Hyperfine, Inc. — Third Quarter 2026 Earnings Summary

Financial Performance:

• Third quarter 2026 revenue reached a record $6.0 million, a 73% increase year-over-year from $3.4 million in Q3 2025 and a 53% increase quarter-over-quarter from $3.9 million in Q2 2026.
• Gross profit totaled a record $3.4 million in Q3 2026, up from $1.8 million in Q3 2025, resulting in a record gross margin of 57% compared to 54% in the prior year period.
• Operating loss narrowed to $7.3 million in Q3 2026, a 19% improvement from $8.9 million in Q3 2025, driven by revenue growth of 73% and gross profit growth of 83% while total operating expenses decreased 1%.
• Net loss for Q3 2026 was $6.0 million ($0.06 per share), compared to a net loss of $11.0 million ($0.14 per share) in Q3 2025; the Q3 2026 figure includes a $1.5 million gain from changes in warrant liabilities, whereas Q3 2025 included a $2.3 million loss.
• Research and development expenses were $3.9 million in Q3 2026, a 3% decrease from $4.0 million in Q3 2025.
• Sales, marketing, general, and administrative expenses were $6.7 million in Q3 2026, remaining flat compared to $6.7 million in Q3 2025.
• Net cash burn for Q3 2026 was $5.6 million, the lowest quarterly level, down from $5.9 million in Q3 2025 and $7.9 million in Q2 2026; Q3 2026 revenue exceeded net cash burn for the first time.
• Cash and cash equivalents were $37.9 million as of September 30, 2026, down from $43.5 million as of June 30, 2026 and $40.8 million as of March 31, 2026.
• Long-term debt, net, stood at $13.352 million as of September 30, 2026, compared to zero as of December 31, 2025.
• Deferred revenue increased to $1.737 million (current) and $830,000 (long-term) as of September 30, 2026, from $1.544 million (current) and $729,000 (long-term) as of December 31, 2025.

Guidance and Future Outlook:

• Management expects full-year 2026 revenue to be approximately $20 million to $22 million, representing 55% growth at the midpoint compared to full-year 2025.
• Management expects full-year 2026 net cash burn to be approximately $26 million to $28 million, representing a 10% decline at the midpoint compared to full-year 2025.
• The company plans to file a new Form S-3 registration statement to replace the existing shelf registration expiring in November 2026, expected to register an aggregate offering amount of $150 million, including a $50 million "at-the-market" offering program.

Business Segments and Product Lines:

• Sold 14 commercial Swoop® systems in Q3 2026, a 75% increase from 8 systems sold in Q3 2025.
• Launched Swoop® system Model 2 in Europe and the UK following CE and UKCA marking, with sales into four international markets.
• Signed an exclusive distributor agreement for Kuwait and the United Arab Emirates.
• Received FDA clearance and CE and UKCA marking for the latest Optive AI™ software, which features improved noise correction, guided scanning, and an isotropic T1 sequence.
• Completed enrollment in the Contrast PMR study, a key milestone toward expanding Swoop® system labeling, with FDA submission expected by the end of 2026.
• Published NEURO PMR study results in the Journal of Neuroimaging showing 92% concordance between portable MRI and high-field MRI in blinded review, and 98% concordance when paired with clinical information.
• Expanded the Swoop® system evidence base with new peer-reviewed publications on Stroke and in the Journal of Neurosurgery, bringing the total to more than 180 publications and 280 scientific presentations.

Market and Competitive Landscape:

• The company highlights opportunities for the Swoop® system in the evolving brain health and longevity fields.
• The Swoop® system is commercially available in a select number of international markets beyond the U.S.
• The company notes the potential for accelerating adoption across multiple sites of care, including hospitals, office-based settings, wellness and longevity centers, and mobile settings.

Risks and Challenges:

• Risks include the success, cost, and timing of product development and commercialization activities, including acceptance by healthcare professionals.
• Challenges involve the ability to grow and manage growth profitably, retain key employees, and raise future financing.
• Regulatory risks include the ability to obtain and maintain clearance or approval for products and any related restrictions.
• Market risks include the size and growth potential of markets, pricing, and reimbursement for medical procedures.
• Operational risks include supply chain constraints, manufacturing capacity, and the ability to maintain existing agreements.
• Financial risks include the inability to predict future financing proceeds, which could cause actual net change in cash to differ materially from net cash burn guidance.

Management Commentary and Tone:

• CEO Maria Sainz stated that Q3 2026 marked the beginning of a new trajectory, delivering record revenue, gross profit, and gross margin.
• Management emphasized that quarterly revenue exceeded net cash burn for the first time, demonstrating operating leverage.
• The CEO expressed excitement about opportunities in the evolving brain health and longevity fields, describing the combination of AI and accessible brain imaging as enabling diagnostic insights at scale.
• Management described the current period as "the new Hyperfine."

Other Key Points:

• The company did not generate any financing proceeds during the third quarter of 2026.
• Net financing proceeds for the nine months ended September 30, 2026, were $25.0 million, compared to $8.1 million for the same period in 2025.
• Total net financing proceeds for the year ended December 31, 2025, were $27.3 million.
• The company has not provided a reconciliation of full-year 2026 net cash burn guidance to forward-looking net change in cash and cash equivalents due to the unpredictability of future financing proceeds.
• The company hosts a conference call on November 9, 2026, to discuss results and provide a business update.