Helius Medical Technologies(US:HSDT)2024-08-13 01:33Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $182,000, a decrease of $74,000 compared to $256,000 in Q2 2023, primarily due to the termination of the Patient Therapy Access Program and temporary cash pay pricing [9] - Revenue increased by 35% compared to Q1 2024, attributed to higher sales in both the US and Canada [9] - Operating loss for Q2 2024 was $3.2 million, consistent with the loss reported in the prior year [9][10] - Net loss for Q2 2024 was $1.6 million, or a loss of $0.64 per share, compared to a net loss of $1.6 million or a loss of $2.92 per share in the prior year [10] Business Line Data and Key Metrics Changes - The company focused on increasing access to PoNS therapy for MS patients, resulting in significant momentum toward greater access [3] - The partnership with Lovell Government Services aimed to make PoNS therapy accessible to veterans, with pricing established for the PoNS device and mouthpiece [4][5] - The company reported the first third-party reimbursement of $23,900 for a PoNS device, indicating progress in reimbursement efforts [4] Market Data and Key Metrics Changes - The VA estimates that between 65,000 and 70,000 veterans in the US live with MS, representing a significant market opportunity for PoNS therapy [4] - The company is actively building a sales representative organization to service VA sites across 13 states, which is critical for expanding sales [6] Company Strategy and Development Direction - The company aims to remove barriers to access and secure reimbursement for PoNS therapy, with a focus on stroke authorization in the US [7] - A registrational program for stroke has been fully enrolled, with expectations to submit for FDA approval in 2025 [7][8] - The company is also expanding its research efforts in Canada to support national reimbursement and strengthen its data package for FDA submission [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the expected Medicare reimbursement effective October 1, 2024, which is anticipated to significantly boost revenues [10] - The company has a strong list of Medicare patients awaiting reimbursement, indicating built-up demand [12] - Management is on track with patient enrollment for the stroke trial and plans to submit to the FDA in the first half of 2025 [13] Other Important Information - The company closed a $6.4 million public offering in May, extending its cash runway into 2025 [10] - The expected final determination from CMS regarding reimbursement rates is anticipated to be announced in late summer [10] Q&A Session Summary Question: What is the pipeline of patients once the final price determination is received from CMS? - The company has maintained a list of Medicare patients and their prescribers, indicating strong built-up demand for reimbursement [12] Question: Where is the company with patient enrollment for the stroke trial? - The company is on track with enrollment and plans to submit to the FDA in the first half of 2025, utilizing its second FDA breakthrough designation [13] Question: What is the status of potential studies or expansion for TBI? - The company is investigating expansion into TBI, with previous studies showing significant cost benefits associated with PoNS therapy for TBI patients [14]