Helius Medical Technologies Inc, a neurotech company focused on neurological wellness, reports financial results for the quarter and full year ended December 31, 2021.

Fourth Quarter and Recent Business Updates

  • U.S. commercial launch of PoNS for multiple sclerosis (“MS”) progressed with first prescriptions received this month.
  • Received marketing authorization in Australia for sale of PoNS as a Class IIa medical device to improve balance and gait.
  • Launched partnership with Medical University of South Carolina for collaborative clinical trial on stroke, allowing for observation of PoNS therapy in a real-world clinical setting.
  • Partnered with NYU Langone Health as the first clinical trial site for the Company-sponsored Therapeutic Experience Program (“TEP”), an open label observational interventional trial designed to evaluate the impact of subjects’ adherence to PoNS Therapy in patients with MS.
  • Closed public offering of common stock with $11.1 million in gross proceeds.
  • Q4 2021 revenue increased by 35% to $258 thousand compared to $191 thousand in Q4 2020 and full year 2021 revenue was $522 thousand vs. $661 thousand in 2020.

“The fourth quarter was an exciting and noteworthy time for the Company. While preparing for the U.S. commercial launch of PoNS for multiple sclerosis, we also received market authorization in Australia for use of PoNS to improve balance and gait, launched our Therapeutic Experience Program with NYU Langone, announced a collaborative clinical trial in stroke with the Medical University of South Carolina, and grew to 37 clinic locations in Canada,” states Dane Andreeff, President and Chief Executive Officer of Helius Medical Technologies.

“In the U.S., the first PoNS prescriptions were received this month, and with the planned finalization of our pivotal stroke trial design and further expansion of TEP expected by the end of the second quarter, 2022 should be another eventful year for Helius, and we look forward to providing updates as our activities progress.”

Fourth Quarter 2021 Financial Results

Total revenue for the fourth quarter of 2021 increased to $258 thousand, a 35% increase compared to $191 thousand in the fourth quarter of 2020, and was comprised primarily of product sales in both periods.

Gross profit for the fourth quarter of 2021 was $129 thousand, compared to gross loss of $10 thousand in the fourth quarter of 2020.

Operating expenses for the fourth quarter of 2021 increased to $4.2 million, compared to $3.0 million in the fourth quarter of 2020, an increase of $1.2 million. The planned increase primarily resulted from increased clinical and development activities preparing for the U.S. commercial launch of PoNS.

Operating loss for the fourth quarter of 2021 increased $1.1 million to $4.1 million, compared to $3.0 million in the fourth quarter of 2020.

Net loss was $4.1 million for the fourth quarter of 2021, compared to $2.5 million in the corresponding prior year period. The basic and diluted net loss per share for the fourth quarter was $1.31 per share, compared to $1.77 per share, for the fourth quarter of 2020.

Helius Medical Technologies – Full Year 2021 Financial Results

Total revenue for the full year 2021 was $522 thousand, compared to $661 thousand for the full year 2020, and was comprised primarily of product sales for both periods.

Gross profit for the full year 2021 was $224 thousand, compared to gross profit of $273 thousand for the full year 2020.

Operating expenses for the full year 2021 increased $3.7 million to $18.4 million, compared to $14.7 million for the full year 2020. In addition to planned increases resulting from infrastructure and product development activities preparing for the commercial launch of PoNS in the U.S., operating expenses for the full year 2021 included non-recurring severance expenses related to the departure of our former chief operating officer of $0.4 million cash expense and $0.5 million non-cash stock-based compensation expense.

Operating loss for the full year 2021 increased $3.7 million to $18.1 million, compared to $14.4 million for the full year 2020.

Net loss for the full year 2021 was $18.1 million, compared to $14.1 million for the full year 2020. The basic and diluted net loss per share for the full year 2021 was $7.38 per share, compared to $11.80 per share, for the full year 2020.

Cash and Liquidity

Cash used in operating activities for the twelve months ended December 31, 2021 was $13.4 million compared to $11.7 million in the prior year.

As of December 31, 2021, the Company had cash of $11.0 million, compared to $3.3 million at December 31, 2020.

The Company had no debt outstanding at December 31, 2021.

2022 Guidance

Helius Medical Technologies currently expects first quarter revenue to range from $150 thousand to $170 thousand and quarterly revenue to increase sequentially each quarter throughout the year as the U.S. commercialization of PoNS develops.

[Source(s): Helius Medical Technologies, GlobeNewswire]

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