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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 12, 2024

 

 

Hyperfine, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-39949	98-1569027
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
351 New Whitfield Street
Guilford, Connecticut				06437
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (866) 796-6767

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Class A common stock, $0.0001 par value per share		HYPR		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On November 12, 2024, Hyperfine, Inc. issued a press release announcing its results for the third quarter ended September 30, 2024 and providing a business update. A copy of the press release is furnished as Exhibit 99.1 hereto.

 

The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description
99.1		Press Release dated November 12, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

The press release may contain hypertext links to information on our website. The information on our website is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			HYPERFINE, INC.
Date:	November 12, 2024	By:	/s/ Brett Hale
			Brett Hale Chief Administrative Officer, Chief Financial Officer, Treasurer and Corporate Secretary

 

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Exhibit 99.1

 

Hyperfine, Inc. Reports Third Quarter 2024 Financial Results

 

GUILFORD, Connecticut, November 12, 2024 (GLOBE NEWSWIRE) – Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced third quarter 2024 financial results and provided a business update.

“The Hyperfine team delivered yet another strong quarter of financial performance across revenue growth, gross margin expansion, and disciplined cash management while executing against several important priorities in our plans to expand into new sites of care and internationally” said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. “I am increasingly confident in our growth prospects in 2025 and beyond as we execute on our expansion strategy with advancements in image quality and clinical evidence.”

 

Third Quarter 2024 Financial Results

 

Recent Achievements and Business Highlights

 

 

Nine Months Financial Results

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2024 Financial Guidance

 

Conference Call

Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Tuesday, November 12, 2024, to discuss its third quarter 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® 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 FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care. The Swoop® system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a portable magnetic resonance brain imaging device for producing images that display the internal structure of the head where a 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 has been approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, CE certification in the European Union, and is also available in New Zealand.

 

The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging and data solutions. 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. Traditionally, access to costly, stationary, conventional MRI technology can be inconvenient or not available when needed most. With the portable, ultra-low-field Swoop® system, Hyperfine, Inc. is redefining the neuroimaging workflow by bringing brain imaging to the patient’s bedside. For more information, visit hyperfine.io.

 

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 2024, 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

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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; 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 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.com

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HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)

		September 30, 2024				December 31, 2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	45,765			$	75,183
Restricted cash			219				621
Accounts receivable, less allowance of $482 and $321 as of September 30, 2024 and December 31, 2023, respectively			6,800				3,189
Unbilled receivables			2,264				942
Inventory			7,044				6,582
Prepaid expenses and other current assets			2,002				2,391
Total current assets			64,094				88,908
Property and equipment, net			3,125				2,999
Other long term assets			2,167				2,292
Total assets		$	69,386			$	94,199
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable		$	1,404			$	1,214
Deferred grant funding			219				621
Deferred revenue			1,413				1,453
Due to related parties			53				61
Accrued expenses and other current liabilities			6,870				5,419
Total current liabilities			9,959				8,768
Long term deferred revenue			1,105				968
Other noncurrent liabilities			—				64
Total liabilities			11,064				9,800
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Class A Common stock, $.0001 par value; 600,000,000 shares authorized; 57,893,458 and 56,840,949 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively			5				5
Class B Common stock, $.0001 par value; 27,000,000 shares authorized; 15,055,288 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively			2				2
Additional paid-in capital			342,367				338,114
Accumulated deficit			(284,052	)			(253,722	)
Total stockholders' equity			58,322				84,399
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$	69,386			$	94,199

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(Unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Sales
Device		$	3,033			$	1,728			$	8,707			$	6,670
Service			610				602				1,862				1,676
Total sales			3,643				2,330				10,569				8,346
Cost of sales
Device			1,359				835				4,280				3,321
Service			376				371				1,224				1,302
Total cost of sales			1,735				1,206				5,504				4,623
Gross margin			1,908				1,124				5,065				3,723
Operating Expenses:
Research and development			5,865				5,739				17,394				16,531
General and administrative			4,510				4,615				13,361				16,103
Sales and marketing			2,496				2,529				6,769				7,575
Total operating expenses			12,871				12,883				37,524				40,209
Loss from operations			(10,963	)			(11,759	)			(32,459	)			(36,486	)
Interest income			585				1,021				2,056				2,920
Other income (expense), net			52				(19	)			73				12
Loss before provision for income taxes			(10,326	)			(10,757	)			(30,330	)			(33,554	)
Provision for income taxes			—				—				—				—
Net loss and comprehensive loss		$	(10,326	)		$	(10,757	)		$	(30,330	)		$	(33,554	)
Net loss per common share attributable to common stockholders, basic and diluted		$	(0.14	)		$	(0.15	)		$	(0.42	)		$	(0.47	)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted			72,678,622				71,464,315				72,219,681				71,178,769

 

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HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

		Nine Months Ended September 30,
		2024				2023
Cash flows from operating activities:
Net loss		$	(30,330	)		$	(33,554	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation			775				791
Stock-based compensation expense			3,308				3,453
Loss on disposal of property and equipment, net			156				48
Other			6				25
Changes in assets and liabilities:
Accounts receivable, net			(3,611	)			(334	)
Unbilled receivables			(1,322	)			(228	)
Inventory			(579	)			(2,494	)
Prepaid expenses and other current assets			(324	)			1,010
Due from related parties			—				48
Prepaid inventory			693				281
Other long term assets			(9	)			142
Accounts payable			193				229
Deferred grant funding			(402	)			(196	)
Deferred revenue			97				(364	)
Due to related parties			(8	)			48
Accrued expenses and other current liabilities			949				(776	)
Operating lease liabilities, net			(2	)			—
Net cash used in operating activities			(30,410	)			(31,871	)
Cash flows from investing activities:
Purchases of property and equipment			(375	)			(546	)
Net cash used in investing activities			(375	)			(546	)
Cash flows from financing activities:
Proceeds from exercise of stock options			160				146
Proceeds from shares issued under “at-the-market” offering program, net of selling costs			805				—
Net cash provided by financing activities			965				146
Net decrease in cash and cash equivalents and restricted cash			(29,820	)			(32,271	)
Cash, cash equivalents and restricted cash, beginning of period			75,804				118,243
Cash, cash equivalents and restricted cash, end of period			45,984				85,972
Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets
Cash and cash equivalents			45,765				85,424
Restricted cash			219				548
Total cash, cash equivalents and restricted cash		$	45,984			$	85,972
Supplemental disclosure of noncash information:
Unpaid purchase of property and equipment		$	571			$	54

 

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