NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq:HSDT) has announced its financial results for the quarter ended June 30, 2024, showcasing significant strides in both financial performance and business development. These advancements highlight the company’s strategic focus on increasing accessibility and reimbursement for its Portable Neuromodulation Stimulator (PoNS®) device.
Second Quarter and Recent Business Updates
One of the most notable achievements of the quarter was securing the first third-party reimbursement for the PoNS device from a major insurance carrier at $23,900. This milestone marks a critical step toward making the PoNS device more accessible to patients suffering from gait and balance impairments due to multiple sclerosis (MS). Additionally, Helius received a preliminary payment determination from the Centers for Medicare & Medicaid Services (CMS) for PoNS, with a final price determination expected on October 1, 2024.
Further reinforcing its market presence, Helius completed site participation enrollment for its U.S. registrational program in stroke, setting the stage for a submission to the U.S. Food and Drug Administration (FDA) in the first half of 2025. This program is being conducted at several leading neurorehabilitation centers across the United States, indicating the high level of clinical interest and support for PoNS.
Helius also secured Federal Supply Schedule contract pricing with the U.S. Department of Veterans Affairs (VA) and Defense Pricing and Contracting Agency (DAPA) contract pricing with the U.S. Department of Defense (DoD) through its partnership with Lovell Government Services. The VA contract prices the PoNS device and mouthpiece at $23,843.72 and $7,344.97, respectively, while the DoD contract prices them at $23,724.50 and $7,308.25, respectively.
In June 2024, Helius began expanding its nationwide sales representation at VA sites, establishing coverage in thirteen states and Puerto Rico. This expansion aims to bolster the company’s presence and accessibility to veterans who could benefit from the PoNS device.
Financial Performance
Helius reported revenue of $182 thousand for the second quarter of 2024, a decrease from $256 thousand in the same period last year. This decline was primarily due to the expiration of the Patient Therapy Access Program (PTAP) on June 30, 2023. However, revenue increased by $47 thousand or 35% compared to the first quarter of 2024, reflecting higher product sales in both the U.S. and Canada. The company’s cost of revenue decreased to $118 thousand, down from $184 thousand in the second quarter of 2023, attributed to lower sales volumes.
Operating expenses remained steady, with selling, general, and administrative expenses at $2.5 million, comparable to $2.6 million in the previous year. Research and development expenses saw a slight increase to $0.9 million, up from $0.7 million in the second quarter of 2023, driven primarily by heightened clinical trial activities.
Helius reported an operating loss of $3.3 million for the quarter, similar to the $3.2 million loss in the prior year. The net loss for the second quarter was $1.6 million, matching the net loss in the corresponding period last year. The basic and diluted net loss per share was $0.64, compared to $2.92 per share in the second quarter of 2023.
CEO Commentary and Strategic Outlook
“Our team has been working tirelessly to get PoNS into the hands of MS patients who suffer from gait and balance impairment. These efforts are starting to pay off and during the quarter we made several important advancements toward removing barriers to our innovative technology. We were pleased to announce the first third-party reimbursement for PoNS from a major insurance carrier at $23,900 and are now just a few weeks away from CMS publishing its final reimbursement rates to be effective on October 1, which we believe will be a significant catalyst for growing revenue as well as negotiating reimbursement with other third-party payers,” stated Helius’ President and Chief Executive Officer, Dane Andreeff.
Andreeff continued, “In June, we completed site participation enrollment for our registrational program in stroke. This groundbreaking program is being conducted at several of the top neurorehabilitation centers in the U.S., and the results will be crucial to seeking regulatory approval in 2025. To bolster our FDA submission and support national reimbursement efforts in Canada, we’ve begun a Canadian study with the goal of enrolling at least 40 subjects at three centers of excellence for stroke rehabilitation.”
“The third quarter of 2024 will be pivotal for Helius and will help frame our future. We expect to have a first read of the primary endpoint’s results of our PoNSTEP study, further expand our VA sales rep organization and penetrate VA sites, and receive final reimbursement determination by CMS. I’m proud of what we’ve accomplished to get to this point and excited about the outlook for Helius as these key milestones play out,” concluded Andreeff.
Cash and Liquidity
As of June 30, 2024, Helius had $6.4 million in cash with no debt, providing a solid foundation for future operations. The company closed on a $6.4 million public offering during the quarter, raising net proceeds of approximately $5.5 million. Cash used in operating activities remained steady at $5.9 million for the six months ended June 30, 2024, consistent with the same period in 2023.
Helius Medical Technologies continues to make significant strides in its mission to improve the quality of life for patients with neurological conditions. With strategic advancements and a focused approach to market expansion, the company is well-positioned for future growth and success.
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