costs. Management highlighted reimbursement progress for the company’s SWIFT accelerated Deep TMS protocol, which is designed to reduce treatment duration from several weeks to a few days. BrainsWay estimates that about 57 million covered lives in the United States now have access to reimbursement for SWIFT. Levy said the protocol is currently focused on patients with major depressive disorder who have not responded well to medication or other treatment approaches. He said adoption can approach 50% of the relevant patient population in local markets where reimbursement is available, though utilization depends on individual payer coverage and whether psychiatrists submit cases to payers. Providers have responded positively to the protocol’s potential to improve patient convenience and increase clinic capacity, Levy said. “A busy clinic can really increase their utilization by using this SWIFT protocol,” he said, adding that providers can treat more patients daily and complete a 30-session treatment protocol within several days. During the quarter, BrainsWay presented prospective 12-month durability data for SWIFT. Levy said the study showed patients maintained meaningful clinical improvement through one year after treatment, including sustained remission rates and continued improvement in functional outcomes. The company also presented results from a real-world study of Deep TMS among patients with comorbid PTSD and major depressive disorder. Across 462 patients treated at 11 clinical sites, more than 83% experienced a meaningful response in PTSD symptoms, while depression symptoms also improved substantially, Levy said. BrainsWay has submitted an application to the Food and Drug Administration seeking clearance for Deep TMS in patients with comorbid PTSD and MDD. BrainsWay continued its strategic minority investment program during and after the quarter. The company invested in Hopemark Health, a behavioral health platform serving clinics in the Chicago area, and later announced investments in Radial Health and Sound Minds Behavioral. Levy said the investments are intended to align BrainsWay with provider organizations that are expanding patient access to interventional psychiatry. He said BrainsWay has completed six minority investments and continues to evaluate additional opportunities, focusing on profitable, growth-oriented providers with experienced management teams. The company also discussed Neurolief, in which BrainsWay holds a minority interest through a convertible loan. Neurolief began commercializing its FDA-approved ProlivRx system following its March approval. Levy said the launch is initially focused on the Department of Veterans Affairs channel and select private clinics. BrainsWay plans to monitor commercial performance during the next 90 days of what Levy described as a soft launch before determining whether to make additional investments in or acquire Neurolief. The decision will depend on commercial milestones related to growth and profitability, he said. Chief Financial Officer Ido Marom said the company generated $6.3 million in operating cash flow during the second quarter, compared with $1.2 million in the first quarter, reflecting payment terms related to certain strategic deals. BrainsWay ended the quarter debt-free with $62.4 million in cash and cash equivalents. Based on first-half performance and continued momentum, BrainsWay raised its 2026 revenue guidance to $68 million to $70 million, from prior guidance of $66 million to $68 million. The new range would represent expected annual growth of 30% to 34%, the company said. Marom also said the company narrowed its operating-margin outlook to 13.5% to 40% of revenue and its adjusted EBITDA outlook to $13 million to $40 million, representing anticipated growth of roughly 90% to 100% from 2025. Brainsway Ltd is a medical device company specializing in non-invasive neuromodulation therapies. Publicly traded on the NASDAQ under the symbol BWAY, the company develops and commercializes deep transcranial magnetic stimulation (Deep TMS) systems designed to treat a range of neuropsychiatric and neurological disorders. Brainsway's technology aims to offer an alternative or complement to traditional pharmacological therapies by targeting precise brain regions with its patented coil designs. The company's flagship Deep TMS platform utilizes proprietary H-coil arrays engineered to reach deeper cortical structures than conventional TMS devices. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Brainsway Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

TranscriptFY2026 Q22026-08-13

FY2026 Q2 earnings call transcript

Earnings source - 51 paragraphs
Operator

Good morning, everyone. My name is Sachi, and I will be your conference operator today. At this time, I would like to welcome everyone to BrainsWay's second quarter 2026 financial results conference call. All lines have been placed on mute to prevent any background noise. With us today are BrainsWay's Chief Executive Officer, Hadar Levy, and Chief Financial Officer, Ido Marom. The format for today's call will be a discussion of recent trends and business updates from Hadar, followed by a detailed discussion of the financials. Then we will open up the call for your questions. Earlier today, BrainsWay released its financial results for the three and six months ended June 30, 2026. A copy of the press release is available on the company's investor relations website, www.brainsway.com.

Operator

Before I turn the call over to management, I would like to remind you that this conference call, including both management's prepared remarks and the question and answer session, may contain projections or other forward-looking statements regarding, among other topics, BrainsWay's anticipated future operating and financial performance, business plans and prospects, and expectations for its products and pipeline, which are all subject to risks and uncertainties, including shifting market conditions resulting from geopolitical, supply chain, and other factors, as well as the use of non-GAAP financial information. Additional information regarding these and other risks are available in the company's earnings release and in its other filings with the SEC, including the Risk Factors section contained in BrainsWay's Form 20-F. Finally, please note that the company's 6-K will be filed tomorrow at approximately 6:00 A.M. Eastern Time in accordance with the SEC's operating schedule.

Operator

I would now like to turn the call over to Hadar.

Hadar Levy

Thank you. Welcome, everyone, and thank you for joining us today. We entered the second half of 2026 from a position of strength with accelerating growth, expanding profitability, and increasing visibility into future revenue. More importantly, we believe BrainsWay is entering the next phase of its evolution from a leading Deep TMS company into a broader platform for interventional psychiatry. Our second quarter results provide further evidence that the foundation of this platform is getting stronger. Revenue grew 35% to $17.1 million for the second quarter, compared with $12.6 million in the prior year period. We achieved this level of growth while maintaining operational discipline, resulting in expanded margin and increased profitability. In the second quarter, operating income increased over 300% to $2.4 million, compared with $0.6 million for the prior year.

Hadar Levy

Adjusted EBITDA increased 141% to $3.5 million, compared with $1.5 million for the same period last year, with adjusted EBITDA margin expanding to 20% from 11%. This also marked our 12th consecutive quarter of profitability, underscoring the scalable nature of the business model. These results matter not only because of the growth they represent today, but because every system we install, every reimbursement expansion we achieve, and every new clinical indication we develop strengthens the platform and expands our long-term opportunity. Let me take a minute to walk you through a few key metrics that we monitor each quarter to measure our continued growth. During the second quarter of 2026, we shipped 125 Deep TMS systems, a 42% increase over the same period last year, bringing our install base to approximately 1,950 systems. Every system represents more than an initial placement.

Hadar Levy

It creates potential for multi-year recurring revenue, additional utilization, new indications and protocols, deeper provider relationship, and greater clinical data. Importantly, as we expand the capabilities of the platform, we increase the potential value of systems that are already in the field. Remaining performance obligations have increased to $80.4 million as of June 30, 2026. A 30% increase compared with the same period last year. We believe the continued growth in remaining performance obligations over the past several quarters demonstrates the strong market demand for Deep TMS, as well as the success of our leasing strategy focus on servicing enterprise customers. This is an important evolution in our business model. As the install base grows, we believe revenue visibility, recurring revenue, and operating leverage can increasingly compound.

Hadar Levy

Our strategy is built around what we believe is a powerful growth flywheel with a series of reinforcing growth drivers that build on one another over time. We believe the expanding clinical evidence for Deep TMS drives broader reimbursement, which in turn supports greater physician confidence and adoption. As adoption grows, our install base expands, creating a large recurring revenue stream and increasing operating leverage. The resulting operating leverage cash flow enable us to reinvest in additional clinical studies, reimbursement initiatives, and strategic partnership. At the foundation of our strategy is the strength of the Deep TMS platform itself. Our systems are supported by one of the industry's most extensive bodies of peer-reviewed clinical evidence, demonstrating efficacy across a broad range of neuropsychiatric disorders, including major depressive disorder, anxious depression, late-life depression, obsessive-compulsive disorder, and smoking addiction.

Hadar Levy

This growing body of evidence has resulted in multiple FDA clearances, increasing physicians' confidence, broader reimbursement support, and ultimately accelerated adoption of Deep TMS. One of the clearest examples of our momentum is the continuing expansion of reimbursement for TMS. Commercial payers increasingly recognize the clinical value of this therapy. While prior authorization requirements continue to become less burdensome. Perhaps just as important for us, we have also seen reimbursement continue to expand to include accelerated treatment protocol, which we called SWIFT. We currently estimate there are approximately 57 million covered lives in the U.S. with access to our SWIFT for accelerated Deep TMS protocol. Every reimbursement expansion lowers barrier to treatment, increases provider confidence in investing in Deep TMS systems, expands patient access, and supports higher utilization across our growing install base. We believe SWIFT represents an important long-term growth opportunity for BrainsWay.

Hadar Levy

By reducing treatment from several weeks to just a few days, SWIFT has the potential to improve convenience for patients, increase treatment capacity for providers, and further strengthen the value proposition for payers. During the quarter, we presented the first prospective 12-month durability data for the SWIFT accelerated Deep TMS protocol. The study demonstrated that patients maintain meaningful clinical improvement through one year following treatment, including sustained remission rates and continued improvements in functional outcome. Importantly, these findings help address one of the key questions surrounding accelerated treatment protocol, not simply whether patients improve quickly, but whether those improvements are durable over time. We believe these findings further strengthen the clinical evidence supporting SWIFT and the case for broader reimbursement adoption, an important driver behind broader adoption of Deep TMS. Beyond expanding adoption within our existing indication, we continue seeking to broaden the clinical utility of Deep TMS platform.

Hadar Levy

During the quarter, we presented results from the largest real-world study to date evaluating Deep TMS in patients with comorbid PTSD and major depressive disorder, which is one of the most challenging psychiatric population to treat. Across 462 patients treated at 11 clinical sites, more than 83% experienced a meaningful response in PTSD symptoms, while substantial improvement were also observed in depression symptoms. We believe these findings further strengthen the growing body of evidence supporting Deep TMS across complex psychiatric disorder and reinforce our recent FDA submission seeking clearance for comorbid PTSD and MDD. If cleared, this would represent another important opportunity to expand the clinical utility of Deep TMS platform, increasing the value proposition for every system already installed in the field without requiring providers to purchase additional capital equipment.

Hadar Levy

Taking together, these clinical regulatory advances are occurring against the backdrop of an interventional psychiatry market that we believe is entering into an important period of long-term growth. Payers are steadily expanding reimbursement for neuromodulation therapies. Demand for non-pharmacologic treatment options continue to grow among both providers and patients, and awareness condition such as treatment-resistant depression, OCD, and PTSD continue to expand. We believe BrainsWay is well-positioned to benefit from these tailwinds, given our clinical evidence base, pipeline strategy, reimbursement infrastructure, and install base of Deep TMS systems. Capturing these opportunities require more than innovative technology. It also required expanding patients' access in investing in providers as they scale their practices. That is one of the key objectives of our strategic minority investment program. This initiative is designed to do much more than efficacy deploy capital in promising investment targets.

Hadar Levy

It allows us to partner with leading behavioral health providers and to align ourselves with organizations that have a plan to grow and succeed by accelerating patient access to care and building awareness of cutting-edge interventional psychiatric treatment approaches. During the quarter, we continued to execute against this strategy with a strategic investment in Hopemark Health, a growth-oriented behavioral health platform serving multiple clinic in the greater Chicago area. Following the close of the quarter, we continued with this strategy through investment in Radial Health, an innovative mental health service platform combining clinical infrastructure, reimbursement capabilities, and AI-guided decision support, as well as in Sound Minds Behavioral, a leading growth-oriented outpatient behavioral health platform with locations across the Mid-Atlantic and Northeast.

Hadar Levy

This minority stake investment reflects our strategy of partnering with leading providers organization and expanding our presence within the broader behavioral health ecosystem while allowing BrainsWay to remain focused on advancing our technology, clinical evidence, and commercial execution. Looking ahead, we continue to assess a pipeline of investment opportunities and remain disciplined in identifying partners that can generate both financial growth and meaningful strategic value. Another important part of our long-term platform strategy is extending neuromodulation beyond the clinic. Today, Deep TMS anchors treatment in the clinical setting. Over time, we see an opportunity to extend the patient's journey into the home and ultimately connect treatment with the data and digital monitoring. That is the strategic context behind our investment in Neurolief. Following the FDA approval for its Proliv™Rx system in March, the commercial launch has begun and progressing.

Hadar Levy

While it remains early in the launch, we are encouraged by the progress being made by Neurolief and the execution discipline that they roll out. International expansion represent another important layer of our long-term opportunity. Across our current partner market, we estimate there are more than 170 million untreated patients. Importantly, we are not starting from zero. We are building on established commercial partnership and existing infrastructure, providing what we believe is an attractive and capital-efficient path to scale. As interventional psychiatry expands globally, we believe our international footprint can become an increasingly important contributor to BrainsWay's growth. In closing, we are pleased with our performance this quarter, but we believe we are still in the early stage of much larger opportunity. For many years, BrainsWay has been known as a Deep TMS company. Today, we are building something broader, a global platform for interventional psychiatry.

Hadar Levy

Every system we install, every reimbursement expansion, every new indication, and every strategic partnership strengthen that platform, and we are building it from a position of increasing financial strength with a strong growth, expanding profitability, and greater revenue visibility. One platform, millions of patients, decades of growth. With that, I will now turn the call over to Ido, for his review of our second quarter 2026 financial results. Ido.

Ido Marom

Thank you, Hadar. During the second quarter of 2026, we continued to execute on our growth strategy, which drove a 35% increase in revenue to $17.1 million compared with $12.6 million for the same period last year. During the quarter, we placed 125 Deep TMS systems, bringing our total installed base to approximately 1,950 systems as of June 30, 2026. Gross profit for the quarter was $12.8 million, up 34% from $9.5 million in the prior year period, while gross margin remained stable at 75%. Turning to operating expenses. Sales and marketing expenses for the second quarter of 2026 totaled $4.9 million, steady with the second quarter of 2025. This reflects continued operating leverage and improved efficiency across our sales organization, enabling us to support our commercial activities while maintaining a disciplined cost structure. Research and development expenses were $3.2 million, compared with $2.3 million last year.

Ido Marom

The increase was primarily driven by investments in clinical development and research, including our ongoing PTSD and alcohol use disorder research initiatives. General and administrative expenses were $2.3 million, compared with $1.6 million in the prior year period, an increase of approximately $0.7 million driven by higher professional fees and administrative costs. Operating income was approximately $2.4 million, compared with $0.6 million reported for the second quarter of 2025, with operating margin expanding to 40% of revenue from 5%. This performance reflects the scaling of operations, the strength of our recurring revenue model and disciplined cost management. For the second quarter ended June 30, 2026, we reported net income of $2.7 million, up 34%, compared with $2 million in the same period of 2025. Adjusted EBITDA was $3.5 million, an increase of 141%, comparing with $1.5 million in the second quarter of 2025.

Ido Marom

Adjusted EBITDA margin expanded to 20% from 11%. As Hadar mentioned earlier, this is the 12th consecutive quarter of positive adjusted EBITDA, and we are very excited by our progress in scaling our growth and profitability. Remaining performance obligations grew to $80.4 million as of June 30, 2026, a 30% year-over-year increase. We believe the steady increase of our RPOs reflect the strength of our business and execution against our long-term strategy. Cash flow from operation was $6.3 million in the second quarter of 2026, compared with $1.2 million in the first quarter, reflecting the strong payment term structure related to certain strategic deals. The capital structure of the company remained debt-free, giving us significant flexibility to pursue strategic growth initiatives, including our minority investment program. We reported cash and cash equivalents of $62.4 million as of June 30, 2026.

Ido Marom

We believe our strong capital position will support the continued growth of our core scientific and technology operations, as well as our strategic investment program, which aims to increase patient access to innovative treatments while also building long-term value for our shareholders. Looking ahead, based on our strong first half performance and continued momentum, we are raising our full year 2026 guidance from a range of $66 million-$68 million to a range of $68 million-$70 million for the full year 2026. This new guidance range, if achieved, will represent a year-over-year expected growth rate of 30%-34%. In addition, we are narrowing our ranges for operating margin to 13.5%-40% of revenue and adjusted EBITDA to $130 million-$40 million, representing anticipated growth of approximately 90%-100% over full year 2025.

Ido Marom

This concludes my prepared remarks, and I will now turn the call back to the operator to please open up the call for questions. Operator?

Operator

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we pull for questions. The first question is from Sam Eiber from BTIG. Please go ahead.

Sam Eiber

Hi. Good morning. Thanks for taking the questions here. Maybe I want to start on the guidance raise. Obviously implying sustained 30% growth in the back half of the year. Maybe you can talk about some of the trends you're seeing into Q3 so far and generally the confidence to sustain this premium growth rate.

Hadar Levy

Yeah. Hi, Sam. Thank you for the question. We are very high confidence based on what we are seeing based on the growing remaining performance obligation that gives us very good visibility toward the second half of the year and also into 2027. There is definitely a very strong demand across the board for Deep TMS product for the MDD, OCD, and specifically, the SWIFT protocol that is today one of the main drivers for the demand. We continue to see some very strong demands for new systems and new orders toward the end of the year, and that's what's really increasing our confidence by raising the guidance.

Sam Eiber

Okay. Very helpful. Then maybe, if I could use my follow-up here on the SWIFT protocol. I guess, generally, what are you hearing from providers that have adopted it so far? Are they generally aware that it exists? How much education do you need to do on the marketplace? Just generally, those that have adopted it, are they starting to see better throughput, better patient demand because of the reduced treatment burden? Generally, what are you hearing from those who have started to use it?

Hadar Levy

Yeah, absolutely. The feedback is very strong and very good. Look, at the end of the day, it's just a matter of better convenience for the patients, but also for the clinic. A busy clinic can really increase their utilization by using this SWIFT protocol, and they can see much more patients on a daily basis and even complete the whole 30 sessions protocol with a few days. There is definitely lots of interest, both from providers and patients. But the main feedback is really about the convenience of those patients that are seeking to get a better treatment in such a shorter time. The economics works very good for the clinic. That's what I think what really drive also some of the payers

Hadar Levy

To continue and extend reimbursement because the demand is growing for the SWIFT protocol.

Sam Eiber

Okay, very good. Thanks for taking the questions, and congrats again on the good quarter.

Hadar Levy

Thank you, Sam.

Operator

The next question is from Jeff Cohen from Ladenburg Thalmann. Please go ahead.

Jeff Cohen

Good morning, Hadar, Ido. A couple questions from our end. Firstly, I wanted to jump back into the SWIFT protocol. Could you give us a sense of the payer environment, and give us a sense of percent of new cases that are falling under the protocol, and then maybe give us a little bit of a sense of types of patients that are falling under that protocol, whether they be MDD or PTSD or OCD, et cetera?

Hadar Levy

Yeah. Currently we're only speaking about MDD patients. Obviously, we are looking to get FDA approval for comorbidity patients with PTSD and MDD. But currently, we're only focusing on MDD patients, which are all kind of drug-resistant. They are the ones that are seeking for a better treatment. They're not responding well for medications or maybe to some other treatment modalities. The percentage, as I said, we have today 57 million people that are eligible for this treatment. I think reimbursement is a key initiative for the adoption of this treatment. But if you're not specifically for psychiatrists that are just not submitting their cases to payers, we definitely a very high growth of this SWIFT protocol. The ones that are still looking for reimbursement, there is a good adoption, but it depends on the local payer in each one of those territories.

Hadar Levy

Overall, I would say once you have reimbursement in your territory, I would say that you can see a significant increase in the adoption of the SWIFT protocol, getting close to 50% of the total population in the local area.

Jeff Cohen

Okay, Got it. As follow-up, you spoke about the [80.4 million] performance obligations. I am assuming that is lease systems, and I am assuming that is a two to three year period. Could you tie that in also to some of the minority investments that you have made so far and how that pipeline may look or what we should anticipate for the back half of the year?

Hadar Levy

Yeah, look, I mean, the backlog is growing, and we are very proud with this 30% increase in the backlog. Remember, these are all orders that we still did not recognize the revenue. It is a backlog of orders that the revenue will be recognized going forward. One of the main driver for supporting this growth is definitely the minority investment that we are making in those growing platforms. Each one of them are expanding. They are not only buying some new locations, but they are also growing organically and expanding the utilization of TMS inside their business. Most of them will most likely going to have more than one system in each location. Based on that, and based on the demand and the growing demand of patients, they will continue to order a bulk of systems from us as utilization grows, since the interventional psychiatry market continue to grow.

Hadar Levy

I do not anticipate this number will continue to grow toward the end of the year. That is what really gives us good visibility when we are entering into 2027.

Jeff Cohen

Perfect. Thanks for taking our questions. Congrats on the quarter.

Hadar Levy

Thank you, Jeff.

Operator

As a reminder to ask a question, please press star one. The next question is from Ahmed Mahmud from H.C. Wainwright. Please go ahead.

Ahmed Mahmud

Thank you for taking our question. This is Ahmed on for Ram. Could you give us some color on how Proliv™Rx sales are ramping, and when do you expect to decide whether to acquire Neurolief and what factors will determine that decision?

Hadar Levy

Thank you for taking this question. I think as I said in my script, Neurolief is a very important factor for our future platform to extend our outreach also for home use care. Currently, Neurolief are running a launch mainly with the VA channel. I think I said in the last call, they already got reimbursement from the VA channel and they are now deploying some of the first commercial stage within the VA channel, but also in some private clinics. The progress are going very well, but what we would like to monitor is in the next 90 days, what we call as a soft launch is just to see what are the main KPIs that will help us to accelerate the growth when you are going to do a full launch of this. Today, we still have only minority investment in Neurolief. It is a convertible loan.

Hadar Levy

We will decide whether we would like to continue and invest or acquire Neurolief based on some commercial milestone, which relates to growth and profitability. There is still time for that. Right now, we are very encouraged with the commercial progress and the soft launch that they are making in the U.S. More to come, and I believe that I will report and give much more details on some of those important metrics toward the end of the year.

Ahmed Mahmud

Thank you. If I could just follow up on the minority investments. Could you give us some color on the cadence and the number of minority investments you plan on making for the second half of this year? When do you expect them to begin accelerating BrainsWay's revenue growth? On a separate follow-up, how might the optimized Deep TMS protocol be elevated earlier in the treatment continuum for major depressive disorder? Thank you.

Hadar Levy

Yeah. Look, on the minority investment, we have done today six minority investment. I believe we are expecting, and we still have a pipeline of minority investment that we are reviewing very carefully in some very thorough due diligence process. There is definitely a good interest. Look, my expectation is to invest in a growing business with the right management team and a profitable business. I would like to make sure that I am investing in the right portfolio that has the ability to grow their business in interventional psychiatry. When they are growing, which means that there is a growing demand by patients. When there is a growing demand by patients, you can assume that there will be also a growing demand for the Deep TMS platform.

Hadar Levy

Again, my expectation is to have at least more than one system in each one of those locations, specifically due to the adoption of the SWIFT protocol. As long as each one of them will continue to grow, and based on their projections, each one of them can expand to 10 to 15 locations every year. If they will execute very well, and they are executing very well, I am expecting to continue and see a very nice demand on and use of the Deep TMS platform. What was the other question?

Ahmed Mahmud

The other question? Yeah. I was asking how might the optimized Deep TMS protocol be elevated early in the treatment continuum.

Hadar Levy

Yeah. I think on the continuum of care, once you've failed in one or two medications, you have several good options. We believe that a very good option is the non-invasive treatment of the Deep TMS, specifically with the SWIFT protocol. There's some other options like psychedelic that are very popular today. Where I'm seeing the continuum of care and in terms of growing the business, we are growing with one of the most growing market, which is interventional psychiatry. I do believe that the future of this business will be offering options to patients, which will be a combination of a few treatment modalities. It could be psychedelic, it could be Deep TMS, and it could be also med management. On the continuum of care, Deep TMS is definitely reaching to an inflection point where exactly it should be.

Hadar Levy

We're seeing some better results and better demands due to that.

Ahmed Mahmud

Thank you.

Operator

There are no further questions at this time. I would like to turn the floor back over to Hadar Levy for closing comments.

Hadar Levy

Thank you. With that, we conclude our remarks for today. I want to thank, again, all the investors and the analysts for following the company. Thank you, and that is it for today. Have a good one.

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Investor releaseQuarter not tagged2026-08-12

BrainsWay Ltd (BRSYF) (Q2 2026) Earnings Call Highlights: Revenue Surges 35% to $17. ...

GuruFocus.com
This article first appeared on GuruFocus. Revenue: $17.1 million in Q2 2026, a 35% increase from $12.6 million in the prior-year period. Gross Profit: $12.8 million, up 34% from $9.5 million year-over-year. Gross Margin: Remained stable at 75%. Operating Income: $2.4 million, up over 300% from $0.6 million in Q2 2025. Operating Margin: Expanded to 14% of revenue, up from 5%. Net Income: $2.7 million, up 34% from $2 million in the same period last year. Adjusted EBITDA: $3.5 million, a 141% increase from $1.5 million, with margin expanding to 20% from 11%. Systems Shipped: 125 deep TMS systems, a 42% increase year-over-year. Installed Base: Approximately 1,950 systems as of June 30, 2026. Remaining Performance Obligations (RPO): $80.4 million, a 30% increase year-over-year. Cash Flow from Operations: $6.3 million in Q2 2026, compared with $1.2 million in Q1 2026. Cash and Cash Equivalents: $62.4 million as of June 30, 2026. Sales and Marketing Expenses: $4.9 million, steady with Q2 2025. Research and Development Expenses: $3.2 million, up from $2.3 million last year. General and Administrative Expenses: $2.3 million, up from $1.6 million in the prior period. Full-Year 2026 Guidance: Raised from $66-$68 million to $68-$70 million, representing expected growth of 30% to 34%. Warning! GuruFocus has detected 5 Warning Signs with BRSYF. Is BRSYF fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue grew 35% to $17.1 million in Q2 2026, with operating income up over 300% and adjusted EBITDA margin expanding to 20%. Shipped 125 deep TMS systems (42% increase) and grew the installed base to approximately 1,950 systems, driving recurring revenue potential. Remaining performance obligations increased 30% to $80.4 million, providing strong revenue visibility into 2027. Expanding reimbursement for the SWIFT accelerated protocol now covers approximately 57 million covered lives, boosting adoption and provider confidence. Strategic minority investments in behavioral health platforms (e.g., HopeMark Health, Radio Health, SoundMind Behavioral) are expanding patient access and driving system demand. R&D expenses increased to $3.2 million (up from $2.3 million) due to clinical development investments, pressuring near-term profitabil…Read full document

This article first appeared on GuruFocus. Revenue: $17.1 million in Q2 2026, a 35% increase from $12.6 million in the prior-year period. Gross Profit: $12.8 million, up 34% from $9.5 million year-over-year. Gross Margin: Remained stable at 75%. Operating Income: $2.4 million, up over 300% from $0.6 million in Q2 2025. Operating Margin: Expanded to 14% of revenue, up from 5%. Net Income: $2.7 million, up 34% from $2 million in the same period last year. Adjusted EBITDA: $3.5 million, a 141% increase from $1.5 million, with margin expanding to 20% from 11%. Systems Shipped: 125 deep TMS systems, a 42% increase year-over-year. Installed Base: Approximately 1,950 systems as of June 30, 2026. Remaining Performance Obligations (RPO): $80.4 million, a 30% increase year-over-year. Cash Flow from Operations: $6.3 million in Q2 2026, compared with $1.2 million in Q1 2026. Cash and Cash Equivalents: $62.4 million as of June 30, 2026. Sales and Marketing Expenses: $4.9 million, steady with Q2 2025. Research and Development Expenses: $3.2 million, up from $2.3 million last year. General and Administrative Expenses: $2.3 million, up from $1.6 million in the prior period. Full-Year 2026 Guidance: Raised from $66-$68 million to $68-$70 million, representing expected growth of 30% to 34%. Warning! GuruFocus has detected 5 Warning Signs with BRSYF. Is BRSYF fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue grew 35% to $17.1 million in Q2 2026, with operating income up over 300% and adjusted EBITDA margin expanding to 20%. Shipped 125 deep TMS systems (42% increase) and grew the installed base to approximately 1,950 systems, driving recurring revenue potential. Remaining performance obligations increased 30% to $80.4 million, providing strong revenue visibility into 2027. Expanding reimbursement for the SWIFT accelerated protocol now covers approximately 57 million covered lives, boosting adoption and provider confidence. Strategic minority investments in behavioral health platforms (e.g., HopeMark Health, Radio Health, SoundMind Behavioral) are expanding patient access and driving system demand. R&D expenses increased to $3.2 million (up from $2.3 million) due to clinical development investments, pressuring near-term profitability. G&A expenses rose to $2.3 million (up from $1.6 million) due to higher professional fees and administrative costs. The company's growth is heavily dependent on the success of the SWIFT protocol and continued reimbursement expansion, which may face payer resistance. The strategic minority investment program carries execution risk, as the company must carefully select partners to generate both financial and strategic value. International expansion remains early-stage, with significant untapped potential but also execution challenges in new markets. Q: Can you discuss the trends you're seeing in Q3 and the confidence behind raising full-year 2026 guidance to $68-$70 million?A: Hadar Levy (Senior Vice President, General Manager of North America) expressed high confidence based on the growing remaining performance obligation (RPO), which provides strong visibility into the second half of 2026 and into 2027. He noted very strong demand across the board for the deep TMS product, specifically for the SWIFT protocol, which is one of the main drivers for new system orders. Q: What feedback are you hearing from providers who have adopted the SWIFT accelerated protocol, and are they seeing better throughput and patient demand?A: Hadar Levy (Senior Vice President, General Manager of North America) stated that feedback is very strong. The SWIFT protocol offers better convenience for both patients and clinics, allowing busy clinics to increase utilization and see more patients daily, even completing the full 30-session protocol in a few days. The economics work well for clinics, and this demand is driving payers to continue expanding reimbursement for the protocol. Q: Can you provide a sense of the payer environment for the SWIFT protocol, the percentage of new cases using it, and the types of patients?A: Hadar Levy (Senior Vice President, General Manager of North America) clarified that the SWIFT protocol is currently focused on treatment-resistant MDD patients. With 57 million covered lives eligible, reimbursement is a key initiative for adoption. In territories where reimbursement is secured, adoption of the SWIFT protocol can reach close to 50% of the total patient population in the local area. Q: Can you tie the $80.4 million in remaining performance obligations to the minority investment strategy and what to anticipate for the back half of the year?A: Hadar Levy (Senior Vice President, General Manager of North America) explained that the growing backlog is a key driver of confidence. The minority investments in growing platforms are supporting this growth, as these partners are expanding locations and increasing TMS utilization. He anticipates the RPO will continue to grow toward the end of the year, providing good visibility into 2027. Q: How is the Prolivarex system launch progressing at Neuronetics, and what factors will determine whether you acquire the company?A: Hadar Levy (Senior Vice President, General Manager of North America) stated that Neuronetics is running a soft launch, primarily with the VA channel, and progress is going well. They are monitoring key performance indicators over the next 90 days to accelerate growth for a full launch. The decision to invest further or acquire will be based on commercial milestones related to growth and profitability, with more details expected toward the end of the year. Q: What is the cadence and number of minority investments planned for the second half of the year, and when will they begin accelerating revenue growth?A: Hadar Levy (Senior Vice President, General Manager of North America) noted that six minority investments have been made to date, with a pipeline of opportunities under review. The strategy is to invest in growing, profitable businesses with strong management teams. As these platforms expand to 10-15 locations per year, they will drive increasing demand for deep TMS systems, with each location potentially housing more than one system. Q: Might the deep TMS protocol be elevated earlier in the treatment continuum for major depression?A: Hadar Levy (Senior Vice President, General Manager of North America) believes that after one or two failed medications, deep TMS, specifically with the SWIFT protocol, is a very good non-invasive treatment option. He sees the future of interventional psychiatry as offering a combination of treatment modalities, including psychedelics, deep TMS, and medication management, with deep TMS reaching an inflection point in the continuum of care. Q: What drove the significant increase in cash flow from operations to $6.3 million in Q2, and how does the company's capital position support its strategic initiatives?A: Ido Marom (Chief Financial Officer) attributed the strong cash flow to favorable payment term structures related to certain strategic deals. The company remains debt-free with $62.4 million in cash, providing significant flexibility to pursue strategic growth initiatives, including the minority investment program aimed at increasing patient access to innovative treatments. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-12

BrainsWay Reports Second Quarter 2026 Financial Results and Operational Highlights

GlobeNewswire
Record second quarter 2026 revenue increased 35% to $17.1 million, compared with Q2 2025 Adjusted EBITDA more than doubled year-over-year to $3.5 million, with margin expanding to 20% Remaining performance obligations grew 30% year-over-year to $80.4 million Shipped a record total 125 Deep TMS systems in Q2 2026, a 42% increase year-over-year Raises FY 2026 revenue and EBITDA guidance BURLINGTON, Mass. and JERUSALEM, Aug. 12, 2026 (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 its second quarter 2026 financial results and provided an operational update. Recent Financial and Operational Highlights Revenue in the second quarter of 2026 increased 35% to $17.1 million, compared with $12.6 million in the second quarter of 2025. Remaining performance obligations (RPOs) rose to $80.4 million as of June 30, 2026, a 30% increase compared with the same period last year. Shipped a record total 125 Deep TMS™ systems during the second quarter of 2026, a 42% increase compared with the same period last year. Total installed base now stands at approximately 1,949. Operating income for the second quarter of 2026 increased more than 300% to $2.4 million, compared with $0.6 million for the prior year period. Operating margin for the quarter expanded to 14% from 5% for the prior year period. Adjusted EBITDA for the second quarter of 2026 increased 141% to $3.5 million, compared with $1.5 million for the prior year period. Adjusted EBITDA margin for the quarter expanded to 20% from 11% for the prior year period. Net income for the second quarter of 2026 increased 34% to $2.7 million, compared with $2.0 million for the prior year period. As of June 30, 2026, cash and cash equivalents and restricted cash totaled $62.4 million, an increase of approximately 6% compared with March 31, 2026. Generated $6.3 million of cash flow from operations during the second quarter of 2026. Continued expansion of insurer coverage for the SWIFT™ (Short-course with Intrinsic Field Targeting) accelerated Deep TMS protocol. Presented real-world data in patients with comorbid post-traumatic stress disorder (PTSD) and major depressive disorder (MDD), demonstrating an 83.5% response rate in PTSD symptoms, with a mean 52% reduction in PCL-5 scores. Presen…Read full document

Record second quarter 2026 revenue increased 35% to $17.1 million, compared with Q2 2025 Adjusted EBITDA more than doubled year-over-year to $3.5 million, with margin expanding to 20% Remaining performance obligations grew 30% year-over-year to $80.4 million Shipped a record total 125 Deep TMS systems in Q2 2026, a 42% increase year-over-year Raises FY 2026 revenue and EBITDA guidance BURLINGTON, Mass. and JERUSALEM, Aug. 12, 2026 (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 its second quarter 2026 financial results and provided an operational update. Recent Financial and Operational Highlights Revenue in the second quarter of 2026 increased 35% to $17.1 million, compared with $12.6 million in the second quarter of 2025. Remaining performance obligations (RPOs) rose to $80.4 million as of June 30, 2026, a 30% increase compared with the same period last year. Shipped a record total 125 Deep TMS™ systems during the second quarter of 2026, a 42% increase compared with the same period last year. Total installed base now stands at approximately 1,949. Operating income for the second quarter of 2026 increased more than 300% to $2.4 million, compared with $0.6 million for the prior year period. Operating margin for the quarter expanded to 14% from 5% for the prior year period. Adjusted EBITDA for the second quarter of 2026 increased 141% to $3.5 million, compared with $1.5 million for the prior year period. Adjusted EBITDA margin for the quarter expanded to 20% from 11% for the prior year period. Net income for the second quarter of 2026 increased 34% to $2.7 million, compared with $2.0 million for the prior year period. As of June 30, 2026, cash and cash equivalents and restricted cash totaled $62.4 million, an increase of approximately 6% compared with March 31, 2026. Generated $6.3 million of cash flow from operations during the second quarter of 2026. Continued expansion of insurer coverage for the SWIFT™ (Short-course with Intrinsic Field Targeting) accelerated Deep TMS protocol. Presented real-world data in patients with comorbid post-traumatic stress disorder (PTSD) and major depressive disorder (MDD), demonstrating an 83.5% response rate in PTSD symptoms, with a mean 52% reduction in PCL-5 scores. Presented the first prospective 12-month durability data for the SWIFT accelerated Deep TMS protocol at the 14th Annual Clinical TMS Society (CTMSS) Meeting, demonstrating sustained clinical improvement through one year following treatment. Continued expanding the Company's growing minority investment portfolio through strategic investments in Hopemark Health and Radial Health, with several previous portfolio investment targets indicating significant growth in patient access to care due to the growth capital afforded under the program. Updated Full-Year 2026 Financial Guidance The Company now expects to report for the full-year ended December 31, 2026: Revenue of $68 million to $70 million, compared to the previous range of $66 to $68 million. The updated revenue guidance represents anticipated growth of approximately 30% to 34% compared with revenue for 2025. Operating income of 13.5% to 14% of revenue, compared to the previous range of 13%-14%. Adjusted EBITDA of $13 million to $14 million, compared to the previous range of $12 million to $14 million. The updated Adjusted EBITDA guidance represents anticipated growth of approximately 90% to 100% over 2025. “This quarter marked our second consecutive quarter of approximately 35% revenue growth and further expansion in operating leverage. Revenue reached a record $17.1 million, Adjusted EBITDA more than doubled to $3.5 million, and we generated more than $6.0 million of operating cash flow. Record system shipments and RPO of $80.4 million further strengthen our visibility into continued growth,” said Hadar Levy, Chief Executive Officer of BrainsWay. “We are seeing strong momentum across the business, which is fueled by expanding reimbursement coverage and increasing utilization throughout our installed base. As a result, we are raising our full-year financial guidance for 2026.” Call and Webcast BrainsWay’s management will host a conference call in English on Wednesday, August 12, 2026, at 8:30 a.m. Eastern Daylight Time (EDT) to discuss these results and answer questions, followed by a webinar hosted in Hebrew on Thursday, August 13, 2026, at 11:00 AM Israel Daylight Time (IDT). All details to access these events are listed below. In English: Date: Wednesday, August 12, 2026 Time: 8:30 AM EDT Dial-In: 1-877-269-7751 (U.S) / 1-201-389-0908 (International) Conference ID: 13761391 The U.S. conference call will be broadcast live and will be available for replay for 30 days on the Company’s website at investors.brainsway.com and through this link: https://viavid.webcasts.com/starthere.jsp?ei=1768433&tp_key=0923ccd15a In Hebrew: Date: Thursday, August 13, 2026 Time: 11:00 AM IDT To register for this webinar, please click here: BrainsWay Q2 2026 IL Investor Webinar Non-IFRS Financial Measures In addition to our results determined in accordance with International Financial Reporting Standards (IFRS), including in particular operating profit and net profit, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net profit adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses. In addition to operating income (loss) and net income (loss), we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-IFRS financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons: Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as stock-based compensation expenses, depreciation and amortization, finance expenses, income taxes, and certain one-time items such as restructuring and litigation expenses, that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired. Our management uses Adjusted EBITDA in conjunction with IFRS financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-IFRS or non-GAAP financial measures to supplement their IFRS or GAAP results. Adjusted EBITDA, however, should not be considered as an alternative to operating profit (loss) or net profit (loss) for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. A reconciliation between the Company’s net profit (loss) and Adjusted EBITDA is presented in the attached summary financial statements. Because of these and other limitations, you should consider Adjusted EBITDA along with other IFRS-based financial performance measures, including net profit (loss) and our IFRS financial results. About BrainsWayBrainsWay 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 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 StatementsThis 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, and also includes any financial guidance and projections contained herein. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: risks relating to the Company’s ability to consummate, finance and close proposed or potential investments, 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 MaromChief Financial [email protected] Investors:Brian RitchieLifeSci Advisors [email protected]

Investor releaseQuarter not tagged2026-08-11

Earnings To Watch: BrainsWay Ltd (BWAY) Q2 2026 -- GF Value Sees 35% Downside

GuruFocus.com

This article first appeared on GuruFocus. BrainsWay Ltd (NASDAQ:BWAY) is set to release its Q2 2026 earnings on Aug 12, 2026. The consensus estimate for Q2 2026 revenue is 16.55 million, and the earnings are expected to come in at 0.07 per share. The full year 2026's revenue is expected to be $67.67 million and the earnings are expected to be $0.31 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 6 Warning Signs with BWAY. Is BWAY fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for BrainsWay Ltd (NASDAQ:BWAY) have increased from $66.37 million to $67.67 million for the full year 2026 and increased from $81.36 million to $82.67 million for 2027 over the past 90 days. Earnings estimates for BrainsWay Ltd (NASDAQ:BWAY) have increased from $0.27 per share to $0.31 per share for the full year 2026 and declined from $0.51 per share to $0.48 per share for 2027 over the past 90 days. In the previous quarter of 2026-03-31, BrainsWay Ltd's (NASDAQ:BWAY) actual revenue was $15.53 million, which beat analysts' revenue expectations of $14.64 million by 6.12%. BrainsWay Ltd's (NASDAQ:BWAY) actual earnings were $0.06 per share, which met analysts' earnings expectations. After releasing the results, BrainsWay Ltd (NASDAQ:BWAY) was down by -2.57% in one day. Based on the one-year price targets offered by 3 analysts, the average target price for BrainsWay Ltd (NASDAQ:BWAY) is $17.67 with a high estimate of $18.00 and a low estimate of $17.00. The average target implies an upside of 15.32% from the current price of $15.32. Based on GuruFocus estimates, the estimated GF Value for BrainsWay Ltd (NASDAQ:BWAY) in one year is $9.90, suggesting a downside of -35.38% from the current price of $15.32. Based on the consensus recommendation from 3 brokerage firms, BrainsWay Ltd's (NASDAQ:BWAY) average brokerage recommendation is currently 1.30, indicating a "Buy" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-07-29

BrainsWay to Report Second Quarter 2026 Financial Results on August 12, 2026

GlobeNewswire

BURLINGTON, Mass. and JERUSALEM, July 29, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that it will report its second quarter 2026 financial results, as well as operational highlights, before the open of the U.S. financial markets on Wednesday, August 12, 2026. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. US Conference Call Dial-In & Webcast Information In English: In Hebrew: The conference calls will be broadcast live and the English webcast 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. About BrainsWayBrainsWay 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 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. Contacts: BrainsWay:Ido MaromChief Financial [email protected] Investors:Jeff WarrenLifeSci [email protected]

Investor releaseQuarter not tagged2026-07-21

The Best "Strong Buy" Stocks to Buy as Q2 Earnings Season Heats Up

Zacks
The Nasdaq jumped on Tuesday as Wall Street bought up chip stocks such as Micron, AMD, and Nvidia. The tech-heavy index is attempting to hold its ground just below its 50-day moving average as investors wait for technology giants such as Google parent Alphabet and Tesla to kick-start the most critical stretch of earnings season for the market on Wednesday. The current Zacks estimates point to what’s shaping up to be another blockbuster quarter for Technology companies, and more importantly, the broader economy. The Magnificent 7’s total Q2 earnings are expected to jump +28.7% YoY on +25.1% higher revenues, according to the most recent Zacks data. More importantly, the rest of the S&P 500 outside of the Mag 7 technology giants are set to report strong second quarter growth. Excluding the Mag 7 entirely, Q2 earnings for the rest of the S&P 500 are still projected to climb 25.3%. Given this backdrop, the Wall Street bulls might be able to push the market to new highs during the heart of Q2 earnings season and in the back half of 2026. Let’s explore how investors can use a Zacks screen to help find some of the best Zacks Rank #1 (Strong Buy) stocks out of a group of over 200 highly-ranked stocks to consider buying as the second quarter earnings season ramps up. Zacks Rank Basics Zacks Rank #1 (Strong Buy) stocks outperform the market in good and bad times. However, there are over 200 stocks that earn a Zacks Rank #1 at any given time. Therefore, it’s helpful to understand how to apply filters to the Zacks Rank in order to narrow the list down to a more manageable and tradable set of stocks. There are only three items on this screen. But together, these three filters can result in some impressive returns. • Zacks Rank equal to 1 Starting with a Zacks Rank #1 is often a strong jumping off point because it boasts an average annual return of roughly 24.4% per year since 1988. • % Change (Q1) Est. over 4 Weeks greater than 0 Positive current quarter estimate revisions over the last four weeks. • % Broker Rating Change over 4 Week equal to Top # 5 Top 5 stocks with the best average broker rating changes over the last four weeks. This strategy comes loaded with the Research Wizard and is called bt_sow_filtered zacks rank5. It can be found in the SoW (Screen of the Week) folder. Here is one of the five stocks that qualified for the Filtered Zacks Rank 5 strategy today……Read full document

The Nasdaq jumped on Tuesday as Wall Street bought up chip stocks such as Micron, AMD, and Nvidia. The tech-heavy index is attempting to hold its ground just below its 50-day moving average as investors wait for technology giants such as Google parent Alphabet and Tesla to kick-start the most critical stretch of earnings season for the market on Wednesday. The current Zacks estimates point to what’s shaping up to be another blockbuster quarter for Technology companies, and more importantly, the broader economy. The Magnificent 7’s total Q2 earnings are expected to jump +28.7% YoY on +25.1% higher revenues, according to the most recent Zacks data. More importantly, the rest of the S&P 500 outside of the Mag 7 technology giants are set to report strong second quarter growth. Excluding the Mag 7 entirely, Q2 earnings for the rest of the S&P 500 are still projected to climb 25.3%. Given this backdrop, the Wall Street bulls might be able to push the market to new highs during the heart of Q2 earnings season and in the back half of 2026. Let’s explore how investors can use a Zacks screen to help find some of the best Zacks Rank #1 (Strong Buy) stocks out of a group of over 200 highly-ranked stocks to consider buying as the second quarter earnings season ramps up. Zacks Rank Basics Zacks Rank #1 (Strong Buy) stocks outperform the market in good and bad times. However, there are over 200 stocks that earn a Zacks Rank #1 at any given time. Therefore, it’s helpful to understand how to apply filters to the Zacks Rank in order to narrow the list down to a more manageable and tradable set of stocks. There are only three items on this screen. But together, these three filters can result in some impressive returns. • Zacks Rank equal to 1 Starting with a Zacks Rank #1 is often a strong jumping off point because it boasts an average annual return of roughly 24.4% per year since 1988. • % Change (Q1) Est. over 4 Weeks greater than 0 Positive current quarter estimate revisions over the last four weeks. • % Broker Rating Change over 4 Week equal to Top # 5 Top 5 stocks with the best average broker rating changes over the last four weeks. This strategy comes loaded with the Research Wizard and is called bt_sow_filtered zacks rank5. It can be found in the SoW (Screen of the Week) folder. Here is one of the five stocks that qualified for the Filtered Zacks Rank 5 strategy today… BrainsWay Ltd. BWAY is at the cutting edge of non-invasive neurostimulation treatments for mental health disorders. The company makes a special helmet-like device that uses magnetic pulses to gently stimulate deeper parts of the brain. BWAY’s non-invasive treatment (called Deep TMS) helps people with depression, anxious depression, OCD, smoking addiction, and beyond, focusing especially on people who haven’t gotten better with meds or therapy. This is BrainsWay’s pitch to patients and Wall Street: Current treatment options, such as pharmacotherapy, psychotherapy, and beyond, are simply “not sufficient for a substantial population of patients.” Image Source: Zacks Investment Research BWAY’s revenue is projected to jump 31% this year and 23% next year. Its adjusted earnings are projected to dip slightly YoY in 2026, before soaring 64% in FY27 to $0.54 a share (blowing away FY25’s $0.36). The Medical – Products company’s earnings outlook has surged 10% for 2026 and 20% for 2027, helping it earn its Zacks Rank #1 (Strong Buy). The recent upward revisions are part of a strong positive trend over the last year. The stock has skyrocketed nearly 1,300% in the past three years, including a 70% YTD climb. The move helped it blow past its previous 2019 peaks following its IPO. BrainsWay stock found technical support recently and might be able to break out to new highs if it sports strong earnings in August. Image Source: Zacks Investment Research All four of the brokerage recommendations Zacks has are “Strong Buys,” and it's trading near its lowest level forward earnings multiple even though its price is near all-time highs. Some investors might also appreciate that BWAY stock trades for $16 a share, which is what many consider a cheap stock. Get the rest of the stocks on this list and start looking for the newest companies that fit these criteria. It's easy to do. And it could help you find your next big winner. Start screening for these companies today with a free trial to the Research Wizard. You can do it. Click here to sign up for a free trial to the Research Wizard today. Want more articles from this author? Scroll up to the top of this article and click the FOLLOW AUTHOR button to get an email each time a new article is published. Disclosure: Officers, directors and/or employees of Zacks Investment Research may own or have sold short securities and/or hold long and/or short positions in options that are mentioned in this material. An affiliated investment advisory firm may own or have sold short securities and/or hold long and/or short positions in options that are mentioned in this material. Disclosure: Performance information for Zacks’ portfolios and strategies are available at: www.zacks.com/performance_disclosure Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Brainsway Ltd. Sponsored ADR (BWAY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-14

BrainsWay Ltd (BRSYF) Q1 2026 Earnings Call Highlights: Record Revenue Growth and Strategic ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BrainsWay Ltd (BRSYF) reported a 35% increase in revenue to $15.5 million for Q1 2026, compared to $11.5 million in the prior-year period. The company achieved its 11th consecutive quarter of profitability, with net income increasing by over 100% to $2.3 million. BrainsWay Ltd (BRSYF) shipped 117 deep TMS systems, a 44% increase over the same period last year, expanding its total install base to approximately 1,820 systems. The company has seen expanded reimbursement coverage, including the elimination of prior authorization requirements for TMS by Evernorth Behavioral Health. BrainsWay Ltd (BRSYF) is actively pursuing strategic equity investments in mental health providers, enhancing growth and collaboration opportunities. Sales and marketing expenses increased to $4.9 million from $4.2 million in the first quarter of 2025, reflecting higher investment in commercial expansions. Research and development expenses rose to $2.8 million from $2.3 million last year, driven by investments in clinical development. General and administrative expenses increased to $1.8 million from $1.5 million in the prior year period. The company is still in the early stages of building awareness and adoption of deep TMS, indicating a long runway for growth. Despite strong performance, the company faces risks and uncertainties due to shifting market conditions, including geopolitical and supply chain factors. Warning! GuruFocus has detected 6 Warning Signs with BRSYF. Is BRSYF fairly valued? Test your thesis with our free DCF calculator. Q: Could you talk about the upcoming PTSD filing and the protocol you anticipate, and if the trial is with or without medication? A: We're excited about the PTSD data submission. This is a comorbidity PTSD treatment for people also suffering from depression, with medication, so we're not washing out patients from medications. The protocol is similar to the depression protocol, using the H1 coil, targeting areas of anxiety and depression, and showing significant reduction in PTSD symptoms. Q: Could you discuss the SWIFT protocol and its utilization in the field, including payer environment acceptance? A: The SWIFT protocol is a game changer, reducing treatment from 20-30 days to jus…Read full document

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BrainsWay Ltd (BRSYF) reported a 35% increase in revenue to $15.5 million for Q1 2026, compared to $11.5 million in the prior-year period. The company achieved its 11th consecutive quarter of profitability, with net income increasing by over 100% to $2.3 million. BrainsWay Ltd (BRSYF) shipped 117 deep TMS systems, a 44% increase over the same period last year, expanding its total install base to approximately 1,820 systems. The company has seen expanded reimbursement coverage, including the elimination of prior authorization requirements for TMS by Evernorth Behavioral Health. BrainsWay Ltd (BRSYF) is actively pursuing strategic equity investments in mental health providers, enhancing growth and collaboration opportunities. Sales and marketing expenses increased to $4.9 million from $4.2 million in the first quarter of 2025, reflecting higher investment in commercial expansions. Research and development expenses rose to $2.8 million from $2.3 million last year, driven by investments in clinical development. General and administrative expenses increased to $1.8 million from $1.5 million in the prior year period. The company is still in the early stages of building awareness and adoption of deep TMS, indicating a long runway for growth. Despite strong performance, the company faces risks and uncertainties due to shifting market conditions, including geopolitical and supply chain factors. Warning! GuruFocus has detected 6 Warning Signs with BRSYF. Is BRSYF fairly valued? Test your thesis with our free DCF calculator. Q: Could you talk about the upcoming PTSD filing and the protocol you anticipate, and if the trial is with or without medication? A: We're excited about the PTSD data submission. This is a comorbidity PTSD treatment for people also suffering from depression, with medication, so we're not washing out patients from medications. The protocol is similar to the depression protocol, using the H1 coil, targeting areas of anxiety and depression, and showing significant reduction in PTSD symptoms. Q: Could you discuss the SWIFT protocol and its utilization in the field, including payer environment acceptance? A: The SWIFT protocol is a game changer, reducing treatment from 20-30 days to just six days, making it more accessible. It shows an 88% response rate and 78% remission rate in six days. Payers are starting to adopt it, seeing cost savings and efficacy, with more expected to follow by year-end. Q: Can you provide details on the anticipated review timeline for the PTSD application and any promotional strategies post-approval? A: Once submitted, the FDA review typically takes up to 90 days. We expect clearance before year-end. Marketing will target outpatient clinics, especially those working with police and military, leveraging our experience treating PTSD patients in Israel and the U.S. Q: What is the sales and marketing strategy for the ProLivRX system, and what is the potential market size? A: The focus is on VA penetration, given the secured contract and reimbursement. The system is priced at $7,800 per unit. We're also exploring enterprise accounts and IDMs. The investment aims to expand BrainSway's market, especially for patients unable to visit clinics. Q: Can you provide the quarter-over-quarter change in remaining performance obligations and any operational disruptions due to the Middle East situation? A: Remaining performance obligations grew 25% year-over-year, from $60 million to $75 million. We haven't seen disruptions from the Middle East situation. Our focus on enterprise accounts and the shift towards deep TMS supports our growth, with strong international demand. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-05-13

Full Transcript: BrainsWay Q1 2026 Earnings Call

Benzinga
BrainsWay (NASDAQ:BWAY) released first-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. Access the full call at https://viavid.webcasts.com/starthere.jsp?ei=1760244&tp_key=9c697b1af2 Brainsway Ltd reported a 35% increase in revenue for Q1 2026, reaching $15.5 million, driven by strong market penetration and execution. The company achieved its 11th consecutive quarter of profitability with a net income increase of over 100% to $2.3 million and an adjusted EBITDA increase of 119% to $2.8 million. A significant growth in remaining performance obligations to $75 million illustrates strong market demand and strategic focus on long-term contracts. Brainsway Ltd is expanding its market presence through multi-pronged strategies, including minority equity investments in mental health providers and strategic partnerships. The company continues to expand its clinical applications, including plans for FDA submission for PTSD treatment in MDD patients and ongoing studies for alcohol use disorder. Expansion in reimbursement coverage is noted, particularly with the adoption of the SWIFT protocol, which significantly reduces treatment schedules. Internationally, the company is experiencing strong demand across Asia Pacific, Canada, and Europe, enhancing its global footprint. Looking ahead, Brainsway Ltd expects full-year 2026 revenue to range between $66 million and $68 million, with anticipated operating income growth and a focus on strategic investments. OPERATOR Good day and welcome to Brainsway Ltd first quarter 2026 earnings conference call all participants will be in the listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Star then one on a touchtone phone. To withdraw your question, please press Star then two. Please note that this event is being recorded. I now hand the conference over to Garth Russell. Please go ahead. Garth Russell (Moderator) Thank you and welcome to BrainsWay's first quarter 2026 earnings conference call. With us today are Brainsway Ltd's Chief Executive…Read full document

BrainsWay (NASDAQ:BWAY) released first-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. Access the full call at https://viavid.webcasts.com/starthere.jsp?ei=1760244&tp_key=9c697b1af2 Brainsway Ltd reported a 35% increase in revenue for Q1 2026, reaching $15.5 million, driven by strong market penetration and execution. The company achieved its 11th consecutive quarter of profitability with a net income increase of over 100% to $2.3 million and an adjusted EBITDA increase of 119% to $2.8 million. A significant growth in remaining performance obligations to $75 million illustrates strong market demand and strategic focus on long-term contracts. Brainsway Ltd is expanding its market presence through multi-pronged strategies, including minority equity investments in mental health providers and strategic partnerships. The company continues to expand its clinical applications, including plans for FDA submission for PTSD treatment in MDD patients and ongoing studies for alcohol use disorder. Expansion in reimbursement coverage is noted, particularly with the adoption of the SWIFT protocol, which significantly reduces treatment schedules. Internationally, the company is experiencing strong demand across Asia Pacific, Canada, and Europe, enhancing its global footprint. Looking ahead, Brainsway Ltd expects full-year 2026 revenue to range between $66 million and $68 million, with anticipated operating income growth and a focus on strategic investments. OPERATOR Good day and welcome to Brainsway Ltd first quarter 2026 earnings conference call all participants will be in the listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Star then one on a touchtone phone. To withdraw your question, please press Star then two. Please note that this event is being recorded. I now hand the conference over to Garth Russell. Please go ahead. Garth Russell (Moderator) Thank you and welcome to BrainsWay's first quarter 2026 earnings conference call. With us today are Brainsway Ltd's Chief Executive Officer Hadar Levy and Chief Financial Officer Ido Marom. The format for today's call will be a discussion of recent trends and business updates from Hadar followed by the detailed discussion of the financials. Then we will open up the call for your questions. Earlier today, Brainsway released its financial Results for the three month period ended March 31. March 31, 2026. A copy of the press release is available on the Company's investor relations website. Before I turn the call over to Hadar, I would like to remind you that this conference call, including both management's prepared remarks and the question and answer session, may contain projections or other forward looking statements regarding, among other topics, Brainsway's anticipated future operating and financial performance, business plans and prospects, and expectations for its products and pipeline, which are all subject to risks and uncertainties, including shifting market conditions resulting from geopolitical supply chain and other factors, as well as the use of non GAAP financial information. Additional information regarding these and other risks are available in the Company's earnings release and in its other filings with the SEC, including the Risk Factor section contained in Brainsway Ltd's Form 20-F. Finally, please note that the company's 6K will be filed tomorrow at approximately 6:00am Eastern Time in accordance with the SEC's operating schedule. With that, I would now like to turn the call over to Hadar. Hadar Levy (Chief Executive Officer) Thank you. Welcome everyone and thank you for joining us today. I will keep today's comments brief as we just provided a comprehensive business overview during our year end call in mid March. We are off to an excellent start in 2026, reporting a 35% increase in revenue to $15.5 million for the first quarter compared with $11.5 million in the prior year period. This performance was driven by the strong execution of our core business and expanded market penetration during the quarter. We achieved our 11th consecutive quarter of profitability, supported by expanding margins and the implementation of our recurring model Let me take a minute to walk you through a few other key metrics that we monitor each quarter to measure our continuing pattern of growth. In the first quarter of 2026, we shipped 117 deep TMS systems, a 44% increase over the same period last year, bringing our total install base to approximately 1820 systems. Remaining performance obligations have increased to $75 million as of March 31, 2026. Notably, the vast majority of the new contracts signed during the quarter were multi year long term agreements and reflecting continued traction with our revenue model. We view the steady increase in RPO over the past three years as a clear indicator of strong market demand, a success of our strategy focused on servicing enterprise customers while also providing greater visibility into future revenue streams. We are proud to have achieved this level of growth while maintaining operational discipline and resulting in increased profitability. In the first quarter, net income increased by over 100% to $2.3 million compared to $1.1 million for the prior year period and adjusted EBITDA increased 119% to $2.8 million compared to $1.3 million for the same period last year. Let me take the next few minutes to offer some colors on our multi prolonged growth strategy and provide updates on our execution across each aspect. First, I would like to remind everyone that our Deep TMS platform is backed by an extensive peer reviewed published clinical evidence demonstrating efficacy and durability across a broad range of conditions including major Depressive Disorder or mdd, anxious depression, late life depression, OCD and smoking addiction. This robust set of clinical evidence has resulted in FDA clearances and broad attention across many of these indications and resulting in accelerated adoption of Deep TMS and in many cases exceeding our expectations. In addition to educating patients and physicians on the benefits of this treatment, we have actively worked with PEAR across the US to expand reimbursement coverage. For example, since the FDA label expansion for adolescents age 15 to 21, we have worked toward getting over 10 pears to add coverage for adolescents depression in. In addition, Evernorth Behavioral Health has eliminated prior authorization requirement for TMS across evernorth and CIGNA plans. We are also seeing expanded reimbursement for clinicians that can deliver tms. For example, a growing number of commercial insurer, Medicare contractors and government payers now allow trained nurse practitioners to to administer Deep TMS when practicing in accordance with applicable regulations and state scope of practice rules. Recently, Optum updated its policy to permit nurse practitioners to order, supervise and administer TMS across plans covering nearly 35 million lives, with several other major pairs, the VA and and tricare, adopting similar approaches. We view this as an important step towards reducing provider constraints and improving access, particularly in areas with psychiatrist shortage, helping more patients benefit from non pharmacologic treatment options we're seeing a meaningful shift in the market as deep tms continue to gain share from alternative treatment modalities including stovato. We believe this momentum is being driven by the strength of our clinical data, expanding reimbursement support and growing demand for non invasive, non pharmacologic therapies. In particular, our 6 days acute phase swift protocol is gaining strong interest from providers and patients because it offers a much shorter treatment schedule while still delivering strong clinical results. In the first quarter we published landmark data in the peer reviewed journal Brain Stimulation validating that Swift protocol reduces acute phase clinic visit by approximately 70% without compromising efficacy. We believe this represents a win for patients, providers and pair alike and expect Swift reimbursement to continue expanding. We recently announced two large pairs as being among the first have issued final or draft coverage policies applicable to swift. Moving to an update on Clinical activities for diptms we are pleased to report that patient recruitment is now actively underway for our multicenter study on deep TMS for alcohol use disorder. This is a major unmet need affecting approximately 29 million Americans with up to 60% of patients relapsing within three to six months despite available treatments. We have also planned to submit an application to the FDA for clearance to treat PTSD symptoms in MDD patients in the next several weeks based on promising data we have collected from US patients primarily treated with the VA system and our enterprise accounts. If cleared by the fda, diptms can offer several meaningful advantages compared with the other treatment options in light of the fact that it is an outpatient procedure that does not require hospitalization or anesthesia and is generally well tolerated. Let me move on. Provide an update around our strategic initiative focused on securing minority equity investment in high performing mental health providers. To date we have completed minority investment in five mental health networks. I'm happy to report that this portfolio of providers is performing well with our capital serving as a real growth catalyst to those networks. This growth also translates into successful brainsway behind having an equity stake in these growing businesses. This strategy also provide us with a clear channel for both commercial and clinical collaboration with the ability to have more direct impact on the field which is an obvious benefit to our business. And we believe the value of these agreements is a two way street as our clinics gain access to brains for important know how and enterprise which are second to none. I'm also very excited to report to you for the first time today that the company just signed another strategic equity agreement with an Illinois group known as HopeMark. The transaction which was made with the MSO servicing Hopemark multiple location is in Chicago area, include an initial $1.5 million investment and up to an additional $1.5 million in potential future milestone based investment, all in exchange for a preferred minority stake in hopemark. Additionally, we're on the gospel of signing another new minority stake transaction with an east coast provider with location in New York, New Jersey, Pennsylvania and Connecticut. We expect to announce more on this deal soon. Looking ahead, we have already identified more than 200 other qualified clinics as a potential candidate for participation in this program. These transactions further demonstrate our continuing confidence in this strategic initiative we firmly believe will further raise awareness and continue to expand patients access to care. We look forward to providing updates on additional investment throughout 2026. Importantly, we are still in the early stage of building awareness and adoption of Deep tms. We estimate that we have penetrated only fraction of our addressable market, highlighting the significant Runway for growth ahead. While DeepTMS remains our core strength, our long term vision is to become the only company in mental health offering database integration of multiple treatments modalities across multiple care settings. As part of this strategy, we executed the strategic investment in neurolef, a developer of Proliv Rx, the world's first wearable non invasive multichannel brain neuromodulation platform that is designed for use at home. Since then this relationship has advanced on multiple fronts. Following the FDA's premark approval of the ProlivaRx system for the treatment resistant MDD, we made an additional 6 million dollar milestone based convertible loan to NeuroLeaf which was completed in late. This bring our total convertible loan investment in New Orleaf to $11 million. As a reminder, our agreement provides for potential third tranche of up to $5 million upon New Orleaf achieving specified commercial targets. No LEAF has made additional meaningful commercial progress. The VA Federal Supply Schedule contracted commercial contract has been secured and Proliv Rx has received approved pricing of $11,800 per unit as an important step toward broader adoption with the VA system and beyond. We are excited to be working with the neuralift team on meaningful synergetic approaches that include the commercial and research infrastructure for both companies. We view Proliv Rx as a complementary offering to diptms where diptims serves patients in the clinical setting. Polyvarax is designed for home use, thereby expanding access to clinically validated neuromodulation for patients who cannot easily get to the clinic. Together, we believe these two platform expand our total addressable market and reinforce our broader mission of increasing patients access to effective non pharmacological mental health treatments. This can also potentially fit within our broader vision for BrainsWay360, a new fully integrated mental health ecosystem we are building around deep TMS next generation rotational field Deep TMS 360, advanced digital tools, diagnostic and an intelligent cloud based platform. Deep TMS 360 is our future platform. With rotational field technology we can stimulate more neurons more effectively and in much shorter time. Clinical research in either already underway or in planning stage in alcohol use disorder, dementia and chronic pain. On another front internationally we are likewise seeing very strong momentum. Demands continue to grow with distributors across Asia Pacific, Canada and Europe accelerating adoption of Deep TMS at an important pace. With that, I will now turn the call over to IDO for his review for our first quarter 2026 financial results. Ido Marom (Chief Financial Officer) IDO thank you Adar during the first quarter of 2026, we continued to execute on our growth strategy, which drove a 35% increase in revenue to $15.5 million compared with $11.5 million for the same period last year. During the quarter, we placed 117 Deep TMS systems, bringing our total install base to approximately 1,820 systems as of March 31, 2026. Gross profit for the quarter was $11.6 million, up 35% from $8.6 million in the prior year period while also keeping a healthy gross margin. This performance reflects our continued growth and increased market penetration both in the US and the international markets. Turning to operating expenses, sales and marketing expenses for the first quarter of 2026 totaled $4.9 million compared to $4.2 million in the first quarter of 2025. The increase was primarily driven by targeted investment in commercial expansions and marketing programs. Research and development expenses were $2.8 million compared with $2.3 million last year. The increase was primarily driven by investments in clinical development and research, including our multicenter trial for alcohol use disorder. General and Administrative expenses were $1.8 million compared with $1.5 million in the prior year period, reflecting the organic growth of our business in addition to the investments we continue to make in strategic initiatives. Operating income was approximately $2 million, compared with $0.6 million reported for Q1 2025. This performance reflects the scaling of operations, strength of our recurring revenue model, and disciplined cost management for the first quarter ended March 31, 2026, we reported net income of $2.3 million compared with $1.1 million in the same period of 2025. Adjusted EBITDA was $2.8 million representing the 11th consecutive quarter of positive adjusted EBITDA compared with $1.3 million in Q1 2025. Remaining performance obligations grew to $75 million as of March 31, 2026, a 25% year over year increase. We believe the steady increase in our RPO's reflects the strength of our business and execution on our long term strategy. Cash flow from operation was positive in Q1 2026, further reinforcing the confidence we have in our recurring model and high collection efficiency. The capital structure for the company remained debt free, giving us significant flexibility to pursue strategic growth initiatives including the various investment Hadar outlined earlier. This is especially notable given additional investment of approximately $9 million made during Q1 2026. In line with our strategic direction, we reported cash and cash equivalents of $58.9 million on March 31, 2026. We believe our strong capital position will support the continuous growth of our core scientific and technology operation as well as our Strategic Investment Program which aims to increase patient access to innovative treatments while also building long term value for our shareholders. Looking ahead, we continue to expect revenue in the range of 66 to 68 million dollars for the full year of 2026. These guidance represent a year over year growth rate of 27 to 30%. In addition, we expect operating income in the range of 13 to 14% of revenue and adjusted EBITDA of 12 to $14 million, representing anticipated growth of 86 to 100% over 2025. This concludes my prepared remarks and I will now turn the call back to the operator to please open up the call for questions. OPERATOR Operator Thank you. We will now Thank you. We will now begin the question and answer session. To ask a question, you may press Star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press Star then two. At this time we will pause momentarily to assemble a roster. Question comes from Jeffrey Cohen with Ledenburg Hellman. Jeffrey Cohen (Equity Analyst) Please go ahead. Good morning Hadar and Ido and congratulations on the strong quarter in progress. So couple questions from Erin. Firstly, could you talk about the upcoming PTSD filing and could you talk to us a little more about the the protocol you anticipate and if the Trial is with or without medication in the case of patients. Hadar Levy (Chief Executive Officer) Yeah. Hey Jeff, thank you and good morning. We're very excited about the submission of the PTSD data. Just to remind everyone this is a comorbidity PTSD treatment for people are also suffering from depression. It's with medication. So we're not washing out patients from medications. but what we have seen based on the data that we are able to see some really, really good results on reducing the symptoms of PTSD for people suffering from depression as well. The protocol is very similar to the depression protocol. It's the exact same coil, it's the H1 coil targeting same areas of anxiety and depression. but we do see some significant reduction in those symptoms for PTSD patients. Jeffrey Cohen (Equity Analyst) Perfect. Okay. And then as a follow up, could you talk about the SWIFT protocol a little bit and talk about what you're finding in the field as far as it being utilized and for one indications and perhaps give us a sense of percentage as far as patients using SWIFT versus the regular protocol. And then maybe also talk about the payer environment or the payers agnostic or the payers taking this on and accepting it as a similar protocol. Hadar Levy (Chief Executive Officer) Yeah, look, I believe the Swift protocol is a game changer in this field. We're talking about a six days acute phase protocol as compared to the standard protocol that is talking about 20 to 30 days. So being able to shorten the number of days that patients need to commit to come daily to the clinic to only six days, obviously make it really accessible for patients. Now when you compare it also to the alternative treatments today in the market like esketamine or some other psychedelic treatment, it's even more compelling because being able to complete the whole course of treatment within six days and see a very strong result, just to remind everyone, and we announced those results, we have seen 88% response rate for the Swift protocol within only six days of treatment and 78% remission rate with only six days. Which means that both the provider and the patients are really now pushing or demanding this treatment modality. You mentioned also the payers. So you know, at the end of the day the peers is asking themselves on actuality basis, am I saving cost for those patients suffering from depression and if they see good results within six days or within 30 days, but they still see some very good results response and remission rates. So the answer will be that they will start to adopt it. So we have seen, we were very happy to see some very early adoption with some of the payers, but we're starting to See more and more PERS now also adopting this Swift protocol. I believe we're going to see some more serious momentum toward the end of the year and I believe the industry is looking for shorter treatment and effective treatment that are saving and improving patient life. Perfect. Thanks for taking our questions. Thank you, Jeff. OPERATOR Thank you. Our next question come from Ram Selvaraju from HC Venride. Please go ahead. Ram Selvaraju (Equity Analyst) Thanks so much for taking our questions and congratulations on excellent operational performance this quarter. Firstly, I wanted to ask about when you submit the application for use of deep TMS in connection with treating PTSD associated with mdd. Maybe give us some additional granularity on what you anticipate the review timeline to be once the application has been submitted and if you can give us some sense of what you anticipate to be any new emergent promotional strategy that you might utilize, assuming that approval for this indication is granted. Secondly, I wanted to ask if you could provide some additional color on what you were just saying hadar about the additional adoption of the Swift system from a reimbursement payerspective, potentially how many more covered lives might have access to the system? How many more reimbursement providers might ultimately ink agreements with you? Thirdly, I wanted to ask about the Proliv RX system and what the sales and marketing strategy is underlying this and if you have any sense of when it might be possible to share with us what the total addressable market looks like and what peak sales might be for this product. Thank you. Hadar Levy (Chief Executive Officer) Yeah, great. Thank you for all this question. Let's start with the ptsd. Usually once we submit the data to the FDA, the clock start ticking. Usually take up to 90 days for us to get the first response and then if everything goes well we can expect to get the FDA approval. Usually there is some back and forth about that. So if I need to put it in the right time frame, we do expect to receive the FDA clearance before the end of this, before the end of the year. So that's about the ptsd. And you also ask about marketing, how are we going to market this? So obviously this is the exact same market that we're playing today, right? For all those outpatients, clinic and specifically the one that are working with the police department or with active military folks. They got the volume of patient that most of them suffering from depression, anxiety and also ptsd. So what will be very, very unique for us is that we have treated hundreds of patients suffering from PTSD in Israel and similar numbers or even greater number also in the US So we are planning to do some meaningful marketing push toward the last quarter of the year to make sure that we're optimizing the revenue from this very, very, very important indication. As for the second question on the adoptions of pair of the SWIFT protocol, so you know, we are looking on this very, very closely. We're speaking today with more than 20 pairs providing all the necessary data. I think that the feedback is very, very positive. I do expect to get reimbursement by PRRS for I would say 40 to 50 million covered life before, before the end of the year. So overall, very good momentum, even faster than we thought. But we truly do believe that, you know, at the end of the day, what really matter is how is the efficacy of the treatment. And if you can deliver great efficacy and great durability in such a short time, I see no reason why the parents will not adopt it if they already fully adopt the standard protocol as well. With regards to your last question about the Prolif rx, so just to remind again, we're still not owning neuraleaf. However, we are watching very carefully on some of their strategic and commercial approach. The main focus right now is penetration in the va. The main reason is because they got listed in the VA contract and they got reimbursement over there. I mentioned on my call that they got a pricing of $11,800 per system. That's a really, really significant reimbursement for this, for this treatment. So the main focus right now is to focus in all VA accounts and start generating some significant revenue. In parallel, the company also doing some limited market release in some leading enterprise Brain Sway enterprise accounts and they're looking also to define some contracts with some IDNs, big IDMs in the US I also mention it, there is additional $5 million investment in Neuralith based on some significant commercial milestone which I'll be more than happy to write the check if they're going to achieve it. But I think that new Olif with the Prolifarex have everything they need in order to execute and to deliver in this very, very important market. Remember, we are the main reason that we invested in this company is to increase the target market for Brain Sway. It's specifically aimed for the people that find difficulties to come to the clinic. They are far away. That also could be a bridge to neuromodulation. It could be a complementary treatment after they are doing the DiPTMS sessions within the clinic. So all in all I do expecting a very, very growth trajectory for Neuraleaf. Specifically with the Proliv Rx device and Ram Selvaraju (Equity Analyst) then two other very quick ones you mentioned in the press release, the versus year ago period growth in remaining performance obligations. Can you just provide us with the quarter over quarter change in remaining performance obligations and then maybe if you could just comment on if you are seeing any disruption at all to operations international sales stemming from the ongoing evolving situation in the Middle East. Thank you. Hadar Levy (Chief Executive Officer) Yeah, I'm going to let it do just to shine in on the remaining performance obligation. And I will take the second. Yes. Ido Marom (Chief Financial Officer) So we mentioned also on the call that our remaining performance obligation grew 25% year over year. So we have a backlog right now which this is our remaining performance obligation of $75 million comparing to approximately 60 that we had in the previous period. And this represents the growth of our remaining performance obligation backlog. And also I believe Hadar will mention we'll add more about the international, but we also see a growth in the revenue mainly in Q1 for the international market as well. So we actually even saw a growth in our revenue and orders this quarter compared to the previous one. Hadar Levy (Chief Executive Officer) Yeah, great. Thank you Ido and for your question. You know our main business today is the US and international markets. So we didn't see any disruptive from any disruption from the current situation. We have enough inventory just to support the demand. I think the TMS market is growing and experiencing a significant amount of consolidation. And with us focusing on those enterprise account and specifically with what we're seeing with shifting among providers toward deep tms away from some other pharmacologic and alternatives like esketamine, I think all of this can really deliver on the record number of units that we were able to deliver in the in the first quarter. And remember, usually there is seasonality in our space. Usually Q1 is a light quarter. People are still sitting on the fence about their budget decisions for the year. So overall I'm very, very proud and very glad to see the good momentum not only in the US but but also in the international markets. I think that on the international markets we continue to strengthen our distribution channels across the world. We see some very, very growing demand not only in mental health. We have some additional approved indication in those markets in recovery area and addiction. And I do anticipate that this momentum will continue to grow. Ram Selvaraju (Equity Analyst) Thank you so much. Hadar Levy (Chief Executive Officer) Thank you Ram. OPERATOR Thank you. Thank you. Okay, this concludes our question and answer session. I would like to turn the conference back over to Hadar and Levy for any closing remarks. Over to you, sir. Hadar Levy (Chief Executive Officer) Yeah, I would like to thank all of the investors, analysts and other participants for their interest in Brainsway Ltd. Please enjoy the rest of your day. Thank you. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga: BRAINSWAY (BWAY): Free Stock Analysis Report This article Full Transcript: BrainsWay Q1 2026 Earnings Call originally appeared on Benzinga.com ᄅ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Investor releaseQuarter not tagged2026-05-13

BrainsWay Reports First Quarter 2026 Financial Results and Operational Highlights

GlobeNewswire
Revenue grew approximately 35% year-over-year to $15.5 million for Q1 2026 Net income increased by over 100% year-over-year to $2.3 million for Q1 2026 Adjusted EBITDA for Q1 of 2026 more than doubled year-over-year to $2.8 million Remaining performance obligations grew 25% year-over-year to approximately $75 million Shipped a record total of 117 Deep TMS Systems, indicating significant demand and further strengthening of relationships with enterprise accounts Reiterates full-year 2026 financial guidance, including revenue of $66 – $68 million, operating income of 13% – 14%, and Adjusted EBITDA of $12 – $14 million Conference call to be held today at 8:30 AM ET BURLINGTON, Mass. and JERUSALEM, May 13, 2026 (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 2026 financial results and provided an operational update. Recent Financial and Operational Highlights Revenue in the first quarter of 2026 increased 35% to $15.5 million, compared with the first quarter of 2025. Remaining performance obligations (RPOs) increased to $75 million as of March 31, 2026, up 25% compared to the prior year period. Shipped a net total of 117 Deep TMS™ systems during the first quarter of 2026, representing a 44% increase compared to the same period last year. Total installed base reached approximately 1,820 systems. Gross margin for the first quarter of 2026 was 75%, steady with the prior year period. Operating income for the first quarter of 2026 was $2.0 million, compared with $0.6 million for the prior year period. Adjusted EBITDA for the first quarter of 2026 increased 117% to $2.8 million, compared with $1.3 million for the prior year period. Net income for the first quarter of 2026 increased over 100% to $2.3 million, compared with $1.1 million for the prior year period. As of March 31, 2026, cash and cash equivalents, and restricted cash totaled $58.9 million. Secured the first insurer coverage for accelerated SWIFT™ (Short‑course with Intrinsic Field Targeting) Deep TMS protocol following FDA clearance. Growing U.S. payer support for psychiatric mental health nurse practitioners administered TMS, with commercial insurers, Medicare Administrative Contractors, and government payers expanding coverage to include tra…Read full document

Revenue grew approximately 35% year-over-year to $15.5 million for Q1 2026 Net income increased by over 100% year-over-year to $2.3 million for Q1 2026 Adjusted EBITDA for Q1 of 2026 more than doubled year-over-year to $2.8 million Remaining performance obligations grew 25% year-over-year to approximately $75 million Shipped a record total of 117 Deep TMS Systems, indicating significant demand and further strengthening of relationships with enterprise accounts Reiterates full-year 2026 financial guidance, including revenue of $66 – $68 million, operating income of 13% – 14%, and Adjusted EBITDA of $12 – $14 million Conference call to be held today at 8:30 AM ET BURLINGTON, Mass. and JERUSALEM, May 13, 2026 (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 2026 financial results and provided an operational update. Recent Financial and Operational Highlights Revenue in the first quarter of 2026 increased 35% to $15.5 million, compared with the first quarter of 2025. Remaining performance obligations (RPOs) increased to $75 million as of March 31, 2026, up 25% compared to the prior year period. Shipped a net total of 117 Deep TMS™ systems during the first quarter of 2026, representing a 44% increase compared to the same period last year. Total installed base reached approximately 1,820 systems. Gross margin for the first quarter of 2026 was 75%, steady with the prior year period. Operating income for the first quarter of 2026 was $2.0 million, compared with $0.6 million for the prior year period. Adjusted EBITDA for the first quarter of 2026 increased 117% to $2.8 million, compared with $1.3 million for the prior year period. Net income for the first quarter of 2026 increased over 100% to $2.3 million, compared with $1.1 million for the prior year period. As of March 31, 2026, cash and cash equivalents, and restricted cash totaled $58.9 million. Secured the first insurer coverage for accelerated SWIFT™ (Short‑course with Intrinsic Field Targeting) Deep TMS protocol following FDA clearance. Growing U.S. payer support for psychiatric mental health nurse practitioners administered TMS, with commercial insurers, Medicare Administrative Contractors, and government payers expanding coverage to include trained nurse practitioners. Advanced with patient recruitment for the Company’s multicenter study of Deep TMS for alcohol use disorder (AUD), a major unmet need affecting approximately 29 million Americans. The Company plans to submit an FDA filing in the second quarter of 2026 for the use of Deep TMS in treating PTSD symptoms in patients with MDD, potentially expanding the Company’s clinical pipeline into a large and underserved market with significant unmet need. Completed a $6 million milestone-based convertible loan to Neurolief following FDA Premarket Approval of ProlivRx system; bringing the Company’s total convertible loan investment in Neurolief to $11 million. Completed an initial $1 million minority stake investment into BrainStim Health Inc., as well as an additional $1 million revenue milestone-based investment in Axis Management Company, supporting the continued execution and expansion of BrainsWay’s minority position investment strategy. Reiterates Full-Year 2026 Financial Guidance The Company expects full-year 2026 revenue of $66 million to $68 million, which represents growth of 27% to 30% compared with revenue for 2025. The Company anticipates continued profitability and positive cash flow, targeting operating income of 13%-14% of revenue and Adjusted EBITDA of $12 million to $14 million, representing anticipated growth of 86% to 100% over 2025. “We are off to an excellent start in 2026, delivering 35% revenue growth in the first quarter while generating $2.8 million of Adjusted EBITDA,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Across the board, we are seeing meaningful progress in expanding awareness and access to Deep TMS, driven by broader reimbursement, increasing provider adoption, and continued engagement with leading mental health networks. These efforts are translating into growing demand, increased utilization, and strong momentum across our business.” “With a strong foundation in place and multiple catalysts ahead, we are well positioned to continue expanding access to Deep TMS and driving sustainable long-term growth. Looking ahead, we remain on track to deliver our full-year 2026 guidance of $66 to $68 million in revenues,” concluded Mr. Levy. Call and Webcasts BrainsWay’s management will host a conference call in English on Wednesday, May 13, 2026, at 8:30 a.m. Eastern Daylight Time (EDT) to discuss these results and answer questions, followed by a webinar hosted in Hebrew on Thursday, May 14, 2026, at 11:00 AM Israel Daylight Time (IDT). All details to access these events are listed below. In English: Date: Wednesday, May 13, 2026 Time: 8:30 AM EDT Dial-In (United States / International): 1-877-300-8521 / 1-412-317-6026 Conference ID: 10208547 A simultaneous webcast of the conference call held in English will be available on the BrainsWay website at investors.brainsway.com and through this link: https://viavid.webcasts.com/starthere.jsp?ei=1760244&tp_key=9c697b1af2 In Hebrew: Date: Thursday, May 14th Time: 11:00 AM IDT To register for this webinar, please click here: BrainsWay Q1 2026 IL Investor Webinar Non-IFRS Financial Measures In addition to our results determined in accordance with International Financial Reporting Standards (IFRS), including in particular operating profit and net profit, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net profit adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses. In addition to operating income (loss) and net income (loss), we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-IFRS financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons: Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as stock-based compensation expenses, depreciation and amortization, finance expenses, income taxes, and certain one-time items such as restructuring and litigation expenses, that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired. Our management uses Adjusted EBITDA in conjunction with IFRS financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-IFRS or non-GAAP financial measures to supplement their IFRS or GAAP results. Adjusted EBITDA, however, should not be considered as an alternative to operating profit (loss) or net profit (loss) for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. A reconciliation between the Company’s net profit (loss) and Adjusted EBITDA is presented in the attached summary financial statements. Because of these and other limitations, you should consider Adjusted EBITDA along with other IFRS-based financial performance measures, including net profit (loss) and our IFRS financial results. About BrainsWay BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 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 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, and also includes any financial guidance and projections contained herein. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: risks relating to the Company’s ability to consummate, finance and close proposed or potential investments, inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission. Contacts: BrainsWay: Ido Marom Chief Financial Officer [email protected] Investors: Brian Ritchie LifeSci Advisors LLC [email protected]

Investor releaseQuarter not tagged2026-05-13

Brainsway Q1 Earnings Call Highlights

MarketBeat
Interested in Brainsway Ltd. Sponsored ADR? Here are five stocks we like better. BrainsWay posted strong Q1 results with revenue up 35% year over year to $15.5 million, its 11th straight profitable quarter, and adjusted EBITDA more than doubling to $2.8 million. The company also shipped 117 Deep TMS systems, lifting its installed base to about 1,820 systems. Recurring revenue and reimbursement progress are accelerating, with remaining performance obligations rising 25% to $75 million and the company saying it expects SWIFT reimbursement coverage for 40 million to 50 million lives by year-end. BrainsWay also highlighted broader payer support, including expanded adolescent depression coverage and reduced prior authorization barriers. BrainsWay reaffirmed full-year 2026 guidance for revenue of $66 million to $68 million, implying 27% to 30% growth, and adjusted EBITDA of $12 million to $14 million. Management also said it plans an FDA submission for PTSD symptoms in patients with major depressive disorder and is advancing studies in alcohol use disorder. Brainsway (NASDAQ:BWAY) reported a strong start to 2026, with first-quarter revenue rising 35% year over year as the company expanded placements of its Deep TMS systems and continued to build its recurring revenue base. Chief Executive Officer Hadar Levy said on the company’s earnings call that revenue for the three months ended March 31, 2026, totaled $15.5 million, compared with $11.5 million in the prior-year period. The company shipped 117 Deep TMS systems during the quarter, a 44% increase from the same period last year, bringing its total installed base to approximately 1,820 systems. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Levy said the quarter marked BrainsWay’s 11th consecutive quarter of profitability, supported by margin expansion and the company’s recurring model. Net income rose to $2.3 million from $1.1 million a year earlier, while adjusted EBITDA increased 119% to $2.8 million from $1.3 million. BrainsWay reported remaining performance obligations of $75 million as of March 31, 2026, up 25% year over year. Levy said most new contracts signed during the quarter were multi-year agreements, which he described as evidence of demand for the company’s technology and the success of its focus on enterprise customers. → MercadoLibre Boldly Invests in Growth: Discount Deep…Read full document

Interested in Brainsway Ltd. Sponsored ADR? Here are five stocks we like better. BrainsWay posted strong Q1 results with revenue up 35% year over year to $15.5 million, its 11th straight profitable quarter, and adjusted EBITDA more than doubling to $2.8 million. The company also shipped 117 Deep TMS systems, lifting its installed base to about 1,820 systems. Recurring revenue and reimbursement progress are accelerating, with remaining performance obligations rising 25% to $75 million and the company saying it expects SWIFT reimbursement coverage for 40 million to 50 million lives by year-end. BrainsWay also highlighted broader payer support, including expanded adolescent depression coverage and reduced prior authorization barriers. BrainsWay reaffirmed full-year 2026 guidance for revenue of $66 million to $68 million, implying 27% to 30% growth, and adjusted EBITDA of $12 million to $14 million. Management also said it plans an FDA submission for PTSD symptoms in patients with major depressive disorder and is advancing studies in alcohol use disorder. Brainsway (NASDAQ:BWAY) reported a strong start to 2026, with first-quarter revenue rising 35% year over year as the company expanded placements of its Deep TMS systems and continued to build its recurring revenue base. Chief Executive Officer Hadar Levy said on the company’s earnings call that revenue for the three months ended March 31, 2026, totaled $15.5 million, compared with $11.5 million in the prior-year period. The company shipped 117 Deep TMS systems during the quarter, a 44% increase from the same period last year, bringing its total installed base to approximately 1,820 systems. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Levy said the quarter marked BrainsWay’s 11th consecutive quarter of profitability, supported by margin expansion and the company’s recurring model. Net income rose to $2.3 million from $1.1 million a year earlier, while adjusted EBITDA increased 119% to $2.8 million from $1.3 million. BrainsWay reported remaining performance obligations of $75 million as of March 31, 2026, up 25% year over year. Levy said most new contracts signed during the quarter were multi-year agreements, which he described as evidence of demand for the company’s technology and the success of its focus on enterprise customers. → MercadoLibre Boldly Invests in Growth: Discount Deepens Chief Financial Officer Ido Marom said gross profit increased 35% to $11.6 million, compared with $8.6 million in the first quarter of 2025. Operating income was approximately $2 million, up from $0.6 million a year earlier. Operating expenses increased as BrainsWay invested in commercial expansion, research and strategic initiatives. Sales and marketing expenses rose to $4.9 million from $4.2 million, research and development expenses increased to $2.8 million from $2.3 million, and general and administrative expenses rose to $1.8 million from $1.5 million. → MP Materials Is Quietly Building a Rare Earth Powerhouse Marom said cash flow from operations was positive during the quarter and that the company remained debt-free. BrainsWay ended the period with $58.9 million in cash and cash equivalents, despite making approximately $9 million in strategic investments during the quarter. BrainsWay reaffirmed its full-year 2026 revenue outlook of $66 million to $68 million, representing expected year-over-year growth of 27% to 30%. The company also expects operating income to equal 13% to 14% of revenue and adjusted EBITDA of $12 million to $14 million, which would represent growth of 86% to 100% over 2025. Levy highlighted growing interest in BrainsWay’s six-day acute phase SWIFT protocol, which he said reduces acute phase clinic visits by approximately 70% without compromising efficacy. The company recently published data on the protocol in the peer-reviewed journal Brain Stimulation. During the question-and-answer session, Levy called SWIFT a “game changer” for the field, contrasting the six-day approach with the standard protocol of 20 to 30 days. He said previously announced results showed an 88% response rate and a 78% remission rate after six days of treatment. Levy said the company is speaking with more than 20 payers about SWIFT reimbursement and expects coverage for 40 million to 50 million lives by the end of the year. He said BrainsWay is seeing early payer adoption and expects further momentum later in 2026. The company also cited broader reimbursement progress for Deep TMS, including coverage expansion for adolescent depression following an FDA label expansion for patients ages 15 to 21. Levy said more than 10 payers have added coverage for adolescent depression. He also noted that Evernorth Behavioral Health eliminated prior authorization requirements for TMS across Evernorth and Cigna plans. BrainsWay said reimbursement policies are also expanding to allow trained nurse practitioners to order, supervise or administer TMS where permitted by regulations and scope-of-practice rules. Levy specifically cited Optum’s policy update covering nearly 35 million lives, along with similar moves by other major payers, the VA and TRICARE. Levy said BrainsWay plans to submit an application to the U.S. Food and Drug Administration in the next several weeks seeking clearance to treat PTSD symptoms in patients with major depressive disorder. In response to an analyst question, he said the proposed use involves patients with comorbid PTSD and depression and does not require patients to stop taking medications. Levy said the protocol is similar to the company’s depression protocol, using the same H1 Coil and targeting areas associated with anxiety and depression. He said BrainsWay expects an initial FDA response within about 90 days after submission and anticipates potential clearance before the end of the year, though he noted there may be back-and-forth with the agency. The company also said patient recruitment is underway for a multi-center study of Deep TMS for alcohol use disorder. Levy described alcohol use disorder as a major unmet need affecting approximately 29 million Americans, with relapse rates of up to 60% within three to six months despite available treatments. BrainsWay continued to expand its strategy of taking minority equity stakes in mental health providers. Levy said the company has completed minority investments in five mental health networks and recently signed another agreement with Hopemark, an Illinois group with multiple locations in the Chicago area. The agreement includes an initial $1.5 million investment and up to an additional $1.5 million tied to future milestones in exchange for a preferred minority stake. Levy also said BrainsWay is close to signing another minority stake transaction with an East Coast provider operating in New York, New Jersey, Pennsylvania and Connecticut. He said the company has identified more than 200 qualified clinics as potential candidates for the program. BrainsWay also updated investors on its relationship with Neurolief, developer of ProlivRx, a wearable, non-invasive, multi-channel neuromodulation platform designed for home use. Following FDA pre-market approval of ProlivRx for treatment-resistant major depressive disorder, BrainsWay made an additional $6 million milestone-based convertible loan to Neurolief in late March, bringing its total convertible loan investment to $11 million. Levy said Neurolief has secured a VA Federal Supply Schedule contract and received approved pricing of $11,800 per unit. He said Neurolief’s near-term commercial focus is VA penetration, limited market release through selected BrainsWay enterprise accounts and potential contracts with large integrated delivery networks. Levy said the company sees ProlivRx as complementary to Deep TMS, with Deep TMS serving patients in clinical settings and ProlivRx aimed at home use for patients who cannot easily reach a clinic. He said the combination could expand BrainsWay’s addressable market and support its broader goal of increasing access to non-pharmacological mental health treatments. Asked about international operations and the situation in the Middle East, Levy said BrainsWay has not seen disruption and has sufficient inventory to support demand. He said international momentum remains strong, with demand from distributors across Asia Pacific, Canada and Europe. Brainsway Ltd is a medical device company specializing in non-invasive neuromodulation therapies. Publicly traded on the NASDAQ under the symbol BWAY, the company develops and commercializes deep transcranial magnetic stimulation (Deep TMS) systems designed to treat a range of neuropsychiatric and neurological disorders. Brainsway's technology aims to offer an alternative or complement to traditional pharmacological therapies by targeting precise brain regions with its patented coil designs. The company's flagship Deep TMS platform utilizes proprietary H-coil arrays engineered to reach deeper cortical structures than conventional TMS devices. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Brainsway Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

As of 2026-09-12 • Updated weeklySource: Earnings sourceIngestion runbook