Hyperfine, Inc. (Nasdaq: HYPR) Announces Fourth Quarter and Full Year 2025 Financial Results

Key Highlights and Recent Achievements

• Product Innovation: Launch of the second-generation Swoop® scanner and Optive AI^TM software. Introduction of a new market segment in neurology office settings, broadening the adoption of portable brain MRI technology.
• Regulatory Progress: Secured FDA clearance for the Optive AI^TM software update, which now includes advanced diffusion imaging capabilities focused on stroke detection.
• Clinical Milestones: First patient enrolled in the Contrast PMR study, supporting future FDA submissions to expand Swoop® system’s use to include gadolinium-based contrast agents.
• Scientific Recognition: NEURO-PMR results were presented at the 2025 American Society of Neuroimaging, demonstrating high diagnostic value and superior patient experience in neurology clinics. Peer-reviewed publications in ‘Stroke: Vascular and Interventional Neurology’ and ‘Clinical Neuroimaging’ highlighted enhanced stroke detection capabilities and significant health economic benefits of the Swoop® system.
• International Expansion: Received regulatory approval in India for the first-generation Swoop® system.
• Funding and Financial Strength: Awarded a \$3.7 million grant from the Gates Foundation to advance global brain health. Raised over \$20 million through an equity public offering in October 2025. Secured a \$40 million senior secured term loan facility in March 2026, with \$15 million funded initially and \$25 million available upon meeting commercial milestones.
• Balance Sheet Improvement: Expected cash runway extends into 2028, providing capital for commercial growth.

Fourth Quarter 2025 Financial Results

• Revenue: \$5.29 million, up 128% from \$2.32 million in Q4 2024.
• Swoop® Systems Sold: Net 16 commercial units sold (Q4 2024: 9 units).
• Gross Profit: \$2.69 million (Q4 2024: \$0.83 million), gross margin improved to 51% from 36%.
• R&D Expenses: \$3.82 million, down from \$5.11 million in Q4 2024.
• SG&A Expenses: \$6.54 million, slightly up from \$6.49 million in Q4 2024.
• Net Loss: \$5.91 million (\$0.06 per share), an improvement from \$10.39 million (\$0.14 per share) in Q4 2024. Includes a \$1.46 million gain from change in fair value of warrant liabilities.

Full Year 2025 Financial Results

• Revenue: \$13.56 million, up 5.2% from \$12.89 million in 2024.
• Swoop® Systems Sold: Net 38 units (2024: 48 units).
• Gross Profit: \$6.75 million (2024: \$5.89 million), gross margin improved to 50% from 46%.
• R&D Expenses: \$17.45 million, down from \$22.50 million in 2024.
• SG&A Expenses: \$26.39 million, flat versus \$26.62 million in 2024.
• Net Loss: \$35.57 million (\$0.43 per share), an improvement from \$40.72 million (\$0.56 per share) in 2024. Includes \$0.83 million gain from change in fair value of warrant liabilities.
• Cash and Cash Equivalents: \$35.09 million as of December 31, 2025.

2026 Financial Guidance

• Revenue: Management expects \$20–\$22 million for full year 2026 (approx. 55% growth at midpoint).
• Cash Burn: Expected to be \$26–\$28 million (10% decline at midpoint vs. 2025).
• Cash Runway: Current financing and debt facility provide expected runway into 2028.

Balance Sheet & Capital Structure

• Total Assets: \$55.26 million as of December 31, 2025.
• Total Liabilities: \$14.26 million.
• Stockholders’ Equity: \$41.01 million.
• Recent Equity Offerings: Raised \$27.5 million in 2025, including October offering and warrant exercises.
• Debt Facility: \$40 million term loan, with initial \$15 million drawn in March 2026.

Key Risks and Forward-Looking Statements

The report contains forward-looking statements regarding financial guidance, product development, regulatory approvals, and commercial expansion. Risks include adoption of Swoop® by healthcare professionals, regulatory changes, ability to raise future funding, competition, market size and growth, pricing and reimbursement, and clinical study outcomes. Investors should note these risks may cause actual outcomes to differ materially from projections.

Potential Share Price Drivers

• Strong Revenue Growth: Q4 revenue surged by 128% year-over-year; 2026 guidance expects 55% growth.
• Product Pipeline: FDA clearance for Optive AI^TM and ongoing clinical studies for expanded indications (contrast agent use).
• International Expansion: Approval in India and ongoing global initiatives, including Gates Foundation grant.
• Financial Stability: Strengthened balance sheet, reduced cash burn, and extended cash runway support commercial growth and reduce risk.
• Clinical Data: Positive published results and ongoing studies may drive further adoption and reimbursement improvements.

Shareholder Considerations

• Rapid revenue and margin growth, improved operating losses, and reduced R&D expenses indicate improving fundamentals.
• Cash runway into 2028 reduces liquidity risk, especially with new equity and debt funding.
• Expansion into new markets and regulatory successes could accelerate adoption and drive future growth.
• Risks remain around adoption, competition, regulatory approvals, and execution of commercial strategy.

Upcoming Events

Hyperfine will host a conference call on March 18, 2026, at 4:30 p.m. ET to discuss Q4 and full year 2025 results and provide business updates. Investors can register via the company’s investor relations website.

About Hyperfine, Inc. and Swoop® System

Hyperfine, Inc. is a health technology company that pioneered the first FDA-cleared portable, ultra-low-field MR brain imaging system. The Swoop® system enables diagnostic imaging at multiple care points, including hospitals and neurology offices, and is CE-marked in Europe and UKCA-marked in the UK.

Disclaimer: This article is for informational purposes only and does not constitute investment advice or a solicitation to buy or sell securities. All forward-looking statements are subject to substantial risks and uncertainties. Investors should review all company filings and consult their own advisers before making investment decisions.

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