Form 8-K - Current report

0001833769false00018337692024-05-132024-05-13

 

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): May 13, 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: [phone]

 

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 May 13, 2024, Hyperfine, Inc. issued a press release announcing its results for the first quarter ended March 31, 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 May 13, 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:	May 13, 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 First Quarter 2024 Financial Results

 

GUILFORD, Connecticut, May 13, 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 first quarter 2024 financial results and provided a business update.

“We have kicked off 2024 strong. I am pleased with our commercial progress shown by sales across US and international accounts, as well as the important milestones we hit in Q1 by commencing CARE PMR study enrollment in Alzheimer’s and launching our 8th generation AI-powered software,” said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. “Commercialization, Clinical Evidence, and Innovation remain our three value drivers. In Q1, we demonstrated that our team is capable of delivering on all three and doing so with strong spending discipline.”

 

Recent Achievements and Business Highlights

•

Initiated enrollment of CARE PMR (Capturing ARIA Risk Equitably with Portable MR) study assessing the clinical utility of the Swoop® System to scan Alzheimer’s patients receiving amyloid-targeting therapy to detect ARIA.

•

Exceeded 100 patients enrolled to date in ACTION PMR (ACuTe Ischemic strOke detectioN with Portable MR), an observational study assessing the use of portable brain imaging to identify strokes and salvageable brain tissue.

•

Launched 8th generation AI-powered brain imaging software for enhanced image quality and ease-of-use.

•

Appointed distributors in key EU markets to support expansion of commercial activity to international markets.

•

Portable Swoop Brain MR accepted and featured prominently in key conferences with four abstracts at International Stroke Conference and 17 at International Society for Magnetic Resonance Medicine.

First Quarter 2024 Financial Results

•

Revenues for the first quarter of 2024 were $3.30 million, up 25%, compared to $2.64 million in the first quarter of 2023.

•

Hyperfine, Inc. sold 13 commercial Swoop® systems in the first quarter of 2024.

•

Gross margin for the first quarter of 2024 was $1.35 million, compared to $1.16 million in the first quarter of 2023.

•

Research and development expenses for the first quarter of 2024 were $5.57 million, compared to $5.46 million in the first quarter of 2023.

•

Sales, marketing, general, and administrative expenses for the first quarter of 2024 were $6.43 million, compared to $8.73 million in the first quarter of 2023.

•

Net loss for the first quarter of 2024 was $9.85 million, equating to a net loss of $0.14 per share, as compared to a net loss of $12.16 million, or a net loss of $0.17 per share, for the first quarter of 2023.

2024 Financial Guidance

•

Management expects revenue for the full year 2024 to be $12 to $15 million.

•

Management expects cash burn for the full year 2024 to be approximately $40 million.

 

Conference Call

Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Monday, May 13, 2024, to discuss its first 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/.

 

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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, the Company’s stroke observational clinical study and 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 CARE PMR 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 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
[e-mail]

 

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HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)

		March 31, 2024				December 31, 2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	63,204			$	75,183
Restricted cash			—				621
Accounts receivable, less allowance of $248 and $321 as of March 31, 2024 and December 31, 2023, respectively			5,343				3,189
Unbilled receivables			895				942
Inventory			7,298				6,582
Prepaid expenses and other current assets			2,950				2,391
Total current assets			79,690				88,908
Property and equipment, net			3,706				2,999
Other long term assets			2,047				2,292
Total assets		$	85,443			$	94,199
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable		$	2,532			$	1,214
Deferred grant funding			—				621
Deferred revenue			1,527				1,453
Due to related parties			45				61
Accrued expenses and other current liabilities			4,663				5,419
Total current liabilities			8,767				8,768
Long term deferred revenue			1,021				968
Other noncurrent liabilities			17				64
Total liabilities			9,805				9,800
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Class A Common stock, $.0001 par value; 600,000,000 shares authorized; 56,952,666 and 56,840,949 shares issued and outstanding at March 31, 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 March 31, 2024 and December 31, 2023, respectively			2				2
Additional paid-in capital			339,201				338,114
Accumulated deficit			(263,570	)			(253,722	)
Total stockholders' equity			75,638				84,399
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$	85,443			$	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 March 31,
		2024				2023
Sales
Device		$	2,704			$	2,132
Service			591				503
Total sales			3,295				2,635
Cost of sales
Device			1,499				1,071
Service			442				409
Total cost of sales			1,941				1,480
Gross margin			1,354				1,155
Operating Expenses:
Research and development			5,570				5,461
General and administrative			4,430				6,182
Sales and marketing			2,004				2,547
Total operating expenses			12,004				14,190
Loss from operations			(10,650	)			(13,035	)
Interest income			796				869
Other income, net			6				6
Loss before provision for income taxes			(9,848	)			(12,160	)
Provision for income taxes			—				—
Net loss and comprehensive loss		$	(9,848	)		$	(12,160	)
Net loss per common share attributable to common stockholders, basic and diluted		$	(0.14	)		$	(0.17	)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted			71,934,045				70,864,226

 

 

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HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

(in thousands)

(Unaudited)

 

		Three Months Ended March 31,
		2024				2023
Cash flows from operating activities:
Net loss		$	(9,848	)		$	(12,160	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation			263				254
Stock-based compensation expense			1,032				1,126
Payments received on net investment in lease			34				2
Changes in assets and liabilities:
Accounts receivable, net			(2,154	)			(915	)
Unbilled receivables			47				(259	)
Inventory			(833	)			(1,122	)
Prepaid expenses and other current assets			(1,252	)			272
Due from related parties			—				48
Prepaid inventory			693				281
Other long term assets			200				(18	)
Accounts payable			1,208				954
Deferred grant funding			(621	)			(58	)
Deferred revenue			127				(125	)
Due to related parties			(16	)			64
Accrued expenses and other current liabilities			(1,392	)			(1,835	)
Operating lease liabilities, net			2				—
Net cash used in operating activities			(12,510	)			(13,491	)
Cash flows from investing activities:
Purchases of property and equipment			(145	)			(61	)
Net cash used in investing activities			(145	)			(61	)
Cash flows from financing activities:
Proceeds from exercise of stock options			55				49
Net cash provided by financing activities			55				49
Net decrease in cash and cash equivalents and restricted cash			(12,600	)			(13,503	)
Cash, cash equivalents and restricted cash, beginning of period			75,804				118,243
Cash, cash equivalents and restricted cash, end of period			63,204				104,740
Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets
Cash and cash equivalents			63,204				104,027
Restricted cash			—				713
Total cash, cash equivalents and restricted cash		$	63,204			$	104,740
Supplemental disclosure of noncash information:
Unpaid purchase of property and equipment		$	742			$	36

 

 

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Document And Entity Information	May 13, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 13, 2024
Entity Registrant Name	Hyperfine, Inc.
Entity Central Index Key	0001833769
Entity Emerging Growth Company	true
Entity File Number	001-39949
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	98-1569027
Entity Address, Address Line One	351 New Whitfield Street
Entity Address, City or Town	Guilford
Entity Address, State or Province	CT
Entity Address, Postal Zip Code	06437
City Area Code	(866)
Local Phone Number	796-6767
Entity Information, Former Legal or Registered Name	N/A
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Class A common stock, $0.0001 par value per share
Trading Symbol	HYPR
Security Exchange Name	NASDAQ

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