BrainsWay Reports Record Financial Results for First Quarter of 2018 and Provides Corporate Update

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First quarter revenues of $3.6 million represent a quarterly record and a  68% increase over first quarter 2017

Increased market demand and leasing model continue to generate sales growth

HACKENSACK, N.J., May XX, 2018 – BrainsWay Ltd. (TASE: BRIN), a leader in the advanced non-invasive treatment of brain disorders, today announced the Company’s financial results for the first quarter ended March 31, 2018, and provided a corporate update.

“Our business model, based on leasing our Deep Transcranial Magnetic Stimulation system (Deep TMS), continues to generate significant market demand and meaningful revenue growth,” said Yaacov Michlin, Chief Executive Officer of Brainsway. “As evidence of this, we reported a quarterly record $3.6 million in total revenue in the first quarter of 2018, an increase of 68% over the first quarter of 2017. Moreover, we continued to increase backlog of committed projected revenues to approximately $25 million at the end of the first quarter.”

“Early in the second quarter, we received 510(k) clearance from the FDA for our next-generation stimulator to be integrated with our Deep TMS system and we launched it with strong interest from the market during the APA conference. Moreover, we are awaiting the FDA’s response on our De Novo application to market our Deep TMS device for the treatment of obsessive compulsive disorder in the U.S. Brainsway’s current business continues to gain traction in the marketplace, while we are also focused on preparing the Company for its next stage of growth driven by clinical and technological innovation,” concluded Mr. Michlin.

Corporate Highlights

  • Received U.S. Food and Drug Administration (FDA) clearance for next-generation stimulator, enhancing the complete Deep TMS system and streamlining treatment for physicians and their patients
  • Continued development of a clinical trial protocol for the Deep TMS device to assess its safety and efficacy in the treatment of patients with opioid use disorder
  • Anticipate regulatory decision shortly from FDA for the use of the Deep TMS system for the treatment of obsessive compulsive disorder
  • Continued patient recruitment into multi-center smoking cessation and PTSD clinical trials for Deep TMS; completion of smoking cessation study expected by end of 2018

First Quarter 2018 Financial Highlights

  • Leasing model continues to generate significant quarter-over-quarter revenue growth
  • Total first quarter 2018 revenue was a record $3.6 million, up 68% over the $2.1 million of total revenues in the first quarter of 2017
    • Leasing revenues of $2.1 million in the first quarter of 2018
    • Sales revenues of $1.5 million in the first quarter of 2018
  • Newly signed contracts increased Brainsway’s backlog at March 31, 2018, to $24.9 million in total committed projected revenues from current leasing customers, not including additional potential usage fees

Balance Sheet

At March 31, 2018, the Company had cash, cash equivalents and short-term deposits of $15.4 million, as compared to cash, cash equivalents and short-term deposits of $16.5 million as of December 31, 2017. Brainsway’s cash use rate is approximately $1 million per quarter, with a reduction of cash burn rate to approximately $600,000 for operational expenses.

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 and breakthrough technology called Deep TMS, which can reach the depth of the brain and produce nerve stimulation or suppression. In the US, the Company’s device is FDA cleared for the treatment of major depression (MDD), and about 90% of MDD patients are eligible for coverage (including from both private and governmental payors).  The Company’s systems have also received CE clearance and are sold worldwide for the treatment of various brain disorders.