Group 1 - Brainsway Ltd. Sponsored ADR (BWAY) shows a significantly improving earnings outlook, making it a solid choice for investors [1] - Analysts are raising their earnings estimates for Brainsway, indicating a positive trend that may reflect in the stock price [2][3] - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), has a strong track record, with 1 ranked stocks averaging a +25% annual return since 2008 [3] Group 2 - For the current quarter, Brainsway is expected to earn $0.04 per share, with a 10% increase in consensus estimates over the last 30 days [5] - The full-year earnings estimate is $0.15 per share, reflecting a -16.67% change from the previous year, but the trend shows three estimates moving higher compared to one negative revision [6] - Brainsway currently holds a Zacks Rank 2 (Buy), indicating promising estimate revisions and potential for significant outperformance compared to the S&P 500 [7] Group 3 - The stock has increased by 23.4% over the past four weeks due to strong estimate revisions, suggesting further upside potential [8]

Core Viewpoint - Brainsway Ltd. (BWAY) has shown a significant price increase of 35.5% over the past four weeks, with analysts projecting further upside potential based on a mean price target of $15.05, indicating a 41.3% increase from the current price of $10.65 [1] Price Targets and Analyst Estimates - The mean price target consists of four short-term estimates with a standard deviation of $0.74, where the lowest estimate is $14.20 (33.3% increase) and the highest is $16 (50.2% increase) [2] - A low standard deviation among price targets suggests a strong consensus among analysts regarding the stock's price direction and magnitude [9] Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about BWAY's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which historically correlates with stock price movements [11] - The Zacks Consensus Estimate for the current year has risen by 11.1% over the past month, with two estimates increasing and one decreasing [12] - BWAY holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for near-term upside [13]

Financial Data and Key Metrics Changes - The company generated $11,500,000 in revenue for Q1 2025, marking a 27% increase year over year from $9,100,000 in Q1 2024 [5][16] - Gross profit for Q1 2025 was $8,600,000, maintaining a gross margin of 75%, compared to $6,800,000 in the prior year [18] - Operating profit for Q1 2025 was approximately $576,000, up from approximately $93,000 in Q1 2024 [19] - Adjusted EBITDA for Q1 2025 was about $1,300,000, representing the seventh consecutive quarter of positive adjusted EBITDA, compared to $715,000 in Q1 2024 [19] - The company reported a net profit of about $1,100,000 for Q1 2025, compared to $111,000 in the same period of 2024 [19] - Cash, cash equivalents, and short-term deposits were approximately $72,000,000 as of March 31, 2025 [19] Business Line Data and Key Metrics Changes - The company shipped a total of 81 Deep TMS systems in Q1 2025, representing a 42% increase compared to the first quarter of 2024 [5] - The installed base of Deep TMS systems increased to 1,434 as of March 31, 2025, compared to 1,158 systems at the same point in the prior year [17] Market Data and Key Metrics Changes - The company has signed a backlog and remaining performance obligation totaling nearly $60,000,000, providing clear visibility into future growth [6] - The commercial growth, particularly in the U.S., is driven by expanded adoption of Deep TMS in treating obsessive-compulsive disorder (OCD), anxious depression, and other mental health conditions [6] Company Strategy and Development Direction - The growth strategy focuses on three key pillars: elevating market awareness of Deep TMS, advancing the R&D roadmap for new treatment indications, and broadening patient access through global expansion and health system integration [9] - The company aims to ramp up activity around OCD in 2025, with over 60% of patients responding positively to Deep TMS therapy [10] - The company is also making progress in increasing attention to clinical data supporting Deep TMS therapy for PTSD and expanding reimbursement in Israel [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive operating environment and strong demand for Deep TMS systems, with approximately 80% of new sales coming from new customers and 20% from competitive conversions [22] - The company reiterated its full-year 2025 financial guidance of $49,000,000 to $51,000,000 in revenue, representing a growth of 20% to 24% over 2024 [15][20] - Management is actively monitoring international trade and tariff policies but does not expect a material impact on gross margin for the current year [14][15] Other Important Information - The company is evaluating the protocol for combining Deep TMS treatment with psychedelic treatments and aims to launch a clinical trial potentially in Q3 2025 [26] - The company is not currently considering a stock repurchase program, focusing instead on expanding top-line revenue and investing in innovation [41][42] Q&A Session Summary Question: Insights on system sales and market expansion - Management noted that approximately 80% of new sales are from greenfield opportunities, with 20% from competitive conversions [22] Question: Discussion on sustainable revenue models - Management explained the evolution of the pay-per-use model, which is being implemented in Israel and some U.S. territories, providing flexibility for providers [24] Question: Update on clinical trials and accelerated protocol data - Management expects to receive FDA clearance for the accelerated protocol data by the end of the year and is working on data collection for PTSD treatments [26] Question: Installed base of OCD helmets - Management confirmed that 57 OCD helmets were shipped during the quarter, bringing the total to approximately 850 globally [30] Question: Geopolitical risks and business disruptions - Management stated that they do not foresee significant negative impacts from geopolitical risks or tariff policies at this time [36][38] Question: Potential stock repurchase program - Management is evaluating options but is currently focused on growth and innovation rather than implementing a stock repurchase program [41][42]

Financial Data and Key Metrics Changes - The company generated $11,500,000 in revenue for Q1 2025, a 27% increase year over year from $9,100,000 in Q1 2024 [4][15] - Gross profit for Q1 2025 was $8,600,000, maintaining a gross margin of 75%, compared to $6,800,000 in the prior year [16] - Operating profit for Q1 2025 was approximately $576,000, up from approximately $93,000 in the same period of 2024 [17] - Adjusted EBITDA for Q1 2025 was about $1,300,000, representing the seventh consecutive quarter of positive adjusted EBITDA, compared to $715,000 in Q1 2024 [17] - The company reported a net profit of about $1,100,000 for Q1 2025, compared to $111,000 in Q1 2024 [18] - Cash, cash equivalents, and short-term deposits totaled approximately $72,000,000 as of March 31, 2025 [18] Business Line Data and Key Metrics Changes - The company shipped a total of 81 Deep TMS systems in Q1 2025, representing a 42% increase compared to Q1 2024 [4] - The installed base of Deep TMS systems increased to 1,434 as of March 31, 2025, compared to 1,158 systems at the same point in the prior year [15] Market Data and Key Metrics Changes - The backlog and remaining performance obligation totaled nearly $60,000,000, providing visibility into future growth [5] - The U.S. market is driving commercial growth, particularly in the treatment of obsessive-compulsive disorder (OCD) and anxious depression [5] Company Strategy and Development Direction - The growth strategy focuses on three key pillars: elevating market awareness of Deep TMS, advancing the R&D roadmap for new treatment indications, and broadening patient access through global expansion [7] - The company aims to ramp up activity around OCD in 2025, with over 60% of patients responding positively to Deep TMS therapy [9] - The company is also working to expand reimbursement for PTSD treatment in Israel and is advancing clinical trials for an accelerated treatment protocol for major depressive disorder [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive operating environment and reiterated full-year 2025 financial guidance of $49,000,000 to $51,000,000 in revenue, representing 20% to 24% growth over 2024 [14][19] - The company does not anticipate a material impact on gross margin from recent international trade and tariff policies [14] Other Important Information - The company is actively monitoring geopolitical risks and tariff policies but does not foresee significant negative impacts on its operations [37] - The company is evaluating the implementation of a stock repurchase program but is currently focused on expanding growth and investing in innovation [41] Q&A Session Summary Question: What is the breakdown of new sales between market expansion and competitive conversions? - Management indicated that approximately 80% of new sales are from greenfield opportunities, while 20% are competitive conversions [21] Question: Can you elaborate on the pay-per-use model? - The pay-per-use model is being implemented in specific segments, providing systems without upfront fees and charging per procedure, which offers flexibility for providers [23] Question: When can we expect data from the accelerated protocol clinical trials? - The company expects to receive FDA clearance for the accelerated protocol data by the end of the year and is also working on data collection for PTSD treatment [25][26] Question: How many OCD helmets were shipped during the quarter? - The company shipped 57 OCD helmets, bringing the total installed base to approximately 850 globally [29] Question: Are there significant geopolitical risks affecting the business? - Management does not see significant geopolitical risks impacting the business at this time, although they are actively monitoring the situation [37] Question: Will there be more upgrades to the current installed base this year or in 2026? - Management expects continued demand growth for Deep TMS systems, indicating a healthy demand for upgrades [39] Question: Is the company considering a stock repurchase program? - Currently, the company is not considering a stock repurchase program, focusing instead on growth and innovation investments [41]

Core Insights - BrainsWay Ltd. achieved record quarterly sales of $11.5 million in Q1 2025, marking a 27% increase compared to Q1 2024 [1][8] - The company reported an operating profit of $0.6 million, a significant increase of 519% year-over-year, and Adjusted EBITDA rose to $1.3 million, up 81% from the previous year [1][8] - The demand for Deep TMS Systems is strong, with a record shipment of 81 systems in Q1 2025, representing a 42% increase from 57 systems shipped in the same period last year [1][8] Financial Performance - Revenue for Q1 2025 was $11.5 million, up 27% from $9.1 million in Q1 2024 [8][21] - Gross margin remained stable at 75% compared to the prior year [8] - Net profit surged by 897% to $1.1 million in Q1 2025, compared to $0.1 million in Q1 2024 [1][8] Operational Highlights - The company is reiterating its full-year 2025 financial guidance, projecting revenue between $49 million to $51 million, with an operating profit margin of 3% to 4% and Adjusted EBITDA of 11% to 12% [5][8] - BrainsWay's CEO highlighted the growing demand for their technology in treating various mental health disorders, including OCD and anxious depression, and emphasized the importance of relationships with large enterprise customers [5][6] Market Expansion - The company is expanding its global market presence, now operating in key markets including Canada, Asia, India, and Europe [6] - Upcoming catalysts for growth include the next-generation Deep TMS 360™ system and the expansion into new indications supported by additional clinical data [6]

Company Overview - BrainsWay Ltd. is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, specifically through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology [4] - The company has obtained three FDA-cleared indications for Deep TMS, which include Major Depressive Disorder (MDD), Anxious Depression, Obsessive-Compulsive Disorder (OCD), and Smoking Addiction [4] - Founded in 2003, BrainsWay operates in both Israel and the U.S. and is committed to increasing global awareness and access to Deep TMS [4] Industry Participation - BrainsWay will participate in the American Psychiatric Association (APA) Annual Meeting from May 17–21, 2025, in Los Angeles, California, showcasing its role in psychiatric care [1] - The company will host live demonstrations of its Deep TMS system at its exhibit booth, providing hands-on interaction with this innovative treatment modality [3] Educational Initiatives - A master course titled "Clinical Applications for Psychiatric Practice: Ketamine and TMS" will be held on May 18, 2025, focusing on integrating novel treatments into clinical psychiatric practice [2] - The course will feature prominent clinician-researchers, including BrainsWay's Chief Medical Officer Dr. Richard Bermudes and Vice President of Medical Affairs Dr. Colleen Hanlon, discussing innovative therapeutic approaches [2][3]

Core Insights - BrainsWay Ltd. will report its first quarter 2025 financial results and operational highlights on May 13, 2025, before the U.S. market opens [1] - A conference call and webcast will be held at 8:30 AM Eastern Time on the same day to discuss the results and business operations [1][2] Company Overview - BrainsWay is a leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [3] - The company has obtained three FDA-cleared indications for its TMS technology, which include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [3] - Founded in 2003, BrainsWay operates in Israel and the U.S. and is focused on increasing global awareness and access to Deep TMS [3]

Financial Performance - For the year ended December 31, 2024, the company reported cash and cash equivalents of $69.6 million, an increase from $46.3 million as of December 31, 2023[520]. - The company achieved positive cash flows from operating activities of $10.3 million in 2024, compared to $1.3 million in 2023, marking an increase of $9.0 million[524]. - The net cash provided by investing activities was $30.3 million in 2024, a significant recovery from the $37.4 million used in 2023[525]. - Net cash provided by financing activities increased to $18.3 million in 2024, compared to $1.0 million used in 2023, primarily due to proceeds from a private placement[526]. - As of December 31, 2024, the company had an accumulated deficit of $98.4 million, reduced from $101.3 million in 2023[520]. - Finance income increased to $2.0 million for the year ended December 31, 2024, up from $1.0 million in 2023, primarily due to the remeasurement of warrants[517]. Capital Raising and Funding - The company raised approximately $20 million in November 2024 from a private placement, which is expected to support ongoing operations and marketing efforts[522]. - The company received grants from the IIA totaling approximately $13.4 million, with royalties paid amounting to $6.2 million as of December 31, 2024[528]. - The Valor Warrant allows for the purchase of 1,500,000 ADSs at an exercise price of $9.50686, which may be exercised if the ADS closing price exceeds the exercise price by 40%[531]. Intellectual Property and Technology - The company’s intellectual property portfolio includes 34 issued U.S. patents and 60 issued patents in other jurisdictions related to Deep TMS technology[535]. - The company owns a family of patent applications covering several H-Coils, including those used in MDD and OCD systems, with one pending patent application in the U.S. and five in other jurisdictions[549]. - The company has faced challenges in protecting its intellectual property, with potential risks related to patent applications and competition in the neuromodulation market[550]. - The company is actively involved in the commercialization of Deep TMS technology, with exclusive licenses for worldwide commercialization from PHS and Yeda[551]. Research and Development - The company has a strong focus on research and development, particularly in the field of TMS technology for treating depression, leveraging exclusive licenses from PHS and Yeda[559]. - The company expects revenue growth from the marketing of its Deep TMS system for MDD, OCD, and smoking addiction[522]. Compensation and Governance - The total compensation for all directors and officers for the year ended December 31, 2024, was approximately $4.9 million, with $3 million paid as salary[584]. - The five highest compensated officers received a total compensation ranging from $307,177 to $804,304, with the CEO Hadar Levy earning $804,304[588]. - The company has adopted a Compensation Recovery Policy to recover incentive-based compensation in case of accounting restatements[585]. - The compensation policy requires approval from the board and shareholders, with specific provisions for non-controlling shareholders[599]. - The company’s compensation committee is responsible for recommending compensation policies and reviewing their implementation every three years[644]. Board of Directors and Committees - The Board of Directors consists of eight independent directors, with terms lasting until the next annual general meeting[609]. - The audit committee consists of three members, all of whom must be independent directors, and is responsible for overseeing financial risk exposures and compliance with legal requirements[629][628]. - The company has established four standing committees: audit committee, compensation committee, nomination committee, and executive committee[621]. - The company complies with Nasdaq requirements for the composition of its audit committee and compensation committee, opting out of certain Israeli Companies Law requirements[620][625]. Employee Relations - As of December 31, 2024, the company had 120 employees, with 49 based in the United States and 71 in Israel[687]. - The company has never experienced any employment-related work stoppages and maintains a good relationship with its employees[688]. - The company provides benefits and working conditions beyond the required minimums as per employment-related laws and regulations[687].

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $11.4 million, a 27% increase year-over-year from $9 million [26] - Full year 2024 revenue reached $41 million, representing a 29% increase from $31.8 million in 2023 [27] - Gross profit for Q4 2024 was $8.5 million, maintaining a gross margin of 75%, compared to $6.7 million in the prior year [28] - Full year 2024 gross profit was $30.6 million, also at a 75% gross margin, up from $23.5 million in 2023 [28] - Net income for Q4 2024 was $1.5 million, compared to $127,000 in Q4 2023 [33] - Full year 2024 net income was approximately $2.9 million, a significant improvement from a net loss of $4.2 million in 2023 [33] Business Line Data and Key Metrics Changes - A total of 75 Deep TMS systems were shipped in Q4 2024, a 25% increase compared to the same period last year [9] - The total installed base of Deep TMS systems reached 1,353 as of December 31, 2024, up from 1,101 a year earlier [26] Market Data and Key Metrics Changes - The company is expanding its market presence across key regions including Canada, Asia, India, and Europe [11] - Anticipated revenue for full year 2025 is projected to be between $49 million and $51 million, indicating a growth of 20% to 24% over 2024 [12][34] Company Strategy and Development Direction - The company aims to solidify its market leadership by advancing the next-generation Deep TMS 360 system, conducting clinical trials, and enhancing commercial presence through targeted sales and marketing initiatives [13] - Focus on increasing sales for OCD treatment, which has a substantial potential market of approximately 400,000 patients annually [15] - Plans to expand reimbursement for PTSD treatment in Israel and explore new treatment avenues for adolescent depression [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining gross margins around 75% for 2025, with expectations for continued profitability [44] - Positive trends in treatment paradigms for MDD and OCD were noted, with expectations for increased payer coverage [52][54] - The company does not foresee significant impacts from macroeconomic changes on its operations [72] Other Important Information - The company reported a strong balance sheet with $69.4 million in cash as of December 31, 2024, including $20 million from equity financing [23][33] - Management is focused on organic growth while exploring collaborations with mental health and addiction centers [66] Q&A Session Summary Question: What were the standout drivers for the 75 placements this quarter? - Management highlighted enterprise accounts as a significant driver, along with increased demand for OCD treatment and utilization for MDD and elderly patients [38] Question: What is the latest on the accelerated treatment protocol? - The recruitment for the protocol is in the final stage, with data analysis expected to begin in Q3 2025 [41] Question: What are the expectations for gross margin in 2025? - Management expects gross margin to remain around 75% for 2025, with potential for improvement [44] Question: Are current centers increasing the use of psychedelic therapy? - There is a growing demand from psychedelic clinics to incorporate Deep TMS technology into their offerings [49] Question: What changes are seen in the treatment paradigm for MDD and OCD? - The treatment paradigm for MDD has improved, with reduced failure requirements for treatment eligibility, while OCD coverage is steadily increasing [52][54] Question: What is the plan for the next-gen TMS 360 system? - A multi-center trial for the TMS 360 system is planned for the second half of 2025, with feasibility studies for Alzheimer’s and Parkinson’s diseases also in consideration [56][57] Question: Will there be any impact from NIH funding cutbacks? - Management confirmed no current impact from NIH funding cutbacks on ongoing projects [75]

Financial Performance - Achieved record quarterly sales of $11.4 million in Q4 2024, a 27% increase compared to Q4 2023[1] - Full year 2024 revenue increased nearly 30% YoY to $41 million[1] - Operating income for the full year 2024 was $1.4 million, compared to an operating loss of $5.0 million in the prior year[5] - Net income for the full year 2024 was $2.9 million, compared to a net loss of $4.2 million in the prior year[5] - Adjusted EBITDA for the full year 2024 was approximately $4.5 million, compared to an adjusted EBITDA loss of $2.4 million for the prior year[5] - Revenues for Q4 2024 increased to $11,414,000, a 26.5% rise from $9,029,000 in Q4 2023[22] - Gross income for Q4 2024 was $8,511,000, up 26.3% from $6,739,000 in Q4 2023[22] - Operating income for the year ended December 31, 2024, was $1,391,000, compared to a loss of $4,959,000 in 2023[22] - Net income for Q4 2024 was $1,548,000, significantly higher than $127,000 in Q4 2023[22] - Adjusted EBITDA for Q4 2024 was $1,360,000, compared to $757,000 in Q4 2023, reflecting a 79.6% increase[27] Future Projections - Company expects revenue for full year 2025 to be between $49 million to $51 million, representing 20% to 24% growth over 2024 revenue[11] Cash and Financing - Increased cash and cash equivalents to $69.4 million as of December 31, 2024, compared to $10.5 million in the prior year[21] - Cash and cash equivalents at the end of Q4 2024 were $69,345,000, up from $10,520,000 at the end of Q4 2023[25] - The company raised $16,353,000 from the issuance of shares in Q4 2024, contributing to a net cash provided by financing activities of $19,585,000[25] Operating Expenses - Total operating expenses for the year ended December 31, 2024, were $29,190,000, slightly higher than $28,436,000 in 2023[22] - Research and development expenses for Q4 2024 were $2,044,000, an increase from $1,434,000 in Q4 2023[22] Product Performance - Shipped a net total of 75 Deep TMS™ systems in Q4 2024, a 25% increase from Q4 2023[5] - Completed a $20 million strategic equity financing transaction with Valor Equity Partners to expand access to Deep TMS™[5] Cash Flow - The company reported a net cash provided by operating activities of $10,230,000 for the year ended December 31, 2024, compared to $1,284,000 in 2023[24]