GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine launches a subscription-based platform designed to empower researchers and developers advancing access and innovation in portable MRI. ...

Summary of Hyperfine's Conference Call Company Overview - **Company**: Hyperfine - **Industry**: Medical Imaging, specifically portable MRI technology - **Product**: First FDA-cleared portable brain MRI system, known as the Swoop® system powered by Optive AI™ [2][9] Key Points and Arguments - **Market Opportunity**: The total addressable market (TAM) for Hyperfine's technology is estimated to be over $6 billion, with potential growth to over $16 billion in the U.S. alone [2][9][26] - **Commercialization Strategy**: Hyperfine is in early commercialization globally, with existing reimbursement similar to conventional MRI [2][10] - **Technology Advantages**: - Portable MRI can be used in various care settings without the need for dedicated chambers or specialized operators [4][5] - The system is designed for ease of use, allowing healthcare professionals with minimal training to operate it [4][12] - The technology enhances timeliness and reduces risks associated with patient transport, especially in critical care [5][6] - **Growth Strategy**: The introduction of the next-generation scanner, Optive AI™, has de-risked the growth strategy, allowing expansion into emergency departments, operating rooms, and neurology offices [3][18] - **Clinical Applications**: The system has been validated through various clinical studies, demonstrating its effectiveness in critical care and neurology [17][18] Financial Insights - **Revenue Model**: Hyperfine's revenue streams include direct device sales and recurring revenue from service and software fees. The MSRP for the Swoop® system is $550,000 [25][26] - **Return on Investment (ROI)**: Hospitals can expect an ROI of approximately 1 to 1.5 years, which is favorable compared to typical capital equipment [21] - **Sales Potential**: A penetration of just 1.5% in the U.S. market could yield $100 million in revenue [26] Additional Important Information - **Regulatory Approvals**: Hyperfine has over 200 patents and has received multiple FDA clearances for its AI-enabled imaging technology [9][14] - **Global Expansion**: The company is looking to enter the Indian market, which is significant for remote and rural care [19] - **Partnerships**: Collaboration with King's College London and support from the Bill and Melinda Gates Foundation for pediatric MRI in low and middle-income settings [10][25] - **Future Applications**: While currently focused on brain imaging, there are plans to explore other applications, such as diabetic foot triage [27] This summary encapsulates the key insights from Hyperfine's conference call, highlighting the company's innovative approach to portable MRI technology and its significant market potential.

Core Viewpoint - Hyperfine, Inc. (HYPR) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Hyperfine's Earnings Outlook - The recent upgrade for Hyperfine reflects an improvement in the company's underlying business, which is expected to positively influence its stock price [5]. - Over the past three months, the Zacks Consensus Estimate for Hyperfine has increased by 5.5%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - Hyperfine's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

分组1 - Hyperfine, Inc. reported a quarterly loss of $0.12 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.14 per share a year ago [1] - The company posted revenues of $2.7 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 7.03%, and down from $3.63 million year-over-year [2] - Hyperfine shares have increased approximately 36.4% since the beginning of the year, outperforming the S&P 500's gain of 9.6% [3] 分组2 - The earnings outlook for Hyperfine is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The estimate revisions trend for Hyperfine was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] - The current consensus EPS estimate for the upcoming quarter is -$0.11 on revenues of $3.87 million, and -$0.49 on revenues of $13.48 million for the current fiscal year [7] 分组3 - The Medical - Instruments industry, to which Hyperfine belongs, is currently ranked in the bottom 39% of over 250 Zacks industries, which may impact stock performance [8]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $2.7 million, representing a 26% sequential increase, driven by the sale of eight systems [5][25] - Gross profit for Q2 2025 was $1.3 million, with a gross margin of 49.3%, an increase of 800 basis points sequentially [27] - Net loss for Q2 2025 was $9.2 million, equating to a net loss of $0.12 per share, consistent with the previous quarter [28] - Cash burn excluding financing decreased by 19% sequentially to $8.1 million [28] Business Line Data and Key Metrics Changes - The company sold eight units in Q2 2025, including its first next-generation subsystem, with a strong average selling price [5][25] - The new subsystem has a manufacturer’s suggested retail price (MSRP) of $550,000, approximately a 15% premium to the prior version [15] - The company is focused on expanding its sales in U.S. hospitals, office settings, and international markets [10][14] Market Data and Key Metrics Changes - The total market opportunity for the company's technology exceeds $6 billion, with a proprietary position as a first mover [9] - The company has begun rolling out its Optive AI software to its installed base, enhancing image quality significantly [7][10] - The company is actively engaged in international markets, with software now available in Canada, Australia, and New Zealand, and plans to launch in Europe by the end of 2025 [22] Company Strategy and Development Direction - The company aims to launch one new product every six months, having received FDA clearance for two major technologies ahead of schedule [6][9] - The next-generation subsystem and Optive AI software are seen as key pillars for future growth, with a focus on driving adoption across multiple care settings [12][14] - The company is transitioning from pilot programs to full launches in office settings, targeting neurology practices specifically [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in strong revenue growth in the second half of 2025, driven by multiple product launches and increased traction in various markets [23][30] - The company anticipates a sequential revenue increase of 50% in Q3 compared to Q2, with expectations for continued margin expansion [30][31] - Management highlighted the importance of cash burn reduction and disciplined spending as key focuses moving forward [28][29] Other Important Information - The company completed its office pilot program and is now launching its next-generation subsystem in the office setting [6][19] - The PRIME study at Yale School of Medicine is evaluating the potential of AI-powered portable MRI technology in emergency departments [18][19] - The company has seen a positive market response to its new products, with significant interest from clinicians [14][40] Q&A Session Summary Question: Guidance for 2025 revenue - Management maintained the full-year 2025 revenue guidance, indicating a significant step up in the second half, with Q3 expected to show a 50% increase over Q2 [37][38] Question: Next-gen SWOOP launch expectations - Management discussed the incremental revenue contributions from new system placements and upgrades, emphasizing a focus on new system sales [41][42] Question: Funnel interest and system placements - Management confirmed a focus on managing separate funnels for hospital and office opportunities, with expectations for increased placements in the second half [56][59] Question: ASP increases and international business impact - Management noted that ASP increases were driven by a favorable sales mix and higher MSRP for new technology, with expectations for continued growth [68][70] Question: Use cases for patients with neuro implants - Management highlighted the safety profile of the low-field strength system, which is favorable for patients with magnetic implants [73][74]

FORM 10-Q Filing Information [Registrant Information](index=1&type=section&id=Registrant%20Information) Provides the basic identification details for Hyperfine, Inc, including its legal name, jurisdiction of incorporation, address, telephone number, and SEC filing status - Hyperfine, Inc. is incorporated in Delaware with its principal executive offices in Guilford, Connecticut[2](index=2&type=chunk) Registrant Information | Indicator | Value | | :---------- | :---- | | Commission File Number | 001-39949 | | Filer Status | Non-accelerated filer, Smaller reporting company, Emerging growth company | | Class A Common Stock Outstanding (as of Aug 1, 2025) | 63,525,713 shares | | Class B Common Stock Outstanding (as of Aug 1, 2025) | 15,055,288 shares | Cautionary Statement Regarding Forward-Looking Statements [Nature of Forward-Looking Statements](index=3&type=section&id=Nature%20of%20Forward-Looking%20Statements) The report contains forward-looking statements based on management's beliefs and assumptions, which are inherently subject to risks and are not guarantees of future performance - Forward-looking statements relate to future events or financial performance, including plans, strategies, and prospects[8](index=8&type=chunk) - Statements are based on management's beliefs and assumptions, but **actual results may differ** due to inherent risks and uncertainties[8](index=8&type=chunk) [Key Areas of Forward-Looking Statements](index=3&type=section&id=Key%20Areas%20of%20Forward-Looking%20Statements) Forward-looking statements cover critical aspects of the Company's operations, including product development, commercialization, regulatory approvals, and financial performance - Success, cost, and timing of product development activities[8](index=8&type=chunk) - Commercialization and adoption of existing and future product offerings[8](index=8&type=chunk) - Ability to obtain and maintain regulatory approval for products[8](index=8&type=chunk) - Size and growth potential of markets for products and services[9](index=9&type=chunk) - History of losses and ability to continue as a going concern[9](index=9&type=chunk) - Estimates regarding expenses, revenue, capital requirements, and needs for additional financing[9](index=9&type=chunk) - Impact of market conditions, global and economic factors (inflation, geopolitical conflicts, export controls, tariffs)[10](index=10&type=chunk) - Intense competition and competitive pressures[10](index=10&type=chunk) - Ability to retain or recruit key employees and directors[10](index=10&type=chunk) PART I — FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents the unaudited condensed consolidated financial statements for Hyperfine, Inc, including balance sheets, statements of operations, and cash flows, with detailed notes [Condensed Consolidated Balance Sheets (unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(unaudited)) Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | $25,420 | $37,645 | | Total current assets | $40,096 | $53,710 | | Total assets | $45,234 | $58,901 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $7,988 | $8,729 | | Warrant liabilities | $1,194 | — | | Total liabilities | $10,108 | $9,861 | | Total stockholders' equity | $35,126 | $49,040 | - **Total assets decreased by $13,667 thousand (23.2%)** from December 31, 2024, to June 30, 2025, primarily due to a decrease in cash and cash equivalents[13](index=13&type=chunk) - **Total stockholders' equity decreased by $13,914 thousand (28.4%)** from December 31, 2024, to June 30, 2025, mainly due to accumulated deficit[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(unaudited)) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | 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 | | Total cost of sales | $1,368 | $1,828 | $2,622 | $3,769 | | Gross margin | $1,328 | $1,803 | $2,211 | $3,157 | | Total operating expenses | $10,923 | $12,649 | $22,708 | $24,653 | | Loss from operations | $(9,595) | $(10,846) | $(20,497) | $(21,496) | | Net loss and comprehensive loss | $(9,225) | $(10,156) | $(18,643) | $(20,004) | | Net loss per common share, basic and diluted | $(0.12) | $(0.14) | $(0.24) | $(0.28) | - **Total sales decreased by 25.8%** for the three months ended June 30, 2025, and by **30.2%** for the six months ended June 30, 2025, compared to the respective prior periods[16](index=16&type=chunk) - **Net loss improved by 9.2%** for the three months ended June 30, 2025, and by **6.8%** for the six months ended June 30, 2025, compared to the respective prior periods[16](index=16&type=chunk) - **Operating expenses decreased by 13.6%** for the three months ended June 30, 2025, and by **7.9%** for the six months ended June 30, 2025, primarily due to reduced R&D and G&A expenses[16](index=16&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20(unaudited)) Changes in Stockholders' Equity (in thousands, except share amounts) | Metric | Balance, Dec 31, 2024 | Net Loss (Q1 2025) | Issuance of common stock and warrants, net | Stock-based compensation expense (Q1 2025) | Balance, Mar 31, 2025 | Net Loss (Q2 2025) | Stock-based compensation expense (Q2 2025) | Balance, June 30, 2025 | | :--------------------------------------- | :-------------------- | :------------------- | :----------------------------------------- | :--------------------------------------- | :-------------------- | :------------------- | :--------------------------------------- | :--------------------- | | Total Stockholders' Equity | $49,040 | $(9,418) | $2,385 | $945 | $43,114 | $(9,225) | $547 | $35,126 | - **Total stockholders' equity decreased** from $49,040 thousand at December 31, 2024, to **$35,126 thousand** at June 30, 2025, primarily due to net losses[19](index=19&type=chunk) - The company issued **4,511,278 shares of Class A common stock and warrants**, generating **$2,385 thousand** in additional paid-in capital during the first quarter of 2025[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows (unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(17,159) | $(21,893) | | Net cash used in investing activities | $(992) | $(216) | | Net cash provided by financing activities | $6,056 | $114 | | Net decrease in cash and cash equivalents and restricted cash | $(12,095) | $(21,995) | | Cash, cash equivalents and restricted cash, end of period | $25,578 | $53,809 | - **Net cash used in operating activities decreased by $4,734 thousand (21.6%)** for the six months ended June 30, 2025, compared to the same period in 2024[23](index=23&type=chunk) - **Net cash provided by financing activities significantly increased to $6,056 thousand** in 2025, primarily due to proceeds from common stock and warrant issuance[23](index=23&type=chunk) - Overall **net decrease in cash and cash equivalents and restricted cash improved by $9,900 thousand (45.0%)** in 2025 compared to 2024[23](index=23&type=chunk) [Notes to Condensed Consolidated Financial Statements (unaudited)](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) [1. Organization and Description of Business](index=9&type=section&id=1.%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) Hyperfine, Inc develops and commercializes the AI-powered portable ultra-low-field (ULF) MR brain imaging Swoop® system, which has multiple FDA clearances and international marketing authorizations - Hyperfine, Inc develops AI-powered portable ultra-low-field (ULF) MR brain imaging systems, specifically the Swoop® system[25](index=25&type=chunk) - Received initial FDA 510(k) clearance for brain imaging in 2020[26](index=26&type=chunk) - Received 510(k) clearance for ninth-generation AI-powered software in July 2024, reducing scan times[26](index=26&type=chunk) - Received 510(k) clearance for tenth-generation Optive AI™ software in May 2025, enhancing image clarity and detail[27](index=27&type=chunk) - Next-generation Swoop® system with Optive AI™ software features new hardware for highest signal-to-noise ratio and exceptional image quality[27](index=27&type=chunk) - Swoop® system has marketing authorization in EU (CE Mark), UK (UKCA Mark), Canada, Australia, and New Zealand[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Outlines the company's accounting policies, going concern assumption, risks, and use of significant estimates in financial reporting - The financial statements are prepared on a going concern basis, but the company has limited revenues and a history of negative working capital, requiring future financing[29](index=29&type=chunk)[30](index=30&type=chunk) - Subject to risks from geopolitical and macroeconomic impacts (conflicts, inflation, tariffs)[35](index=35&type=chunk) - Relies on single-source manufacturers and suppliers, posing supply chain disruption risks[36](index=36&type=chunk) - Cash and cash equivalents are deposited with major financial institutions, exceeding insured amounts at times[43](index=43&type=chunk) - Significant estimates include revenue recognition, allowance for credit losses, inventory valuation, deferred tax assets, stock-based compensation, and warrant liabilities valuation[43](index=43&type=chunk) Customer Concentration (Revenue > 10%) | Period | Number of Customers | Revenue Contribution (in thousands) | | :-------------------------------- | :------------------ | :-------------------------------- | | Three Months Ended June 30, 2025 | 4 | $402, $362, $321, $310 | | Six Months Ended June 30, 2025 | None | N/A | | Three Months Ended June 30, 2024 | 4 | $721, $434, $394, $378 | | Six Months Ended June 30, 2024 | 2 | $1,146, $721 | - A new accounting pronouncement, ASU 2024-03, on expense disaggregation disclosures, is effective for fiscal years beginning after December 15, 2026, and is currently being evaluated for impact[42](index=42&type=chunk) [3. Revenue Recognition](index=13&type=section&id=3.%20REVENUE%20RECOGNITION) Details revenue disaggregation by product type, recognition timing, and remaining performance obligations Disaggregated Revenue (in thousands) | Revenue Type | Recognition Pattern | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------- | :------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Device | Point in time | $2,128 | $2,970 | $3,650 | $5,674 | | Service | Over time | $568 | $661 | $1,183 | $1,252 | | Total revenue | | $2,696 | $3,631 | $4,833 | $6,926 | Contract Balances (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Accounts receivable, net | $5,057 | $5,956 | | Unbilled receivables - current | $1,892 | $2,349 | | Unbilled receivables - non-current | $937 | $825 | | Deferred revenue | $1,370 | $1,460 | | Long term deferred revenue | $914 | $1,054 | - Revenue recognized from beginning deferred revenue balance: **$430 thousand** (Q2 2025), **$829 thousand** (H1 2025), **$489 thousand** (Q2 2024), **$879 thousand** (H1 2024)[49](index=49&type=chunk) - Remaining performance obligations: **$5,939 thousand** (June 30, 2025) vs **$5,644 thousand** (Dec 31, 2024)[50](index=50&type=chunk) - Expects to recognize **~17%** of remaining performance obligations in FY2025 and **~83%** in FY2026 and thereafter[55](index=55&type=chunk) [4. Fair Value of Financial Instruments](index=15&type=section&id=4.%20FAIR%20VALUE%20OF%20FINANCIAL%20INSTRUMENTS) Financial instruments are measured at fair value using a three-tier hierarchy, with warrant liabilities classified as Level 3 - Cash and cash equivalents are measured at fair value using **Level 1 inputs** (quoted prices in active markets)[61](index=61&type=chunk) Warrant Liabilities Fair Value (in thousands) | Date | Fair Value | | :---------------- | :--------- | | June 30, 2025 | $1,194 | | February 12, 2025 | $2,858 | - Warrant liabilities are measured at fair value using **Level 3 inputs**, with a decrease in fair value from February 12, 2025, to June 30, 2025, primarily due to changes in Class A common stock price[61](index=61&type=chunk)[135](index=135&type=chunk) [5. Inventories](index=16&type=section&id=5.%20INVENTORIES) Details the composition of inventory, which consists of raw materials and finished goods, and shows a decrease in total value Inventories (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :----------- | :------------ | :---------------- | | Raw materials | $2,463 | $3,070 | | Finished goods | $2,419 | $2,762 | | Total inventories | $4,882 | $5,832 | - **Total inventories decreased by $950 thousand (16.3%)** from December 31, 2024, to June 30, 2025[63](index=63&type=chunk) [6. Property and Equipment, Net](index=16&type=section&id=6.%20PROPERTY%20AND%20EQUIPMENT,%20NET) Property and equipment, net, remained stable, with depreciation expense detailed for the reporting periods Property and Equipment, Net (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Total historical cost | $7,163 | $6,679 | | Less: Accumulated depreciation | $(4,041) | $(3,557) | | Property and equipment, net | $3,122 | $3,122 | Depreciation Expense (in thousands) | Period | 2025 | 2024 | | :-------------------------------- | :--- | :--- | | Three Months Ended June 30, | $283 | $253 | | Six Months Ended June 30, | $512 | $516 | [7. Right-of-Use (ROU) Assets and Leases Liabilities](index=17&type=section&id=7.%20RIGHT-OF-USE%20(ROU)%20ASSETS%20AND%20LEASES%20LIABILITIES) Details operating lease ROU assets and liabilities for corporate offices and a warehouse Operating Lease Balances (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Operating lease ROU assets | $254 | $341 | | Current lease liabilities | $238 | $269 | | Non-current lease liabilities | $12 | $78 | - Weighted-average remaining lease term: **14 months**[67](index=67&type=chunk) - Annual weighted-average discount rate: **9.78%**[67](index=67&type=chunk) - Future minimum commitments: **$136 thousand** for 2025 and **$114 thousand** thereafter[68](index=68&type=chunk) [8. Accrued Expenses and Other Current Liabilities](index=17&type=section&id=8.%20ACCRUED%20EXPENSES%20AND%20OTHER%20CURRENT%20LIABILITIES) Accrued expenses and other current liabilities decreased, driven primarily by lower bonuses and contracted services Accrued Expenses and Other Current Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Bonuses | $1,277 | $2,144 | | Contracted services | $657 | $1,755 | | Legal fees | $474 | $176 | | Payroll and related benefits | $559 | $756 | | Operating lease liabilities | $238 | $269 | | Other | $225 | $473 | | Total | $3,430 | $5,573 | - The decrease of **$2,143 thousand (38.4%)** was mainly driven by lower bonuses and contracted services[69](index=69&type=chunk) [9. Stockholders' Equity](index=17&type=section&id=9.%20STOCKHOLDERS%27%20EQUITY) Details changes in stockholders' equity, including capital raised from stock offerings and equity plan activity - Under the ATM program, **1,579,912 Class A common shares** were issued as of June 30, 2025, for net proceeds of **$1,633 thousand**[71](index=71&type=chunk) - In February 2025, the company issued **4,511,278 Class A common shares and warrants** in a registered direct offering, generating **$6,000 thousand** in gross proceeds[72](index=72&type=chunk) - **Outstanding stock options decreased** from 18,396,536 at January 1, 2025, to **17,016,565** at June 30, 2025, due to exercises and forfeitures/cancellations[74](index=74&type=chunk) - **Outstanding RSUs increased significantly** from 138,902 at January 1, 2025, to **2,567,691** at June 30, 2025, primarily due to new hire and annual employee grants[79](index=79&type=chunk) Stock-Based Compensation Expense (in thousands) | Functional Line Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Cost of sales | $48 | $24 | $66 | $48 | | Research and development | $367 | $387 | $712 | $724 | | Sales and marketing | $71 | $47 | $134 | $86 | | General and administrative | $61 | $716 | $580 | $1,348 | | Total | $547 | $1,174 | $1,492 | $2,206 | [10. Net Loss Per Share](index=19&type=section&id=10.%20NET%20LOSS%20PER%20SHARE) Reports basic and diluted net loss per share, noting that all common equivalent shares were anti-dilutive Net Loss Per Share (Basic and Diluted) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss (in thousands) | $(9,225) | $(10,156) | $(18,643) | $(20,004) | | Weighted-average shares used to compute net loss per share (basic and diluted) | 78,077,118 | 72,041,332 | 76,893,733 | 71,987,688 | | Basic and dilutive net loss per share | $(0.12) | $(0.14) | $(0.24) | $(0.28) | - The inclusion of outstanding stock options, RSUs, and warrants would have been **anti-dilutive** for all periods presented due to the net loss position[81](index=81&type=chunk)[83](index=83&type=chunk) [11. Income Taxes](index=20&type=section&id=11.%20INCOME%20TAXES) The effective income tax rate was 0.0% due to a full valuation allowance against net deferred tax assets - The effective tax rate was **0.0%** for the three and six months ended June 30, 2025, due to a full valuation allowance against deferred tax assets[85](index=85&type=chunk)[86](index=86&type=chunk) - The primary reconciling items to the federal statutory rate of 21.0% were deferred state income taxes, R&D credits, stock-based compensation, and the valuation allowance[85](index=85&type=chunk) - The One Big Beautiful Bill Act (OBBBA), enacted on July 4, 2025, will be evaluated for its impact on future tax rates[87](index=87&type=chunk) [12. Related Party Transactions](index=21&type=section&id=12.%20RELATED%20PARTY%20TRANSACTIONS) Details related party transactions with 4Catalyzer Corporation (4C) for office space and administrative services Related Party Payments to 4C (in thousands) | Service | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :---------------- | :------------------------------- | :----------------------------- | :------------------------------- | :----------------------------- | | Rent | $115 | $203 | $120 | $248 | | Master Services Agreement | $33 | $58 | $31 | $65 | - As of June 30, 2025, **$59 thousand** was due to 4C for expenses paid on Hyperfine's behalf[89](index=89&type=chunk) [13. Commitments and Contingencies](index=21&type=section&id=13.%20COMMITMENTS%20AND%20CONTINGENCIES) Outlines commitments related to a 401(k) plan, BMGF grants, and purchase orders, with no material legal contingencies - No matching contributions were made to the 401(k) plan for the reported periods[90](index=90&type=chunk) - Awarded **$4.9 million** in grants from BMGF (2020-2021) for deploying 25 Swoop® systems for a multi-site study, completed by February 2024[91](index=91&type=chunk) - Awarded an additional **$3.354 million** BMGF grant in May 2023 to develop scalable neurodevelopment measurement via ULF MRI in neonates/infants in low-to-middle income countries through February 2026[91](index=91&type=chunk) - During H1 2025, completed **$492 thousand** in grant deliverables and received **$616 thousand** in cash funding[92](index=92&type=chunk) - As of June 30, 2025, restricted cash of **$158 thousand** was offset by deferred grant funding[92](index=92&type=chunk) - Purchase commitments are primarily short-term and generally allow for cancellation or rescheduling[92](index=92&type=chunk) - The company is not a party to any material litigation and has not recorded any liability for indemnification obligations[93](index=93&type=chunk)[94](index=94&type=chunk) [14. Reportable Segments and Geographic Information](index=22&type=section&id=14.%20REPORTABLE%20SEGMENTS%20AND%20GEOGRAPHIC%20INFORMATION) The company operates as a single business segment with all long-lived assets located in the United States - The company operates in **one business segment**, managed by the CEO as the chief operating decision maker[95](index=95&type=chunk) - All long-lived assets are located in the **United States**[96](index=96&type=chunk) Non-U.S. Revenue (in thousands) | Period | 2025 | 2024 | | :-------------------------------- | :--- | :--- | | Three Months Ended June 30, | $492 | $1,901 | | Six Months Ended June 30, | $1,566 | $4,335 | [15. Subsequent Events](index=22&type=section&id=15.%20SUBSEQUENT%20EVENTS) No subsequent events requiring disclosure were identified through the financial statement issuance date - No subsequent events requiring disclosure were identified through the financial statement issuance date[97](index=97&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on financial condition, results of operations, key performance metrics, and critical accounting policies [Overview](index=23&type=section&id=Overview) Hyperfine is a health technology company commercializing its AI-powered portable ULF MR brain imaging Swoop® system to increase access to MRI in various care settings - Hyperfine's mission is to revolutionize patient care globally through accessible, affordable, AI-powered portable ULF MR brain imaging with the Swoop® system[100](index=100&type=chunk) - Swoop® system is the **first FDA-cleared, portable, ULF, MR brain imaging system**[101](index=101&type=chunk) - Estimated U.S. total addressable market for Swoop® system device placements is **over $16 billion**[102](index=102&type=chunk) - The system integrates deep learning (AI) to enhance image quality and reduce scan artifacts[103](index=103&type=chunk) - Received FDA 510(k) clearance for ninth-generation software (July 2024) and tenth-generation Optive AI™ software (May 2025), improving scan times and image clarity[105](index=105&type=chunk) - Next-generation Swoop® system with Optive AI™ software features new hardware for exceptional low-field MRI image quality[106](index=106&type=chunk) [Key Performance Metrics](index=24&type=section&id=Key%20Performance%20Metrics) Management monitors total revenues and Swoop® system units sold, both of which decreased year-over-year Key Performance Metrics | Metric | 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 revenues (in millions) | $2.7 | $3.6 | $4.8 | $6.9 | | Total Swoop® system units sold | 8 | 13 | 14 | 26 | - **Total revenues decreased by 25.8% (Q2) and 30.2% (H1) YoY**, primarily due to fewer units sold[109](index=109&type=chunk) - **Total Swoop® system units sold decreased by 38.5% (Q2) and 46.2% (H1) YoY**[109](index=109&type=chunk) [Factors Affecting Results of Operations](index=24&type=section&id=Factors%20Affecting%20Results%20of%20Operations) Key factors influencing results include technical innovation, U.S. commercialization, and global expansion - Continuous investment in technical innovation, including AI and cloud technology, to improve image quality and develop new applications[110](index=110&type=chunk) - U.S. commercialization efforts expanding beyond critical care to emergency departments and neurology clinics, supported by the next-generation Swoop® system with Optive AI™ software[111](index=111&type=chunk) - International expansion in Canada, Europe, Australia, and New Zealand, bolstered by CE Mark and UKCA Mark approval for ninth-generation software[112](index=112&type=chunk)[113](index=113&type=chunk) - Grant funding from the Bill and Melinda Gates Foundation (BMGF) supports global expansion and deployment of Swoop® systems in low-to-middle income countries for neurodevelopment research[114](index=114&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Compares results of operations year-over-year, showing decreased sales but an improved net loss due to reduced operating expenses and a gain from warrant liabilities Sales Performance (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :---------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Device sales | $2,128 | $2,970 | (28.4)% | $3,650 | $5,674 | (35.7)% | | Service sales | $568 | $661 | (14.1)% | $1,183 | $1,252 | (5.5)% | | Total sales | $2,696 | $3,631 | (25.8)% | $4,833 | $6,926 | (30.2)% | - **Device sales decreased** primarily due to lower units sold, partially offset by an increase in average selling price[118](index=118&type=chunk)[119](index=119&type=chunk) - **Service sales decreased** due to one-time revenue in 2024 and a subscription business model in prior years[120](index=120&type=chunk)[121](index=121&type=chunk) Cost of Sales Performance (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :---------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Device cost of sales | $1,097 | $1,422 | (22.9)% | $2,082 | $2,921 | (28.7)% | | Service cost of sales | $271 | $406 | (33.3)% | $540 | $848 | (36.3)% | | Total cost of sales | $1,368 | $1,828 | (25.2)% | $2,622 | $3,769 | (30.4)% | | Percentage of revenue | 50.7% | 50.3% | | 54.3% | 54.4% | | - **Cost of device sales decreased** due to lower units sold[122](index=122&type=chunk)[123](index=123&type=chunk) - **Cost of service sales decreased** due to lower headcount and infrastructure costs[124](index=124&type=chunk) Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :----------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Research and development | $4,541 | $5,959 | (23.8)% | $9,578 | $11,529 | (16.9)% | | General and administrative | $3,859 | $4,421 | (12.7)% | $8,067 | $8,851 | (8.9)% | | Sales and marketing | $2,523 | $2,269 | 11.2% | $5,063 | $4,273 | 18.5% | | Total operating expenses | $10,923 | $12,649 | (13.6)% | $22,708 | $24,653 | (7.9)% | - **R&D expenses decreased** due to lower headcount and consulting expenses[125](index=125&type=chunk)[126](index=126&type=chunk) - **G&A expenses decreased** primarily due to lower stock-based compensation[128](index=128&type=chunk)[129](index=129&type=chunk) - **Sales and marketing expenses increased** due to higher salary and benefits and marketing expenses[130](index=130&type=chunk)[131](index=131&type=chunk) Other Income/Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :-------------------------------- | :------------------------------- | :------------------------------- | :--------- | :----------------------------- | :----------------------------- | :--------- | | Interest income | $239 | $675 | (64.6)% | $556 | $1,471 | (62.2)% | | Change in fair value of warrant liabilities | $46 | — | NM | $1,664 | — | NM | | Other income (expense), net | $85 | $15 | NM | $(366) | $21 | NM | - **Interest income decreased** due to lower cash balances[132](index=132&type=chunk)[133](index=133&type=chunk) - **Gain from change in fair value of warrant liabilities (H1 2025) was $1.7 million**, primarily due to changes in Class A common stock price[134](index=134&type=chunk)[135](index=135&type=chunk) - **Other income (expense), net, decreased** for H1 2025 due to financing costs allocated to warrant liabilities, partially offset by favorable foreign exchange[136](index=136&type=chunk)[137](index=137&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company has a history of net losses and expects existing cash to fund operations for at least 12 months, but may require additional financing - Funded operations primarily through common stock, preferred stock, and warrants[138](index=138&type=chunk) - Incurred a **net loss of $18.6 million** for H1 2025 and an **accumulated deficit of $313.1 million** as of June 30, 2025[139](index=139&type=chunk) - Cash and cash equivalents: **$25.4 million** as of June 30, 2025[139](index=139&type=chunk) - Expects existing cash and sales to fund operations for **at least 12 months**, but future cash needs may accelerate[140](index=140&type=chunk) - Filed a **$150 million shelf registration statement** in November 2023, including a **$50 million 'at-the-market' (ATM) equity program**[141](index=141&type=chunk) - Under ATM, **1,579,912 shares** of Class A common stock sold for **$1,633 thousand net proceeds** as of June 30, 2025[141](index=141&type=chunk) - Closed a **$6.0 million gross proceeds** registered direct offering of 4,511,278 Class A common shares and warrants in February 2025[141](index=141&type=chunk) - Future cash requirements depend on market adoption, sales/marketing expansion, R&D costs, regulatory approvals, and competitive developments; inability to obtain additional funds could lead to delays or cessation of operations[143](index=143&type=chunk)[144](index=144&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(17,159) | $(21,893) | | Net cash used in investing activities | $(992) | $(216) | | Net cash provided by financing activities | $6,056 | $114 | | Net decrease in cash, cash equivalents, and restricted cash | $(12,095) | $(21,995) | - **Net cash used in operating activities decreased** due to lower net loss and favorable changes in working capital[146](index=146&type=chunk)[147](index=147&type=chunk) - **Net cash used in investing activities increased** due to higher purchases of property and equipment[149](index=149&type=chunk)[150](index=150&type=chunk) - **Net cash provided by financing activities significantly increased** due to proceeds from the issuance of common stock and warrants[151](index=151&type=chunk)[152](index=152&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=32&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) No material changes were made to critical accounting policies, which rely on significant estimates and assumptions - Financial statements require significant estimates and assumptions, which are evaluated on an ongoing basis[157](index=157&type=chunk) - No material changes to critical accounting policies were reported, except for the evaluation of ASU 2024-03[158](index=158&type=chunk)[159](index=159&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks from interest rates, inflation, and foreign exchange fluctuations - **Interest Rate Risk:** Primarily affects cash, cash equivalents, and restricted cash; a 0.5 percentage point decrease in interest rates would decrease earnings before income taxes by **$0.1 million** annually[161](index=161&type=chunk)[162](index=162&type=chunk) - **Inflation Risk:** Not deemed to have a material effect on the business, but inability to offset higher costs through price increases could be harmful[163](index=163&type=chunk) - **Foreign Exchange Risk:** Limited exposure as most transactions are in U.S. dollars; no hedging strategies are currently utilized[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were deemed effective, with no material changes to internal controls - Disclosure controls and procedures were **effective** at a reasonable assurance level as of June 30, 2025[165](index=165&type=chunk) - **No material changes** in internal control over financial reporting occurred during the three months ended June 30, 2025[166](index=166&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently involved in any material legal proceedings[169](index=169&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported, except for an update on international trade disputes - No material changes to risk factors from the 2024 Annual Report on Form 10-K, except for an update on international trade disputes[170](index=170&type=chunk) - Changes in U.S. trade policy, including new or increased tariffs, could raise material or component costs, reducing margins or impacting product affordability[171](index=171&type=chunk) - Retaliatory tariffs could delay supplies and adversely affect international market operations or growth[171](index=171&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[172](index=172&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable for the reporting period - Not applicable[174](index=174&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for the reporting period - Not applicable[175](index=175&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading arrangements were adopted, modified, or terminated by officers or directors - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated by officers or directors during the three and six months ended June 30, 2025[176](index=176&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed with the report, including officer certifications and XBRL documents - Includes Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002[178](index=178&type=chunk) - Contains Inline XBRL Instance Document, Taxonomy Extension Schema Document, and Cover Page Interactive Data File[178](index=178&type=chunk) Signatures [Authorized Signatories](index=36&type=section&id=Authorized%20Signatories) The report was duly signed by the President and CEO, and the CAO and CFO on August 13, 2025 - The report was signed by Maria Sainz (President and CEO) and Brett Hale (CAO, CFO, Treasurer, and Corporate Secretary) on August 13, 2025[182](index=182&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) 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](index=1&type=section&id=Introduction%20and%20CEO%20Statement) 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](index=2&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk) [Recent Achievements and Business Highlights](index=1&type=section&id=Recent%20Achievements%20and%20Business%20Highlights) 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](index=1&type=section&id=Product%20Development%20%26%20Regulatory%20Clearances) 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](index=7&type=chunk) - Secured **FDA clearance for a next-generation Swoop® scanner** powered by Optive AI™ software[7](index=7&type=chunk) - These clearances position Hyperfine at the **forefront of accessible, AI-integrated imaging**[7](index=7&type=chunk) [Commercialization & Market Expansion](index=1&type=section&id=Commercialization%20%26%20Market%20Expansion) 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](index=7&type=chunk) - Commenced **commercial rollout of Optive AI™ software** to installed base of Swoop® scanners in the U.S., Canada, Australia, and New Zealand markets[7](index=7&type=chunk) - Successfully completed neurology office pilot and initiated a **full-scale commercial launch** to unlock new revenue opportunity[7](index=7&type=chunk) [Clinical Studies & Data](index=1&type=section&id=Clinical%20Studies%20%26%20Data) 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](index=7&type=chunk) - 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](index=7&type=chunk) - 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](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) 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](index=1&type=section&id=Key%20Financial%20Metrics) 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](index=1&type=section&id=Operating%20Expenses) 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](index=1&type=section&id=System%20Sales) 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](index=7&type=chunk) [2025 Financial Guidance](index=1&type=section&id=2025%20Financial%20Guidance) Hyperfine maintains its full-year 2025 revenue growth guidance and significantly reduced its cash burn expectations, reflecting improved financial discipline [Full Year Revenue Guidance](index=1&type=section&id=Full%20Year%20Revenue%20Guidance) 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](index=6&type=chunk) [Full Year Cash Burn Guidance](index=3&type=section&id=Full%20Year%20Cash%20Burn%20Guidance) 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](index=8&type=chunk) - This represents a **27% decline at the midpoint** as compared to 2024[8](index=8&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) 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](index=6&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) 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](index=8&type=section&id=CONSOLIDATED%20STATEMENT%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) 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](index=9&type=section&id=CONSOLIDATED%20STATEMENT%20OF%20CASH%20FLOWS) 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](index=21&type=chunk) [Company and Legal Disclosures](index=3&type=section&id=Company%20and%20Legal%20Disclosures) 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](index=3&type=section&id=About%20Hyperfine%2C%20Inc.%20and%20the%20Swoop%C2%AE%20Portable%20MR%20Imaging%C2%AE%20Systems) 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](index=10&type=chunk) - The mission of Hyperfine, Inc. is to **revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging**[10](index=10&type=chunk) - 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](index=11&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=13&type=chunk) - 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](index=13&type=chunk) - 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](index=14&type=chunk) [Conference Call](index=3&type=section&id=Conference%20Call) 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](index=9&type=chunk) - Interested parties were encouraged to register online via https://investors.hyperfine.io/ and a live and archived audio webcast was available[9](index=9&type=chunk) [Investor Contact](index=5&type=section&id=Investor%20Contact) 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](index=15&type=chunk)

Core Insights - Hyperfine, Inc. announced its second quarter 2025 financial results and significant business updates, highlighting key advancements in its AI-powered portable MRI technology and strong financial performance [1][2]. Business Highlights - The company received FDA clearances for its Optive AI software and the next-generation Swoop® system, marking a pivotal moment in its technology development [6]. - A commercial rollout of the next-gen Swoop® system began shortly after FDA clearance, with initial shipments to U.S. hospitals [6]. - The completion of a pilot neurology office program was announced, paving the way for a full-scale commercial launch [6]. - Enrollment of the 100th patient in the NEURO PMR study was achieved, which evaluates the use of AI-powered portable MRI in neurology offices [6]. - The PRIME study was initiated at Yale School of Medicine to assess the impact of AI-driven portable MRI in emergency departments [6]. - New data presented at the 2025 Alzheimer's Association International Conference indicated that the Swoop® system showed 100% sensitivity in detecting mild and moderate ARIA-E in Alzheimer's patients undergoing Lecanemab therapy [6]. Financial Results - Revenues for Q2 2025 reached $2.7 million, a 26% increase compared to Q1 2025 [6]. - The company sold 8 commercial Swoop® systems in Q2 2025, up from 6 in Q1 2025 [6]. - Gross margin for Q2 2025 was $1.3 million, representing a gross margin of 49.3%, an increase of 800 basis points from Q1 2025 [6]. - Research and development expenses decreased to $4.5 million in Q2 2025 from $5.0 million in Q1 2025 [6]. - Sales, marketing, general, and administrative expenses also decreased to $6.4 million in Q2 2025 from $6.7 million in Q1 2025 [6]. - The net loss for Q2 2025 was $9.2 million, consistent with the net loss of $9.4 million in Q1 2025, equating to a net loss of $0.12 per share [6]. Financial Guidance - Management expects full-year 2025 revenue to be 10% to 20% higher than in 2024 [6]. - Cash burn for the full year 2025 is projected to be approximately $27 to $29 million, reflecting a 27% decline at the midpoint compared to 2024 [6].

Product & Technology - Hyperfine launched the next-generation Swoop system with Optive AI software in mid-2025, which is the first FDA-cleared, AI-powered portable MR brain imaging system[4,74] - The Swoop system is designed to improve brain health globally by expanding brain MR imaging to multiple healthcare settings[4,10] - The new Swoop system powered by Optive AI software brings image quality closer to conventional 1.5T MRI[40,75] Market Opportunity & Growth Strategy - The company estimates a total addressable market (TAM) exceeding $6 billion, potentially expanding to over $16 billion with new sites of care[4,19] - Hyperfine has an installed base of over 180 Swoop systems globally as of June 2025[60] - The company's growth strategy focuses on expanding to new sites of care, including emergency departments, clinics, and neurology offices, as well as geographic expansion[74] Financial Performance - Hyperfine anticipates revenue between $27 million and $29 million for FY25, with gross margins between 47% and 50%[71] - The company projects a 10-20% year-over-year revenue growth for 2025[68] - Hyperfine had $25.4 million in cash and cash equivalents as of June 30, 2025, with a cash runway expected to last until the end of 2026[71]

Summary of Hyperfine (HYPR) Conference Call Company Overview - Hyperfine is a med tech company that has introduced the first AI-powered portable brain MRI system, enhancing accessibility and affordability of brain imaging [2][3] - The company recently received FDA clearance for its next-generation system, branded as Optiv AI, which aims to improve diagnostic quality and expand the use of MRI across various care settings [3][4] Core Points and Arguments - **Market Need**: Less than 10% of the global population has ready access to conventional MRI due to high costs and complexity, leaving 90% without access [5][6] - **Technology Advantages**: The new system operates at a field strength of 64 millitesla compared to conventional systems at 1.5 tesla, allowing for easier deployment in various settings such as neurology offices and emergency rooms [7][8] - **Broad FDA Indication**: The system can be used for patients of all ages and is covered by the same CPT reimbursement codes as conventional MRI, facilitating its adoption [8][9] - **Image Quality**: The new scanner powered by Optiv AI significantly improves image quality, with users noting that images are comparable to those from conventional 1.5 tesla MRI systems [11][12] - **Total Addressable Market (TAM)**: The TAM for Hyperfine's technology is estimated to exceed $16 billion when considering inpatient, outpatient, and community settings [13][14] Growth Strategy - **Expansion into Multiple Care Settings**: The company aims to deploy its technology in various settings, including hospitals and neurology offices, to increase its market presence [14][15] - **Sales Cycle and Decision Making**: The sales cycle is shorter in office settings, with a significant opportunity as only 5% of neurology offices currently have imaging capabilities [16][17] - **Pilot Programs**: Successful pilot programs have been conducted, leading to accreditation and first payments from CMS for scans performed in offices [18][19] Financial Performance - **Revenue and Growth Projections**: Hyperfine reported $12.9 million in revenue last year and expects growth of 10% to 20% this year, with gross margins projected between 47% to 50% [23][24] - **Cash Burn and Runway**: The company estimates a cash burn of €25 million to €28 million this year, with a runway extending until the end of 2026 [24] Additional Insights - **Manufacturing and Supply Chain**: The company is ramping up manufacturing for the new system and has derisked its supply chain [28] - **International Expansion**: Plans are in place to launch the new software internationally by the end of the year, with hardware expected to follow in 12 to 18 months [31] Conclusion - Hyperfine is positioned to transform the accessibility of brain MRI through its innovative technology, with a strong focus on expanding its market reach and improving patient outcomes while maintaining a solid financial profile [25][26]