Helius Medical Technologies(US:HSDT)2022-05-12 16:08Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was $190,000, a 126% increase from $84,000 in Q1 2021 [32] - Gross profit for Q1 2022 was $66,000, slightly down from $69,000 in the prior year [32] - Operating expenses increased to $4.6 million in Q1 2022 from $3.6 million in Q1 2021, primarily due to increased compensation expenses [33] - Operating loss for Q1 2022 was $4.6 million compared to a loss of $3.5 million in the prior year [34] - Net loss for Q1 2022 was $4.3 million, or a loss of $1.15 per share, compared to a net loss of $3.4 million, or a loss of $1.65 per share in the same period last year [34] - Cash burn from operations was $4.7 million in Q1 2022, up from $2.9 million in Q1 2021 [35] - As of March 31, 2022, the company had $6.3 million in cash and no debt [36] Business Line Data and Key Metrics Changes - PoNS Therapy was commercially available in the U.S. for the first time in Q1 2022, targeting gait deficits due to mild-to-moderate MS symptoms [8][9] - The established U.S. list price for the PoNS device is $25,700, with a one-time cost of $17,800 for the controller and $7,900 for the mouthpiece [17] - The company has received 23 prescriptions, with two patients purchasing devices on a cash-pay basis [20] Market Data and Key Metrics Changes - Approximately 1 million people in the U.S. suffer from MS, with over 70% reporting difficulties walking [21] - The company has 41 authorized PoNS clinics in Canada, up from 37 at the end of 2021, representing a more than 10% increase [29] Company Strategy and Development Direction - The company aims to expand accessibility of PoNS Therapy through patient assistance programs and is pursuing third-party coverage [18] - The company is optimistic about the new Transitional Coverage for Emerging Technologies (TCET) proposed by CMS, which may include PoNS due to its FDA breakthrough designations [19] - The company plans to enhance its marketing initiatives and hire experienced sales representatives to support the U.S. launch [23] Management's Comments on Operating Environment and Future Outlook - Management expects second quarter revenue to be modestly above first quarter levels, with future quarterly revenue anticipated to increase sequentially throughout the year and into 2023 [37] - The company believes it can achieve positive quarterly cash flow from operations by Q4 2023 [37] - The analysis indicates that approximately 128,000 patients treated for MS annually in the U.S. would qualify for PoNS treatment, representing a multi-billion dollar market opportunity [38] Other Important Information - The Therapeutic Experience Program (TEP) aims to treat 40 to 50 patients across 10 to 12 Centers of Excellence during 2022 [15] - The company is actively working to publish results from its clinical experience program in Canada by late 2022 [30] Q&A Session Summary Question: Can you talk about the progress on the payer front and discussions regarding TCET? - Management is assisting patients with reimbursement claims and is optimistic about the TCET program, which is similar to the previous MCIT program [45] Question: Can you discuss the audience engagement and commercial efforts? - Engagement has been meaningful with key stakeholders including neurologists and physical therapists, who are becoming familiar with the therapy [46][48] Question: How are the clinics in Canada performing? - Clinics are now operating at full capacity, and there is a consistent flow of patients for treatments, especially in MS [49] Question: What is the status of manufacturing and inventory? - The company has sufficient inventory to meet demand in both the U.S. and Canada, despite labor issues affecting production timelines [50] Question: Any activity outside North America? - The company has received TGA clearance in Australia, which presents a larger market opportunity due to broader treatment indications [51]