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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): May 5, 2022

Akoya Biosciences, Inc.

(Exact name of registrant as specified in its charter)


Delaware

    

001-40344

    

47-5586242

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)

100 Campus Drive, 6th Floor
Marlborough, MA

    

01752

(Address of principal executive offices)

(Zip Code)

(855) 896-8401

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K 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

    

Name of each exchange on which registered

Common stock, par value $0.00001 per share

AKYA

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 May 5, 2022, Akoya Biosciences, Inc. (the “Company”) issued a press release announcing its financial condition and results of operations for the period ended March 31, 2022. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information under Item 2.02 of this Current Report on Form 8-K, including the press release furnished as Exhibit 99.1, is being furnished, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Company’s filings, whether made before or after the date hereof, regardless of any general incorporation language in any such filing.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

    

Description of Exhibits

99.1

Press Release, dated May 5, 2022

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

2

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.

Date: May 5, 2022

Akoya Biosciences, Inc.

By:

/s/ Brian McKelligon

Brian McKelligon

Chief Executive Officer

3

Exhibit 99.1

Akoya Reports First Quarter 2022 Operating Results and Raises Full Year 2022 Revenue Guidance

May 5, 2022

Q1 2022 revenue $16.9 million, 38% growth over prior year period

Raising FY 2022 revenue guidance range to $70-73 million

MARLBOROUGH, Mass.— Akoya Biosciences, Inc. (Nasdaq: AKYA) (“Akoya”), The Spatial Biology Company®, today announced its financial results for the first quarter ending March 31, 2022.

“Akoya remains on an exciting trajectory, delivering record revenue and system placements in the first quarter,” said Brian McKelligon, Chief Executive Officer, Akoya Biosciences.  “This quarter was highlighted by the commercial launch of the PhenoCycler-Fusion System, showcasing powerful new data of our 100+ plex antibody panels and new universal chemistry capabilities at the recent AACR meeting. We continued to execute on all segments of the business and are confident in our updated full year revenue guidance.”

First Quarter 2022 Financial Highlights

Total revenue was $16.9 million in the first quarter of 2022, compared to $12.2 million in the prior year period; an increase of 38%.
Product revenue was $13.3 million in the first quarter of 2022, compared to $10.0 million in the prior year period; an increase of 34%; within product revenue, reagent revenue was $4.6 million for the quarter, versus $2.5 million in the prior year period, an increase of 82%.
Services and other revenue totaled $3.6 million in the first quarter of 2022, compared to $2.2 million in the prior year period; an increase of 58%.
Gross profit was $10.1 million in the first quarter of 2022, compared to $7.4 million in the prior year period; an increase of 36%; and gross profit margin was 60% in the first quarter of 2022.
51 instruments were sold in the first quarter of 2022; 14 PhenoCyclers, 37 PhenoImagers (which includes Fusion and HT).
Instrument installed base of 748 as of March 31, 2022; 196 PhenoCyclers, 552 PhenoImagers (of which 28 are the new Fusion instruments).
Combined-unit PhenoCycler-Fusion installed base of 23 as of March 31, 2022.

First Quarter 2022 Business Highlights

As of March 31, 2022, there have been 531 total publications featuring Akoya’s platforms; 112% growth from 251 total publications as of March 31, 2021.
Appointment of Dr. Ehab El-Gabry, M.D. as Akoya’s new Chief Medical Officer, who brings over 20 years of leadership experience in pathology and IVD development that are critical for Akoya’s vision of advancing spatial phenotyping in precision medicine and cancer care.
Showcased new data for a panel of 100+ protein markers for deep spatial phenotyping at single-cell resolution across an entire tissue sample at AACR.

Previewed the new universal chemistry to enable accelerated validation of biomarkers discovered using deep spatial phenotyping at AACR.
Launched world tour for PhenoCycler-Fusion across 29 cities in North America, Europe, and Asia-Pacific; please visit https://www.akoyabio.com/fusion-tour/ for a full list of the world tour cities and dates to experience the PhenoCycler-Fusion at a city near you.
$94 million of cash and cash equivalents as of March 31, 2022, well capitalized to deliver on our existing strategic plan.

2022 Outlook

The company, based on its updated plans and initiatives, is raising its full year 2022 revenue guidance range to $70-73 million.

Webcast and Conference Call Details

Akoya will host a conference call today, May 5, 2022, at 5:00 p.m. Eastern Time to discuss its first quarter 2022 financial results. The dial-in numbers are (833) 562-0146for domestic callers or (661) 567-1226for international callers, followed by Conference ID: 7363649. A live webcast of the conference call will be available on the “Investors” section of the Company's website at https://investors.akoyabio.com/. The webcast will be archived on the website following the completion of the call for three months.

Forward-Looking Statements

This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including expectations regarding our ability to market and sell our PhenoCycler and PhenoImager platforms and increase awareness of spatial biology technology, our research and development efforts and other matters regarding our business strategies, use of capital, results of operations and financial position and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.


About Akoya Biosciences

As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research via its key platforms: PhenoCycler™, PhenoImager™ Fusion and PhenoImager HT. To learn more about Akoya, visit www.akoyabio.com.

Investor Contact:

Priyam Shah

Akoya Biosciences, Inc.

investors@akoyabio.com

Media Contact:

Christine Quern

Akoya Biosciences, Inc.

cquern@akoyabio.com


AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

Condensed Consolidated Balance Sheets (unaudited)

(in thousands)

    

March 31, 2022

    

December 31, 2021

Assets

 

  

 

  

Current assets

Cash and cash equivalents

$

93,938

$

113,079

Accounts receivable, net

 

11,314

 

9,444

Inventories, net

 

11,373

 

9,014

Prepaid expenses and other current assets

 

9,841

 

9,277

Total current assets

 

126,466

 

140,814

Property and equipment, net

 

7,588

 

7,487

Demo inventory, net

 

2,225

 

2,548

Intangible assets, net

 

20,960

 

21,150

Goodwill

 

18,262

 

18,262

Operating lease right of use assets, net

9,937

Financing lease right of use assets, net

1,047

Other non-current assets

643

646

Total assets

$

187,128

$

190,907

Liabilities and Stockholders’ Equity

Current liabilities

Accounts payable, accrued expenses and other current assets

$

23,656

$

23,198

Current portion of operating lease liabilities

2,805

Current portion of financing lease liabilities

383

Deferred revenue

 

4,892

 

4,484

Total current liabilities

 

31,736

 

27,682

Deferred revenue, net of current portion

 

1,519

 

1,330

Long-term debt, net

 

32,576

 

32,471

Contingent consideration liability, net of current portion

 

6,755

 

7,850

Operating lease liabilities, net of current portion

7,506

Financing lease liabilities, net of current portion

448

Other long-term liabilities

 

36

 

223

Total liabilities

 

80,576

 

69,556

Total stockholders' equity

106,552

121,351

Total liabilities and stockholders' equity

$

187,128

$

190,907


AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

Consolidated Statements of Operations (unaudited)

(in thousands, except share and per share amounts)

Three months ended

March 31, 

March 31, 

    

2022

    

2021

Revenue:

 

  

 

  

Product revenue

$

13,343

$

9,963

Service and other revenue

 

3,551

 

2,249

Total revenue

 

16,894

 

12,212

Cost of goods sold:

 

  

 

  

Cost of product revenue

$

4,080

$

3,607

Cost of service and other revenue

 

2,718

 

1,200

Total cost of goods sold

$

6,798

$

4,807

Gross profit

$

10,096

$

7,405

Operating expenses:

 

  

 

  

Selling, general and administrative

 

18,193

 

8,179

Research and development

 

5,714

 

3,192

Change in fair value of contingent consideration

 

200

 

426

Depreciation and amortization

 

1,543

 

1,009

Total operating expenses

 

25,650

 

12,806

Loss from operations

 

(15,554)

 

(5,401)

Other income (expense):

 

  

 

  

Interest expense, net

 

(749)

 

(751)

Change in fair value of warrant liability

 

 

(1,870)

Other expense, net

 

(74)

 

(66)

Loss before benefit (provision) for income taxes

(16,377)

(8,088)

Benefit (provision) for income taxes

 

(22)

 

6

Net loss

$

(16,399)

$

(8,082)

Dividends accrued on redeemable convertible preferred stock

(1,190)

Accretion of redeemable convertible preferred stock

(296)

Adjusted net loss attributable to common stockholders

(16,399)

(9,568)

Net loss per share attributable to common stockholders, basic and diluted

$

(0.44)

$

(3.54)

Weighted-average shares outstanding, basic and diluted

 

37,464,496

 

2,706,133