Chris von Jako
Analyst · Oppenheimer. Please proceed with your question
Thank you, Bob. Welcome everyone and thank you for joining us today. Today, we're extremely pleased to report third quarter 2020 revenues of $6 million, representing a significant 25% increase over our second quarter of 2020, and even a small increase over the same period last year, which of course was prior to the onset of COVID-19. These results were driven by a multitude of positive catalysts in our business in the industry overall. First, I'd like to provide a brief update on the current operating environment. Importantly, the large majority of clinics are now operating at or near-normal levels with some even experiencing patient treatment volumes above pre-COVID levels. This provides us with optimism as we head into the final months of 2020, but we have continued our judicious approach of implementing expense reductions without sacrificing our long-term growth objectives. Of course, business conditions during COVID continue to evolve and we will continue to monitor the impact of the pandemic on the fourth quarter operations, especially with the latest spike in cases across the U.S. With that said, according to the information from IQVIA, total patient visit metrics both in person and telehealth continue to improve in the U.S. We view patient visit data as a leading indicator of treatment volume and these metrics help provide us with confidence on the outlook of our business. To this end, patient visits to psychiatrists are up almost 60% and versus pre-COVID levels. These trends are very likely to continue as depression rate in the U.S. adults has tripled since the onset of COVID. Because Deep TMS has a clear patient impact and customer economic benefit, we believe that Brainsway has a critical role to serve in treating patients suffering from both depression and OCD. Importantly, Brainsway and our innovative Deep TMS therapy are highly differentiated by superior science, robust clinical evidence in industry-leading customer support. We have a vast clinical and commercial experience with our Deep TMS system. Which has been subject to – of no less than 32 completed randomized clinical trials, which is more than any other company in our field. Furthermore, Brainsway's Deep TMS has been utilized to treat over 95,000 patients for depression and OCD and this translates into over 2.5 million individual treatment sessions. Moreover, our flexible business model allows customers to be the lease or purchase our system, which continues to help grow the demand for our technology. In addition, favorable reimbursement trends for Deep TMS depression treatment continued to be an important tailwind for our business. We continue to see reductions in reimbursement requirements from four prior antidepressant treatment failures to two-prior failures. This significantly reduces the hurdles patients must overcome in order to access our life-changing treatment. Just in the last six months reimbursement requirements have been eased by Blue Cross Blue Shield in five states as well as by Cigna and Aetna. As of the end of the third quarter, Deep TMS for depression was covered by over 60 commercial insurers and all seven Medicare administrative contractors. These payers collectively represent more than 275 million covered lives. In general, we continue our efforts to leverage these favorable trends in depression reimbursement. This together with our efforts to obtain further clearances in seeking expanded coverage for these indications will help us expand our total addressable market. In this regard, we are highly focused on securing reimbursement in OCD, our second major indication which is a critical priority for BrainsWay. To further support our continued efforts, we recently expanded our reimbursement and market access team including the addition of a professional with over 20 years of relevant experience to lead our initiatives in this important area. I would like now to emphasize the ways in which BrainsWay has adopted a systematic wide-scale effort to utilize a meticulous data-driven approach towards commercial success. This ranges from significantly increasing our data for OCD to further bolstering the data around our positive safety profile and to tracking our marketing efforts and reach. In terms of OCD, we collected new post-marketing clinical data on 219 patients at 22-clinical Deep TMS sites, which was published in the peer-reviewed journal of Psychiatric Research. Our analysis of this real-world information resulted in several interesting findings within various subgroups. For example, the study show that 73% of patients reach initial response at an early stage of Deep TMS treatment, which was administered as an agile form of therapy. The data also revealed that the therapeutic effect can be maintained for weeks after treatment. We intend to leverage this new data with insurance companies as we continue our efforts to obtain reimbursement. As far as our safety profile as many of you may know, our device is not associated with any systematic side effects. However, BrainsWay has diligently collected comprehensive safety data to give us a better understanding of the risks or treatment and recently published its analysis in the Journal of Brain Stimulation. These findings indicate a marketed decrease in the risks associated with our device. We now have the most comprehensive published clinical safety data by far of any TMS company and we believe that it suggests a safety profile that is second to none in the TMS industry. It's also worth noting some impressive gains from our data we now track to better measure our website user volume and patient education initiatives. From April through October, approximately 3,200 registrants participated in 57 webinars hosted by BrainsWay. In the third quarter alone, organic user volume of our recently launched website increased by a robust 30%. To mark OCD awareness week, which took place in October, we teamed up with social media influencers in two OCD patients treated with Deep TMS to launch a social media campaign called #TheRealOCD. We yielded about 400,000 impressions from this campaign. And it was picked up by over 80 media outlets with a cumulative potential reach of 244 million. As I mentioned, we believe the metrics, initiatives and achievements all clearly demonstrate a persistent commitment to a data-driven commercialization approach. Moving on since becoming CEO of BrainsWay in January, I've spent a considerable amount of time working to strengthen our commercial structure into an industry-leading team. In order to further expand our sales efforts over the course of 2021, we intend to increase the number of U.S. sales territories we cover from the beginning of this year at 12 to 16. We also continue to see significant progress and opportunities for our business outside the U.S. Even amidst the pandemic we have seen a ramp in sales efforts from some of our distribution partners and agents. In Japan, we received regulatory approval for Deep TMS to treat depression. We continue to work through our distribution partner towards securing reimbursement in our steady contact with the relevant governmental authorities. Our commercial team is also actively working on developing various synergistic opportunities in other new territories around the globe. As I stated, expanding the marketing indications for Deep TMS is a key to our growth strategy to this end we were thrilled to announce in the third quarter that we received the third FDA-cleared indication for Deep TMS for smoking addiction. We view this milestone as further validation of our scientific leadership position and this represents the first FDA clearance in the addiction space for any TMS device. Smoking is one of the leading causes of death in the U.S. and also leads to other serious conditions such as lung cancer and heart disease. Approximately, 34 million U.S. adults smoke cigarettes and nearly 500,000 die from smoking each year. Further only around 6% of those who try to quit each year are successful. While other therapies are currently available, a substantial medical need continues to exist for treatments that can assist smokers in quitting. BrainsWay received FDA clearance in this indication based on data from a pivotal study of 262 patients. These patients were highly addicted to cigarettes with a long history of smoking and with 70% having failed three or more attempts to quit. Of those patients who completed a full course of Deep TMS treatment, 28% achieved four consecutive weeks of absence of smoking. In addition, the average number of cigarettes smoked per week dropped from 127 at baseline to 32 by week six. These compelling data has been submitted to a peer-reviewed journal for publication. As I mentioned on the previous earnings call, we are excited about this new indication and we're gearing up for a controlled market release during the first quarter of 2021. Our focus will be gathering closed marketing data and refining our broader launch strategy. Turning to Investor Relations. I want to emphasize that Judy and I remain highly active in sharing BrainsWay's compelling growth story with both institutional and retail investors. We recently participated in several virtual investor conferences sponsored by Cantor Fitzgerald, Oppenheimer, H.C. Wainwright and others and have multiple other investor events on a calendar over the next few months. Moreover, I'm pleased to share with you today that we will be hosting a key opinion leader virtual investor event this coming Monday, November 23 at 10:00 a.m. Eastern Time. This exciting event will feature Dr. Owen Muir of Brooklyn Minds who will discuss the current treatment landscape and unmet medical need in treating patients with depression and OCD. Before turning the call over to Judy, I want to acknowledge my gratitude to our hard-working customers on the front line of this mental health crisis. And to the entire BrainsWay team for their continued support and dedication which has produced significant achievements during the first nine months of this year. Thank you again for joining us today. With that, I will now pass the call to Judy for her review of our third quarter financial results. Judy?