Release Date: August 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Helius Medical Technologies Inc (HSDT, Financial) has partnered with Lovell Government Services to make PoNS therapy accessible to MS patients treated at the VA and other federal agencies.
- PoNS was approved for inclusion in Lovell’s VA federal supply schedule and the General Services Administration Advantage contracts, establishing market pricing for the device.
- The company received its first third-party reimbursement from a major insurance carrier for a PoNS device.
- Helius Medical Technologies Inc (HSDT) is actively pursuing stroke authorization in the US, with significant progress in clinical trials and enrollment.
- The company has extended its cash runway into 2025 with a $6.4 million public offering and potential additional proceeds from warrants.
Negative Points
- Total revenue for the second quarter of 2024 decreased by $74,000 compared to the same period in 2023.
- Operating loss for the second quarter of 2024 remained flat at $3.2 million, indicating no improvement from the prior year period.
- The company’s cash burn from operations was flat at $5.9 million for the first half of 2024, showing no reduction in operational expenses.
- PoNS sales have been muted due to primarily being on a cash pay basis, which is not feasible for the majority of patients.
- The company is still investigating the expansion into TBI (Traumatic Brain Injury) and has not yet initiated new studies in this area.
Q & A Highlights
Q: Once the final price determination is received from CMS, do you have a pipeline of patients, and what impact will that have on initial sales?
A: Yes, we have a strong list of Medicare patients with their prescribers waiting for CMS and Medicare reimbursement. This built-up demand is expected to significantly boost initial sales. (Dane Andreeff, President, CEO, Director)
Q: Where are you with patient enrollment for the stroke trial, and are you still on target for completing it and submitting to the FDA in the first half of 2025?
A: Enrollment is on track, and we are on target to submit to the FDA in the first half of 2025. We will be using our second FDA breakthrough designation, which provides a 150-day notice period. (Dane Andreeff, President, CEO, Director)
Q: Where are you with potential studies or expansion for TBI (Traumatic Brain Injury)?
A: We are still investigating the expansion into TBI. A study by Pacific Blue Cross showed significant benefits, with eight out of nine long-term disability patients showing no balance and gait issues after using PoNS therapy for 14 weeks. This resulted in significant cost savings. (Dane Andreeff, President, CEO, Director)
Q: Can you provide more details on the recent third-party reimbursement and its impact?
A: In May, we received the first third-party reimbursement of $23,900 from a major insurance carrier for a PoNS device. This is a significant step towards establishing market pricing and pursuing further reimbursement from CMS and other third-party payers. (Jeffrey Mathiesen, CFO, Treasurer, Company Secretary, Director)
Q: What are the financial highlights for the second quarter of 2024?
A: Total revenue was $182,000, a decrease from $256,000 in Q2 2023. However, revenue increased by 35% compared to Q1 2024. Operating loss remained flat at $3.2 million, and we reported a net loss of $1.6 million. We have $6.4 million in cash and no debt. (Jeffrey Mathiesen, CFO, Treasurer, Company Secretary, Director)
Q: How is the sales rep organization progressing to service VA sites?
A: We have established sales representatives covering 13 states, including Texas and Florida, plus Puerto Rico. Having boots on the ground representatives focused on neurological disorders is critical to building out sales across VA facilities in the US. (Jeffrey Mathiesen, CFO, Treasurer, Company Secretary, Director)
Q: What are the expected timelines for CMS final reimbursement rates and their impact?
A: CMS is expected to publish final reimbursement rates in the coming weeks, effective October 1, 2024. This will enable us to further expand reimbursement across third-party payers and significantly boost our revenues. (Jeffrey Mathiesen, CFO, Treasurer, Company Secretary, Director)
Q: What progress has been made towards stroke authorization in the US?
A: We have made meaningful progress, including enrolling participants in our registrational program and starting additional studies in Canada. We expect the results to bolster our FDA submission for regulatory approval in 2025. (Dane Andreeff, President, CEO, Director)
Q: Can you elaborate on the recent financing and its impact on the company's runway?
A: In May, we closed a $6.4 million public offering, extending our cash runway into 2025. This financing includes warrants that could provide additional proceeds to fund operations well into the second half of next year. (Jeffrey Mathiesen, CFO, Treasurer, Company Secretary, Director)
Q: What is the outlook for PoNS sales and the pathway to positive cash flow?
A: With recent inroads into the VA and expected Medicare reimbursement effective October 1, we are positioned to significantly boost revenues later this year, providing a pathway to positive cash flow. (Jeffrey Mathiesen, CFO, Treasurer, Company Secretary, Director)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
