Solana Company Q4 FY2020 Earnings Call

· Earnings call transcript and AI-powered summary

  • Date: Q4 2020 and Full Year 2020
  • Company: Helius Medical Technologies
  • CEO: Dane Andreeff
  • CFO/COO: Joyce LaViscount
  • VP & GM, Canadian Operations: Mark Leno

US Regulatory Progress

  • Focus is on gaining US FDA clearance for PoNS device for gait deficit in MS patients (~1M MS patients in the US).
  • Received Breakthrough Device Designation from FDA in May 2020.
  • Submitted a de novo classification and clearance request on August 4, 2020.
  • Received additional information request from FDA in October; response submitted January 11, 2021.
  • Expected FDA decision within 150 days of complete submission, likely in first half of 2021.

Canadian Commercial Update

  • Q4 2020 revenue: $191,000, up from $152,000 in Q4 2019 (+25.6%).
  • Continued business disruption due to COVID-19 restrictions impacting clinic operations and patient visits.
  • 31 clinics now trained and authorized for PoNS treatment, with varying degrees of limited capacity (15%-40%).

Financial Overview

  • Gross Loss: $10,000 in Q4 2020, improved by $146,000 YoY (94% reduction).

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Operator: Please standby. Good evening ladies and gentlemen, and welcome to the Fourth Quarter and Fiscal Year 2020 Earnings Conference Call for Helius Medical Technologies. At this time, all participants have been placed in a listen-only mode. Please note that this conference call is being recorded, and that the recording will be available on the company's website for replay shortly. Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including among other things risks and uncertainties around the clinical development process and FDA regulatory submission and approval process and other risks identified in the Risk Factors section of our most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Dane Andreeff: Thank you operator, and welcome everyone to Helius Medical's fourth quarter and full year 2020 earnings conference call. I'm joined on this call today by Joyce LaViscount, our Chief Financial Officer and Chief Operating Officer; and Mark Leno, our Vice President and General Manager of our Canadian operations. Let me provide you with a quick agenda of what we are going to focus on today as part of our continued strategy to reposition Helius to create intermediate

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