Christopher von Jako
Analyst · Raymond James. Please proceed with your question
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?