BrainsWay Reports Financial Results for Fourth Quarter and Full-Year 2018

Full-Year 2018 revenues of $16.4 million increased 47% over full-year 2017

Fourth quarter revenues of $4.8 million, up 32% over the prior year quarter

HACKENSACK, N.J., March 26, 2019 – BrainsWay Ltd. (TASE: BRIN), a leader in the advanced non-invasive treatment of brain disorders, has issued the Company’s financial results for the quarter and year ended December 31, 2018.

Full-Year 2018 Financial Highlights

• Total revenue for the year ended December 31, 2018, was $16.4 million, up 47% from the $11.1 million in the year ended December 31, 2017
  • Recurring leasing revenues of $9.6 million, an increase of 44% over the year ended December 31, 2017
• Installed base of approximately 383Deep TMS systems as of December 31, 2018, up 47% from the installed base of 259 systems at December 31, 2017
• Following receipt in August 2018 of marketing clearance from the U.S. Food and Drug Administration (FDA) for the Deep TMS System for the treatment of obsessive-compulsive disorder (OCD) in adults, BrainsWay shipped a total of 57OCD coils to new and existing customers through the end of 2018
• Newly signed contracts in the fourth quarter representing future projected revenues of $4.9 million increased BrainsWay’s minimal total committed projected revenues from current leasing customers at December 31, 2018, to $38.6 million, not including additional potential usage fees

Corporate Highlights

• Deep TMS System selected by the FDA from over 250 applications to participate in the “FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder,” a new program launched by the FDA to help combat the opioid crisis; furthermore, FDA has granted Breakthrough Device Designation for the Company’s deep transcranial magnetic stimulation (Deep TMS) system (with the H7-Coil) for the treatment of Opioid Use Disorder (OUD). These developments create an expedited pathway for prioritized FDA review of clinical trail design and potential future marketing authorization submissions.
• Deep TMS System approved in Japan by the PMDA for the treatment of patients suffering from Major Depressive Disorder who did not benefit from previous antidepressants
• Entered into exclusive distribution agreements in Asia-Pacific region
• Acquired a multi-channel TMS patent portfolio from TMS Innovations LLC, and entered into an exclusive option agreement with Stanford University granting BrainsWay the option to exclusively in-license additional multi-channel TMS-related patents
• Enrolled 257 participants in its multi-center study for smoking cessation. Expected completion of recruitment shortly after recruitment of 260 participants.

 Fourth Quarter 2018 Financial Highlights

• Fourth quarter revenue was a quarterly record of $4.8 million, up 32% over the $3.6 million of total revenues in the fourth quarter of 2017, and up 11% sequentially over total revenues in the third quarter of 2018
  • Recurring leasing revenues of $2.8 million, an increase of 45% over the fourth quarter of 2017
• Gross margin for the fourth quarter of 2018 remained 77%
• 23% reduction in operating loss to $1.7 million in the fourth quarter of 2018, as compared to an operating loss of $2.1 million in the fourth quarter of 2017

About BrainsWay

BrainsWay is engaged in the research, development and sales and marketing of a medical system for non-invasive treatment of common brain disorders. The medical system developed and manufactured by the company is based on a unique breakthrough technology called Deep TMS, which can reach significant depth and breadth of the brain and produce broad stimulation and functional modulation of targeted brain areas. In the U.S., the Company’s device has been FDA cleared for the treatment of major depressive disorder (MDD) since 2013, and in August 2018 was FDA cleared (De-Novo) for the treatment of Obsessive Compulsive Disorder (OCD). The Company’s systems have also received CE clearance and are sold worldwide for the treatment of various brain disorders.