NeuroOne — Fiscal Q4 2026 Earnings Summary

Financial Performance

• Preliminary fiscal Q4 2026 product revenue is expected to be approximately $3.8 million, representing a 38.4% year-over-year increase compared to $2.7 million in Q4 2025.
• Preliminary full-year 2026 product revenue is expected to be approximately $10.5 million, representing a 15.6% year-over-year increase.
• Full-year revenue of $10.5 million landed at the top of the previously announced guidance range of $9.2 million to $10.5 million.
• Product orders increased 24.2% in fiscal 2026 compared to fiscal 2025.
• Total open purchase orders for shipments through the first quarter of fiscal 2027 increased to $5.4 million as of September 30, 2026.
• Complete financial results, including earnings, profit margins, cash flow, and debt metrics, are not included in this preliminary release and are expected to be announced in December 2026.

Guidance and Future Outlook

• The company enters fiscal 2027 with $5.4 million in open purchase orders providing visibility into anticipated product shipments, cash flow, and revenue opportunities.
• Approximately $1.0 million of a record $4.5 million purchase order shipped in September 2026.
• Shipments of the remaining $3.6 million from the record order are expected to begin during the first quarter of fiscal 2027 and continue into the second quarter of fiscal 2027, subject to manufacturing and delivery schedules.
• Future growth drivers identified include the commercialization of the trigeminal neuralgia system, international market expansion, and the advancement of the drug delivery platform.

Business Segments and Product Lines

• NeuroOne secured a $4.5 million product purchase order in September 2026, the largest in the company's history.
• The company markets four FDA-cleared product families: Evo® Cortical Electrodes, Evo® sEEG Electrodes, OneRF® Ablation System (for brain), and OneRF® Trigeminal Nerve Ablation System.
• The company is engaged in research and development for drug delivery, basivertebral nerve ablation, and spinal cord stimulation programs.

Market and Competitive Landscape

• The press release does not provide specific data on market share, specific competitor performance, or detailed market trend analysis beyond the company's own growth metrics.

Risks and Challenges

• Risks include potential supply chain disruptions and labor shortages.
• Risks exist regarding the ability to secure or retain coverage and adequate reimbursement for the technology.
• Risks include uncertainties associated with capital requirements and the ability to raise additional funds to achieve business objectives.
• Risks include the possibility that partnerships may not facilitate commercialization or market acceptance, and that technology may not perform as expected based on pre-clinical and clinical trial results.
• Risks include changes in regulatory requirements, decisions by regulatory authorities, and the ability to protect intellectual property rights.
• Risks include inaccuracies in estimating the size and growth potential of the markets for the technology.

Management Commentary and Tone

• CEO Dave Rosa stated, "Momentum continues to build across our business," and noted the company enters fiscal 2027 from a "position of strength."
• Management expressed confidence in being "very well positioned" with additional growth drivers.

Other Key Points

• The financial results included in this press release are preliminary, unaudited, and subject to adjustment upon completion of year-end accounting and audit procedures.
• Complete financial results for the fourth quarter and full fiscal year 2026 are expected to be announced in December 2026, coinciding with the filing of the Annual Report on Form 10-K with the SEC.
• The company is a medical technology firm focused on transforming the surgical diagnosis and treatment of neurological disorders.