Helius Medical Technologies(US:HSDT)2023-03-10 23:19Financial Data and Key Metrics Changes - Total revenue for Q4 2022 was $282,000, a 9% increase from $258,000 in Q4 2021, primarily driven by product sales [17] - Full year 2022 revenue reached $787,000, reflecting a 51% increase over 2021, attributed to the U.S. commercial launch of PoNS for MS [17] - Operating loss for Q4 2022 was $2.7 million, improved from a loss of $4.1 million in the prior year [18] - Net loss for Q4 2022 was $4.9 million, or $0.17 per share, compared to a net loss of $4.1 million, or $1.31 per share, for the same period last year [41] - Cash burn from operations for Q4 2022 was $2.1 million, significantly lower than the average quarterly run rate of approximately $4.1 million over the previous three quarters [19] Business Line Data and Key Metrics Changes - The majority of U.S. PoNS device prescriptions in Q4 were through the Patient Therapy Access Program (PTAP) [11] - The PoNS therapy showed a significant improvement in functional gait assessment scores for stroke patients, with an average improvement of 6.7 points over a 14-week treatment period [6] Market Data and Key Metrics Changes - PoNS therapy has received FDA breakthrough designation for both stroke and MS in the U.S., enhancing its market potential [3] - In Canada, PoNS has been authorized for the treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury and mild-to-moderate symptoms of MS, with recent approval for stroke treatment [10][37] Company Strategy and Development Direction - The company aims to improve access to PoNS therapy through partnerships, such as with UpScript for telehealth services [4] - Helius is focused on gathering data to support insurance reimbursement for PoNS therapy, with ongoing programs like PoNSTEP and a registry for MS patients [25][46] - The company plans to extend the PTAP program through June 2023 to enhance patient access [35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about revenue growth in 2023, expecting to exceed prior year levels as U.S. commercialization of PoNS develops [42] - The company anticipates quarterly fluctuations in revenue due to the ongoing rollout of PoNS in the U.S. [67] - Management highlighted the importance of reimbursement for achieving full revenue potential [42] Other Important Information - As of December 31, 2022, the company had $14.5 million in cash and no debt, providing a cash runway through 2023 [42] - The company is actively engaging with the neurology community to educate about PoNS therapy and its benefits [13] Q&A Session Summary Question: What is driving the PTAP extension? - Management confirmed that the extension is primarily driven by the cash price being prohibitive and the need to increase awareness among physical therapists [22] Question: What is the status of TEP traction? - Currently, five sites are enrolled in the TEP program, with plans to increase to 10-12 by year-end [23] Question: When will data for stroke trials be available? - Management indicated that they have not yet rolled into the stroke trial but are working on generating evidence for insurance reimbursement through the PoNSTEP program [24][25] Question: What is the pricing for PTAP? - The PTAP is priced at $3,895, with cash pay pricing around $14,500 [27] Question: What is the follow-up process for leads generated from the PT conference? - The follow-up process involves targeting super regional PT clinics for national rollout of PoNS training, which is free and can be completed in under three hours [50] Question: What is the status of operations in Australia? - The PoNS device is approved for balance and gait deficits in Australia, and the company is exploring distribution partnerships [53] Question: What are the goals for the upcoming neurology conference? - The goal is to educate general neurologists about PoNS therapy and its effectiveness for gait deficits due to MS [55]