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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call highlights strong financial performance, including record revenue and gross margins, a significant partnership with Zimmer Biomet, and improved net loss figures. The Q&A reveals reliance on Zimmer for revenue and some uncertainty regarding non-Zimmer revenue, but overall sentiment remains positive due to the partnership's potential and no debt. The capital raise ensures financial stability, and the addition of a Chief Medical Advisor indicates strategic growth. Despite some risks and uncertainties, the overall outlook is positive, likely resulting in a stock price increase of 2% to 8%.
Product Revenue $4.7 million (97% increase year-over-year from $2.4 million in the first half of fiscal 2024). The increase is attributed to the successful launch and adoption of the OneRF ablation system.
License Revenue $3 million (compared to $0 in the first half of fiscal 2024). This revenue was derived from the expanded exclusive distribution agreement with Zimmer.
Product Gross Profit $2.7 million (57.9% of revenue, more than double the gross profit of $0.7 million or 27.9% of revenue in the first half of fiscal 2024). The increase is due to higher product revenue and improved margins.
Net Loss (Q2 FY 2025) $2.3 million or $0.07 per share (improved from a net loss of $2.9 million or $0.11 per share in Q2 FY 2024). The improvement is due to increased revenue and reduced operating expenses.
Net Loss (First 6 months FY 2025) $0.5 million or $0.02 per share (significantly improved from a net loss of $6.2 million or $0.25 per share in the first half of FY 2024). This improvement is attributed to increased product revenue and reduced operating expenses.
Total Operating Expenses (Q2 FY 2025) $3.5 million (compared to $3.3 million in Q2 FY 2024). The slight increase is due to higher R&D expenses.
Total Operating Expenses (First 6 months FY 2025) $6.7 million (4% decrease from $6.9 million in the first half of FY 2024). The decrease is due to reduced SG&A and R&D expenses.
Cash and Cash Equivalents $1.3 million (compared to $1.4 million as of September 30, 2024). The slight decrease is due to operational cash flow.
Working Capital $2 million (compared to $2.4 million as of September 30, 2024). The decrease is attributed to operational cash flow.
Debt No debt outstanding as of March 31, 2025. This reflects a strong balance sheet position.
Net Cash from Capital Raise $8.2 million in net proceeds from an oversubscribed capital raise with institutional investors. This funding is expected to support operations through at least fiscal 2026.
Product Revenue Growth: Product revenue increased 97% to $4.7 million in the first half of fiscal 2025.
Product Gross Margins: Product gross margins increased to 57.9%, more than double the margin in the first half of fiscal 2024.
OneRF Ablation System: The OneRF ablation system is FDA cleared and commercially available, treating patients suffering from seizures due to epilepsy.
Trigeminal Nerve Ablation System: Filed 510(k) submission with the FDA for the OneRF trigeminal nerve ablation system, aimed at treating trigeminal neuralgia.
Market Expansion: Initiating process to secure ISO 13485 certification for international commercialization.
Distribution Partnership: Expanding distribution through Zimmer Biomet, a major player in the epilepsy market.
Operational Efficiencies: Reduced hospitalizations from two to one with the OneRF system, improving patient outcomes.
Cost Reduction: Bringing critical functions in-house to reduce costs.
Strategic Partnerships: In discussions with top-tier partners for spinal cord nerve ablation and stimulation applications.
Financial Positioning: Successfully raised $8.2 million in net proceeds, fully funding operations through at least fiscal 2026.
Earnings Expectations: NeuroOne Medical Technologies Corporation reported an EPS of $-72.98, significantly missing expectations of $-0.09, indicating potential financial instability.
Regulatory Risks: The company is pursuing FDA clearance for new applications, which involves inherent risks of delays or rejections that could impact revenue generation.
Market Competition: NeuroOne faces competitive pressures from other medical technology companies, particularly in the epilepsy treatment market, which could affect market share and pricing.
Supply Chain Challenges: The company relies on strategic distribution partners like Zimmer Biomet, and any disruptions in these partnerships could hinder product availability and sales.
Economic Factors: The overall economic environment may impact hospital budgets and spending on medical technologies, potentially affecting sales and revenue growth.
International Market Entry: NeuroOne is initiating efforts to secure ISO 13485 certification for international markets, which poses risks related to regulatory compliance and market acceptance.
Funding and Financial Stability: While the company has secured funding through fiscal 2026, any failure to achieve key milestones could necessitate additional financing, which may dilute existing shareholder value.
Product Revenue Growth: Product revenue increased 97% to $4.7 million in the first half of fiscal 2025.
Product Gross Margin: Product gross margins increased to 57.9%, more than double the margin in the first half of fiscal 2024.
FDA Submission: Filed 510(k) submission with the FDA for the OneRF trigeminal nerve ablation system, aimed at treating trigeminal neuralgia.
Strategic Partnerships: In discussions with top-tier strategic partners for applications leveraging the platform technology, including spinal cord nerve ablation.
International Expansion: Initiating process to secure ISO 13485 certification for international commercialization.
Team Expansion: Welcomed new Chief Medical Advisor and General Counsel to reduce costs and enhance expertise.
Fiscal Year 2025 Revenue Guidance: Expect product revenue to be in the range of $8.0 million to $10 million, representing an increase of 132% to 190% over fiscal 2024.
Product Gross Margin Guidance: Expect product gross margin to be between 47% and 51%, compared to 31% in fiscal 2024.
Cash Flow Breakeven: Potential to reach cash flow breakeven if key milestones are achieved.
Funding Outlook: Fully funded through at least fiscal 2026 with no need for additional dilutive financing.
Upfront License Payment: Received an upfront license payment of $3 million from Zimmer in the fiscal first quarter of 2025.
Capital Raise: Completed an oversubscribed capital raise with institutional investors in April, totaling $8.2 million in net proceeds.
ATM Program: Generated net proceeds of $0.3 million by selling common stock under the ATM program at an average price of $1.16 per share.
The earnings call reveals strong financial performance with significant improvements in gross margins and a reduced net loss. The strategic plan outlines ambitious growth prospects, including new product developments and market expansions. Although some uncertainty exists around partnerships and timelines, the overall sentiment is optimistic with increased revenue guidance and improved financial health. The Q&A section did not highlight any major concerns, supporting a positive outlook. Given these factors, a positive stock price movement is likely over the next two weeks.
The earnings call reveals strong financial performance, with significant revenue and margin growth, reduced expenses, and improved net loss. The partnership with Zimmer Biomet and international expansion plans are promising. Despite management's cautious stance on 2026 guidance, the optimistic FY 2025 outlook and strategic partnerships suggest a strong positive sentiment. The Q&A session highlights potential growth areas and addresses concerns, further solidifying the positive outlook. Given the context and potential for expansion, a strong positive stock price movement is expected, likely exceeding 8%.
The earnings call highlights strong financial performance, including record revenue and gross margins, a significant partnership with Zimmer Biomet, and improved net loss figures. The Q&A reveals reliance on Zimmer for revenue and some uncertainty regarding non-Zimmer revenue, but overall sentiment remains positive due to the partnership's potential and no debt. The capital raise ensures financial stability, and the addition of a Chief Medical Advisor indicates strategic growth. Despite some risks and uncertainties, the overall outlook is positive, likely resulting in a stock price increase of 2% to 8%.
NeuroOne's earnings report highlights strong financial performance with record product sales and gross margins, along with a significant partnership expansion with Zimmer Biomet. Despite some uncertainties in the Q&A, the company's improved financial health, no debt, and guidance of being fully funded through fiscal 2026 are positive indicators. The competitive pressures and supply chain challenges are present but are outweighed by the strategic partnership and financial improvements. The stock is likely to see a positive reaction over the next two weeks.
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