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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

____________

Form 10-Q

[ X ]

x  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2017

March 31, 2021

or

[ ]

o 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: 001-36426

____________

AquaBounty Technologies, Inc.

(Exact name of the registrant as specified in its charter)

Delaware

04-3156167

Delaware04-3156167

(State or other jurisdiction of


incorporation or organization)

(I.R.S. Employer


Identification No.)

2 Mill & Main Place, Suite 395

Maynard, Massachusetts 01754

(978) 648-6000

(Address and telephone number of the registrant’s principal executive offices)

Title of each class

Trading Symbol(s)

Name of exchange on which registered

Common Stock, par value $0.001 per share

AQB

The NASDAQ Stock Market LLC

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 (the “Exchange Act”) 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  þx    No  

o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files).

Yes  þx    No  

o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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

o

Accelerated filer

o

Non-accelerated filerþ

x

Smaller reporting company

x

Emerging growth companyþ

x

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 Exchange Act).

Yes  ¨    No  þ

x

At November 2, 2017,May 3, 2021, the registrant had 8,895,094 71,022,426 shares of common stock, par value $0.001 per share (“Common SharesShares”) outstanding.









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Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q, particularly the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains forward looking statements. All statements other than present and historical facts and conditions contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial positions, business strategy, plans, and our objectives for future operations, are forward-looking statements. When used in this Quarterly Report on Form 10-Q, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. These forward-looking statements include statements that are not historical facts, including statements regarding management’s expectations for future financial and operational performance and operating expenditures, expected growth, and business outlook; the nature of and progress toward our commercialization plan; the future introduction of our products to consumers; the countries in which we may obtain regulatory approval and the progress toward such approvals; the volume of eggs or fish we may be able to produce; the timeline for our production of saleable fish; the expected advantages of land-based systems over sea cage production; the validity and impact of legal actions; the completion of renovations at our farms; and the establishment of a larger-scale grow-out facility.

We have based these forward-looking statements on our current expectations, assumptions, estimates, and projections. While we believe these expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks, uncertainties, and other factors, many of which are outside of our control, which could cause our actual results, performance, or achievements to differ materially from any results, performance, or achievements expressed or implied by such forward-looking statements. Forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

the anticipated benefits and characteristics of our AquAdvantage salmon product;

the implementation and likelihood of achieving the business plan, future revenue, and operating results;

our plans for (including without limitation, projected costs, locations and third-party involvement) and the timing of the development of new farms and the output of those farms;

developments concerning our research projects;

our expectations regarding our ability to successfully enter new markets or develop additional products;

our competitive position and developments and projections relating to our competitors and our industry;

expectations regarding anticipated operating results;

our cash position and ability to raise additional capital to finance our activities;

the impact of the COVID-19 coronavirus outbreak (the “COVID-19 pandemic”) on our business, operations and financial results, any of which could be significantly impaired by the COVID-19 pandemic;

our ability to protect our intellectual property and other proprietary rights and technologies;

the impact of and our ability to adapt to changes in laws or regulations and policies;

the ability to secure any necessary regulatory approvals to commercialize any products;

the rate and degree of market acceptance of any products developed through the application of bioengineering, including bioengineered fish;

our ability to retain and recruit key personnel;

the success of any of our future acquisitions or investments;

our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act (the “JOBS Act”);

our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; and

other risks and uncertainties referenced under “Risk Factors” below and in any documents incorporated by reference herein.

We caution you that the foregoing list may not contain all of the risks to which the forward-looking statements made in this Quarterly Report on Form 10-Q are subject. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included, particularly in the section titled “Risk Factors,” that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments that we may make.

Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this Quarterly Report on Form 10-Q. We do not undertake and specifically decline any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments unless required by federal securities law. New risks emerge from time to time, and it is not possible for us to predict all such risks. 


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PART I. FINANCIAL INFORMATION

Item 1.  Financial Statements

AquaBounty Technologies, Inc.

Consolidated Balance Sheets

(Unaudited)

As of

March 31,

December 31,

2021

2020

Assets

Current assets:

Cash and cash equivalents

$

210,899,434

$

95,751,160

Inventory

2,106,473

1,525,377

Prepaid expenses and other current assets

470,961

405,370

Total current assets

213,476,868

97,681,907

Property, plant and equipment, net

27,904,874

26,930,338

Right of use assets, net

327,386

341,997

Intangible assets, net

242,120

245,546

Restricted cash

500,000

500,000

Other assets

84,685

76,715

Total assets

$

242,535,933

$

125,776,503

Liabilities and stockholders' equity

Current liabilities:

Accounts payable and accrued liabilities

$

1,555,066

$

1,760,103

Other current liabilities

62,765

62,483

Current debt

378,791

259,939

Total current liabilities

1,996,622

2,082,525

Long-term lease obligations

274,232

290,327

Long-term debt

8,622,436

8,528,490

Total liabilities

10,893,290

10,901,342

Commitments and contingencies

 

 

Stockholders' equity:

Common stock, $0.001 par value, 80,000,000 shares authorized;

70,983,145 (2020: 55,497,133) shares outstanding

70,983

55,497

Additional paid-in capital

384,459,964

263,629,116

Accumulated other comprehensive loss

(187,219)

(267,258)

Accumulated deficit

(152,701,085)

(148,542,194)

Total stockholders' equity

231,642,643

114,875,161

Total liabilities and stockholders' equity

$

242,535,933

$

125,776,503

(Unaudited)
  As of
  September 30, December 31,
  2017 2016
Assets    
Current assets:    
Cash and cash equivalents $4,717,821
 $3,324,609
Certificate of deposit 13,489
 10,666
Other receivables 219,334
 164,743
Inventory 78,499
 
Prepaid expenses and other current assets 245,242
 72,983
Total current assets 5,274,385
 3,573,001
     
Property, plant and equipment, net 19,478,853
 1,723,707
Definite-lived intangible assets, net 188,421
 198,698
Indefinite-lived intangible assets 191,800
 191,800
Other assets 162,093
 21,628
Total assets $25,295,552
 $5,708,834
     
Liabilities and stockholders’ equity    
Current liabilities:    
Accounts payable and accrued liabilities $1,602,396
 $1,017,851
Current debt 55,223
 17,913
Total current liabilities 1,657,619
 1,035,764
     
Long-term debt 3,059,990
 2,645,015
Total liabilities 4,717,609
 3,680,779
     
Commitments and contingencies 

 

     
Stockholders’ equity:    
Common stock, $0.001 par value, 200,000,000 shares authorized;    
8,895,094 (2016: 6,463,936) shares outstanding 8,895
 6,464
Additional paid-in capital 126,681,495
 101,581,724
Accumulated other comprehensive loss (243,188) (286,272)
Accumulated deficit (105,869,259) (99,273,861)
Total stockholders’ equity 20,577,943
 2,028,055
     
Total liabilities and stockholders’ equity $25,295,552
 $5,708,834

See accompanying notes to these unaudited interim consolidated financial statements.



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AquaBounty Technologies, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three Months Ended March 31,

2021

2020

Revenues

Product revenues

$

74,372

$

6,753

Costs and expenses

Product costs

1,554,655

841,434

Sales and marketing

318,635

50,788

Research and development

500,620

568,762

General and administrative

1,785,510

1,637,190

Total costs and expenses

4,159,420

3,098,174

Operating loss

(4,085,048)

(3,091,421)

Other income (expense)

Interest expense

(78,804)

(17,045)

Other income (expense), net

4,961

(1,152)

Total other income (expense)

(73,843)

(18,197)

Net loss

$

(4,158,891)

$

(3,109,618)

Other comprehensive income (loss):

Foreign currency translation income (loss)

80,039

(381,985)

Total other comprehensive income (loss)

80,039

(381,985)

Comprehensive loss

$

(4,078,852)

$

(3,491,603)

Basic and diluted net loss per share

$

(0.06)

$

(0.11)

Weighted average number of common shares -

basic and diluted

64,550,920

27,116,754

(Unaudited)
  Three Months Ended
September 30,
 Nine Months Ended
September 30,
  2017 2016 2017 2016
         
Revenues        
Product revenues $

$

$53,278

$
         
Costs and expenses        
Product costs 
 
 50,777
 
Sales and marketing 195,947
 209,556
 607,145
 650,075
Research and development 860,903
 974,980
 2,517,242
 2,705,978
General and administrative 1,382,380
 824,381
 3,453,516
 2,428,044
Total costs and expenses 2,439,230
 2,008,917
 6,628,680
 5,784,097
         
Operating loss (2,439,230) (2,008,917) (6,575,402) (5,784,097)
         
Other income (expense)        
Gain on disposal of equipment 
 
 
 2,861
Interest expense (5,597) (131,301) (16,130) (238,940)
Other income (expense), net (1,392) (1,608) (3,866) (4,463)
Total other income (expense) (6,989) (132,909) (19,996) (240,542)
         
Net loss $(2,446,219) $(2,141,826) $(6,595,398) $(6,024,639)
         
Other comprehensive income (loss):        
Foreign currency translation gain (loss) 34,933
 13,659
 43,084
 (86,516)
Total other comprehensive income (loss) 34,933
 13,659
 43,084
 (86,516)
         
Comprehensive loss $(2,411,286) $(2,128,167) $(6,552,314) $(6,111,155)
         
         
Basic and diluted net loss per share $(0.28) $(0.41) $(0.76) $(1.15)
Weighted average number of common shares -        
basic and diluted 8,895,094
 5,250,510
 8,731,178
 5,249,776
         

See accompanying notes to these unaudited interim consolidated financial statements.



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AquaBounty Technologies, Inc.

Consolidated Statements of Changes in Stockholders’ Equity

(Unaudited)

Common stock issued and outstanding

Par value

Additional paid-in capital

Accumulated other comprehensive loss

Accumulated deficit

Total

Balance at December 31, 2019

21,635,365

$

21,635

$

156,241,363

$

(360,160)

$

(132,142,209)

$

23,760,629

Net loss

(3,109,618)

(3,109,618)

Other comprehensive income (loss)

(381,985)

(381,985)

Issuance of common stock, net of expenses

10,350,000

10,350

14,511,354

14,521,704

Share based compensation

100,319

101

205,252

205,353

Balance at March 31, 2020

32,085,684

32,086

170,957,969

(742,145)

(135,251,827)

34,996,083

Common stock issued and outstanding

Par value

Additional paid-in capital

Accumulated other comprehensive loss

Accumulated deficit

Total

Balance at December 31, 2020

55,497,133

$

55,497

$

263,629,116

$

(267,258)

$

(148,542,194)

$

114,875,161

Net loss

(4,158,891)

(4,158,891)

Other comprehensive income (loss)

80,039

80,039

Cashless exercise of options for common stock

4,354

4

(4)

Issuance of common stock, net of expenses

14,950,000

14,950

119,105,487

119,120,437

Exercise of warrants for common stock

491,133

491

1,595,691

1,596,182

Share based compensation

40,525

41

129,674

129,715

Balance at March 31, 2021

70,983,145

70,983

384,459,964

(187,219)

(152,701,085)

231,642,643

(Unaudited)
  Common stock issued and outstanding Par value Additional paid-in capital Accumulated other comprehensive loss Accumulated deficit Total
Balance at December 31, 2016 6,463,936
 $6,464
 $101,581,724
 $(286,272) $(99,273,861) $2,028,055
             
Net loss         (6,595,398) (6,595,398)
Other comprehensive loss       43,084
   43,084
Issuance of common stock, net of expenses 2,421,073
 2,421
 24,986,836
     24,989,257
Exercise of options for common stock 8,334
 8
 27,494
     27,502
Share based compensation 1,751
 2
 85,441
     85,443
Balance at September 30, 2017 8,895,094
 $8,895
 $126,681,495
 $(243,188) $(105,869,259) $20,577,943

See accompanying notes to these unaudited interim consolidated financial statements.



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AquaBounty Technologies, Inc.

Consolidated Statements of Cash Flows

(Unaudited)

Three Months Ended March 31,

2021

2020

Operating activities

Net loss

$

(4,158,891)

$

(3,109,618)

Adjustment to reconcile net loss to net cash used in

operating activities:

Depreciation and amortization

422,185

347,859

Share-based compensation

129,715

205,353

Other non-cash charge

4,203

Changes in operating assets and liabilities:

Inventory

(577,154)

(610,200)

Prepaid expenses and other assets

(63,966)

(107,922)

Accounts payable and accrued liabilities

(274,486)

339,818

Net cash used in operating activities

(4,518,394)

(2,934,710)

Investing activities

Purchase of property, plant and equipment

(1,208,183)

(691,351)

Proceeds from sale of asset held for sale

98,000

Proceeds from legal settlement, net

1,014,008

Other investing activities

(11,010)

(1,307)

Net cash (used in) provided by investing activities

(1,219,193)

419,350

Financing activities

Proceeds from issuance of debt

187,120

Repayment of term debt

(38,885)

(39,391)

Proceeds from the issuance of common stock, net

119,120,437

14,521,704

Proceeds from the exercise of stock options and warrants, net

1,596,182

Net cash provided by financing activities

120,864,854

14,482,313

Effect of exchange rate changes on cash, cash equivalents and restricted cash

21,007

(15,951)

Net change in cash, cash equivalents and restricted cash

115,148,274

11,951,002

Cash, cash equivalents and restricted cash at beginning of period

96,251,160

2,798,744

Cash, cash equivalents and restricted cash at end of period

$

211,399,434

$

14,749,746

Reconciliation of cash, cash equivalents and restricted cash reported

in the consolidated balance sheet:

Cash and cash equivalents

$

210,899,434

$

14,749,746

Restricted cash

500,000

Total cash, cash equivalents and restricted cash

$

211,399,434

$

14,749,746

Supplemental disclosure of cash flow information and

non-cash transactions:

Interest paid in cash

$

73,685

$

17,045

Property and equipment included in accounts payable and accrued liabilities

$

82,068

$

257,884

(Unaudited)
  Nine Months Ended
September 30,
  2017 2016
     
Operating activities    
Net loss $(6,595,398) $(6,024,639)
Adjustment to reconcile net loss to net cash used in    
operating activities:    
Depreciation and amortization 137,229
 109,207
Share-based compensation 85,443
 166,478
Gain on disposal of equipment 
 (2,861)
Changes in operating assets and liabilities:    
Other receivables (43,346) 13,174
Inventory (78,499) 
Prepaid expenses and other assets (309,986) (27,313)
Accounts payable and accrued liabilities 128,917
 332,254
Net cash used in operating activities (6,675,640) (5,433,700)
     
Investing activities    
Purchase of property, plant and equipment (17,235,184) (757,402)
Proceeds from sale of equipment 
 23,844
Payment of patent costs 
 (5,665)
Net cash used in investing activities (17,235,184) (739,223)
     
Financing activities    
Proceeds from issuance of debt 256,807
 547,142
Repayment of term debt (23,677) (1,866)
Proceeds from the issuance of convertible debt 
 7,500,000
Proceeds from the issuance of common stock, net 24,989,257
 
Proceeds from the exercise of stock options 27,502
 
Net cash provided by financing activities 25,249,889
 8,045,276
     
Effect of exchange rate changes on cash and cash equivalents 54,147
 (2,249)
Net change in cash and cash equivalents 1,393,212
 1,870,104
Cash and cash equivalents at beginning of period 3,324,609
 1,313,421
Cash and cash equivalents at the end of period $4,717,821
 $3,183,525
     
Supplemental disclosure of cash flow information and    
non-cash transactions:    
Interest paid in cash $16,130
 $1,440
Property and equipment included in accounts payable and accrued liabilities $472,283
 $

See accompanying notes to these unaudited interim consolidated financial statements.



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AquaBounty Technologies, Inc.

Notes to the consolidated financial statements

For the ninethree months ended September 30, 2017March 31, 2021 and 20162020 (unaudited)

1. Nature of business and organization

AquaBounty Technologies, Inc. (the “Parent” and, together with its subsidiaries, the “Company”) was incorporated in December 1991 in the State of Delaware for the purpose of conducting research and development of the commercial viability of a group of proteins commonly known as antifreeze proteins. In 1996, the Parent obtained the exclusive licensing rights for a gene construct (transgene) used to create a breed of farm‑raisedfarm-raised Atlantic salmon that exhibit growth rates that are substantially faster than traditionalconventional salmon.

In 2015, the Parent obtained approval from the US Food and Drug Administration (the “FDA”) for the production sale, and consumptionsale of its AquAdvantage® SalmonAquAdvantage salmon product in the United States.
InStates and in 2016, the Parent obtained regulatory approval from Health Canada the department of the government of Canada responsible for national public health, for the saleproduction and consumptionsale of its AquAdvantage Salmonsalmon product in Canada. Previously, in 2013, the Parent obtained approval from Environment Canada, the agency of the government of Canada responsible for regulating environmental policies and issues, for the production of the product.

AQUA Bounty Canada Inc. (the “Canadian Subsidiary”) was incorporated in January 1994 in Canada for the purpose of establishing a commercial biotechnology laboratory to conduct research and development programs related to the Parent’s technologies.

technologies and to commercialize the Parent’s products in Canada.

AquaBounty Panama, S. de R.L. (the “Panama Subsidiary”) was incorporated in May 2008 in Panama for the purpose of conducting commercial trials of the Company’s AquAdvantage Salmon.

Parent’s products. Operations at the site concluded in May 2019.

AquaBounty Farms, Inc. (“AquaBounty Farms”(the “U.S. Subsidiary”) was incorporated in December 2014 in the State of Delaware for the purpose of conducting field trials and commercializing the Company’s AquAdvantage SalmonParent’s products in the United States.

AquaBounty Farms Indiana LLC (the “Indiana Subsidiary”), which is wholly owned by the U.S. Subsidiary, was formed in June 2017 in the State of Delaware for the purpose of operating the Company’sits aquaculture facility in Albany, Indiana, and is wholly owned by AquaBounty Farms.

Indiana.

AquaBounty Brasil Participações Ltda. (the “Brazil Subsidiary”) was incorporated in May 2015 in Brazil for the purpose of conducting commercialfield trials ofand commercializing the Company’s AquAdvantage Salmon.

Parent’s products in Brazil.

2. Basis of presentation

The unaudited interim consolidated financial statements include the accounts of AquaBounty Technologies, Inc. and its wholly owned direct and indirect subsidiaries, AQUA Bounty Canada Inc.; AquaBounty Panama, S. de R.L.; AquaBounty Farms, Inc.; AquaBounty Farms Indiana LLC; and AquaBounty Brasil Participações Ltda. The entities are collectively referred to herein as the “Company.” All inter-companyintercompany transactions and balances have been eliminated upon consolidation.

The unaudited interim consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“GAAP”) consistent with those applied in, and should be read in conjunction with, the Company’s audited financial statements and related footnotes for the year ended December 31, 2016.2020. The unaudited interim consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the Company’s financial position as of September 30, 2017,March 31, 2021, and its results of operations and cash flows for the interim periods presented and are not necessarily indicative of results for subsequent interim periods or for the full year. The unaudited interim consolidated financial statements do not include all of the information and footnotes required by GAAP for complete financial statements, as allowed by the relevant SEC rules and regulations; however, the Company believes that its disclosures are adequate to ensure that the information presented is not misleading.

On January 5, 2017,

Liquidity

In February 2021, the Company implementedcompleted an equity raise with net proceeds of $119.1 million and has $210.9 million in cash and cash equivalents as of March 31, 2021. While the Company has experienced net losses and negative cash flows from operations since inception, management believes that it has sufficient cash to meet the Company's requirements for at least the next twelve months from the filing date. However, until such time as the Company reaches profitability, it may require additional financing to fund its operations and execute its business plan.

Inventories

Inventories are mainly comprised of feed, eggs, fish in process and packaging materials. Fish in process inventory is measured based on the estimated biomass of fish on hand. The Company has established a 1-for-30 reverse splitstandard procedure to estimate the biomass of fish on hand using counting and sampling techniques.

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The Company measures inventory at the lower of cost or net realizable value (NRV). The NRV calculation contains various estimates and assumptions in regard to the calculation of the biomass, including expected yield, the market value of the biomass and estimated costs of completion and transportation. As of March 31, 2021, the NRV of the Company’s conventional salmon biomass was valued at $0 as a result of its outstanding common shares. All share balancesdecision to harvest and donate this fish. The NRV of the Company’s AquAdvantage salmon biomass was valued at $1.8 million.

The Company also considers capacity utilization in calculating its inventory value with any excess capacity charged to production costs as idle capacity. Inventory reserves are recorded as needed to represent the difference between the carrying value and the NRV calculation, taking into consideration the expected timing and disposition of the inventory.

Revenue recognition

The Company records revenue on the sale of a product when all revenue recognition criteria are fulfilled, including identifying the contract with a customer; identifying the performance obligations in the unaudited interim consolidated financial statementscontract; determining the transaction price; allocating the transaction price to the performance obligations in the contract; and accompanying notes have been restatedrecognizing revenue when (or as) the Company satisfies a performance obligation. The Company evaluates customer credit risk in order to reflect this change.

conclude it is “probable” it will collect the amount of consideration due in exchange for the goods or services.

Net loss per share

Basic and diluted net loss per share available to common stockholders has been calculated by dividing net loss by the weighted average number of common shares outstanding during the year. Basic net loss is based solely on the number of common shares outstanding during the year. Fully diluted net loss per share includes the number of shares of common stock issuable upon the exercise of warrants and options with an exercise price less than the fair value of the common


5



stock. Since the Company is reporting a net loss for all periods presented, all potential common shares are considered anti‑anti-dilutive and are excluded from the calculation of diluted net loss per share.
Accounting Pronouncements
The Company has adopted Accounting Standards Update (“ASU”) 2017-01, “Business Combinations: Clarifying the Definition of a Business.” The revised guidance changes the definition of a business to assist entities with evaluating whether a set of transferred assets and activities is a business.
The Company has adopted ASU 2014-09, “Revenue from Contracts with Customers,” which supersedes the revenue recognition requirements in Accounting Standard Codification (“ASC”) 605, “Revenue Recognition,” and most industry-specific guidance throughout the ASC. ASU 2014-09 established principles for recognizing revenue upon the transfer of promised goods or services to customers, in an amount that reflects the expected consideration received in exchange for those goods or services.
The Company has adopted ASU 2015-11, “Inventory: Simplifying the Measurement of Inventory.” The main provision of the guidance is that an entity should measure inventory at the lower of cost or net realizable value (“NRV”), where NRV is defined as the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.
The Company has adopted ASU 2016-09, “Compensation – Stock Compensation.” The areas for simplification in this update involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows.
Liquidity and Management’s Plan

At September 30, 2017, the Company’s cash balance totaled $4.7 million. Management has evaluated the Company’s cash resources in view of its planned spending for ongoing operations, capital expenditures, and working capital for the next twelve months and has determined that its current funds will be used by the end of December 2017. However, management believes thatMarch 31, 2021, the Company can continue ashad 1,141,847 potentially dilutive securities outstanding, consisting of 457,722 warrants and 684,125 stock options.

Accounting Pronouncements

Management does not expect any recently issued, but not yet effective, accounting standards to have a going concern. Management’s assessment is basedmaterial effect on its belief that the Company will be able to raise additional equityresults of operations or debt to fund its requirements. Additionally, management could slow down spending to conserve the Company’s cash if there is a delay in obtaining new funding. Therefore, the accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

condition.

3. Risks and uncertainties

The Company is subject to risks and uncertainties common in the biotechnology and aquaculture industries. Such risks and uncertainties include, but are not limited to: (i) results from current and planned product development studies and trials; (ii) decisions made by the FDA or similar regulatory bodies in other countries with respect to approval and commercial sale of any of the Company’s proposed products; (iii) the commercial acceptance of any products approved for sale and the Company’s ability to manufacture, distribute, and sell for a profit any products approved for sale; (iv) the Company’s ability to obtain the necessary patents and proprietary rights to effectively protect its technologies; and (v) the outcome of any collaborations or alliances entered into by the Company.

COVID-19

The COVID-19 pandemic continues to spread throughout the United States and the world, and now includes several variants of the virus. Because infections of this virus and the incidences of the disease it causes, certain national, provincial, state, and local governmental authorities in the United States and Canada have issued, and continue to update, proclamations and directives aimed at minimizing the spread of the virus. These directives currently remain in effect and the Company is monitoring their status.

The ultimate impact of the COVID-19 pandemic on the Company’s operations is unknown and will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the COVID-19 pandemic, new information which may emerge concerning the severity of the COVID-19 pandemic, and any additional preventative and protective actions that governments, or the Company, may direct, which may result in an extended period of continued business disruption and reduced operations.

To date, the Company’s farm operations have not been materially affected by the pandemic, although management has made modifications to biosecurity procedures and the farm sites to adapt to local requirements and to provide a safe work environment. The Company’s current preventative and protective measures include, but are not limited to, segregating farm workers to specific

6


Table of Contents

locations, rotating shifts, and monitoring worker temperatures upon arrival at the Company’s facilities. To the extent possible, work-from-home is utilized for employees that do not have fish care responsibilities.

The Company experienced delays in capital projects due to the pandemic, including, but not limited to, a six-month delay in the completion of the processing facility at the Indiana farm, which did not become operational until November 2020. Management utilized third party alternatives for fish processing during the delay. During Q1 2021, project delays were limited to extended lead-times on equipment purchases. However, the Company could experience delays on purchases of capital equipment and supplies and other materials required in its operations due to vendor shortages or it could be impacted by transportation or other supply chain disruptions to its partners or customers.

The Company has been primarily impacted by a reduction in the market price and demand for Atlantic salmon due to the pandemic’s impact on the food service sector. This had and continues to have a negative impact on revenue and inventory value, as the company is not yet an established vendor and customers have been reluctant to add a new supplier during a period of depressed demand. Consequently, in December 2020, the Company made the decision to donate substantially all of the conventional salmon to local food charities, which are experiencing unprecedented need during the pandemic. This decision was made to ease the capacity constraints at the Indiana farm to provide space for the growing biomass of AquAdvantage salmon. The donation program commenced in February 2021 and is expected to be completed in May 2021, though the Company is exploring the possibility of continuing the donation program for fish that do not meet customer specifications.

Management expects the financial impact of the pandemic to continue through at least the first half of 2021, as the industry waits for the roll-out of COVID-19 vaccines and the subsequent reopening of the food service sector. Any financial impact beyond the near-term cannot be reasonably estimated at this time but may have a material adverse impact on the Company’s business, financial condition, and results of operations in 2021.

Concentration of credit risk

Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and certificates of deposit. This risk is minimizedmitigated by the Company’s policy of investing in financial instruments with short-term maturities issued by highly rated financial institutions. The Company’s cash balances may at times exceed insurance limitations. The Company holds cash balances in bank accounts located in Canada to fund its local operations. These amounts are subject to foreign currency exchange risk, which is mitigatedminimized by the Company’s policy to limit the balances held in these accounts. Balances in Canadian bank accounts totaled $85,005$83 thousand at September 30, 2017.

Financial instruments
The carrying amounts reported in the consolidated balance sheets for other receivables and accounts payable approximate fair value based on the short-term maturity of these instruments. As of September 30, 2017, the carrying value of term debt approximates its fair value since it provides for market terms and interest rates.
Included in other assets is a long-term investment that consists of 216,281 shares of common stock of A/F Protein, Inc. (“AFP”), equating to less than 1% ownership, with a cost basis of $21,628, which the Company believes to be the best estimate of market value.

6



March 31, 2021.

4. Inventory

Major classifications of inventory are summarized as follows:

March 31, 2021

December 31, 2020

Feed

$

234,804

244,311

Eggs and fry

57,175

54,929

Packaging

4,422

6,452

Fish in process, net

1,810,072

1,219,685

Inventory, net

$

2,106,473

1,525,377

  September 30, December 31,
  2017 2016
Feed $36,403
 $
Fish in process 42,096
 
Total inventory $78,499
 $

5. Property, plant and equipment

Major classifications of property, plant and equipment are summarized as follows:

March 31, 2021

December 31, 2020

Land

$

728,316

$

724,785

Building and improvements

14,214,666

14,048,917

Construction in process

3,887,384

3,212,287

Equipment

14,380,752

13,819,210

Office furniture and equipment

217,246

202,596

Vehicles

29,044

28,700

Total property and equipment

$

33,457,408

$

32,036,495

Less accumulated depreciation and amortization

(5,552,534)

(5,106,157)

Property, plant and equipment, net

$

27,904,874

$

26,930,338

7


  September 30, December 31,
  2017 2016
Land $665,733
 $157,107
Building and improvements 8,618,289
 1,436,814
Construction in process 3,731,112
 277,352
Equipment 7,873,930
 1,037,549
Office furniture and equipment 81,521
 78,780
Vehicles 29,311
 27,201
Total property and equipment $20,999,896
 $3,014,803
Less accumulated depreciation and amortization (1,521,043) (1,291,096)
Property, plant and equipment, net $19,478,853
 $1,723,707
Depreciation and amortization expense was $126,951 and $99,196 for the nine months ended September 30, 2017 and 2016, respectively.

Included asin construction in process is $3.7$2.1 million for renovation and new construction costs incurred at ourrelated to the Rollo Bay farm site. The Company currentlysite and renovations to the Fortune Bay hatchery, $1.2 million for construction related to the Indiana farm site, and $583 thousand related to design work for a new 10,000 metric ton farm. An additional $1.2 million has an additional $2.1 millionbeen committed to these renovations.

On June 22, 2017, the Company purchased the aquaculture facility of Bell Fish Company LLC in Albany, Indiana, for $14.2 million, including legal and other expenses incurred. The facility and related assets acquired from Bell Fish Company LLC provide one input into the Company's process for growing its product, and, accordingly, the purchase of the facility was accounted for as an asset purchase rather than the acquisition of a “business,” consistent with ASU 2017-01, “Business Combinations: Clarifying the Definition of a Business.” There are no future obligations related to the asset purchase for the Company, no liabilities were assumed, and no workforce, inventory, or customers were acquired. The Company allocated the purchase price to land, buildings, and equipment based on external valuations and management’s estimates. The Company intends to invest approximately $5.0 million to upgrade the facility for use to grow out its AquAdvantage Salmon for harvest and sale in the United States. The facility is currently idle while repairs and upgrades are performed.
projects.

6. Accounts payable and accrued liabilities

Accounts payable and accrued liabilities include the following:

March 31, 2021

December 31, 2020

Accounts payable

$

644,459

$

799,888

Accrued payroll including vacation

520,162

583,301

Accrued professional fees and contract services

246,968

278,165

Accrued construction costs

141,767

86,052

Accrued taxes and other

1,710

12,697

Accounts payable and accrued liabilities

$

1,555,066

$

1,760,103

  September 30, December 31,
  2017 2016
Accounts payable $490,840
 $161,768
Accrued payroll including vacation 316,588
 242,436
Accrued professional fees 211,232
 500,430
Accrued research and development costs 65,000
 87,751
Accrued taxes 126,990
 22,994
Accrued construction costs 387,038
 
Accrued other 4,708
 2,472
Accounts payable and accrued liabilities $1,602,396
 $1,017,851

7



7. Debt

The current material terms and conditions of debt outstanding are as follows:

Interest
rate

Monthly
repayment

Maturity
date

March 31, 2021

December 31, 2020

ACOA AIF Grant

0%

Royalties

-

$

2,280,591

$

2,253,595

ACOA term loan #1

0%

C$3,120

Feb 2027

175,941

181,203

ACOA term loan #2

0%

C$4,630

Sep 2029

374,990

381,451

Kubota Canada Ltd

0%

C$1,142

Jan 2025

41,730

43,925

PEI Finance term loan

4%

C$16,313

Nov 2023

2,020,523

2,014,321

DFO term loan

0%

C$2,091

Aug 2032

189,313

First Farmers Bank & Trust term loan

5.375%

$56,832

Oct 2028

4,000,000

4,000,000

Total debt

$

9,083,088

$

8,874,495

less: debt issuance costs

(81,861)

(86,066)

less: current portion

(378,791)

(259,939)

Long-term debt, net

$

8,622,436

$

8,528,490

  Interest
rate
 Monthly
repayment
 Maturity
date
 September 30, 2017 December 31, 2016
ACOA AIF grant (C$2,871,919) 0% Royalties - $2,301,556
 $2,135,846
ACOA term loan (C$337,000) 0% C$3,120 June 2026 260,071
 
Finance PEI term loan (C$717,093) 4% C$4,333 July 2021 553,586
 527,082
Total debt       $3,115,213
 $2,662,928
less: current portion       (55,223) (17,913)
Long-term debt       $3,059,990
 $2,645,015

Estimated principal payments remaining on loan debt are as follows (1):follows:

AIF

ACOA

FPEI

Kubota

DFO

FFBT

Total

2021

$

$

55,388

$

56,441

$

8,165

$

$

116,675

$

236,669

2022

73,851

78,313

10,886

482,306

645,356

2023

73,852

1,885,769

10,886

16,606

509,256

2,496,369

2024

73,851

10,886

19,928

537,276

641,941

2025

73,851

907

19,928

567,735

662,421

Thereafter

2,280,591

200,138

132,851

1,786,752

4,400,332

Total

$

2,280,591

$

550,931

$

2,020,523

$

41,730

$

189,313

$

4,000,000

$

9,083,088

YearTotal
2017$12,414
201860,094
201960,912
2020349,662
20212,499,578
Thereafter132,553
Total$3,115,213
(1) Repayments of the AIF grants are based on revenue projections for AquAdvantage Salmon.
Atlantic Canada Opportunities Agency (“ACOA”)
ACOA is a Canadian government agency that provides funding to support the development of businesses and to promote employment in the Atlantic region of Canada.

In January 2009,September 2020, the Canadian Subsidiary was awardedentered into a grant from ACOAContribution Agreement with DFO's Atlantic Fisheries Fund, whereby it is eligible to provide a contribution towards the funding of a research and development project. The total amount claimed under the award over the five-year claim period was $2,301,556. No further funds are available under this grant. Amounts claimed byreceive up to C$1.9 million ($1.4 million) to finance new equipment for its Rollo Bay farm (the “DFO Term Loan”). On February 25, 2021, the Canadian Subsidiary must be repaidborrowed C$238,400 ($187,120) under the DFO Term Loan. Borrowings are interest free and monthly repayments commence in the form of a 10% royalty on any products that are commercialized out of this research project until the loan is fully repaid. The Company expects to make its first repaymentMarch 2023, with maturity in 2018.

In February 2016, the Canadian Subsidiary executed an agreement with ACOA to partially finance the renovations to the Rollo Bay site. The terms of the agreement include funding up to $270,072 with repayment commencing after the final draw-down of the funds. The loan term is nine years with a zero percent interest rate. As of September 30, 2017, the Canadian Subsidiary has drawn down the full amount of available funds and commenced repayment.
Finance PEI (“FPEI”)
FPEI is a corporation of the Ministry of Economic Development and Tourism for Prince Edward Island, Canada, and administers business financing programs for the provincial government. In August 2016, the Canadian Subsidiary obtained a loan from FPEI in the amount of $574,678 to partially finance the purchase of the assets of the former Atlantic Sea Smolt plant in Rollo Bay West on Prince Edward Island. The loan is being repaid through monthly payments of principal and interest with a balloon payment for the balance due in July 2021. The loan is collateralized by a mortgage executed by the Canadian Subsidiary, which conveys a first security interest in all of its current and acquired assets. The loan is guaranteed by the Parent.
2032.

The Company recognized interest expense of $16,112$79 thousand and $238,931$17 thousand for the ninethree months ended September 30, 2017March 31, 2021 and 2016,2020, respectively, on its interest-bearing debt. Interest

8. Leases

Lease expense in 2016 included $237,500 for the convertible debt facility with Intrexon Corporation (“Intrexon”), its majority shareholder.


8



8. Stockholders’ equity
three months ended three months ended March 31, 2021 and 2020, amounted to $22 thousand and $20 thousand, respectively. The Company is presently authorized to issue up to 240 million shares of stock, of which 40 million are authorized as preferred stock and 200 million as common stock.
Common stock
The holdersweighted average remaining lease term of the common stockCompany’s operating leases was 23 years as of March 31, 2021. Lease payments included in operating cash flows totaled $22 thousand and $21 thousand for the three months ended March 31, 2021 and 2020, respectively.

8


The table below summarizes the Company’s lease obligations and remaining payments at March 31, 2021:

March 31, 2021

December 31, 2020

Lease

Lease

Remaining

Remaining

Lease

Remaining

Lease

Type

Term

Years

Payments

Liability

Payments

Liability

Maynard Office Lease

Operating

Mar 2023

1.92

134,463

120,384

150,918

134,099

Indiana Auto Lease

Operating

Feb 2021

-

-

1,157

821

Indiana Well Lease

Operating

Dec 2048

27.69

682,809

216,613

686,809

217,890

Total

817,272

336,997

838,884

352,810

Less: current portion

(82,979)

(62,765)

(83,571)

(62,483)

Long-term leases

$ 734,293

$ 274,232

$ 755,313

$ 290,327

Remaining payments under leases are entitled to one vote for each share heldas follows at all meetings of stockholders. Dividends and distribution of assets ofMarch 31, 2021:

Year

Office

Well

Amount

2021

49,960

11,999

61,959

2022

67,602

16,478

84,080

2023

16,901

16,972

33,873

2024

-

17,481

17,481

2025

-

18,006

18,006

Thereafter

-

601,873

601,873

Total Lease Payments

134,463

682,809

817,272

9. Stockholders’ equity

Recent issuances

On February 8, 2021, the Company completed a public offering of 14,950,000 Common Shares for net proceeds of approximately $119.1 million.

Warrants

The following table summarizes information about outstanding warrants at March 31, 2021:

Number of
options

Weighted
average
exercise price

Outstanding at December 31, 2020

948,855

$

3.25

Issued

-

Exercised

(491,133)

3.25

Expired

-

Outstanding at March 31, 2021

457,722

3.25

Exercisable at March 31, 2021

457,722

3.25

During the three months ended March 31, 2021, the Company issued 491,133 Common Shares at $3.25 per share in conjunction with the eventexercise of liquidation are subject towarrants, with total proceeds of $1.6 million. All remaining warrants have an expiration date of January 17, 2023.

Share-based compensation

At March 31, 2021, the preferential rights of any outstanding preferred shares.

Restricted stock
The Company grants restricted common stock to the Chairman of the Board of Directors as part of his compensation package. Generally, the shares are fully vestedhas reserved 1,591,453 Common Shares issuable upon the third anniversaryexercise of the grant date. Unvested shares can be canceled upon terminationoutstanding stock options and future issuances under its 2006 and 2016 Equity Incentive Plans.

9


Restricted stock

A summary of the Company’s unvested shares of restricted stockCommon Shares as of September 30, 2017,March 31, 2021, is as follows:

Shares

Weighted
average grant
date fair value

Balance at December 31, 2020

72,653

$

1.90

Granted

40,525

6.72

Vested

(43,822)

3.27

Balance at March 31, 2021

69,356

$

3.85

  Shares 
Weighted
average grant
date fair value
Unvested at December 31, 2016 4,169
 $7.72
Granted 1,751
 14.20
Vested (2,378) 8.09
Unvested at September 30, 2017 3,542
 $10.68

During the ninethree months ended September 30, 2017March 31, 2021 and 2016,2020, the Company expensed $19,235$107 thousand and $13,165,$84 thousand, respectively, related to the Chairman’s restricted stock awards. At September 30, 2017,March 31, 2021, the balance of unearned share-based compensation to be expensed in future periods related to the restricted stock awards is $37,817.$260 thousand. The period over which the unearned share-based compensation is expected to be earned is approximately 2.43 years.

Stock options

In 2006, the Company established its 2006 Equity Incentive Plan (the “2006 Plan”). The 2006 Plan provided for the issuance of incentive stock options to employees of the Company and non‑qualified stock options and awards of restricted stock to directors, officers, employees, and consultants of the Company. In accordance with its original terms, no further shares may be granted under the 2006 Plan subsequent to March 18, 2016. All outstanding awards under the 2006 Plan will continue until their individual termination dates.
In March 2016, the Company’s Board of Directors adopted the AquaBounty Technologies, Inc. 2016 Equity Incentive Plan (the “2016 Plan”) to replace the 2006 Plan. The 2016 Plan provides for the issuance of incentive stock options, non‑qualified stock options, and awards of restricted and direct stock purchases to directors, officers, employees, and consultants of the Company. The aggregate number of shares of common stock that may be issued pursuant to awards granted under the 2016 Plan cannot exceed 450,000. The 2016 Plan was approved by the Company’s shareholders at its Annual Meeting on April 26, 2016.

The Company’s option activity under the 2006 Plan and the 2016 Plan is summarized as follows:

Number of
options

Weighted
average
exercise price

Outstanding at December 31, 2020

657,414

$

4.28

Granted

48,914

6.72

Exercised

(16,667)

6.90

Expired

(5,536)

6.90

Outstanding at March 31, 2021

684,125

$

4.37

Exercisable at March 31, 2021

586,746

$

4.39

  Number of
options
 Weighted
average
exercise price
Outstanding at December 31, 2016 185,591
 $7.89
Issued 52,500
 14.20
Exercised (8,334) 3.30
Expired (2,554) 19.50
Outstanding at September 30, 2017 227,203
 $9.39
Exercisable at September 30, 2017 183,373
 $8.28

Unless otherwise indicated, options issued to employees, members of the Board of Directors, and non-employees are vested daily over one to three years and are exercisable for a term of ten years from the date of issuance.

The fair values of stock option grants to employees and members of the Board of Directors during 2021 were measured on the date of grant using Black-Scholes, with the following weighted average assumptions:

March 2021

Expected volatility

111%

Risk free interest rate

0.80%

Expected dividend yield

0%

Expected life (in years)

5


9



The weighted average fair value of stock options granted during the ninethree months ended September 30, 2017,March 31, 2021, was $4.55. The intrinsic value of options exercised during the nine months ended September 30, 2017, was $43,420. $5.31.

The total intrinsic value of all options outstanding was $325,754$2.4 million and $602,773$3.6 million at September 30, 2017,March 31, 2021, and December 31, 2016,2020, respectively. The total intrinsic value of exercisable options was $325,310$2.1 million and $597,872$3.2 million at September 30, 2017,March 31, 2021 and December 31, 2016,2020, respectively.

The following table summarizes information about options outstanding and exercisable at September 30, 2017:March 31, 2021:

Weighted
average exercise
price of outstanding
options

Number of
options
outstanding

Weighted
average remaining
estimated life
(in years)

Number of
options
exercisable

Weighted average
price of outstanding
and exercisable
options

$1.88 - $2.50

531,519

8.0

481,470

$3.30 - $6.72

60,516

8.7

13,186

$7.50 - $10.80

20,503

3.3

20,503

$14.20 - $23.40

71,587

5.0

71,587

684,125

586,746

$4.39

Weighted average exercise price of outstanding options Number of options outstanding Weighted average remaining estimated life (in years) Number of options exercisable Weighted average exercise price of outstanding and exercisable options
$3.30 79,337
 1.8 79,337
  
$3.60 800
 4.8 800
  
$5.70 10,336
 7.4 10,132
  
$6.90 29,038
 3.7 28,296
  
$7.50 15,837
 5.6 15,837
  
$9.60 8,300
 7.9 8,300
  
$9.90 800
 0.8 800
  
$10.50 1,600
 5.8 1,600
  
$10.80 2,400
 6.8 2,400
  
$14.20 52,500
 9.6 9,616
  
$23.40 26,255
 6.3 26,255
  
  227,203
   183,373
 $8.28

Total share-based compensation on stock-option grantsstock options amounted to $66,208$22 thousand and $153,313$121 thousand for the ninethree months ended September 30, 2017March 31, 2021 and 2016,2020, respectively. At September 30, 2017,March 31, 2021, the balance of unearned share-based compensation to be expensed in future periods related to unvested share-based awards was $186,921.$324 thousand. The period over which the unearned share-based compensation is expected to be earned is approximately 2.43 years.

9.

10. Commitments and contingencies

The Company recognizes and discloses commitments when it enters into executed contractual obligations with other parties. The Company accrues contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.

In July 2017,

See Note 5 for commitments related to the Company’s renovation and construction costs.

The Company extendedis subject to legal proceedings and claims arising in the lease for its office space in Maynard, Massachusetts. The new lease for 3,558 square feetnormal course of office space has a term of five years and seven months, ending March 2023, with total annual rent payments of approximately$60 thousand increasing to $68 thousand during the term of the lease. The lease includes a period of free rent totaling$26,830, which is being amortized over the lease term.business. There have been no other material changes to the commitments and contingencies disclosed in our annual reportthe Company’s Annual Report on Form 10-K as of and for the year ended December 31, 2016.

10. Related Party Collaboration Agreement
In February 2013,2020.

11. Subsequent Events

Department of Fisheries and Oceans Loan

On April 27, 2021, the Company entered into an Exclusive Channel Collaboration agreement (“ECC”) with Intrexon pursuant to which the Company will use Intrexon’s UltraVector and other technology platforms to develop and commercialize additional genetically modified traits in finfish for human consumption.

Total Intrexon service costs incurredCanadian Subsidiary borrowed C$276,840 or approximately $221,470 under the terms of this agreement for the nine months ended September 30, 2017 and 2016, amounted to $447,382 and $717,141, respectively, and are included as a component of research and development expense in our Consolidated Statements of Operations and Comprehensive Loss. Included in accounts payable and accrued liabilities at September 30, 2017, and December 31, 2016, are amounts due to Intrexon under the ECC totaling $65,000 and $73,780, respectively.


its DFO Term Loan (see Note 7).


10

11



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

The following "Management's“Management’s Discussion and Analysis of Financial Condition and Results of Operations"Operations” should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10‑Q10-Q and our Annual Report on Form 10-K for the year ended December 31, 2016,2020, which was filed on March 16, 2017.

This discussion and analysis also contains forward-looking statements and should be read in conjunction with the disclosures and information contained in “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2016. Our actual results may differ materially from those discussed below. The following discussion and analysis is intended to enhance the reader’s understanding of our business environment. The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date hereof.
9, 2021.

Overview

We believe that we are a leader in the field of biotechnology toolsland-based aquaculture and the use of technology for improving theits productivity of aquaculture.and sustainability. Our lead product is the AquAdvantage Salmon,salmon, which received FDA approval in 2015 as the first genetically modifiedbioengineered animal available for sale for human consumption. We intend to commencehave commenced commercial activities with operations in marketsthe United States and Canada where we have received regulatory approval. The first stepsWe are actively engaged in genetic, genomic, fish health and fish nutrition research, which drive continuous improvement in our commercial plan have been implemented, includingoperations and may lead to new, disruptive technologies and products that could further expand our competitive offerings.

COVID-19

The COVID-19 pandemic continues to spread throughout the following:

we received approval fromUnited States and the world, and now includes several variants of the virus. Because infections of this virus and the incidences of the disease it causes, certain national, provincial, regulatorystate, and local governmental authorities in Prince Edward Island for the construction of a broodstock facility to house our non-transgenic Atlantic salmon stock and a 250-metric-ton recirculating aquaculture system (“RAS”) facility to grow out our AquAdvantage Salmon;
we are continuing an active search in both the United States and Canada have issued, and continue to update, proclamations and directives aimed at minimizing the spread of the virus. These directives currently remain in effect and we are monitoring their status.

The ultimate impact of the COVID-19 pandemic on our operations is unknown and will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the COVID-19 pandemic, new information which may emerge concerning the severity of the COVID-19 pandemic, and any additional preventative and protective actions that governments, or we, may direct, which may result in an extended period of continued business disruption and reduced operations.

To date, our farm operations have not been materially affected by the pandemic, although we have made modifications to biosecurity procedures and our farm sites to adapt to local requirements and to provide a safe work environment. Our current preventative and protective measures include, but are not limited to, segregating farm workers to specific locations, rotating shifts, and monitoring worker temperatures upon arrival at our facilities. To the extent possible, work-from-home is utilized for eitheremployees that do not have fish care responsibilities.

We experienced delays in capital projects due to the pandemic, including a six-month delay in the completion of the processing facility at our Indiana farm, which did not become operational until November 2020. We utilized third party alternatives for fish processing during the delay. During Q1 2021, project delays were limited to extended lead-times on equipment purchases. However, we may experience delays on purchases of capital equipment and supplies and other materials required in our operations due to vendor shortages or we may be impacted by transportation or other supply chain disruptions to our partners or customers.

We have been primarily impacted by a reduction in the market price and demand for Atlantic salmon due to the pandemic’s impact on the food service sector. This had and continues to have a negative impact on our revenue and inventory value, as we are not yet an existing land-based RAS facility or a site on whichestablished vendor and customers have been reluctant to buildadd a new facilitysupplier during a period of depressed demand. Consequently, in December 2020, we made the decision to donate substantially all of our conventional salmon to local food charities, which continue to experience unprecedented need during the pandemic. This decision was made to ease the capacity constraints at our Indiana farm to provide space for our growing biomass of AquAdvantage salmon. The donation program commenced in February 2021 and is expected to be completed in May 2021, though we are exploring the possibility of continuing the donation program for fish that do not meet customer specifications.

We expect the financial impact of the pandemic to continue through at least the first half of 2021, as the industry waits for the commercial productionroll-out of AquAdvantage Salmon;COVID-19 vaccines and

we made our first sales of AquAdvantage Salmon from our farm site in Panama.
In addition, on June 22, 2017, we purchased certain assets the subsequent reopening of the aquaculture facilityfood service sector. Any financial impact beyond the near-term cannot be reasonably estimated at this time but may have a material adverse impact on our business, financial condition, and results of Bell Fish Company LLC, whichoperations in 2021.

We remain focused on maintaining a strong balance sheet, liquidity, and financial flexibility and continue to monitor developments as we intenddeal with the disruptions and uncertainties from a business and financial perspective relating to use to grow out our AquAdvantage Salmon for sale and consumption in the United States. The facility and related assets acquired from Bell Fish Company LLC provide one input into the Company's process for growing its product, and, accordingly, the purchase of the facility was accounted for as an asset purchase rather than the acquisition of a “business,” consistent with ASU 2017-01, “Business Combinations: Clarifying the Definition of a Business.”

COVID-19 pandemic.

Revenue

We currently generate product revenue through the sales of our conventional Atlantic salmon, salmon eggs, fry, and byproducts. We expect revenues in 2021 to include our AquAdvantage Salmon. Revenue is recognized whensalmon, but that our revenues will be modest and infrequent for at least the Company identifies the performance obligation in the contract, determines the transaction price, allocates the transaction price to the performance obligations, and recognizes revenue upon completionfirst half of the performance obligation. Sales orders contain a single deliverable, AquAdvantage Salmon,year until the U.S. economy begins to recover from the COVID-19 pandemic and revenue is recognized upon delivery. During June 2017, the Company completed its first salesfood service operations begin to return to

normal capacity. In the future, we believe that our revenue will depend upon the number of countries in which we have received regulatory approval for the sale of our products, the number and capacity of grow-out facilitiesfarms we have in operation and the market acceptance we achieve.

Cost of Products
Cost of products includes

Production Costs

Production costs include the labor and related costs to grow out our fish, including feed, oxygen, and other direct costs; an application of overhead; and the cost to process and ship our fishproducts to customers.

A portion of production costs are absorbed into inventory as fish in process to the extent that these costs do not exceed the net realizable value of the fish in process. The costs that are not absorbed into inventory, as well as any valuation reserves against inventory are classified as other production costs. As of March 31, 2021, we had forty-three employees engaged in production activities.

Sales and Marketing Expenses

Our sales and marketing expenses currently include personnel costs, travel, and consulting fees for market-related activities. As of September 30, 2017,March 31, 2021, we had three employeesone employee dedicated to sales and marketing.

We expect our sales and marketing expenses to increase as our production output and revenues grow.

Research and Development Expenses

As of September 30, 2017,March 31, 2021, we employed nineteenfifteen scientists and technicians at our facilities on Prince Edward Island to oversee our broodstock of AquAdvantage Salmon,salmon, as well as the lines of fish we maintain for research and development purposes. We recognize research and development expenses as they are incurred. Our research and development expenses consist primarily of:

salaries and related overhead expenses for personnel in research, development functions, and development functions;

brood-stock husbandry;

fees paid to contract research organizations Intrexon, and consultants who perform research for us;


11



costs related to laboratory supplies used in our research and development efforts;

and

costs related to the operation of our field trials; and

costs related to the grow-out of fish at the Panama site that are not capitalized in inventory.
trials.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related costs for employees in executive, corporate, and finance functions. Other significant general and administrative expenses include corporate governance and public market maintenance,company costs, regulatory compliance,affairs, rent and utilities, insurance, and legal services, along with the maintenance and repair costs for our Indiana facility.service. We had thirteenfifteen employees in our general and administrative group at September 30, 2017.

March 31, 2021.

Other Income (Expense)

Interest expense includes the interest on our outstanding loans.loans and amortization of debt issuance costs. Other income (expense) includes bank charges, fees, interest income, and interest income.

miscellaneous gains or losses on asset disposals.

Results of Operations

Comparison of the three months ended September 30, 2017,March 31, 2021, to the three months ended September 30, 2016.

March 31, 2020.

The following table summarizes our results of operations for the three months ended September 30, 2017March 31, 2021 and 2016,2020, together with the changes in those items in dollars and as a percentage (all dollar amounts in thousands):

Three Months Ended March 31,

Dollar

%

2021

2020

Change

Change

(unaudited)

Product revenue

$

74

$

7

67

957%

Operating expenses:

Product costs

1,555

842

713

85%

Sales and marketing

319

51

268

525%

Research and development

500

569

(69)

(12)%

General and administrative

1,785

1,637

148

9%

Operating loss

4,085

3,092

993

32%

Total other expense

74

18

56

311%

Net loss

$

4,159

$

3,110

1,049

34%

  
Three Months Ended
September 30,
 
Dollar
Change
 
%
Change
  2017 2016  
  (unaudited)    
Product revenue $
 $
 $
  %
         
Operating expenses:        
Product costs 
 
 
  %
Sales and marketing 196
 210
 (14) (7)%
Research and development 861
 975
 (114) (12)%
General and administrative 1,382
 824
 558
 68 %
Operating loss 2,439
 2,009
 430
 21 %
Total other (income) expense 7
 133
 (126) (95)%
Net loss $2,446
 $2,142
 $304
 14 %

Product Revenue

Product revenue for the three months ended March 31, 2021 consisted of conventional Atlantic salmon fry and eggs. Product revenue for the three months ended March 31, 2020 consisted of conventional Atlantic salmon fry.

Production Costs

Production costs for the three months ended March 31, 2021, were up from the corresponding period in 2020, due to production cost increases related to increasing fish biomass at the Indiana and Rollo Bay farms. Increases included headcount additions, feed costs and other direct supplies.

Sales and Marketing Expenses

Sales and marketing expenses for the three months ended September 30, 2017,March 31, 2021, were downup from the corresponding period in 20162020 due to lower travel and outside services costs. We expect thatan increase in promotional expenses related to marketing activities for our sales and marketing expenses will increase as we move forward with our commercialization planssalmon. Costs for AquAdvantage Salmon.

the current period also include a $174 thousand charge related to the donation program of conventional Atlantic salmon to local food charities.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2017,March 31, 2021, were slightly down from the corresponding period in 20162020 due to a reductiondecrease in outside contract research expenses and an allocation of cost to inventory, which were partiallyservice fees, partly offset by increased compensation, as we continuedpersonnel costs. During the current period, research activities included feed nutrition trials, discovery research in salmon immunology and work on a genome study to expand our internal research group. We expect that our research and development expenses will increase as we further develop our Rollo Bay farm site and as we continue to pursue regulatory approval for additional products.

identify genes associated with economically important traits in salmon.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2017,March 31, 2021, were up significantly versusfrom the corresponding period in 20162020 due to increasedan increase in outside consulting and advisory fees, partly offset by decreases in travel, legal fees, stock compensation charges higher professional fees, corporate taxes, and the costs for maintenance and repairs of our Indiana site, which were partially offset by a reduction in legal fees. We expect that our general and administrative expenses will continue to increase as we incur increased costs to comply with corporate governance and reporting and other requirements applicable to U.S. public companies.


12



personnel costs.

Total Other (Income) Expense

Total other (income) expense is comprised of interest on debt, bank charges, and interest income for the three months ended September 30, 2017,March 31, 2021, and interest on the convertible debt with Intrexon, interest on debt, bank charges, and interest income for the three months ended September 30, 2016.

Comparison of the nine months ended September 30, 2017, to the nine months ended September 30, 2016.
The following table summarizes our results of operations for the nine months ended September 30, 2017 and 2016, together with the changes in those items in dollars and as a percentage (all dollar amounts in thousands):
  
Nine Months Ended
September 30,
 
Dollar
Change
 
%
Change
  2017 2016  
  (unaudited)    
Product revenue $53
 $
 $53
  %
         
Operating expenses:        
Product costs 51
 
 51
  %
Sales and marketing 607
 650
 (43) (7)%
Research and development 2,517
 2,706
 (189) (7)%
General and administrative 3,453
 2,428
 1,025
 42 %
Operating loss 6,575
 5,784
 791
 14 %
Total other (income) expense 20
 241
 (221) (92)%
Net loss $6,595
 $6,025
 $570
 9 %
Product Revenue and Gross Margin
The first sales of AquAdvantage Salmon were recognized during the nine months ended September 30, 2017. Regulatory approval for the harvest and export of our fish from our Panama farm site was received during the current period, and a batch of fish was sold and shipped to customers in Canada.
Gross margin on product sales was $3 thousand, as the inventory had been previously valued at NRV on our balance sheet. We expect that sales of our fish will be infrequent and of small quantities until our Indiana and Rollo Bay facilities are operational and the fish in those facilities have matured, which is expected in the second half of 2019.
Sales and Marketing Expenses
Sales and marketing expenses for the nine months ended September 30, 2017, were down from the corresponding period in 2016 due to lower travel and outside service costs.
Research and Development Expenses
Research and development expenses for the nine months ended September 30, 2017, were down from the corresponding period in 2016 due to a reduction in outside contract research expenses and an allocation of cost to inventory, which were partly offset by an increase in compensation.
General and Administrative Expenses
General and administrative expenses for the nine months ended September 30, 2017, were significantly higher than the corresponding period in 2016 due to increased compensation charges and higher professional fees, corporate taxes, and the costs of maintenance and repair of the Indiana site, which were partially offset by a reduction in stock compensation charges and legal fees.
Total Other (Income) Expense
Total other (income) expense is comprised of interest on debt, bank charges, and interest income for the nine months ended September 30, 2017. Total other (income) expense is comprised of interest on the convertible debt with Intrexon, gains on asset disposals, bank charges, and interest income for the nine months ended September 30, 2016.
Liquidity and Capital Resources
Sources of Liquidity
We have incurred losses from operations since our inception in 1991, and, as of September 30, 2017, we had an accumulated deficit of $105.9 million. On February 22, 2016, we entered into a convertible debt facility with Intrexon (the

13



“Debt Facility”). Advances under the Debt Facility carried an interest rate of 10% per year and had a maturity date of March 1, 2017. The entire $10 million (plus accrued interest) under the Debt Facility was converted into 1,212,908 shares of AquaBounty common stock on December 16, 2016. On January 18, 2017, we completed a private placement of 2,421,073 shares of our common stock to Intrexon for proceeds of approximately $25 million. As of September 30, 2017, we had a cash balance of $4.7 million.
2020.

Cash Flows

The following table sets forth the significant sources and uses of cash for the periods set forth below (in thousands):

Three Months Ended March 31,

Dollar

%

2021

2020

Change

Change

(unaudited)

Net cash provided by (used in):

Operating activities

$

(4,518)

$

(2,935)

(1,583)

54%

Investing activities

(1,219)

422

(1,641)

(389)%

Financing activities

120,865

14,483

106,382

735%

Effect of exchange rate changes on cash

21

(19)

40

(211)%

Net increase in cash

$

115,149

$

11,951

103,198

864%

 
Nine Months Ended
September 30,
 
Years Ended
December 31,
 2017 2016 2016 2015 2014
 (unaudited)      
Net cash provided by (used in):         
Operating activities$(6,676) $(5,434) $(7,449) $(6,748) $(6,561)
Investing activities(17,235) (739) (1,074) (105) (152)
Financing activities25,250
 8,045
 10,541
 3,044
 10,024
Effect of exchange rate changes on cash54
 (2) (7) (41) (23)
Net increase (decrease) in cash$1,393
 $1,870
 $2,011
 $(3,850) $3,288

Cash Flows from Operating Activities

Net cash used in operating activities during the ninethree months ended September 30, 2017,March 31, 2021 was primarily comprised of our $6.6$4.2 million net loss, offset by non-cash depreciation and stock compensation charges of $223$552 thousand and increased by working capital uses of $303$911 thousand. Net cash used in operating activities during the ninethree months ended September 30, 2016,March 31, 2020 was primarily comprised of our $6.0$3.1 million net loss, offset by non-cash depreciation and stock compensation charges of $273553 thousand, and increased by working capital sourcesuses of $318$378 thousand.

Spending on operations increased duringdue to increases in production activities at our Rollo Bay and Indiana farm sites and outside consulting and advisory fees. Cash used by working capital increased in the current period and was due to compensation increases, maintenancean increase in inventory and repair costsreceivables and a decrease in accounts payable and accrued liabilities, offset by a decrease in prepaid expenses.

Cash Flows from Investing Activities

During the three months ended March 31, 2021, we used $1.2 million for renovations to our Indiana farm site, construction charges at our Rollo Bay farm site and renovations at our Fortune Bay hatchery, $41 thousand on deposits on equipment purchases, and $11 thousand on capitalized software. During the same period in 2020, we used $691 thousand for renovations to our Indiana farm site and higher charges for professional fees and corporate taxes. The increase in cash used by working capital in the current period was due to the establishment of inventory and an increase in prepaid expenses offset by an increase in accounts payable and accrued liabilities.

Cash Flows from Investing Activities
During the nine months ended September 30, 2017, we used $14.2 million for the purchase of certain assets of Bell Fish Company LLC and $3.0 million for construction charges at our Rollo Bay farm site. During the same period in 2016, we used $700 thousand for the purchase of certain assets of Atlantic Sea Smolt Ltd., $57 thousand for property and equipment purchases, and $6 thousand for patent charges. This wassite, offset by $24$98 thousand in proceeds from the sale of existing assets.
equipment and $1.0 million in net proceeds from a legal settlement.

Cash Flows from Financing Activities

During the ninethree months ended September 30, 2017,March 31, 2021, we received approximately $25.0$119.1 million in net proceeds from the issuance of our common stockCommon Shares in a private placement of shares, $257 thousand in proceeds from the issuance of term debt, and $28 thousand in proceedspublic offering, $1.6 million from the exercise of employee stock options.warrants, and $187 thousand from new debt. This was offset by $24$39 thousand in the repayment of debt. During the same period in 2016,2020, we received $7.5approximately $14.5 million in net proceeds from the issuance of convertible debt and $547 thousandCommon Shares in proceeds from the issuance of term debt.a public offering. This was offset by $2$39 thousand in the repayment of debt.

Future Capital Requirements

We

In February 2021, we completed an equity raise with net proceeds of $119.1 million and have evaluated$210.9 million of cash and cash equivalents as of March 31, 2021. While we have experienced net losses and negative cash flows from operations since inception, we believe that we have sufficient cash to meet our cash resources in view of our planned spendingrequirements for ongoing operations, capital expenditures, and working capital forat least the next twelve months and have determined that our current funds will be used byfrom the end of December 2017. We intend to devote a significant portion of our existing cash to our farm sites in Indiana and Rollo Bay and the continued investment in our research and development projects. We plan to seek additional financing in the form of debt or equity to fund our cash requirements.

We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:
the timing of additional regulatory approvals and permits for AquAdvantage Salmon, if any;
the cost to complete construction activities at our Rollo Bay site;

14



the cost to upgrade the equipment at our Indiana site; and
the timing of costs related to the FDA legal challenge.
filing date.

Until such time, if ever, as we can generate positive operating cash flows, we may finance our cash needs through a combination of equity offerings, debt financings, government or other third-party funding, strategic alliances, and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of holders of our common stock will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders of our common stock. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional funds through government or other third-party funding; marketing and distribution arrangements; or other collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or to grant licenses on terms that may not be favorable to us.

Management believes that the Company can continue as a going concern. Management’s assessment is based on its belief that the Company will be able to raise additional equity or debt to fund its requirements. Additionally, management could slow down spending to conserve the Company’s cash if there is a delay in obtaining new funding. Therefore, the accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. However, if

If we are unable to generate additional funds in the future through financings, sales of our products, government grants, loans, or from other sources or transactions, we will exhaust our resources and will be unable to maintain our currently planned operations. If we cannot continue as a going concern, our stockholders would likely lose most or all of their investment in us.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

Critical Accounting Policies and Estimates

This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our consolidated financial statements, which we have prepared in accordance with GAAP. The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions.

During

There have been no material changes to these estimates, or the ninepolicies related to them, during the three months ended September 30, 2017,March 31, 2021. For a full discussion of these estimates and policies, see “Critical Accounting Policies and Estimates” within “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the Company adopted the following critical accounting policy:year ended December 31, 2020.

Business Combinations: Clarifying the Definition

15


The Company has adopted ASU 2017-01, “Business Combinations: Clarifying the Definition of a Business.” The revised guidance changes the definition of a business to assist entities with evaluating whether a set of transferred assets and activities is a business. During the quarter ended June 30, 2017, the Company acquired certain assets of Bell Fish Company LLC in Albany, Indiana, for $14.2 million, including legal and other expenses incurred. Management concluded, based on its analysis of the assets acquired, that the facility and related assets would provide one input into the Company’s process for growing its product, and, accordingly, the acquisition was accounted for as an asset purchase.

Item 3.  Quantitative and Qualitative Disclosures About Market Risk

The following sections provide quantitative information on our exposure to interest rate risk and foreign currency exchange risk. We make use of sensitivity analyses, which are inherently limited in estimating actual losses in fair value that can occur from changes in market conditions.

Interest Rate Risk

Our primary exposure to market risk is interest rate risk associated with debt financing that we utilize from time to time to fund operations or specific projects. The interest on this debt is usually determined based on a fixed rate and is contractually set in advance. At September 30, 2017,March 31, 2021, and December 31, 2016,2020, we had $814 thousand and $527 thousand, respectively,$6.0 million in interest-bearing debt instruments on our consolidated balance sheet. All of our interest-bearing debt is at fixed rates.


15



rates, except for our loan with First Farmers Bank and Trust, which has a rate reset in July 2025.

Foreign Currency Exchange Risk

Our functional currency is the U.S. Dollar. The functional currency of our Canadian subsidiary is the Canadian Dollar, and the functional currency of our Panama, U.S., and Brazil subsidiaries is the U.S. Dollar. For the Canadian Subsidiary, assets and liabilities are translated at the exchange rates in effect at the balance sheet date, equity accounts are translated at the historical exchange rate, and the income statement accounts are translated at the average rate for each period during the year. Net translation gains or losses are adjusted directly to a separate component of other comprehensive loss within shareholders’ equity (deficit).

Item 4.  Controls and Procedures

Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Form 10-Q. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the quarter ended September 30, 2017,March 31, 2021, the Company’s disclosure controls and procedures are effective in recording, processing, summarizing, and reporting, on a timely basis, information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act and are effective in ensuring that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Management’s Report on

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(g) and 15d-15(f)) that occurred during the fiscal quarter covered by this report that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.



16




PART II. OTHER INFORMATION

Item 1.  Legal Proceedings

Lawsuit Against the FDA Approval of NADA

AquAdvantage Salmon

On March 30, 2016, a coalition of non-governmental organizations filed a complaint in the United States District Court for the Northern District of California against the FDA, the United States Fish and Wildlife Service, and related individuals for their roles in the approval of AquAdvantage Salmon.salmon. Subsequently, the Fish and Wildlife Service was dismissed from the case, and AquaBounty joined the case as an intervenor to protect AquaBounty’s interests. The coalition, including the CentreCenter for Food Safety and Friends of the Earth, claimsclaimed that the FDA had no statutory authority to regulate genetically modifiedbioengineered animals, and, if it did, that the agency failed to analyze and implement measures to mitigate ecological, environmental, and socioeconomic risks that could impact wild salmon and the environment, including the risk that AquAdvantage Salmonsalmon could escape and threaten endangered wild salmon stocks. This lawsuit is currentlyIn December 2019 the court found that FDA had authority/jurisdiction over genetically engineered animals, and in November 2020, the judge remanded the Environmental Assessment (the approval) to FDA on National Environmental Protection Act (NEPA) and Endangered Species Act (ESA) grounds. In December 2020, the plaintiffs filed a motion to alter or amend the judgment. In February 2021, the judge denied that motion. In April 2021, FDA/US Department of Justice filed a notice of appeal relating to several claims in the discovery phasecase, but subsequently withdrew the appeal, and the date to file appeals in the case has expired. The court decision from the Northern District of litigation.

California does not have a current business impact on AquaBounty’s egg production in Prince Edward Island, Canada, AquaBounty’s salmon production in Albany, Indiana or AquaBounty’s sales of its fish.

Other than as set forth above, we are not party to any legal proceedings the outcome of which, we believe, if determined adversely to us, would individually or in the aggregate have a material adverse effect on our future business, consolidated results of operations, cash flows, or financial position. We may, from time to time, be subject to legal proceedings and claims arising from the normal course of business activities.

Item 1A. Risk Factors

As disclosed in "Item“Item 1A. Risk Factors"Factors” in our Annual Report on Form 10-K for the year ended December 31, 2016,2020, which was filed on March 16, 2017,9, 2021, there are a number of risks and uncertaintiesfactors that may have a material effect on the operatingcould affect our business, financial condition, and results of our business and our financial condition. There are no material additional updates or changes to ouroperations. The following risk factors since the filing ofare either new or have changed materially from those set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, except for material changes2020. You should carefully review the risks described below and those described in our Annual Report on Form 10-K, including our consolidated financial statements and related notes, and in other reports we file with the Securities and Exchange Commission, in evaluating our business. We cannot assure you that any of the events discussed in the following risk factors:factors below will not occur. These risks could have a material and adverse impact on our business, results of operations, financial condition, or prospects. If that were to happen, the trading price of our common stock could decline, and you could lose all or part of your investment.

This Quarterly Report on Form 10-Q also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including the risks faced by us described below, elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K. See “Cautionary Note Regarding Forward-Looking Statements” for information relating to these forward-looking statements.

Risks Relating to our Business and Operations

We have a history of net losses and will likely incur future losses and may not achieve or maintain profitability.

In the period from incorporation to March 31, 2021, we have incurred cumulative net losses of approximately $153 million. These losses reflect our personnel, research and development, production and marketing costs. We have constructed a 250-metric-ton annual capacity production facility in Rollo Bay and in 2017 we acquired a facility in Indiana, which has undergone renovations to increase its annual capacity to 1,200 metric tons. We expect revenues to be modest and infrequent for at least the first half of 2021 until the U.S. economy begins to recover from the COVID-19 pandemic and food service operations begin to return to normal capacity. However, our ability to realize revenues and the timing thereof are not certain, and achieving revenues does not assure that we will become profitable.

We may need substantial additional capital in the future in order to fund our business plans.

To date we have not generated any profit and expect to incur losses for the foreseeable future and may never become profitable. Therefore, based on our current business plan, we may need to raise further funds. Any issuance of shares of our common stock could have an effect of depressing the market price of shares of our common stock through dilution of earnings per share or otherwise. The amount and timing of the expenditures needed to achieve our commercialization plans, including the construction

of four to five new, land-based RAS farms at a cost that could exceed $175 million each, will depend on numerous factors, some of which are outside our control. Changes in our plans could also result in the need for additional funds.

We may have to label our AquAdvantage Salmon at the retail level as containing a genetically modified organism, which could negatively impact consumer acceptance.

Until the recent passage of the National Sea Grant College Program Reauthorizationlimited success in July 2016, which contained the National Bioengineered Food Disclosure Standard, or Labeling Act, our AquAdvantage Salmon did not need to be labeled as containing a genetically modified organism, because it had been deemed to be “substantially equivalent” to the traditional product. However, because several states either passed or considered new laws specifying varying requirements for labeling products sold at the retail level that contain genetically modified ingredients, the United States Congress passed the Labeling Act to establish a national standard for package labeling for foods containing genetically modified ingredients. The United States Department of Agriculture has until July 2018 to implement this new law. In addition, a bill was introduced in the United States Senate in July 2017 that could, if it became law, require labeling specific to AquAdvantage Salmon, rather than applicable to all genetically modified foods. Labeling requirements could cause consumers to view the label as either a warning or as an indication that AquAdvantage Salmon is inferior to traditional Atlantic salmon, which could negatively impactgaining consumer acceptance of our product.
We may become subject to increasing regulation, changes in existing regulations,products.

There is an active and reviewvocal group of existing regulatory decisions.

Regulations pertainingopponents to genetically modified animals are still developingengineered products who wish to ban or restrict the technology and could change from their present state. In addition, new legislation could require newwho, at a minimum, hope to sway consumer perceptions and acceptance of this technology. Their efforts include regulatory frameworks, changes in existing regulation, or re-evaluation of prior regulatory decisions. For example, in July 2017, a bill was introduced in the United States Senate that could, if it became law, requirelegal challenges and labeling unique to AquAdvantage Salmon,campaigns for genetically engineered products, as well as re-examinationapplication of the environmental assessments used by the FDA’s 2015 approvalpressure to multiple channels of the NADA for AquAdvantage Salmon. Such legislatively imposed review ofdistribution including, but not limited to distributors, food service operators, and consumer retail outlets seeking a completed regulatory process could result in new restrictions on, or delays in, commercialization of our product in the United States. We could be subjectcommitment not to increasing or more onerous regulatory hurdles as we attempt to commercialize our product, which could require us to incur significant additional capital and operating expenditures and other costs in complying with these laws and regulations. Our regulatory burdenscarry genetically engineered Atlantic salmon. Consumer acceptance could also increasebe adversely affected if AquAdvantage Salmon are found, orsalmon were believed to grow to a larger final size than traditionalconventional Atlantic salmon. We may not be able to overcome the negative consumer perceptions that these organizations have instilled against our products.

Our business is affected by the quality and quantity of the salmon that we harvest.

We sell our products in a highly competitive market.  Our ability to successfully sell our products, and the price that we receive, is highly dependent on the quality of the salmon that we produce.  A number of factors can negatively affect the quality of the salmon that we sell, including the quality of our broodstock, water conditions in our farms, the food and additives consumed by our fish, population levels in the tanks, and the amount of time that it takes to bring a fish to harvest, including transportation and processing. We have experience operating RAS facilities and raising salmon, and while we actively monitor these factors using rigorous standard operating procedures, we cannot always ensure optimal growing conditions.  Although fish grown in RAS production systems are not subject to the disease and parasite issues that can affect salmon grown in ocean pens, there is the potential for organisms that are ubiquitous to freshwater environments to become pathogenic if the fish are subjected to stressful conditions or there is an issue with biomass management.

We maintain high standards for the quality of our product and if we determine that a harvest has not met such standards, we may be required to reduce our inventory and write down the value of the harvest to reflect net realizable value.  Sub-optimal conditions could lead to smaller harvests and or lower quality fish.  Conversely, if we experience better than expected growth rates, we may not be able to process and bring our fish to market in a timely manner, which may result in overcrowding that can cause negative health impacts and/or require culling our fish population. 

Further, if our salmon is perceived by the market to be of lower quality than other available sources of salmon or other fish, we may experience reduced demand for our product and may not be able to sell our products at the prices that we expect or at all. For example, we concluded 2020 with a conventional Atlantic salmon harvest that met our high standards for nutrition, taste and texture. However, unlike our AquAdvantage salmon, the conventional salmon did not achieve the same high level of color consistency, due in part to the maturity of the male population and the quality of the ingredients in the feed. We identified and successfully addressed the source of the color inconsistency in the conventional salmon, and our production plans call for only raising our all-female AquAdvantage salmon moving forward. However, we reduced the net realizable value of our conventional salmon to $0 as of December 31, 2020 as we decided to donate the entire conventional salmon biomass during the first and second quarters of 2021. As we continue to expand our operations and build new farms, we potentially may face additional challenges with maintaining the quality of our products.  We cannot guarantee that we will not face quality issues again in the future, any of which could cause damage to our reputation, and a loss of consumer confidence in our products, which could have a material adverse effect on our business results and the value of our brands.

In addition, we may be required to recall some of our products if they spoil, become contaminated, are tampered with or are mislabeled. A widespread product recall could result in significant losses due to the costs of a recall, the destruction of product inventory and lost sales due to the unavailability of product for a period of time. Such a product recall also could result in adverse publicity, damage to our reputation, and a loss of consumer confidence in our products, which could have a material adverse effect on our business results and the value of our brands.

Business, political, or economic disruptions or global health concerns, such as the COVID-19 pandemic, could seriously harm our current or planned business and increase our costs and expenses.

Broad-based business or economic disruptions, political instability, or global health concerns could adversely affect our current or planned production, sale, distribution, research and development, and expansion. For example, the COVID-19 pandemic has continued to spread, and the related adverse public health developments, including orders to shelter-in-place, travel restrictions, and mandated business closures, have adversely affected workforces, organizations, customers, economies, and financial markets globally, leading to an economic downturn and increased market volatility. It has also disrupted the normal operations of many businesses, including ours.

Global health concerns like the coronavirus pandemic could in themselves result in social, economic, and labor instability in the countries in which we or the third parties with whom we engage operate. The COVID-19 pandemic and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, including salmon in the institutional sales chain that includes restaurants, has fallen, with a resulting drop in the prices for those goods and services. We have been impacted by the reduction in food service demand for salmon due to the pandemic in the form of significantly lower than expected sales and a reduction in the value of our inventory. In response to the COVID-19 pandemic, we have provided our administrative employees with the option to work remotely, and we have limited the number of staff in any given area of our farm sites. We have also implemented policies and procedures at our farms to react to any outbreak of the virus.

As a result of the COVID-19 pandemic, we have and may continue to experience disruptions that could severely impact our business, including disruptions or restrictions on our ability to travel, obtain regulatory approvals from the FDA and other regulators, pursue partnerships and other business transactions, conduct production activities, and make shipments, as well as be impacted by the temporary closure of the facilities of suppliers. While we have taken steps to address the impact of the coronavirus on our operations, and we believe that our suppliers and potential customers continue to operate in the ordinary course in all material respects, we cannot presently predict the scope and severity of any additional business shutdowns or disruptions or the future impact on consumer demand. For example, we have been primarily impacted by a reduction in the market price and demand for Atlantic salmon due to the pandemic’s impact on the food service sector. This had and continues to have a negative impact on our revenue and inventory value. If we or any of the third parties with whom we engage, including suppliers, distributors, service providers, regulators, and overseas business partners, experience additional or continued shutdowns or other disruptions, or consumer demand remains materially reduced, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively impacted, our anticipated revenues could decrease, and our costs and expenses could rise as a result of our efforts to address such disruptions.

In addition, the trading prices for our common stock and the stock of other biotechnology and food companies have been highly volatile as a result of the COVID-19 pandemic. As a result, we may face difficulties raising capital through sales of our common stock or such sales may be on unfavorable terms. The COVID-19 pandemic continues to rapidly evolve, and the extent to which it may impact our business and planned programs will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease; the duration of the pandemic; travel restrictions and other actions to contain the pandemic or address its impact, such as social distancing and quarantines or lock-downs in the United States, Canada, and other countries; business closures or business disruptions; and the effectiveness of actions taken in the United States, Canada, and other countries to contain and address the disease.

Our term loan includes financial covenants that must be met, or our loan will be in default.

In 2020, we entered into a term loan agreement with First Farmers Bank and Trust in the amount of $4 million, which is secured by the assets of our Indiana subsidiary and a corporate guarantee. The agreement contains certain financial and non-financial covenants, which if not met, could result in a default event on the loan. In that event, we would be required to disclose the default in our public filings, which could have an adverse effect on the price of our common shares.

We or regulatory agencies approving of our products may be sued by non-governmental organizations and others who are opposed to the development or commercialization of genetically engineered products.

There are many organizations in the United States and elsewhere that are fundamentally opposed to the development of genetically engineered products. These groups have a history of bringing legal action against companies attempting to bring new biotechnology products to market. On December 23, 2013, an application was filed by two NGOs with the Canadian Federal Court seeking judicial review to declare invalid the decision by the Canadian Minister of the Environment to publish in the Canadian Gazette a Significant New Activity Notice (“SNAN”) with respect to AquAdvantage salmon. Though the Canadian Federal Court dismissed this challenge, the petitioners filed an appeal of the ruling, which was subsequently dismissed by the Canadian Federal Court of Appeal on October 21, 2016.

On March 30, 2016, a coalition of non-governmental organizations filed a complaint in the United States District Court for the Northern District of California against the FDA, the United States Fish and Wildlife Service, and related individuals for their roles in the approval of AquAdvantage salmon. Subsequently, the Fish and Wildlife Service was dismissed from the case, and AquaBounty joined the case as an intervenor to protect AquaBounty’s interests. The coalition, including the Center for Food Safety and Friends of the Earth, claims that the FDA had no statutory authority to regulate genetically engineered animals, and, if it did, that the agency failed to analyze and implement measures to mitigate ecological, environmental, and socioeconomic risks that could impact wild salmon and the environment, including the risk that AquAdvantage salmon could escape and threaten endangered wild salmon stocks. In December 2019 the court found that FDA had authority/jurisdiction over genetically engineered animals and in November 2020, the judge remanded the Environmental Assessment (the approval) to FDA on National Environmental Protection Act (NEPA) and

Endangered Species Act (ESA) grounds. In April 2021, FDA/US Department of Justice filed a notice of appeal relating to several claims in that case, and subsequently withdrew the appeal, and the date to file appeals in the case has expired. The court decision from the Northern District of California does not have a current business impact on AquaBounty’s egg production in Prince Edward Island, Canada, AquaBounty’s salmon production in Albany, Indiana, or AquaBounty’s sales of its fish.

The price of our shares of common stock is likely to be volatile.

The share price of publicly traded emerging companies can be highly volatile and subject to wide fluctuations. The prices at which our common stock is quoted and the prices which investors may realize will be influenced by a large number of factors, some specific to our company and operations and some that may affect the quoted land-based fish farming industry, the biotechnology sector, or quoted companies generally. These factors could include variations in our operating results, publicity regarding the process of obtaining regulatory approval to commercialize our products, divergence in financial results from analysts’ expectations, changes in earnings estimates by stock market analysts, overall market or sector sentiment, legislative changes in our sector, the performance of our research and development programs, large purchases or sales of our common stock, currency fluctuations, legislative changes in the bioengineering environment, future sales of our common stock or the perception that such sales could occur and general economic conditions. Certain of these events and factors are outside of our control. Stock markets have from time to time experienced severe price and volume fluctuations, which, if recurring, could adversely affect the market prices for our common stock.

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

None.

Item 3.  Defaults Upon Senior Securities

None.


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Item 4.  Mine Safety Disclosures

Not applicable.

Item 5.  Other Information

None.



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Item 6. Exhibits

EXHIBIT INDEX

Exhibit Number

Exhibit Description

Exhibit Number

31.1

Exhibit Description

31.2

32.1+

101.INS

XBRL instance document.

101.SCH

XBRL taxonomy extension schema document.

101.CAL

XBRL taxonomy extension calculation linkbase document.

101.LAB

XBRL taxonomy label linkbase document.

101.PRE

XBRL taxonomy extension presentation linkbase document.

101.DEF

XBRL taxonomy extension definition linkbase document.

104

Cover Page Interactive Data File-the cover page interactive data file does not appear in the Interactive Data File because the XBRL tags are embedded within the Inline XBRL document.


+ The certification furnished in Exhibit 32.1 hereto is deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. 


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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, thereunto duly authorized.

AQUABOUNTY TECHNOLOGIES, INC.

November 2, 2017

May 4, 2021

/s/ Ronald L. StotishSylvia Wulf

Ronald L. Stotish

Sylvia Wulf

President, Chief Executive Officer, and Director (Principal

(Principal Executive Officer)

November 2, 2017

May 4, 2021

/s/ David A. Frank

David A. Frank

Chief Financial Officer and Treasurer (Principal

(Principal Financial Officer and Principal Accounting Officer)


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