Brainsway(BWAY)

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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]
Brainsway(BWAY) - 2020 Q3 - Earnings Call Transcript
2020-11-18 17:37
Brainsway Ltd. (NASDAQ:BWAY) Q3 2020 Earnings Conference Call November 18, 2020 8:30 AM ET Company Participants Bob Yedid - LifeSci Advisors, Investor Relations Chris von Jako - President & Chief Executive Officer Judy Huber - Chief Financial Officer Conference Call Participants Steven Lichtman - Oppenheimer Jayson Bedford - Raymond James Jeffrey Cohen - Labenberg Kyle Mixon - Cantor Fitzgerald Operator Greetings, and welcome to the Brainsway Third Quarter 2020 Earnings Conference Call. At this time, all pa ...
Brainsway(BWAY) - 2020 Q2 - Earnings Call Transcript
2020-08-12 21:09
BrainsWay Ltd. (NASDAQ:BWAY) Q2 2020 Earnings Conference Call August 12, 2020 8:30 AM ET Company Participants Bob Yedid - LifeSci Advisors, Investor Relations Christopher von Jako - President & Chief Executive Officer Judy Huber - Chief Financial Officer Conference Call Participants Jeffery Cohen - Ladenburg Thalmann Jayson Bedford - Raymond James Steven Lichtman - Oppenheimer & Co. Kyle Mixon - Cantor Fitzgerald Operator Greetings. Welcome to BrainsWay Second Quarter 2020 Earnings Conference Call. At this ...
Brainsway(BWAY) - 2020 Q1 - Earnings Call Transcript
2020-06-25 11:24
BrainsWay Ltd. (NASDAQ:BWAY) Q1 2020 Earnings Conference Call June 24, 2020 8:30 AM ET Company Participants Bob Yedid - MD, LifeSci Advisors, IR Christopher von Jako - President and CEO Judy Huber - Chief Financial Officer Conference Call Participants Jayson Bedford - Raymond James Steven Lichtman - Oppenheimer & Co. Jeffery Cohen - Ladenburg Thalmann Operator Welcome, ladies and gentlemen, thank you for standing by. And welcome to the BrainsWay Reports First Quarter 2020 financial results and operational h ...
Brainsway(BWAY) - 2019 Q4 - Earnings Call Transcript
2020-03-23 17:34
Call Start: 08:30 January 1, 0000 9:05 AM ET Brainsway Ltd. (NASDAQ:BWAY) Q4 2019 Earnings Conference Call March 23, 2020 08:30 AM ET Company Participants Bob Yedid - LifeSci Advisors Christopher von Jako - CEO Hadar Levy - COO and CFO Conference Call Participants Craig Bijou - Cantor Fitzgerald Jayson Bedford - Raymond James & Associates, Inc. Steven Lichtman - Oppenheimer & Co. Inc. Jeffery Cohen - Ladenburg Thalmann Operator Ladies and gentlemen, thank you for standing by and welcome to the Brainsway Rep ...
Brainsway(BWAY) - 2019 Q4 - Annual Report
2020-03-23 12:02
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, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of ...
Brainsway(BWAY) - 2019 Q3 - Earnings Call Transcript
2019-11-25 16:10
Financial Data and Key Metrics Changes - The company reported record quarterly revenue of $5.9 million, a 38% increase compared to Q3 2018 [14][20] - Recurring revenues reached $3.4 million, reflecting a 40% increase year-over-year [14][20] - Gross profit for Q3 2019 was $4.8 million, up 43% from $3.4 million in Q3 2018, with a gross margin of 81%, an increase from 78% in the prior year [20][22] Business Line Data and Key Metrics Changes - The installed base of Deep TMS systems increased by 138 units to a total of 488 systems, with a quarter-over-quarter increase of 32 systems [15] - The company shipped 132 OCD coils since obtaining marketing clearance in August 2018, with demand exceeding supply in Q3 [15][22] Market Data and Key Metrics Changes - The company entered exclusive distribution agreements in Taiwan, the Philippines, South Korea, and Thailand, expected to contribute to results in Q4 and beyond [19] - The U.S. market remains a primary focus, with strong demand anticipated for the Deep TMS system [24] Company Strategy and Development Direction - The company is focused on expanding its sales force and enhancing marketing activities globally, with plans to add two new sales reps in Q4 [16] - A robust clinical pipeline is in place, with ongoing studies in smoking cessation, PTSD, and opioid abuse, alongside efforts to develop new technologies [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong market demand for the Deep TMS system, with a positive outlook for Q4 and 2020 [24] - The company is actively pursuing reimbursement for OCD therapy in the U.S., which is expected to enhance growth opportunities [28][35] Other Important Information - The company ended Q3 with cash and cash equivalents of $23.9 million, down from $27.6 million at the end of Q2 2019, indicating a strong balance sheet to support growth initiatives [23][24] Q&A Session Summary Question: Sales disruption due to leadership changes - Management reported no disruption in sales due to recent leadership changes, stating business continued as usual [27] Question: Demand for OCD coils and reimbursement progress - Management acknowledged a seasonal decrease in demand for OCD coils but expects stronger demand in Q4, with ongoing efforts for reimbursement [28] Question: Growth expectations for business components in 2020 - Management indicated that the leasing model will remain the primary focus, with confidence in growth opportunities, especially with potential reimbursement for OCD [29] Question: Manufacturing issues affecting OCD orders - Management clarified that the decrease in orders was due to seasonality rather than manufacturing issues, with expectations for a ramp-up in Q4 [33] Question: Revenue opportunities in Asia - Management highlighted the significant market opportunity in Japan, with a leasing model expected to be used, pending reimbursement [39] Question: Timing of smoking cessation study results - Management confirmed results are expected to be published in the coming weeks as a press release [40] Question: Sales force efficiency and account management - Management stated that the current sales force is sufficient to cover key U.S. markets, with plans to add a few more reps [42] Question: Utilization trends and geographical strength - Management reported strong utilization rates, particularly in major U.S. hubs like California, New York, and Texas, which are expected to drive growth [46] Question: Trends in leasing versus purchasing for MDD - Management expects the leasing model to continue being favored, with some hospitals still opting for outright purchases [47]
Brainsway(BWAY) - 2019 Q2 - Earnings Call Transcript
2019-08-26 17:45
Financial Data and Key Metrics Changes - The company reported record revenue of $5.7 million for Q2 2019, a robust increase of 53% compared to Q2 2018 [10][24] - Recurring revenue increased by 43% year-over-year, accounting for over 57% of total revenues [10][24] - Gross profit for Q2 2019 was $4.3 million, with a gross margin of 76%, slightly down from 77% in Q2 2018 [26] Business Line Data and Key Metrics Changes - The company installed 40 Deep TMS systems during the quarter and shipped 30 OCD coils, totaling 115 OCD coils shipped since receiving FDA marketing clearance [9][25] - The active installed base increased to 456 Deep TMS systems, reflecting a growth of 40 systems from the previous quarter [25] Market Data and Key Metrics Changes - There are approximately 16 million adults in the U.S. suffering from Major Depressive Disorder (MDD), with over 3 million not achieving remission after multiple antidepressant treatments [7] - The company estimates around 400,000 adults with Obsessive-Compulsive Disorder (OCD) are treatment-resistant and seeking alternatives [8] Company Strategy and Development Direction - The company aims to accelerate growth by expanding its sales force and enhancing marketing activities globally [12] - Plans to build clinical evidence for Deep TMS through key publications and studies are underway, with significant results published in reputable journals [13][15] - The company is expanding into additional territories, including exclusive distribution agreements in Taiwan and the Philippines, and has received regulatory clearance in Japan [17] Management's Comments on Operating Environment and Future Outlook - Management expressed strong confidence in business growth and highlighted the importance of insurance coverage for OCD therapy as a key growth driver [10][36] - The company is optimistic about the potential for OCD treatment and is actively working on reimbursement processes [36] Other Important Information - The company completed a successful NASDAQ IPO with gross proceeds of over $30 million [8] - Total operating expenses for Q2 2019 were $7 million, up from $3.9 million in Q2 2018, primarily due to investments in growth [29] Q&A Session Summary Question: Expectations for revenue in the second half - Management refrained from providing specific revenue guidance but noted the visibility from lease agreements and growth in additional territories [34][35] Question: Utilization of OCD systems - The company indicated that initial revenue from OCD systems is limited, with significant growth expected upon receiving insurance reimbursements [36] Question: Transition after the departure of the Head of Sales - Management assured that a strong team is in place to handle the transition smoothly and plans to expand the sales team [37] Question: Details on OCD coil sales - Approximately 50% of the 30 additional OCD coils sold were to new customers, with reimbursement being a major factor for clinics not ordering [39] Question: Features of the new stimulator - The new stimulator has been launched in the U.S. and is expected to enhance technical capabilities, with plans for further features linked to EEG [40] Question: Impact of Japan on revenue - Management does not expect a practical revenue impact from Japan in 2019, with a launch anticipated towards the end of the year [50]