UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 10-Q _________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39949 _________________ Hyperfine, Inc. (Exact name of registrant as specified in its charte ...

Hyperfine, Inc. (NASDAQ:HYPR) Q2 2022 Earnings Conference Call August 10, 2022 4:30 PM ET Company Participants Marissa Bych - Gilmartin Group LLC Scott Huennekens - Interim President and Chief Executive Officer Alok Gupta - Chief Financial Officer Conference Call Participants Lawrence Biegelsen - Wells Fargo Vijay Kumar - Evercore ISI Operator Ladies and gentlemen, thank you for standing by and welcome to the Hyperfine Q2 2022 Earnings Conference Call. At this time all participants are in a listen-only mode ...

HYPERFINE Defining the Future of Life-Saving Diagnostics at the Point of Care Corporate Presentation | May 11, 2022 © 2022 Hyperfine, Inc. Forward Looking Statements This presentation includes forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are for ...

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) Summarizes the company's quarterly report filing details, classification, and outstanding common stock [Filing Details](index=1&type=section&id=Filing%20Details) Details Hyperfine, Inc.'s Quarterly Report on Form 10-Q filing for Q1 2022 and its regulatory classifications - Hyperfine, Inc. filed a **Quarterly Report on Form 10-Q** for the period ended **March 31, 2022**[2](index=2&type=chunk) - The company is classified as a **non-accelerated filer**, a **smaller reporting company**, and an **emerging growth company**[4](index=4&type=chunk) Outstanding Common Stock as of May 10, 2022 | Class | Shares Outstanding | | :------------------------------- | :----------------- | | Class A common stock | 55,277,061 | | Class B common stock | 15,055,288 | [Explanatory Note](index=2&type=section&id=EXPLANATORY%20NOTE) Provides context on the business combination that led to Hyperfine, Inc.'s formation and Nasdaq listing [Business Combination Overview](index=2&type=section&id=Business%20Combination%20Overview) Outlines the December 2021 business combination forming Hyperfine, Inc. and its subsequent Nasdaq listing under 'HYPR' - HealthCor Catalio Acquisition Corp. (now Hyperfine, Inc.) completed a business combination with Legacy Hyperfine and Liminal Sciences, Inc. on **December 22, 2021**[8](index=8&type=chunk) - Following the business combination, HealthCor changed its name to **Hyperfine, Inc.**, and its Class A common stock is listed on the Nasdaq Global Market under the symbol **'HYPR'**[8](index=8&type=chunk) [Cautionary Statement Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20STATEMENT%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) Highlights the inherent risks and uncertainties associated with the company's forward-looking statements regarding future performance [Forward-Looking Statements and Risks](index=3&type=section&id=Forward-Looking%20Statements%20and%20Risks) Discusses the company's forward-looking statements on future events and financial performance, subject to inherent risks and uncertainties - The report includes **forward-looking statements** concerning future events and financial performance, based on management's beliefs and assumptions[10](index=10&type=chunk) - Key areas of forward-looking statements include **product development, commercialization, regulatory approval, market size, pricing, financing, competition, and the impact of COVID-19**[11](index=11&type=chunk)[13](index=13&type=chunk) - These statements are subject to **risks and uncertainties**, detailed in the 'Risk Factors' sections of the Annual Report on Form 10-K and this quarterly report[10](index=10&type=chunk)[12](index=12&type=chunk) [PART I — FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) Presents the company's unaudited condensed combined and consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents Hyperfine, Inc.'s unaudited condensed combined and consolidated financial statements, including balance sheets and cash flows [Condensed Combined and Consolidated Balance Sheets (Unaudited)](index=5&type=section&id=Condensed%20Combined%20and%20Consolidated%20Balance%20Sheets%20(unaudited)) Provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific reporting dates Condensed Combined and Consolidated Balance Sheets (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :---------------------------------- | :------------- | :---------------- | | Total current assets | $173,729 | $197,485 | | Total assets | $178,828 | $202,473 | | Total current liabilities | $11,414 | $15,736 | | Total liabilities | $12,265 | $16,246 | | Total stockholders' equity | $166,563 | $186,227 | - Total assets decreased from **$202.5 million** at December 31, 2021, to **$178.8 million** at March 31, 2022[16](index=16&type=chunk) - Total stockholders' equity decreased from **$186.2 million** at December 31, 2021, to **$166.6 million** at March 31, 2022[16](index=16&type=chunk) [Condensed Combined and Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=6&type=section&id=Condensed%20Combined%20and%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(unaudited)) Details the company's financial performance over the period, including sales, expenses, and net loss Condensed Combined and Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Total sales | $1,509 | $331 | | Total cost of sales | $1,425 | $608 | | Gross margin | $84 | $(277) | | Total operating expenses | $23,855 | $7,528 | | Loss from operations | $(23,771) | $(7,805) | | Net loss and comprehensive loss | $(23,775) | $(7,794) | | Net loss per common share (basic and diluted) | $(0.34) | $(4.86) | - Total sales increased significantly by **355.9%** from **$331 thousand** in Q1 2021 to **$1.509 million** in Q1 2022[18](index=18&type=chunk) - The company achieved a **positive gross margin of $84 thousand** in Q1 2022, compared to a **negative gross margin of $(277) thousand** in Q1 2021[18](index=18&type=chunk) - Net loss increased from **$(7.794) million** in Q1 2021 to **$(23.775) million** in Q1 2022, primarily due to increased operating expenses[18](index=18&type=chunk) [Condensed Combined and Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Deficit) (Unaudited)](index=7&type=section&id=Condensed%20Combined%20and%20Consolidated%20Statements%20of%20Changes%20in%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20(Deficit)%20(unaudited)) Outlines changes in the company's equity, reflecting net loss and stock-based compensation impacts Changes in Stockholders' Equity (in thousands) | Metric | Balance, Dec 31, 2021 | Net Loss | Stock-based Compensation Expense | Balance, Mar 31, 2022 | | :-------------------------- | :-------------------- | :------- | :------------------------------- | :-------------------- | | Additional Paid-in Capital | $322,540 | — | $4,111 | $326,651 | | Accumulated Deficit | $(136,320) | $(23,775) | — | $(160,095) | | Total Stockholders' Equity | $186,227 | $(23,775) | $4,111 | $166,563 | - Accumulated deficit increased by **$23.8 million** due to the net loss for the quarter[20](index=20&type=chunk) - Stock-based compensation expense contributed **$4.1 million** to additional paid-in capital during the quarter[20](index=20&type=chunk) [Condensed Combined and Consolidated Statements of Cash Flows (Unaudited)](index=8&type=section&id=Condensed%20Combined%20and%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) Summarizes the inflows and outflows of cash from operating, investing, and financing activities Condensed Combined and Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(27,289) | $(7,486) | | Net cash used in investing activities | $(308) | $(170) | | Net cash provided by financing activities | — | $31,210 | | Net (decrease) increase in cash and cash equivalents and restricted cash | $(27,597) | $23,554 | | Cash, cash equivalents and restricted cash, end of period | $163,563 | $87,840 | - Net cash used in operating activities significantly increased from **$(7.5) million** in Q1 2021 to **$(27.3) million** in Q1 2022[24](index=24&type=chunk) - Cash, cash equivalents, and restricted cash decreased by **$27.6 million** in Q1 2022, ending the period at **$163.6 million**[24](index=24&type=chunk) [Notes to Condensed Combined and Consolidated Financial Statements (Unaudited)](index=9&type=section&id=Notes%20to%20Condensed%20Combined%20and%20Consolidated%20Financial%20Statements%20(unaudited)) Provides detailed explanations and disclosures supporting the condensed financial statements, including accounting policies and business context [1. Organization and Description of Business](index=9&type=section&id=1.%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) Describes Hyperfine, Inc.'s formation through a business combination, its mission, and the commercial status of its Swoop® Portable MR Imaging SystemTM - Hyperfine, Inc. aims to provide **affordable and accessible MRI imaging and monitoring** globally[27](index=27&type=chunk) - The **Swoop® Portable MR Imaging SystemTM** received FDA 510(k) clearance in 2020 and is commercially available in the U.S., Canada, New Zealand, and Pakistan[27](index=27&type=chunk) Swoop System Installations as of March 31, 2022 | Category | Number of Units | | :---------------- | :-------------- | | Total Installed | 85 | | Research Units | 27 | [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Outlines the company's accounting policies, including basis of presentation, COVID-19 impact, segment information, and new accounting pronouncements - The financial statements are prepared in accordance with **U.S. GAAP** and reflect all normal recurring adjustments for interim periods[28](index=28&type=chunk)[30](index=30&type=chunk) - The **COVID-19 pandemic** has adversely impacted operations, particularly salesforce access, hospital spending, and supply chain, leading to increased product costs and extended lead times for components[32](index=32&type=chunk) - The company aggregates Legacy Hyperfine and Liminal into a **single operating segment** due to similar qualitative and economic characteristics[38](index=38&type=chunk) - The company is evaluating the impact of **ASU 2016-02 (Leases)** and **ASU No. 2016-13 (Credit Losses)**, effective for annual periods beginning January 1, 2022, and January 1, 2023, respectively, but does not expect a material impact from the lease standard[42](index=42&type=chunk)[43](index=43&type=chunk) [3. Revenue Recognition](index=12&type=section&id=3.%20REVENUE%20RECOGNITION) Details revenue recognition policies, disaggregated by device and service, and outlines contract balances and remaining performance obligations Disaggregated Revenue (in thousands) | Product Type | Pattern of Recognition | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :----------- | :--------------------- | :-------------------------------- | :-------------------------------- | | Device | Point in time | $1,192 | $169 | | Service | Over time | $317 | $162 | | Total revenue| | $1,509 | $331 | Contract Balances (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :-------------------- | :------------- | :---------------- | | Accounts receivable, net | $1,944 | $553 | | Unbilled receivables | $478 | $91 | | Deferred revenue | $973 | $730 | | Long term deferred revenue | $851 | $510 | - Remaining performance obligations totaled **$3.975 million** as of March 31, 2022, with **39%** expected in FY2022 and **61%** in FY2023 and beyond[52](index=52&type=chunk) [4. Fair Value of Financial Instruments](index=13&type=section&id=4.%20FAIR%20VALUE%20OF%20FINANCIAL%20INSTRUMENTS) Explains the company's fair value measurement hierarchy and the valuation of financial instruments, including money market funds - The company uses a **three-tier hierarchy** for fair value measurement, with no Level 3 inputs[54](index=54&type=chunk)[57](index=57&type=chunk) - Money market funds, valued using quoted market prices (**Level 1**), totaled **$41.417 million** as of March 31, 2022[58](index=58&type=chunk) [5. Inventories](index=14&type=section&id=5.%20INVENTORIES) Details inventory composition and changes, noting no significant adjustments for net realizable value or obsolescence in Q1 2022 Inventory Summary (in thousands) | Category | March 31, 2022 | December 31, 2021 | | :--------------- | :------------- | :---------------- | | Raw materials | $2,356 | $2,355 | | Finished goods | $2,182 | $1,955 | | Total inventories| $4,538 | $4,310 | - No inventory adjustments for net realizable value or excess/obsolete inventory were recorded in **Q1 2022**, compared to **$75 thousand** in Q1 2021[60](index=60&type=chunk) [6. Property and Equipment, Net](index=15&type=section&id=6.%20PROPERTY%20AND%20EQUIPMENT,%20NET) Reports on the company's property and equipment, net, and the significant increase in depreciation and amortization expense for Q1 2022 Property and Equipment, Net (in thousands) | Category | March 31, 2022 | December 31, 2021 | | :-------------------------- | :------------- | :---------------- | | Total historical cost | $5,521 | $5,163 | | Less: Accumulated depreciation | $(1,644) | $(1,410) | | Property and equipment, net | $3,877 | $3,753 | - Depreciation and amortization expense increased by **163.5%** from **$96 thousand** in Q1 2021 to **$253 thousand** in Q1 2022[61](index=61&type=chunk) [7. Accrued Expenses and Other Current Liabilities](index=15&type=section&id=7.%20ACCRUED%20EXPENSES%20AND%20OTHER%20CURRENT%20LIABILITIES) Details the decrease in accrued expenses and other current liabilities, driven by reductions in bonus and contracted services accruals Accrued Expenses and Other Current Liabilities (in thousands) | Category | March 31, 2022 | December 31, 2021 | | :-------------------------------- | :------------- | :---------------- | | Bonus | $2,724 | $3,421 | | Contracted services | $1,842 | $2,711 | | SPAC bonus and other costs | $250 | $1,071 | | Payroll and related benefits | $1,321 | $441 | | Total accrued expenses and other current liabilities | $6,616 | $8,115 | - Accrued expenses and other current liabilities decreased by **$1.499 million (18.5%)** from December 31, 2021, to March 31, 2022[62](index=62&type=chunk) [8. Equity Incentive Plan](index=15&type=section&id=8.%20EQUITY%20INCENTIVE%20PLAN) Describes the equity incentive plan, outstanding stock options and RSUs, and the significant increase in stock-based compensation expense in Q1 2022 Equity Incentive Plan Activity (Q1 2022) | Metric | Stock Options | Restricted Stock Units | | :------------------------ | :------------ | :--------------------- | | Outstanding at Jan 1, 2022 | 7,522,136 | 117,516 | | Granted | 4,231,693 | 1,660,535 | | Forfeited | (271,368) | — | | Outstanding at Mar 31, 2022| 11,482,461 | 1,778,051 | Stock-Based Compensation Expense by Functional Line Item (in thousands) | Functional Line Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :------------------- | :-------------------------------- | :-------------------------------- | | Cost of sales - Device | $16 | — | | Research and development | $781 | $209 | | Sales and marketing | $96 | $6 | | General and administrative | $3,218 | $52 | | Total | $4,111 | $267 | - Total stock-based compensation expense increased by **$3.844 million (1439.7%)** year-over-year[68](index=68&type=chunk) [9. Net Loss Per Share](index=16&type=section&id=9.%20NET%20LOSS%20PER%20SHARE) Reports basic and diluted net loss per share, noting the exclusion of anti-dilutive common equivalent shares due to the net loss position Net Loss Per Share Calculation | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :---------------------------------------------------------------- | :-------------------------------- | :-------------------------------- | | Net Loss (in thousands) | $(23,775) | $(7,794) | | Weighted-average shares used to compute net loss per share | 70,332,349 | 1,602,732 | | Basic and dilutive loss per share | $(0.34) | $(4.86) | Anti-Dilutive Common Equivalent Shares | Category | March 31, 2022 | March 31, 2021 | | :------------------------------------------ | :------------- | :------------- | | Outstanding options to purchase common stock | 11,482,461 | 1,851,656 | | Outstanding RSUs | 1,778,051 | — | | Earn-Out Shares | 10,000,000 | — | | Total anti-dilutive common equivalent shares | 23,260,512 | 37,608,824 | - Earn-Out Shares of up to **10,000,000 Class A common stock** are contingent on the stock price reaching **$15.00** for 20 trading days within a 30-day period or a transaction with a value greater than or equal to **$15.00 per share** within three years of the Closing Date[71](index=71&type=chunk) [10. Income Taxes](index=17&type=section&id=10.%20INCOME%20TAXES) States the company's 0.0% effective income tax rate and the full valuation allowance against deferred tax assets due to historical losses - The estimated annual effective income tax rate was **0.0%** for Q1 2022 and Q1 2021[74](index=74&type=chunk) - A **full valuation allowance** is recorded against net deferred tax assets, indicating that the company does not expect to realize these benefits in the near future[75](index=75&type=chunk) [11. Related Party Transactions](index=18&type=section&id=11.%20RELATED%20PARTY%20TRANSACTIONS) Details related party transactions, including subleasing from 4Catalyzer Corporation and a significant decrease in service expenses from 4C - The company subleases office and lab space from **4Catalyzer Corporation (4C)**, a related party[76](index=76&type=chunk) - Expenses from 4C for services decreased from **$870 thousand** in Q1 2021 to **$154 thousand** in Q1 2022[79](index=79&type=chunk) - Legacy Hyperfine and Liminal terminated the ARTSA and entered into **Master Services Agreements** with 4C for general administration, facilities, IT, financing, legal, and HR services[79](index=79&type=chunk) [12. Commitments and Contingencies](index=19&type=section&id=12.%20COMMITMENTS%20AND%20CONTINGENCIES) Outlines commitments for 401(k) and Bill & Melinda Gates Foundation grants, with no material legal proceedings or earn-out liabilities - No matching contributions were made to the **401(k) plan** for the three months ended March 31, 2022 and 2021[83](index=83&type=chunk) - The company received grants totaling **$4.91 million** from the Bill & Melinda Gates Foundation for deploying **25 Swoop systems** for research, with **$1.983 million** in restricted cash as of March 31, 2022[84](index=84&type=chunk) - No liability has been recognized for a potential **$1.000 million** payment to a third-party service provider related to Earn-Out Shares, as the criteria have not been met[88](index=88&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Hyperfine's financial condition, operational results, and future outlook, focusing on the Swoop system, COVID-19 impact, and liquidity needs [Overview](index=21&type=section&id=Overview) Introduces Hyperfine's mission to democratize MRI with its Swoop system, emphasizing bedside use, AI integration, and future brain sensing platform - Hyperfine's mission is to provide **affordable and accessible MRI imaging and monitoring** globally[90](index=90&type=chunk) - The **Swoop system** is designed for bedside use, offering high-quality images at lower magnetic field strength, and is commercially available in the U.S., Canada, New Zealand, and Pakistan[90](index=90&type=chunk)[93](index=93&type=chunk) - The company is optimizing its software ecosystem with **AI** to improve image quality, aid analysis, and reduce diagnosis time, with future plans for an enhanced MRI system and a brain sensing platform[92](index=92&type=chunk)[110](index=110&type=chunk) [COVID-19 Impact](index=22&type=section&id=COVID-19) Discusses the ongoing adverse impact of COVID-19 on sales, hospital spending, and supply chain, leading to potential cost increases and lead time extensions - **COVID-19** continues to create commercial challenges, restricting salesforce visits, decreasing hospital spending, and limiting physical access to facilities, slowing Swoop device demonstrations and sales[97](index=97&type=chunk) - The company anticipates potential negative impacts on its **supply chain**, including increased product costs and extended lead times for components, particularly semiconductors, due to raw material demand surges and labor/transportation constraints[99](index=99&type=chunk) - Mitigation efforts include shifting to **domestic suppliers**, increasing communication with suppliers, and providing advanced forecasts[99](index=99&type=chunk) [Key Performance Metrics](index=23&type=section&id=Key%20Performance%20Metrics) Highlights the total installed base of Swoop systems as a key growth metric, showing a significant increase to 85 units by March 31, 2022 - The **total installed base of Swoop devices** is a key metric for business growth[104](index=104&type=chunk) Swoop Total Installed Units | Category | As of March 31, 2022 | As of March 31, 2021 | | :-------------------------- | :------------------- | :------------------- | | Commercial systems installations | 38 | 9 | | Grant fulfillment installations | 20 | 2 | | Research units | 27 | 17 | | Total Installed Units | 85 | 28 | - Total installed units increased by **203.6%** year-over-year[105](index=105&type=chunk) [Factors Affecting Results of Operations](index=23&type=section&id=Factors%20Affecting%20Results%20of%20Operations) Discusses strategic partnerships, international expansion, and technical innovation as key drivers, expecting increased R&D expenses to lead to future profitability - Market expansion is a key growth driver, with plans for direct sales and distribution partners in target regions like the **UK and Australia**[108](index=108&type=chunk) - Partnerships, such as with the **Bill & Melinda Gates Foundation**, support deploying Swoop systems in low-middle resource settings for research and clinical use, with **20 units** provisioned to BMGF as of March 31, 2022[109](index=109&type=chunk) - Technical innovation focuses on enhancing the Swoop system's user interface, integrating **AI for automated image analysis**, and developing new imaging applications and a brain sensing platform, which is expected to increase R&D expenses but positively impact future profitability[110](index=110&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Analyzes Hyperfine's Q1 2022 financial performance, noting significant sales growth, increased costs, and a substantial rise in net loss Key Financial Highlights (in thousands) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change % | | :-------------------------- | :-------------------------------- | :-------------------------------- | :------- | | Total sales | $1,509 | $331 | 355.9% | | Total cost of sales | $1,425 | $608 | 134.4% | | Gross margin | $84 | $(277) | NM | | Total operating expenses | $23,855 | $7,528 | 216.9% | | Loss from operations | $(23,771) | $(7,805) | 204.6% | | Net loss | $(23,775) | $(7,794) | 205.0% | [Sales](index=25&type=section&id=Sales) Reports a **355.9% increase in total sales** to **$1.5 million** in Q1 2022, driven by device sales growth and increased service revenue Sales Performance (in thousands) | Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Amount Change | % Change | | :------- | :-------------------------------- | :-------------------------------- | :------------ | :------- | | Device | $1,192 | $169 | $1,023 | 605.3% | | Service | $317 | $162 | $155 | 95.7% | | Total | $1,509 | $331 | $1,178 | 355.9% | - Device sales increased due to **higher volume** and a pricing strategy that increased device price and lowered subscription price[115](index=115&type=chunk) - Service sales growth is attributed to an increase in the **installed base of commercial systems**, generating recurring revenue[116](index=116&type=chunk) [Cost of Sales](index=26&type=section&id=Cost%20of%20sales) Details a **134.4% increase in total cost of sales** to **$1.4 million** in Q1 2022, driven by higher device manufacturing and service labor costs Cost of Sales Performance (in thousands) | Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Amount Change | % Change | | :------- | :-------------------------------- | :-------------------------------- | :------------ | :------- | | Device | $1,037 | $548 | $489 | 89.2% | | Service | $388 | $60 | $328 | 546.7% | | Total | $1,425 | $608 | $817 | 134.4% | - Cost of device sales increased due to **higher third-party manufacturing costs** and increased product hardware and labor costs from higher sales volume[119](index=119&type=chunk) - Cost of service sales increased primarily due to **higher internal overheads and labor costs**[120](index=120&type=chunk) [Research and Development Expenses](index=26&type=section&id=Research%20and%20development) Reports an **86.3% increase in R&D expenses** to **$8.3 million** in Q1 2022, driven by higher personnel, stock-based compensation, and professional service costs Research and Development Expenses (in thousands) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Amount Change | % Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :------------ | :------- | | Research and development | $8,334 | $4,474 | $3,860 | 86.3% | - The increase was driven by a **$3.5 million** rise in personnel costs, a **$0.6 million** increase in stock-based compensation, and higher professional services and depreciation[121](index=121&type=chunk) [General and Administrative Expenses](index=26&type=section&id=General%20and%20administrative) Highlights a **511.4% surge in G&A expenses** to **$11.4 million** in Q1 2022, primarily due to increased personnel, stock-based compensation, and professional service costs General and Administrative Expenses (in thousands) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Amount Change | % Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :------------ | :------- | | General and administrative | $11,360 | $1,858 | $9,502 | 511.4% | - The increase was primarily due to a **$3.2 million** rise in personnel costs, a **$3.2 million** increase in stock-based compensation, and higher professional services (**$1.2 million**), insurance (**$0.8 million**), and technology costs (**$0.5 million**)[122](index=122&type=chunk) [Sales and Marketing Expenses](index=26&type=section&id=Sales%20and%20marketing) Reports a **247.9% increase in sales and marketing expenses** to **$4.2 million** in Q1 2022, driven by higher personnel, stock-based compensation, and advertising costs Sales and Marketing Expenses (in thousands) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Amount Change | % Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :------------ | :------- | | Sales and marketing | $4,161 | $1,196 | $2,965 | 247.9% | - The increase was primarily due to a **$1.9 million** rise in personnel expenses, a **$0.1 million** increase in stock-based compensation, and higher product advertising/marketing (**$0.6 million**) and travel expenses (**$0.2 million**)[124](index=124&type=chunk) [Interest Income](index=27&type=section&id=Interest%20income) Notes a decrease in interest income to **$1 thousand** in Q1 2022, primarily due to lower money market balances and reduced interest rates Interest Income (in thousands) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Amount Change | % Change | | :------------- | :-------------------------------- | :-------------------------------- | :------------ | :------- | | Interest income| $1 | $5 | $(4) | (80.0)% | [Other Income (Expense), Net](index=27&type=section&id=Other%20income%20(expense),%20net) Reports an unfavorable decrease in other income (expense), net, to **$(5) thousand** in Q1 2022, mainly due to prior period foreign currency gains Other Income (Expense), Net (in thousands) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Amount Change | % Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :------------ | :------- | | Other income (expense), net | $(5) | $6 | $(11) | (183.3)% | [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses Hyperfine's funding history, significant cash burn, and net losses, highlighting current cash position and future capital requirements - The company has funded operations primarily through **equity issuances** and has incurred significant cash burn and recurring net losses[127](index=127&type=chunk) Liquidity Overview (in thousands) | Metric | March 31, 2022 | | :-------------------------- | :------------- | | Net loss (Q1 2022) | $(23,775) | | Accumulated deficit | $(160,095) | | Net proceeds from Business Combination | $141,500 | | Cash and cash equivalents | $161,580 | - Future cash requirements are expected to be substantial for sales and marketing, product development, and inventory, with potential need for **additional financing**[129](index=129&type=chunk)[131](index=131&type=chunk) [Cash Flows](index=28&type=section&id=Cash%20flows) Analyzes cash flows, noting a significant increase in cash used in operating activities and no cash provided by financing activities in Q1 2022 Summary of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(27,289) | $(7,486) | | Net cash used in investing activities | $(308) | $(170) | | Net cash provided by financing activities | — | $31,210 | | Net (decrease) increase in cash, cash equivalents, and restricted cash | $(27,597) | $23,554 | - Net cash used in operating activities in Q1 2022 was driven by a **net loss of $23.8 million** and a **$7.9 million** impact from changes in operating assets and liabilities[134](index=134&type=chunk) - Financing activities provided **no cash** in Q1 2022, a significant change from **$31.2 million** provided in Q1 2021, which included proceeds from Series D convertible preferred stock and an investment from 4Bionics, LLC[139](index=139&type=chunk) [Contractual Obligations](index=29&type=section&id=Contractual%20obligations) Outlines contractual obligations, including 401(k) plan and Bill & Melinda Gates Foundation grants for Swoop device deployments - No matching contributions were made to the **401(k) plan** for the three months ended March 31, 2022 and 2021[140](index=140&type=chunk) - **BMGF grants totaling $4.91 million** are designed to support the deployment of **25 Swoop devices** and other services for research over approximately two years[141](index=141&type=chunk) - As of March 31, 2022, **20 Swoop system units** and **10 baby cradles** were provisioned and delivered to BMGF[141](index=141&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=29&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Discusses the reliance on estimates and assumptions in financial statements, noting no material changes to critical accounting policies since the 2021 Annual Report - The preparation of financial statements requires management to make **estimates and assumptions** that affect reported amounts[143](index=143&type=chunk)[144](index=144&type=chunk) - No material changes to critical accounting policies and estimates have occurred since the **2021 Annual Report on Form 10-K**, except for those related to recently issued accounting pronouncements[145](index=145&type=chunk)[146](index=146&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Identifies interest rate fluctuations as the primary market risk, with no material impact expected from a 10% change due to short-term cash equivalents - The company's primary market risk is from **interest rate fluctuations**[147](index=147&type=chunk) - Cash equivalents included **$41.4 million** in money market funds as of March 31, 2022[148](index=148&type=chunk) - Due to the short-term nature of cash equivalents, a hypothetical **10% change in interest rates** is not expected to materially affect cash flows or operating results[148](index=148&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Reports ineffective disclosure controls and procedures due to material weaknesses in internal control over financial reporting, with ongoing remediation efforts - Disclosure controls and procedures were **not effective** as of March 31, 2022, due to material weaknesses in internal control over financial reporting[149](index=149&type=chunk) - Material weaknesses include **limited accounting personnel** and inadequate supervision of outsourced financial reporting prior to the Business Combination[151](index=151&type=chunk) - Another material weakness involved the **misclassification of Class A ordinary shares** subject to possible redemption, leading to a restatement[152](index=152&type=chunk) - Management is implementing a remediation plan, including hiring experienced accounting and finance resources and enhancing internal controls[154](index=154&type=chunk) [PART II — OTHER INFORMATION](index=32&type=section&id=PART%20II%20OTHER%20INFORMATION) Presents additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) States that Hyperfine, Inc. is not currently involved in any material legal proceedings - The company is **not involved in any material legal proceedings**[157](index=157&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Confirms no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes to risk factors have occurred since the **2021 Annual Report on Form 10-K**[158](index=158&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no unregistered sales of equity securities or share repurchases during Q1 2022 - **No unregistered sales of equity securities** occurred[159](index=159&type=chunk) - The company did **not repurchase any equity securities** during Q1 2022[160](index=160&type=chunk) [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) States that this item is not applicable to the company for the reporting period - This item is **not applicable**[161](index=161&type=chunk) [Item 4. Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that this item is not applicable to the company for the reporting period - This item is **not applicable**[162](index=162&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) States that this item is not applicable to the company for the reporting period - This item is **not applicable**[163](index=163&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed with the Form 10-Q, including agreements, officer certifications, and Inline XBRL documents - Exhibits include the **Amended and Restated Registration Rights Agreement** and **Form of Restricted Stock Unit Agreement**[165](index=165&type=chunk) - Certifications from the **Principal Executive Officer** and **Principal Financial Officer** (Sections 302 and 906 of Sarbanes-Oxley Act) are filed as exhibits[165](index=165&type=chunk) - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase) are also included[165](index=165&type=chunk)[166](index=166&type=chunk)[168](index=168&type=chunk) [Signatures](index=36&type=section&id=SIGNATURES) Contains the official signatures for the Quarterly Report on Form 10-Q [Report Signatures](index=36&type=section&id=Report%20Signatures) Confirms the signing of the Quarterly Report on Form 10-Q by the President, CEO, and CFO on May 12, 2022 - The report was signed by **Dave Scott, President and CEO**, and **Alok Gupta, CFO**, on **May 12, 2022**[171](index=171&type=chunk)

Hyperfine, Inc. (NASDAQ:HYPR) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Marissa Bych - Gilmartin Group IR Dave Scott - President and CEO Alok Gupta - CFO Conference Call Participants Lawrence Biegelsen - Wells Fargo Vijay Kumar - Evercore ISI Operator Good afternoon, and welcome to Hyperfine's First Quarter 2022 Earnings Conference Call. At this time all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today's ...

HYPERFINE Defining the Future of Life-Saving Diagnostics at the Point of Care Corporate Presentation | March 23, 2022 © 2022 Hyperfine, Inc. Forward Looking Statements This presentation includes forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are f ...

Market Opportunity - The Swoop scanner targets a $15.9 billion global imaging market, expected to grow at a 5.2% CAGR from 2021 to 2028[22] - The global imaging market is projected to grow from $15.9 billion to over $20 billion, with significant opportunities for the Swoop scanner in underpenetrated markets[43] - The market for global non-invasive brain trauma monitoring devices is expected to grow from approximately $10.1 billion in 2019 to $18.3 billion by 2027, at a CAGR of 7.7%[48] Product Features and Benefits - The Swoop scanner reduces the conventional MRI workflow time from an average of 25.8 hours to 90 minutes, achieving a 94% reduction[32] - The Swoop scanner has the potential to increase the utilization of existing MRI suites by 20% through bedside imaging, allowing for more outpatient procedures[33] - The Swoop scanner is designed to provide immediate point-of-care brain imaging, particularly beneficial for critically ill patients who cannot be transported[31] - The Swoop scanner's lower price point makes it accessible for hospitals that cannot afford conventional MRI or CT scanners[31] - The Swoop scanner is designed to improve patient care by reducing the risk of injury during transport and minimizing anxiety related to imaging procedures[32] - The Swoop scanner is designed to facilitate early diagnosis and intervention, potentially leading to cost savings for patients, providers, and payors[37] - The Swoop portable MRI system delivers diagnostic quality images with a resolution of 1.5 mm x 1.5 mm x 5 mm, compared to conventional MRI's typical resolution of 1.0 mm x 1.0 mm x 5 mm, despite operating at a lower magnetic field strength of 0.064-Tesla[62] - The Swoop scanner can be powered by a standard wall outlet and uses less than 900W of electricity, eliminating the need for liquid helium and other complex infrastructure required by conventional MRI systems[71] Research and Development - The company is developing non-invasive brain sensing technology to monitor key brain vital signs, aiming to enhance patient care and expand its product offerings[41] - Approximately 30% of conventional MRI scans suffer from moderate to severe image quality issues due to patient motion, which the company aims to address with its newly developed motion compensation technology that has received FDA clearance for clinical use[57] - The company is investing $50 million in R&D for new technologies aimed at improving imaging capabilities[2] - Research and development investments increased by 10% to $150 million, focusing on innovative technologies in the utility sector[3] - Research and development investments increased by 30%, focusing on innovative medical imaging solutions[112] Financial Performance - The company reported a revenue increase of 15% year-over-year, reaching $1.5 billion for the quarter[2] - The company reported a significant increase in revenue, achieving $1.5 billion in Q3 2023, representing a 25% year-over-year growth[2] - The company provided guidance for Q4 2023, projecting revenue between $1.6 billion and $1.8 billion, which reflects a growth rate of 20% to 30% compared to Q4 2022[4] - The company incurred net losses of $64.9 million and $23.4 million for the years ended December 31, 2021 and 2020, respectively, with an accumulated deficit of $136.3 million as of December 31, 2021[189] - The company may need to raise additional capital to fund commercialization plans for its products, including manufacturing, sales, and marketing activities[193] Regulatory and Compliance - The FDA requires pre-market review for medical devices, with significant user fees over $12,000 for 510(k) and $374,000 for PMA in FY 2022[130] - The company is subject to FDA inspections and must comply with Good Manufacturing Practice requirements, which include extensive quality management protocols[152] - The company must ensure compliance with evolving EU laws on data export, particularly following the invalidation of the EU-U.S. Privacy Shield[171] - The company faces potential fines of up to $100,000 per violation under the federal Anti-Kickback Statute, with imprisonment for up to ten years for serious violations[157] Strategic Initiatives - The company aims to expand its market presence in the UK, Australia, New Zealand, and Pakistan through strategic partnerships and grant funding[34] - The company plans to continue building its direct commercial infrastructure in the U.S. while exploring distributor partnerships for international sales[95] - The company is exploring partnerships with healthcare providers to expand its reach in the medical sector[112] Competitive Landscape - The competitive landscape includes established players like General Electric and Siemens, with significant barriers to entry for new entrants in the medical imaging market[103] - The company faces significant competition from established players in the medical imaging market, including General Electric, Siemens, and Philips[205] Corporate Governance and Sustainability - The company emphasizes environmental sustainability initiatives, including efforts to reduce its environmental footprint and increase energy efficiency[81] - The company is focused on enhancing its corporate governance practices and sustainability measures over time[88] - The company is committed to diversity, equity, and inclusion, focusing on building a diverse workforce to enhance innovation and performance[85]

Hyperfine, Inc. (NASDAQ:HYPR) Q4 2021 Earnings Conference Call March 23, 2022 4:30 PM ET Company Participants Dave Scott - President and Chief Executive Officer Alok Gupta - Chief Financial Officer Conference Call Participants Vijay Kumar - Evercore ISI Anthony Petrone - Mizuho Group Operator Thank you, and thank you all for joining today’s call. Joining me are Dave Scott, President and Chief Executive Officer; and Alok Gupta, Chief Financial Officer of Hyperfine. Earlier today, Hyperfine released financial ...

HYPERFINE Defining the Future of Life-Saving Diagnostics at the Point of Care Corporate Presentation | January 2022 © 2022 Hyperfine, Inc. Forward Looking Statements This presentation includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Hyperfine's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of fut ...

Table of Contents Commission file number: 001-39935 HEALTHCOR CATALIO ACQUISITION CORP. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended September 30, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (Exact Name of Registrant as Specified in Its Charter) | Cayman Islands | 9 ...