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

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