NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) recently announced results for the quarter and full year ending December 31, 2022.
Fourth Quarter and Recent Business Updates
- Q4 2022 revenue increased 9% to $282 thousand compared to Q4 2021, and increased 44% compared to Q3 2022
- Full year 2022 revenue increased 51% to $787 thousand compared to 2021
- Introduced UpScript Telehealth e-commerce site, allowing Americans with balance and gait deficits to access online health evaluations, fulfill Portable Neuromodulation Stimulator (PoNS®) Therapy prescriptions through a network of licensed providers, and order home delivery of PoNS devices
- Shipped first e-commerce orders in January 2023
- Extended Patient Therapy Access Program (PTAP) through June 30, 2023, giving more qualifying patients access to PoNS Therapy at a significantly reduced price
- Added three Centers of Excellence in Company’s Therapeutic Experience Program (PoNSTEP), a multi-center, company-sponsored, open label observational interventional trial to evaluate the impact of subjects’ adherence to PoNS Therapy
- Authorization from Health Canada to market PoNS for the treatment of gait deficit due to mild and moderate symptoms from stroke
“We finished our launch year strong, with 44% sequential quarterly revenue growth and the introduction of several programs to increase access to PoNS Therapy for patients suffering from balance and gait impairment. Earlier in the year, we implemented an online training module to standardize the training process and enable faster onboarding of physical therapists. More recently, we launched the ponstherapy.com e-commerce site and also expanded our PTAP program, which provides qualifying MS patients access to PoNS Therapy at a nearly 85% discount to list price. These efforts are already beginning to pay off, and it’s gratifying to see patients who are suffering from MS more quickly receive the relief that they need,” said Dane Andreeff, President and Chief Executive Officer of Helius.
“We are also thrilled to add gait deficit due to mild and moderate symptoms from stroke as another indication for which PoNS has received market authorization in Canada, as announced earlier today. PoNS is a breakthrough technology, and we are excited about the tremendous opportunity to help patients suffering from balance and gait impairment. With the positive reception to PoNS in the North American marketplace and our strong balance sheet and reduced cash burn, we are well-positioned to build on our momentum in 2023,” Andreeff concluded.
Fourth Quarter 2022 Financial Results
Total revenue for the fourth quarter of 2022 was $282 thousand, an increase of 9% compared to $258 thousand in the fourth quarter of 2021 and was comprised primarily of product sales in both periods.
Cost of revenues was $150 thousand for the three months ended December 31, 2022, compared to $129 thousand for the comparable period in 2021, primarily due to increased revenues.
Gross profit for the fourth quarter of 2022 was $132 thousand, compared to gross profit of $129 thousand in the fourth quarter of 2021.
Operating expenses for the fourth quarter of 2022 decreased to $2.8 million, compared to $4.2 million in the fourth quarter of 2021. The decrease was primarily the result of lower product development and clinical trial activities following the U.S. commercial launch of PoNS.
Operating loss for the fourth quarter of 2022 decreased $1.4 million to a loss of $2.7 million, compared to an operating loss of $4.1 million in the fourth quarter of 2021.
Net loss was $4.9 million for the fourth quarter of 2022, compared to a net loss of $4.1 million in the corresponding prior year period. The basic and diluted net loss per share for the fourth quarter 2022 was $0.17, compared to net loss per share of $1.31 in the fourth quarter 2021.
Full Year 2022 Financial Results
Total revenue for the full year 2022 was $787 thousand, compared to $522 thousand for the full year 2021, reflecting the U.S. commercial launch of PoNS for MS in April 2022, partially offset by a decrease in product sales in Canada, mostly attributable to lower Canadian to U.S. dollar translation rates during 2022.
Cost of revenue for the full year 2022 increased $165 thousand to $463 thousand, compared to cost of revenue of $298 thousand for the full year 2021, primarily attributable to overhead costs, including salaries and benefits of employees involved in management of the supply chain, and inventory-related cost of sales due to higher sales volume.
Gross profit for the full year 2022 was $324 thousand, compared to gross profit of $224 thousand for the full year 2021.
Operating expenses for the full year 2022 decreased $2.5 million to $15.8 million, compared to $18.4 million for the full year 2021, due primarily to a $2.0 million decrease in stock-based compensation expense and a decrease in product development and clinical trial expenses as the Company transitioned from product development and clinical trials to U.S. commercialization activities, partially offset by increased compensation expenses related to personnel additions in late 2021 and early in 2022 to support the U.S. commercial launch.
Operating loss for the full year 2022 decreased $2.6 million to $15.5 million, compared to $18.1 million for the full year 2021.
Net loss for the full year 2022 was $14.1 million, compared to $18.1 million for the full year 2021. The basic and diluted net loss per share for the full year 2022 was $1.04 per share, compared to $7.38 per share, for the full year 2021.
Cash and Liquidity
Cash used in operating activities for the three months ended December 31, 2022 was $2.1 million, a significant decrease from the average quarterly run rate of approximately $4.1 million over the previous three quarters of 2022, reflecting the results of the Company’s focus on reducing cash burn and extending its cash runway beyond 2023. Cash used in operations for the twelve months ended December 31, 2022 was $14.3 million compared to $13.4 million in the prior year.
As of December 31, 2022, the Company had cash of $14.5 million, compared to $11.0 million at December 31, 2021.
The Company had no debt outstanding at December 31, 2022.
The Company currently expects 2023 revenues to exceed prior year levels and increase throughout the year, though it may experience quarterly fluctuations as it makes refinements to its U.S. commercial roll-out of PoNS. The Company also believes broad third-party payer reimbursement will be needed to achieve its full revenue potential.
For more information, visit www.heliusmedical.com.
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