8-K
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.

 

 


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)

 

 

 

 

 

 


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

 


EX-99.1

 

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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

Revenues for the third quarter of 2023 were $2.33 million, compared to $2.35 million in the third quarter of 2022.
Hyperfine, Inc. sold six commercial Swoop® systems in the third quarter of 2023.
Gross margin for the third quarter of 2023 was $1.12 million, resulting in a 48% gross margin, compared to $0.69 million in the third quarter of 2022.
Research and development expenses for the third quarter of 2023 were $5.74 million, compared to $7.34 million in the third quarter of 2022.
Sales, marketing, general, and administrative expenses for the third quarter of 2023 were $7.14 million, compared to $6.63 million in the third quarter of 2022.
Net loss for the third quarter of 2023 was $10.76 million, equating to a net loss of $0.15 per share, as compared to a net loss of $13.17 million, or a net loss of $0.19 per share, for the third quarter of 2022.

Nine Months Financial Results

Revenues for the nine months ended September 30, 2023 were $8.35 million, compared to $5.39 million in the nine months ended September 30, 2022.
Gross margin for the nine months ended September 30, 2023 was $3.72 million, resulting in a 45% gross margin, compared to $0.61 million in the nine months ended September 30, 2022.
Research and development expenses for the nine months ended September 30, 2023 were $16.53 million, compared to $22.94 million in the nine months ended September 30, 2022.
Sales, marketing, general, and administrative expenses for the nine months ended September 30, 2023 were $23.68 million, compared to $37.92 million in the nine months ended September 30, 2022.
Net loss for the nine months ended September 30, 2023 was $33.55 million, equating to a net loss of $0.47 per share, as compared to a net loss of $60.11 million, or a net loss of $0.85 per share, for the nine months ended September 30, 2022.

2023 Financial Guidance

Management expects revenue for the full year 2023 to be $11 to $13 million.
Management expects cash burn for the full year 2023 to be $41 to $44 million.

 

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