This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
Fourth quarter revenues were $6.3 million, up 32% over the same quarter in the prior year.
PATTERSON, N.J., March 23, 2020 – 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
• Total revenue for the year ended December 31, 2019, was $23.1 million, up 41% from $16.4 million generated in 2018.
• Total lease revenue for the year was $13.2 million, up 38% from $9.6 million in 2018.
• As of December 31, 2019, BrainsWay’s Deep TMS installed base was 530 total systems after adding 42 systems during the fourth quarter. This is compared to 383 total systems at year-end 2018.
• As of December 31, 2019, the Company had shipped 173 OCD coils as add-on helmets to certain of BrainsWay’s new
and existing systems since marketing clearance was obtained in August 2018.
• Net loss for the year was $10.3 million, compared to a loss of $6.5 million in 2018.
• As of December 31, 2019, the Company had cash and short-term investments of approximately $21.9 million, compared to $23.9 million at September 30, 2019. BrainsWay has no debt (other than certain liabilities with respect to R&D grants).
Financial Results for the Fourth Quarter Ended December 31, 2019
• Quarterly record revenue of $6.3 million, an increase of 32% over the fourth quarter of 2018.
• Quarterly recurring revenues of $3.5 million, an increase of 27% over the fourth quarter of 2018.
• Gross margin for the fourth quarter of 2019 was 77%, the same as the fourth quarter of 2018.
• Research and development (R&D) expenses for the quarter were $1.8 million, in-line with the R&D expense recorded during the same period in 2018.
• Sales and marketing expenses for the quarter were $3.6 million, compared to $2.5 million in the same period in 2018. The increase was primarily driven by an expansion of the sales force and enhanced marketing activities primarily in the U.S. for both MDD and OCD.
• General and administrative expenses for the quarter were $1.4 million, compared to $1.1 million for the same period in 2018. The increase was due to additional costs associated with BrainsWay being a public company in the U.S. and an increase in an allowance for doubtful accounts.
• Operating expenses for the quarter totaled $6.8 million, compared to $5.4 million in the fourth quarter of 2018. The increase was primarily driven by the enhanced sales and marketing activities, as well as the increased general and administrative costs incurred following BrainsWay’s IPO on the NASDAQ in April 2019.
• Operating loss for the quarter was $2.0 million, compared to $1.8 million for the same period in 2018. The increase in operating loss is in-line with the Company’s strategy to accelerate growth by increasing the size of its sales force and enhancing marketing activities globally.
• Net loss for the quarter was $2.3 million, compared to $2.1 million for the same period in 2018.
• Cash used in operating activities for the three months ended December 31, 2019, was $1.2 million, compared to $1.0 million in the fourth quarter of 2018. During the fourth quarter of 2019, the Company increased its net trade receivables by $0.5 million.
Recent Corporate Developments
• Appointed Dr. von Jako, a science-driven senior executive with over 25 years of experience managing businesses and leading global medical technology companies, as President and Chief Executive Officer.
• Reported positive final results of pivotal, multicenter study evaluating Deep TMS for smoking cessation; the study met both the primary and secondary endpoints with statistical significance.
• In advanced stages of preparing premarket notification (510(k)) application for submission; regulatory decision
from U.S. Food and Drug Administration generally expected within 12 months from time of submission.
• Reported positive results from a randomized controlled double-blind clinical trial evaluating Deep TMS for the treatment of adults with ADHD.
• Data showed a statistically significant improvement in patient-reported assessments of inattention, in addition to
a substantial 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.
• Announced that interim results from a multicenter randomized controlled double-blind clinical trial of Deep TMS did not demonstrate sufficient efficacy relative to sham control treatment in post-traumatic stress disorder patients.
• Based on the interim analysis, the Company will not invest additional resources in order to continue this study.
• Appointed Avner Lushi, an accomplished business leader with close to 20 years of experience in the healthcare industry, as well as in corporate strategy and finance, as an independent director to the Board of Directors.
Conference Call and Webcast
BrainsWay’s 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:
Dial in information:
Standard international: +44 (0) 2071 928000
Israel, 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 www.BrainsWay.com. The webcast replay will be available on the website for two weeks following the completion of the call.
BrainsWay is a commercial stage medical device company focused on the development and sale of non-invasive neuromodulation products using the Company’s 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.