false000183376900018337692023-11-092023-11-09

 

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 09, 2023

 

 

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 9, 2023, Hyperfine, Inc. issued a press release announcing its results for the third quarter ended September 30, 2023 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 9, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

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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 9, 2023	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 2023 Financial Results

 

GUILFORD, Connecticut, November 9, 2023 (GLOBE NEWSWIRE) – Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system—the Swoop® system—today announced third quarter 2023 financial results and provided a business update.

“We remain focused on our three strategic pillars of innovation, clinical evidence, and commercialization, all while actively managing our spending, resulting in meaningful progress in the transformation of the business” said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. “The quarter was dominated by U.S. direct deals driving record average selling price and gross margin percentage for our business. We also received FDA clearance for our latest AI-powered software and drove strong progress on all our clinical programs, including our upcoming Alzheimer’s feasibility study.”

Third Quarter 2023 Financial Results

Nine Months Financial Results

2023 Financial Guidance

 

Conference Call

Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Thursday, November 9, 2023, to discuss its third quarter 2023 financial results and provide a business update. Those interested in listening should register online by visiting

 

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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 medical technology company that has redefined brain imaging with the Swoop® system—the world’s 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 and 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, the Company’s goals and commercial plans, the Company’s Alzheimer’s feasibility study, the benefits of the Company’s products and services, and the Company’s future 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 inability to maintain the listing of the Company’s Class A common stock on the Nasdaq Stock Market LLC; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability 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 inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability 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 inability to successfully complete and generate positive data from the ACTION PMR study and the Alzheimer’s feasibility study; 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

 

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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
Marissa Bych
Gilmartin Group LLC
marissa@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, 2023				December 31, 2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	85,424			$	117,472
Restricted cash			548				771
Accounts receivable, less allowance of $241 and $180 as of September 30, 2023 and December 31, 2022, respectively			2,437				2,103
Unbilled receivables			682				454
Inventory			6,940				4,622
Prepaid expenses and other current assets			2,184				3,194
Due from related parties			—				48
Total current assets			98,215				128,664
Property and equipment, net			3,158				3,248
Other long term assets			1,691				2,139
Total assets		$	103,064			$	134,051
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable		$	908			$	678
Deferred grant funding			548				771
Deferred revenue			1,454				1,378
Due to related parties			48				—
Accrued expenses and other current liabilities			5,253				5,976
Total current liabilities			8,211				8,803
Long term deferred revenue			1,086				1,526
Total liabilities			9,297				10,329
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Class A Common stock, $.0001 par value; 600,000,000 shares authorized; 56,537,946 and 55,622,488 shares issued and outstanding at September 30, 2023 and December 31, 2022, 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, 2023 and December 31, 2022, respectively			2				2
Additional paid-in capital			336,798				333,199
Accumulated deficit			(243,038	)			(209,484	)
Total stockholders' equity			93,767				123,722
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$	103,064			$	134,051

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

 

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(Unaudited)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Sales
Device		$	1,728			$	1,945			$	6,670			$	4,305
Service			602				403				1,676				1,085
Total sales			2,330				2,348				8,346				5,390
Cost of sales
Device			835				1,215				3,321				3,511
Service			371				445				1,302				1,272
Total cost of sales			1,206				1,660				4,623				4,783
Gross margin			1,124				688				3,723				607
Operating Expenses:
Research and development			5,739				7,338				16,531				22,937
General and administrative			4,615				3,198				16,103				26,570
Sales and marketing			2,529				3,434				7,575				11,345
Total operating expenses			12,883				13,970				40,209				60,852
Loss from operations			(11,759	)			(13,282	)			(36,486	)			(60,245	)
Interest income			1,021				170				2,920				203
Other income (expense), net			(19	)			(59	)			12				(63	)
Loss before provision for income taxes			(10,757	)			(13,171	)			(33,554	)			(60,105	)
Provision for income taxes			—				—				—				—
Net loss and comprehensive loss		$	(10,757	)		$	(13,171	)		$	(33,554	)		$	(60,105	)
Net loss per common share attributable to common stockholders, basic and diluted		$	(0.15	)		$	(0.19	)		$	(0.47	)		$	(0.85	)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted			71,464,315				70,509,639				71,178,769				70,398,103

 

 

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HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

(in thousands)

(Unaudited)

 

		Nine Months Ended September 30,
		2023				2022
Cash flows from operating activities:
Net loss		$	(33,554	)		$	(60,105	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation			791				754
Stock-based compensation expense			3,453				8,859
Loss on disposal of property and equipment, net			48				—
Payments received on net investment in lease			25				6
Changes in assets and liabilities:
Accounts receivable, net			(334	)			(2,149	)
Unbilled receivables			(228	)			(1,384	)
Inventory			(2,494	)			308
Prepaid expenses and other current assets			1,010				(439	)
Due from related parties			48				14
Prepaid inventory			281				—
Other long term assets			142				62
Accounts payable			229				(1,522	)
Deferred grant funding			(196	)			(1,403	)
Deferred revenue			(364	)			1,098
Due to related parties			48				(1,920	)
Accrued expenses and other current liabilities			(776	)			827
Net cash used in operating activities			(31,871	)			(56,994	)
Cash flows from investing activities:
Purchases of property and equipment			(546	)			(427	)
Net cash used in investing activities			(546	)			(427	)
Cash flows from financing activities:
Proceeds from exercise of stock options			146				2
Net cash provided by financing activities			146				2
Net decrease in cash and cash equivalents and restricted cash			(32,271	)			(57,419	)
Cash, cash equivalents and restricted cash, beginning of period			118,243				191,160
Cash, cash equivalents and restricted cash, end of period			85,972				133,741
Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets
Cash and cash equivalents			85,424				132,482
Restricted cash			548				1,259
Total cash, cash equivalents and restricted cash		$	85,972			$	133,741
Supplemental disclosure of noncash information:
Noncash acquisition of fixed assets		$	54			$	—
Write-off of notes receivable		$	—			$	90

 

 

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