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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2020
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____________________ to
_____________________
Commission File Number: 001-36426
AquaBounty Technologies, Inc.
(Exact name of the registrant as specified in its
charter)
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Delaware |
04-3156167 |
(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)
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Title of each class |
Trading Symbol(s) |
Name of exchange on which registered |
Common Stock, par value $0.001 per share
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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 ☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T during the preceding 12
months (or such shorter period that the registrant was required to
submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, 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.
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Large accelerated filer |
☐ |
Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
Smaller reporting company |
☒ |
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Emerging growth company |
☒ |
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
At November 2, 2020, the registrant had 44,960,806 shares of
common stock, par value $0.001 per share (“Common Shares”)
outstanding.
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AquaBounty Technologies, Inc. |
FORM 10-Q |
For the Quarterly Period Ended September 30, 2020 |
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TABLE OF CONTENTS |
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Page |
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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 and the cost and 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 JOBS Act; and
•our
estimates regarding expenses, future revenue, capital requirements,
and needs for additional financing.
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.
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
AquaBounty Technologies, Inc.
Consolidated Balance Sheets
(Unaudited)
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As of |
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September 30, |
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December 31, |
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2020 |
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2019 |
Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
38,989,366 |
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$ |
2,798,744 |
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Other receivables |
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62,034 |
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55,198 |
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Inventory |
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2,869,470 |
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1,232,049 |
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Prepaid expenses and other current assets |
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820,193 |
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391,162 |
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Total current assets |
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42,741,063 |
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4,477,153 |
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Property, plant and equipment, net |
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25,699,143 |
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25,065,836 |
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Right of use assets, net |
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356,788 |
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399,477 |
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Definite-lived intangible assets, net |
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147,311 |
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157,588 |
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Indefinite-lived intangible assets |
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101,661 |
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101,661 |
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Restricted cash |
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500,000 |
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— |
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Other assets |
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50,213 |
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32,024 |
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Total assets |
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$ |
69,596,179 |
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$ |
30,233,739 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
2,116,877 |
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$ |
1,462,809 |
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Current lease liabilities and other |
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62,627 |
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62,286 |
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Current debt |
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152,501 |
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163,155 |
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Total current liabilities |
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2,332,005 |
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1,688,250 |
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Long-term lease obligations |
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306,174 |
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352,808 |
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Long-term debt, net |
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8,425,552 |
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4,432,052 |
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Total liabilities |
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11,063,731 |
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6,473,110 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Common stock, $0.001 par value, 50,000,000 shares
authorized;
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44,916,926 (2019: 21,635,365) shares outstanding
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44,917 |
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21,635 |
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Additional paid-in capital |
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201,402,983 |
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156,241,363 |
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Accumulated other comprehensive loss |
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(490,153) |
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(360,160) |
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Accumulated deficit |
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(142,425,299) |
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(132,142,209) |
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Total stockholders’ equity |
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58,532,448 |
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23,760,629 |
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Total liabilities and stockholders’ equity |
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$ |
69,596,179 |
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$ |
30,233,739 |
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See accompanying notes to these unaudited interim consolidated
financial statements.
AquaBounty Technologies, Inc.
Consolidated Statements of Operations and Comprehensive
Loss
(Unaudited)
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Three Months Ended
September 30, |
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Nine Months Ended
September 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Revenues |
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Product revenues |
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$ |
67,763 |
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$ |
— |
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$ |
77,466 |
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$ |
140,371 |
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|
Costs and expenses |
|
|
|
|
|
|
|
|
Production costs |
|
1,355,939 |
|
|
846,306 |
|
|
3,238,689 |
|
|
2,649,674 |
|
Sales and marketing |
|
143,646 |
|
|
206,256 |
|
|
331,868 |
|
|
381,637 |
|
Research and development |
|
458,462 |
|
|
446,582 |
|
|
1,662,879 |
|
|
1,923,512 |
|
General and administrative |
|
1,722,874 |
|
|
1,500,448 |
|
|
5,053,608 |
|
|
4,960,553 |
|
Total costs and expenses |
|
3,680,921 |
|
|
2,999,592 |
|
|
10,287,044 |
|
|
9,915,376 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(3,613,158) |
|
|
(2,999,592) |
|
|
(10,209,578) |
|
|
(9,775,005) |
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(38,335) |
|
|
(17,933) |
|
|
(73,527) |
|
|
(45,483) |
|
Other income (expense), net |
|
1,705 |
|
|
(697) |
|
|
15 |
|
|
11,603 |
|
Total other income (expense) |
|
(36,630) |
|
|
(18,630) |
|
|
(73,512) |
|
|
(33,880) |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,649,788) |
|
|
$ |
(3,018,222) |
|
|
$ |
(10,283,090) |
|
|
$ |
(9,808,885) |
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Foreign currency translation gain (loss) |
|
86,491 |
|
|
(38,892) |
|
|
(129,993) |
|
|
133,448 |
|
Total other comprehensive income (loss) |
|
86,491 |
|
|
(38,892) |
|
|
(129,993) |
|
|
133,448 |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(3,563,297) |
|
|
$ |
(3,057,114) |
|
|
$ |
(10,413,083) |
|
|
$ |
(9,675,437) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.09) |
|
|
$ |
(0.14) |
|
|
$ |
(0.31) |
|
|
$ |
(0.50) |
|
Weighted average number of Common Shares - |
|
|
|
|
|
|
|
|
basic and diluted |
|
38,911,054 |
|
|
21,604,072 |
|
|
32,756,074 |
|
|
19,556,607 |
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these unaudited interim consolidated
financial statements.
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, 2018
|
|
15,098,837 |
|
$ |
15,099 |
|
|
$ |
142,707,957 |
|
|
$ |
(574,186) |
|
|
$ |
(118,914,567) |
|
|
$ |
23,234,303 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
(2,763,932) |
|
|
(2,763,932) |
|
Other comprehensive income (loss)
|
|
|
|
|
|
|
|
87,552 |
|
|
|
|
87,552 |
|
Issuance of common stock, net
|
|
3,345,282 |
|
3345 |
|
6,606,310 |
|
|
|
|
|
6,609,655 |
|
Exercise of warrants
|
|
76,797 |
|
77 |
|
250,347 |
|
|
|
|
|
250,424 |
|
Share based compensation
|
|
176,561 |
|
|
176 |
|
|
138,322 |
|
|
|
|
|
138,498 |
|
Balance at March 31, 2019
|
|
18,697,477 |
|
$ |
18,697 |
|
|
$ |
149,702,936 |
|
|
$ |
(486,634) |
|
|
$ |
(121,678,499) |
|
|
$ |
27,556,500 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
(4,026,731) |
|
|
(4,026,731) |
|
Other comprehensive income (loss)
|
|
|
|
|
|
|
|
84,788 |
|
|
|
|
84,788 |
|
Issuance of common stock, net
|
|
2,901,078 |
|
2901 |
|
5,782,792 |
|
|
|
|
|
5,785,693 |
|
Share based compensation
|
|
|
|
|
|
318,218 |
|
|
|
|
|
318,218 |
|
Balance at June 30, 2019
|
|
21,598,555 |
|
$ |
21,598 |
|
|
$ |
155,803,946 |
|
|
$ |
(401,846) |
|
|
$ |
(125,705,230) |
|
|
$ |
29,718,468 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
$ |
(3,018,222) |
|
|
$ |
(3,018,222) |
|
Other comprehensive income (loss)
|
|
|
|
|
|
|
|
$ |
(38,892) |
|
|
|
|
$ |
(38,892) |
|
Exercise of warrants for common stock
|
|
6,767 |
|
$ |
7 |
|
|
$ |
21,986 |
|
|
|
|
|
|
$ |
21,993 |
|
Share based compensation
|
|
|
|
|
|
$ |
196,736 |
|
|
|
|
|
|
$ |
196,736 |
|
Balance at September 30, 2019 |
|
21,605,322 |
|
$ |
21,605 |
|
|
$ |
156,022,668 |
|
|
$ |
(440,738) |
|
|
$ |
(128,723,452) |
|
|
$ |
26,880,083 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
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 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
(3,523,684) |
|
|
(3,523,684) |
|
Other comprehensive income (loss)
|
|
|
|
|
|
|
|
165,501 |
|
|
|
|
165,501 |
|
Issuance of common stock, net
|
|
20,000 |
|
|
20 |
|
|
40,580 |
|
|
|
|
|
|
40,600 |
|
Share based compensation
|
|
|
|
|
|
103,891 |
|
|
|
|
|
103,891 |
|
Balance at June 30, 2020
|
|
32,105,684 |
|
$ |
32,106 |
|
|
$ |
171,102,440 |
|
|
$ |
(576,644) |
|
|
$ |
(138,775,511) |
|
|
$ |
31,782,391 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
$ |
(3,649,788) |
|
|
$ |
(3,649,788) |
|
Other comprehensive income (loss)
|
|
|
|
|
|
|
|
$ |
86,491 |
|
|
|
|
$ |
86,491 |
|
Issuance of common stock, net of expenses
|
|
12,650,000 |
|
$ |
12,650 |
|
|
$ |
29,701,947 |
|
|
|
|
|
|
$ |
29,714,597 |
|
Exercise of warrants for common stock
|
|
161,242 |
|
$ |
161 |
|
|
$ |
523,876 |
|
|
|
|
|
|
$ |
524,037 |
|
Share based compensation
|
|
|
|
|
|
$ |
74,720 |
|
|
|
|
|
|
$ |
74,720 |
|
Balance at September 30, 2020 |
|
44,916,926 |
|
$ |
44,917 |
|
|
$ |
201,402,983 |
|
|
$ |
(490,153) |
|
|
$ |
(142,425,299) |
|
|
$ |
58,532,448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these unaudited interim consolidated
financial statements.
AquaBounty Technologies, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
2020 |
|
2019 |
|
|
|
|
|
Operating activities |
|
|
|
|
Net loss |
|
$ |
(10,283,090) |
|
|
$ |
(9,808,885) |
|
Adjustment to reconcile net loss to net cash used in |
|
|
|
|
operating activities: |
|
|
|
|
Depreciation and amortization |
|
1,082,261 |
|
|
928,476 |
|
Share-based compensation |
|
383,964 |
|
|
653,452 |
|
Gain on disposal of equipment |
|
(1,816) |
|
|
(8,548) |
|
Other non-cash charges |
|
41,967 |
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
Other receivables |
|
(8,252) |
|
|
45,880 |
|
Inventory |
|
(1,638,981) |
|
|
(400,716) |
|
Prepaid expenses and other assets |
|
(527,913) |
|
|
(43,404) |
|
Accounts payable and accrued liabilities |
|
366,403 |
|
|
345,569 |
|
Net cash used in operating activities |
|
(10,585,457) |
|
|
(8,288,176) |
|
|
|
|
|
|
Investing activities |
|
|
|
|
Purchase of property, plant and equipment |
|
(2,640,039) |
|
|
(1,824,831) |
|
Proceeds from sale of equipment |
|
99,816 |
|
|
8,548 |
|
Proceeds from legal settlement, net |
|
1,014,008 |
|
|
— |
|
Other investing activities |
|
(18,900) |
|
|
12 |
|
Net cash used in investing activities |
|
(1,545,115) |
|
|
(1,816,271) |
|
|
|
|
|
|
Financing activities |
|
|
|
|
Proceeds from issuance of debt |
|
4,221,130 |
|
|
900,767 |
|
Payment of debt issuance costs |
|
(91,620) |
|
|
— |
|
Repayment of term debt |
|
(49,862) |
|
|
(57,001) |
|
Proceeds from the issuance of common stock, net |
|
44,236,301 |
|
|
12,395,348 |
|
Proceeds from the exercise of stock options and warrants,
net |
|
524,037 |
|
|
272,416 |
|
Net cash provided by financing activities |
|
48,839,986 |
|
|
13,511,530 |
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
(18,792) |
|
|
15,993 |
|
Net change in cash, cash equivalents and restricted
cash |
|
36,690,622 |
|
|
3,423,076 |
|
Cash, cash equivalents and restricted cash at beginning of
period |
|
2,798,744 |
|
|
3,002,557 |
|
Cash, cash equivalents and restricted cash at the end of
period |
|
$ |
39,489,366 |
|
|
$ |
6,425,633 |
|
|
|
|
|
|
Supplemental disclosure of cash flow information and |
|
|
|
|
non-cash transactions: |
|
|
|
|
Interest paid in cash |
|
$ |
47,275 |
|
|
$ |
45,483 |
|
Property and equipment included in accounts payable and accrued
liabilities |
|
$ |
517,344 |
|
|
$ |
119,541 |
|
See accompanying notes to these unaudited interim consolidated
financial statements.
AquaBounty Technologies, Inc.
Notes to the consolidated financial statements
For the nine months ended September 30, 2020 and 2019
(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-raised Atlantic salmon that exhibit
growth rates that are substantially faster than conventional
salmon.
In 2015, the Parent obtained approval from the US Food and Drug
Administration (the “FDA”) for the production, sale, and
consumption of its AquAdvantage salmon product in the United
States.
In 2016, the Parent obtained approval from Health Canada for the
sale and consumption of its AquAdvantage salmon product in Canada.
Previously, in 2013, the Parent obtained approval from Environment
Canada for the production of the product.
AQUA Bounty Canada Inc. (the “Canadian Subsidiary”) was
incorporated in January 1994 for the purpose of establishing a
commercial biotechnology laboratory to conduct research and
development programs related to the Parent’s 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 Parent’s products. Operations
at the site concluded in May 2019.
AquaBounty Farms, Inc. (the “U.S. Subsidiary”) was incorporated in
December 2014 in the State of Delaware for the purpose of
conducting field trials and commercializing the Parent’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 its
aquaculture facility in Albany, Indiana.
AquaBounty Brasil Participações Ltda. (the “Brazil Subsidiary”) was
incorporated in May 2015 for the purpose of conducting field
trials and commercializing the 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 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 intercompany 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, 2019. 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, 2020, 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.
Certain balances in the 2019 financial statements have been
reclassified to conform with the presentation of the 2020 unaudited
interim consolidated financial statements.
Liquidity Matters
The Company has experienced net losses and negative cash flows from
operations since its inception and has cumulative losses
attributable to common stockholders of $142.4 million as of
September 30, 2020. At September 30, 2020, the Company’s
cash balance totaled $39.5 million. Management has evaluated its
cash resources in view of its planned spending for on-going
operations, capital expenditures, and working capital and believes
that its current cash balance, along with the expected revenues
from its farms, will meet the Company’s cash requirements for at
least the next twelve months from the filing date, taking into
consideration the foreseeable financial impact of delays or other
events associated with the COVID-19 pandemic. Management also has
the discretion to reduce spending and delay capital projects if
necessary, in order to preserve cash. Until such time, if ever, as
the Company can generate positive operating cash flows, it may
finance its cash needs through a combination of equity offerings,
debt financings, government or other third-party funding, strategic
alliances, and licensing arrangements. The current COVID-19
pandemic has introduced uncertainty into the financial markets and,
as a result, future funding sources may be more difficult to
obtain, if at all.
Inventories
Inventories are mainly comprised of feed, eggs, fish in process and
packaging materials. Inventories are measured 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 and
transportation.
Fish in process inventory is a biological asset that is measured
based on the estimated biomass of fish on hand. The Company
has
established a standard procedure to estimate the biomass of fish on
hand using counting and sampling techniques.
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 contract; determining the transaction price;
allocating the transaction price to the performance obligations in
the contract; and recognizing revenue when (or as) the Company
satisfies a performance obligation. The Company evaluates customer
credit risk in order to 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
period. Basic net loss is based solely on the number of Common
Shares outstanding during the period. Fully diluted net loss per
share includes the number of Common Shares potentially issuable
upon the exercise of warrants and options with an exercise price
less than the fair value of the Common Shares. Since the Company is
reporting a net loss for all periods presented, all potential
Common Shares are considered anti-dilutive and are excluded from
the calculation of diluted net loss per share.
At September 30, 2020, the Company had 2,164,610 potentially
dilutive securities outstanding, consisting of 1,501,062 warrants
and 663,548 stock options.
Accounting Pronouncements
Management does not expect any recently issued, but not yet
effective, accounting standards to have a material effect on its
results of operations or financial condition.
3. Risks and uncertainties
In addition to the risks inherent in the Company’s industry and its
stage of commercialization, the impact of the COVID-19 pandemic
introduces a novel risk that is difficult to assess or predict. To
date, the Company’s farm operations have not been adversely
affected by the pandemic, although the Company has made
modifications to its biosecurity procedures and its farm sites to
adapt to local requirements and to provide a safe work
environment.
The Company has experienced delays in capital projects due to the
pandemic, including a delay in the completion of its processing
facility at the Indiana farm. The delay in the completion of this
project is expected to continue into the fourth quarter of 2020 and
the Company is therefore utilizing third party alternatives for
fish processing in the interim. The Company has also seen a
reduction in the market price for Atlantic salmon due to the
pandemic’s impact on demand in the food service sector. This has
had a negative impact on the Company’s revenue and inventory value
in the current quarter and is likely to continue for the
near-term.
Concentration of credit risk
Financial instruments that potentially subject the Company to
credit risk consist principally of cash, cash equivalents and
restricted cash. This risk is minimized by the Company’s policy of
investing in financial instruments with short-term maturities
issued by highly rated financial institutions. The Company’s cash,
cash equivalents and restricted 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
mitigated by the Company’s policy to limit the balances held in
these accounts. Balances in Canadian bank accounts totaled $133
thousand at September 30, 2020.
4. Inventory
Major classifications of inventory are summarized as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2020 |
|
2019 |
Feed |
|
$ |
221,300 |
|
|
$ |
251,778 |
|
Eggs and fry |
|
41,151 |
|
|
55,887 |
|
Packaging |
|
3,105 |
|
|
— |
|
Fish in process |
|
2,603,914 |
|
|
924,384 |
|
Total inventory |
|
$ |
2,869,470 |
|
|
$ |
1,232,049 |
|
5. Property, plant and equipment
Major classifications of property, plant and equipment are
summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2020 |
|
2019 |
Land |
|
$ |
711,073 |
|
|
$ |
718,586 |
|
Building and improvements |
|
13,717,243 |
|
13,297,489 |
Construction in process |
|
2,257,913 |
|
2,105,873 |
Equipment |
|
13,369,665 |
|
12,275,619 |
Office furniture and equipment |
|
200,862 |
|
201,813 |
Vehicles |
|
27,365 |
|
28,097 |
Total property and equipment |
|
$ |
30,284,121 |
|
|
$ |
28,627,477 |
|
Less accumulated depreciation and amortization |
|
(4,584,978) |
|
|
(3,561,641) |
|
Property, plant and equipment, net |
|
$ |
25,699,143 |
|
|
$ |
25,065,836 |
|
Included in construction in process is $1.9 million for
construction related to the Rollo Bay farm site. An additional $185
thousand has been committed.
Included in construction in process is $407 thousand for
construction related to the Indiana farm site. An additional $1.3
million has been committed.
In December 2019, the Company reclassified certain feed mill
equipment at the Indiana farm as held for sale, a component of
prepaid expenses and other current assets, and adjusted the
carrying value to fair value less estimated selling costs. During
the first quarter of 2020, the equipment was sold, resulting in
proceeds of $98 thousand. No gain or loss was recognized upon
the sale of the equipment.
In March 2020, the Company settled an outstanding legal claim
against a third party resulting in net proceeds of $1.0 million.
The proceeds received reduced the carrying value of the acquired
equipment. Depreciation on these items has been recalculated
prospectively over their remaining useful lives.
6. Accounts payable and accrued liabilities
Accounts payable and accrued liabilities include the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2020 |
|
2019 |
Accounts payable |
|
$ |
983,709 |
|
|
$ |
809,444 |
|
Accrued payroll including vacation |
|
414,228 |
|
|
236,489 |
Accrued professional fees and contract services |
|
295,272 |
|
|
346,349 |
Accrued construction costs |
|
277,268 |
|
|
— |
|
Accrued taxes and other |
|
146,400 |
|
|
70,527 |
Accounts payable and accrued liabilities |
|
$ |
2,116,877 |
|
|
$ |
1,462,809 |
|
7. Debt
The current material terms and conditions of debt outstanding are
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Original loan amount |
|
Interest
rate |
|
Monthly
repayment |
|
Maturity
date |
|
September 30, 2020 |
|
December 31, 2019 |
ACOA AIF grant (C$2,871,919)
|
|
0% |
|
Royalties |
|
- |
|
$ |
2,148,770 |
|
|
$ |
2,206,208 |
|
ACOA term loan (C$337,000)
|
|
0% |
|
C$3,120 |
|
June 2026 |
|
172,774 |
|
|
184,583 |
|
ACOA term loan (C$500,000)
|
|
0% |
|
C$4,630 |
|
November 2028 |
|
363,708 |
|
|
384,100 |
|
Kubota Canada Ltd. (C$95,961)
|
|
0% |
|
C$1,142 |
|
January 2025 |
|
44,446 |
|
|
53,533 |
|
Finance PEI term loan (C$2,717,093)
|
|
4% |
|
C$16,313 |
|
November 2023 |
|
1,938,608 |
|
|
1,766,783 |
|
First Farmers Bank &Trust ($4,000,000)
|
|
5.375% |
|
$56,832 |
|
October 2028 |
|
4,000,000 |
|
|
— |
|
Total debt |
|
|
|
|
|
|
|
$ |
8,668,306 |
|
|
$ |
4,595,207 |
|
less: debt issuance costs |
|
|
|
|
|
|
|
(90,253) |
|
|
— |
|
less: current portion |
|
|
|
|
|
|
|
(152,501) |
|
|
(163,155) |
|
Long-term debt |
|
|
|
|
|
|
|
$ |
8,425,552 |
|
|
$ |
4,432,052 |
|
Estimated principal payments remaining on loan debt are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year |
|
AIF |
|
ACOA |
|
FPEI |
|
Kubota |
|
FFBT |
|
Total |
2020 |
|
$ |
— |
|
|
$ |
17,396 |
|
|
$ |
17,982 |
|
|
$ |
2,564 |
|
|
$ |
— |
|
|
$ |
37,942 |
|
2021 |
|
— |
|
|
69,583 |
|
|
73,337 |
|
|
10,257 |
|
|
116,675 |
|
|
269,852 |
|
2022 |
|
— |
|
|
69,583 |
|
|
76,325 |
|
|
10,257 |
|
|
482,306 |
|
|
638,471 |
|
2023 |
|
— |
|
|
69,582 |
|
|
1,770,964 |
|
|
10,256 |
|
|
509,256 |
|
|
2,360,058 |
|
2024 |
|
— |
|
|
69,582 |
|
|
— |
|
|
10,257 |
|
|
537,276 |
|
|
617,115 |
|
Thereafter |
|
2,148,770 |
|
|
240,756 |
|
|
— |
|
|
855 |
|
|
2,354,487 |
|
|
4,744,868 |
|
Total |
|
$ |
2,148,770 |
|
|
$ |
536,482 |
|
|
$ |
1,938,608 |
|
|
$ |
44,446 |
|
|
$ |
4,000,000 |
|
|
$ |
8,668,306 |
|
In response to the COVID-19 pandemic, the Company was informed by
Atlantic Canada Opportunities Agency (ACOA) on March 19, 2020,
that all payments to the Canadian government would be deferred for
three months, commencing April 1, 2020. On June 15, 2020,
the Company was informed that payments would be deferred an
additional three months, recommencing October 1, 2020. On
October 14, 2020, the Company was informed that payments would
continue to be deferred until further notice. A revised loan
amortization schedule has not yet been received from
ACOA.
In 2018, the Canadian Subsidiary obtained a new loan from Finance
PEI (FPEI) in the amount of C$2.0 million ($1.5 million).
The loan has an interest rate of 4% and is collateralized by a
mortgage executed by the Canadian Subsidiary, which conveys a first
security interest in all of its current and acquired assets. On
March 24, 2020, the Company was informed by FPEI that all
payments would be deferred for three months due to the pandemic. On
April 23, 2020, the Canadian Subsidiary received the final
C$300 thousand ($221 thousand) of funds available under
the loan. Payments on the loan recommenced on August 1,
2020.
On July 31, 2020, the Company’s Indiana Subsidiary obtained a
$4.0 million loan from First Farmers Bank and Trust. Net
proceeds were $3.9 million after deducting $90 thousand
in loan settlement costs. The loan bears interest at a rate of
5.375% for the first five years. On July 31, 2025 the interest rate
resets to the then US Treasury 5-year maturities rate plus 5% and
remains fixed at that rate through maturity on October 1, 2028. The
note requires interest only payments for the first 13 months,
followed by monthly principal and interest payments of
approximately $57 thousand through maturity. Proceeds from the
loan may be used for the purpose of performing equipment upgrades,
purchasing equipment and other improvements to the Indiana farm.
The Company must comply with certain financial and non-financial
covenants. The loan is also subject to certain prepayment penalties
and is secured by the assets of the Indiana subsidiary and a
guarantee by the Parent. The loan agreement requires the Company to
maintain a $500 thousand minimum cash balance with the bank
throughout the loan term. This amount is reflected as restricted
cash on the balance sheet.
The Company recognized interest expense of $73 thousand and $44
thousand for the nine months ended September 30, 2020 and
2019, respectively, on its interest-bearing debt.
8. Leases
Lease expense for the nine months ended September 30, 2020 and
2019, amounted to $60 thousand and $102 thousand, respectively. The
weighted average remaining lease term of the Company’s operating
leases was 23 years as of September 30, 2020. Lease payments
included in operating cash flows totaled $63 thousand and $122
thousand for the nine months ended September 30, 2020 and
2019, respectively.
The table below summarizes the Company’s lease obligations and
remaining payments at September 30, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
Lease Type |
End Date |
Remaining Years |
Remaining Payments |
Lease Liability |
|
Remaining Payments |
Lease Liability |
Maynard Office Lease |
Operating |
Mar 2023 |
2.5 |
$ |
167,374 |
|
$ |
147,541 |
|
|
$ |
215,556 |
|
$ |
186,323 |
|
Indiana Auto Lease |
Operating |
Feb 2021 |
0.4 |
2,368 |
|
2,034 |
|
|
5,999 |
|
5,533 |
|
Indiana Well Lease |
Operating |
Dec 2048 |
28.3 |
690,691 |
|
219,226 |
|
|
702,341 |
|
223,238 |
|
Total leases |
|
|
|
$ |
860,433 |
|
$ |
368,801 |
|
|
$ |
923,896 |
|
$ |
415,094 |
|
Less: current portion |
|
|
|
(84,220) |
|
(62,627) |
|
|
(85,011) |
|
(62,286) |
|
Long-term leases |
|
|
|
$ |
776,213 |
|
$ |
306,174 |
|
|
$ |
838,885 |
|
$ |
352,808 |
|
Remaining payments under leases are as follows at
September 30, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year |
|
Office |
|
Auto |
Well |
Total |
2020 |
|
$ |
16,456 |
|
|
$ |
1,211 |
|
$ |
3,883 |
|
$ |
21,550 |
|
2021 |
|
66,416 |
|
|
1,157 |
|
15,998 |
|
83,571 |
|
2022 |
|
67,602 |
|
|
— |
|
16,478 |
|
84,080 |
|
2023 |
|
16,900 |
|
|
— |
|
16,972 |
|
33,872 |
|
2024 |
|
— |
|
|
— |
|
17,481 |
|
17,481 |
|
Thereafter |
|
— |
|
|
— |
|
619,879 |
|
619,879 |
|
Total Lease Payments |
|
$ |
167,374 |
|
|
$ |
2,368 |
|
$ |
690,691 |
|
$ |
860,433 |
|
9. Stockholders’ equity
Recent issuances
On February 12, 2020, the Company completed a public offering
of 10,350,000 Common Shares. Net proceeds to the Company were $14.5
million after deducting discounts, fees, and expenses. TS
Biotechnology Holdings, which is managed by Third Security and is
controlled by Randal J. Kirk, our largest shareholder, participated
in this offering, purchasing 5,175,000 Common Shares for a total of
approximately $7.8 million in gross proceeds.
On May 6, 2020, the Company issued 20,000 restricted common
shares to a consultant. The Company recorded a charge of
$41 thousand in conjunction with the share
issuance.
On August 7, 2020, the Company completed a public offering of
11,000,000 Common Shares. Net proceeds to the Company were
$25.8 million after deducting discounts, fees, and expenses.
TS Biotechnology Holdings, which is managed by Third Security and
is controlled by Randal J. Kirk, our largest shareholder,
participated in this offering, purchasing 4,000,000 Common Shares
for a total of approximately $10 million in gross
proceeds.
On August 17, 2020, the Company issued 1,650,000 Common Shares in
conjunction with the overallotment exercise by the underwriters in
the August 7, 2020 offering. Net proceeds to the Company were
$3.9 million after deducting discounts, fees, and
expenses.
Warrants
The following table summarizes information about outstanding
warrants at September 30, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
warrant shares |
|
Weighted average
exercise price |
Outstanding at December 31, 2019 |
|
1,662,304 |
|
|
$3.25 |
|
|
|
|
|
|
Exercised |
|
(161,242) |
|
|
3.25 |
|
|
|
|
|
Outstanding at September 30, 2020 |
|
1,501,062 |
|
$3.25 |
|
Exercisable at September 30, 2020 |
|
1,501,062 |
|
$3.25 |
|
During the nine months ended September 30, 2020, the Company issued
161,242 Common Shares at $3.25 per share in conjunction with the
exercise of warrants, with total proceeds of
$524 thousand.
Share-based compensation
At September 30, 2020, the Company has reserved 1,658,315 shares of
common stock issuable upon the exercise of outstanding stock
options and future issuances under its 2006 and 2016 Equity
Incentive Plans.
Restricted stock
A summary of the Company’s shares of restricted stock as of
September 30, 2020, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
Weighted
average grant
date fair value |
Balance at December 31, 2019 |
39,900 |
|
|
$2.31 |
|
Granted |
100,319 |
|
|
1.88 |
|
Vested |
(61,894) |
|
|
2.10 |
|
Balance at September 30, 2020 |
78,325 |
|
|
$1.92 |
|
During the nine months ended September 30, 2020 and 2019, the
Company expensed $160 thousand and $279 thousand, respectively,
related to the restricted stock awards. At September 30, 2020,
the balance of unearned share-based compensation to be expensed in
future periods related to the restricted stock awards is $121
thousand. The period over which the unearned share-based
compensation is expected to be earned is approximately 2.5
years.
Stock options
The Company’s option activity is summarized as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
options |
|
Weighted average
exercise price |
Outstanding at December 31, 2019 |
573,925 |
|
|
$4.94 |
|
Issued |
104,458 |
|
|
1.99 |
|
|
|
|
|
Expired |
(14,835) |
|
|
11.62 |
|
Outstanding at September 30, 2020 |
663,548 |
|
|
$4.33 |
|
Exercisable at September 30, 2020 |
587,738 |
|
|
$4.64 |
|
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 2020 were measured on the date of
grant using Black-Scholes, with the following weighted average
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 2020 |
|
March 2020 |
|
January 2020 |
|
|
Expected volatility |
|
104% |
|
102% |
|
101% |
|
|
Risk free interest rate |
|
0.31% |
|
0.66% |
|
1.67% |
|
|
Expected dividend yield |
|
0% |
|
0% |
|
0% |
|
|
Expected life (in years) |
|
5 |
|
5 |
|
5 |
|
|
The weighted average fair value of stock options granted during the
nine months ended September 30, 2020, was $1.49.
The total intrinsic value of all options outstanding was $1.2
million and $1 thousand at September 30, 2020, and
December 31, 2019, respectively. The total intrinsic value of
exercisable options was $1 million at September 30, 2020, and
$1 thousand at December 31, 2019, respectively.
The following table summarizes information about options
outstanding and exercisable at September 30,
2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
$1.88 - $2.50
|
|
531,519 |
|
|
8.5 |
|
455,709 |
|
|
|
$3.30 - $6.90
|
|
37,139 |
|
|
1.8 |
|
37,139 |
|
|
|
$7.50 - $10.80
|
|
21,303 |
|
|
3.6 |
|
21,303 |
|
|
|
$14.20 - $23.40
|
|
73,587 |
|
|
5.6 |
|
73,587 |
|
|
|
|
|
663,548 |
|
|
|
|
587,738 |
|
|
$4.64 |
Total share-based compensation on stock options amounted to $224
thousand and $374 thousand for the nine months ended
September 30, 2020 and 2019, respectively. At
September 30, 2020, the balance of unearned share-based
compensation to be
expensed in future periods related to unvested share-based awards
was $111 thousand. The period over which the unearned share-based
compensation is expected to be earned is approximately 2.7
years.
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.
See Note 5 for commitments related to our renovation and
construction costs.
There have been no other material changes to the commitments and
contingencies disclosed in our Annual Report on Form 10-K as
of and for the year ended December 31, 2019.
11. Subsequent Events
Department of Fisheries and Oceans Loan
The Canadian Subsidiary has been approved for a loan from the
Department of Fisheries and Oceans in Canada. The loan amount is
for C$1.9 million ($1.4 million), the interest rate is 0%
and monthly repayments of C$16,865 ($12,650) will commence in March
2023 for a term of 9.5 years. Proceeds will be used to complete
construction on the Canadian Subsidiary’s broodstock facility at
its Rollo Bay site.
Special Shareholder Meeting
The Company has filed a preliminary Proxy Statement for a special
Shareholder Meeting to seek approval for an increase in the number
of authorized shares of common stock from 50 million to
80 million shares. The Special Shareholder Meeting is to be
held on November 19, 2020.
Item 2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations
The following “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” should be read in conjunction
with the unaudited financial information and the notes thereto
included in this Quarterly Report on Form 10-Q and our Annual
Report on Form 10-K for the year ended December 31, 2019,
which was filed on March 10, 2020.
Overview
We believe that we are a leader in the field of land-based
aquaculture and the use of technology for improving its
productivity and sustainability. Our lead product is the
AquAdvantage salmon, which received FDA approval in 2015 as the
first bioengineered animal available for sale for human
consumption. We have commenced commercial activities with
operations in the United States and Canada where we have received
regulatory approval.
COVID-19
In March 2020, the World Health Organization declared the
outbreak of a novel coronavirus, SARS-CoV-2, as a pandemic, which
continues to spread throughout the United States and worldwide.
Because infections of this virus and incidences of the disease it
causes, COVID-19, have been reported throughout both the United
States and Canada, certain national, provincial, state, and local
governmental authorities have issued proclamations and directives
aimed at minimizing the spread of the virus. Additional, more
restrictive proclamations and directives may be issued in the
future.
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. 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
employees that do not have fish care responsibilities. Any
resulting financial impact cannot be reasonably estimated at this
time but may have a material adverse impact on our business,
financial condition, and results of operations.
To date, our farm operations have not been adversely 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.
We have experienced delays in capital projects due to the pandemic,
including a delay in the completion of the processing facility at
the Indiana farm. The delay in the completion of this project is
expected to continue into the fourth quarter of 2020 and we are
therefore utilizing third party alternatives for fish processing in
the interim. We have also seen a reduction in the market price for
Atlantic salmon due to the pandemic’s impact on demand in the food
service sector. This has had a negative impact on our revenue and
inventory value and is likely to continue for the
near-term.
We remain focused on maintaining a strong balance sheet, liquidity,
and financial flexibility and continue to monitor developments as
we deal with the disruptions and uncertainties from a business and
financial perspective relating to the COVID-19 pandemic. Management
expects that all of its operations, across all of its geographies,
will be impacted to some degree, but the significance of the impact
of the COVID-19 pandemic on our business and the duration for which
it may have an impact cannot be determined at this
time.
Revenue
We currently generate product revenue through the sales of our
conventional Atlantic salmon, salmon eggs, fry, and byproducts. We
expect that our sales will be modest and infrequent in the
near-term as we slowly build our sales and distribution supply
chain for our Indiana and Rollo Bay farm sites and as we deal with
the supply chain disruption from the COVID-19
pandemic.
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 AquAdvantage salmon, the number and capacity of
grow-out farms we have in operation, and the market acceptance we
achieve.
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
products 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. As our
farms in Indiana and Rollo Bay ramp up their production activity,
the costs that are not absorbed into inventory are classified as
other production costs. As of September 30, 2020, we had
forty-one employees engaged in production activities.
Sales and Marketing Expenses
Our sales and marketing expenses currently include consulting fees
for market-related activities. As of September 30, 2020, we
had no employees dedicated to sales and marketing.
Research and Development Expenses
As of September 30, 2020, we employed seventeen scientists and
technicians at our facilities on Prince Edward Island to oversee
our broodstock of AquAdvantage 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 brood-stock husbandry;
•fees
paid to contract research organizations and consultants who perform
research for us;
•costs
related to laboratory supplies used in our research and development
efforts; and
•costs
related to the operation of our field 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 company costs,
regulatory compliance, rent and utilities, insurance, and legal
service. We had thirteen employees in our general and
administrative group at September 30, 2020.
Other Income (Expense)
Interest expense includes the interest on our outstanding loans and
amortization of debt issuance costs. Other income (expense)
includes bank charges, fees, interest income, and miscellaneous
gains or losses on asset disposals.
Results of Operations
Comparison of the three months ended September 30, 2020, to
the three months ended September 30, 2019.
The following table summarizes our results of operations for the
three months ended September 30, 2020 and 2019, together with
the changes in those items in dollars and as a percentage (all
dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Dollar
Change |
|
%
Change |
|
|
2020 |
|
2019 |
|
|
|
|
(unaudited) |
|
|
|
|
Product revenue |
|
$ |
68 |
|
|
$ |
— |
|
|
$ |
68 |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Production costs |
|
1,356 |
|
|
846 |
|
|
510 |
|
|
60 |
% |
Sales and marketing |
|
144 |
|
|
206 |
|
|
(62) |
|
|
(30) |
% |
Research and development |
|
458 |
|
|
447 |
|
|
11 |
|
|
2 |
% |
General and administrative |
|
1,723 |
|
|
1,500 |
|
|
223 |
|
|
15 |
% |
Operating loss |
|
3,613 |
|
|
2,999 |
|
|
614 |
|
|
20 |
% |
Total other (income) expense |
|
37 |
|
|
19 |
|
|
18 |
|
|
95 |
% |
Net loss |
|
$ |
3,650 |
|
|
$ |
3,018 |
|
|
$ |
632 |
|
|
21 |
% |
Product Revenue
Product revenue for the three months ended September 30, 2020
consisted of conventional Atlantic salmon and eggs. There was no
product revenue for the three months ended September 30, 2019. We
expect our sales will be modest in the near-term as we build our
customer base while dealing with the production and market
disruption from the COVID-19 pandemic.
Production Costs
Production costs for the three months ended September 30,
2020, were up from the corresponding period in 2019, due to
production cost increases related to increasing fish biomass at the
Indiana and Rollo Bay farms as they continue their
ramp-up.
Costs for the current period also include a $403 thousand charge to
reduce the value of fish in process inventory at the Indiana farm
to reflect the reduction in the Net Realizable Value due to a
reduction in the market price and demand for conventional Atlantic
salmon.
Sales and Marketing Expenses
Sales and marketing expenses for the three months ended
September 30, 2020, were down from the corresponding period in
2019 due to a decrease in personnel, offset by an increase in
charges related to the commencement of marketing activities for our
salmon. We expect that our sales and marketing expenses will
increase as we increase sales of our fish.
Research and Development Expenses
Research and development expenses for the three months ended
September 30, 2020, were slightly up from the corresponding
period in 2019 due to increased personnel costs, offset by a
decrease in outside contract service fees. We expect that our
research and development expenses will increase as we expand our
broodstock capacity, commence new field trials, and continue to
pursue regulatory approval for additional products and additional
markets.
General and Administrative Expenses
General and administrative expenses for the three months ended
September 30, 2020, were up from the corresponding period in
2019 due to an increase in personnel associated compensation,
regulatory legal fees associated with the FDA legal challenge, and
corporate costs, offset by decreases in travel and stock
compensation charges. We expect that our general and administrative
expenses will fluctuate based on our legal fees associated with the
FDA legal challenge.
Total Other (Income) Expense
Total other (income) expense is comprised of interest on debt, bank
charges, gain on disposal of equipment and interest income for the
three months ended September 30, 2020, and interest on debt,
bank charges, and interest income for the three months ended
September 30, 2019.
Comparison of the nine months ended September 30, 2020, to the
nine months ended September 30, 2019.
The following table summarizes our results of operations for the
nine months ended September 30, 2020 and 2019, 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 |
|
|
2020 |
|
2019 |
|
|
|
|
(unaudited) |
|
|
|
|
Product revenue |
|
$ |
77 |
|
|
$ |
140 |
|
|
$ |
(63) |
|
|
(45) |
% |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Production costs |
|
3,239 |
|
|
2,650 |
|
|
589 |
|
|
22 |
% |
Sales and marketing |
|
332 |
|
|
382 |
|
|
(50) |
|
|
(13) |
% |
Research and development |
|
1,663 |
|
|
1,923 |
|
|
(260) |
|
|
(14) |
% |
General and administrative |
|
5,053 |
|
|
4,960 |
|
|
93 |
|
|
2 |
% |
Operating loss |
|
10,210 |
|
|
9,775 |
|
|
435 |
|
|
4 |
% |
Total other (income) expense |
|
74 |
|
|
34 |
|
|
40 |
|
|
118 |
% |
Net loss |
|
$ |
10,284 |
|
|
$ |
9,809 |
|
|
$ |
475 |
|
|
5 |
% |
Product Revenue
Product revenue for the nine months ended September 30, 2020
consisted of conventional Atlantic salmon, fry and eggs. For the
comparative period in 2019, revenue included the sale of
AquAdvantage salmon from our Panama demonstration
farm.
Production Costs
Production costs for the nine months ended September 30, 2020,
were up from the corresponding period in 2019, due to production
cost increases related to increasing fish biomass at the Indiana
and Rollo Bay farms as they continue their ramp-up.
Costs for the current period also include a $719 thousand charge to
reduce the value of the fish in process inventory at the Indiana
farm to reflect the reduction in the Net Realizable Value due to a
reduction in the market price and demand for Atlantic salmon due to
the impact of COVID-19 on the food service industry.
Sales and Marketing Expenses
Sales and marketing expenses for the nine months ended
September 30, 2020, were down from the corresponding period in
2019 due to a decrease in personnel cost, offset by an increase in
charges related to the commencement of marketing activities for our
salmon.
Research and Development Expenses
Research and development expenses for the nine months ended
September 30, 2020, were down from the corresponding period in
2019 due to lower field trial costs, primarily related to the
closing of our demonstration farm in Panama, and lower personnel
costs, offset by an increase in outside contract service
fees.
General and Administrative Expenses
General and administrative expenses for the nine months ended
September 30, 2020, were up slightly from the corresponding
period in 2019 due to an increase in personnel costs, regulatory
legal fees associated with the FDA legal challenge, and outside
consulting fees, offset by a decrease in travel and stock
compensation charges.
Total Other (Income) Expense
Total other (income) expense is comprised of interest on debt, bank
charges a gain on disposal of equipment and interest income for the
nine months ended September 30, 2020, and interest on debt,
bank charges, and interest income for the nine months ended
September 30, 2019.
Cash Flows
The following table sets forth the significant sources and uses of
cash for the periods set forth below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
2020 |
|
2019 |
|
(unaudited) |
Net cash provided by (used in): |
|
|
|
Operating activities |
$ |
(10,585) |
|
|
$ |
(8,288) |
|
Investing activities |
(1,545) |
|
|
(1,816) |
|
Financing activities |
48,840 |
|
|
13,511 |
|
Effect of exchange rate changes on cash |
(19) |
|
|
16 |
|
Net increase (decrease) in cash |
$ |
36,691 |
|
|
$ |
3,423 |
|
Cash Flows from Operating Activities
Net cash used in operating activities during the nine months ended
September 30, 2020, was primarily comprised of our $10.3
million net loss, offset by non-cash depreciation and stock
compensation charges of $1.5 million, and increased by working
capital uses of $1.8 million. Net cash used in operating activities
during the nine months ended September 30, 2019, was primarily
comprised of our $9.8 million net loss, offset by non-cash
depreciation and stock compensation charges of $1.6 million, and
increased by working capital uses of $61 thousand.
Spending on operations increased due to increases in production
activities at our Rollo Bay and Indiana farm sites, offset by lower
field trial costs related to our demonstration farm in Panama and
travel. Cash used by working capital increased in the current
period and was due primarily to an increase in inventory and
prepaid expenses, offset by an increase in accounts payable and
accrued liabilities.
Cash Flows from Investing Activities
During the nine months ended September 30, 2020, we used $2.6
million for renovations to our Indiana farm site and for
construction charges at our Rollo Bay site, offset by
$100 thousand in proceeds from the sale of equipment and
$1 million in net proceeds from a legal settlement. During the
same period in 2019, we used $1.8 million for renovations to our
Indiana farm site and for construction charges at our Rollo Bay
site, offset by $9 thousand in proceeds from the sale of
equipment.
Cash Flows from Financing Activities
During the nine months ended September 30, 2020, we received
approximately $44 million in net proceeds from the issuance of
Common Shares in two public offerings, $524 thousand from the
exercise of warrants, and $4.2 million from new debt. This was
offset by $50 thousand in the repayment of debt. During the
same period in 2019, we received approximately $12.4 million
in net proceeds from the issuance of Common Shares in a public
offering, $272 thousand from the exercise of warrants, and
$901 thousand from new debt. This was offset by
$57 thousand in the repayment of debt.
Future Capital Requirements
As discussed in Note 2 to the financial statements, the
Company has experienced net losses and negative cash flows from
operations since its inception and has cumulative losses
attributable to common stockholders of $142.4 million and a
cash balance of $39.5 million as of September 30, 2020.
Management believes its current cash balance, along with the
expected revenues from its farms will meet the Company’s cash
requirements for at least the next twelve months from the filing
date. Management also has the discretion to reduce spending and
delay capital projects if necessary, in order to preserve
cash.
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.
The current COVID-19 pandemic has introduced uncertainty and
volatility into the financial markets and as a result sources of
future funding may be more difficult to obtain, if at
all.
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.
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.
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, 2020, and December 31, 2019,
we had $5.8 million and $1.8 million, respectively, in
interest-bearing debt instruments on our consolidated balance
sheet. All of our interest-bearing debt is at fixed rates for the
next five years, at which point one outstanding loan will have a
one-time rate reset for the remainder of its term.
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, 2020, 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.
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.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Lawsuit Against the FDA Approval of 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. Subsequently, the
Fish and Wildlife Service was dismissed from the case, and we
joined the case as an intervenor to protect our interests. The
coalition, including the Center for Food Safety and Friends of the
Earth, claims that the FDA had no statutory authority to regulate
bioengineered 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. The
court issued an initial ruling that the FDA has statutory authority
to regulate bioengineered animals. The substantive briefing on the
specific challenge to the FDA’s approval of the original
AquAdvantage salmon NADA has been completed and oral arguments on
this part of the case concluded in August 2020. We are waiting for
a ruling from the court.
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 1A. Risk Factors” in our Annual Report on
Form 10-K for the year ended December 31, 2019, which was filed on
March 10, 2020, and our Quarterly Report on Form 10-Q, for the
quarter ended June 30, 2020, which was filed on August 6, 2020,
there are a number of risks and uncertainties that may have a
material effect on the operating results of our business and our
financial condition. The following risk factors are either new or
have changed materially from those set forth in our Annual Report
on Form 10-K for the year ended December 31, 2019. You should
carefully review the risks involved and those described in our
Annual Report on Form 10-K, our Quarterly Report on Form 10-Q for
the quarter ended June 30, 2020, and in other reports we file with
the Securities and Exchange Commission in evaluating our
business.
Risks Relating to our Business
Ethical, legal, and social concerns about bioengineered products
and perceived environmental impacts could lead to legal challenges,
limit or prevent the use of our products, and limit our
revenues.
Our technologies include the use of bioengineering. Public
perception about the safety and environmental hazards of, and
ethical concerns over, bioengineered products could influence
public acceptance of our technologies and products. Activist groups
opposing the bioengineering of organisms have in the past pressured
a number of retail food outlets and grocery chains to publicly
state that they will not carry bioengineered Atlantic salmon, and
they could file lawsuits to prevent the production and sale of our
products. If we are not able to overcome the ethical, legal, and
social concerns relating to bioengineering, products using our
technologies may not be accepted in the marketplace, and demand for
our products could fall short of what we expect. These concerns
could also result in increased expenses, regulatory scrutiny,
delays, or other impediments to implementation of our business
plan.
The subject of bioengineered products has received negative
publicity, which has aroused public debate. This adverse publicity
could lead to lawsuits against the production, distribution, and
sale of bioengineered products; greater regulation of those
products; and trade restrictions on their importation. Further,
there is a concern that products produced using our technologies
could be perceived to cause adverse events, which could also lead
to negative publicity.
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 may 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. 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 ability to generate revenue to support our operations depends
on maintaining regulatory approvals for AquAdvantage salmon and our
farm sites and obtaining new approvals for farm sites and the sale
of our products in other markets, the receipt of which is
uncertain.
As a bioengineered animal for human consumption, AquAdvantage
salmon required approval from the FDA in the United States and the
Ministers of Health and Environment in Canada before it could be
produced, sold, or consumed in those countries. Our FDA approval
covers the production of our eggs in our hatchery in Canada and the
grow-out of our eggs in our facilities in Indiana and Rollo Bay.
FDA approvals will be needed for each additional facility we plan
to operate. Additionally, we will require local regulatory
approvals in other countries in which we hope to operate. There is
no guarantee that we will receive or be able to maintain regulatory
approvals from the FDA or other regulatory bodies or that there
will not be a significant delay before approval. There is also no
guarantee that any approvals granted will not be subject to onerous
obligations in relation to matters such as production or labeling,
or that any regulator will not require additional data prior to
approval, which may be costly and time-consuming to
acquire.
The ability of the FDA to review and approve new products can be
affected by a variety of factors, including government budget and
funding levels and statutory, regulatory, and policy changes.
Average review times at the agency have fluctuated in recent years
as a result. In addition, government funding of other agencies on
which our operations may rely is subject to the political process,
which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the time
necessary for new applications to be reviewed and/or approved by
necessary government agencies, which would adversely affect our
business. For example, over the last several years the U.S.
government has shut down several times, and certain regulatory
agencies, such as the FDA, have had to furlough critical FDA and
other government employees and stop critical activities.
Separately, in response to the COVID-19 pandemic, on March 10,
2020, the FDA announced its intention to postpone most inspections
of foreign manufacturing facilities and products through
April 2020. On March 18, 2020, the FDA announced its
intention to temporarily postpone routine surveillance inspections
of domestic manufacturing facilities. Regulatory authorities
outside the United States may adopt similar restrictions or other
policy measures in response to the COVID-19 pandemic. If a
prolonged government shutdown occurs, it could significantly impact
the ability of the FDA to timely review and process our regulatory
submissions, which could have a material adverse effect on our
business. Future shutdowns could also affect other government
agencies, such as the SEC, which may also impact our business by
delaying review of our public filings, to the extent such review is
necessary, and our ability to access the public
markets.
Security breaches and other disruptions could compromise our
information, expose us to fraud or liability, or interrupt our
operations, which would cause our business and reputation to
suffer.
In the ordinary course of our business, we use our servers and
networks to store sensitive data, including our proprietary
business and financial information; general business information
regarding our customers, suppliers, and business partners; and
personally identifiable information of our employees. The secure
storage and maintenance of this information is critical to our
operations. Despite our security measures, our information
technology and infrastructure may be vulnerable to attacks by
hackers or breached due to employee error or malfeasance. A breach
of our security could compromise our networks, and the information
stored there could be
accessed, manipulated, publicly disclosed, lost, or stolen. Any
such access, manipulation, disclosure, or loss of information could
result in errors in our records, fraudulent use of our financial
information or theft of assets, legal claims or proceedings,
liability under laws that protect the privacy of personal
information, theft of our intellectual property, or damage to our
reputation. In addition, our systems could be the subject of denial
of service or other interference, which could disrupt our
operations and commercial transactions. Any of the foregoing could
adversely affect our business, revenues, and competitive
position.
If our technologies or products are stolen, misappropriated, or
reverse engineered, or we find it necessary to grant interests in
our technologies to third parties, others could use the
technologies to produce competing technologies or products or could
limit our ability to fully realize the value of those
technologies.
Third parties, including our collaborators, contractors, and others
involved in our business often have access to, and may require that
we grant interests in, our technologies. If our technologies or
products were stolen, misappropriated, or reverse engineered, or if
we are forced to grant broad interests in our technologies, they
could be used by other parties that may be able to reproduce our
technologies or products using our technologies for their own
commercial gain. If this were to occur, it would be difficult for
us to challenge this type of use, especially in countries with
limited intellectual property protection. In addition, third
parties granted interests in our technologies could seek to prevent
or limit our use or commercialization of those technologies based
on claims of partial ownership.
If we lose key personnel, including key management personnel, or
are unable to attract, train, and retain additional personnel, it
could delay our commercialization plans, limit our production
capacity, or harm our research and development efforts, and we may
be unable to sell or develop our own products.
Our success depends substantially on the efforts and abilities or
our officers and other key employees. The loss of any key members
of our management, or the failure to attract or retain other key
employees who possess the requisite expertise for the conduct of
our business, could prevent us from developing and commercializing
our products and executing on our business strategy. We may not be
able to attract or retain qualified employees in the future due to
the intense competition for qualified personnel among aquaculture,
biotechnology, and other technology-based businesses, or due to the
unavailability of personnel with the particular qualifications or
experience necessary for our business. For production positions,
effective training will be needed for new hires due to the overall
lack of industry experience in land-based aquaculture in North
America. If we are not able to attract, train, and retain the
necessary personnel to accomplish our business objectives, we may
experience staffing constraints that could adversely affect our
ability to meet the demands of our customers in a timely fashion,
adequately staff existing or new production facilities, or support
our internal research and development programs. In particular, our
production facilities require individuals experienced or trained in
RAS-based aquaculture, and our product development programs are
dependent on our ability to attract and retain highly skilled
scientists. Competition for experienced production staff,
scientists, and other technical personnel from numerous companies
and academic and other research institutions may limit our ability
to attract and retain such personnel on acceptable
terms.
A shutdown of or damage to any of our farms could result in our
prematurely harvesting fish, a loss of a material percentage of our
fish in production, a delay in our commercialization plans, and a
negative impact on our results of operations.
At present, we only have farms in Albany, Indiana, and Prince
Edward Island, Canada. As an interruption in the oxygen supply,
water quality systems, or other critical infrastructure of an
aquaculture facility for more than a short period of time can lead
to the loss of a large number of fish, any shutdown of or damage to
either of our farms—for example, due to natural disaster, reduction
in water supply, interruption in services beyond our backup
capacity, or human interference—could require us to prematurely
harvest some or all of the fish at that farm or could result in a
loss of a material percentage of our fish in production. Shutdown
or significant damage could also result in delays in our
commercialization plans, an inability to meet customer demand, an
increase in costs, and a negative impact on our results of
operations.
The successful development of our business depends on our ability
to efficiently and cost-effectively produce and sell salmon at
large commercial scale.
Although we have over two decades of experience in successfully
raising Atlantic salmon in land-based systems, we have only begun
to produce them at commercial scale. Our business plans depend on
our ability to increase our production capacity through the
development of larger farms. We have limited experience
constructing, ramping up, and managing such large, commercial-scale
facilities, and we may not have anticipated all of the factors that
could affect our production, harvest, sale, and delivery of salmon
at such a scale. For example, our salmon may not perform as
expected when raised at very large commercial scale, we may
encounter operational challenges for which we are unable to
identify a workable solution, control deficiencies may surface, our
vendors may experience capacity constraints, or our production cost
and timeline projections may prove to be inaccurate. Any of these
could decrease process efficiency, create delays, and increase our
costs. We are also subject to volatility in market demand and
prices, such as the disruption to the salmon market and the
resulting reduction in market prices for salmon caused by the
COVID-19 pandemic.
We remain dependent on third parties for the processing,
distribution, and sale of our products.
At present, we rely on third parties to process our fish, deliver
them to seafood vendors, and ultimately sell them to consumers.
While we carefully select processors or other intermediaries in the
supply chain, any failure on their part to maintain quality
standards or
proper food handling processes could subject us to product
liability claims, product recalls, increased scrutiny from
regulators, and loss of consumer confidence in the safety and
quality of our products. Seafood vendors may reject our products
due to their particular product or volume requirements, extract
pricing concessions that reduce our margins, or fail to adequately
promote and sell our products. Our reliance on third parties could
therefore result in a reduction in our revenues, an increase in our
costs, delays in commercialization, additional regulatory
requirements, or negative public opinion that could impact future
sales and growth.
Risks Relating to our Common Stock
The significant share ownership position of certain affiliates
allows them to influence corporate matters.
Based solely on a Schedule 13D/A filed on August 13, 2020, by
Randal J. Kirk; Third Security; TS AquaCulture LLC (“TS
AquaCulture”); and TS Biotechnology Holdings, LLC (“TS
Biotechnology”), TS AquaCulture owns 8,239,199 shares of our common
stock, or approximately 18.3% of our outstanding shares, and TS
Biotechnology owns 9,175,000 shares of our common stock, or
approximately 20.4% of our outstanding shares. In addition,
entities controlled by Mr. Kirk, including Third Security and its
affiliates other than TS AquaCulture and TS Biotechnology,
currently hold 837,554 shares of our common stock, or approximately
1.9% of our outstanding shares. TS AquaCulture and TS Biotechnology
are managed by Third Security, and TS AquaCulture is
successor-in-interest to Precigen under the Relationship Agreement.
See “Related-Party Transactions, Policies, and
Procedures-Relationship Agreement with TS AquaCulture.” Further,
Alana D. Czypinski, a member of the Company’s Board of Directors,
is married to Randal J. Kirk and has reported that she owns 3,249
shares of our common stock, which includes 1,090 shares of common
stock underlying outstanding stock options that are or will be
immediately exercisable within 60 days of September 30, 2020 in her
own name, which is less than one percent of our outstanding shares.
Based on these holdings, Mr. Kirk, Third Security’s Chief Executive
Officer and Senior Managing Director, and Ms. Czypinski have each
reported control over approximately 40.6% of our outstanding
shares. Mr. Kirk and Ms. Czypinski each disclaim beneficial
ownership of the shares owned directly by the other, and Ms.
Czypinski disclaims beneficial ownership of the shares deemed
beneficially owned by Mr. Kirk, other than those that she owns
directly.
Item 2. Unregistered Sales of Equity Securities and
Use of Proceeds
None.
Item 3. Defaults Upon Senior
Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
Item 6. Exhibits
EXHIBIT INDEX
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Exhibit Number |
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Exhibit Description |
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* Previously filed
† Schedules, exhibits, and similar supporting attachments or
agreements to the Loan and Security Agreement are omitted pursuant
to Item 601(a)(5) of Regulation S-K. The Registrant agrees to
furnish a supplemental copy of any omitted schedule or similar
attachment to the Securities and Exchange Commission upon
request.
+ 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.
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.
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AQUABOUNTY TECHNOLOGIES, INC.
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November 3, 2020 |
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/s/ Sylvia Wulf
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Sylvia Wulf
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President, Chief Executive Officer, and Director (Principal
Executive Officer) |
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November 3, 2020 |
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/s/ David A. Frank
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David A. Frank
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Chief Financial Officer and Treasurer (Principal Financial Officer
and Principal Accounting Officer) |