Press Release: Hyperfine, Inc. Reports Fourth Quarter and Full Year 2024 Financial Results

Dow Jones
03-18

Hyperfine, Inc. Reports Fourth Quarter and Full Year 2024 Financial Results

GUILFORD, Conn., March 17, 2025 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system--the Swoop$(R)$ system--today announced fourth quarter and full year 2024 financial results and provided a business update.

"I am pleased with the many milestones we achieved in the fourth quarter of 2024. These set the stage well for us to execute on our expansion plan, drive accelerated growth across multiple sites of care globally and meaningfully reduce cash burn in 2025," said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. "This year, we are planning two AI-powered software launches, with image quality approaching that of high-field. 2025 will be a tale of two halves, starting the year with commercial activity mainly in our U.S. critical care business and by the end of the year, we expect to be actively selling into several sites of care in the hospital setting, neurology offices and into more international markets."

Recent Achievements and Business Highlights

   -- Strengthened our financial profile by completing a reorganization to 
      lower our operating costs and raising $6.0 million through a registered 
      direct offering to extend our cash runway, which is now expected to 
      enable us to conduct our planned operations until the end of 2026. 
 
   -- Accreditation guidelines published by the Intersocietal Accreditation 
      Commission $(IAC)$ including ultra-low-field MRI technology and allowing 
      accredited facilities to qualify for reimbursement from the US Centers 
      for Medicare & Medicaid Services $(CMS)$. 
 
   -- Obtained CE and UKCA Mark approval of 9th generation AI-powered brain 
      imaging software with enhanced speed. The Swoop(R) system is now 
      available in five European language configurations (English, German, 
      Spanish, Italian, and French). 
 
   -- Expanded global market reach with new distribution partnerships and 
      exited 2024 with 13 distribution partners covering Canada and several 
      countries across Europe, Asia Pacific, and the Middle East. 
 
   -- High exposure at leading conferences with one presentation at the 
      Clinical Trials on Alzheimer's Disease (CTAD) conference, 11 
      presentations at the Radiological Society of North America (RSNA), and 
      two presentations recently at the 2025 International Stroke Conference, 
      including subsets of ACTION PMR and CARE PMR study data. 

Fourth Quarter 2024 Financial Results

   -- Revenues for the fourth quarter of 2024 were $2.32 million, compared to 
      $2.69 million in the fourth quarter of 2023. 
 
   -- Hyperfine, Inc. sold nine commercial Swoop(R) systems in the fourth 
      quarter of 2024, compared to seven in the fourth quarter of 2023. 
 
   -- Gross margin for the fourth quarter of 2024 was $0.8 million, compared to 
      $1.03 million in the fourth quarter of 2023. 
 
   -- Research and development expenses for the fourth quarter of 2024 were 
      $5.11 million, compared to $5.96 million in the fourth quarter of 2023. 
 
   -- Sales, marketing, general, and administrative expenses for the fourth 
      quarter of 2024 were $6.49 million, compared to $6.70 million in the 
      fourth quarter of 2023. 
 
   -- Net loss for the fourth quarter of 2024 was $10.39 million, equating to a 
      net loss of $0.14 per share, as compared to a net loss of $10.68 million, 
      or a net loss of $0.15 per share, for the fourth quarter of 2023. 

Full Year 2024 Financial Results

   -- Revenues for the full year 2024 were $12.89 million, up 17%, compared to 
      $11.03 million in 2023. 
 
   -- Hyperfine, Inc. sold 48 commercial Swoop(R) systems in 2024, compared to 
      37 in 2023. 
 
   -- Gross margin for the full year 2024 was $5.89 million, compared to $4.76 
      million in 2023, and representing 46% gross margin in 2024, compared to 
      43% gross margin in 2023. 
 
   -- Research and development expenses for the full year 2024 were $22.50 
      million, compared to $22.49 million in 2023. 
 
   -- Sales, marketing, general, and administrative expenses for the full year 
      2024 were $26.61 million, compared to $30.38 million in 2023. 
 
   -- Net loss for the full year 2024 was $40.72 million, equating to a net 
      loss of $0.56 per share, as compared to a net loss of $44.24 million, or 
      a net loss of $0.62 per share, for 2023. 
 
   -- Cash and cash equivalents totaled $37.64 million as of December 31, 2024. 

2025 Financial Guidance

   -- Management expects revenue for the first half of 2025 to be approximately 
      $6 million. Management expects annual revenue growth for the full year 
      2025 to be 20% to 30% over 2024. 
 
   -- Management expects cash burn for the full year 2025 to be approximately 
      $25 to 27 million, representing a 32% decline at the midpoint as compared 
      to 2024. 

Conference Call

Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Monday, March 17, 2025, to discuss its fourth quarter and full year 2024 financial results and provide a business update. Those interested in listening should register online by visiting https://investors.hyperfine.io/. and clicking on News & Events. Participants are encouraged to register more than 15 minutes before the start of the call. A live and archived audio webcast will be available through the Investors page of Hyperfine, Inc.'s corporate website at https://investors.hyperfine.io/.

About Hyperfine, Inc. and the Swoop(R) Portable MR Imaging(R) System

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop(R) system--the first U.S. Food and Drug Administration (FDA)-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop(R) system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit hyperfine.io.

The Swoop(R) Portable MR Imaging(R) system is FDA cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop(R) system also has CE Mark in the European Union and UKCA Mark in the United Kingdom. The Swoop(R) system is commercially available in a select number of international markets.

Hyperfine, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the "Company") may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations about the Company's financial and operating results, including, the Company's expected revenue and cash burn for the full year 2025, the Company's cash runway, the Company's goals and commercial plans, including the Company's plans to expand internationally and in new sites of care, the Company's stroke observational clinical study and Alzheimer's feasibility study, the benefits of the Company's products and services, progress on improvements and advancements in the Company's products and services, and the Company's future performance, including its financial performance, and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company's product development and commercialization activities, including the degree that the Swoop(R) system is accepted and used by healthcare professionals; the ability to maintain the listing of the Company's Class A common stock on the Nasdaq Stock Market LLC; the Company's ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the ability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the ability of the Company to identify, in-license or acquire additional technology; the ability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; anticipated National Institutes of Health funding pressures; the expected effect from U.S. export controls and tariffs; the ability of

the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company's products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company's products and services and reimbursement for medical procedures conducted using the Company's products and services; the Company's ability to successfully complete and generate positive data from the ACTION PMR study and the CARE PMR study; the Company's ability to generate clinical evidence of the benefits of the Company's products and services and to progress on product advancements and improvements; the Company's estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company's financial performance; and other risks and uncertainties indicated from time to time in the Company's filings with the Securities and Exchange Commission, including those under "Risk Factors" therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Investor Contact

Webb Campbell

Gilmartin Group LLC

webb@gilmartinir

 
                HYPERFINE, INC. AND SUBSIDIARIES 
                   CONSOLIDATED BALANCE SHEETS 
        (in thousands, except share and per share amounts) 
                           (Unaudited) 
                                                December 31, 
                                            --------------------- 
                                              2024        2023 
                                            ---------   --------- 
ASSETS 
CURRENT ASSETS: 
   Cash and cash equivalents                $  37,645   $  75,183 
   Restricted cash                                 28         621 
   Accounts receivable, less allowance of 
    $651 and $321 in 2024 and 2023, 
    respectively                                5,956       3,189 
   Unbilled receivables                         2,349         942 
   Inventory                                    5,832       6,582 
   Prepaid expenses and other current 
    assets                                      1,900       2,391 
   Due from related parties                        --          -- 
                                             --------    -------- 
Total current assets                        $  53,710   $  88,908 
   Property and equipment, net                  3,122       2,999 
   Other long term assets                       2,069       2,292 
                                             --------    -------- 
Total assets                                $  58,901   $  94,199 
                                             ========    ======== 
LIABILITIES AND STOCKHOLDERS' EQUITY 
CURRENT LIABILITIES: 
   Accounts payable                         $   1,607   $   1,214 
   Deferred grant funding                          28         621 
   Deferred revenue                             1,460       1,453 
   Due to related parties                          61          61 
   Accrued expenses and other current 
    liabilities                                 5,573       5,419 
                                             --------    -------- 
Total current liabilities                   $   8,729   $   8,768 
   Long term deferred revenue                   1,054         968 
   Other noncurrent liabilities                    78          64 
                                             --------    -------- 
Total liabilities                           $   9,861   $   9,800 
                                             --------    -------- 
 
STOCKHOLDERS' EQUITY: 
   Class A Common stock, $.0001 par value; 
    600,000,000 shares authorized; 
    58,076,261 and 56,840,949 shares 
    issued and outstanding at December 31, 
    2024 and 2023, respectively                     5           5 
   Class B Common stock, $.0001 par value; 
    27,000,000 shares authorized; 
    15,055,288 shares issued and 
    outstanding at December 31, 2024 and 
    2023                                            2           2 
   Additional paid-in capital                 343,475     338,114 
   Accumulated deficit                       (294,442)   (253,722) 
                                             --------    -------- 
Total stockholders' equity                  $  49,040   $  84,399 
                                             --------    -------- 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY  $  58,901   $  94,199 
                                             ========    ======== 
 
 
                      HYPERFINE, INC. AND SUBSIDIARIES 
           CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE 
                                    LOSS 
             (in thousands, except share and per share amounts) 
                                 (Unaudited) 
                          Three months ended              Year ended 
                              December 31,                December 31, 
                       -------------------------   ------------------------- 
                          2024          2023          2024          2023 
                       -----------   -----------   -----------   ----------- 
Sales 
   Device              $     1,743   $     2,076   $    10,450   $     8,746 
   Service                     578           610         2,440         2,286 
                        ----------    ----------    ----------    ---------- 
     Total sales       $     2,321   $     2,686   $    12,890   $    11,032 
Cost of sales 
   Device              $     1,107   $     1,142   $     5,387   $     4,463 
   Service                     388           510         1,612         1,812 
                        ----------    ----------    ----------    ---------- 
     Total cost of 
      sales            $     1,495   $     1,652   $     6,999   $     6,275 
                        ----------    ----------    ----------    ---------- 
Gross margin                   826         1,034         5,891         4,757 
Operating Expenses: 
   Research and 
    development        $     5,105   $     5,962   $    22,499   $    22,493 
   General and 
    administrative           4,133         4,173        17,494        20,276 
   Sales and 
    marketing                2,353         2,528         9,122        10,103 
                        ----------    ----------    ----------    ---------- 
Total operating 
 expenses                   11,591        12,663        49,115        52,872 
Loss from operations   $   (10,765)  $   (11,629)  $   (43,224)  $   (48,115) 
                        ----------    ----------    ----------    ---------- 
   Interest income     $       436   $       922   $     2,492   $     3,842 
   Other income 
    (expense), net             (61)           23            12            35 
                        ----------    ----------    ----------    ---------- 
Loss before provision 
 for income taxes      $   (10,390)  $   (10,684)  $   (40,720)  $   (44,238) 
Provision for income 
taxes                           --            --            --            -- 
                        ----------    ----------    ----------    ---------- 
Net loss and 
 comprehensive loss    $   (10,390)  $   (10,684)  $   (40,720)  $   (44,238) 
                        ==========    ==========    ==========    ========== 
   Net loss per 
    common share 
    attributable to 
    common 
    stockholders, 
    basic and 
    diluted            $     (0.14)  $     (0.15)  $     (0.56)  $     (0.62) 
   Weighted-average 
    shares used to 
    compute net loss 
    per share 
    attributable to 
    common 
    stockholders, 
    basic and 
    diluted             72,990,908    71,724,900    72,413,541    71,316,424 
 
 
               HYPERFINE, INC. AND SUBSIDIARIES 
             CONSOLIDATED STATEMENT OF CASH FLOWS 
                        (in thousands) 
                          (Unaudited) 
                     Three months ended        Year ended 
                         December 31,          December 31, 
                     -------------------   ------------------- 
                       2024       2023       2024       2023 
                     --------   --------   --------   -------- 
Cash flows from 
operating 
activities: 
  Net loss           $(10,390)  $(10,684)  $(40,720)  $(44,238) 
  Adjustments to 
  reconcile net 
  loss to net cash 
  used in 
  operating 
  activities: 
    Depreciation          234        263      1,009      1,054 
    Stock-based 
     compensation 
     expense            1,054      1,288      4,362      4,741 
    Write-off of 
     equipment             59        176        215        224 
    Other                 (17)        --        (11)        25 
    Changes in 
    assets and 
    liabilities            --         -- 
     Accounts 
      receivable          844       (752)    (2,767)    (1,086) 
     Unbilled 
      receivables         (85)      (260)    (1,407)      (488) 
     Inventory          1,141        285        562     (2,209) 
     Prepaid 
      expenses and 
      other current 
      assets              102        486       (222)     1,496 
     Due from 
      related 
      parties              --         --         --         48 
     Prepaid 
      inventory            --       (693)       693       (412) 
     Other long 
      term assets         334       (362)       325       (220) 
     Accounts 
      payable             189        304        382        533 
     Deferred grant 
      funding            (191)        73       (593)      (123) 
     Deferred 
      revenue              (4)      (119)        93       (483) 
     Due to related 
      parties               8         13         --         61 
     Accrued 
      expenses and 
      other current 
      liabilities      (1,632)        34       (683)      (742) 
     Operating 
      lease 
      liabilities, 
      net                  (3)        10         (5)        10 
                      -------    -------    -------    ------- 
      Net cash used 
       in operating 
       activities    $ (8,357)  $ (9,938)  $(38,767)  $(41,809) 
                      -------    -------    -------    ------- 
Cash flows from 
investing 
activities: 
  Purchases of 
   property and 
   equipment               (8)      (258)      (383)      (804) 
                      -------    -------    -------    ------- 
    Net cash used 
     in investing 
     activities      $     (8)  $   (258)  $   (383)  $   (804) 
                      -------    -------    -------    ------- 
Cash flows from 
financing 
activities: 
  Proceeds from 
   exercise of 
   stock options           11         28        171        174 
  Proceeds from 
   shares issued 
   under 
   "at-the-market" 
   offering 
   program, net of 
   selling costs           43         --        848         -- 
    Net cash 
     provided by 
     financing 
     activities      $     54   $     28   $  1,019   $    174 
                      -------    -------    -------    ------- 
Net decrease in 
 cash and cash 
 equivalents and 
 restricted cash       (8,311)   (10,168)   (38,131)   (42,439) 
Cash, cash 
 equivalents and 
 restricted cash, 
 beginning of 
 period                45,984     85,972     75,804    118,243 
                      -------    -------    -------    ------- 
Cash, cash 
 equivalents and 
 restricted cash, 
 end of period       $ 37,673   $ 75,804   $ 37,673   $ 75,804 
                      =======    =======    =======    ======= 
Reconciliation of 
cash, cash 
equivalents, and 
restricted cash 
reported in the 
balance sheets 
  Cash and cash 
   equivalents       $ 37,645   $ 75,183   $ 37,645   $ 75,183 
  Restricted cash          28        621         28        621 
                      -------    -------    -------    ------- 
Total cash, cash 
 equivalents and 
 restricted cash     $ 37,673   $ 75,804   $ 37,673   $ 75,804 
                      =======    =======    =======    ======= 
Supplemental 
disclosure of cash 
flow information: 
  Cash received 
   from exchange of 
   research and 
   development tax 
   credits           $     --   $    519   $     --   $    519 
                      =======    =======    =======    ======= 
Supplemental 
disclosure of 
noncash 
information: 
  Unpaid purchase 
   of property and 
   equipment         $    194   $    (51)  $    765   $      3 
                      =======    =======    =======    ======= 
 

(END) Dow Jones Newswires

March 17, 2025 16:05 ET (20:05 GMT)

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