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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): March 21, 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 March 21, 2023, Hyperfine, Inc. (the “Company”) issued a press release announcing its results for the fourth quarter and year ended December 31, 2022 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 March 21, 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:	March 21, 2023	By:	/s/ Alok Gupta
			Alok Gupta Chief Financial Officer

 

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Exhibit 99.1

 

Hyperfine, Inc. Reports Fourth Quarter and Full Year 2022 Financial Results

GUILFORD, Connecticut, March 21, 2023 (GLOBE NEWSWIRE) – Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world's first FDA-cleared portable MRI system™ today announced fourth quarter and full year 2022 financial results and provided a business update.

 

“We made measurable progress at Hyperfine over the past year. We delivered $6.8 million in revenue in 2022, received multiple FDA clearances and international approvals, including CE Marking, in recent months, and saw a large number of publications and presentations on the clinical value of Swoop published and presented via major journals and meetings. We also implemented important measures to right size our business and extend our cash runway through the end of 2025, ending the year with a healthy balance sheet. These achievements lay the foundation for strong forward growth,” said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. “We believe the opportunity for Hyperfine to transform access to MRI scans across clinical uses and sites of service is incredibly compelling. Our team is dedicated to expanding commercial placements while focusing on additional innovation and clinical evidence. We look forward to growing our impact in the field of medical imaging and diagnostics.”

 

Recent Achievements

 

Fourth Quarter 2022 Financial Results

 

Full Year 2022 Financial Results

2023 Financial Guidance

 

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Conference Call

Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Tuesday, March 21, 2023, to discuss its fourth quarter and full year 2022 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 medical technology company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. The Swoop® system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a bedside 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 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 and Pakistan.

 

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. Hyperfine, Inc. (“the Company”)’s actual results 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 commercial plans, 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 impact of COVID-19 on the Company’s business; the inability to maintain the listing of the Company’s Class A common stock on the Nasdaq; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition and the Company’s ability 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 estimates regarding expenses, future 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

 

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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
Marissa Bych
Gilmartin Group LLC
marissa@gilmartinir.com

 

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HYPERFINE, INC. AND SUBSIDIARIES

COMBINED AND CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)

 

		December 31,				December 31,
		2022				2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	117,472			$	188,498
Restricted cash			771				2,662
Accounts receivable, net			2,103				553
Unbilled receivables			454				91
Inventory			4,622				4,310
Prepaid expenses and other current assets			3,194				1,357
Due from related parties			48				14
Total current assets		$	128,664			$	197,485
Property and equipment, net			3,248				3,753
Other long term assets			2,139				1,235
Total assets		$	134,051			$	202,473
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable		$	678			$	2,248
Deferred grant funding			771				2,662
Deferred revenue			1,378				730
Due to related parties			—				1,981
Accrued expenses and other current liabilities			5,976				8,115
Total current liabilities		$	8,803			$	15,736
Long term deferred revenue			1,526				510
Total liabilities		$	10,329			$	16,246
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Class A Common stock, $.0001 par value; 600,000,000 shares authorized; 55,622,488 and 55,277,061 shares issued and outstanding at December 31, 2022 and December 31, 2021, 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, 2022 and December 31, 2021, respectively			2				2
Additional paid-in capital			333,199				322,540
Accumulated deficit			(209,484	)			(136,320	)
Total stockholders' equity		$	123,722			$	186,227
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$	134,051			$	202,473

 

 

 

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HYPERFINE, INC. AND SUBSIDIARIES

COMBINED AND CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(Unaudited)

 

		Three months ended December 31,								Year ended December 31,
		2022				2021				2022				2021
Sales
Device		$	941			$	194			$	5,246			$	715
Service			483				242				1,568				781
Total sales		$	1,424			$	436			$	6,814			$	1,496
Cost of sales
Device		$	720			$	638			$	4,231			$	2,058
Service			404				251				1,676				605
Total cost of sales		$	1,124			$	889			$	5,907			$	2,663
Gross margin			300				(453	)			907				(1,167	)
Operating Expenses:
Research and development		$	5,219			$	8,893			$	28,156			$	25,842
General and administrative			5,836				12,149				32,406				27,497
Sales and marketing			2,874				4,592				14,219				10,362
Total operating expenses			13,929				25,634				74,781				63,701
Loss from operations		$	(13,629	)		$	(26,087	)		$	(73,874	)		$	(64,868	)
Interest income		$	558			$	5			$	761			$	18
Other income (expense), net			12				(3	)			(51	)			(1	)
Loss before provision for income taxes		$	(13,059	)		$	(26,085	)		$	(73,164	)		$	(64,851	)
Provision for income taxes			—				—				—				—
Net loss and comprehensive loss		$	(13,059	)		$	(26,085	)		$	(73,164	)		$	(64,851	)
Net loss per common share attributable to common stockholders, basic and diluted		$	(0.19	)		$	(13.79	)		$	(1.04	)		$	(17.57	)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted			70,588,368				1,892,208				70,449,191				3,690,523

 

 

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HYPERFINE, INC. AND SUBSIDIARIES

COMBINED AND CONSOLIDATED STATEMENT OF CASH FLOWS

(in thousands)

(Unaudited)

 

		Three months ended December 31,								Year ended December 31,
		2022				2021				2022				2021
Cash flows from operating activities:
Net loss		$	(13,059	)		$	(26,085	)		$	(73,164	)		$	(64,851	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			261				337				1,015				726
Stock-based compensation expense			1,793				3,770				10,652				6,901
Write-off of other assets - related party			—				984				—				984
Other			85				59				91				85
Changes in assets and liabilities
Accounts receivable			599				387				(1,550	)			(379	)
Unbilled receivables			1,021				(43	)			(363	)			(91	)
Inventory			(620	)			(1,603	)			(312	)			(2,667	)
Prepaid expenses and other current assets			(1,398	)			2,243				(1,837	)			(666	)
Due from related parties			(48	)			(1	)			(34	)			1,451
Other assets - related party			—				102				—				260
Prepaid inventory			(281	)			—				(281	)			—
Other long term assets			(694	)			(587	)			(632	)			(1,201	)
Accounts payable			(48	)			(2,487	)			(1,570	)			1,436
Deferred grant funding			(488	)			(805	)			(1,891	)			1,052
Deferred revenue			566				126				1,664				1,082
Due to related parties			(61	)			647				(1,981	)			1,845
Accrued expenses and other current liabilities			(2,973	)			4,821				(2,146	)			6,851
Net cash used in operating activities		$	(15,345	)		$	(18,135	)		$	(72,339	)		$	(47,182	)
Cash flows from investing activities:
Purchases of property and equipment			(158	)			(975	)			(585	)			(2,711	)
Net cash used in investing activities		$	(158	)		$	(975	)		$	(585	)		$	(2,711	)
Cash flows from financing activities:
Proceeds from exercise of stock options			5				35				7				1,497
Proceeds from issuance of Series D convertible preferred stock			—				—				—				30,468
Stock issuance costs related to Series D convertible preferred stock			—				—				—				(7	)
Repayment of notes payable			—				(178	)			—				(178	)
Investment from 4Bionics, LLC			—				—				—				3,516
Net proceeds from equity infusion from the Business Combination			—				141,471				—				141,471
Net cash provided by financing activities		$	5			$	141,328			$	7			$	176,767
Net (decrease) increase in cash and cash equivalents and restricted cash			(15,498	)			122,218				(72,917	)			126,874
Cash, cash equivalents and restricted cash, beginning of period			133,741				68,942				191,160				64,286
Cash, cash equivalents and restricted cash, end of period		$	118,243			$	191,160			$	118,243			$	191,160
Reconciliation of cash, cash equivalents, and restricted cash reported in the statement of financial position
Cash and cash equivalents		$	117,472			$	188,498			$	117,472			$	188,498
Restricted cash			771				2,662				771				2,662
Total cash, cash equivalents and restricted cash		$	118,243			$	191,160			$	118,243			$	191,160
Supplemental disclosure of cash flow information:
Cash received from exchange of research and development tax credits		$	—			$	50			$	131			$	374
Supplemental disclosure of noncash information:
Write-off of notes receivable		$	—			$	—			$	90			$	—
Issuance of Class A Common Stock to a service provider in exchange for the service provided in connection with the Business Combination		$	—			$	3,000			$	—			$	3,000

 

 

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