Helius Medical Technologies, Inc. Reports First Quarter 2024 Financial Results
Helius Medical Technologies (Nasdaq: HSDT) reported its Q1 2024 financial results. Revenue rose to $135,000 from $111,000 in Q1 2023, driven by higher product sales in the U.S. and Canada. Operating loss decreased to $3.4 million, down from $3.8 million in the prior year. Net loss remained stable at $2.5 million, with a net loss per share improving to $3.08, compared to $4.42 previously. The company successfully closed a $6.4 million public offering, netting $5.6 million. Helius received HCPCS codes for its PoNS device, with final reimbursement rates to be determined by October 1, 2024. The company expanded its stroke registrational program and partnered with Lovell Government Services to access federal healthcare systems.
- Q1 2024 revenue increased to $135,000, a rise from $111,000 in Q1 2023.
- Operating loss decreased to $3.4 million, compared to $3.8 million in Q1 2023.
- Net loss per share improved to $3.08 from $4.42 in the prior year.
- Closed a $6.4 million public offering, netting $5.6 million in proceeds.
- Received HCPCS codes for the PoNS device, with final reimbursement rates expected by October 1, 2024.
- Expanded stroke registrational program with six new sites in the U.S. and Canada.
- Partnership with Lovell Government Services to make PoNS available to federal healthcare systems, including VA and DoD.
- Total revenue of $135,000 remains relatively low.
- Operating expenses were still high at $3.4 million, despite a decrease.
- Net loss remained substantial at $2.5 million.
- Cash used in operating activities was $3.0 million in Q1 2024.
Insights
The first quarter financial results for Helius Medical Technologies demonstrate some positive momentum in terms of revenue growth and cost management. Revenue increased to
Operating expenses saw a decrease from
The successful public offering, raising
Rating: 0
The recent HCPCS codes and preliminary reimbursement determinations for the Portable Neuromodulation Stimulator (PoNS®) are noteworthy. This development paves the way for broader market penetration, especially within the Medicare demographic. The anticipated finalization of reimbursement rates by October 2024 could significantly increase product accessibility and drive sales, potentially transforming the company's revenue base.
Moreover, the partnership with Lovell Government Services to supply PoNS to federal healthcare systems, including the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD), opens new, lucrative market segments. These agreements could provide stable, high-volume contracts, thus positively impacting future revenue streams.
While the addition of six more sites to the stroke registrational program indicates robust pipeline development, investors should be cognizant of the time required for regulatory submissions and approvals, targeted for early 2025. This timeline suggests long-term growth potential but may not immediately impact the stock price.
Rating: 1
The alignment with the U.S. Food and Drug Administration (FDA) on the stroke development plan is a substantial step forward for Helius. Optimizing the stroke development plan enhances the probability of regulatory success, which is critical for the company's future growth. Adding more sites to the stroke registrational program in the U.S. and Canada shows a strong commitment to expanding clinical evidence and supports the case for broader market approval and adoption.
Additionally, PoNS' potential reimbursement by Medicare could make this innovative therapeutic approach more accessible to stroke patients, a substantial target demographic given the prevalence of stroke-related disabilities. The strategic focus on balance and gait deficits addresses significant unmet medical needs, potentially leading to a higher quality of life for patients.
However, investors should remain aware of the inherent risks in clinical trials and regulatory processes, which can be unpredictable. Any delays or negative outcomes could impact the company's trajectory.
Rating: 1
Company to host call at 4:30pm today
NEWTOWN, Pa., May 13, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced results for the quarter ended March 31, 2024.
First Quarter and Recent Business Updates
- Received Healthcare Common Procedure Coding System (“HCPCS”) codes and preliminary determination for reimbursement for the Portable Neuromodulation Stimulator (“PoNS®”) mouthpiece and controller from the Centers for Medicare & Medicaid Services (“CMS”), paving the way toward final price determination on October 1, 2024.
- Added six more sites to the stroke registrational program in the U.S. and Canada; reached alignment with the U.S. Food and Drug Administration (“FDA”) on optimizing the stroke development plan.
- Announced partnership with Lovell® Government Services to make PoNS available to federal healthcare systems, including the U.S. Department of Veterans Affairs (“VA”) and Department of Defense (“DoD”).
- Q1 2024 revenue of
$135 thousand , compared to$111 thousand in Q1 2023, reflecting increased product sales in both the U.S. and Canada. - Closed on
$6.4 million public offering, raising net proceeds of approximately$5.6 million .
“We marched one step closer to an important milestone when CMS released its preliminary Medicare payment determinations for the PoNS Controller and Mouthpiece earlier this month. This was a significant achievement for Helius, and at the HCPCS public meeting later this month, we will present arguments to support higher reimbursement rates than those established in the preliminary determinations. Once the reimbursement amount is finalized, the payment rates are expected to be effective October 1,” stated Helius’ President and Chief Executive Officer, Dane Andreeff.
“We believe the establishment of Medicare payment rates will make it easier to expand reimbursement across third-party payers, creating a pathway to positive cash flow as we continue pursuing stroke authorization in the U.S. We remain on track for an early 2025 regulatory submission for stroke, and we added several new sites to our registrational program during the quarter to advance this objective. It’s an exciting time at Helius with the achievement of two monumental goals in sight and the cash that will help us get there,” concluded Andreeff.
First Quarter 2024 Financial Results
Total revenue for the first quarter of 2024 was
Cost of revenue was
Operating expenses for the first quarter of 2024 decreased to
Operating loss for the first quarter of 2024 decreased
Net loss was
Cash and Liquidity
Cash used in operating activities for the three months ended March 31, 2024, was
As of March 31, 2024, the Company had cash of
Conference Call
| Date: | Monday, May 13, 2024 |
| Time: | 4:30 p.m. Eastern Time |
| Register (Audio only): | Click Here |
| Webcast: | Click Here |
The webcast will be archived under the Newsroom section of the Company’s investor relations website.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information about the PoNS® or Helius Medical Technologies, visit www.heliusmedical.com.
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (PoNS) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.
PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com.
Cautionary Disclaimer Statement
Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding the sufficiency of the Company’s future cash position, the development, commercialization and success of the Company’s PoNS and PoNS Treatment, future decisions and approvals from applicable regulatory entities in the U.S. and Canada, the Company’s strategic operating plans, and the uses and effectiveness of PoNS and PoNS Therapy.
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, availability of funds, the Company’s ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company’s ability to obtain national Medicare insurance coverage and to obtain a reimbursement code, the Company’s ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.
The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
Investor Relations Contact
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
| Helius Medical Technologies, Inc. | ||||||||
| Unaudited Condensed Consolidated Statements of Operations | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | ||||||||
| Product sales, net | $ | 124 | $ | 106 | ||||
| Other revenue | 11 | 5 | ||||||
| Total revenue | 135 | 111 | ||||||
| Cost of revenue | 123 | 122 | ||||||
| Gross profit (loss) | 12 | (11 | ) | |||||
| Operating expenses | ||||||||
| Selling, general and administrative expenses | 2,633 | 2,874 | ||||||
| Research and development expenses | 788 | 886 | ||||||
| Amortization expense | 7 | 39 | ||||||
| Total operating expenses | 3,428 | 3,799 | ||||||
| Loss from operations | (3,416 | ) | (3,810 | ) | ||||
| Nonoperating income (expense) | ||||||||
| Interest income (expense), net | (8 | ) | 100 | |||||
| Change in fair value of derivative liability | 1,142 | 1,221 | ||||||
| Foreign exchange loss | (288 | ) | (5 | ) | ||||
| Other income, net | 54 | — | ||||||
| Nonoperating income, net | 900 | 1,316 | ||||||
| Loss before provision for income taxes | (2,516 | ) | (2,494 | ) | ||||
| Provision for income taxes | — | — | ||||||
| Net loss | $ | (2,516 | ) | $ | (2,494 | ) | ||
| Loss per share | ||||||||
| Basic | $ | (3.08 | ) | $ | (4.42 | ) | ||
| Diluted | $ | (3.08 | ) | $ | (4.42 | ) | ||
| Weighted average number of common shares outstanding | ||||||||
| Basic | 817,327 | 564,134 | ||||||
| Diluted | 817,327 | 564,134 | ||||||
| Helius Medical Technologies, Inc. | ||||||||
| Unaudited Condensed Consolidated Balance Sheets | ||||||||
| (in thousands, except share and per share data) | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 3,638 | $ | 5,182 | ||||
| Accounts receivable, net | 49 | 117 | ||||||
| Other receivables | 513 | 520 | ||||||
| Inventory, net | 384 | 457 | ||||||
| Prepaid expenses and other current assets | 940 | 1,162 | ||||||
| Total current assets | 5,524 | 7,438 | ||||||
| Property and equipment, net | 174 | 178 | ||||||
| Intangible assets, net | 17 | 24 | ||||||
| Operating lease right-of-use asset, net | 42 | 52 | ||||||
| Total assets | $ | 5,757 | $ | 7,692 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 814 | $ | 531 | ||||
| Accrued and other current liabilities | 674 | 1,260 | ||||||
| Current portion of operating lease liabilities | 46 | 45 | ||||||
| Current portion of deferred revenue | 42 | 43 | ||||||
| Total current liabilities | 1,576 | 1,879 | ||||||
| Operating lease liabilities, net of current portion | — | 12 | ||||||
| Deferred revenue, net of current portion | 115 | 128 | ||||||
| Derivative liability | 2,080 | 3,323 | ||||||
| Total liabilities | 3,771 | 5,342 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Class A common stock, | 1 | 1 | ||||||
| Additional paid-in capital | 164,843 | 162,979 | ||||||
| Accumulated deficit | (162,473 | ) | (159,957 | ) | ||||
| Accumulated other comprehensive loss | (385 | ) | (673 | ) | ||||
| Total stockholders' equity | 1,986 | 2,350 | ||||||
| Total liabilities and stockholders' equity | $ | 5,757 | $ | 7,692 | ||||
FAQ
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