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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

           QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022

or

            TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________ to ___________

Commission File Number: 001-40344

Akoya Biosciences, Inc.

(Exact name of registrant as specified in its charter)

Delaware

    

47-5586242

(State or other jurisdiction of
incorporation or organization)

(I.R.S. Employer Identification No.)

100 Campus Drive, 6th Floor
Marlborough, Massachusetts

01752

(Address of principal executive offices)

(Zip Code)

(855) 896-8401

Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.00001 per share

AKYA

Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes      No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes     No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer 

Accelerated filer 

Non-accelerated filer  

Smaller reporting company 

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.   

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes     No 

Number of shares of the registrant’s common shares outstanding at October 28, 2022: 37,955,857

AKOYA BIOSCIENCES, INC.

TABLE OF CONTENTS

Page

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Consolidated Balance Sheets at September 30, 2022 (Unaudited) and December 31, 2021

2

Consolidated Statements of Operations (Unaudited) for the Three and Nine Months Ended September 30, 2022 and 2021

3

Consolidated Statements of Comprehensive Loss (Unaudited) for the Three and Nine Months Ended September 30, 2022 and 2021

4

Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) (Unaudited) for the Three and Nine Months Ended September 30, 2022 and 2021

5

Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2022 and 2021

7

Notes to Consolidated Financial Statements (Unaudited)

8

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

29

Item 3. Quantitative and Qualitative Disclosures About Market Risk

45

Item 4. Controls and Procedures

45

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

45

Item 1A. Risk Factors

45

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

46

Item 3. Defaults Upon Senior Securities

46

Item 4. Mine Safety Disclosures

46

Item 5. Other Information

46

Item 6. Exhibits

48

Signatures

49

Akoya Biosciences, Inc.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This report 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 report other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, 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 this report and in other documents we file with the Securities and Exchange Commission (the “SEC”) 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 report represent our views as of the date of this report. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

Unless otherwise stated or the context otherwise indicates, references to “we,” “us,” “our” and similar references refer to Akoya Biosciences, Inc. and its consolidated subsidiary.

1

AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

    

September 30, 2022

    

December 31, 2021

(unaudited)

Assets

 

  

 

  

Current assets

 

  

 

  

Cash and cash equivalents

$

51,836

$

113,079

Marketable securities

29,868

Accounts receivable, net

 

8,680

 

9,444

Inventories, net

 

13,063

 

9,014

Prepaid expenses and other current assets

 

8,297

 

9,277

Total current assets

 

111,744

 

140,814

Property and equipment, net

 

10,492

 

7,487

Restricted cash

 

302

 

302

Demo inventory, net

 

2,064

 

2,548

Intangible assets, net

 

20,442

 

21,150

Goodwill

 

18,262

 

18,262

Operating lease right of use assets, net

11,307

Financing lease right of use assets, net

1,504

Other assets

 

340

 

344

Total assets

$

176,457

$

190,907

Liabilities and Stockholders’ Equity

 

  

 

  

Current liabilities

 

  

 

  

Accounts payable

$

8,172

$

9,435

Accrued expenses and other current liabilities

 

14,037

 

13,491

Current portion of operating lease liabilities

3,004

Current portion of financing lease liabilities

593

Current portion of capital lease liabilities

 

 

272

Deferred revenue

 

5,876

 

4,484

Total current liabilities

 

31,682

 

27,682

Deferred revenue, net of current portion

 

1,477

 

1,330

Long-term debt, net of debt discount

 

52,714

 

32,471

Deferred tax liability, net

 

125

 

26

Capital lease liabilities, net of current portion

 

 

197

Operating lease liabilities, net of current portion

8,723

Financing lease liabilities, net of current portion

692

Contingent consideration liability (Note 4), net of current portion

 

5,956

 

7,850

Total liabilities

 

101,369

 

69,556

Stockholders’ equity:

 

  

 

  

Preferred Stock, $0.00001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2022 and December 31, 2021

Common Stock, $0.00001 par value; 500,000,000 shares authorized at September 30, 2022 and December 31, 2021; 37,947,853 and 37,424,101 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

2

 

2

Additional paid in capital

 

223,025

 

217,456

Accumulated deficit

 

(147,873)

 

(96,107)

Other comprehensive loss

(66)

Total stockholders’ equity

 

75,088

 

121,351

Total liabilities and stockholders’ equity

$

176,457

$

190,907

See accompanying notes to consolidated financial statements.

2

AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

(in thousands except share & per share data)

Three months ended

Nine months ended

September 30, 

September 30, 

September 30, 

September 30, 

    

2022

    

2021

    

2022

    

2021

Revenue:

 

  

 

  

  

 

  

Product revenue

$

14,438

$

10,874

$

41,942

$

31,556

Service and other revenue

 

4,414

 

2,602

 

11,698

 

7,203

Total revenue

 

18,852

 

13,476

 

53,640

 

38,759

Cost of goods sold:

 

Cost of product revenue

$

5,455

$

3,594

$

14,733

$

10,381

Cost of service and other revenue

 

2,490

 

1,429

 

7,563

 

4,386

Total cost of goods sold

$

7,945

$

5,023

$

22,296

$

14,767

Gross profit

$

10,907

$

8,453

$

31,344

$

23,992

Operating expenses:

 

Selling, general and administrative

 

19,922

 

13,725

 

58,705

 

31,970

Research and development

 

5,466

 

3,999

 

16,778

 

10,138

Change in fair value of contingent consideration

 

357

 

224

 

(599)

 

1,050

Depreciation and amortization

 

1,815

 

1,244

 

4,975

 

3,352

Total operating expenses

 

27,560

 

19,192

 

79,859

 

46,510

Loss from operations

 

(16,653)

 

(10,739)

 

(48,515)

 

(22,518)

Other income (expense):

 

 

  

 

 

Interest expense

 

(1,109)

 

(763)

 

(2,707)

 

(2,271)

Change in fair value of warrant liability

 

 

 

 

(2,728)

Gain on extinguishment of debt

2,476

Other expense, net

 

(89)

 

(126)

 

(395)

 

(244)

Loss before benefit (provision) for income taxes

(17,851)

(11,628)

(51,617)

(25,285)

Benefit (provision) for income taxes

 

(21)

 

11

 

(149)

 

23

Net loss

$

(17,872)

$

(11,617)

$

(51,766)

$

(25,262)

Dividends accrued on redeemable convertible preferred stock

(1,435)

Accretion of redeemable convertible preferred stock

(296)

Adjusted net loss attributable to common stockholders

(17,872)

(11,617)

(51,766)

(26,993)

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

$

(0.47)

$

(0.31)

$

(1.37)

$

(1.15)

Weighted-average shares outstanding, basic and diluted

 

37,900,821

 

37,162,489

 

37,660,814

 

23,407,358

See accompanying notes to consolidated financial statements.

3

AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)

(in thousands)

Three months ended

Nine months ended

September 30, 

September 30, 

September 30, 

September 30, 

    

2022

    

2021

    

2022

    

2021

Net loss

$

(17,872)

$

(11,617)

$

(51,766)

$

(25,262)

Other comprehensive loss:

 

  

 

  

 

  

 

  

Unrealized gain (loss) on marketable securities

 

26

 

 

(66)

 

Total other comprehensive income (loss)

 

26

 

 

(66)

 

Comprehensive loss

$

(17,846)

$

(11,617)

$

(51,832)

$

(25,262)

See accompanying notes to consolidated financial statements.

4

AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED

STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (Unaudited)

(in thousands, except share data)

Series B

Series C

Series D

Redeemable

Redeemable

Redeemable

Series A

Convertible

Convertible

Convertible

Convertible

Class A

Class B

Additional

Accumulated

Total

Preferred Stock

Preferred Stock

Preferred Stock

Preferred Stock

Common Stock

Common Stock

Paid in

Accumulated

other comprehensive

Stockholders’

    

Shares

    

Amount

    

Shares

    

Amount

    

Shares

    

Amount

  

  

Shares

    

Amount

    

Shares

    

Amount

    

Shares

    

Amount

    

Capital

    

Deficit

    

loss

    

equity (deficit)

Balance at December 31, 2021

 

$

 

$

 

$

 

$

 

37,424,101

$

2

 

$

 

$

217,456

$

(96,107)

$

$

121,351

Exercise of stock options

 

 

 

 

 

 

 

 

 

78,257

 

 

 

55

55

Net loss

(16,399)

(16,399)

Stock-based compensation

1,545

1,545

Balance at March 31, 2022

$

$

$

$

37,502,358

$

2

$

$

219,056

$

(112,506)

$

$

106,552

Exercise of stock options

 

 

 

 

 

 

 

 

 

264,297

 

 

 

 

 

164

 

 

 

164

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(17,495)

 

 

(17,495)

Other comprehensive loss

(92)

(92)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,721

 

 

 

1,721

Balance at June 30, 2022

 

$

 

$

 

$

 

$

 

37,766,655

$

2

 

$

 

$

220,941

$

(130,001)

$

(92)

$

90,850

Exercise of stock options

63,102

40

40

Exercise of stock warrant

118,096

Net loss

(17,872)

(17,872)

Other comprehensive income

26

26

Stock-based compensation

2,044

2,044

Balance at September 30, 2022

 

$

 

$

 

$

 

$

 

37,947,853

$

2

 

$

 

$

223,025

$

(147,873)

$

(66)

$

75,088

See accompanying notes to consolidated financial statements.

5

AKOYA BIOSCIENCES, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED

STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (Unaudited)

(in thousands, except share data)

Series B

Series C

Series D

Redeemable

Redeemable

Redeemable

Series A

Convertible

Convertible

Convertible

Convertible

Class A

Class B

Additional

Total

Preferred Stock

Preferred Stock

Preferred Stock

Preferred Stock

Common Stock

Common Stock

Paid in

Accumulated

Stockholders’

    

Shares

    

Amount

    

Shares

    

Amount

    

Shares

    

Amount

  

  

Shares

    

Amount

    

Shares

    

Amount

    

Shares

    

Amount

    

Capital

    

Deficit

    

equity (deficit)

Balance at December 31, 2020

 

13,715,330

$

11,500

 

26,732,361

$

30,107

 

16,390,217

$

27,500

 

5,013,333

$

1,253

 

$

 

2,563,765

$

1

 

$

$

(52,280)

$

(51,026)

Exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

271,334

 

 

 

44

 

 

44

Accrued dividends

 

 

180

 

 

510

 

 

500

 

 

 

 

 

 

 

 

(298)

 

(892)

 

(1,190)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,082)

 

(8,082)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

254

 

 

254

Balance at March 31, 2021

13,715,330

$

11,680

26,732,361

$

30,617

16,390,217

$

28,000

5,013,333

$

1,253

$

2,835,099

$

1

$

$

(61,254)

$

(60,000)

Conversion of Class B shares

2,835,099

1

(2,835,099)

(1)

Exercise of stock options

189,175

99

99

Accrued dividends

37

105

103