midastouch017
2年前
Publication Analyzes Clinical Efficacy of Deep TMS™ in Treating Different Brain Regions Associated with Major Depressive Disorder
https://finance.yahoo.com/news/publication-analyzes-clinical-efficacy-deep-130000866.html
Study Results Outline a Potential Path to More Personalized Medicine in Noninvasive Brain Stimulation
BURLINGTON, Mass. and JERUSALEM, Jan. 31, 2023 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced the publication of a comparative study of BrainsWay’s Deep Transcranial Stimulation (Deep TMS™) H1 Coil, which targets the lateral prefrontal cortex, and the Company’s H7 Coil, which targets the medial prefrontal cortex. Published in The Journal of Clinical Investigation (JCI) Insight, the study, which enrolled 169 treatment-resistant depression patients, validates the efficacy of both BrainsWay coils for depression, and also identifies preliminary predictors that could help optimize treatment based on individual patients’ attributes.
The primary endpoint of the study – non-inferiority of the H7 Coil in reducing depressive scores when compared to the H1 Coil – was successfully demonstrated among the overall patient population. This study served as the basis for BrainsWay’s August 2022 H7 Coil FDA clearance for depression. This publication of the study also includes a new retrospective analysis of the clinician rating scales and EEG data, revealing intriguing differences between the patient treatment of the two coils. Categorizing patients according to “clusters” of clinical depressive and anxiety baseline symptoms derived from a subset of the Hamilton Depression Rating Scale (HDRS-21) resulted in two subject groups: One with higher severity of the cluster, which on average responded better to the H1 Coil, and another with lower severity of the cluster, which on average responded better to the H7 Coil. This retrospective analysis was referred to in the publication as the “Clinical Differential Predictor” for TMS H-Coils.
Another interesting finding involved retrospective EEG analysis, which showed that brain activity measured during the first treatment session correlated with the clinical outcomes ultimately achieved after the full course of treatment. This finding suggests that specific brain patterns observed in an individual’s response to either coil during the early stages of treatment might be predictive of the longer-term outcome of treatment with that coil.
“This study is a significant milestone for depression and anxious depression patients and reinforces our commitment to bring mental health within reach for all,” said Christopher von Jako, Ph.D., President and CEO of BrainsWay.
“This study is an important scientific step forward toward personalized psychiatry,” said Prof. Abraham Zangen, Head of the Brain Stimulation and Behavior Lab and the Chair of the PsychoBiology Brain Program at Ben-Gurion University and a scientific consultant for and member of the board of directors of BrainsWay. “Previously published case series had indicated that the H7 Coil was potentially effective in treating depression in patients that did not achieve response or remission after undergoing treatment with TMS coils which target the lateral prefrontal cortex. While the similar reduction in depression scores notably validated the non-inferiority between the H1 and H7 Coils, we were truly inspired by the subsequent retrospective analyses of the clinician rating scales and EEG data. Once we apply the categorization technique employed in this study, the potential exists to increase depression response rates even further. For example, patients categorized as having high cluster severity demonstrated response rates of 95%. We look forward to further validating these preliminary predictors in subsequent research as we continue our quest to optimize patient outcomes.”
The paper, “Pursuing personalized medicine for depression by targeting lateral or medial prefrontal cortex with Deep TMS,” was published in The Journal of Clinical Investigation (JCI) Insight. For more information, please visit: https://insight.jci.org/articles/view/165271
About Major Depressive Disorder and Anxious Depression
Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 21 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep, and changes in appetite. 60-90% of depression patients also exhibit comorbid moderate to severe anxiety, a condition commonly referred to as anxious depression. These anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the recent COVID pandemic.
About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
Forward-Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.
Contacts:
Scott Areglado
SVP and Chief Financial Officer
617-771-2287
SAreglado@BrainsWay.com
Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com
Media Contact:
Meghan Laska
(610) 212-0125
Meghan.Laska@BrainsWay.com
midastouch017
2年前
BrainsWay Announces Significant Private Insurance Coverage from Cigna Corporation for the Treatment of OCD Utilizing Deep TMS™
https://finance.yahoo.com/news/brainsway-announces-significant-private-insurance-113000484.html
Cigna® Issues Favorable Policy for Deep TMS to Address Medication-Resistant Obsessive-Compulsive Disorder
BURLINGTON, Mass. and JERUSALEM, Israel, Sept. 14, 2022 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that Cigna Corporation has announced positive coverage applicable to Deep Transcranial Magnetic Stimulation (TMS) for the treatment of obsessive-compulsive disorder (OCD). Cigna, one of the largest major medical insurance company in the United States, provides commercial health coverage to about 17 million members in 13 states, has Medicare Advantage plans in 16 states, and participates in the Health Insurance Marketplace© online exchange. With this new policy, Cigna joins the ranks of Centene, Highmark, Health Care Services Corporation, Blue Cross Blue Shield, Tricare, and Palmetto GBA Medicare, resulting in over 86 million adults now having access to BrainsWay’s pioneering Deep TMS™ OCD treatment.
“The establishment of this positive coverage for OCD further facilitates BrainsWay’s ability to capitalize on its leadership role in advancing treatment of this debilitating condition,” said Christopher von Jako, PhD, President and Chief Executive Officer of BrainsWay. “More importantly, the continued reimbursement momentum for Deep TMS is resulting in increased access of our unique therapy that is critical to our mission of improving the health and transforming the lives of those suffering from disorders with limited treatment options.”
Cigna will be issuing an updated revision to its TMS medical coverage policy effective September 15, 2022 extending coverage to patients aged 18 and older diagnosed with OCD. Under the revised policy, an initial 30-36 TMS treatment session regimen will be classified as medically necessary after a failure of two or more medication trials and a trial of evidence-based psychotherapy without significant improvement in symptoms. Patients with 30% or greater improvement in their Yale-Brown Obsessive Compulsive Scale (Y-BOCS) maintained for at least two months would also be candidates for an additional regimen of 30-36 sessions.
“This achievement is a further acknowledgement of the substantial efforts contributed by the principal investigators in the pilot and pivotal trials of Deep TMS, the clinicians in the field today treating OCD patients, and BrainsWay’s partners dedicated to expanding access and awareness to this life-changing treatment,” said Aron Tendler, MD, Chief Medical Officer of BrainsWay. “OCD is a difficult to treat disease, and almost half of the patients with OCD are treatment-resistant. BrainsWay continues to be a trailblazer in the field, and remains the only TMS company to have demonstrated clinical efficacy in treating OCD through randomized, placebo-controlled data.”
BrainsWay’s patented H7 Coil is designed to penetrate deeper and broader structures of the brain associated with OCD. The Company’s Deep TMS system received De Novo clearance from the U.S. Food and Drug Administration (FDA) for the treatment of OCD in late 2018 and was launched for full market release in 2019. As of June 30, 2022, 368 OCD coils had been shipped as add-on helmets to accompany BrainsWay platform systems. Approximately 45% of all BrainsWay systems in the field have an H7 Coil.
“The economic burden on the U.S. healthcare system for OCD treatments is over $10.6 billion per year, and we are excited that Cigna’s medical and behavioral health leadership has recognized the value we can offer these patients,” said Scott Blackman, Director of Market Access at BrainsWay. “This positive coverage decision supplements the growing body of compelling clinical evidence supporting the treatment of OCD with our Deep TMS H7 Coil.”
About Obsessive-Compulsive Disorder
Obsessive-compulsive disorder (OCD) is a chronic and debilitating condition with a lifetime prevalence in the United States of 2.3%. Characterized by uncontrollable, reoccurring thoughts (obsessions) and behaviors (compulsions) that the sufferer feels compelled to repeat over and over, OCD is considered by the World Health Organization (WHO) to be one of the top 10 debilitating medical conditions associated with a decreased quality of life and loss of income. Due to the complexity and heterogeneity of the condition, coupled with the high percentage of patients that are drug-resistant, many patients suffering from OCD do not respond well to first line treatment options. The economic burden on the U.S. healthcare system for OCD treatments is estimated to be over $10.6 billion per year.
About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
Forward Looking 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. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.
Contacts:
BrainsWay:
Scott Areglado
SVP and Chief Financial Officer
Scott.Areglado@BrainsWay.com
Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com
Media Contact:
Meghan Laska
(610) 212-0125
Meghan.Laska@BrainsWay.com
midastouch017
2年前
BrainsWay Receives New FDA Clearance for Treating Depression and Anxious Depression
https://finance.yahoo.com/news/brainsway-receives-fda-clearance-treating-120000993.html
Depression Clearance for the Proprietary Deep TMS™ H7 Coil Represents the Company’s 9th FDA Clearance
BURLINGTON, Mass. and JERUSALEM, Aug. 29, 2022 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s Deep TMS™ H7 Coil for its use in treating adults suffering from major depressive disorder and depression including those with comorbid anxiety symptoms commonly known as anxious depression.
“This clearance is a significant milestone in BrainsWay’s pursuit of refining and optimizing noninvasive options for treatment-resistant mental health conditions,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Clinicians are accustomed to having myriad pharmaceutical options to tailor treatment plans for their patients, and expanding depression clearance to the Deep TMS H7 Coil provides them with another powerful non-pharmaceutical tool. Similar to most medical interventions, TMS treatment for depression is not a one-size-fits-all solution with respect to all anatomical targets: The H1 Coil targets one region of the brain and the H7 Coil targets a different region, and we now see that stimulating either of these regions can mitigate depressive symptoms. We believe that this clearance may advance our goal of enabling clinicians to provide more personalized medicine for their patients depending upon what works best for them.”
The FDA’s grant of clearance was based on its review of successful results from a randomized, double-blind, controlled multicenter trial completed by the Company. The trial was designed to better understand the H7 Coil’s efficacy in addressing treatment-resistant depression. The study, which included 144 subjects, found overall efficacy rates for the H7 Coil which were comparable to those achieved with BrainsWay’s H1 Coil.
“This study was originally conducted after receiving feedback from Deep TMS practitioners in the field which indicated that certain depressed patients not responding to treatment with the H1 Coil would sometimes see success when switched over to the H7 Coil,” said Dr. Aron Tendler, BrainsWay’s Chief Medical Officer. “Now we have high-quality randomized study data which validates this observation scientifically.”
With this new clearance, there is no need to upgrade or add software to systems currently installed in the field. BrainsWay’s Deep TMS H7 Coil, which is housed within a cushioned, cooled helmet, has been cleared to treat obsessive-compulsive disorder since 2018. It can now be put to use against depression. The H7 Coil is designed to allow for stimulation of deeper and broader brain structures than traditional TMS coils.
BrainsWay will be implementing a training program in the coming months to educate customers on using the Deep TMS H7 Coil to treat depression within the new FDA clearance.
“This latest clearance, our ninth from the FDA, is a testament to BrainsWay’s unparalleled commitment to take on ambitious research projects that continue to advance the field. This research further cements BrainsWay’s leadership position in the field and exemplifies its relentless dedication to the improved health and transformed lives of its growing patient base,” said Dr. von Jako.
About Major Depressive Disorder and Anxious Depression
Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 21 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep, and changes in appetite. 60-90% of depression patients also exhibit comorbid moderate to severe anxiety, a condition commonly referred to as anxious depression. These anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the recent COVID pandemic.
About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
Forward-Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.
Contacts:
Scott Areglado
SVP and Chief Financial Officer
617-771-2287
SAreglado@BrainsWay.com
Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com
Media Contact:
Meghan Laska
(610) 212-0125
Meghan.Laska@BrainsWay.com
midastouch017
3年前
BrainsWay Ltd.'s (BWAY) CEO Christopher von Jako on Q2 2021 Results - Earnings Call Transcript
Aug. 11, 2021 12:54 PM ETBrainsWay Ltd. (BWAY), BRSYF
BrainsWay Ltd. (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 time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]
Please note, this conference is being recorded. I will now turn the conference over to your host, Brian Ritchie with LifeSci Advisors. You may begin.
Brian Ritchie
Thank you, all. And welcome to BrainsWay’s second quarter 2021 earnings conference call. With us today are BrainsWay’s President and Chief Executive Officer, Christopher von Jako; and Chief Financial Officer, Scott Areglado.
The format for today’s call will be a discussion of second first quarter trends and business updates from Chris, followed by a detailed discussion of the financials from Scott. Then we will open up the call for your questions. Earlier this morning, BrainsWay released financial results for the three months and six months ended June 30, 2021. A copy of the press release is available on the company’s Investor Relations website.
Before I turn the call over to Chris and Scott, I’d 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 topic BrainsWay’s anticipated future operating and financial performance, business plans and prospects and expectations for its products and pipelines, which are all subject to risks and uncertainties, including shifting market conditions resulting from the COVID-19 pandemic, as well as the use of non-GAAP financial information.
Additional information regarding these risks are available in the company’s earnings released and in its other filings with the SEC, including the Risk Factors section contained in BrainsWay’s Form 20-F.
I would now like to turn the call over to Chris.
Christopher von Jako
Thank you, Brian, and welcome, everyone, and thank you for joining us today. We are extremely pleased with our strong performance in the second quarter. We expect that the current operating trends in our business and our most recent achievements, especially on the reimbursement front will continue to drive further growth and momentum for BrainsWay. I’ll discuss all of this further shortly, but first, I will provide a brief overview of our key second quarter financial results.
We achieve $7 million in revenue for the second quarter of 2021, which represents a significant 45% increase over our second quarter 2020 and demonstrate the continued resiliency of our business through the pandemic. We have now demonstrated a strong year-over-year growth in multiple consecutive quarters and believe the progress we have achieved during this period is sustainable throughout 2021.
Importantly, the operating environment continues to improve as we learn to cope with the pandemic. That said, in light with a recent spread of the Delta variant we will, of course, continue to closely monitor the situation and work to adapt appropriately.
I noted on our last call that patient treatments with Deep TMS were continued to increase since the end of 2020. I’m pleased to report that this is once again the case in the second quarter. As I’ve mentioned in prior quarters, mental health issues continue to rise dramatically as we all live for the impacts of the pandemic. As a result, we have all seen an increase in the prominence of mental health in the media. Moreover, these issues are affecting those at younger ages that historically been the case.
According to a recent article published by the Washington Post, the pandemic has negatively impacted college students’ mental health during a year of remote schooling and increased isolation. The article focuses on how a lack of human connection and in-person support has led to an increased stress, anxiety and feelings of hopelessness for students across the U.S.
As more younger individuals are seeking treatment for mental health, raising awareness around newer treatment methods like Deep TMS has become critical as they reach adulthood. As such, we continue to ramp up our patient awareness initiatives.
During the second quarter we hosted six well attended webinars. We have a number of additional webinars throughout the third quarter, including one we’re particularly excited about, which will be led by a Deep TMS patient who has benefited tremendously from our technology.
We also continue to leverage our website to educate prospective patients on the benefits of Deep TMS. In continuation of recent trends, we are pleased to report that our organic website traffic has again increased significantly, up over 210% in the first half of 2012, as compared to the first half of last year. We continue to add fresh content, enhance the user experience on our website.
Moreover, on My BrainsWay, our customer portal, we have streamlined navigation and improve the content, including robust insurance, reimbursement and policy information. Thus enabling our customers to have the information they need at the click of a mouse.
I will now briefly review the patient awareness campaign we initiated in May around Mental Health Awareness Month. The goal of this initiative was to reach any patient seeking an alternative to traditional medical management of their mental health.
We conducted a social media follower campaign, utilizing micro-to-mid tier influences to create content in line with BrainsWay broader message on mental health awareness and the utility of Deep TMS. The campaign resulted in BrainsWay securing hundreds of new followers, including increases of 91% on Facebook and 25% on Instagram.
The Mental Health Awareness initiative in May was part of our ongoing large scale Digital Patient Awareness Campaign. While still in the initial phases of this campaign, our patient inquiries have grown by nearly 300% in June and July.
As pleased as we are with the success of our collective digital efforts, we all know that there is no substitute for in-person interactions. In this regard, I’m pleased to report that our sales professionals in-person access to customers has increased steadily from the first quarter to the second quarter.
Likewise, we return to live in-person conferences with our participation at the June 2021 Annual Clinical TMS Society Meeting, an important medical meeting in our space. We had a significant presence at this meeting, including presentations by Professor Abraham Zangen, a co-developer of our Deep TMS technology; and by Dr. Aron Tendler, our Chief Medical Officer.
The event also featured 11 poster presentations, highlighting important research done on Deep TMS, which represented 25% of all posters displayed at the meeting. The meeting also included two showcase presentations. The first focused on the impressive body of evidence behind Deep TMS treatments for OCD, an important driver behind our recent favorable OCD coverage decisions.
The second presentation was delivered by Dr. Shan Siddiqi of the Brigham and Women’s Hospital in Boston, whose lab is dedicated to research on brain circuitry. His presentation focus on how BrainsWay’s three commercially available helmets are specifically designed to broadly engage various anatomical and functional brain circuits.
Looking ahead, we are scheduled to participate in four additional in-person industry conference over the balance of the year and we are hopeful that the COVID environment will allow these events to proceed as planned.
I will now turn to Deep TMS for the treatment of OCD. During the second quarter we shipped 22 add-on helmets, increasing the total number to 247. This represents over one-third of our total install base that have opted to offer OCD treatment, which we view is a testament to the strong belief the benefits of Deep TMS treatment for OCD.
I’m very excited to discuss with you today the critical progress we’ve achieved around OCD reimbursement in the second quarter, which represents an important step in our plan to further expand our market penetration in this key indication.
First, Centene, one of the largest healthcare plans in the U.S. published a positive coverage policy for Deep TMS in this indication. Importantly, the establishment of this policy was the first of its kind in the treatment of OCD.
Centene provides coverage to about 25 million members in all 50 states, including Medicaid and Medicare members, as well as to individuals and families served by health insurance marketplace, the TRICARE Program and Commercial Insurance.
Centene’s new policy specifies the coverage will be exclusive for the treatment of OCD who has Deep TMS. This decision fall at Centene’s review of an extensive body of published clinical evidence demonstrating the safety and efficacy of Deep TMS treatment for OCD.
Following this, we announced the first draft Medicare Local Coverage Determination or LCD was published proposing coverage applicable to Deep TMS system for the treatment of OCD. The draft LCD was issued by Palmetto, a Medicare Administrative Contractor or MAC, whose jurisdiction covers Medicare members in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia and West Virginia, representing over 9 million covered lives. A final policy is expected later this year.
Most recently, Health Care Services Corporation or HCSC, an independent licensee of Blue Cross Blue Shield Association issued a positive coverage policy as well to Deep TMS for the treatment of OCD.
HCSC is the largest customer owned health insurance company and the fourth largest in the U.S., covering approximately 17 million lives. HCSC offers a wide variety of healthcare plans and related services through its operating divisions and subsidiaries, including Blue Cross Blue Shield of Illinois, Montana, New Mexico, Oklahoma and Texas.
Each of these positive reimbursement decisions enhance and streamline access to Deep TMS for OCD. We will, of course, continue to work to drive further coverage to positive -- further positive coverage developments from other major health plans.
We continue to reach out to payers with our growing body of clinical evidence to support Deep TMS treatments for patients with OCD. Our requests are based on the strength of evidence from a pilot and pivotal studies published in 2018 and 2019. And nine additional studies published in 2020 and 2021, including a real world evidence study which analyzed 219 patients from 22 medical centers.
We also continue to achieve incremental reimbursement progress in depression. As a reminder, four of the top 10 commercial payers in the U.S., representing approximately 83 million lives now provide coverage for Deep TMS for depression, following two failed medication trials.
Importantly, the trend of decreasing the number of required prior medication failures before qualifying for Deep TMS is continuing among other payers as well. Again, this trend is important as it further lowers the barriers to access our life changing approach to patient care.
Recently, several smaller private payers have come down from four to two or three medication failures. Likewise, the recent draft Palmetto LCD reduced the number of required medication treatment failures from four to two.
Once the Palmetto LCD is final, four of the seven MACs across the country will provide coverage for our depression therapy after just one or two failed medication trials. These four MACs cover 42 million lives and represent nearly 70% of all Medicare beneficiaries in the U.S.
With that, I would like now to provide a brief update on our controlled market release of Deep TMS for smoking addiction. You will recall that this new commercial offering the first of its kind is being launched a phased rollout. We have now completed the first phase, which was a controlled market release designed to gauge the customer experience and initial receptiveness among the limited and select group of customers.
We’re pleased to report excellent early feedback from our customers, including very encouraging anecdotal quit rates to the patients being tracked as part of this phase. We’re now conducting additional consumer market research to further cultivate our messaging around this market offering in preparation for our broader launch, which we intend to execute in two additional phases, a limited market release that will make the offering available to a somewhat wider group and then a subsequent full commercial launch.
Turning to Investor Relations, we will be presenting at a number of healthcare investment conferences during the remainder of 2021 and we will host a KOL event for investors and analysts on August 31st that will highlight the OCD vacation. This upcoming virtual event will feature a presentation by Dr. Kimberly Cress, past President of the Clinical TMS Society, who will discuss the current treatment landscape and unmet medical need in treating patients with OCD. In addition, Dr. Tendler will discuss Deep TMS as a well tolerated and effective treatment for OCD. We look forward to your participation in this informative event.
Finally, as always, I would like to express my gratitude to our hard working customers on the front line of this mental health crisis. And of course to the entire BrainsWay team for the continued support and dedication to our mission of boldly advancing neuroscience to improve health and transform lives.
With that, I will now pass the call to Scott for his review of our second quarter 2021 financial results. Scott?
Scott Areglado
Thank you, Chris. I will jump right into the discussion of our financial results. Revenue for the second quarter of 2021 was $7 million, a 45% increase compared to the second quarter 2020 revenue of $4.8 million, which was impacted by the pandemic. This year-over-year revenue growth was driven by the increase in direct sales.
On a sequential basis second quarter revenue of 2021 grew $0.9 million or 14% over the first quarter of 2021. Our recurring revenues, primarily derived from leases were $3.6 million. Lease revenue in the second quarter of 2021 represented 51% of our total revenue, highlighting the recurring nature and predictability of BrainsWay’s overall revenue.
For the first half of 2021, revenues were $13.1 million, representing a 46% or $4.1 million increase compared to revenue of $9 million for the first half of 2020, which as I mentioned previously, was pandemic impacted. As of June 30, 2021, BrainsWay’s installed base totaled 682 Deep TMS systems, which reflects an increase of 30 systems on a sequential basis.
Gross profit for the second quarter of 2021 was $5.7 million, compared to $3.8 million during the prior year period. Gross margin for the quarter was 81%, as compared to 79% in the second quarter of 2020. Gross profit for the first half of 2021 was approximately $10.4 million or a 79% margin, compared to a $7 million gross profit or a 78% margin during the prior year period. Margins can fluctuate slightly, however we expect margins to be in this range in the back half of 2021.
Moving on to operating expenses, for the second quarter of 2021, research and development expenses were $1.7 million, as compared to $1 million in the second quarter of 2020 and primarily consists of costs associated with the continued development of our patented Deep TMS technology. Research and development expenses for the first half of 2021 were $2.6 million, as compared to $2.8 million in the prior year period.
Sales and marketing expenses for the second quarter of 2021 were $4.2 million, compared to $2.2 million for the second quarter of 2020. For the first half of 2021, sales and marketing expenses were $7.3 million, as compared to $5.9 in the prior year period. As Chris mentioned, we have invested in digital marketing campaigns to create awareness, as well as increased sales professionals to drive further growth.
Moving on to G&A, expenses for the second quarter of 2021 were $1.4 million, compared to $0.8 million for the second quarter of 2020 and $2.8 million for the first half of 2021, as compared to $2.1 million in the prior year period.
Total operating expenses were $7.2 million for the second quarter of 2021, compared to $4 million for the same period in 2020. These significant change in operating expenses on a year-over-year basis are reflective of cash preservation efforts to mitigate the effects of the pandemic in 2020.
Total operating expenses for the first half of 2021 totaled $12.7 million, as compared to $10.8 million in the prior year period. We expect to continue to invest in initiatives to drive commercial adoption of our primary indications in depression, OCD and smoking, and additional clinical studies, with the Q2 run rate reflective of expenses in the second half of the year.
Operating loss for the second quarter was $1.5 million, compared to an operating loss of $215,000 for the same period in 2020, reflecting the cash preservation efforts in the second quarter of 2020. Operating loss for the first half of 2021 totaled $2.3 million, as compared to $3.8 million in the prior period.
For the second quarter ended June 30, 2021, we incurred a net loss of $1.9 million, compared to a net loss of $571,000 in the second quarter of 2020. For the first half of 2021, net loss was $3.3 million, as compared to a net loss of $4 million in the prior year period.
Moving on to the balance sheet, we ended the quarter with cash, cash equivalents and short-term deposits of $55.9 million, compared to $17.2 million as of the end of December 31, 2020. We believe that our strong balance sheet allows us to continue our sales and marketing efforts to drive additional adoption of our multi-indication Deep TMS system, as well as invest in R&D in order to commercialize additional potential indications of our differentiated innovative technology. We believe these initiatives and investments will help drive long-term shareholder value.
This concludes our prepared remarks. I will now ask the Operator to please open up the call for questions. Operator?
Question-and-Answer Session
Operator
[Operator Instructions] And our first question is from Jayson Bedford with Raymond James. Please proceed with your question.
Jayson Bedford
Good morning and congrats on the progress. Just a few questions. First, Chris, you alluded to the Delta variant, have you seen an impact on your business over the last few weeks?
Christopher von Jako
We haven’t. And obviously -- and you go into Q2 and just looking at procedure volumes, procedure volume has actually continued to increase in all of Q2 and actually going into Q3 as well. And nothing -- no changes also on the side of the sales front either.
Jayson Bedford
Okay. And then just in terms of the 2Q strength, do you feel confident that this wasn’t just a fulfillment of kind of backlogged orders and I guess it’s just you talked about seeing continued momentum and maybe that answers the question, but I guess, just commentary on backlog and was 2Q helped by just fulfillment of backup orders?
Christopher von Jako
You mean, coming from Q1?
Jayson Bedford
Correct.
Christopher von Jako
Yeah. No. I don’t think we had any hangover from Q1 at all. I think we continue to build up momentum going into Q2. As you know, we we’ve been increasing sales people this year as well. And I think, we’ve been continuously working on improving our sales force and our talents, and I think that, that kind of shows through into Q2.
Jayson Bedford
Okay. And then just a couple OCD questions, is there a direct correlation between the new OCD reimbursement and OCD helmet placement, meaning, are the new coils being placed in settings where there is comparatively heavy -- heavier coverage from Centene or HCSC?
Christopher von Jako
Yeah. That’s a great question. I think that, probably, the news of the first three positive coverage policies was definitely more helpful in the second quarter, as they started to see the trend continue. So we saw, obviously, with the number of systems that we shipped with a higher number of components of OCD add-on helmets to it. So I’m -- we’re extremely encouraged by this.
So there’s the highest, probably, number of OCD helmets with number of systems that we shipped. So we’re really excited about that. I mean, obviously, the announcement of the coverage termination actually came right after our last earnings calls and I think it ramped up the sales team, as well as a number of our customers.
Jayson Bedford
Okay. Just, I guess, on that and looking on the other side, it looks like only a couple of your existing users added OCD in the quarter, which I’m a bit surprised by. But what’s the source of resistance right now for those users who have not yet adopted OCD, which appears to be two-thirds of the base?
Christopher von Jako
Well, I think, in general, there are certain practices that are not focused on OCD in particular, right? There are some practices that just don’t focus on OCD. And I think others are probably encouraged by the news, but continuing to wait for further expansion of the OCD coverage. Right now we have probably about 40 million covered lives and we still have some continued work to do. But, I think, overall, both from our customer base, as well as from our sales force, there’s a great deal of excitement and we continue to have great results with our post-marketing efforts as well on understanding how these patients are doing.
Jayson Bedford
Okay. That’s helpful. Maybe this last one for Scott, gross margin strength in 2Q, your comment suggest that it will continue in the second half, what’s the driving force around the step up in gross margin? Is it just…
Scott Areglado
Yeah. Maybe my comment might bit on...
Jayson Bedford
…the platform…
Scott Areglado
Yeah. I think Q2 in particular was a little blip there. I think what I was trying to say is that, the year-to-date margin is probably more reflective of where we’re going to be in the back half. Maybe that didn’t come out right.
Jayson Bedford
Okay.
Scott Areglado
I think we’re still going to see 78%, 79% in the back half there. I think Q1 was a bit of a blip.
Jayson Bedford
Okay. Thank you.
Scott Areglado
Yeah.
Christopher von Jako
Thanks, Jayson.
Operator
And our next question is from Steven Lichtman with Oppenheimer. Please proceed with your question.
Steven Lichtman
Thanks. Hi, guys, and congratulations.
Christopher von Jako
Hi.
Steven Lichtman
Chris, how are you thinking about the potential for incremental OCD revenue here in the near-term by treatments in the geographic areas where there are new policies? Is that something we could see here in the second half of the year or should we thinking about that as a more noticeable pickup in 2022?
Christopher von Jako
I think it’s probably further down, Steve. Again, we’re still in the early phases, right, with Centene and HCSC, right? And obviously, we are really excited about Palmetto. It’s only covering a certain number of states and a certain number of covered lives. So I would say, probably, going into 2022, we’ll see probably further momentum around it.
Steven Lichtman
Got it. You talked about sales force investments. Where are you now in terms of number of reps and what’s your latest thinking on where you’d like to end at, at the end of the year?
Christopher von Jako
Yeah. If memory serves me correctly, I think, at the beginning of the year we’re at 12 and we’re up to 16 now. And as I probably mentioned before, our short-term goals right now get to 18, and I think, probably, by the end of Q3 we’ll be at 18.
Steven Lichtman
Okay. Great. And then just on the smoking cessation, when are you thinking of timing wise about the limited launch and then the potential full launch?
Christopher von Jako
Yeah. Thanks for the question. So, as I mentioned in the prepared remarks, early data has been really extremely good for us in the controlled market release. We’ve actually hit our criteria for all of that to head into the limited market launch now. We just -- over the last several weeks, we just finalized our education with a sales force and we’re already starting to quote out to a more limited group of customers there. So we’re already into the limit market phase and we’re looking for probably the full commercial phase, probably start sometime later this year.
Steven Lichtman
Great. And then, lastly, obviously, OCD reimbursement has been sort of the headline here in the last few months, but the reduction in number of failed meds on the depression side, as you mentioned, those continue? What have you seen in terms of that driving increased demand for systems for potential new customers, you guys look back over the last few quarters?
Christopher von Jako
I think it’s really impactful when it comes to the small private psychiatrists offices, who have these patients already in their waiting room and to be able to go to a patient that has already two failed medications, as opposed to waiting for an additional two additional medications, which could push it out another year or a year and a half or two years in timeframe before they’re applicable to have reimbursement. I think it’s a big difference.
And I think that, when it happened with a number of our customers, anecdotally, I spoke to a number of them in different places in the U.S. and they were very excited, and we may said it impacted them quite a bit, just looking and understanding of how they’re going to be treating these patients moving forward.
Steven Lichtman
Great. Thanks, Chris.
Christopher von Jako
Thanks, Steve.
Operator
And our next question is from Jeffrey Cohen with Ladenburg Thalmann. Please proceed with your question.
Jeffrey Cohen
Hi, Chris and Scott. How are you?
Scott Areglado
Good morning, Jeff.
Christopher von Jako
Good. Thanks, Jeff.
Jeffrey Cohen
Just a couple from our end, I guess, firstly going back to Jayson’s original question two. If you could give us a little color perhaps on just your two graphic overlay versus some hot spots on the COVID side, we’re just trying to get a better quantification of cadence for Q3 in general back half commentary?
Christopher von Jako
Yeah. Thanks, Jeff. Like I said earlier, we haven’t seen any real effects as of recent. I looked at the numbers we were tracking from a sales perspective. The number of meetings something, I’ll say that, it’s steadily progressing Q1 to Q2 and its increased also into Q3. So, we’re not seeing any regional effects at this time.
Jeffrey Cohen
Okay. Great. And then, secondly, could you talk a little more about the payer environment and how that reflects pharma sales? You had some commentary that it looks like you’re moving a little earlier in the treatment paradigm from one or two pharma sales as opposed to three or four. Can you provide any commentary there…
Christopher von Jako
Yeah.
Jeffrey Cohen
… and what kind of discussion the company is having on the payer side?
Christopher von Jako
Yeah. One of the great things, Jeff, is that, since we’re having all these conversations directly with the payers related to OCD, we also take the opportunity to actually chat and update information about depression as well.
And as I mentioned in my prepared comments, more and more, even a smaller players are now moving from four medications down to either three or two, which is I think really exciting. And then, as I also mentioned that, seven there are Medicare administrators throughout the United States that cover the whole global area. And now, in fact, with Palmetto moving from four down to two, that makes four out of the 70 to two or one. In fact, the other three Medicare providers are actually at one failure.
So, I think it’s -- overall, it’s a really good trend. It’s going to open up access. It’s going to be good for patients and it’s going to be good for the providers as well. No one doubt, I think, we’ll see that continue, I hope to be a trend of moving closer, even getting to maybe one like some of these Medicare providers allow.
Jeffrey Cohen
Okay. Got it. And then, one more quick one, cadence in rollout as you’re kind of planning and expecting on the nicotine addiction side. So, it kind of looks similar to the OCD coils as we saw in 2018 the original 58 and they’re getting toward the 200 a couple of years later?
Christopher von Jako
Yeah. I think it’s probably too early to kind of give some numbers around that this time. I mean, as I mentioned, probably, on the last call, we rolled out to 10 of our customers with our new smoking addiction helmet or as we call it internally H4 system.
And then, over the second quarter, we rolled out to additional five. So we’re at 15 customers right now that have the technology. And once we’ll get into limited market, we will continue to kind of provide insight in later quarters.
Jeffrey Cohen
Perfect. Okay. Thanks for taking the questions.
Christopher von Jako
Thanks, Steve, oh, Jeff, sorry.
Operator
Our next question is from Jason Wittes with Northland. Please proceed with your question.
Jason Wittes
Hi. Thanks for taking the questions. So, for OCD, you guys, it seems have done a pretty good job of making sure that, if I’m correct, that the reimbursement is specific to deep brain. Is that the strategy or has that been the strategy and the case in terms of most of your discussions with the insurers? And secondly, does that help in terms of copycats trying to sneak in even though I know they don’t necessarily have direct OCD approval?
Christopher von Jako
Jason, thanks for the question. Yeah. You’re right. That has been the strategy for us. I think, as I mentioned in our prior calls, when we’re meeting with these payers, it’s really a primary focus for us to make sure they understand the difference between Deep TMS and traditional PMS and the benefits of Deep TMS.
Us going deeper and broader makes a huge difference, especially in the outcomes of the patients. And as you know, we’re very, very particular about the way we do our research and conduct our clinical trials. And in that way, we’ve shown the benefits of what Deep TMS is doing, particularly for these OCD patients. And we have been very particular, as you mentioned, in getting Deep TMS as to be the provider of this OCD technology or treatment, as you mentioned. So it has been…
Jason Wittes
Okay. Thanks.
Christopher von Jako
…an important part of the strategy. Thanks, Jason.
Jason Wittes
Yeah. No. Helpful. And also related to that, the MACs decision to go from four to two failed therapy attempts, that’s specific to all stimulant or deep -- stimulation or is that specific to deep brain stimulation? Just want clarification on that?
Christopher von Jako
No. That’s for all TMS whether for us with Deep TMS or traditional TMS.
Jason Wittes
Okay. And then I know it’s still early in smoking cessation. So you may have limited comments, but the big question I have and I think a lot of investors have is, it seems like there’s a big out of pocket opportunity here. Has that been tested yet? Can you comment on how big or how realistic or that opportunity might be?
Christopher von Jako
Yeah. That’s been a big part of our focus with the controlled market release to try to understand how we’re marketing to patients. Are there opportunities for other reimbursements associated around the treatment as well?
We in fact just a couple of weeks ago we brought all of our controlled market release customers together and had a call with them. It was really helpful to kind of understand thoughts specifically best practices around patient targeting, patient messaging, insurance billing and treatment protocol.
So we’re learning a lot and we look forward to share further information as we continues down this path. But I think, as I mentioned the prepared remarks, early and total evidence was very good about treatments. We’ve probably treated around a couple dozen patients to-date and it’s been very well accepted so far.
Jason Wittes
Okay. Helpful. And then on OCD, I know that you talked about different pricing strategies. Is there a separate -- is it still basically a leasing type agreement or is there actual additional payments related to OCD from the third of your install base that has opted to get the helmet?
Christopher von Jako
Yeah. Thanks for that question. So, traditionally in the past we were more on a fee-per-use but we’ve kind of opened it up with all of our three strategies. So, doing what we call like a risk share model, which is the fee-per-use. We also sell the helmet directly and we also lease the helmet as an uptick on increased, if they’re depressions system and then they can opt to also lease the helmet as well.
Jason Wittes
Okay. Is there is there an incremental break piece of OCD in those revenue numbers that you supplied that today or is that, I guess, it’s just not something you’re breaking out at the moment?
Scott Areglado
Yeah. So we don’t break it out, but certainly, this incremental revenue associated with the additional helmet.
Christopher von Jako
It also obviously drives…
Jason Wittes
Okay.
Christopher von Jako
… additional sales…
Scott Areglado
Yeah.
Christopher von Jako
… overall -- it’s system sales, right, because the differentiation of the technology between us and other traditional TMS systems.
Jason Wittes
Okay. And then maybe last question, I think you mentioned, your goal is to get to 18 sales reps in the U.S.?
Christopher von Jako
Yes.
Jason Wittes
It seems like you could go bigger especially -- or are you -- or is that something that maybe you reevaluate after you look -- you kind of complete your evaluation of the smoking cessation trials or commercial trials?
Christopher von Jako
Yeah. We definitely -- we can definitely go bigger. We just wanted to do it in a kind of a phased approach. So our goals for this year was 18. Those we are going to probably most definitely increase going into 2022. But right now our short-term effort is to get to 18.
Jason Wittes
Okay. Great. Thanks I’ll jump back in queue.
Christopher von Jako
Yeah. Thank you.
Operator
[Operator Instructions] Our next question is from Ram Selvaraju with H.C. Wainwright. Please proceed with your question.
Ram Selvaraju
Thanks very much for taking my questions and congratulations on a really solid quarter here. Firstly, I wanted to drill down a little bit further into what you envisage to be the long-term plan, the long-term goal for the expansion of the number of sales reps in the field? And if you could please relate that to the target prescriber base, because it seems as though the prescriber base is enormous relative to the number of sales reps that you currently have and I just wanted to know kind of what’s the ultimate goal or what’s the ultimate sales rep number objective that you have relative to the prescriber base that you’re targeting?
Christopher von Jako
Yeah. Ram, thanks for the question. I appreciate it. So, in general, we were at 12 and our goal was to grow by 50% in a systematic way. We think, probably, over time, in the short-term, probably, up closer to around 40 is where we’re thinking to kind of cover the complete territories that we’re looking at. But that can change, obviously, depending on our rollout of smoking, which is we may go in a number of other different areas with smoking as well as an indication. Obviously, we know it’s outside of psychiatry as well. And so, I think, just to give you kind of a short-term thought, that’s sort of the thinking.
Ram Selvaraju
Okay. And then, just a couple of questions regarding the revolving reimbursement picture, are you seeing an evolution in the thinking among reimbursement agencies regarding coverage of Deep TMS procedures in patients who may already have had Deep TMS applied once, at least once in their prior treatment history or are you seeing that remaining effectively static? And then the second question is whether you are seeing any changes in the thinking among reimbursement agencies with respect to prior authorizations, the number of prior treatments, for example, in the context of MDD?
Christopher von Jako
So, is your first question, I assume is also related to depression, correct?
Ram Selvaraju
Correct. Yeah.
Christopher von Jako
Yeah. So, in general, without getting too technical and too deep, there are a couple of things that when your depression patients come in, they look for response and someone to get to remission. And if somebody has a response on the technology, the payers will continue to actually pay for TMS treatments in the future, which I think is important. And we’ve shown in a head-to-head study that our response rates are actually higher than traditional TMS. So, I think that’s an important indicator.
So and remember that depression is episodic. So as soon as somebody gets to remission, if they come back and have another episode of depression, as long as they respond to the technology, currently the payers are paying in.
And then to your second question, as I mentioned, initially when TMS started getting reimbursed by payers on a broader wider scale, they started four failed medications. And the recent trend starting in about late 2019 has been moving down from four down to two.
We’ve seen, as I mentioned in my prepared remarks, that that trend continues of going down from four down to two and in some cases even one, which I think is just extremely helpful with all the details around where medications in.
After the first medication there’s only roughly about a 50% chance that there’ll be a response and then it just gets worse and worse after the next medications. So getting it down closer to one failed treatment I think is going to be a continued trend that happens.
Ram Selvaraju
Okay. And then on the reimbursement front also, I wanted to ask if you expect any additional draft LCDs before the end of this year.
Christopher von Jako
I mean, we’re hopeful to it. I can’t give guidance around it. I was -- in my last couple of calls including the last one that we had, I was very hopeful that we would end up getting at least one coverage just from the receptiveness of the conversations we were having around OCD. And then boom the day after the call we got one and then a couple days later we got another one and then the third one. So I’m hopeful, but I can’t give guidance on it. It’s really very hard to predict. But I think…
Ram Selvaraju
Okay. And with…
Christopher von Jako
I think one…
Ram Selvaraju
Okay.
Christopher von Jako
… additional thing, Ram, is that we have actually met with all the Medicare providers, all of the MACs and introduced all of the information to them already.
Ram Selvaraju
Great. And then with respect to the smoking cessation controlled launch, can you just give us a bit more color on how the kinetics of the launch are going to dovetail with what you expect to be evolution in the reimbursement picture there?
Christopher von Jako
Yeah. Again, it’s probably too early to kind of predict on how that will go. Obviously, we have done we’ve done a bunch of work around understanding the reimbursement landscape in smoking and also trying to understand exactly what our strategy is moving forward.
I think it’s really important as we’ve done with OCD to be focused on gathering post-marketing data and also making sure that we’re publishing that data in an appropriate way to give us further evidence to support any reimbursement efforts moving forward.
Ram Selvaraju
Thank you.
Christopher von Jako
Thanks so much.
Operator
And we have reached the end of the question-and-answer session. I will now turn the call over to Chris von Jako for closing remarks.
Christopher von Jako
Thank you so much. I’d like to thank all the investors and other participants for their interest in BrainsWay. With that, please enjoy the rest of your day.
Operator
This concludes today’s conference and you may disconnect your lines at this time. Thank you for your participation.
midastouch017
3年前
BrainsWay Reports First Quarter 2021 Financial Results and Operational Highlights
https://finance.yahoo.com/news/brainsway-reports-first-quarter-2021-120000230.html
Strong Revenue Growth of 47% Year-over-Year in Q1 2021
Successfully Executed Initial U.S. Controlled Market Release of Deep TMS for Smoking Addiction
Strengthened Balance Sheet Through Successful Equity Offering; Ended Q1 2021 with $58.5 Million in Cash
Conference Call to be held Today at 8:30 AM ET
CRESSKILL, N.J. and JERUSALEM, May 20, 2021 (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 2021 financial results and provided an operational update.
Recent Financial and Operational Highlights
For the three months ended March 31, 2021, revenues were $6.1 million, a 47% increase as compared to the same period in 2020.
Operating loss for the first quarter of 2021 was $2.1 million, which included a one-time $2.0 million expense for stock-related compensation, as compared to $3.6 million for the first quarter of 2020.
As of March 31, 2021, BrainsWay’s Deep TMS installed base was 652 total systems, a 19% increase from the installed base at the same point in the prior year.
During the first quarter 2021, the Company shipped 9 OCD coils as add-on helmets to certain of BrainsWay’s new and existing systems, increasing the total number of OCD add-on helmets to 225.
Surpassed 100,000 patients treated with Deep TMS therapy.
Launched Deep TMS as an aid for short-term smoking cessation in the U.S.
Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s Theta Burst three-minute protocol utilizing Deep TMS for the treatment of major depressive disorder (MDD).
Appointed seasoned healthcare industry finance executive R. Scott Areglado as Senior Vice President and Chief Financial Officer.
“We are extremely pleased with the overall trends in our business, and are working to continue the strong momentum achieved late in 2020 and during the first quarter throughout the year,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Our revenues of $6.1 million represented a significant 47% increase over our first quarter of 2020, demonstrating the resiliency of our business and continued emergence from the COVID-19 pandemic. We marked a true milestone for our revolutionary approach to mental health treatment with the recent treatment of our 100,000th patient, and this was complemented by impressive commercial and regulatory achievements, including our successful follow-on raise of $45.2 million in gross proceeds, the controlled market release of our smoking addiction system, and the FDA’s clearance of our three-minute Theta Burst depression protocol. We believe these accomplishments position us well to generate long-term shareholder value and to advance in our mission to improve health and transform lives.”
First Quarter 2021 Financial Results
Total revenues for the first quarter of 2021 were $6.1 million, compared to $4.2 million in the first quarter of 2020, an increase of 47%. Quarterly recurring lease revenues were $3.5 million, remaining consistent with the first quarter of 2020, and comprising approximately 56% of total revenues.
Gross margin for the first quarter of 2021 was 75%, compared to 76% for the first quarter of 2020.
Operating expenses for the first quarter of 2021 were $6.8 million, including a one-time $2.0 million expense for stock-related compensation, compared to $6.8 million for the first quarter of 2020.
For the three months ended March 31, 2021, operating loss was $2.1 million, of which $2.0 million was a one-time expense for stock-related compensation. This is compared to an operating loss of $3.6 million during the same period in the prior year.
As of March 31, 2021, the Company had cash and short-term deposits of approximately $58.5 million, compared to $17.2 million at December 31, 2020. The significantly increased cash position reflects the completion of the Company’s public offering, which was closed in March 2021 and generated gross proceeds of $45.2 million.
Conference Call and Webcast
BrainsWay’s management will host a conference call today, May 20, 2021, at 8:30 a.m. Eastern Time to discuss these results and answer questions.
Thursday, May 20, at 8:30 AM Eastern Time:
United States:
877-407-3982
Israel:
1 809 406 247
International:
201-493-6780
Conference ID:
13719155
Webcast:
http://public.viavid.com/index.php?id=144607
To listen to a live webcast, please visit the Investors section of the BrainsWay website at www.BrainsWay.com. Please access the Company’s website at least 10 minutes ahead of the conference call to register. The webcast replay will be available on the website for two weeks following the completion of the call.
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 studies demonstrating clinically proven efficacy. Current indications include major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Cresskill, NJ and Jerusalem, Israel, BrainsWay is committed to increasing global awareness 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. 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. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, and the effect of the global COVID-19 health pandemic on our business and continued uncertainty and market impact relating thereto.
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, including the Company's Annual Report on Form 20-F. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov.
Contacts:
BrainsWay:
Scott Areglado
SVP and Chief Financial Officer
Scott.Areglado@BrainsWay.com
Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com
BRAINSWAY LTD.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands (except share and per share data)
March 31,
December 31,
2021
2020
ASSETS
Unaudited
Audited
Current Assets
Cash and cash equivalents
$
58,280
$
16,961
Short-term deposits
221
221
Trade receivables, net
6,674
5,582
Other accounts receivable
1,516
1,534
Total current assets
66,691
24,298
Long-term deposits
165
163
Leased systems
4,538
4,966
System components and other property and equipment
4,696
4,584
Total assets
$
76,090
$
34,011
LIABILITIES AND EQUITY
Current Liabilities
Trade payables
$
1,072
$
781
Other accounts payable
3,557
3,769
Deferred revenue
1,812
1,543
Liability in respect of research and development grants
417
707
Total current liabilities
6,858
6,800
Deferred revenue and other liabilities
1,939
2,015
Liability in respect of research and development grants
5,963
5,524
Warrants
7
38
Total Liabilities
14,767
14,377
Equity:
Share capital
346
233
Share premium
137,282
95,135
Share-based payment
5,906
3,748
Adjustments arising from translating financial statements from
functional currency to presentation currency
(2,188
)
(2,188
)
Accumulated deficit
(80,023
)
(77,294
)
Total Equity
61,323
19,634
Total Liabilities and Equity
$
76,090
$
34,011
BRAINSWAY LTD.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands (except share and per share data)
For the three months ended March 31,
2021
2020
(Unaudited)
Revenues
$
6,121
$
4,157
Cost of revenues
1,515
1,015
Gross profit
4,606
3,142
Research and development expenses, net
1,228
1,795
Selling and marketing expenses
3,578
3,713
General and administrative expenses
1,956
1,255
Total operating expenses
6,762
6,763
Operating loss
(2,156
)
(3,621
)
Finance (expense) income, net
(412)
309
Loss before income taxes
(2,568
)
(3,312
)
Income taxes
160
130
Net loss and total comprehensive loss
$
(2,728
)
$
(3,442
)
Basic and diluted net comprehensive loss per share
$
(0.11
)
$
(0.15
)
BRAINSWAY LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
For the three months ended March 31,
2021
2020
(Unaudited)
Cash flows from operating activities:
Net loss and total comprehensive loss
$
(2,728
)
$
(3,442
)
Adjustments to reconcile net loss to net cash used in operating activities:
Adjustments to profit or loss items:
Depreciation and amortization
403
445
Depreciation of leased systems
292
294
Finance expenses (income), net
412
(309
)
Cost of share based payment
2,158
308
Income taxes
160
130
Changes in asset and liability items:
Decrease (increase) in trade receivables
(1,093
)
88
Decrease in other accounts receivable
18
264
Increase (decrease) in trade payables
291
(413
)
Increase (decrease) in other accounts payable
(212
)
74
Increase (decrease) in deferred revenues and other liabilities
162
(15
)
Cash paid and received during the period for:
Interest paid
(20
)
(23
)
Interest received
2
31
Taxes paid
(160
)
(9
)
Cash used from operating activities:
(315
)
(2,577
)
Cash flows from investing activities:
Purchase of property and equipment(*)
(379
)
(946
)
Withdrawal of long-term deposits, net
-
10
Net cash used for investing activities
(379
)
(936
)
Cash flows from financing activities:
Receipt of government grants
90
42
Repayment of lease liability
-
(110
)
Issuance of share capital
42,260
-
Net cash provided by (used for) financing activities
42,350
(68
)
Exchange rate differences on cash and cash equivalents
(337
)
(124
)
Increase (decrease) in cash and cash equivalents
41,319
(3,705
)
Cash and cash equivalents at the beginning of the period
16,961
21,674
Cash and cash equivalents at the end of the period
$
58,280
$
17,969
(a) Significant non cash transactions:
Purchase of property and equipment on credit
-
192
(*) Derived mainly from purchase of system components
midastouch017
4年前
BrainsWay Ltd. (BWAY) CEO Christopher von Jako on Q1 2020 Results - Earnings Call Transcript
Jun. 25, 2020 7:24 AM ET | About: Brainsway Ltd. (BWAY), BRSYF
Q1: 06-24-20 Earnings Summary
Press Release
EPS of $-0.15 beats by $0.00 Revenue of $4.16M (-19.78% Y/Y) beats by $0.01M
Subscribers Only
Earning Call Audio
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 highlights. At this time all participants are in a listen-only mode. After the speaker presentation there will be a question and answer session. [Operator Instructions] I must also advise you that the conference today 24th of June 2020 is being recorded.
I would like now to hand the conference over to your first speaker today, Bob Yedid. Please go ahead, sir.
Bob Yedid
Thank you all for participating in today's call. With us today are BrainsWay’s, President and Chief Executive Officer, Christopher von Jako; and Chief Financial Officer, Judy Huber. Earlier today BrainsWay released financial results for the first quarter ended March 31, 2020. A copy of the press release is available on the company's website.
Before I turn over the call to Chris and Judith, 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 forward-looking statements regarding future events or the future performance of BrainsWay, including but not limited to any statements relating to commercial plans or activities, financial projections, clinical studies, R&D plans, and/or anticipated timelines.
These statements are only predictions and BrainsWay cannot guarantee that they will in fact occur. BrainsWay does not assume any obligation to update that information. Investors are cautioned that all forward-looking statements involve risks and uncertainties, such as reliance on third parties and shifting market conditions, particularly during the COVID-19 pandemic, which may cause actual results to differ from those anticipated by BrainsWay at this time.
Additional risks concerning factors that may cause actual events, results, or achievements to materially differ from those contained in the forward-looking statements can be found in the Company's registration statement on Form 20F and in its other filings with the Securities and Exchange Commission.
With those prepared remarks, it's now my pleasure to turn the call over to BrainsWay's CEO, Christopher von Jako. Chris?
Christopher von Jako
Thank you, Bob, and welcome everyone to BrainsWay's first quarter 2020 earnings call. On today's call as we continue to operate in the midst of the ongoing COVID global health pandemic. I will provide an update on how we have worked to address the unique set of challenges caused by the virus.
I'll then turn the call over to Judy Huber, our new Chief Financial Officer to discuss our financial results. I will conclude by highlighting our reimbursement progress, clinical trial activities and R&D efforts, as well as other key recent achievements and focus areas for the remainder of 2020. We will then open up the call for your questions.
With that, let me begin by discussing our broad response to COVID-19. First and foremost, our top priority is the health and wellbeing of our loyal and growing customer base, the patients they serve and of course, our dedicated employees and their families. We remain firmly committed to serving our customers during this difficult period.
We fully understand the importance of patients continuing to receive their Deep TMS treatment. Therefore, BrainsWay has remained fully operational in the United States throughout the COVID-19 pandemic. Despite the outbreak, many of our customers have also remained operational during this time. The most impacted states have been along the east and west coast.
Of course, throughout the country, there were some clinics that temporarily shut down, saw some fewer patients and some closed for a mandatory two week period upon learning that COVID 19 patient had visited the clinic. Many clinics are progressing toward near normal operations at this time, and have instituted various steps to decrease the risk of spreading the virus. These include social distancing, cleaning and disinfecting the equipment between sessions and other operating measures.
It is very important to note that beyond the direct effect of the physical health, we are unfortunately beginning to learn more about the sequential impact on mental health these uncertain times are having on a significant number of people; some sobering statistics, a federal emergency hotline for emotional stress registered at 1,000% increase in calls on April 2020 of April 2019; and Talkspace, which provides online therapy has logged a 65% increase in new patients.
Moreover, according to Mental Health America, the use of their free screening tools for anxiety and depression are up 370% and 394%, respectively since January. Indeed, just a few weeks ago, the FDA placed Zoloft, a popular antidepressant drug on its shortage list. This was followed from a report from the Census Bureau data, which revealed that over a third of Americans are showing signs of clinical anxiety or depression.
The survey of the US households was done between late April and mid-May. Furthermore, it is thought that OCD may potentially be heightened by the fear of the virus, for example, causing patients to feel an even greater need to wash their hands excessively due to the fear of germs. Also, experts are concerned about a rise of suicides, overdose deaths, and substance abuse disorders that historically follow economic downturns in a natural disasters.
All of this means that BrainsWay needs to be even greater resource than ever for our customers which treat patients suffering from depression and OCD. And we are trying to do exactly that. We have used this period to enhance awareness from an educational standpoint. For example, since the beginning of April, we have hosted a total of 31 webinars for our current and potential new customers.
These have been presented by a wide variety of key opinion leaders, customers practice success consultants, our Chief Medical Officer Dr. Aron Tendler, in other BrainsWay employees. In addition, we recently launched a new website, which offers significantly upgraded user friendliness and adds a broad range of our educational information and new webinar content, which is now available on demand.
Management has also acted aggressively to offset the effects of the COVID-19 pandemic from a financial perspective. We have implemented a significant expense reduction program. This includes cutting all non-essential spend, such as on promotional items and events. In addition, we reduced salaries across the board beginning in April, ranging from 5% for employees and manufacturing to 30% for myself.
As previously communicated our results in the first quarter were impacted due impart to certain customers being unable to finalize orders or to accept delivery of ordered systems as a result of the temporary shutdown of certain physician offices and clinics. This trend continued in the second quarter, and we expect a similar impact on our financial results for the current period. However, as I noted earlier, many clinics are nearing the ability to conduct more normalized business operations.
With that, I will now pass the call to Judy, for her review of our first quarter financial results. Judy?
Judy Huber
Thank you, Chris. I'm excited to participate in my first BrainsWay earnings call and I'm thrilled to have joined this growing and dynamic company. We are proud of the way our business performed in the first quarter amidst the COVID-19 pandemic.
Let's turn to our financial results for the first quarter of 2020. We generated quarterly revenue of $4.2 million, a decrease of 20% over the first quarter of 2019. Our recurring revenues primarily derived from leases were $3.5 million, an increase of 13% year over year. As of March 31, 2020 BrainsWay’s installed base totaled 548 Deep TMS systems, which reflects a quarter over quarter increase of 18 units.
Since the first quarter of 2019 BrainsWay’s installed base has increased by 132 systems or over 32%. During the first quarter of 2020 BrainsWay shipped 10 OCD coils to new and existing customers, bringing the company's total OCD coils to 183.
As Chris noted, in response to the impact of COVID-19 on our business, we put an expense reduction program in place that remains ongoing. This includes cuts to sales and marketing activities, delays in certain R&D projects and salaries.
That said the company is still considering certain specific sales and marketing hires as part of its broader growth strategy. It is critical that we balance appropriately managing expenses during this temporarily challenging period with the need to properly invest in the long term growth of our business.
Moving on gross profit from the first quarter of 2020 was $3.1 million compared to $4 million during the prior year period. Gross margin for the quarter was 76%, which was slightly lower than the first quarter of 2019 gross margin of 78%. This was due to a higher percentage of lease revenues versus direct purchases.
Research and development expenses for the quarter were $1.8 million, similar to the same period in 2019, and primarily consisted of costs associated with the continued development of our patented Deep TMS technology.
Sales and marketing expenses for the first quarter of 2020 were $3.7 million, an increase of $900,000 over the prior year period. The increase was primarily driven by enhanced marketing activities for depression and OCD and the company's larger sales force when compared to 2019.
General and administrative expenses for the quarter were $1.3 million as compared to $1 million in the prior year period. This increase was driven by an increase in non-cash provision for doubtful accounts.
Total operating expenses for the first quarter totaled $6.8 million compared to $5.6 million in the same period last year. For the first quarter ended March 31, 2020, we incurred a net loss of $3.4 million compared to a net loss of $1.9 million recorded in the first quarter of 2019.
Moving to the balance sheet. We ended the quarter with cash and cash equivalents of $18.2 million, compared to $21.9 million at December 31 2019. Cash used during the first quarter was in line with our expectations, given that most of the COVID 19 cost reduction efforts were implemented in Q2.
We believe that our strong balance sheet will allow us, at the appropriate time, to expand our sales and marketing efforts to drive additional adoption of the Deep TMS system and to continue to invest in R&D in order to explore new potential indications. Looking ahead, as Chris noted, many of our customer trends we experienced in the first quarter, we can have continued throughout the second quarter. Therefore, we expect a similar impact on our second quarter financial results.
While we do not intend to provide quarterly guidance as a standard practice, given the extenuating circumstances caused by COVID-19, we believe it is important that our investors and analysts have firm and understanding of the current state of our business as possible in this evolving healthcare environment. Therefore, for the second quarter of 2020, we expect revenues in the range of $4.6 million and $4.9 million.
With that, I'd like to turn the call back over to Chris for some further thoughts before we open up the call for the Q&A session. Chris?
Christopher von Jako
Thank you, Judy. I would like now to provide an update on some of the progress we have achieved recently with reimbursement both in major depression and OCD. Let's begin with depression. At the end of the first quarter, we received reimbursement coverage for Deep TMS from Humana, a major national health care plan, which had not previously covered Deep TMS.
This plan includes approximately 20 million covered lives, many of whom will now be eligible for Deep TMS. Also in the first quarter, Cigna reduced its requirement from failing three prior antidepressants to two before being eligible for Deep TMS coverage. Likewise, last month Aetna reduced its requirement from four to two and also reduced the patient minimum age requirement from 21 to 18.
For OCD, we continue to work with payers on securing reimbursement and continue to collect post marketing data in support of our efforts to expand coverage to include this indication. In support of our reimbursement efforts in OCD, the results of 192 patient post-marketing clinical study from 22 Deep TMS sites was submitted to a peer reviewed journal in April.
In this real world clinical study, the majority of OCD patients benefited from Deep TMS treatment, and the onset of improvement usually occurred within 20 sessions. The authors also saw that extending the treatment course beyond 29 sessions resulted in the continued reduction of OCD symptoms, raising the prospective benefit of extending treatment protocols in non-responders. We look forward to sharing further details on the results of this post marketing study once we have additional information on the timing of the publication.
I'd like now to discuss our ongoing efforts to ramp up our R&D initiatives. We have a robust clinical pipeline. In addition to our FDA cleared treatments for depression and OCD, we have various ongoing or planned studies and several potential new indications for Deep TMS.
Following final positive results from our multicenter smoking cessation study last year, we submitted a 510(k) application to the FDA in April for this potential indication. If we received FDA clearance, we expect to execute a controlled market release in early 2021. As a reminder, approximately 38 million US adults smoke cigarettes and 480,000 die from smoking each year.
So this is obviously a serious public health issue. There are limited treatment options that exist today in this area, and Deep TMS may be able to address the significant unmet medical need. Our current objective is to initiate at least one initial clinical trial by the end of this year, and we're currently working with our collaborators in the FDA in clinical trial design.
This trial will likely be another addiction disorder, specifically for opioid abuse disorder. In opioid abuse, please recall that BrainsWay was selected by the FDA as part of its innovation challenge and received the breakthrough device designation from the agency.
I'd like to highlight that May was Mental Health Awareness Month. As part of this initiative, we organized a social media sweepstake called Stand Against the Stigma, with a goal of encouraging conversation around mental health among the general public.
Through this engaging campaign, many people shared their own personal mental health experiences, helping us to work towards the goal of destigmatizing mental illness. To help kick off the campaign and start conversation, we tapped into Deep TMS patient advocates who recorded short videos talking about their own mental health journey.
We received many entries in this campaign, and we recorded over 1 million audience impressions, serving to significantly enhance awareness around mental health generally and BrainsWay specifically.
Let's now turn to some recently announced management hires and promotions that position BrainsWay for long term success. In May, we were pleased to promote Hadar Levy to Senior Vice President and General Manager of North America. Hadar now oversees many aspects of our North American business. He is an integral leader of BrainsWay and has been a key contributor to our strong growth.
Simultaneously with Hadar’s promotion we also announced Judy Huber's appointment as CFO. Judy has more than 30 years of financial and strategic experience and we're excited to have her on board to further enhance our financial infrastructure.
We also promoted Amit Ginou to Vice President Site Manager in Israel. Amit is a long term employee of BrainsWay and has been a valuable asset and the development and execution of the important Deep TMS clinical trials that have directly fueled our growth.
And most recently, we appointed Chris Boyer as Vice President of Global Marketing in May. Chris has more than 15 years of medical device marketing and business development experience in both privately held and multibillion dollar publicly traded medical device companies. And we're excited to leverage his extensive experience, leading and growing commercial organizations.
We have an extremely strong leadership team in place. And we know the role that our industry plays is more essential than ever. We at BrainsWay are proud to be deeply engaged with our customers in providing the tools support and services and most importantly hope to the many who depend on them in their daily lives.
Before turning it over to the Q&A, I'd like to thank our talented and dedicated employees for their continued support and commitment, which has produced significant achievements this quarter, despite the challenging environment we all find ourselves in. Our team is focused on improving people's lives with our game changing product.
With that, I will now ask the operator to please open up the call for questions. Operator?
Question-and-Answer Session
Operator
Ladies and gentlemen, we will now begin the question and answer session. [Operator Instructions] We will now be taking our first question from the line of Jayson Bedford from Raymond James. Please go ahead. Your line is now open.
Jayson Bedford
Good morning. Thanks. Can you hear me okay?
Christopher von Jako
Sure. Perfect, Jayson. Thanks.
Jayson Bedford
So a few questions here just on 2Q expectation of $4.6 million to $4.9 million. Not many companies seeing a sequential improvement. So I just wanted a little bit more detail. Is the 2Q number just fulfilling the first quarter backlog or have you seen progress throughout the last couple months of 2Q?
Christopher von Jako
Jayson, did I understand you correctly? Are you saying is some of the orders that from the backlog from Q1, is that was that your question? I mean from the end of the year.
Jayson Bedford
The question, I guess is more in 2Q because obviously there's implied sequential increase from 1Q to 2Q. Is underlying demand increasing here in 2Q relative to 1Q or is the 2Q expectation just a fulfillment of the deferrals in 1Q?
Christopher von Jako
It's probably a combination of the both. There was some systems in Q1 that obviously we had orders for, we couldn't fulfill during that time period. And then those obviously leaked into Q2. But we do see, as I mentioned in my prepared statements, there is opening up. We have been getting orders in some places and have been able to ship in some places. And now we are having that additional ability to now ship some of those orders now.
Jayson Bedford
Okay. And when you look back at 1Q, were there orders that were in fact cancelled or were they largely just deferred? Whether it be just into 2Q or 3Q?
Christopher von Jako
Yeah, just deferred.
Jayson Bedford
Okay. And can we assume that most of the new installs in practices are new to TMS or are you displacing others at this point?
Christopher von Jako
Again, it's a combination typically of our current customers that are expanding and also new customers.
Jayson Bedford
Okay. And then just maybe a last one for me and this is a little bit more qualitative. But given COVID and the current state of the world and your comments around the unfortunate increase in anxiety and depression, have your discussions with psychiatrists changed or have you seen more interest around Deep TMS? Thanks.
Christopher von Jako
Thanks, Jayson. I would say in general, yes. Most of the psychiatrists that we've spoken to understand that with COVID, the pandemic like we're hearing you are seeing in the media quite a bit and also my prepared statements, that anxiety and depression are on the rise. There's no question. And we feel obviously that we have a major role to play in that. And we're obviously happy that we could play that role. Thanks, Jayson.
Jayson Bedford
Thank you.
Operator
We will now be taking our next question from the line of Steven Lichtman from Oppenheimer & Co. Please go ahead. Your line is open.
Steven Lichtman
Thank you. Good morning. Chris, you mentioned a lot of positive movement on TMS reimbursement in the quarter. I guess two questions on that. One, was there a particular publication that drove these changes? And two, have you seen an increase in interest yet from potential customers, given that it can be used earlier now in the treatment paradigm?
Christopher von Jako
Thanks Steve. Thanks for the question, Steven. In general, I'm not sure if there was a publication that really spawned that on. I think that we've seen over the last several years that some of these payers maybe in general the data is becoming better and better around TMS and more knowledge around TMS, but they have been reducing that.
So I think overall, it's generally a very good trend. I think it's also a very good trend with COVID as well. They have the ability of another potential treatment for depression, I think is valuable and it’s important.
And Steven I don't think I got your second question. I'm sorry, I kind of focused on the first one. Can you repeat the second part of that question?
Steven Lichtman
Yeah, sure, no problem. Given that you're on a lease model and not on a per click model, just wondering what the positive impact could potentially be here from the improved reimbursement? Are customers yet showing more interest given that it can be used earlier in sort of their treatment paradigm? I mean what's the positive impact you think you might see from this sort of improved reimbursement environment for TMS?
Christopher von Jako
Yes. So I think overall, it's generally very good for our patients. It's very good for our customers, who can open up more access to the treatment to their patients. I think in general, these 2 occurrences just happened in the last couple of months. But I think overall, it's a very positive sign. As you know, most of our business model is based on leasing. We do in some cases, payments per patient, which is a positive effect of that for us. But I think in general, it's positive for the patients and also for our customers.
Steven Lichtman
And then on OCD, have you seen yet interest in more out of pocket payments from patients, given the impacts you spoke about from COVID-19? Are you seeing more interest in people just paying out of pocket even before reimbursement or not yet?
Christopher von Jako
I don't think we see that yet. We know that there are pockets in areas in the country where there has been reimbursement that obviously takes some time and effort on our customer standpoint, working together with us to try to do the appeals and get reimbursement.
But we know that, in general, there is out of pocket pay for OCD as well. So we haven't actually seen the trend yet. I think it's probably too early to see that trend. But obviously, I mean, the main thing for us is to continue to work on our reimbursement efforts. And I'm just delighted today to share this 192 patient study that was done and was submitted to a journal. So I'm very excited to get that out into the public domain as well.
Steven Lichtman
Thanks Chris. And then lastly, can you talk about the rollout of smoking cessation? Can you remind us just in general, will it look similar to OCD in terms of the coil placement and then it will be more on a per patient basis? Is that the intention?
Christopher von Jako
Yes. So we're really looking forward obviously to rolling that out. And it depends really obviously working with the FDA on that to try to figure out when we can get the premarket clearance for that. So the goal would be to roll into a controlled market release, hopefully towards the end of this year or the beginning of next year.
And I'm really excited to have Chris Boyer on staff now. He and I worked together in the past. And we've done similar types of rollouts in the past. We haven't finalized actually the commercial roll up, how we're going to do it. And so we're hoping to share that with you on probably the next earnings call, the one after that.
But I could say it may be similar in the way as we've done OCD, but we need to finalize that.
Steven Lichtman
Thanks, Chris and Judy.
Christopher von Jako
Thank you Steven.
Operator
We will now be taking our next question from the line of Jeffrey Cohen from Ladenburg Thalmann. Please go ahead. Your line is now open.
Jeffrey Cohen
Perfect. So a couple of questions. So firstly on the OCD indication, it looks like you said you placed 10 units taking the total up to 183 for the quarter. On the other units, you're talking about 548 for Q1.
I'm a little off that number at around 525. I think I'm thinking about, what did I have, 202 sold, commercialized and around 324 as far as the lease program. Any insight there as far as where I am the low or for the quarter, how many were commercialized and were they purchased or leased?
Judy Huber
So I'm not sure where you may be low. I think that we had a strong placement of the 18 systems. The majority of those were on the lease side. And as you can see from the numbers, we only had about 17% of direct purchase deals in the first quarter.
Jeffrey Cohen
Got it. And on the smoking cessation, since your submission in April, has there been any discussion with the FDA since or nothing that you're waiting to hear back?
Christopher von Jako
No. We've had some discussions with the FDA, Jeff. They are ongoing discussions right now with the FDA.
Jeffrey Cohen
Okay. In running this study and interacting with some of these physicians out there, has there been any discussion about radically [ph] and any combo studies or head to head studies?
Christopher von Jako
Sorry, say it again, Jeff. I missed it.
Jeffrey Cohen
Has there been any discussion with any of the docs or centers as far as chances radically and doing some studies as comparisons?
Christopher von Jako
No, we haven't actually got to that point. There has been no discussions around that as of now.
Jeffrey Cohen
Okay. That’s all from me. Thanks.
Christopher von Jako
Thank you. Thank you so much.
Operator
There are no further questions on the phone.
Christopher von Jako
Sorry. Say it again, operator. I didn't hear you.
Operator
Sorry. There are no sure questions on the phone. Please go ahead.
Christopher von Jako
Okay. So thanks. In conclusion, I want to thank all of the investors and other participants for the interest in BrainsWay for joining today's call. I'd also like to thank the customers for partnering with BrainsWay and for their unrelented dedication to patient wellness. With that, please enjoy the rest of your day. Operator, you can end the call.
Operator
That does conclude our conference for today. Thank you for participating. You may all disconnect.
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