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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): November 8, 2023

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 November 8, 2023, Akoya Biosciences, Inc. (the “Company”) issued a press release announcing its financial condition and results of operations for the period ended September 30, 2023. 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 November 8, 2023

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: November 8, 2023

Akoya Biosciences, Inc.

By:

/s/ Brian McKelligon

Brian McKelligon

Chief Executive Officer

3

Exhibit 99.1

Akoya Reports Record Revenue in the Third Quarter of 2023 and Reiterates Full Year 2023 Revenue Guidance

November 8, 2023

Q3 2023 revenue $25.2 million, 34% y/y growth

Reiterating FY 2023 revenue guidance range of $95-98 million

MARLBOROUGH, Mass.— Akoya Biosciences, Inc. (Nasdaq: AKYA) (“Akoya”), The Spatial Biology Company®, today announced its financial results for the third quarter ending September 30, 2023.

"Akoya delivered strong financial performance in the third quarter with another record revenue quarter while maintaining operating expenses at a steady or reduced level, solidifying the path towards achieving positive cash flow," explained Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "We are executing on our plan to improve workflow throughput, with the ongoing 2.0 instrument field upgrades across the industry's largest installed base and by expanding our menu of ready-to-use panels. Akoya is strategically positioned to scale spatial biology by setting the standard in the industry."

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Third Quarter 2023 Financial Highlights

Total revenue was $25.2 million in the third quarter of 2023, compared to $18.9 million in the prior year period; an increase of 34%.
Product revenue (which includes instruments, reagents, and software) was $18.0 million in the third quarter of 2023, compared to $14.4 million in the prior year period; an increase of 25%.
oInstrument revenue was $12.0 million, compared to $9.5 million in the prior year period; an increase of 27%.
oReagent revenue was $5.7 million, compared to $4.7 million in the prior year period; an increase of 21%.
Service and other revenue totaled $7.2 million in the third quarter of 2023, compared to $4.4 million in the prior year period; an increase of 62%.
Gross profit was $15.3 million in the third quarter of 2023, compared to $10.9 million in the prior year period; an increase of 40%.
oGross profit margin was 60.6% in the third quarter of 2023, compared to 57.9% in the prior year period.
$78.6 million of cash and cash equivalents as of September 30, 2023, with $11.3 million in additional debt capacity.

Third Quarter 2023 Business Highlights

69 instruments were sold in the third quarter of 2023: 27 PhenoCyclers, 42 PhenoImagers (which includes Fusion and HT), compared to 55 instruments sold in the prior year period (17 PhenoCyclers, 38 PhenoImagers).
Instrument installed base of 1,132 as of September 30, 2023 (327 PhenoCyclers, 805 PhenoImagers), compared to an installed base of 863 in the prior year period (229 PhenoCyclers, 634 PhenoImagers); an increase of 31%.
oCombined-unit PhenoCycler-Fusion installed base of 186 as of September 30, 2023, compared to 72 in the prior year period.

1,070 total publications citing Akoya’s technology as of September 30, 2023, compared to 691 total publications in the prior year period: an increase of 55%.
The University of Queensland and Akoya Biosciences have comprehensively mapped the spatial proteome of head and neck squamous cell carcinoma (HNSCC) using ultrahigh-plex phenotyping (100+ protein biomarkers) on the PhenoCycler-Fusion, as published in an article in the inaugural issue of GEN Biotechnology.
Ongoing Fusion 2.0 and HT 2.0 field upgrades with rolling launch of new ready-to-use PhenoCode Panels.
oShowcased Akoya’s new 2.0 solutions, data, and applications at the 2023 Society for Immunotherapy of Cancer (SITC) conference held November 1-5 in San Diego, CA.

YTD 2023 Financial and Business Highlights

Total revenue was $70.1 million YTD as of September 30, 2023, compared to $53.6 million in the prior year period; an increase of 31%.
Product revenue was $50.7 million YTD as of September 30, 2023, compared to $41.9 million in the prior year period; an increase of 21%.
Services and other revenue totaled $19.4 million YTD as of September 30, 2023, compared to $11.7 million in the prior year period; an increase of 66%.
Gross profit was $39.7 million YTD as of September 30, 2023, compared to $31.3 million in the prior year period and gross profit margin was 56.6% YTD as of September 30, 2023, compared to 58.4% in the prior year period.
198 instruments were sold YTD as of September 30, 2023; 73 PhenoCyclers, 125 PhenoImagers, compared to 166 instruments sold in the prior year period; an increase of 19%.

2023 Financial Outlook

The Company, based on its current plans and initiatives, continues to expect full year 2023 revenue in the range of $95-98 million.

Webcast and Conference Call Details

Akoya will host a conference call today, November 8, 2023, at 5:00 p.m. Eastern Time to discuss its third quarter 2023 financial results. Investors interested in listening to the conference call are required to register online. 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 our other products and services, our ability to increase awareness of spatial biology technology, our ability to execute on our plans and expectations, our research and development efforts and other matters regarding our business strategies, future performance, 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: PhenoCode™ Panels and PhenoCycler®, PhenoImager® Fusion and PhenoImager HT Instruments. To learn more about Akoya, visit www.akoyabio.com.

Investor Contact:

Priyam Shah

Sr. Director, Investor Relations

Akoya Biosciences

investors@akoyabio.com

Media Contact:

Christine Quern

617-650-8497

media@akoyabio.com

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AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

Condensed Consolidated Balance Sheets (unaudited)

(in thousands)

    

September 30, 2023

    

December 31, 2022

Assets

 

  

 

  

Current assets

Cash and cash equivalents

$

78,595

$

74,229

Marketable securities

6,989

Accounts receivable, net

 

16,096

 

9,729

Inventories, net

 

18,752

 

14,486

Prepaid expenses and other current assets

 

3,505

 

6,764

Total current assets

 

116,948

 

112,197

Property and equipment, net

 

10,843

 

10,174

Demo inventory, net

 

1,305

 

2,084

Intangible assets, net

 

18,123

 

20,048

Goodwill

 

18,262

 

18,262

Operating lease right of use assets, net

9,003

10,785

Financing lease right of use assets, net

1,776

1,490

Other non-current assets

984

991

Total assets

$

177,244

$

176,031

Liabilities and Stockholders’ Equity

Current liabilities

Accounts payable, accrued expenses and other current liabilities

$

25,084

$

27,147

Current portion of operating lease liabilities

2,790

3,009

Current portion of financing lease liabilities

799

620

Deferred revenue

 

6,850

 

6,279

Total current liabilities

 

35,523

 

37,055

Deferred revenue, net of current portion

 

2,782

 

2,114

Long-term debt, net

 

63,818

 

63,277

Contingent consideration liability, net of current portion

 

5,255

 

6,039

Operating lease liabilities, net of current portion

6,752

8,203

Financing lease liabilities, net of current portion

914

675

Other long-term liabilities

 

227

 

87

Total liabilities

 

115,271

 

117,450

Total stockholders' equity

61,973

58,581

Total liabilities and stockholders' equity

$

177,244

$

176,031


AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

Consolidated Statements of Operations (unaudited)

(in thousands, except share and per share amounts)

Three months ended

Nine months ended

September 30, 

September 30, 

September 30, 

September 30, 

    

2023

    

2022

    

2023

    

2022

Revenue:

 

  

 

  

 

  

 

  

Product revenue

$

18,048

$

14,438

$

50,719

$

41,942

Service and other revenue

 

7,167

 

4,414

 

19,427

 

11,698

Total revenue

 

25,215

 

18,852

 

70,146

 

53,640

Cost of goods sold:

 

  

 

  

 

  

 

  

Cost of product revenue

6,208

5,455

19,747

14,733

Cost of service and other revenue

3,731

2,490

10,714

7,563

Total cost of goods sold

9,939

7,945

30,461

22,296

Gross profit

15,276

10,907

39,685

31,344

Operating expenses:

 

  

 

  

 

  

 

  

Selling, general and administrative

 

19,017

 

19,922

 

63,483

 

58,705

Research and development

 

5,173

 

5,466

 

17,219

 

16,778

Change in fair value of contingent consideration

 

262

 

357

 

1,019

 

(599)

Depreciation and amortization

 

2,375

 

1,815

 

6,193

 

4,975

Total operating expenses

 

26,827

 

27,560

 

87,914

 

79,859

Loss from operations

 

(11,551)

 

(16,653)

 

(48,229)

 

(48,515)

Other income (expense):

 

  

 

  

 

  

 

  

Interest expense

 

(2,239)

 

(1,109)

 

(6,468)

 

(2,707)

Interest income

1,074

136

2,576

212

Other expense, net

 

(185)

 

(225)

 

(338)

 

(607)

Loss before provision for income taxes

(12,901)

(17,851)

(52,459)

(51,617)

Provision for income taxes

 

(15)

 

(21)

 

(62)

 

(149)

Net loss

$

(12,916)

$

(17,872)

$

(52,521)

$

(51,766)

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

$

(0.26)

$

(0.47)

$

(1.23)

$

(1.37)

Weighted-average shares outstanding, basic and diluted

 

48,975,432

 

37,900,821

 

42,686,065

 

37,660,814