Helius Medical Technologies(HSDT)
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Helius Medical Technologies(HSDT) - 2022 Q4 - Earnings Call Transcript
2023-03-10 23:19
Financial 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]
Helius Medical Technologies(HSDT) - 2022 Q4 - Annual Report
2023-03-09 21:39
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the Fiscal Year Ended December 31, 2022 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) Delaware 36-4787690 ...
Helius Medical Technologies(HSDT) - 2022 Q3 - Earnings Call Transcript
2022-11-14 15:45
Helius Medical Technologies, Inc. (NASDAQ:HSDT) Q3 2022 Earnings Conference Call November 14, 2022 8:30 AM ET Company Participants Lisa Wilson - Investor Relations Dane Andreeff - President & Chief Executive Officer Jeff Mathiesen - Chief Financial Officer Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann Jonathan Aschoff - ROTH Capital Partners Operator Good day, and thank you for standing by. Welcome to the Helius Medical Technologies Q3 2022 Earnings Call. [Operator Instructions] Please be ...
Helius Medical Technologies(HSDT) - 2022 Q3 - Quarterly Report
2022-11-14 13:15
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of Registrant as specified in its charter) Indicate by check mark wh ...
Helius Medical Technologies(HSDT) - 2022 Q2 - Earnings Call Transcript
2022-08-15 23:08
Financial Data and Key Metrics Changes - Total revenue for Q2 2022 was $119,000, an increase of 68% compared to $71,000 in Q2 2021 [21] - Gross profit for Q2 2022 was $31,000, up from $4,000 in the prior year [21] - Operating expenses decreased to $3.5 million in Q2 2022 from $6.2 million in Q2 2021, primarily due to lower stock-based compensation and clinical trial costs [22] - Net loss for Q2 2022 was $3.8 million, or $0.97 per share, compared to a net loss of $6 million, or $2.58 per share, in the same period last year [22] - Cash burn from operations was $3.7 million in Q2 2022, slightly down from $3.8 million in Q2 2021 [23] Business Line Data and Key Metrics Changes - The first commercial sales of the Portable Neuromodulation Stimulator (PoNS) device were reported, contributing $63,000 to total revenue [21][7] - The company has received over 300 inquiries regarding PoNS therapy, indicating strong market interest [9] Market Data and Key Metrics Changes - In Canada, the number of authorized PoNS clinics increased to 41 from 37 at the end of 2021 [18] - Sales in the U.S. are currently on a cash pay basis, with a list price of $25,700 for the PoNS device [13] Company Strategy and Development Direction - The company is focusing on expanding its commercial presence through telehealth and e-commerce initiatives, expected to launch later this year [12] - A self-paced online training module for physical therapists has been implemented to expedite the training process [11] - The company aims to establish a registry program for MS patients treated with PoNS therapy to collect health and economic data [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the reception of PoNS therapy and expects revenue to increase sequentially throughout the year and into 2023 [25] - The company is currently evaluating additional measures to achieve greater market adoption in Canada [19] - Management acknowledged challenges in training physical therapists and obtaining prescriptions but believes new initiatives will help overcome these hurdles [32] Other Important Information - The company closed an $18 million public offering after Q2 2022, increasing its cash balance to approximately $19.7 million [23] - A pilot trial for stroke patients is expected to commence soon, with full enrollment anticipated by mid-2023 [17] Q&A Session Summary Question: What is the impact of foreign exchange loss for the quarter? - Management indicated that the foreign exchange loss relates to intercompany activity and does not forecast FX impacts [29] Question: Can you discuss the size of the commercial organization and audience uptake? - The commercial uptake is in the early stages, with a focus on training physical therapists and engaging with neurologists and PT clinics [31] Question: What is the status of discussions with payers in the U.S.? - Management noted that they are in early stages of payer discussions and are looking to replicate successful pilot studies from Canada in the U.S. [34] Question: What is the enrollment size for the pilot trial in South Carolina for stroke? - The enrollment size for the pilot trial is 12 patients [35]
Helius Medical Technologies(HSDT) - 2022 Q2 - Quarterly Report
2022-08-15 21:50
Table of Contents For the quarterly period ended June 30, 2022 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of Registrant as specified in its charter) | Delaware | 36-4787690 | | -- ...
Helius Medical Technologies(HSDT) - 2022 Q1 - Earnings Call Transcript
2022-05-12 16:08
Financial 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]
Helius Medical Technologies(HSDT) - 2022 Q1 - Quarterly Report
2022-05-12 12:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of Registrant as specified in its charter) Delaware 36-4787690 (State or other jurisdictio ...
Helius Medical Technologies(HSDT) - 2021 Q4 - Earnings Call Transcript
2022-03-15 01:39
Helius Medical Technologies, Inc. (NASDAQ:HSDT) Q4 2021 Earnings Conference Call March 14, 2022 5:00 PM ET Company Participants Michelle Bilski - In-Site Communications, IR Dane Andreeff - President and CEO Jeff Mathiesen - CFO Conference Call Participants Destiny Hance - Ladenburg Thalmann Operator Ladies and gentlemen, thank you for standing by, and welcome to the Helius Medical Technologies Earnings Results Call. [Operator Instructions] Please be advised that today's conference call is being recorded. I ...
Helius Medical Technologies(HSDT) - 2021 Q4 - Annual Report
2022-03-14 21:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the Fiscal Year Ended December 31, 2021 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) Delaware 36-4787690 (State or other ju ...