Monthly Archives: March 2020

"When you're looking for a voice, you never know where it's going to come from."

Pete "Merf" Kelleher, one-third of the English production trio TMS, is musing about the runaway success of Lewis Capaldi's sparse and aching "Someone You Loved," which marks the biggest track in their already stacked discography.

"Traditionally, we've definitely been keen to overproduce records and just throw loads of sh-t in there," Kelleher explains to Billboard from the trio's home base in London. "It's really interesting that it's one of our biggest song ever and there's such minimal productions. There have been songs that took us months, meanwhile here we are with our most successful and it's so chill."

Kelleher, alongside cohorts Tom "Froe" Barnes and Ben Kohn, have carved out a unique niche on the charts. The childhood friends initially started out with hip-hop records, but a stint working on the U.K. iteration of The X Factorled them to a collaboration with Little Mix, which then enabled them to dive headfirst into the world of pop. Before long, they were focusing on crafting bubblegum singles for a range of British acts, whether the aforementioned girl group ("Wings" and "DNA"), boy band The Vamps ("Last Night") or singer-songwriter James Arthur ("You're Nobody 'til Somebody Loves You"). G-Eazy and Bebe Rexha's "Me, Myself and I" also served as an early glimmer of global success, peaking on the Hot 100 at No. 7 in 2016.

But it's with another singer-songwriter, the Scottish-born Capaldi, that the group has enjoyed their most impressive smash. "We've released a lot of stuff, but 'Someone You Loved' felt like a perfect storm," says Kohn of the sleeper hit's critical and commercial success which resulted in three weeks at No. 1 on the Billboard Hot 100 and seven weeks atop the chart in the U.K. While it was subsequently nominated for a Grammy, it wound up taking home song of the year honors at the recent Brit Awards, the latter experience being a mixed bag. "Not to totally sh-t on them, but you finally win and (as a producer or songwriter) you're lucky if you even get a seat, and if you get an award you have to pay for it," says Kohn, who noted that sharing the success with Capaldi made the honor a bit sweeter.

"We've all been best friends since we were kids, and to get to that point where you have this mad ride and it culminates in actually winning an award is absolutely mental," says Kelleher of the celebratory night. "Lewis and his team organized a boat trip on the river afterwards with his friends, family and all of us. We were trying to thank him for everything he had done for us and he wasn't having it. He was too busy thanking us. We couldn't get him to accept it."

The slow-burn success of "Someone You Loved," which was released in November 2018 and didn't top the Hot 100 until a few days shy of a full year later (a strategy the trio credits to Capaldi's manager Ryan Walter), mirrored the gradual collaborative process that birthed the future hit. "Our first session with Lewis was in the summer of 2017," remembers Kohn of the creative rendezvous that was set up between Capaldi and their manager Paul Centellas. "The songs we wound up making that day were all above average. Lewis' voice was amazing and there was really good energy, so with all that we knew there was something there." Those initial tracks have yet to see the light of day, and the trio and Capaldi didn't meet again until a year later.

During a third session in August 2018, however, TMS and Capaldi bore tangible fruit. "We wrote another song and then there was a little lull, so we said, 'Let's work on something else for a couple of hours.' Then we made and pretty much finished 'Someone You Loved.'"

"Lewis only did three takes of the chorus and almost every sound you hear in that record was made in those two hours," says Barnes of the rapid fruition, which was also a result of a budget as minimal as its eventual production. (The song is inspired by Capaldi's grandmother, with the singer creating the song's melody 10 minutes prior to his session with TMS.) "Production-wise there's not much in there, but what is, is important," explains Barnes, who also helped Capaldi co-write its tender lyrics with Kohn and Kelleher. "The only thing that was added and taken away was strings. I also think there might have been a hint of a halftime snare for five minutes in my headphones, but it was quickly taken away."

Did the guys think the song would become a milestone in their career? "We write 250 or 300 songs a year," notes Kelleher. "It was another great cut with Lewis, but whenever somebody says 'This is a hit!' what they mean is, 'This is one of the better ones.' Like, so much sh-t has to happen for it to be a hit. It almost didn't make the album."

The trio, who first started concocting tracks a full two decades ago, has no doubt entered a new career phase after the explosive success of "Someone You Loved." With the commercial peak of the Capaldi track behind them, they're now looking forward to the release of a pop record with another yet another English artist: Dua Lipa. TMS is credited with producing Lipa's "Cool" from her upcoming Future Nostalgia, and much like the incongruous journey that birthed "Someone You Loved," "Cool" has faced similar twists and turns.

"We actually started it at a writing camp for Rihanna at (London's) RAK Studios," says Kelleher of the massive opportunity, with TMS working alongside British singer-songwriters Kamille and Shakka. "You turn up with all of your gear and it was promised Rihanna would be there, so we brought our A-game."

While the pop superstar never actually appeared, the enticing possibility of an impending visit pushed the group to concoct four songs within a 12-hour period. "Out of those four, three have been cut," says Kelleher. "One was a Kamille record, one was cut by Gorgon City and then 'Cool' is coming out with Dua. It underwent a rewrite and it's now pretty wildly changed, she made it her own. We're pretty proud of it and can't wait to hear it in the context of the album."

With the "Someone You Loved" cycle coming to a close and a new era dawning, the trio likens their success to a video game. "It's like reaching another level," says Kohn. "You're not worried about the boss you just beat, you're trying to beat the next boss. I think when you're experiencing everything in the moment you're going, 'Wow, that's crazy,' but I don't know how much you're feeling it. It's really about what's next."

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Production Team TMS on the Unlikely Success of 'Someone You Loved' - Billboard

Fourth quarter revenues were $6.3 million, up 32% over the same quarter in the prior year

PATTERSON, N.J., March 23, 2020 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (BrainsWay or the Company), a global leader in the advanced non-invasive treatment of brain disorders, today reported financial results for the quarter and full-year ended December 31, 2019, and provided an operational update.

We are very pleased with our solid fourth quarter and full-year 2019 results. Our strong results are indicative of the continued growing demand for our deep transcranial magnetic stimulation (Deep TMS) system in major depressive disorder (MDD) and obsessive compulsive disorder (OCD). In addition, we have achieved key progress in advancing our clinical pipeline for future potential applications, stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. Like other organizations, BrainsWay continues to monitor the rapidly evolving impact of the coronavirus closely, and our thoughts are with all of those affected. Without question, our top priority is the health and well-being of our loyal and growing customer base, their patients, and our employees. We have already taken steps to minimize the spread of coronavirus, while at the same time ensuring our customers that we remain fully operational as patients continue to receive their Deep TMS treatments.

Financial Results for the Full-Year Ended December 31, 2019

Financial Results for the Fourth Quarter Ended December 31, 2019

Recent Corporate Developments

Conference Call and WebcastBrainsWays management will host a conference call on Monday, March 23, 2020, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Monday, March 23, at 8:30 AM Eastern Time:

Telephone conferenceDial in information:Standard international: +44 (0) 2071 928000Israel, Tel Aviv (Local):+972-3 721 7998 United States, New York (Local):+1 631-510-7495 Confirmation Code: 7074659

To listen to a live webcast, please visit the Investors section of the BrainsWay website at http://www.BrainsWay.com. The webcast replay will be available on the website for two weeks following the completion of the call.

About BrainsWay BrainsWay is a commercial stage medical device company focused on the development and sale of non-invasive neuromodulation products using the Companys proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) technology for the treatment of major depressive disorder (MDD) and obsessive compulsive disorder (OCD), for which BrainsWay received marketing authorization from the U.S. Food and Drug Administration (FDA) in 2013 (for MDD) and in August 2018 (for OCD). BrainsWay is currently conducting clinical trials of Deep TMS in other psychiatric, neurological and addiction disorders.

Forward Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words intends, may, will, plans, expects, anticipates, projects, predicts, estimates, aims, believes, hopes, potential or similar words. 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. For example, such uncertainties include the recent outbreak of theCoronavirus (COVID-19), whichhas led governments and authorities around the globe to take various precautionary measures in order to limit the spread of theoutbreak, including government-imposed quarantines and other public health safety measures. These measures could have an adverse effect on the global markets and its economy, including on the availability and pricing of materials, manufacturing and delivery efforts, sales to existing and potential customers and leads, collections from accounts and other aspects of the global economy. Therefore, theCoronaviruscould disrupt production and cause delays in the supply and delivery of products used in our operations, may further divert the attention and efforts of the medical community to coping with theCoronavirus, impact the recruitment of subjects to existing and planned clinical trials, disrupt the marketplace in which we operate, and may have a material adverse effects on our operations, sales, revenues, collections, and R&D efforts. 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 in the Companys 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 Companys 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.

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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 Companys filings with the U.S. Securities and Exchange Commission.

Contacts: BrainsWay Ltd. Hadar Levy Chief Operating Officer and Chief Financial Officer Hadarl@BrainsWay.com

Investors:Bob YedidLifeSci Advisors646-597-6989Bob@LifeSciAdvisors.com

BRAINSWAYLTD.

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BrainsWay Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights - Yahoo Finance

Russian President Vladimir Putin has ordered the country's military to extend all help to Italy, following which among other things the Russian military will be deploying a Soviet-era jet engine power disinfection machine, TMS-65U.

TMS-65U is a special disinfection truck with a jet engine mounted in the back, which the Russian military uses to clean vehicles coated in chemical agents or create massive smokescreens to hide friendly movements on the battlefield.

A TMS-65U vehicle is made up of a Ural-375 6x6 4.5-ton truck with a modified Klimov VK-1 turbojet engine first used in the MiG-15 fighter jet in 1947 mounted inside a turret on the rear of the vehicle.

These military vehicles are handled by Russia's Nuclear, Biological, and Chemical Protection Troops, also known collectively by the acronym RKhB.

The RKhB is a chemical warfare unit, which was formed during the Soviet era in 1918. In modern Russia, RKhB is tasked with identifying nuclear, biological, and chemical hazards and decontaminating impacted areas.

The RKhB provides similar services after any terrorist attack involving weapons of mass destruction or man-made or natural disasters involving similar threats.

Russia extends all help to Italy

As per a statement by the Russian Defense Ministry, President Vladimir Putin has issued the order to the country's military sanctioning all support to Italy by sending medical help from Sunday. The Russian military has been briefed to provide all help to Italy to battle the new coronavirus (COVID 19).

The order was dispatched from President Putin's officer after Italian Prime Minister Giuseppe Conte held a long conversation over the phone with Putin on Saturday.

In the conversation, the Russian leader offered his support and help in the form of mobile disinfection vehicles and specialists to help the worst-hit Italian regions, reported The Moscow Times.

On Saturday, Italy recorded its worst death count from coronavirus of almost 800, taking the toll in the world's hardest-hit country to over 5,000.

The Russian Defense Ministry said military transport planes would deliver eight mobile brigades of military medics, special disinfection vehicles and other medical equipment to Italy starting from Sunday. A total of seven cargo planes will be flying to Italy from Russia to drop all the necessary items and the team.

Russia will also be deploying about 100 military personnel from the virology and epidemics department, Interfax cited the Defense Ministry as saying.

In Russia, until now there has been only one coronavirus related deaths, and 306 reported cases of COVID 19 infection.

Read more:

VIDEO: What is TMS-65U? Soviet-era MiG-15 fighter jet engine powered special vehicle deployed by Russia to battle coronavirus in Italy - International...

Mar 23, 2020 (Thomson StreetEvents) -- Edited Transcript of Brainsway Ltd earnings conference call or presentation Monday, March 23, 2020 at 12:30:00pm GMT

* Christopher R. von Jako

Brainsway Ltd. - President & CEO

Brainsway Ltd. - CFO & COO

Raymond James & Associates, Inc., Research Division - Senior Medical Supplies and Devices Analyst

Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research

Oppenheimer & Co. Inc., Research Division - MD and Senior Analyst

* Robert A. Yedid

Ladies and gentlemen, thank you for standing by, and welcome to today's BrainsWay reports Fourth Quarter and Full Year 2019 Financial Results and Operational Highlights Conference Call. (Operator Instructions) I must advise you that this conference is being recorded today, Monday, the 23rd of March 2020.

I would now like to hand the conference over to your first speaker today, Bob Yedid. Thank you. Please go ahead, sir.

Robert A. Yedid, LifeSci Advisors, LLC - MD [2]

Good morning, and afternoon to everyone. I'd like to welcome all of you to BrainsWay Ltd.'s Fourth Quarter and Full Year Conference Call. With us today are Chris von Jako, Chief Executive Officer; and Hadar Levy, Chief Financial Officer. They will provide an overview of the company's business activities and developments for the fourth quarter. We will then open up the call for questions and answers.

Before I turn over the call to Chris and Hadar, 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 and other 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 time lines. When used in this call, the words anticipate, could, enable, estimate, intend, expect, believe, potential, will, should, project and similar expressions as they relate to BrainsWay are, as such, a forward-looking statement. 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 that 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 F1 and its other filings with the Securities and Exchange Commission.

Today, the company issued a press release announcing the financial results for Q4 and full year 2019. So participants in this call who may have not already done so can find this release on BrainsWay's website as we provide a summary of the results on this call.

With those remarks, I'd like to now -- it's my pleasure to turn the call over to BrainsWay's CEO, Chris von Jako. Chris?

Christopher R. von Jako, Brainsway Ltd. - President & CEO [3]

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Thank you, Bob, and welcome, everyone, to BrainsWay's Fourth Quarter and Full Year 2019 Earnings Call. As you know, I stepped into the role of CEO in January of this year, although I had the opportunity to introduce myself on our third quarter earnings call last November.

Today, I'd like to provide you with an overview of how I spent my first 80 days as CEO as well as my initial impressions of BrainsWay. I'll turn the call over to Hadar Levy, our Chief Financial Officer, to discuss our financial results after. I'll then conclude by highlighting our R&D efforts and clinical trial activities as well as other key focus areas for 2020.

With that, let me begin by briefly reviewing my first few months as CEO. Over this period, I've spent a significant amount of time listening to our key stakeholders, including customers, key opinion leaders, our sales and development teams and investors. Quite simply, these interactions have left me even more energized and optimistic about our future potential than it already was. We have developed some great relationships with our current customer base, and we have a clear opportunity to grow with these existing customers and expand with new customers.

From a technology standpoint, we have a safe and effective product that has well-differentiated technology to serve multiple very large markets of underserved patients. Importantly, we are not only focused on the growth of our technology for major depressive disorder, or MDD, which itself represents a target market of over 17 million patients in the U.S., but also for obsessive compulsive disorder, or OCD, which affects over 2 million patients in the U.S. alone. Moreover, we have a robust pipeline of other psychiatric, neurological and addiction disorders.

I would now like to briefly discuss the coronavirus, which is causing meaningful complications to daily life and business operations for us all. Our primary concern is for the health and safety of our customers, their patients, our employees and their families. We are following all CDC guidelines to help combat this global health pandemic. Of course, these are challenging times, and we recognize the importance of patients continuing to receive their Deep TMS treatment. Therefore, BrainsWay remains fully operational and dedicated to serving customers to the best of our ability.

With investors, because travel has been severely limited, we are now operating in a virtual world. With that said, we have been aggressively telling our story to investors and are continuing to build relationships that will serve us well. In fact, I recently conducted conference calls with investors around 2 large health care investment bank-sponsored meetings. We will continue to conduct virtual meetings with investors over the coming months in order to share our company's differentiated technology and value proposition.

As I mentioned, our Deep TMS system has demonstrated clinical efficacy in MDD and OCD and is well tolerated. Of significance, our FDA clearance in both MDD and OCD provide us with substantial competitive advantage in the marketplace. Our customers can treat both sets of patients with our platform technology, while other TMS technologies can only treat MDD patients.

With this, we have a unique opportunity to create a medical device leader in the noninvasive brain disorder treatment space. We have a proven track record of sales execution, continue to focus on the science to improve our technology and conduct clinical trials to potentially expand into new indications. In addition, we have a strong balance sheet with the necessary resources to support our growth plans as well as a talented and dedicated employee base.

We delivered very solid results in the fourth quarter and full year 2019. Moreover, I'm proud to report that we installed our 500th system in the fourth quarter. We now have treated over 50,000 patients and delivered over 1 million treatments with our Deep TMS system. We also delivered positive results in multiple clinical studies, which I will discuss further following Hadar's review of the financial results.

Before I turn the call over to Hadar, I'd like to briefly discuss the importance of what we do here at BrainsWay every day. When people think of the costliest major health conditions, diseases such as cancer, diabetes and heart disease always come to mind. However, the conditions that top the list are diseases that unfortunately also have had a long stigma associated with it, mental health disorders.

Today's most common treatment options are various forms of psychiatric medications and therapy. More recently added are -- and far less common are neurostimulation devices that are implanted into the brain. For this reason, I could hear the excitement and the voices of many psychiatrists I have talked to about BrainsWay's noninvasive Deep TMS. It is clear to me that they view Deep TMS as a potential game-changing option for many people suffering from mental health disorders.

With that, I will now pass the call over to Hadar for his review of our financial results.

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Hadar Levy, Brainsway Ltd. - CFO & COO [4]

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Thank you, Chris. We are very pleased with our strong performance in the fourth quarter and throughout the year in 2019. Our positive results reflect the continued increase in demand for our Deep TMS system.

Let's turn to our key results for the fourth quarter of 2019. We generated a quarterly record revenue of $6.3 million, an increase of 32% over the fourth quarter of 2018. Our recurring revenue was $3.5 million, an increase of 25% year-over-year. This recurring revenue demonstrates the benefit of the BrainsWay business model, in which a significant portion of our Deep TMS customers entered into a lease arrangement that generates recurring revenue over a 3- to 4-year period and provides greater predictability of our future growth.

Since year-end 2018, BrainsWay installed base has increased by 147 systems, reaching a total of 530 Deep TMS systems as of December 31, 2019, and reflecting a quarter-over-quarter increase of 42 systems.

At year-end 2019, the company had shipped 173 OCD coils as add-on helmets to certain of BrainsWay new and existing systems since marketing clearance was obtained in August 2018. You will recall that in the third quarter, demands for additional OCD coils outpaced our ability to fully satisfy all the orders we received. As we expected, this additional demand was fulfilled in the fourth quarter. I should add that we continue to work to obtain reimbursement in the U.S. for our OCD treatment.

While I will review our financial results in greater detail shortly, you will note an increase in our operating expenses year-over-year in the fourth quarter and for the full year of 2019. This is primarily due to the investments we are making in the future growth of our business, one of the key objectives we set when we successfully completed our U.S. IPO last year.

We added a net of 6 new sales professional in 2019, ending the year with 18 total sales professional in the U.S. We intend to add approximately 6 new sales professional in 2020.

As a reminder, a key part of our strategy is that we intend to execute upon our growth strategy by continuing to invest in our sales and marketing activities globally. While we are attuned to the short-term challenges in this difficult period, we remain confident that this investment will help drive long-term growth.

Now I would like to provide a detailed review of our financial performance in the fourth quarter of 2019. I discussed our strong top line results earlier, so I will now review our profitability metrics. Gross profit for the fourth quarter of 2019 was $4.9 million, an increase of 32% from $3.7 million during the prior year period. Gross margin for the fourth quarter of 2019 was 77%, the same as the prior year period. Research and development expenses for the quarter were $1.8 million, similar to the same period in 2018 and primarily consisted of the continued development of our Deep TMS technology, including finalizing the smoking cessation study and conducting clinical trials for treatment of PTSD and other disorders. Sales and marketing expenses for the fourth quarter of 2019 were $3.6 million, an increase of $1.1 million over the prior year. The increase was mainly driven by enhanced marketing activities for MDD and OCD, and a larger number of sales professional as compared to 2018. General and administrative expenses for the quarter were $1.4 million as compared to $1.1 million in the prior year period. This increase was driven by additional costs associated with our current status as a public company in the U.S. and an increase in noncash provision for doubtful debt. Total operating expenses for the fourth quarter totaled $6.8 million compared to $5.4 million a year ago. For the fourth quarter ended December 31, 2019, we incurred a net loss of $2.3 million compared to $2.1 million recorded in the fourth quarter of 2018.

For the full year of 2019, we are proud of our strong growth in revenue and systems. In 2019, we reported revenue of $23.1 million, an increase of 41% over our revenue of $16.4 million in 2018. The recurring revenue was $13.3 million, an increase of 38% over 2018. In 2019, we incurred a net loss of $10.4 million compared to $6.5 million in the prior year as we increased our sales and marketing effort and incurred higher expenses as a public company.

Moving to the balance sheet. We ended 2019 with a cash and cash equivalent of $21.9 million compared to $23.7 million as of September 30, 2019. Cash used during the fourth quarter was in line with our expectations. We believe that our strong balance sheet will allow us, at appropriate time, to expand our sales and marketing efforts further to drive additional adoption of the Deep TMS system, continue to invest in R&D in order to explore new potential indications.

With that, I'd like to turn the call over to Chris for some further thoughts before we open up the call for questions and answer. Chris?

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Christopher R. von Jako, Brainsway Ltd. - President & CEO [5]

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Thanks, Hadar. I would like to discuss our ongoing efforts to ramp up our R&D efforts. We have a robust clinical pipeline, including studies in multiple potential indications for Deep TMS beyond our FDA-cleared treatments for MDD and OCD. During the fourth quarter, we announced final positive results from our multicenter smoking cessation study. The data from this large randomized pivotal study demonstrated that our Deep TMS can potentially play an important role in helping cigarette smokers who seek to quit. Within the next few weeks, we intend to submit a 510(k) application to the FDA for this expanded indication. We expect a regulatory decision from the FDA and our submission within the next 12 months.

Importantly, our preparations for this new and large potential indication are currently underway. Approximately 38 million U.S. 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.

Last month, we also announced positive results from our feasibility study of Deep TMS in the treatment of adults with ADHD. The results showed a statistically significant improvement in patient-reported assessments of inattention, together with a significant increase in activity that was observed within the dorsolateral prefrontal cortex, a part of the brain previously shown to have reduced activity in adults with ADHD. These patients currently take a significant amount of medications, some of which carry substantial side effects. And the compelling results of the study indicate that Deep TMS to potentially provide a nonpharmaceutical treatment option. We are currently evaluating the next steps further -- for further research into this area.

We also recently announced the interim results in our PTSD study. Unfortunately, Deep TMS did not demonstrate sufficient efficacy relative to sham-controlled treatments of PTSD patients. Based on this interim analysis, we will not invest additional resources in order to continue this study. We are, however, performing additional analysis and considering future PTSD studies using alternative parameters.

In opioid abuse, please recall that BrainsWay was selected by the FDA as part of its innovation challenge and received a breakthrough device designation by the FDA. We continue to work internally and with FDA in an effort to initiate this study. We expect to submit an investigational new device application later this year.

Moving on, I would like to highlight the appointment of Avner Lushi to our Board of Directors in February. Avner is an accomplished business leader with close to 20 years of experience in the health care industry as well as in corporate strategy and finance. We look forward to his continued contributions to our business.

Now to summarize. We had an outstanding 41% growth in year-over-year revenues driven by demand for our Deep TMS system. For 2020, we are focused on continued implementation of our growth strategy in target regions in the U.S., our continued efforts to secure reimbursement for OCD, target expansion efforts in OUS regions, improving our overall operational efficiency, executing our planned clinical trials and product development initiatives. We're also increasing our investor relations outreach, and we have a number of investment conferences on the schedule for the year. We will continue to conduct -- continue meeting with -- in-person and virtually with key investment analysts and institutional investors throughout the year. With that, I will now ask the operator to please turn it over for questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) We have your first question from the line of Craig Bijou of Cantor Fitzgerald.

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Craig William Bijou, Cantor Fitzgerald & Co., Research Division - Research Analyst [2]

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Let me start with a couple on COVID-19. So I think you guys do have some visibility into the utilization of your systems. So I wanted to know what kind of impact are you seeing in terms of patients getting treatment? Or what have you been hearing from your customers? And then also maybe just comments on how the -- how COVID-19 has impacted your selling process?

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Christopher R. von Jako, Brainsway Ltd. - President & CEO [3]

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Craig, thanks a lot. Appreciate the question. Obviously, as I said in our opening statements, obviously, it's impacting all of us. We have reached out to a number of our customers, some of the large and even smaller customers, and we continue to do so. For now, we see that these are essential treatments for these patients, and they're continuing to treat in a majority of our centers, which obviously is great. I think, in general, from what we have heard from a number of our clinics that they're taking, obviously, extra precautions. In addition to that, they're obviously taking additional extra precautions with elderly patients. So with that, you also asked a question, I think, about the sales force. Is that what you did, I'm sorry?

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Craig William Bijou, Cantor Fitzgerald & Co., Research Division - Research Analyst [4]

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Yes. Just the impact that some of the restrictions are having on your -- the sales process that you guys are seeing?

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Christopher R. von Jako, Brainsway Ltd. - President & CEO [5]

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Yes. I mean it really is regionally dependent right now, depending on state to state. Our salespeople are still getting out and having meetings, but they're doing quite a bit of also virtual meetings. We've had some really good success over the last 2 weeks of having virtual meetings, and it was really nice to hear from a number of the salespeople about that, those are continuing to happen. So I think we're continuing to push forward in our sales efforts. Obviously, we are hampered by what's happening, but we're continuing to push forward.

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Craig William Bijou, Cantor Fitzgerald & Co., Research Division - Research Analyst [6]

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Great. That's helpful. On OCD helmets, they were obviously strong in the quarter. Hadar, I think you talked specifically about that. But just remind us how we should think about the timing of contribution -- timing and amount of the contribution? And maybe if you can just expand on your thoughts on the reimbursement timing?

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Hadar Levy, Brainsway Ltd. - CFO & COO [7]

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So -- obviously, the reimbursement is the key factor for the usage of the coil. We do see some increase in the usage of the OCD. Right now, I would say that it's not really material, but we are very happy to see the increase of usage of the OCD. With respect to the reimbursement, we're still working very hard to get the reimbursement, and we hope to get the reimbursement as soon as possible.

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Craig William Bijou, Cantor Fitzgerald & Co., Research Division - Research Analyst [8]

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Great. And last one for me. Just how should we think about cash burn in 2020, maybe relative to 2019? And then, I guess, how do you plan on balancing some of your investments to grow the business versus any of the near-term disruption from COVID-19?

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Christopher R. von Jako, Brainsway Ltd. - President & CEO [9]

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So yes, thank you for the question. Obviously, from our part, we're looking at things from a cash conserve -- we're trying to conserve our cash at the moment in certain places. So we're kind of looking, from an expense side, we had some open headcount, and we're probably pushing those off for a little bit. We're looking at other cash conserving measures as well.

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Operator [10]

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Your next question comes from the line of Jayson Bedford from Raymond James & Associates, Inc.

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Jayson Tyler Bedford, Raymond James & Associates, Inc., Research Division - Senior Medical Supplies and Devices Analyst [11]

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Just a few, and not surprisingly, they're COVID-19 related. But as you think about the current U.S. market, are capital decisions still being made? And would you expect to see more interest in the lease model versus the outright sale model?

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See the rest here:

Edited Transcript of BRIN.TA earnings conference call or presentation 23-Mar-20 12:30pm GMT - Yahoo Finance

Pokemon GO

The excitement around this is inevitably dampened due to the coronavirus pandemic, but Pokmon GO has made some adjustments to the new A Drive to Investigate research event that should make it easy to do without groups and, ideally, possible to complete without leaving your house. The new Genesect special research went live this morning, and so we can get an idea of all quest steps and rewards thanks to players around the world. If you were wondering whether or not to drop some cash on it, this should help.

Here are the steps:

Part 1

Part 1 rewards: 5 Premium Raid Passes, Pinsir encounter and Genesect Cap

Part 2

Part 2 Rewards: 3 Charged TMs, Skarmory encounter and 3 Super Incubators

Part 3:

Part 4:

Part 4 rewards:3 Fast TMs, Genesect encounter and Glacial Lure Module

Part 5:

Part 5 rewards: Poffin, 10 Genesect Candy and 3 Star Pieces

And there you have it. This will not be the most interesting special research weve ever done, but these are trying times. If you want to play without leaving the house, remember that incense is stronger and cheaper than usual, and that you dont have to do this all right away. Just wait it out, catch what you can and you can accomplish this in no time.

Well have more updates soon, but I wonder what its like over at Niantic right now. As it becomes clear that we may be in this for the long haul, I imagine theyre working on mew ways to make this playable from home that they might never have considered otherwise.

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A Drive To Investigate: Full Genesect Special Research Tasks, Steps And Rewards In Pokmon GO - Forbes