EX-99.1 2 hypr-ex99_1.htm EX-99.1 EX-99.1

 

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Exhibit 99.1

 

Hyperfine, Inc. Reports First Quarter 2025 Financial Results

 

GUILFORD, Connecticut, May 13, 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® system—today announced first quarter 2025 financial results and provided a business update.

“Our commercial efforts have primarily focused on the hospital business, where we’ve continued to experience longer and more variable sales cycles in the first quarter. During this time, we also made meaningful progress in expanding our pipeline, now including promising early opportunities in the neurology office setting. We’re enthusiastic about growing our presence across both hospitals and neurology offices, setting the stage for accelerated growth and a more diversified revenue profile beginning in the second half of 2025. Additionally, we expect upcoming FDA clearances to bring to market a new standard in image quality for portable brain MRI.” said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. “This first quarter was rich in progress related to our office business launch readiness and the technical work related to next gen Swoop® system technology. I am very excited about the prospects for Hyperfine in the second half of 2025 and beyond.”

 

Recent Achievements and Business Highlights

Strengthened our financial profile by completing a reorganization to lower our operating costs and raising $6 million of gross proceeds through a registered direct offering to extend our cash runway, which is still expected to enable us to conduct our planned operations until the end of 2026.
Submitted next gen Swoop® system technology to the U.S. Food and Drug Administration (the “FDA”).
Started patient enrollment in NEURO PMR study to evaluate use of AI-powered portable MRI in neurology offices. The study is now expected to be completed by the end of the third quarter of 2025.
High exposure at leading conferences with two presentations at the 2025 International Stroke Conference, including subsets of ACTION PMR.

First Quarter 2025 Financial Results

Revenues for the first quarter of 2025 were $2.1 million, compared to $3.3 million in the first quarter of 2024.
Hyperfine, Inc. sold six commercial Swoop® systems in the first quarter of 2025.
Gross margin for the first quarter of 2025 was $0.9 million, compared to $1.3 million in the first quarter of 2024, and representing 41.3% gross margin in the first quarter of 2025, compared to 41.1% in the first quarter of 2024.
Research and development expenses for the first quarter of 2025 were $5.0 million, compared to $5.6 million in the first quarter of 2024.
Sales, marketing, general, and administrative expenses for the first quarter of 2025 were $6.7 million, compared to $6.4 million in the first quarter of 2024.
Net loss for the first quarter of 2025 was $9.4 million, equating to a net loss of $0.12 per share, as compared to a net loss of $9.8 million, or a net loss of $0.14 per share, for the first quarter of 2024.

2025 Financial Guidance

Management now expects revenue for the first half of 2025 to be approximately $5 to $6 million. Management expects annual revenue growth for the full year 2025 to be 10% to 20% over 2024.
Management now expects cash burn for the full year 2025 to be approximately $25 to $28 million, representing a 31% decline at the midpoint as compared to 2024.

 

Conference Call

 


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Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Tuesday, May 13, 2025, to discuss its first quarter 2025 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® Portable MR Imaging® System

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® 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® 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® Portable MR Imaging® 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® system also has CE Mark in the European Union and UKCA Mark in the United Kingdom. The Swoop® 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 in new sites of care, in hospitals and neurology offices, the Company’s stroke observational clinical study and NEURO PMR multi-center, prospective observational study, the benefits of the Company’s products and services, progress on improvements and advancements in the Company’s products and services and the timing of FDA clearances, 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® 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, CARE PMR study and NEURO 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

 


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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

 


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HYPERFINE, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)

 

 

March 31,
2025

 

 

December 31,
2024

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

33,093

 

 

$

37,645

 

Restricted cash

 

 

441

 

 

 

28

 

Accounts receivable, less allowance of $790 and $651 as of March 31, 2025 and December 31, 2024, respectively

 

 

5,330

 

 

 

5,956

 

Unbilled receivables

 

 

1,937

 

 

 

2,349

 

Inventory

 

 

4,639

 

 

 

5,832

 

Prepaid expenses and other current assets

 

 

2,963

 

 

 

1,900

 

Total current assets

 

 

48,403

 

 

 

53,710

 

Property and equipment, net

 

 

3,094

 

 

 

3,122

 

Other long term assets

 

 

1,880

 

 

 

2,069

 

Total assets

 

$

53,377

 

 

$

58,901

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Accounts payable

 

$

2,305

 

 

$

1,607

 

Deferred grant funding

 

 

441

 

 

 

28

 

Deferred revenue

 

 

1,406

 

 

 

1,460

 

Due to related parties

 

 

54

 

 

 

61

 

Accrued expenses and other current liabilities

 

 

3,773

 

 

 

5,573

 

Total current liabilities

 

 

7,979

 

 

 

8,729

 

Warrant liabilities

 

 

1,240

 

 

 

 

Long term deferred revenue

 

 

1,028

 

 

 

1,054

 

Other noncurrent liabilities

 

 

16

 

 

 

78

 

Total liabilities

 

 

10,263

 

 

 

9,861

 

 

 

 

 

 

 

 

STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Class A Common stock, $0.0001 par value per share; 600,000,000 shares authorized; 62,784,562 and 58,076,261 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively

 

 

6

 

 

 

5

 

Class B Common stock, $0.0001 par value per share; 27,000,000 shares authorized; 15,055,288 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively

 

 

2

 

 

 

2

 

Additional paid-in capital

 

 

346,966

 

 

 

343,475

 

Accumulated deficit

 

 

(303,860

)

 

 

(294,442

)

Total stockholders' equity

 

 

43,114

 

 

 

49,040

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

 

$

53,377

 

 

$

58,901

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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HYPERFINE, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(Unaudited)

 

 

Three Months Ended
March 31,

 

 

 

2025

 

 

2024

 

Sales

 

 

 

 

 

 

Device

 

$

1,522

 

 

$

2,704

 

Service

 

 

615

 

 

 

591

 

Total sales

 

 

2,137

 

 

 

3,295

 

Cost of sales

 

 

 

 

 

 

Device

 

 

985

 

 

 

1,499

 

Service

 

 

269

 

 

 

442

 

Total cost of sales

 

 

1,254

 

 

 

1,941

 

Gross margin

 

 

883

 

 

 

1,354

 

Operating Expenses:

 

 

 

 

 

 

Research and development

 

 

5,037

 

 

 

5,570

 

General and administrative

 

 

4,208

 

 

 

4,430

 

Sales and marketing

 

 

2,540

 

 

 

2,004

 

Total operating expenses

 

 

11,785

 

 

 

12,004

 

Loss from operations

 

 

(10,902

)

 

 

(10,650

)

Interest income

 

 

317

 

 

 

796

 

Change in Fair Value of Warrant Liabilities

 

 

1,618

 

 

 

 

Other (expense) income, net

 

 

(451

)

 

 

6

 

Loss before provision for income taxes

 

 

(9,418

)

 

 

(9,848

)

Provision for income taxes

 

 

 

 

 

 

Net loss and comprehensive loss

 

$

(9,418

)

 

$

(9,848

)

Net loss per common share attributable to common stockholders, basic and diluted

 

$

(0.12

)

 

$

(0.14

)

Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted

 

 

75,697,199

 

 

 

71,934,045

 

 

 


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HYPERFINE, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF CASH FLOWS

(in thousands)

(Unaudited)

 

 

 

Three Months
Ended
March 31,

 

 

 

2025

 

 

2024

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(9,418

)

 

$

(9,848

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation

 

 

229

 

 

 

263

 

Stock-based compensation expense

 

 

945

 

 

 

1,032

 

Change in fair value of warrant liabilities

 

 

(1,618

)

 

 

 

Other

 

 

11

 

 

 

34

 

Changes in assets and liabilities:

 

 

 

 

 

 

Accounts receivable, net

 

 

626

 

 

 

(2,154

)

Unbilled receivables

 

 

412

 

 

 

47

 

Inventory

 

 

1,193

 

 

 

(833

)

Prepaid expenses and other current assets

 

 

(1,241

)

 

 

(1,252

)

Prepaid inventory

 

 

 

 

 

693

 

Other long term assets

 

 

128

 

 

 

200

 

Accounts payable

 

 

600

 

 

 

1,208

 

Deferred grant funding

 

 

413

 

 

 

(621

)

Deferred revenue

 

 

(80

)

 

 

127

 

Due to related parties

 

 

(7

)

 

 

(16

)

Accrued expenses and other current liabilities

 

 

(1,435

)

 

 

(1,392

)

Operating lease liabilities, net

 

 

(7

)

 

 

2

 

Net cash used in operating activities

 

 

(9,249

)

 

 

(12,510

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(472

)

 

 

(145

)

Net cash used in investing activities

 

 

(472

)

 

 

(145

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

33

 

 

 

55

 

Proceeds from shares issued under “at-the-market” offering program, net of selling costs

 

 

129

 

 

 

 

Proceeds from issuance of common stock and warrants, net of offering costs

 

 

5,420

 

 

 

 

Net cash provided by financing activities

 

 

5,582

 

 

 

55

 

Net decrease in cash and cash equivalents and restricted cash

 

 

(4,139

)

 

 

(12,600

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

37,673

 

 

 

75,804

 

Cash, cash equivalents and restricted cash, end of period

 

 

33,534

 

 

 

63,204

 

Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets

 

 

 

 

 

 

Cash and cash equivalents

 

 

33,093

 

 

 

63,204

 

Restricted cash

 

 

441

 

 

 

 

Total cash, cash equivalents and restricted cash

 

$

33,534

 

 

$

63,204

 

Supplemental disclosure of noncash information:

 

 

 

 

 

 

Initial measurement of warrant liabilities

 

$

2,858

 

 

$

 

Unpaid purchase of property and equipment

 

$

509

 

 

$

742

 

Unpaid financing issuance costs

 

$

238

 

 

$