Hyperfine, Inc. (HYPR) came out with a quarterly loss of $0.14 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post a loss of $0.14 per share when it actually produced a loss of $0.14, delivering no surprise. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Hyperfine, which belongs to the Zacks Medical - ...

Hyperfine (HYPR) recently announced the receipt of FDA 510(k) clearance for the ninth generation of its AIpowered Swoop system software. It is the world's first FDA-cleared portable magnetic resonance (MR) brain imaging system. The advanced software significantly reduces scan times across multiple MR sequences without sacrificing image quality. With the launch of the ninth-generation AI-powered software, Hyperfine keeps expanding the Swoop system's clinical utility and workflow fit. In acute care settings, ...

Another Notable Development Hyperfine's track record of securing international approvals supports its expansion into global markets. Along with the latest expansion in the European market, the company also announced a distribution agreement to develop Asian markets. Estimates for Medpace's 2024 EPS have remained unchanged at $11.29 in the past 30 days. Shares of the company have soared 73.3% in the past year compared with the industry's 5.2% growth. With the recent addition of distributors and the previousl ...

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 March 31, 2024 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 cha ...

Hyperfine, Inc. (HYPR) came out with a quarterly loss of $0.14 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.17 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post a loss of $0.17 per share when it actually produced a loss of $0.15, delivering a surprise of 11.76%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Hyperfine, which belongs to the Zacks M ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) Hyperfine reported a strong Q1 2024, achieving commercial progress, clinical milestones, and product innovation with spending discipline [Q1 2024 Performance Overview](index=1&type=section&id=Q1%202024%20Performance%20Overview) Hyperfine achieved strong Q1 2024 commercial progress, clinical milestones, and product innovation, maintaining spending discipline - CEO Maria Sainz expressed satisfaction with the **strong start to 2024**, highlighting commercial progress in US and international markets, and key Q1 milestones[3](index=3&type=chunk) - The company's three **core value drivers**—Commercialization, Clinical Evidence, and Innovation—were successfully delivered upon in Q1 with **strong spending discipline**[3](index=3&type=chunk) [Business Update](index=1&type=section&id=Business%20Update) Hyperfine advanced clinical studies, launched AI software, expanded internationally, and gained visibility for its portable brain imaging system [Recent Achievements and Business Highlights](index=1&type=section&id=Recent%20Achievements%20and%20Business%20Highlights) Hyperfine achieved Q1 2024 milestones, including advancing clinical studies, launching AI software, and expanding international commercial reach - Initiated enrollment of CARE PMR study to assess the clinical utility of the Swoop® System for detecting ARIA in Alzheimer's patients receiving amyloid-targeting therapy[7](index=7&type=chunk) - Exceeded **100 patients enrolled** in ACTION PMR, an observational study for acute ischemic stroke detection using portable brain imaging[7](index=7&type=chunk) - Launched **8th generation AI-powered brain imaging software**, enhancing image quality and ease-of-use[7](index=7&type=chunk) - Appointed distributors in key EU markets to support international commercial expansion[7](index=7&type=chunk) - The portable Swoop Brain MR was prominently featured at key conferences, with **four abstracts** at the International Stroke Conference and **17** at the International Society for Magnetic Resonance Medicine[7](index=7&type=chunk) [Company and Product Description](index=3&type=section&id=Company%20and%20Product%20Description) Hyperfine developed the FDA-cleared portable Swoop® system, an ultra-low-field MRI for accessible bedside brain imaging globally - Hyperfine, Inc. developed the Swoop® system, the first **FDA-cleared portable, ultra-low-field, magnetic resonance brain imaging system**[8](index=8&type=chunk) - The Swoop® system received initial U.S. FDA clearance in **2020** and is approved for brain imaging in several countries, including Canada, Australia, the UK (UKCA certified), and the EU (CE certified), and is also available in New Zealand[8](index=8&type=chunk) - The company's mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging and data solutions, bringing brain imaging to the patient's bedside[9](index=9&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) Hyperfine reported a 25% Q1 2024 revenue increase, improved gross margin, reduced expenses, and provided full-year 2024 guidance [First Quarter 2024 Financial Results](index=1&type=section&id=First%20Quarter%202024%20Financial%20Results) Hyperfine reported a 25% Q1 2024 revenue increase to $3.30 million, driven by 13 Swoop® system sales, improving gross margin and reducing net loss Q1 2024 Financial Highlights | Metric | Q1 2024 (in millions) | Q1 2023 (in millions) | Change (%) | | :----- | :-------------------- | :-------------------- | :--------- | | Revenue | $3.30 | $2.64 | 25% | | Gross Margin | $1.35 | $1.16 | 16.4% | | R&D Expenses | $5.57 | $5.46 | 2.0% | | SG&A Expenses | $6.43 | $8.73 | -26.3% | | Net Loss | $(9.85) | $(12.16) | -19.0% | | Net Loss per Share | $(0.14) | $(0.17) | -17.6% | - Hyperfine, Inc. sold **13 commercial Swoop® systems** in the first quarter of 2024[7](index=7&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2024 total sales increased to $3.295 million, primarily from device sales, with improved gross margin and a net loss of $9.848 million Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Q1 2024 | Q1 2023 | YoY Change | | :-------------------- | :------ | :------ | :--------- | | **Sales** | | | | | Device | $2,704 | $2,132 | +26.8% | | Service | $591 | $503 | +17.5% | | **Total Sales** | **$3,295**| **$2,635**| **+25.0%** | | **Cost of Sales** | | | | | Device | $1,499 | $1,071 | +40.0% | | Service | $442 | $409 | +8.1% | | **Total Cost of Sales**| **$1,941**| **$1,480**| **+31.1%** | | **Gross Margin** | **$1,354**| **$1,155**| **+17.2%** | | **Operating Expenses**| | | | | Research and development| $5,570 | $5,461 | +2.0% | | General and administrative| $4,430 | $6,182 | -28.3% | | Sales and marketing | $2,004 | $2,547 | -21.4% | | **Total Operating Expenses**| **$12,004**| **$14,190**| **-15.4%** | | **Loss from operations**| **$(10,650)**| **$(13,035)**| **-18.3%** | | Interest income | $796 | $869 | -8.4% | | **Net loss** | **$(9,848)**| **$(12,160)**| **-19.0%** | | **Net loss per common share**| **$(0.14)**| **$(0.17)**| **-17.6%** | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $85.443 million by March 31, 2024, primarily due to reduced cash, with stockholders' equity at $75.638 million Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2024 | December 31, 2023 | Change | | :-------------------- | :------------- | :---------------- | :----- | | **ASSETS** | | | | | Cash and cash equivalents | $63,204 | $75,183 | $(11,979) | | Total current assets | $79,690 | $88,908 | $(9,218) | | **Total assets** | **$85,443** | **$94,199** | **$(8,756)** | | **LIABILITIES** | | | | | Total current liabilities | $8,767 | $8,768 | $(1) | | **Total liabilities** | **$9,805** | **$9,800** | **$5** | | **STOCKHOLDERS' EQUITY**| | | | | Accumulated deficit | $(263,570) | $(253,722) | $(9,848) | | **Total stockholders' equity**| **$75,638**| **$84,399** | **$(8,761)** | [Condensed Consolidated Statement of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statement%20of%20Cash%20Flows) Q1 2024 net cash used in operating activities was $12.510 million, resulting in an end-of-period cash balance of $63.204 million Condensed Consolidated Statement of Cash Flows (in thousands) | Metric | Q1 2024 | Q1 2023 | Change | | :-------------------- | :------ | :------ | :----- | | Net cash used in operating activities | $(12,510) | $(13,491) | $981 | | Net cash used in investing activities | $(145) | $(61) | $(84) | | Net cash provided by financing activities | $55 | $49 | $6 | | **Net decrease in cash and cash equivalents and restricted cash** | **$(12,600)**| **$(13,503)**| **$903** | | Cash, cash equivalents and restricted cash, end of period | $63,204 | $104,740 | $(41,536) | [2024 Financial Guidance](index=1&type=section&id=2024%20Financial%20Guidance) Management expects full-year 2024 revenue between $12 million and $15 million and a cash burn of approximately $40 million - Management expects full-year 2024 revenue to be **$12 million to $15 million**[7](index=7&type=chunk) - Management expects full-year 2024 cash burn to be approximately **$40 million**[7](index=7&type=chunk) [Corporate Information](index=1&type=section&id=Corporate%20Information) This section covers forward-looking statement disclaimers, investor contact details, and Q1 2024 earnings conference call information [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This disclaimer warns that actual results may differ from expectations due to various risks, including product development and regulatory approvals - The press release includes forward-looking statements, and actual results may differ from expectations due to **significant risks and uncertainties**[11](index=11&type=chunk) - Factors that may cause differences include success of product development and commercialization, regulatory clearance, ability to grow, competition, market size, pricing, and ability to complete clinical studies[11](index=11&type=chunk) [Investor Relations](index=3&type=section&id=Investor%20Relations) Provides contact information for investor inquiries, directing them to Marissa Bych at Gilmartin Group LLC - Investor contact is Marissa Bych of Gilmartin Group LLC, reachable at **marissa@gilmartinir.com**[12](index=12&type=chunk) [Conference Call Details](index=1&type=section&id=Conference%20Call%20Details) Hyperfine hosted a conference call on May 13, 2024, to discuss Q1 2024 financial results and provide a business update - A conference call was hosted on **Monday, May 13, 2024**, at **1:30 p.m. PT/ 4:30 p.m. ET** to discuss Q1 2024 financial results and provide a business update[6](index=6&type=chunk) - Interested participants could register online at **https://investors.hyperfine.io/**, where a live and archived audio webcast was also available[6](index=6&type=chunk)

Wall Street expects a year-over-year increase in earnings on higher revenues when Hyperfine, Inc. (HYPR) reports results for the quarter ended March 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on May 13, 2024, might help the stock move higher if these key numbers are better than exp ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 Commission file number: 001-39949 Hyperfine, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 98-1569027 (I.R.S. Employer Identification No.) 351 New Whitfield Street Guilford, Connecticut 06437 (Address o ...

Financial Data and Key Metrics Changes - For the full-year 2023, the company generated $11 million in revenue, up 62% compared to 2022, with Q4 revenue of $2.7 million, an 89% increase year-over-year [28][41] - Gross profit for the full-year was $4.8 million, compared to $0.9 million in 2022, with a gross margin of 43.1%, up 30 percentage points from the prior year [22][41] - The net loss for Q4 was $10.7 million, equating to a net loss of $0.15 per share, an improvement from a net loss of $13.1 million or $0.19 per share in the same period of the prior year [42] Business Line Data and Key Metrics Changes - The company sold seven Swoop systems in Q4, predominantly through U.S. direct sales, achieving a record average selling price [29] - The implementation programs run by the clinical support team have resulted in strong user advocates across various hospital departments [30] Market Data and Key Metrics Changes - The company is focusing on expanding its commercial efforts into select international markets, having received regulatory clearances such as CE and UKCA approval for its latest AI-powered software [19][71] - There is significant demand for brain MRI technology due to new FDA requirements for monitoring MRIs for patients on amyloid-targeting therapies [11] Company Strategy and Development Direction - The company is committed to three strategic pillars: innovation, clinical evidence, and commercialization, with a focus on expanding its Alzheimer's program [9][15] - The company plans to maintain a robust cadence of innovation to support the use of Swoop, particularly in stroke and Alzheimer's [9][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth opportunities in Alzheimer's care, highlighting the potential for the Swoop system to improve access and equity in treatment [32][35] - The company expects to achieve revenue in the range of $12 million to $15 million for 2024, with a first-quarter expectation of over $3 million [43] Other Important Information - The company has initiated a new study called Care PMR to assess the use of the Swoop system in detecting ARIA complications in Alzheimer's patients [37] - The company has a cash runway into early 2026, with total cash burn expectations of approximately $40 million for 2024, down from $42 million in 2023 [44][60] Q&A Session Summary Question: What led to the revenue shortfall in Q4? - Management indicated that variability in deal closures affected Q4 performance, but they are confident in the progress made in Q1 [64] Question: Can you explain the guidance for 2024 revenue? - Management provided a range of $12 million to $15 million, emphasizing steady progress in adoption and commercialization while investing in R&D and clinical evidence [50][72] Question: How does the company plan to manage cash flow and burn rate? - The company is focused on maintaining spending discipline while investing in growth initiatives, with a projected cash burn of approximately $40 million for 2024 [53][60]

Hyperfine, Inc. (NASDAQ:HYPR) Q3 2023 Earnings Call November 9, 2023 4:30 PM ET Company Participants Marissa Bych - Investor Relations Maria Sainz - President and Chief Executive Officer Brett Hale - Chief Administrative Officer and Chief Financial Officer Conference Call Participants Neil Chatterji - B. Riley Operator Good afternoon, and welcome to Hyperfine's Third Quarter 2023 Earnings Conference Call. Currently, all participants are in a listen-only mode. We will be facilitating a question-and-answer se ...