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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 13, 2024

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 13, 2024, Akoya Biosciences, Inc. (the “Company”) issued a press release announcing its financial condition and results of operations for the period ended March 31, 2024. 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 13, 2024

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 13, 2024

Akoya Biosciences, Inc.

By:

/s/ Brian McKelligon

Brian McKelligon

Chief Executive Officer

3

Exhibit 99.1

Akoya Biosciences Reports First Quarter 2024 Financial Results

May 13, 2024

MARLBOROUGH, Mass.— Akoya Biosciences, Inc. (Nasdaq: AKYA) (“Akoya”), The Spatial Biology Company®, today announced its financial results for the first quarter ending March 31, 2024.

Business Highlights

Revenue was $18.4 million in the first quarter of 2024, compared to $21.4 million in the prior year period; a decrease of 14%. Reagents and services revenue continued to increase.
Akoya announced the establishment of a new Manufacturing Center of Excellence in Marlborough, Massachusetts to scale internal reagent manufacturing to meet the accelerating demand for reagents.
Akoya’s partner Acrivon Therapeutics presented initial positive Phase 2b clinical data for the ACR-368 therapeutic in patients positive for the ACR-368 OncoSignature Assay in ovarian and endometrial cancer, deployed on the PhenoImager HT platform.
Akoya and NeraCare, a leading developer of laboratory tests for the prognosis of melanoma patients, announced an exclusive partnership to enable personalized therapy selection for early-stage melanoma patients at high risk of relapse and death.
Akoya and Shanghai KR Pharmtech announced that the KR-HT5 instrument, based on the PhenoImager HT, has received premarket approval from China’s National Medical Products Administration (NMPA).

“While we made meaningful progress in advancing both our operational and clinical objectives, our first quarter results fell short of expectations due to three main factors. First, systemic pressure on capital expenditures persisted. Second, certain pharmaceutical partner lab services revenue were deferred to the second half of 2024 due to revised clinical trial milestones. Third, the completion and launch of our fully operational Manufacturing Center of Excellence temporarily impacted reagent fulfillment times, delaying instrument purchases,” said Brian McKelligon, CEO of Akoya Biosciences. “With the industry’s leading installed base, normalization of pharmaceutical partner revenue in the second half of 2024, and now resolved reagent availability issues, we believe that our foundational initiatives will lead us back to strong top-line growth and achievement of our profitability objectives.”

First Quarter 2024 Financial Results

Revenue was $18.4 million in the first quarter of 2024, compared to $21.4 million in the prior year period; a decrease of 14%. Reagents and services revenue continued to increase.
For the first quarter of 2024, reported gross margin was 46% while non-GAAP adjusted gross margin was 57% when excluding the write off from discontinued legacy instruments. Both GAAP and non-GAAP adjusted gross margin were 57% for the first quarter of 2023.
For the first quarter of 2024, operating expenses were $30.0 million and non-GAAP operating expenses were $25.6 million when excluding an impairment charge for facility consolidation and restructuring associated with a reduction in force in January. Both GAAP and non-GAAP operating expenses were $29.7 million for the first quarter of 2023.

For the first quarter of 2024, loss from operations was $21.6 million and non-GAAP loss from operations was $15.2 million, excluding the items noted above. Both GAAP and non-GAAP loss from operations were $17.4 million for the first quarter of 2023.
Ended the quarter with an instrument installed base of 1,213 (354 PhenoCyclers, 859 PhenoImagers), a year-over-year increase of 22% compared to an installed base of 992 in the prior year period (273 PhenoCyclers, 719 PhenoImagers).
1,307 total publications citing Akoya’s technology as of March 31, 2024, compared to 860 total publications in the prior year period: an increase of 52%.
$61.6 million of cash, cash equivalents and marketable securities as of March 31, 2024.

2024 Financial Outlook

Akoya is updating its revenue outlook for the full year 2024 while maintaining its commitment to achieving operating cash flow breakeven by year end. The Company now expects full year 2024 revenue to be in the range of $104.0-$112.0 million.

Webcast and Conference Call Details

Akoya will host a conference call today, May 13, 2024, at 5:00 p.m. Eastern Time to discuss its first quarter 2024 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.

Non-GAAP Financial Measures

In addition to reporting financial measures in accordance with generally accepted accounting principles (“GAAP”), Akoya is including in this press release “non-GAAP adjusted gross profit,” “non-GAAP adjusted gross margin,” “non-GAAP operating expense,” and “non-GAAP loss from operations,” all of which are non-GAAP financial measures. Akoya defines non-GAAP adjusted gross profit as gross profit margin adjusted for certain excess and obsolete inventory charges. Non-GAAP adjusted gross margin is defined as non-GAAP adjusted gross profit divided by total revenue. Akoya defines non-GAAP operating expense as operating expense adjusted for impairment and restructuring charges. Akoya defines non-GAAP loss from operations as loss from operations adjusted for certain excess and obsolete inventory charges, impairment, and restructuring charges.

Akoya includes these non-GAAP financial measures because it believes they allow investors to understand and evaluate the Company’s core operating performance and trends. In particular, the exclusion of certain items in calculating non-GAAP adjusted gross profit, non-GAAP adjusted gross margin, non-GAAP operating expense, and non-GAAP loss from operations can provide useful measures for period-to-period comparisons of the Company’s core business. These non-GAAP financial measures have limitations as analytical tools, including the fact that such non-GAAP financial measures may not be comparable to similarly titled measures presented by other companies because other companies may calculate non-GAAP adjusted gross profit, non-GAAP adjusted gross margin, non-GAAP operating expense, and non-GAAP loss from operations differently than Akoya does. For more information regarding these non-GAAP financial measures, see the tables included at the end of this press release.


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 statements regarding our expectations for full year 2024 revenue, our growth prospects, our ability to achieve operating cash flow breakeven, projected timing for achieving operating cash flow breakeven, our expectations regarding our ability to market, sell and meet demand for our products and services, our expectations regarding our current and potential partnerships and collaborations, and other statements regarding our business strategies, use of capital, results of operations, financial and operational performance 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

investors@akoyabio.com

Media Contact:

Christine Quern

media@akoyabio.com

Bottom of Form

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AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

Condensed Consolidated Balance Sheets (unaudited)

(in thousands)

    

March 31, 2024

    

December 31, 2023

Assets

 

  

 

  

Current assets

Cash and cash equivalents

$

13,039

$

83,125

Marketable securities

48,536

Accounts receivable, net

 

13,473

 

16,994

Inventories, net

 

22,988

 

17,877

Prepaid expenses and other current assets

 

3,793

 

3,794

Total current assets

 

101,829

 

121,790

Property and equipment, net

 

8,964

 

10,729

Demo inventory, net

 

726

 

893

Intangible assets, net

 

16,699

 

17,412

Goodwill

 

18,262

 

18,262

Operating lease right of use assets, net

5,568

8,365

Financing lease right of use assets, net

1,348

1,562

Other non-current assets

1,354

1,356

Total assets

$

154,750

$

180,369

Liabilities and Stockholders’ Equity

Current liabilities

Accounts payable, accrued expenses and other current liabilities

$

23,209

$

25,209

Current portion of operating lease liabilities

2,654

2,681

Current portion of financing lease liabilities

718

767

Deferred revenue

 

6,612

 

6,688

Total current liabilities

 

33,193

 

35,345

Deferred revenue, net of current portion

 

2,928

 

3,193

Long-term debt, net

 

75,469

 

75,254

Contingent consideration liability, net of current portion

 

4,015

 

5,765

Operating lease liabilities, net of current portion

5,713

6,238

Financing lease liabilities, net of current portion

634

766

Other long-term liabilities

 

75

 

38

Total liabilities

 

122,027

 

126,599

Total stockholders' equity

32,723

53,770

Total liabilities and stockholders' equity

$

154,750

$

180,369


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, 

    

2024

    

2023

    

Revenue:

 

  

 

  

 

Product revenue

$

12,140

$

15,524

Service and other revenue

 

6,210

 

5,886

Total revenue

 

18,350

 

21,410

Cost of goods sold:

 

  

 

  

Cost of product revenue

6,723

5,751

Cost of service and other revenue

3,248

3,366

Total cost of goods sold

9,971

9,117

Gross profit

8,379

12,293

Operating expenses:

 

  

 

  

Selling, general and administrative

 

19,863

 

23,124

Research and development

 

5,554

 

6,378

Change in fair value of contingent consideration

 

179

 

227

Impairment

2,971

Restructuring

 

1,397

 

Total operating expenses

 

29,964

 

29,729

Loss from operations

 

(21,585)

 

(17,436)

Other income (expense):

 

  

 

  

Interest expense

 

(2,612)

 

(2,054)

Interest income

937

765

Other expense, net

 

(161)

 

(48)

Loss before provision for income taxes

(23,421)

(18,773)

Provision for income taxes

 

(63)

 

(29)

Net loss

$

(23,484)

$

(18,802)

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

$

(0.48)

$

(0.49)

Weighted-average shares outstanding, basic and diluted

 

49,188,170

 

38,326,024


AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

Gross Profit to Non-GAAP Adjusted Gross Profit Reconciliation and Calculation of Gross Margin and Non-GAAP Adjusted Gross Margin (unaudited)

(in thousands)

Three months ended

March 31, 

March 31, 

    

2024

    

2023

Total revenue

$

18,350

$

21,410

Gross profit

8,379

12,293

Provision for excess and obsolete inventories - product discontinuation and lease exit inventory charges

2,045

Non-GAAP adjusted gross profit

$

10,424

$

12,293

Gross margin

46%

57%

Non-GAAP adjusted gross margin

57%

57%


AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

Operating Expense to Non-GAAP Operating Expense Reconciliation (unaudited)

(in thousands)

Three months ended

March 31, 

March 31, 

    

2024

    

2023

Operating expenses

$

29,964

$

29,729

Impairment

(2,971)

Restructuring

(1,397)

Non-GAAP operating expenses

$

25,596

$

29,729


AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

Loss From Operations to Non-GAAP Loss From Operations Reconciliation (unaudited)

(in thousands)

Three months ended

March 31, 

March 31, 

    

2024

    

2023

Loss from operations

$

(21,585)

$

(17,436)

Provision for excess and obsolete inventories - product discontinuation and lease exit inventory charges

2,045

Impairment

2,971

Restructuring

1,397

Non-GAAP loss from operations

$

(15,172)

$

(17,436)


v3.24.1.1.u2
Document and Entity Information
May 13, 2024
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date May 13, 2024
Entity File Number 001-40344
Entity Registrant Name Akoya Biosciences, Inc.
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 47-5586242
Entity Address, Address Line One 100 Campus Drive
Entity Address, Adress Line Two 6th Floor
Entity Address, City or Town Marlborough
Entity Address, State or Province MA
Entity Address, Postal Zip Code 01752
City Area Code 855
Local Phone Number 896-8401
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock, par value $0.00001 per share
Trading Symbol AKYA
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
Entity Central Index Key 0001711933
Amendment Flag false

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