Helius Medical Technologies(US:HSDT)2024-05-13 23:21Financial Data and Key Metrics Changes - Total revenue for Q1 2024 was $135,000, an increase of $24,000 compared to $111,000 in Q1 2023, reflecting increased product sales in both the U.S. and Canada [12] - Cost of revenue remained relatively flat at $123,000 in Q1 2024 compared to $122,000 in the prior year [12] - Operating loss for Q1 2024 was $3.4 million, compared to a loss of $3.8 million in the prior year [41] - Net loss for Q1 2024 was $2.5 million, or a loss of $3.08 per share, compared to a net loss of $2.5 million, or a loss of $4.42 per share in the prior year [41] - Cash burn from operations decreased to $3 million in Q1 2024 from $3.2 million in Q1 2023 [41] - As of March 30, 2024, the company had $3.6 million in cash and no debt [41] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $0.8 million in Q1 2024 from $0.9 million in Q1 2023, primarily due to a decrease in product development expenses and clinical trial activities [25] - Selling, general and administrative expenses decreased to $2.6 million in Q1 2024 from $2.9 million in Q1 2023, mainly due to a decrease in professional fees and payroll-related expenses [40] Market Data and Key Metrics Changes - The company is targeting regulatory submission by early 2025 for stroke treatment, with a goal of receiving marketing authorization later in the year [52] - The preliminary Medicare payment determinations for the PoNS controller and mouthpiece were released, with a public meeting scheduled for May 29, 2024 [20] Company Strategy and Development Direction - The company is focused on securing widespread reimbursement for PoNS and achieving FDA approval for stroke, with both goals in sight [4][11] - The partnership with Global Government Services aims to make PoNS available to federal healthcare systems, enhancing access for veterans suffering from MS [10] - The company is working to establish sites in Canada as part of a government-funded initiative to validate the effectiveness of PoNS therapy for stroke [38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving CMS reimbursement as early as October 1, 2024, which would significantly boost revenues and provide a pathway to positive cash flow [11][42] - The company highlighted the importance of engaging with the physical therapy community to facilitate the adoption of PoNS therapy [24] Other Important Information - The company closed a $6.4 million public offering, extending its cash runway into 2025 [26] - The company is in the process of having PoNS Therapy contracted with the FSS and GSA, with expectations to start receiving prescriptions in early June 2024 [28][31] Q&A Session Summary Question: Can you provide an update on the timeline with the Lovel Government Services agreement? - Management indicated that they are in the process of finalizing the agreement and expect to start receiving prescriptions soon, with training for VA rehab experts ongoing [28][31] Question: What demand have you seen from new physical therapists taking the training program for PoNS Therapy? - Management noted that there has been steady and increasing interest from physical therapists, particularly in Canada, as they aim to fill in the map with registered PoNS trainers [35][36]