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.
PATTERSON, N.J., April 13, 2020 – BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in the advanced non-invasive treatment of brain disorders, today announced a preliminary, unaudited revenue range for the first quarter ended March 31, 2020. Specifically, the Company expects first quarter revenues to be within the range of $3.9 million to $4.2 million.
“Our revenue estimate for the first quarter reflects the impact that the COVID-19 global health pandemic is having on our business,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “This impact is due in part to certain new customers who have not previously offered deep transcranial magnetic stimulation (Deep TMS) treatment being unable to finalize orders or to accept delivery of ordered systems as a result of the temporary shutdown of certain physician offices and clinics. Importantly, as TMS treatments are often considered a medical necessity, many offices and clinics with existing TMS technology remain open and operational. Therefore, many patients in need are still receiving their Deep TMS treatment. With a large and growing installed base of Deep TMS systems in major depressive disorder and obsessive-compulsive disorder, BrainsWay is well-positioned to serve these individuals.”
“Moreover, the Company is well positioned to fund our future growth due to our strong cash position and debt-free balance sheet. In order to limit the short-term impact of COVID-19 on our business, we have put in place a number of cost-cutting measures, such as reducing or temporarily eliminating our spend on travel, marketing-related events and various outside services, delaying salary raises, and freezing hires for certain positions,” continued Dr. von Jako. “Longer-term, the challenges posed by COVID-19 globally to so many people are, unfortunately, likely to evolve into mental health issues for some. Once this health crisis subsides, we look forward to being able to provide these individuals with an effective and safe solution through our Deep TMS system.”
BrainsWay is applying for the Payroll Protection Program Loan under the recently passed CARES Act and, to the extent other loan and aid
programs become available, will seek to participate in them as appropriate. The Company expects to report full first quarter financial results in June 2020.
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.