Hyperfine(HYPR) - 2025 Q2 - Quarterly Results

Executive Summary This section provides an overview of Hyperfine, Inc.'s Q2 2025 financial results and strategic milestones, including FDA clearances and commercialization efforts Introduction and CEO Statement Hyperfine, Inc. announced its second quarter 2025 financial results and provided a business update, highlighting significant FDA clearances for its latest software and next-generation Swoop® system, alongside the successful completion of its neurology office pilot program - Hyperfine, Inc. (Nasdaq: HYPR) is a health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system[2] - CEO Maria Sainz highlighted FDA clearances for Optive AI™ software and the next-generation Swoop® system, and the completion of the neurology office pilot program as key inflection points[3] - These critical milestones are believed to establish a strong foundation for accelerated momentum in the second half of 2025, while delivering strong sequential financial results and driving leverage and spending discipline[3] Recent Achievements and Business Highlights Hyperfine achieved significant milestones in product development, regulatory clearances, market expansion, and clinical studies, reinforcing its leadership in AI-integrated imaging Product Development & Regulatory Clearances Hyperfine secured FDA clearance for two breakthrough innovations: the 10th generation software, Optive AI™, for all Swoop® systems, and a next-generation Swoop® scanner powered by this new software, positioning the company at the forefront of accessible, AI-integrated imaging - Secured FDA clearance for Optive AI™, the 10th generation software for all Swoop® systems[7] - Secured FDA clearance for a next-generation Swoop® scanner powered by Optive AI™ software[7] - These clearances position Hyperfine at the forefront of accessible, AI-integrated imaging[7] Commercialization & Market Expansion The company commenced commercial rollout of both the next-gen Swoop® system and Optive AI™ software to its installed base in the U.S., Canada, Australia, and New Zealand. Additionally, Hyperfine successfully completed its neurology office pilot and initiated a full-scale commercial launch to expand revenue opportunities - Commenced commercial rollout of the next-gen Swoop® system powered by Optive AI™ software, with first commercial shipments in U.S. hospitals within weeks of FDA clearance[7] - Commenced commercial rollout of Optive AI™ software to installed base of Swoop® scanners in the U.S., Canada, Australia, and New Zealand markets[7] - Successfully completed neurology office pilot and initiated a full-scale commercial launch to unlock new revenue opportunity[7] Clinical Studies & Data Hyperfine announced the enrollment of the 100th patient in the NEURO PMR study and initiated the PRIME study at Yale School of Medicine to evaluate AI-driven portable MRI in emergency department triaging. Promising new data also showed 100% sensitivity of the Swoop® system in detecting mild and moderate ARIA-E in Alzheimer's patients - Announced enrollment of 100th patient in the NEURO PMR study, a multi-center study to evaluate use of AI-powered portable MRI in neurology offices[7] - Initiated the PRIME study at Yale School of Medicine to evaluate the impact of AI-driven portable MRI in triaging a broad range of emergency department patients[7] - Promising new data at the 2025 Alzheimer's Association International Conference showed the Swoop® AI-powered portable MRI system demonstrated 100% sensitivity in detecting mild and moderate ARIA-E in Alzheimer's patients undergoing Lecanemab therapy[7] Second Quarter 2025 Financial Results Hyperfine reported strong sequential financial performance in Q2 2025, with increased revenue, improved gross margin, and reduced operating expenses, alongside higher system sales Key Financial Metrics Hyperfine reported Q2 2025 revenues of $2.7 million, a 26% increase compared to Q1 2025. Gross margin improved significantly to 49.3%, up 800 basis points sequentially, while net loss slightly decreased to $9.2 million, or $0.12 per share | Metric | Q2 2025 | Q1 2025 | Change (QoQ) | | :----- | :------ | :------ | :----------- | | Revenue | $2.7 million | N/A | +26% (vs Q1 2025) | | Gross Margin | $1.3 million | $0.9 million | +$0.4 million | | Gross Margin % | 49.3% | N/A | +800 basis points (vs Q1 2025) | | Net Loss | $9.2 million | $9.4 million | -$0.2 million | | Net Loss per Share | $0.12 | $0.12 | No change | Operating Expenses Research and development expenses for Q2 2025 decreased to $4.5 million from $5.0 million in Q1 2025. Sales, marketing, general, and administrative expenses also saw a reduction, totaling $6.4 million compared to $6.7 million in the previous quarter | Expense Category | Q2 2025 | Q1 2025 | Change (QoQ) | | :--------------- | :------ | :------ | :----------- | | Research and development | $4.5 million | $5.0 million | -$0.5 million | | Sales, marketing, general, and administrative | $6.4 million | $6.7 million | -$0.3 million | System Sales Hyperfine sold 8 commercial Swoop® systems in the second quarter of 2025, an increase from 6 systems sold in the first quarter of 2025 - Hyperfine, Inc. sold 8 commercial Swoop® systems in the second quarter of 2025, up from 6 Swoop® systems in the first quarter of 2025[7] 2025 Financial Guidance Hyperfine maintains its full-year 2025 revenue growth guidance and significantly reduced its cash burn expectations, reflecting improved financial discipline Full Year Revenue Guidance Management maintains its expectation for full-year 2025 revenue to grow by 10% to 20% compared to 2024 - Management continues to expect revenue for the full year 2025 to be 10% to 20% over 2024[6] Full Year Cash Burn Guidance Hyperfine's management now anticipates full-year 2025 cash burn to be approximately $27 million to $29 million, representing a 27% decline at the midpoint compared to 2024 - Management now expects cash burn for the full year 2025 to be approximately $27 million to $29 million[8] - This represents a 27% decline at the midpoint as compared to 2024[8] Consolidated Financial Statements This section presents Hyperfine's balance sheets, statements of operations, and cash flows, detailing asset and liability changes, revenue, net loss, and cash movements for Q2 and YTD 2025 CONSOLIDATED BALANCE SHEETS As of June 30, 2025, Hyperfine reported total assets of $45.2 million, a decrease from $58.9 million at December 31, 2024, primarily due to a reduction in cash and cash equivalents. Total liabilities increased slightly to $10.1 million, while total stockholders' equity decreased to $35.1 million | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | :-------------------- | | Cash and cash equivalents | $25,420 | $37,645 | -$12,225 | | Total current assets | $40,096 | $53,710 | -$13,614 | | Total assets | $45,234 | $58,901 | -$13,667 | | Total current liabilities | $7,988 | $8,729 | -$741 | | Total liabilities | $10,108 | $9,861 | +$247 | | Total stockholders' equity | $35,126 | $49,040 | -$13,914 | CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS For the three months ended June 30, 2025, total sales were $2.7 million, down from $3.6 million in the prior year, resulting in a net loss of $9.2 million ($0.12 per share). For the six months, total sales were $4.8 million, with a net loss of $18.6 million ($0.24 per share), showing an improvement from the prior year's net loss of $20.0 million | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total sales | $2,696 | $3,631 | $4,833 | $6,926 | | Gross margin | $1,328 | $1,803 | $2,211 | $3,157 | | Research and development | $4,541 | $5,959 | $9,578 | $11,529 | | General and administrative | $3,859 | $4,421 | $8,067 | $8,851 | | Sales and marketing | $2,523 | $2,269 | $5,063 | $4,273 | | Total operating expenses | $10,923 | $12,649 | $22,708 | $24,653 | | Loss from operations | $(9,595) | $(10,846) | $(20,497) | $(21,496) | | Net loss | $(9,225) | $(10,156) | $(18,643) | $(20,004) | | Net loss per common share | $(0.12) | $(0.14) | $(0.24) | $(0.28) | CONSOLIDATED STATEMENT OF CASH FLOWS For the six months ended June 30, 2025, net cash used in operating activities improved to $(17.2) million from $(21.9) million in the prior year. Net cash provided by financing activities significantly increased to $6.1 million, driven by proceeds from stock and warrant issuance. The net decrease in cash and cash equivalents was $(12.1) million | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | :-------------------- | | Net cash used in operating activities | $(17,159) | $(21,893) | +$4,734 | | Net cash used in investing activities | $(992) | $(216) | -$776 | | Net cash provided by financing activities | $6,056 | $114 | +$5,942 | | Net decrease in cash and cash equivalents and restricted cash | $(12,095) | $(21,995) | +$9,900 | | Cash, cash equivalents and restricted cash, end of period | $25,578 | $53,809 | -$28,231 | - Proceeds from issuance of common stock and warrants, net of offering costs, contributed $5,184 thousand to financing activities for the six months ended June 30, 2025[21] Company and Legal Disclosures This section provides essential information about Hyperfine, its portable MR imaging systems, cautionary forward-looking statements, and investor contact details About Hyperfine, Inc. and the Swoop® Portable MR Imaging® Systems Hyperfine, Inc. is a health technology company that developed the FDA-cleared, portable, ultra-low-field Swoop® system for brain imaging. Its mission is to revolutionize patient care globally through accessible, clinically relevant diagnostic imaging, with the system cleared for all ages and available in select international markets - Hyperfine, Inc. (Nasdaq: HYPR) is a groundbreaking health technology company that redefined brain imaging with the Swoop® system, the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system[10] - The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging[10] - The Swoop® Portable MR Imaging® systems are FDA cleared for brain imaging of patients of all ages and are commercially available in a select number of international markets[11] Forward-Looking Statements This section includes cautionary forward-looking statements regarding Hyperfine's financial and operating results, commercial plans, and future performance. It emphasizes that actual results may differ materially from expectations due to various risks and uncertainties, and the company does not undertake to publicly update or revise these statements - This press release includes 'forward-looking statements' regarding the Company's financial and operating results, commercial plans, product benefits, and future performance[13] - These statements involve significant risks and uncertainties that could cause actual results to differ materially from expected results, with most factors outside the Company's control[13] - The Company cautions readers not to place undue reliance on forward-looking statements and does not undertake any obligation to release publicly any updates or revisions[14] Conference Call Hyperfine, Inc. hosted a conference call on August 13, 2025, to discuss its second quarter 2025 financial results and provide a business update. Registration and webcast details were provided for interested participants - Hyperfine, Inc. hosted a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Wednesday, August 13, 2025, to discuss its second quarter 2025 financial results and provide a business update[9] - Interested parties were encouraged to register online via https://investors.hyperfine.io/ and a live and archived audio webcast was available[9] Investor Contact Investor relations inquiries can be directed to Webb Campbell of Gilmartin Group LLC - Investor contact is Webb Campbell of Gilmartin Group LLC, reachable at webb@gilmartinir.com[15]