Brainsway(BWAY)

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Brainsway(BWAY) - 2022 Q1 - Quarterly Report
2022-03-08 16:00
[Financial and Operational Highlights](index=1&type=section&id=Recent%20Financial%20and%20Operational%20Highlights) BrainsWay reported strong 2021 financial and operational growth, including **34%** revenue increase and **20%** Deep TMS installed base expansion Full-Year 2021 Key Metrics | Metric | Value | Change vs 2020 | | :--- | :--- | :--- | | Full-Year Revenue | $29.7 million | +34% | | Q4 Revenue | $8.5 million | +20% | | Total Deep TMS Installed Base | 754 systems | +20% | | Cash and Equivalents (as of Dec 31, 2021) | $57.3 million | N/A | - Achieved final Local Coverage Determination (LCD) from a Medicare Administrative Contractor (Palmetto GBA MAC), providing Deep TMS™ coverage for OCD treatment to over **9 million** patients. This brings the total number of covered lives for OCD to approximately **60 million**[3](index=3&type=chunk)[5](index=5&type=chunk) - As of year-end 2021, the company had shipped **302** OCD coils as add-on helmets for its Deep TMS systems[3](index=3&type=chunk) - The company has demonstrated year-over-year revenue growth for **six** consecutive quarters, despite challenges from the Omicron surge[4](index=4&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) Revenue grew in Q4 and full-year 2021, but increased operating expenses led to higher losses, while an equity offering significantly strengthened cash [Fourth Quarter 2021 Financial Results](index=2&type=section&id=Fourth%20Quarter%202021%20Financial%20Results) Q4 2021 revenue increased **20%** to **$8.5 million** with stable gross margin, but operating expenses rose, leading to a higher operating loss Q4 2021 vs Q4 2020 Financials | Metric | Q4 2021 | Q4 2020 | | :--- | :--- | :--- | | Total Revenues | $8.5 million | $7.1 million | | Gross Margin | 77% | 77% | | Operating Expenses | $8.0 million | $5.9 million | | Operating Loss | $1.5 million | $0.4 million | [Full-Year 2021 Financial Results](index=2&type=section&id=Financial%20Results%20for%20the%20Full-Year%20Ended%20December%2031%2C%202021) Full-year 2021 revenue grew **34%** to **$29.7 million**, with positive cash from operations, despite a widened net loss, and a **$57.3 million** cash balance from an equity offering Full-Year 2021 vs 2020 Financials | Metric | FY 2021 | FY 2020 | | :--- | :--- | :--- | | Total Revenue | $29.7 million | $22.1 million | | Cash from Operations | $0.9 million | ($1.4 million) | | Net Loss | $6.5 million | $5.4 million | | Cash & Equivalents (Year-End) | $57.3 million | $17.2 million | [Financial Statements](index=5&type=section&id=Financial%20Statements) Financial statements reflect increased assets and equity from an offering, strong revenue growth offset by higher expenses leading to a larger net loss, and positive cash from operations [Consolidated Statements of Financial Position](index=5&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20FINANCIAL%20POSITION) Total assets more than doubled to **$75.7 million** by year-end 2021, driven by increased cash and a substantial rise in total equity to **$57.3 million** due to an equity offering Balance Sheet Highlights (in thousands USD) | Account | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | **$75,732** | **$34,011** | | Cash, cash equivalents & short-term deposits | $57,349 | $17,182 | | **Total Liabilities** | **$18,408** | **$14,377** | | **Total Equity** | **$57,324** | **$19,634** | [Consolidated Statements of Comprehensive Loss](index=6&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20LOSS) Full-year 2021 revenue increased **34%** to **$29.7 million**, but rising operating expenses led to a widened net loss of **$6.5 million**, or **($0.21)** per share Income Statement Summary (in thousands USD, except per share data) | Metric | Full-Year 2021 | Full-Year 2020 | Q4 2021 | Q4 2020 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $29,657 | $22,057 | $8,470 | $7,066 | | Gross Profit | $23,058 | $16,999 | $6,564 | $5,500 | | Operating Loss | ($4,999) | ($4,829) | ($1,452) | ($407) | | Net Loss | ($6,462) | ($5,385) | ($1,347) | ($406) | | Basic and Diluted Net Loss per Share | ($0.21) | ($0.24) | ($0.04) | ($0.02) | [Consolidated Statements of Cash Flows](index=7&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) In 2021, cash from operations turned positive at **$0.9 million**, while investing activities used **$42.2 million**, and financing activities provided **$41.5 million** from a share issuance Cash Flow Summary (in thousands USD) | Cash Flow Activity | Full-Year 2021 | Full-Year 2020 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $884 | ($1,436) | | Net cash used in investing activities | ($42,216) | ($2,465) | | Net cash provided by (used in) financing activities | $41,516 | ($1,030) | | **Cash and cash equivalents at end of year** | **$16,921** | **$16,961** | [Company Overview and Forward-Looking Statements](index=3&type=section&id=About%20BrainsWay) BrainsWay, a leader in Deep TMS™, holds three FDA-cleared indications, but faces future risks including market acceptance, regulatory approvals, competition, and reimbursement challenges - BrainsWay is the only TMS company with **three** FDA-cleared indications backed by pivotal studies: major depressive disorder (including anxious depression), obsessive-compulsive disorder, and smoking addiction[11](index=11&type=chunk) - The company is conducting additional clinical trials to expand the use of Deep TMS for other psychiatric, neurological, and addiction disorders[11](index=11&type=chunk) - Key risks include changes in technology, delays in clinical trials, failure to obtain regulatory approvals, competition, and inadequate reimbursement from third-party payers[12](index=12&type=chunk) [Conference Call and Webcast Information](index=2&type=section&id=Conference%20Call%20and%20Webcast) BrainsWay management will host a conference call and webcast on **Wednesday, March 9, 2022, at 8:30 AM Eastern Time**, to discuss Q4 and full-year 2021 results - Event: Discussion of Q4 and Full-Year 2021 Results[8](index=8&type=chunk) - Date and Time: **Wednesday, March 9, 2022, at 8:30 AM Eastern Time**[8](index=8&type=chunk)[9](index=9&type=chunk) - Access: Available via webcast at the company's investor relations website or by phone using Conference ID **13727217**[9](index=9&type=chunk)[10](index=10&type=chunk)
Brainsway(BWAY) - 2021 Q3 - Earnings Call Transcript
2021-11-17 17:41
BrainsWay Ltd. (NASDAQ:BWAY) Q3 2021 Earnings Conference Call November 17, 2021 8:30 AM ET Company Participants Bob Yedid - LifeSci Advisors, IR Christopher von Jako - President and CEO Scott Areglado - Chief Financial Officer Conference Call Participants Steven Lichtman - Oppenheimer Destiny Hance - Ladenburg Thalmann Jayson Bedford - Raymond James Boobalan Pachaiyappan - H.C. Wainwright Operator Greetings and welcome to the BrainsWay Third Quarter 2021 Earnings Conference Call. At this time, all participa ...
Brainsway(BWAY) - 2021 Q3 - Earnings Call Presentation
2021-11-17 17:10
Elevating Mental Health Treatments November 2021 Nasdaq/TASE: BWAY Disclaimer Safe Harbor and Non-GAAP Financial Measures This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company's securities or to participate in any investment in the Company. No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessment of the matters containe ...
Brainsway(BWAY) - 2021 Q3 - Quarterly Report
2021-11-16 16:00
Exhibit 99.1 BRAINSWAY LTD. 19 Hartum Street, Bynet Building, 3rd Floor Har HaHotzvim, Jerusalem 9777518 Israel NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on December 22, 2021 The Annual General Meeting of Shareholders of BrainsWay Ltd. (the "Company"), will be held at the offices of the Company, 19 Hartum Street, Bynet Building, 3rd Fl, Har HaHotzvim, Jerusalem, Israel on December 22, 2021 at 3:00 p.m. Israel time, or at any adjournments thereof (the "Annual Meeting"), for the following pu ...
Brainsway (BWAY ) Investor Presentation - Slideshow
2021-09-17 19:59
Elevating Mental Health Treatments Christopher von Jako, PhD September 2021 Nasdaq/TASE: BWAY Disclaimer Safe Harbor and Non-GAAP Financial Measures This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company's securities or to participate in any investment in the Company. No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessm ...
Brainsway(BWAY) - 2021 Q2 - Earnings Call Transcript
2021-08-11 16:54
BrainsWay Ltd. (NASDAQ:BWAY) Q2 2021 Earnings Conference Call August 11, 2021 8:30 AM ET Company Participants Brian Ritchie - LifeSci Advisors, IR Christopher von Jako - President and CEO Scott Areglado - Chief Financial Officer Conference Call Participants Jayson Bedford - Raymond James Steven Lichtman - Oppenheimer Jeffrey Cohen - Ladenburg Thalmann Jason Wittes - Northland Ram Selvaraju - H.C. Wainwright Operator Greetings. Welcome to the BrainsWay Second Quarter 2021 Earnings Conference Call. At this ti ...
Brainsway(BWAY) - 2021 Q2 - Earnings Call Presentation
2021-08-11 16:03
Boldly Advancing Neuroscience August 2021 Nasdaq/TASE: BWAY Disclaimer Safe Harbor and Non-GAAP Financial Measures This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company's securities or to participate in any investment in the Company. No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessment of the matters contained herei ...
Brainsway(BWAY) - 2021 Q1 - Earnings Call Transcript
2021-05-20 15:38
BrainsWay Ltd. (NASDAQ:BWAY) Q1 2021 Earnings Conference Call May 20, 2021 8:30 AM ET Company Participants Bob Yedid - LifeSci Advisors, LLC Chris von Jako - President & Chief Executive Officer Scott Areglado - Chief Financial Officer Conference Call Participants Steven Lichtman - Oppenheimer Jeffrey Cohen - Ladenburg Thalmann Kyle Mikson - Cantor Fitzgerald Jason Wittes - Northland Capital Markets Operator Greetings, and welcome to the BrainsWay First Quarter 2021 Earnings Conference Call. At this time, al ...
Brainsway(BWAY) - 2020 Q4 - Annual Report
2021-04-18 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR For the transition period from _____ to ______ ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) ...
Brainsway(BWAY) - 2020 Q4 - Earnings Call Transcript
2021-03-25 17:54
Financial Data and Key Metrics Changes - BrainsWay achieved record quarterly revenues of $7.1 million in Q4 2020, a 17% increase from Q3 2020 and a 12% increase from Q4 2019 [9][29] - Full year 2020 revenue was $22.1 million, down 5% compared to 2019, primarily due to the pandemic's impact on customer operations [29] - Gross profit for Q4 2020 was $5.5 million, with a gross margin of 78%, compared to 77% in Q4 2019 [30] - The company reported a net loss of $267,000 in Q4 2020, an improvement from a net loss of $1.7 million in Q4 2019 [33] Business Line Data and Key Metrics Changes - The install base of Deep TMS systems increased to 629 by the end of 2020, reflecting a 19% increase from the end of 2019 [30] - Recurring revenue for Q4 2020 was $3.4 million, consistent with Q4 2019 [29] - The company plans to expand its sales force from 13 to 18 territories, a nearly 40% increase, to enhance market penetration [20] Market Data and Key Metrics Changes - Over 60 commercial insurers and all seven MACs provided nationwide Medicare coverage for Deep TMS for depression by the end of 2020, covering over 275 million lives [19] - The pandemic has led to an increase in depression and OCD trends, with one in three adults affected by pandemic-related anxiety [12][13] Company Strategy and Development Direction - The company intends to utilize proceeds from a recent financing to expand its sales force and invest in commercialization and marketing initiatives [10] - BrainsWay is focused on securing reimbursement for OCD treatments and expanding its digital marketing strategy [15][23] - The introduction of Deep TMS for smoking addiction represents a new commercial offering, with initial treatments already underway [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism for steady business progression in 2021, anticipating better performance in the second half of the year [12][37] - The company is monitoring the ongoing impact of the pandemic on operations and expects to see increased patient treatment volumes as conditions stabilize [11][12] Other Important Information - The company has a strong balance sheet with cash and equivalents of $17.2 million as of December 31, 2020, not including $41.9 million in net proceeds from a follow-on offering closed in March 2021 [34] - BrainsWay's Deep TMS system has been the subject of 32 completed randomized control clinical trials, more than any other company in the field [26] Q&A Session Summary Question: Can you comment on first half trends? - Management indicated that first half trends are similar to Q4 2020, with expectations for continued progression as COVID-19 conditions improve [37] Question: How many systems sold in Q4 went to existing users versus new customers? - Approximately 40% of the 36 systems sold went to existing customers, with the remaining 60% to new customers [39] Question: What is the confidence level regarding OCD reimbursement? - Management expressed improved confidence due to positive meetings with payers and the complexity of OCD treatment options [40] Question: What are the expectations for operating expenses in 2021? - Operating expenses are expected to increase, particularly in sales and marketing, but not dramatically compared to 2020 [43] Question: Can you provide insights on lease versus purchase trends? - The company expects lease versus purchase trends to remain stable, with a preference for leasing among customers [62] Question: What is the outlook for the smoking cessation program? - The rollout of the smoking cessation program is expected to be gradual, with a focus on data collection and market understanding [75] Question: What are the plans for new indications? - Management indicated plans to launch new studies for potential indications later in the year, including addiction and neurological conditions [77]