Solana Company Q3 FY2020 Earnings Call

· Earnings call transcript and AI-powered summary

  • Date: November 12, 2020
  • Executives Present: Dane Andreeff (Interim President and CEO), Joyce LaViscount (CFO & COO), Mark Leno (VP & GM of Canadian Operations)

Company Highlights

  • Dane Andreeff appointed as Interim President and CEO in August 2020. He increased his personal investment in the company (6.3% ownership) and declined compensation to align with shareholders.
  • Continued progress in U.S. regulatory strategy focusing on multiple sclerosis (MS) indication for PoNS device.
  • Request for de novo classification and FDA clearance submitted August 4th, 2020; currently under substantial review. Additional data and label modifications requested by FDA on October 19.
  • Company preparing a response to FDA and plans to submit in H1 2021.
  • CMS concluded public comment period on a rule that could enable Medicare coverage for breakthrough devices like PoNS upon FDA clearance — would aid commercialization efforts in the U.S.

Canada Commercial Update

  • Q3 2020 Revenue: $131,000 vs $150,000 in Q3 2019 — impacted by COVID-19-related clinic restrictions and patient hesitancy.
  • Clinic productivity estimated at only ~30% of normal levels due to social distancing, immune-suppressed patient populations, and government-imposed capacity limits.

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Operator: Please standby. Good evening, ladies and gentlemen, and welcome to the Third Quarter of 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 those identified in the Risk Factors section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q. Such factors may be updated from time to time in our filings – in our other filings with the SEC, which are available on our website. All statements made during this call are as of November 12, 2020. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise except as required by law. I would now like to turn the call over to Mr. Dane Andreeff, Helius Medical's Interim President and Chief Executive Officer. Please go ahead, sir. Dane Andreeff: Great. Thank you, operator, and hello and welcome to everyone to Helius Medical's third quar

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