Helius Medical Technologies, Inc. Reports Second Quarter 2024 Financial Results

Helius Medical Technologies, Inc. (NASDAQ:HSDT), a pioneering neurotech company, has recently reported its financial results for the second quarter of 2024. The company has been at the forefront of developing innovative neuromodulation treatments aimed at addressing balance and gait deficits. This report comes at a crucial time as Helius continues to make significant strides in removing barriers to their technology, which includes obtaining reimbursement from a major insurance carrier and initiating a Canadian study to support their regulatory submissions. These advancements are pivotal as the company prepares for what is expected to be a transformative third quarter in 2024.

One of the most notable achievements for Helius during this period was the completion of site enrollment for their registrational program focused on stroke treatment. This milestone is critical as it sets the stage for future regulatory approvals and commercial success. Despite a decrease in total revenue for the second quarter compared to the same period in the previous year, there was a notable increase from the first quarter of 2024. This uptick can be attributed to the company’s strategic efforts to streamline operations and focus on high-impact initiatives. Additionally, the cost of revenue saw a decline due to lower sales, which further underscores the company’s ability to manage its resources efficiently.

Operating expenses for Helius remained relatively flat, with selling, general, and administrative expenses comparable to the previous year. Research and development expenses saw a slight increase, reflecting the company’s ongoing commitment to innovation and clinical advancement. The total operating loss for the second quarter was marginally higher than the prior year period, yet the net loss remained consistent with the previous year’s figures. As of June 30, 2024, Helius reported a cash and liquidity position of $6.4 million, with no outstanding debt, providing a solid financial foundation for future endeavors.

The company’s flagship product, the Portable Neuromodulation Stimulator (PONS®), continues to be a cornerstone of their commercial strategy. This device delivers mild electrical impulses through a mouthpiece to improve balance and gait, particularly in patients with multiple sclerosis (MS) in the United States, and stroke or brain injury patients in Canada and Australia. Helius aims to seek broader regulatory approval for PONS® in the United States by 2025, which could significantly expand their market reach and impact. The strategic operating plans also include expanding their Veterans Affairs (VA) sales representative organization and securing national Medicare insurance coverage, both of which are expected to drive substantial growth.

Potential risks for Helius include the availability of funds, supply chain disruptions, and delays in the FDA regulatory processes. However, the company’s leadership remains optimistic about overcoming these challenges. The CEO expressed confidence in the future, highlighting upcoming milestones such as the first read of the primary endpoint’s results for their clinical trial in stroke, expanding sales, and receiving the final reimbursement determination from the Centers for Medicare & Medicaid Services (CMS). These developments are anticipated to be significant catalysts for the company’s growth trajectory.

Helius Medical Technologies hosted a webcast to discuss their second quarter results, providing investors and stakeholders with insights into their financial performance and strategic direction. During the call, the CEO and CFO elaborated on the progress made in the second quarter and outlined the company’s plans for the remainder of the year. They emphasized the importance of the upcoming third quarter, which is expected to be a defining period for Helius as they advance towards key regulatory and commercial milestones.

The company’s focus on neuromodulation for balance and gait deficits positions them uniquely within the neurotech industry. Their technology platform is designed to amplify the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, offering a novel therapeutic approach for patients with neurologic diseases. The PONS® device, in particular, has shown promising results in improving gait and balance, reducing the risk of falls, and enhancing the quality of life for patients with MS, stroke, and traumatic brain injury.

In the second quarter of 2024, Helius made significant progress in removing barriers to their technology. This included receiving the first third-party insurance reimbursement for their product, which is a critical step towards broader market acceptance and financial sustainability. The company expects the final reimbursement rates from CMS to be a major catalyst for revenue growth, providing a more predictable and stable revenue stream. Additionally, the initiation of a Canadian study is expected to support their FDA submission and national reimbursement efforts, further strengthening their regulatory position.

Despite the challenges faced in the second quarter, Helius demonstrated resilience and strategic foresight. Total revenue for the quarter was $182 thousand, a decrease from the previous year due to the termination of a program and temporary pricing adjustments. However, revenue increased by 35% compared to the first quarter of 2024, indicating positive momentum and the effectiveness of their strategic initiatives. The company’s operating loss of $3.3 million was in line with expectations, reflecting the investments made in research and development and commercial expansion.

Helius Medical Technologies’ financial stability is underpinned by their sufficient cash reserves and lack of debt, providing a runway into 2025. This financial health enables the company to continue investing in critical areas such as clinical trials, regulatory submissions, and commercial infrastructure. The company’s leadership is committed to executing their strategic plan, which includes expanding their sales force, securing additional reimbursement approvals, and advancing their clinical programs.

The third quarter of 2024 is anticipated to be a pivotal period for Helius, with several key milestones on the horizon. The results from their registrational program in stroke treatment will be particularly important, as they will inform future regulatory submissions and commercial strategies. Additionally, the company is focused on expanding their presence in the VA system and securing national Medicare coverage, both of which are expected to drive significant revenue growth and market penetration.

In conclusion, Helius Medical Technologies, Inc. (NASDAQ:HSDT) has made substantial progress in the second quarter of 2024, despite facing various challenges. The company’s commitment to innovation, strategic execution, and financial prudence positions them well for future success. As they move into the third quarter, Helius is poised to achieve critical milestones that will shape their trajectory in the neurotech industry. Investors and stakeholders will be closely watching the company’s progress, particularly the outcomes of their clinical trials and regulatory submissions, which are expected to be significant drivers of growth and value creation.